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VAERS: Adverse Events After Covid Vaccine

Id # Report Text Vax Date AE Date Age Sex
902464 within 15 minutes progressive light-headedness leading to near-syncope and diaphoresis.  After 20 minutes symptoms subsided. 12/15/2020 12/15/2020 42 M
902465 Pt felt wave come over body @ 1218 starting in head and going down. Bad taste in mouth, tingling in body ,  legs, back , across stomach, BP 150/100 P 120@ 1219, EMS activated. BP 120/80, P 80 Pt alert and oriented, Pt declined transport and Benadryl. Symptoms come and go, pt feels better but then bad taste in mouth starts, shaking of hands, tingling starts again in stomach and back. @ 1300 pt requests Benadryl, 25 mg administered. Pt notified family by phone of circumstances and family in transit.@1324 BP 120/80, P 84, tongue tingling and pt  reports smelling chemical smell. @1345 Pt complained of mouth itching, EMS activated and will transport to Medical Center.  Pt oriented and transported at @13 12/15/2020 12/15/2020 60 F
902524 I am a immunization nurse at this location.  I gave 2 of the first 4 Covid vaccinations given at our location.  Then I received dose # 5.  It was easy.  I did a couple of things and then returned to my desk.  As I sat down, my arm started feeling very heavy.  I was unable to send a text.  I told staff that I was feeling funny and that I was going to the other room to lay down.  Staff followed me and took my Pulse 100 and BP 164/ 82 (high for me!)  .  I felt shaky, but my hands were not shaking.  Put a wet cloth on my head and laid there a few minutes, telling staff stories and laughing at my BP.  When I sat up, my BP was 126/74 and pulse was 80.  I stood up for a minute or two, then my legs got heavy and I sat down for a few more minutes.  I went to the bathroom and came back to my desk, but was weak and tired.  I ate and drank some fluids.  Because it was snowing  and I live 25 miles away, I accepted a ride home from a co-worker.  I walked across the parking lot without problems and talked all the way home.  At home, I was tired, but had a sandwich and talked on the phone.  I would still describe myself as tired, but functioning. 12/15/2020 12/15/2020 59 F
902746 Following first dose, patient became hypotensive, pale, and diaphoretic. Denies syncope. Patient went to nearby emergency department at Hospital. Was monitored for several hours and was discharged in stable condition. 12/15/2020 12/15/2020 37 F
902768 Nausea, tremors, and decrease in HR.  Patient taken to ED.  No epinephrine injection administered. 12/16/2020 12/16/2020 42 F
902790 11 minutes after first dose of Covid Pfizer vaccine, patient became unresponsive, pale, diaphoretic with possible seizure activity. Patient dropped all belongings, leaned to the left side, with eyes rolling back in her head.  Episode lasted about a minute. Patient could not remember what had happened. Vitals were BP 110/60, HR 64, RR 22. Patient was advised to go to ED for further evaluation but she refused. Patient was given a snack and an RN stayed with her for about 20 more minutes to monitor. 12/16/2020 12/16/2020 31 F
902811 Associate received vaccine at 12:15 pm and was monitored for 15 minutes. After 15 minutes, associate went to check out table. While at check out table, associate fell to ground and was experiencing seizure like activity. Supportive treatment was administerd and associate was transferred to ED. 12/16/2020 12/16/2020 39 F
903014 Patient reported to CNA that they felt like they soiled their pants.  CNA confirmed that patient did not soil themself and transferred patient to the restroom. While the patient was on the toilet attempting to have a bowel movement the CNA reported patient had 10 seconds of tonic clonic behavior and then went unresponsive and then back to tonic clonic behavior.  This happened 3 times prior to getting patient put back into his bed.  Patient went unconscious after last episode while on bed for a more extended period of time while a STAT page was called.  Physical Therapist and Aid sternal rubbed him and he had gasp and woke up.  Prior to and immediately following the episode his vitals were within normal limits.  Neuro exam was unremarkable after patient came to.  When he woke up he knew his name, date, and day of the week.  He was only confused to where he was.  Patient was agreeable to be transported out.  EMS was called and transported the patient to Hospital.  Patient displayed no seizure activity or neurological deficits in ER.   Patient had a CT scan, which came back normal.  Virals remained within normal limits and laboratory values were noncontributory.  He was diagnosed with a UTI due to the presence of hematuria associated with a syncopal episode.  Patient had a Foley catheter upon admission to the nursing home.  Patient was administered Ceftriaxone at the hospital and discharged back to Nursing Home on Omnicef the same day.  Patient is back at nursing home facility and has not displayed any additional signs of seizure.  He is stable and Foley catheter has been removed.  Facility spoke to wife who reported that patient did not have a seizure history. 12/15/2020 12/16/2020 86 M
903016 Approximately 11 minutes after receiving the vaccine, the patient complained of shortness of breath, tingling in arms and hands, numbness and tingling in legs and feet, and was observably shaking, with no complaints of swelling in throat or other signs of anaphylaxis. Patient was brought to ER in same facility via stretcher and was examined by staff there. ER report states the patient presented with shortness of breath and what appeared to be a panic attack, with fast breathing, slight flushing, and shaking. Per ER report, the patient was treated for an acute anaphylactic reaction, with clear lungs and given an EpiPen shot in the right thigh. IV was initiated and given a fluid bolus, solu medrol, famotidine, and lorazepam. Labs and a chest x-ray done and reviewed. After treatment, patient found to be stable and was discharged home at 4:42 pm with orders for famotidine, albuterol inhaler, and epinephrine pen. 12/16/2020 12/16/2020 54 F
903030 ~30 minutes after vaccination, patient reported lightheadedness, difficulty swallowing, SOB, feeling flushed, pallor, bilateral arm tingling, brief chest pain and tremors. Symptoms lasted approximately 30 minutes and then resolved. Benadryl given after resolution of acute symptoms. Reported a metallic taste in her mouth immediately after receiving the COVID vaccine (dose #1). Had uneventful 15 minute recovery period immediately after vaccination. 12/16/2020 12/16/2020 54 F
903167 Began to feel weak, felt as though going to faint, became cool and clammy, BP 100/70 P 46, O2 Sat 100% on room air, no loss of consciousness.  Taken to ED - noted patient did not eat prior to getting the vaccine 12/16/2020 12/16/2020 43 F
903271 About 20 minutes after the injection, the arm i received the injection in became very cold, changed color like I was not perfusion to the limb. This was gone in about two hours. Woke up eye lid continually twitching. 12/17/2020 12/17/2020 31 F
903332 seizure approximately 24 hours after vaccination 12/17/2020 12/18/2020 51 M
903338 5-10 minutes after vaccination, vasovagal syncope: pallor, diaphoresis,  dizziness, tunnel vision, nausea, weakness, tingling in arms/legs, BP 103/69 12/17/2020 12/17/2020 30 F
903407 Patient with a h/o syncope to vaccines, felt light headed and laid down on floor roughly 3-5 minutes after vaccination in the observation area.  Patient pale, pulse regular in mid-60's, A&O x3, conversant.  Medical assistance team called, bp 94/60, lightheaded after attempt at standing for 90 seconds.  Transported to ED for observation. 12/18/2020 12/18/2020 29 F
903510 PATIENT fainted AT WORK THE DAY FOLLOWING HER VACCINE. BLOOD SUGAR AND VITALS WE'RE CHECKED FOLLOWING THE FAINTING SPELL AND WERE IN NORMAL RANGE. SHE WAS passed out FOR "A FEW MINUTES" PER WITNESSES AND WRITTEN REPORT. SHE SLEPT WELL THE NIGHT BEFORE.  SHE WAS UNINJURED AS A COWORKER CAUGHT HER. AFTER HER VITALS WE'RE CHECKED SHE FELT WELL AND RETURNED TO WORK AND WORKED THE ENTIRE REST OF HER SHIFT WITHOUT INCEIDENT OR COMPLAINT. 12/16/2020 12/17/2020 24 F
903519 Chills, low grade fever, body aches, injection site muscle spasm, burning sensation in the chest 12/17/2020 12/17/2020 52 F
903540 After the patient received Covid vaccine, she started experiencing itching.  The nurse monitoring the patient noticed she was scratching.  The patient continued to itch during the 15 minute observations period but no other adverse effects were noticed.  The observation period was extended to 30 minutes and then the patient was released.  An hour after she left the vaccination site she experienced an episode of vomiting which resolved.  Her husband noticed her to be pale upon returning home.  Later that night the patient was visibly shaking and had another episode of vomiting.  All symptoms have since resolved. 12/16/2020 12/16/2020 49 F
903569 within 5 min, pt reported feeling dizzy and lightheaded. No loss of consciousness. Pt also reports  having eaten  M and Ms as only food today. Pt happened to have a pulse ox on self (is an RT). SaO2 96% on room air, pulse 94. Pt given some trail mix and water and began to feel better. Upon standing pt reported not feeling well again and returned to seated. Pt then began with jerky muscular movements of upper extremities and stuttered speech. Pt states that this is how her PNES presents.  No loss of mentation or consciousness. EMT team called for transfer to ER. Pt alert and oriented on transfer 12/18/2020 12/18/2020 48 F
903762 PT RECEIVED COVID VACCINE. WAITED THE REQUIRED 15 MIN OBSERVATION TIME. AFTER THE 15 MINUTES PT STATED  SHE NOTICED SOME LIP SWELLING AND THROAT TIGHTNESS. PATIENT ALERTED STAFF. PT ASSISTED TO SITTING POSITION. PT REFUSED TO LAY DOWN. BP AT 1233 WAS 160/102 HR 99. PT VISABLLY shaking. PT STATED NO DIFFICULTY BREATHING. PT ADMINISTERED 25MG IM BENADRYL PER EMERGENCY ORDERS AT 1235. BP BP AT 1238 WAS 150/91 HR 80 SAT 96. CALLED TO PATIENT. NO INCREASED SYMPTOMS. PT WAS TOLD TO STAY TO BE MONITORED FOR FEW HOURS. RECHECKED PT AFTER 15 BP 151/76 HR 90 O2 100% ON RA. AT TIME OF THIS ENTRY PATIENT NO LONGER COMPLAINS OF FURTHER SYMPTOMS AND IS IMPROVING. 12/18/2020 12/18/2020 48 F
903769 5 minutes after receiving vaccine I felt like I was going to pass out. They took me to the ER. Heart rate went up to 160 at one point. Was given steroids, Benadryl, and Pepcid and that helped. This helped and then heart rate went up again. tremors and BP was up. 12/17/2020 12/17/2020 26 F
903785 12/16/2020 five hours after the injection  Pain at the injection site no redness or swelling, intense soreness, shortly after severe chills, shaking, without fevers, myalgia every muscle in my body was sore and heavy feeling and was difficult for me to walk or move and had to hold on to things to walk, intense fatigue I should not have tried to work and 36 hours later I felt better, I never felt hot and this morning 12/18/2020 I felt recovered 90% with mild lower extremity pain 12/16/2020 12/16/2020 41 F
903827 Head felt like she was swimming, headache, heaviness in chest, lump in throat, BP spiked then dropped, fainted - was given benadryl by mouth and Solumedrol IM 12/17/2020 12/17/2020 49 F
903864 carpopedal spasm of both hands immediately following receipt of vaccine 12/18/2020 12/18/2020 38 F
903876 Within half hour of receiving COVID vaccine, patient developed headache, then began feeling lightheaded and began pale. Attempted to lay down, upon standing felt lightheaded and noted some numbness around her lips, arms, and legs. Symptoms include faintness, near syncope, and numbness. After about 10-15 minutes of not feeling well, patient was escorted to the Emergency Room. Patient received fluids and was discharged home. Patient reports at 5pm that she continues to have slight headache and arm soreness with no further near syncopal episodes. 12/18/2020 12/18/2020 32 F
904052 nausea, elevated blood pressure, syncopal episode x3, ?? seizure 12/18/2020 12/18/2020 41 F
904082 was in waiting area and about 10 min after vaccine said she got tachycardiac and checked her heart rate on the apple watch and it was 140.  She felt tunnel vision also   did not alert staff in waiting area as did not want to call attention to herself.  Symptoms subsided after 1-2 minutes.  said she would have passed out if she stood up at the time.  Went back to work and told coworker.  Vaccine clinic staff called her this am and she is fine- no further symptoms. 12/18/2020 12/18/2020 36 F
904158 I started having chills before bed 12 hours after receiving vaccine. I woke up late morning (now 24 hours later)with a terrible migraine and continued to have chills. I went to the bathroom after I woke up and felt very nauseated and sick. I then started seeing black dots and felt very dizzy. Soon after my vision went completely black for what seemed to be about 5 min. I was shaking, having difficulty breathing and fell to the ground. My fiancé called 911 and an ambulance was on its way. The EMTs showed up and took my vitals. At this point I was able to see again and was sitting down. My blood sugar was normal along with my oxygen stats. My blood pressure was low while sitting and standing.  I was starting to feel better and didn?t end up going to the hospital. I continue to have chills, body aches and a headache but so far no more blackening out episodes. It was the scariest experience  of my life! 12/18/2020 12/19/2020 29 F
904189 Patient began to feel lighththeaded and "woozy" about 20 minutes after injection.  No loss of consciousness, BP 118/78, HR regular, color pink, began to complain of "sore" on one side of throat, began clearing her throat frequently, 12/19/2020 12/19/2020 29 F
904215 brief lightheadedness  Pt arrived at observation area at 1500. Was informed she has a history of allergies in teh past so instructed patient to wait or 30 minutes in observation area. Around 1505, pt stated she was feeling lightheaded, near syncope. Advised pt to lay on ground. Vitals taken - BP 140s/90s, with HR 118, pulse ox 100%. After 5 min, pt stated she was feeling better while laying down. At 1515, vitals retaken with BP 120s/80s HR 90s. At 1520, pt sat up from floor still feeling better. At 1525 pt sat in chair feeling better and at 1530 pt stated feeling no side effects. 12/19/2020 12/19/2020 33 F
904329 Vaccination given at 12:50  12:54?started feeling lightheaded.  Sitting in chair in observation waiting area.   RN present in observation area.   12:55? feeling not right. Water given. Feeling nauseated.   1302?unable to hear BP via manual cuff in chair times 2   Lowered to floor and feet elevated   1305 ?88/54, 60 HR still nauseated and lightheaded.   1309?911 called   13:10?felt she was improving. Nausea better. 104/66, 68  13:12?110/68 HR 68 13:15?felling better. Sat up on floor. 98/50, 88 13:18?EMS arrived. BS 98. BP 112/72 Refused to go to ER by ambulance. Medics left.  13:25? RN and RN assisted patient to wheelchair.  After talking with patient she did agree to going to ER to be seen by physician.  Wheeled to ER and care assumed by ER team.   Patient never lost consciousness and never had change in mentation. She always maintained conversation and orientation. She states didn?t feel sick enough to go to ER.    Patient was discharged from ER to home. 12/19/2020 12/19/2020 40 F
904359 Within 5 minutes, started feeling very tired and dizzy, leaned head back trying to relax.  Approximately 15 minutes after vaccine had seizure lasting up to 15 seconds possibly.  Brought to floor carefully.  Then had small second seizure (about 5 seconds in duration).  Difficulty Breathing immediately.  Then extreme trouble breathing/stopped breathing , given 0.3 mg EpiPen in right thigh, gasped and began breathing again.  Checked pulse (80 b/pm) then waited about 3 minutes and EMTs arrived.  BP was 140/90 ish.  Both higher but not terribly high. 12/19/2020 12/19/2020 19 M
904374 Severe arm pain x2 days - injected in shoulder not deltoid Sudden onset of chills, severe shaking, shortness of breath, 02 sat = 89% that lasted 15 minutes (took Tylenol 1000 mg immediately).  This occurred about 1.5 days after injection 12/16/2020 12/18/2020 59 F
904385 Patient is a pleasant 83 y.o. female pediatrician with history of Sjogren's, hypothyroidism, hyperlipidemia, hypertension who had been at Hospital to get her Covid vaccine.  30 minutes after doing so she reports being in the lobby and about to walk upstairs and feeling fine. The next thing she knows she wakes up on the stairs with her nose and face bleeding surrounded by healthcare team. She denies any precipitating symptoms such as chest pain, shortness of breath, fevers dizziness, headache.  She reports feeling well otherwise in the last few days.  I did a thorough bony palpation exam including spine and he only point of tenderness besides on her face was the area above her right ankle. She does not have a history of syncope or collapse 12/16/2020 12/16/2020 83 F
904389 Employee reported chills, shaking, dizziness "like you feel after you faint, spacey". 12/19/2020 12/19/2020 32 F
904495 Patient with symptoms of severe myalgias, low back spasms, fevers, chills, headache, SOB since Saturday.  Treatment included intravenous fluids, Tylenol, magnesium repletion, frequent reassessments, infectious disease consultation in the Emergency room. 12/17/2020 12/19/2020 57 M
904534 About two to three minutes after the Covid vaccine was administered in the vaccine clinic at my hospital where I work, I began to experience pre-syncopal symptoms (mostly light-headedness and nausea). I stood up to get help and walked to the back of the auditorium where they were observing us for 15 minutes post-vaccine, and due to standing and walking, I became much more dizzy and lightheaded and then  sat down on the floor and was eased to a lying-down position on the floor by a nurse as I briefly lost consciousness. I regained consciousness very quickly (maybe 10-20 seconds, but I'm not sure) and was taken care of by a set of nurses who noted me to be hypotensive and pale, with I think a bit of a lower heart rate, though I'm not sure what my vitals were exactly. They had me then stand to do orthostatic vitals and I was orthostatic. I was too dizzy to remain standing and felt very nauseas so I was taken to the ED (in the hospital where I work) to be observed. I had a normal EKG, blood glucose, and urine sample there. After having some juice and lying down, I felt better but was very cold and had some chills. After a little over an hour, they released me from the ED and it seems to have all been an episode of vaso-vagal syncope. I've had vaso-vagal responses before, but not in response to a vaccine since I was about 13, so I was surprised by how quick and severe the vaso vagal response was.  Later in the day, I felt better but was fatigued and had a headache. I also had a lot of pain at the injection site. The day after the vaccine I felt tired and had a headache, and for part of the day a mild sore throat. Now two days after the vaccine, I feel much better, and the arm pain is more mild. 12/18/2020 12/18/2020 29 F
904555 I had no reaction following the vaccination.  The next day I had very mild soreness at the injection site. The next morning (about 36 hours after the vaccination) I woke up with fatigue and a sore throat.  I had breakfast and about 10 minutes later I vomited everything (projectile vomiting, no nausea or abdominal pain). An hour later I had episode of severe watery diarrhea (just one episode).  Felt very weak so I decided to sit down, stumbled to a chair, and then proceeded to have a syncopal episode with about 4 minutes of seizure like activity (witnessed, I don't remember that part).  Decided to go to the ER, where I had labs, EKG, CXR, head CT scan, MRI and EEG.  I was admitted for 24 hour observation, all the tests were normal. 12/15/2020 12/17/2020 63 M
904585 About 3-5 min after injection I felt tingling and warmth/flushing in my entire left arm and anterior chest, upper back and achy pain in my left upper trap- felt like a warm IV running through my arm. Associated with tongue tingling. Symptoms lasted about 10 minutes with the exception of the achy upper trap pain which lasted a couple hours - being a health care provider I associated these symptoms with anxiety/excitement about receiving the vaccine but subsequently developed other unexpected symptoms. Over the course of the next several hours noted metallic taste and transient extremity tingling (all extremities) also with some extremity and facial itching - no rash. Now >24 hours after still have the intermittent and transient extremity tingling (most notable in LE's and feet, but also in arms) and skin itchiness/prickly sensation though improved. Had one episode this afternoon (~28 hours after vaccine) of lightheaded, nausea, chills and profound sensation of extremities being "heavy" - felt like pre-syncope - which resolved in about 30 min with rest, hydration . 12/19/2020 12/19/2020 39 F
904605 syncope following vaccine 12/17/2020 12/17/2020 30 M
904998 Pfizer-BioNTech COVID-19 vaccine EUA  On Friday December 18th at 2:45 p.m. I received my first dose of the vaccine.   After the injection while waiting in the observation area, I noticed my arm felt cold and felt weaker.  I was able to move my hand and did not have tingling.  I was cleared to leave after 15 minutes.   While driving home approximately 35 minutes after the injection I had a quick onset hot flash (felt like it came from my left arm which is where I received the injection).  Then my heart started pounding. I noticed my heart rate was climbing.  It topped out at 170.   I was having difficulty in breathing but that was related to my heart rate.  I pulled over and called 911.  I felt as if I was going to pass out.  After 2 minutes or so my heart slowed and stayed at a rate between 120-130.  I never lost consciousness.  I canceled the ambulance and felt as if I could drive home.    30 minutes later the episode happened again.   All the same symptoms as the first. The pounding felt harder and it was slightly harder to breath until the rate came down again.   Again, I felt as if I was going to lose consciousness but never did.  Each episode lasted about 2 minutes from hot flash to slower heart rate.   This time the ambulance came.  No rash.  No hives.  No swelling.   BP-160/90 HR-120-130 Sinus Tachycardia on a 3 lead EKG  I did not need transport to the hospital.   I started feeling much better around 5:00 p.m.   The coldness I felt in my arm was gone.  My arm no longer felt weak.  The hot flash, rapid heart rate and faint feeling did not return.   I am a Paramedic with the Fire Department.  Provided the Vaccine to EMS workers.   I received my vaccine at the: Fire Department December 18, 2020 Injection time 2:45 p.m. 12/18/2020 12/18/2020 50 M
905131 Sudden onset of intense rush of heat through body, intense increase in heart rate and inability to swallow,  trembling and shaking.  Employee was in car, returned to hospital ER.  ER administered fluids, and diphenhydramine. 12/18/2020 12/18/2020 49 F
905165 Clammy, flush, dizziness, syncope, tachycardia 12/21/2020 12/21/2020 24 F
905183 12/21@11:50-Caller stated that he had vaccine at 9am and  had a seizure about 4am the next morning. Patient also had slight head. Caller  stated that he is feeling better no medications were given .Caller had  Cat scan  and EEG.  Caller has follow up 12/22. 12/17/2020 12/18/2020 51 M
905188 Patient reported twitching to right eye and a warm sensation 5 mins after injection. Resolved by 10:41am. 12/21/2020 12/21/2020 64 M
905316 Severe soreness at injection site, uncontrollable shaking and chills, severe joint pain, muscle aches, heaviness of limbs, migraine like headache, abdomen bloating and weakness all within 12 hours of vaccination.  Continued off and on over next 48-72 hours although symptoms were more mild within 48-72 hours. 12/17/2020 12/19/2020 54 F
905423 On 12/20 at 9am started having left sided facial numbness, tingling, flushing. Near syncope episode (tachycardia, diaphoretic, blurred vision) around 1130am. Took Benadryl seemed to help. On 12/21- around 7a near syncope episode, tachycardia, diaphoretic, facial flushing, itching.  Took Benadryl-improvement in facial itching, decreased heart rate. 12/17/2020 12/20/2020 34 F
905463 Pfizer-BioNTech COVID 19 Vaccine  42 y.o. female had just received her vaccine when she became very lightheaded, was placed on a stretcher and brought to ED further evaluation. Patient has hx of rheumatoid arthritis.  Stated that she has not eaten since earlier this morning, did have some nausea vomiting earlier that is now resolved, feels that it was related to "an adrenaline rush just prior to her vaccination.  Upon arrival to ED she is denying any headache, fever, sweats, chills, cough, shortness of breath, angioedema, chest pain, palpitations, vomiting, edema, claudication, urticarial.  Diagnosed with near syncope. 12/17/2020 12/17/2020 42 F
905503 During the 15-minute observation period the patient became flushed and began complaining of a headache.  She then went unconscious and had tonic-like activity for approximately 2 minutes.  The patient subsequently stopped the seizure-like activity and woke up but was confused and was acting in a postictal fashion.  She was evaluated emergently upon arrival in the ED and noted to have an altered mental status.  Physician noted that this does not appear to be an allergic or anaphylactic reaction.  There was no evidence of rash and lung sounds were clear with no wheezing.  Subsequent CT showed a diffuse subarachnoid hemorrhage and patient was transferred to the Medical Center for further treatment. 12/21/2020 12/21/2020 43 F
905551 Pfizer-BioNTech COVID-19 Vaccine EUA:  Allergic reaction after receiving a COVID shot. Pt reports a rush of dizziness, diaphoretic, nausea, and near syncope. Pt appears pale but alert and oriented upon arrival.  Patient was given IM epi, IV Solu-Medrol, Benadryl, and Pepcid, placed on a cardiac monitor. He was given 1 L of normal saline.  Patient observed here in the ED for almost 8 hours. He has been persistently tachycardic; Admitted as inpt. for observation.  Discharged from inpt status on 12.18.2020 @ 2152. 12/18/2020 12/18/2020 40 M
905557 Symptoms began 12/18/2020 at 9pm with severe fatigue and chills.  Woke up at 0030 12/19/2020 with severe shaking chills, headache, body aches, dry cough and nausea, temperature spiked to 103.2 @ 0230, took 600mg Motrin and 500mg Tylenol but fever stayed at 103 until 0600 and slowly came down to 98 by 0900 12/19/2020; symptoms were resolved except for fatigue until approx 5pm 12/19/2020 when fatigue increased and chills came back with headache and body aches, fever spiked to 102.3 and lasted until approx 9pm after taking 600mg Motrin and 500mg  Tylenol,  I was able to sleep well Saturday night.  Woke up Sunday 12/20/2020 at 0730 feeling well but within an hour I developed a dry cough and shortness of breath with exertion and noted elevated heart rate (90-120bpm).  This lasted all day.  At 3pm 12/20 I began to get fatigued again.  I felt very clammy and flushed and checked my temperature and it was back up to 101.6.  Fever came down to 100 by 7pm and stayed there until approx 930pm.  I woke up this morning feeling slightly better.  I still have  a cough and shortness of breath 12/18/2020 12/18/2020 47 F
905604 Pfizer-BioNTech COVID-19 Vaccine EUA.  Symptoms: shaking, chills, sore arm, fever: 101 beginning at 11:30pm. Took Tylenol Extra Strength prior to bed at 2am. Woke up with headache and fever of 99.4 approximately 6 hours later and took more Tylenol Extra Strength. Felt tired during the day. Rechecked temperature at 8:00pm (12/19) and fever remained at 99.4 , but did not take Tylenol. 12/18/2020 12/18/2020 58 F
905673 12/16/2020 WENT TO SLEEP AT 10PM 12/17/2020 - WOKE UP ABOUT 1:00 AM;  101 TEMP, shaking, CHILLS, BODY ACHES, RIGHT ARM VERY SORE, TRIED TO GO BACK TO SLEEP 12/18/2020 - FATIGUE, BODY ACHES, TEMP SUBSIDED; EVENING FELT SHAKY; 'CALLED OUT OF WORK' (NIGHTSHIFT NURSE) 12/19/2020 - ALL SYMPTOMS SUBSIDED 09/2020-10/2020 HAD FLU SHOT 'CANT REMEMBER EXACT DATE' 12/16/2020 12/17/2020 24 F
905675 18 minutes post vaccine dose 1, Pfizer COVID vaccine, development of globus sensation without airway compromise or stridor.  Frequent throat clearing and swallowing.  Followed by diaphoresis, loss of vision, extreme neuropathic tingling over entire head non painful.  Bradycardic event to heart rate 35 recorded by Apple watch.  loss of consciousness with pupil dilation.  Weak pulses but no loss of pulse.  Heart rate recovered quickly.  Blood pressure after initiation of iv fluids was normal in upright position once loss of consciousness subsided.  Continued globus sensation.  30 minutes after initial event, again developed clammy hands, head tingling and worsening globus sensation but again no stridor or airway compromise.  Given PO Benadryl 25 mg which did resolve globus sensation in next 30 minutes.  Monitored for one hour post event with no subsequent symptoms other than fatigue. 12/21/2020 12/21/2020 39 F
905767 approx. 10 min after injection felt light headed, flushed, and pre syncope. BP and HR were taken by staff and ER physician,, BP was hypertensive for me 145/90, 145/104, 137/89, 138/86, 132/91. I am normally 116/74. HR was 100. Oxygen was 100%,  At 12;33 was given 50mg IM x 1 Benadryl. 12:40 felt loopy and shakey.  12:54 moved to room in PACU and monitored by nurse. BP remained in the 130-140's until appox 1430 BP returned to normal 118/80 and Benedryl had worn off. My co-worker took me home. 12/18/2020 12/18/2020 52 F
905784 Fever (100 degrees Fahrenheit); Violent chills; she was shaking/Her hands shake terrible; she slept the entire night, which she never does; This is a spontaneous report from a contactable consumer reporting for herself.  A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left deltoid on 16Dec2020 08:05 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient experienced fever on 17Dec2020 with outcome of not recovered, violent chills on 16Dec2020 19:00 with outcome of recovering. The reporter described the events as pretty bad violent chills where she was shaking, and she could not get warm. Her hands shake terrible. She did not realize she had a fever until she slept the entire night through 16Dec2020-17Dec2020 which she never does. She took her temperature after she woke on 17Dec2020 09:50am and her temperature was 100 degrees Fahrenheit which is her ongoing temperature at time of the call.  She asked if there are any recommendations regarding treatment or management of fever following administration of the vaccine; like if it is ok to take Tylenol or something.  Information about lot/batch number has been requested. 12/16/2020 12/16/2020 72 F
905805 Date:  12/21/2020                                                                                       Subjective Patient is a 33 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.     She was given the Pfizer vaccination in the left deltoid muscle.    During her 15 minute waiting period after the injection, the patient began to experience feelings of hypoglycemia. She checked her blood glucose with her own monitor and had 77 at 1104. She chewed 1 glucose tab that she had in her purse. She noted some difficulty with swallowing it and notified clinic staff. Associated dizziness and was escorted by clinic staff to the emergency bay.     This provider was notified of patient reaction and she was then assessed in the emergency bay area. She denied difficulty breathing and chest pain, history of adverse reactions with prior vaccinations or allergies to medications with the exception of spironolactone.   Pateint had already been given a bottle of water by clinic staff and reported that the glucose tablet went down easier following the water. She took a second glucose tab sometime before 1113. She rechecked her sugar and had slight increase of 79. She did eat breakfast this morning about 0800 and had a protein bar right before her arrival today.    Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea and increased work of breathing, vomiting, abdominal pain, hypotension and chest pain.   Review of Systems  HENT: Positive for trouble swallowing. Negative for facial swelling, hearing loss, rhinorrhea and voice change.   Eyes: Negative for redness.  Respiratory: Negative for cough, chest tightness and shortness of breath.   Cardiovascular: Negative for chest pain.  Skin: Negative for color change, pallor and rash.  Neurological: Positive for dizziness. Negative for syncope and speech difficulty.  Psychiatric/Behavioral: Negative for agitation and confusion. The patient is not nervous/anxious.       Objective Vitals There were no vitals filed for this visit.      Physical Exam Constitutional:      General: She is not in acute distress. HENT:     Head: Normocephalic and atraumatic.     Nose: No rhinorrhea.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.  Skin:    General: Skin is warm and dry.     Coloration: Skin is not pale.     Findings: No rash.  Neurological:     Motor: No weakness.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Assessment/Plan  Patient is a 33-year-old female who has a 15-year history of type 2 diabetes, and experienced a hypoglycemic event without complaint of chest pain or shortness of breath.   Vital signs obtained at 1105 with blood pressure within normal limits at 132/88, heart rate 83 and 98% O2 saturation on room air.  Patient continued to compensate appropriately and reported feeling slightly better.  Glucose checks repeated by patient at 1117 was 84, vital signs were blood pressure 116/80, heart rate 89, O2 saturation of 98% on room air.  She continues to deny chest pain, shortness of breath or difficulty swallowing at this time.     At 1117 a 10 mg cetirizine was administered by mouth.  Patient was able to swallow this with a small sip of water without any difficulty.    1121, patient continues to deny chest pain or shortness of breath.  She continues to be compensating appropriately and sitting at the edge of the bed.  She states that she is feeling better.   Vital signs obtained at 1123 with blood glucose per the patient's own meter, continuing to elevate at 103, blood pressure within normal limits at 116/91, heart rate at 85 and 100% O2 saturation on room air.    At 1126, the patient continues to feel better.  She is provided a granola bar to eat.  She does note feeling sleepy though attributes this to this being the first day she has had off after working 4 days last week.  She notes that she has been sleepy even prior to her arrival at the vaccine clinic today.  She is able to eat the granola bar and continues conversing appropriately without difficulty.  She continues taking small sips of water without issues.  Continues to deny chest pain or shortness of breath.  Blood sugar is rechecked at 1138 and continues to elevate to 116. She reports that her meter says her sugar is "stable."   Final set of vital signs obtained at 1138 revealed blood glucose within normal limits at 116, blood pressure of 119/84, heart rate 83 and 100% O2 sats on room air.  Patient denied complaints of chest pain, shortness of air, nausea, dizziness or blurred vision at this time.  She felt much improved and we discussed her leaving the clinic and heading home to have lunch.  She had no further complaints.  She was able to rise to standing on her own without any further issues and ambulated out of the clinic without difficulty.   She was advised with strict return precautions should she develop chest pain or shortness of breath to present to the ED or call 911.  She expressed understanding of this.   LPN, RN, PharmD present through this encounter and assisted as asked of the, by this provider.    Follow up response to treatment:excellent.   Patient discharge:  Stable to go home and follow up with PCP.   Orders Placed This Encounter Procedures ? COVID-19 MRNA LNP-S PF   PA-C Electronically Signed 12/21/2020 11:17 AM 12/21/2020 12/21/2020 33 F
905854 Vaccine on Wednesday. Sneezing (allergies) around the time of injection. Sore arm for a day. Felt fine on Thursday and Friday. A little off on Saturday.  Myalgia, headache w temp of 99 on Sunday.  Took Tylenol at 2000 and went to bed. Did not sleep well. Temp at 0400 was 100. Took additional Tylenol.  Achínese returned at 1100 on Monday. No fever. shaking chills but no fever from 1400-1500. Resolved but temp of 101.2.  This is where I am now. 12/16/2020 12/19/2020 65 F
905866 On 12/19/20 Woke up at 4:30 , 3 hours after going to bed (9.5 hrs after receiving vaccination) with left arm throbbing. Was nauseated, whole body violently shaking, feverish (never took temperature).  States he could not control shaking. Lasted about 30 minutes, could barely walk. Afterwards felt achy and very weak.  Felt better on awakening, but whole body aching and weakness returned around 600PM and again at 1000PM.  Took Tylenol/Ibuprofen for relief. On 12/20 at 600PM also experienced whole body aching and felt generally poorly.  12/21/2020 Doing well today. 12/18/2020 12/19/2020 28 M
905896 Patient observed for over an hour due to symptom development including complaints of pressure in head, diaphoretic, swelling and increase muscle tone/rigidity in her left arm, tongue feeling thick. Brought to ED for care after an hour of observation.  In the ED, left arm rigidity/spasm worsened.    Here is the physician note: Patient's headache is improved.  She has no neurological deficits or subjective complaints or objective exam consistent with a recurrent CVA.  She has no evidence of significant anaphylaxis related to the immunization.  May be a recurrence of her underlying medical problems that she has been seen by neurology for something similar.  Possible unmasking of this is related to the Covid vaccine is difficult to determine.  We will have her work individually with our pharmacy, infectious disease team to determine whether she is a candidate for a second vaccination.  She would like to return home right now her CT labs are otherwise unremarkable I think this is reasonable.  Return precautions for more significant etiologies were discussed at length.   Received lorazepam 0.5 mg IV x1, diphenhydramine 25 mg IV x1, and methylprednisolone 60 mg IV x1. 12/20/2020 12/20/2020 49 F
905998 Patient received dose #1 COVID-19 vaccine administration on 12/17/20. A day later on 12/18/20, patient experienced cold sweats, cough, body aches, fatigue, H/A, vomiting x2, chills, shaking, fatigue, and diarrhea. 12/17/2020 12/18/2020 29 F
905999 Employed as a nurse at this hospital. Around 8 PM she received her COVID-19 vaccine.  She waited the 15 minutes she was required to wait and then walked to her car.  She reports that as she walked to her car she had a pain in her left shoulder which was short-lived but followed by numbness and tingling of her left arm and the left side of her face going up the back of her head.  Symptoms started around 8:20pm.  She reported back to the clinic to report the symptoms--she lives along and wanted to be assessed before going home.   In the clinic, she was assessed by myself.  Employee noted that she had not eaten.  She ate in the clinic and had something to drink.  While in the clinic over the next 10-15 minutes, she noted that she had some numbness and tingling in her feet and calves bilaterally.   No leg pain or swelling.   Around 9pm, the clinic was closing and she could no longer be monitored under observation.  She opted to go to the ER for observation.    Per ER note-- She denies any headache.  She denies any left-sided weakness.  Patient is right-handed.  She also reports some mild chest heaviness that lasted for about 20 minutes and then resolved.  No shortness of breath.  No dizziness, syncope or presyncope.  No nausea or vomiting.  No rash.  No visual or speech changes.  No ataxia.  Patient continues to have the left-sided numbness and tingling but states that it is less intense than it was.  She denies any other complaints.  Follow up this AM-- Pt is only fatigued and has some muscle soreness where she had the vaccination.  All of her symptoms have resolved and she is not having any further sxs of chest tightness or numbness 12/20/2020 12/20/2020 49 F
906041 Employee, 1st Pfizer COVID19 vaccine today. ~6min s/p shot, he felt a little itchy just @injection site, then got anxious & felt woozy, sweaty. Wearing big mask and a face shield, seemed anxious. Walked independently to go lay down. No syncope. BP up to 140/90, HR 90, RR 20, breathing fine, no itchy throat/swelling/hives. Improved w laying down. To ER out of an abundance of caution-- vitals nL, nL exam, still itchy at shot site. Got 1L NS IV, 25mg PO Benadryl for itchiness- likely anxiety > severe allergy 12/18/2020 12/18/2020 25 M
906074 Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving Pfizer-BioNTech COVID-19 vaccine patient experienced dizziness and "shakiness" in extremities. No hives, no swelling, no shortness of breath, no chest pain, no loss of consciousness, no numbness, and no tingling noted at any time. Initial vital signs: blood pressure 140/78 mmHg, temperature 98.7 degrees Fahrenheit, pulse 106 beats per minute, respiratory rate 20 breaths per minute, oxygen saturation 98% on room air. Repeat vitals 14 minutes later: blood pressure 125/88 mmHg, temperature 98.6 degrees Fahrenheit, pulse 110 beats per minute, repiratory rate 18 breaths per minute, oxygen saturation 98% on room air. Thirty minutes after repeat vitals assessed patient stated they felt much better and able to leave clinic ambulatory with a steady gait. Patient was awake alert and oriented the entire time. 12/21/2020 12/21/2020 33 F
906126 Feeling of going to pass out; PVC's; PVC's; shaking feeling internally from neck down to ankles; Sweating; palpitations; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (lot number: FK5730), via an unspecified route of administration at site of right arm at 10:15 on 17Dec2020 at single dose for immunisation. Medical history included Chronic migraine. Occasional PAC/PVC's. Concomitant medication included clonidine (strength: 0.02 mg). Within about 5 minutes of receiving the vaccine, the patient experienced shaking feeling internally from neck down to ankles, sweating, feeling of going to pass out. Some palpitations and PVC's. shaking Symptoms lasted approx 4 hours. The patient visited emergency due to events. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on 17Dec2020. 12/17/2020 12/17/2020 60 F
906228 fever/chill, extreme fatigue, body aches, headache, near syncope, nausea 12/20/2020 12/19/2020 F
906272 19 y/o fully immunized female with history of anxiety presents for dizziness and nausea x 2 hours.  Received COVID vaccine at 14:30.  At 16:30 went from sitting to standing, felt dizzy and nauseous.  No syncope.  No palpitations.  Similar reaction to influenza vaccine.  No intervention required to previous vaccination.  No history of anaphylaxis.  BP 125/88, pulse 88, RR 18, 02 95%, temp 37.3. 12/21/2020 12/21/2020 19 F
906440 Felt dizzy with blurred vision for a few seconds. Began to have chills for a few minutes, with concurrent shaking. 12/22/2020 12/22/2020 32 M
906463 About 10 hours after I received the vaccine  I developed chills and a slight fever (99.4). About 18 hours after I received it I developed shaking chills, fever of 100.6, and severe body aches. The fever responded to ibuprofen. It is now approx 28 hours after I was vaccinated and my fever and chills have returned along with the body aches. It is hard to tell if this is from the vaccine or if it from an unresolved pneumonia, as these are symptoms I had with the pneumonia and strep infection. 12/21/2020 12/21/2020 52 F
906467 Racing & pounding heart, dizziness, tingling feeling prior to dizziness, then shaking hands. After shaking, heart rate returned to normal. No blood pressure change was noted. Whole event lasted no more than 5-10 minutes. 12/21/2020 12/21/2020 46 F
906481 20 hours after vaccine, I had uncontrollable shaking, fever 99-101, headache, and I am still experiencing on the left side of my neck - clavicle, and in my axilla under my arm, clusters of lymph nodes that wont go away.  Fever, chills, head ache and body ache all went away and lasted only for 2 days. The lymph nodes are still pretty big and are still here . 12/17/2020 12/18/2020 55 F
906482 0843 vaccine administered.  0855 patient reported a rapid heart rate (112 beats per minute) and tremors.  No airway complications. 12/22/2020 12/22/2020 33 F
906495 11 minutes into the vaccination, patient noted to have tongue and mouth tingling and heart racing.  No noted tongue/lip/throat swelling, dyspnea, n/v, abdominal pain, rash, near-syncope. Started to improve after 30 seconds.. H/o tachycardia secondary to salmon, no prior anaphylaxis or use of epinephrine in the past. Sent to ED for evaulation 12/19/2020 12/19/2020 51 M
906496 Developed tachycardia, tremors, hypertension, rash. Given diphenhydramine and fluid bolus in ED and discharged home. 12/18/2020 12/18/2020 41 F
906532 seizure, resident sent to er and in CCU 12/19/2020 12/20/2020 40 F
906541 From patient interview: The patient stated feeling dizzy with lightheadedness and seeing spots. She felt like she was going to pass out. She was transported to our emergency department for examination. When I spoke with her she was resting and felt she had returned to baseline.  From medical record:Patient Stated Complaint syncope, Narrative of Presenting Problem Patient is a 35-year-old female with history of vasovagal episodes during her prior pregnancy was in the hospital getting a Covid vaccination and became weak dizzy and sweaty and had a syncopal episode while in a chair. Patient did not hit her head. Upon evaluation patient is awake alert lying supine with no complaints. Patient states she has been suffering with Covid related anxiety and depression. 12/22/2020 12/22/2020 35 F
906544 Hypertensive to 190/80; shaking; chills; after 30 minutes, BP reduced 159/80; sent to ER; monitored; sent home; resolved, per follow-up call following day. 12/18/2020 12/18/2020 59 F
906728 Approx 5 minutes after receipt of vaccine, patient reported experiencing palpitations.  Vitals signs were checked and HR elevated to the 130s (regular rhythm) and systolic BP elevated to the 160-170s mmHg;  pulse ox within normal limits.  Some mild tremors noted in left > right hand.   Patient placed in supine position and given 12.5mg IV benadryl and 4mg x2 doses =8mg total IV dexamethasone with symptomatic improvement and normalization of HR / BP.  No hypotension or hypoxia throughout the event.  No angioedema or urticaria. 12/16/2020 12/16/2020 58 F
906778 Hypotension and syncope without tachycardia, 15 minutes after injection. Patient was repositioned supine, which caused her to regain consciousness.  Give 1 liter NS over 2 hours and discharged in good condition. 12/21/2020 12/21/2020 79 F
906822 I received the Covid 19 vaccination at 3:00 pm on 12/18 no trouble went home. Upon going to sleep the left arm was numb thought and got up to use the bathroom had diarrhea. While in the restroom hit face had a syncope episode regain  conscience went to ER had 4 stitches in chin. Since 12/20 felt fine and was able to return to work. 12/18/2020 12/19/2020 41 F
906827 45 minutes after vaccination felt faint, palpitations, nausea and tremor in hands followed by syncope, after awoke had ongoing muscle spasm/tremor in legs.  Taken to ED and labs, IVF, CXR. Observed x 90 minutes and discharged- returned to work as scrub tech in OR. Left early, no further issues that day.  Next am on arising had 12/21/2020 12/21/2020 32 F
906833 Employee received vaccine and had no signs of adverse reaction after vaccination. Employee went to eat something and fainted. Shortly after employee had an emesis as well. Felt fine afterward and vitals were within normal limits. 12/22/2020 12/22/2020 25 F
906950 Severe headache chills, body aches, arm pain, Nausea, fainted on standing, dizziness 12/21/2020 12/22/2020 57 F
906955 Reports after covid vaccination while she was driving home she experienced swelling of the tongue, dry mouth, legs twitching, and diarrhea. Went to ER for treatment. 12/18/2020 12/18/2020 52 F
907027 at about 3am (15 hours after vaccinated), I had the chill, I was freezing from the shoulder down. I had to put on 2 coats and 3 blankets because I was shaking/tremoring. also, headache and body ache. I whole body is hot and my back felt weak. the chill was more apparent toward the night. 12/21/2020 12/22/2020 44 M
907037 After injection had L arm pain, the following day (12/17) pain continued . 12/18  onset of  fever max temp 38,  chills, fatigue, muscle pain and nausea. Treated with Tylenol for symptom relief. Symptoms continue and worsened 12/19 and 12/20. 12/20 underwent video clinician visit for symptoms and inability to return to work for continued symptoms 4 days after vaccination, last day of fever.  12/21 covid and flu swab negative symptoms all continued fatigue very evident going to and from swab exam. 12/22 morning near syncope while getting ready for day,  tachycardia, underwent ED eval was given fluids and labs drawn and discharged home with improvement in tachycardia and lightheaded/dizziness with fluids, another covid swab was negative along with negative RVP. Continued to have fatigue 12/22 evening. 12/16/2020 12/18/2020 31 M
907057 This nurse was notified that the worker was having tachycardia post vaccination. The worker had a baseline HR of 75 while at rest, per wrist band monitor belonging to worker. Worker's HR steadily increased as high as 94 BPM. The worker was shaking and the worker complained of throat not feeling right and dizziness. Worker described their throat as feeling tight. This nurse brought the worker to the back area of the clinic, asked the observer to initiate a MET, and this nurse went to med room and took an EpiPen from the box. This nurse administered the EpiPen into the right thigh at 1600. by 1604 the MET team had arrived. The MET team spent 20 to 25 minutes with worker. The MET team included two PICU physicians, one being a fellow. This nurse was advised that the worker was asked if wanted to go to the ED (by the worker) and worker declined. This nurse agreed to observe the worker until the close of clinic at 1730. Vitals take at 1720 were as follows: 89 HR, 94% O2 sat, 124/66 BP (RUE), 16RR.  Worker was no longer feeling dizzy, no throat symptoms,  and refused ED observation and went home. Nothing further reported. 12/21/2020 12/21/2020 42 F
907075 Patient experienced bronchospasm with coughing and tongue itching approximately 10 minutes after the injection. 12/22/2020 12/22/2020 43 F
907101 patient felt slightly nauseated at 10 minutes after injection, then developed slight sweating; BP 160/81; 83 at 5:45 and then 158/87 with HR 82 at 5: 52 pm.  Her lungs were clear, she was speaking in full sentences and was denying any chest pressure, her usual sense of asthma exacerbation.  At 6:05 it was 164/83 with HR 79 and patient developed a dry cough; we decided to have her wait just a bit longer, then cough worsened, so  at 6:25, decision was made to have patient seen in ER for further assessment, and en route in wheelchair to ER the dry cough became persistent, spasmodic and patient was unable to speak.  Epi-Pen was injected in right mid thigh, and patient transported to ED urgent eval.   She noted immediate palpitations, and slight improvement of breahting, was able to speak in four word sentences.  On arrival to the ED, patient was administered Duonebs, Albuterol neb, IV Benedryl, IV Solumedrol;  CXR was obtained, with results pending.  Patient was sent to observation for ongoing monitoring and assessment of breathing.  at 6:30 PM in the ER, she 12/22/2020 12/22/2020 41 F
907110 Right side facial swelling and right eye twitching sensation. Given Benadryl 50mg. 12/22/2020 12/22/2020 52 F
907175 Congenital anomaly or birth defect; This is a spontaneous report from a contactable consumer (patient).   A 57-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included high blood pressure and hypertension and more epileptic seizures. Concomitant medication included unspecified pneumococcal vaccine on 12Dec2020 for immunization. The patient previously received flu shot (Influenza virus vaccine) and pneumonia shot (Pneumonia vaccine) both on 20Oct2020 for immunization. The patient experienced congenital anomaly or birth defect (as reported) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported information is unclear. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. 12/22/2020 57 F
907185 40 minutes later, I became flushed, hot, sweaty and clammy and tachycardic along with a syncope episode. Nausea came after, and only treatment was fluids. This episode happened after discharge around 9:45pm and then returned to the hospital for the same course of action. 12/22/2020 12/22/2020 25 F
907320 12/21/2020 2:20PM Facial spasms, left side of face-- eye, nose,  lip (prominent) - occurring for minutes at time, symptoms have not resolved 12/21/2020 12/21/2020 32 F
907329 Employee presented to COVID Clinic for Moderna COVID 19 vaccination 1st dose. Given to right arm. Left clinic after waiting 15 minute observation time. She returned to work and returned about 45 minutes reporting she was having difficulty taking deep breaths, numbness to bilateral extremities, abdominal discomfort and lightheaded, NO rash or hives noted. VSS stable A&O, Within a few minutes employee started vomiting, shaking, and C/O of severe abdominal discomfort, Epinephrine injection 0.5mg given to left arm. Employee transported to ED. 12/22/2020 12/22/2020 35 F
907330 Employee presented to COVID Clinic for Moderna COVID 19 vaccination 1st dose. Given to left arm. Left clinic prior to completing 15 minute observation time and told an MA in waiting area that she felt ill ot her stomach and having trouble taking deep breaths.  Employee found in nearby Bathroom sitting on the floor, she had vomited, reported she was lightheaded, couldn't breath, shaking, abdominal discomfort sweating,  attempted to move employee to wheelchair, did respond well to transfer to Wheelchair, She reported symptoms worsening: HA, abdominal pain and developed blotchy skin, hyperventilating, and dizzy. CODE Blue called, patient given Epinephrine injection 0.5mg patient sent to ER 12/22/2020 12/22/2020 50 F
907370 I woke up at 2AM with a funny sensation in my esophagus, it felt tight and hot, the trouble breathing woke me up, I had chills, shaking, but no fever, extreme muscle weakness, I could barely walk steps. My main issue was the trouble breathing. Went to the ER and pulse/ox was 96/97 so it was good my oxy saturation was really good. They just observed me for some hours and by 5AM and I discharged and on Saturday I woke up ok but felt weak. I still feel some muscle weakness. 12/18/2020 12/19/2020 23 F
907390 64y/o FEMALE presents to the ED for evaluation of facial itching after COVD vaccine in left arm. The patient states shortly after the vaccine (about 10 minutes) her nose and mouth started itching. She was given PO Pepcid and IM Benadryl PTA in ED. She denies any associated SOB, nausea vomiting wheezes or near syncope. Denies fever/chills, n/v/d or other complaints at this time. IMPRESSION/PROBLEM LIST:---------------------1. Adverse Reaction to Vaccine for COVID 12/22/2020 12/22/2020 64 F
907426 48 y.o female with history of atrial tachycardia who presents to the ED via EMS for a possible adverse reaction to Covid vaccine.  Patient received her Covid vaccine around 1600 today, and soon became diaphoretic, shaky, and lightheaded.  She had presented to the emergency department.  Currently she denies any chest pain, difficulty breathing, throat swelling, tongue swelling, or any other symptoms currently except for palpitations.  Allergic Reaction The primary symptoms are  shortness of breath. The primary symptoms do not include cough, abdominal pain, vomiting, dizziness or rash. The current episode started 1 to 2 hours ago. The problem has not changed since onset. The onset of the reaction was associated with a new medication. Significant symptoms also include flushing.   48-year-old female with a history of atrial septal defect, status post atrial septal defect repair in 1980. She works as a nurse at Hospital and has been experiencing increasing rapid palpitations associated with chest pain, and hypertension.  With her episodes, she experiences marked lightheadedness, dyspnea, and feeling marked anxiety, as well as chest tightness. She received the COVID-19 vaccine today and while waiting in the observation room,she started feeling unwell, with rapid palpitations, associated with lightheadedness and dyspnea. She last had a sustained episode 2 - 3 weeks ago and had presented to ER and Hospital. No syncope. No orthopnea, PND or increased lower extremity swelling. Active Hospital Problems   Diagnosis ? Atrial paroxysmal tachycardia ? History of repair of atrial septal defect       1. Paroxysmal atrial tachycardia in setting of prior atrial septal defect repair - she is having breakthrough episodes through flecainide/digoxin - it is likely her atrial tachycardia is related to her ASD patch. Will hold flecainide/digoxin for now, and try to schedule an ablation during her hospital admission due to highly symptomatic episodes resulting in multiple ER visits.   2. Acute renal insufficiency - most likely pre-renal - iv fluids started.   3. Possible COVID-19 vaccine reaction - she probably had an incidental atrial tachycardia episode post vaccine administration, rather than an actual adverse reaction. Continue to monitor. 12/22/2020 12/22/2020 48 F
907478 seizure (Grand mal) 12/18/2020 12/20/2020 67 M
907520 Nexk to my head feel really hot, nauseous, dizziness, high blood pressure, shaking feel Hot and cold 12/20/2020 12/20/2020 31 F
907637 Employee received vaccine, within 10minutes, c/o of weakness, dizziness, shaking.... no complaints of Shortness of breath or tightness... refused to receive any additional treatment.  Continued monitoring for another 2 hours, no additional symptoms, then developed numbness and tingling around mouth and trouble swallowing....  sent to ER. 12/21/2020 12/21/2020 42 F
907675 shaking chills for at least 4 hours; nausea; fatigue; This is a spontaneous report from a non-contactable nurse. A 68-year-old female patient started to receive bnt162b2 (BNT162B2), via an unspecified route of administration from an unspecified date at a single dose unspecified dose for an unspecified indication. Medical history included covid-19 (Prior to vaccination).  The patient's concomitant medications were not reported. It was reported that 24 hours after the first vaccine, the patient had shaking chills for at least 4 hours. She was wrapped in 2 heavy blankets and a heating pad. She also had nausea and fatigue. Symptoms gone the next day. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected. 12/23/2020 68 F
907695 extreme diaphoresis; Diarrhea; shaking chills; shaking chills; visual disturbances; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection via an unspecified route of administration in the left arm on 10Dec2020 at 23:30 (at the age of 47-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 11Dec2020 at 00:15, the patient experienced extreme diaphoresis, diarrhea, shaking chills and visual disturbances. No treatment was provided for the events extreme diaphoresis, diarrhea, shaking chills and visual disturbances. The outcome of the events extreme diaphoresis, diarrhea, shaking chills and visual disturbances was recovered in Dec2020. Since the vaccination, the patient had a Nasal Swab, Covid test name post vaccination on 11Dec2020 was negative.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. 12/10/2020 12/11/2020 47 F
907789 Patient received vaccine and entered waiting queue. Within 1 0 minutes, pt requested help from pharmacy vaccination team because she felt severely dizzy. Patient ended up passing out in seated position. Systolic blood pressure dropped to ~80. Patient normalized 5-10 minutes after syncope. Blood pressure normalized. Patient escorted out in stretcher. 12/23/2020 12/23/2020 52 F
907818 Within 15 minutes after the vaccine patient started to have tachycardia, dizziness, and light headedness with syncope episode.  She was taken to the ER where she improved .  No further syncope episodes and released. 12/22/2020 12/22/2020 31 F
907836 About 15 minutes I started to get hives, skin reaction and felt chest pressure, I let Dr. know I wasn't feeling well, administered Epinephrine with own EpiPen,  noticeable hives and redness across neck and upper chest.  Transported to the ED.   2nd dose of Epinephrine at 1:20pm for throat swelling and bronchospasm. 12/23/2020 12/23/2020 40 F
907915 Right after patient was given vaccine injection he started to feel lightheaded and woozy. He had just worked the night shift and hadn't eaten anything. No prior illness reported. Patient brought to emergency department to be evaluated. Received 500ml of fluids and symptoms resolved and he went home. Diagnosis of near syncope. 12/22/2020 12/22/2020 65 M
907924 45-60 minutes post vaccination, patient experienced right eye twitching continuous for a few hours, then intermittent x 24 hrs; now resolved 12 hours post vaccination, patient experienced right ear/jaw numbness that lasted up to 36hrs 36 hrs post vaccination, the numbness is spreading to the right cheek no affect in muscle function, just numb pt seen at urgent care facility 12/23 @~0830 and prednisone initiated 12/21/2020 12/21/2020 38 F
907944 Progress Notes PA-C (Physician Assistant) ? ? Orthopedics Cosigned by: MD at 12/22/2020  9:48 AM         Patient:    Date:  12/21/2020                                                                                             Subjective Patient is a 34 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.      She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience generalized feelings of "not feeling quite right" as well as anxiety/nervousness, nausea and chills.  She denied difficulty breathing, throat tightness, dizziness, chest pain, or other GI complaints.   This provider noticed her raising her hand from across the waiting area and tended to her where she noted the above complaints. she was then assessed in the emergency bay area. She was monitored for severe reaction symptoms, including rapid progression of symptoms, vomiting, hypotension, chest pain, collapse and Respiratory distress.   Past medical history includes anxiety for which she takes Effexor on a daily basis as well as type 2 diabetes, diagnosed approximately seven or 8 years ago during a pregnancy.  She is on oral medication during the day and insulin at nighttime.  She did take her oral medication today and last ate a pasta lunch right before arriving to the vaccine clinic.  Last A1c was 6.5.  Patient states that she generally runs a postprandial blood glucose following a heavy meal of about 180.    She reported a previous history of anxiety and nervousness following vaccinations in the past.  Most recently, she experienced a 30-minute period of anxiety and nervousness following her flu vaccine this past October.  These feelings passed without further incidents.     Review of Systems  Constitutional: Positive for chills.  HENT: Negative for drooling, facial swelling, hearing loss, rhinorrhea, sneezing and trouble swallowing.   Eyes: Negative for redness and visual disturbance.  Respiratory: Negative for cough, chest tightness and shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Positive for nausea. Negative for vomiting.  Skin: Negative for color change, pallor and rash.  Neurological: Negative for dizziness, speech difficulty and light-headedness.  Psychiatric/Behavioral: Negative for agitation and confusion. The patient is nervous/anxious.          Objective   She ambulates into the emergency treatment bay under her own power and without difficulty.  She is seated on the gurney, and continues to answer questions appropriately.   Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is not toxic-appearing or diaphoretic.  HENT:     Head: Normocephalic and atraumatic.     Nose: No rhinorrhea.  Cardiovascular:     Rate and Rhythm: Regular rhythm. Tachycardia present.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.  Skin:    General: Skin is warm and dry.     Coloration: Skin is not pale.     Findings: No rash.  Neurological:     Mental Status: She is alert.     Gait: Gait normal.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.         Assessment/Plan  Stress reaction secondary to vaccine administration and history of anxiety and nervousness following vaccinations.   Vital signs obtained at 1352 with blood pressure at 154/95, mild tachycardia at 109 and 97% O2 saturation on room air.  Patient denies any chest pain, shortness of breath time.   She is given a bottle of water and assisted to lie down with the head of the bed slightly elevated. She continues conversating appropriately without any acute distress.  Vitals reassessed at 1359 with blood pressure of 133/76, heart rate 97% on room air. Dr. at the bedside now.  Suggested obtaining a blood glucose.  Blood glucose obtained at 1405, elevated at 234.  She continues to deny any chest pain, shortness of breath, chest tightness, swelling in the throat, nausea/vomiting or other GI complaints.   Vital signs checked again at 1406 with blood pressure 133/77, heart rate 107 and 97% on room air.   Vital signs last checked at 1415 to reveal a blood glucose of 219, blood pressure 127/82, heart rate 100 and O2 saturation of 97% on room air.  Patient has no additional complaints at this time and reports feeling well.  Her mother has driven her to the clinic today.  She felt that she was able to safely walk out with any issues.  She was assisted by nursing staff and ambulated out of the treatment bay independently.   Treatment included routine surveillance of vital signs at about a 5-minute intervals following notification of her feeling poorly.  Vital signs continued to normalize and remained stable through the duration of her 30 minutes following her vaccination.    Follow up response to treatment: excellent.   Patient discharge:  Stable to go home and follow up with PCP.  Recommend to patient that she present to the ED or call 911 should she develop any symptoms up to and including but not limited to chest pain, shortness of breath, chest tightness, signs or symptoms of angioedema, or syncope.  She expresses understanding the above and has no further questions today.     Orders Placed This Encounter Procedures COVID-19 MRNA  PA-C Electronically Signed 12/21/2020 1:51 PM 12/22/2020 12/22/2020 34 F
908009 Resident noted to be experiencing a full body tonic/clonic seizure approximately one hour and forty-five minutes post receiving the vaccine. Supplemental oxygen via nasal cannula provided, vital sign monitoring, solu-medrol IM provided, epinephrine IM provided, clonidine tablet provided PO, stat labs ordered: CBC, BMP, depakene level, UA. Resident exhibited positive reaction to interventions. seizure lasted approximately 5 minutes, afterwards resident presented at baseline: alert and oriented x3 and communicative. Oral intake tolerated approximately an hour and a half post seizure. Enhanced monitoring in place. 12/23/2020 12/23/2020 57 M
908021 I have been experiencing intermittent, involuntary twitching of my my left thumb that started around 12;00 noon. There is no numbness or tingling (normal injection site ache, however) or recognizable pattern of when the twitching occurs, and the twitching does not seem to last longer than 10 seconds at the most before stopping. 1-3 minutes will pass before my thumb starts twitching again. Other digits do not seem to be affected. I did not experience this prior to the COVID-19 vaccine administration and not have any neurological conditions that this would be a symptom of. 12/23/2020 12/23/2020 47 M
908055 Approximately three hours after receiving the vaccine I was violently puking and nauseous. I never had a fever, but I had uncontrollable shaking and chills. 12/21/2020 12/21/2020 33 F
908071 hand shaking, chills, rash, nausea, lightheadedness ? reports hard to take a deep breath, given diphenhydramine 50 mg PO x 1 @ 10:15 in clinic and an additional 25 mg PO x 1 @ 10:30 in the clinic.  Symptoms persisted - pt anxious - taken to ED for evaluation.  After 10-15 minutes in ED, her symptoms subsided ? she only had mild tingling in the left hand along with two red spots on the back of her neck.  Given prednisone 50 mg PO x 1 in ED.  observed in ED for 2 hours ? pt feels much better ? pt felt comfortable going home ? told to continue to take Benadryl and prednisone for next 3 days.  Instructions given to return to ED for any worsening of symptoms.  Rx with Prednisone 50 mg daily x 3 12/23/2020 12/23/2020 32 F
908072 5 minutes after administration of vaccine, patient states he does not feel well.  He was sitting and passed out. 12/23/2020 12/23/2020 28 M
908077 site soreness and residual headache at base of skull x3 days On 12/18 at 12 noon, I found myself passed out in my office at work laying over my keyboard. My assistant had me on-hold at that time and estimated I was out for 1 minute. Was loopy the entire next day. Just hydrated and rested. Felt great by Monday 12/17/2020 12/18/2020 64 F
908096 WAS HAVING MYALGIAS AND MILD FEVER STARTING ABOUT 12 HOURS AFTER VACCINE, BUT AT 2 AM,  I WOKE UP TO URINATE, FELT SOME DIZZINESS.  AT THE END OF VOIDING I COULD TELL I COULDN'T THINK RIGHT AND HAD TROUBLE FLUSHING.  TRIED TO WALK BACK TO BED AND HAD A syncope AS I GRABBED THE DOOR HANDLE.  STUMBLED DOWN SLOWLY AND LOSS CONSCIOUSNESS FOR A SHORT WHILE, SECONDS.  LAYED IN THE FLOOR FOR A BIT AND WHEN I STOOD UP AGAIN AND WALKED TO MY ROOM HAD ANOTHER syncope.  WOKE UP AFTER SEVERAL SECONDS AND WAS NOT CONFUSED AND DIDN'T REMEMBER THE SECOND TIME I FELL BUT COULD UNDERSTAND I HAD passed out.  MY WIFE SAYS I HAD MY EYES OPEN AND WAS STIFF BUT NO TONIC CLONIC MOVEMENTS.   AFTER THE EVENTS I WAS ABLE TO GET BACK IN BED AND AFTER A LITTLE WHILE TESTED FOR ORTHOSTASIS.  WHEN I STOOD UP I STARTED FEELING THE LIGHT HEADEDNESS AGAIN AND PRODROME TO FAINTING AND LAYED BACK DOWN.    HR 60, MY BASELINE IS 50-60.  HAD A FEVER OF 100.7.  I TOOK 650 MG OF TYLENOL AND WENT BACK TO BED.  I DIDN'T SLEEP WELL BUT NOW (THE FOLLOWING MORNING) I AM FEELING BACK TO NORMAL MINUS SOME MILD SOARNESS.   I HAD A RAPID COVID PCR TODAY THAT IS NEGATIVE.  NO OTHER LABS.  I HAD NEVER fainted BEFORE THIS EPISODE.   I DID NOT HAVE ANY TRAUMA FROM syncope. 12/21/2020 12/22/2020 41 M
908148 rash, vomiting, nausea, hives, migraines, tremors, facial swelling 12/19/2020 12/19/2020 34 F
908229 Vaccination to right deltoid; 7 days later developed diminished grip strength in right hand, right thoracolumbar muscle spasm with tingling radiculopathy to right hand and leg 12/15/2020 12/21/2020 38 F
908287 patient's several members of family tested positive for COVID 19 virus and was potentially exposed; it was like she got the flu/whole flu like symptoms; Sore throat; Joint ache; Body ache; Low grade fever; Running nose; Terrible headache; Laryngitis; Muscle ache; Loss of smell; Chest discomfort; Joint discomfort; This is a spontaneous report from a contactable nurse. A 53-year-old female patient started to receive bnt162b2 (reported as Pfizer-BioNtech vaccine; lot number: EH9899), intramuscular on left arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included migraine, arthritis, gastritis, and esophageal spasms all from unknown dates and unknown if ongoing. Concomitant medications included dicyclomine, biotin, tocopherol (VITAMIN E [TOCOPHEROL]), and ergocalciferol (VIT D). Patient reported getting the vaccine and is now having a reaction. Patient stated that she got the COVID vaccine on 18Dec2020 at 7 in the morning and she started to get sick 5 in the morning the next day. Patient stated she worked night shift the next day and got sick and it was like she got the flu from the shot. When the above concern was paraphrased, the patient stated, "Yes I had all of my joint ache, body ache, I had low grade fever, running nose, terrible headache, just whole flu like symptoms". The patient was informed the role of the Pfizer Drug Safety and permission to probe was asked from the patient. Patient also stated, "Yes, I always get my flu shot every year for many years, two other times I have been sick from the flu shot (Further clarification was Unknown) and it was like this it was like the flu and I believe this because of the shot but you know I mean I still think it would have been, I think it is better than having received COVID itself". Patient mentioned taking turmeric. Patient mentioned that she had a COVID test done on Thursday at the clinic that she works at and that must have been negative because nobody contacted her and it was just they do random testing because of the patients she works with. Patient further stated "I got my vaccine between 7-8 am mornings Friday morning and then around 5 am on Saturday morning, I started feeling really bad and then when I woke up at 4 in the afternoon I was done. It is probably, yes 18Dec, 7 or 8 in the morning I got the shot and then 19Dec at 5 am is when I started getting sick, by the evening I was full grown sick and I had to call I am sick because I couldn't pull another 12 hour shift". The patient also reported that she was much better today (unspecified date), had a sore throat and headaches but her joint pains were better, and she has no fever not even low grade fever. It was further stated that the patient received first dose of Pfizer-BioNtech vaccine on Friday 18Dec2020. Developed symptoms on Sat 19Dec2020 which included "sore throat, laryngitis, muscle ache, loss of smell, chest discomfort, low grade fever, joint discomfort". Patient mentioned that she took Theraflu and NyQuil. Patient also stated, "And the only other question is because when I called up to work to tell them to give me COVID a day for COVID pay because it was COVID related and they said they were not sure if they could. This is COVID related they should pay me for a day of COVID pay, correct. Who would know that?". It was also found out "recently" that patient's several members of family tested positive for COVID 19 virus and was potentially exposed. It was asked that if patient gets tested for COVID virus, will she be positive because of receiving the Pfizer-BioNtech vaccine and can patient test positive for COVID 19 virus after receiving the Pfizer-BioNtech vaccine. Outcome of the event 'Low grade fever' was recovered, unknown for event 'patient's several members of family tested positive for COVID 19 virus and was potentially exposed', while recovering for the remaining events. 12/18/2020 12/19/2020 53 F
908293 Left arm start swelling at the injection site and down to the elbow  around 5:30pm; This is a spontaneous report from a contactable consumer reporting for herself.     A 47-years-old female patient  received  bnt162b2 (BNT162B2; Lot #Eh9899) vaccine, via an unspecified route of administration in the left arm  on 20Dec2020 10:00 at single dose for covid-19 immunisation .  Medical history included hypertension from an unknown date , migraine from an unknown date , partial seizures from an unknown date , intracranial aneurysm from an unknown date. Concomitant medication included spironolactone (SPIRONOLACTONE), hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ), estradiol (ESTRADIOL).  The patient was allergic to lisinopril , amlodipine , gentamicin sulfate; methylmethacrylate;polymethylmethacrylate;zirconium dioxide , zonisamide .  The patient  left arm start swelling at the injection site and down to the elbow  around 5:30pm with outcome of recovering. 12/20/2020 12/20/2020 47 F
908333 Nausea (dry heave), Light-headedness, slight hand tremors, increased respirations, pain and warmth at injection site, tiredness, slight facial skin tightening, tingling of hands and feet 12/23/2020 12/23/2020 40 F
908336 No symptoms during the mandatory 15 minute post-vaccine period in clinic waiting area. Experienced mild fatigue/general tiredness approximately 6-7 hours after receiving vaccine (given 12:35 pm). Full body chills/muscle spasms then occurred around 9:30 pm and lasted about 40 minutes. 12/22/2020 12/22/2020 25 F
908342 seizure witness by wife who is a physician. Bit tongue.  No history of seizure or other neurologic disease. 12/19/2020 12/23/2020 48 M
908352 Patient developed arm muscle twitching the day after injection. 12/21/2020 12/22/2020 51 F
908401 Vaccine administered at 0730. Pt went home and went to bed. Woke up at 0930 with shaking, chills and feeling like she was going to pass out. Evaluated in ER and noted to have sinus tachycardia in 140-160's. Given 5mg IV Lopressor which took heart rate down to 110's. Admitted to hospital 12/23/2020. 12/23/2020 12/23/2020 24 F
908404 Full body shakes and chills that woke me up out of a deep sleep. Felt like my body was convulsing, resolved about 4 hours Nausea and Vomiting for about, resolved after 2 hours Woke up and feel weak, and have a headache. Current as of 12-24-2020 at 8:30 AM  No treatment was taken 12/23/2020 12/24/2020 21 M
908520 10 minutes after injection, patient began to have redness/flushing of her face/neck. Symptoms partially resolved. She flushed approximately 3 times. Reported tingling in fingers bilaterally. Kept rubbing her fingers together and shaking hands. Pulse 107, BP 154/101. Patient states normal BP for her is 120/60. Hives and itching also reported. Patient states often flushes/gets hives when stressed/upset.  No issues prior to injection. Patient take to hospital ED for observation. Symptoms had resolved when she spoke to the ED doc but are lingering today 12/24 as of 1030 am. 12/23/2020 12/23/2020 47 F
908594 12-18 0730- received vaccine at work.  I am a registered nurse. 12-19 11am feeling extremely fatigued, chills, mild aches, and temp 100.1 12-19 2pm  temp 101.8 and more severe arthalgia, myalgia, and shivering.... cant get warm 12-19 6pm temp 102.1 and rigors.... shaking head to toe and severe aches/ pains 12-19 11pm temp 104.1  12-20 temp 102.5 12-21  SOB, bradycardia to 41, dizziness, temp 100.5 12-22 SOB, vomiting, cough, temp 99.6 12-23 SOB, cough, diagnosed with Covid pneumonia 12/18/2020 12/19/2020 49 F
908597 Developed severe epigastric pain and had a syncopal episode while at lunch. Individual lost consciousness for a few seconds and returned to baseline with in a minute. No further care was needed or given. 12/18/2020 12/19/2020 22 M
908603 Headache: 2/10, global/ diffuse, responds to excedrin & getting, worse in the morning.  +R Foot went numb and the resolved. No tingling, weakness, or numbness, dysphagia, slurred speech, seizures, blurry vision.  Thirst: Very thirsty.  ALtered Mentation: Slower in responding, Having to really think before she speaks  Muscle spasms  +hot flashes  no fever, chills, chest pain, or sob.  hyper-emotional (Sponteneous crying). 12/19/2020 12/20/2020 61 F
908609 Patient was in the 15 minute post-observation window and was scheduling his appt for second dose. Patient noted that he has a fear of needles and mentioned that he was feeling light-headed and experiencing tunnel vision..  He subsequently became diaphoretic and syncopal. He spontaneously recovered and was helped back into the chair. Did not fall to ground or hit his head. A SWAT was called. During SWAT evaluation, patient was given cool compress for neck and mentioned that this has happened before with injections. Subsequently had another syncopal episode and witnessed clonic seizure of roughly 25 seconds in duration. Patient again spontaneously recovered and was brought to the ED. the patient was unable to recall the events and has no history of seizure activity. Patient was given crackers and juice in ED and monitored for approximately 3 hours. Patient was discharged to home. 12/23/2020 12/23/2020 28 M
908619 12/22/2020  at 3:00pm Moderna Vaccine administered. 12/23/2020 at 2:00pm  Strong shaking chills. Temperature started at 99.8. 12/23/2020 at 4pm Chills continue. Temp 101.4 Body aches. 12/23/2020 4:30pm Advil 3 tabs taken. 12/23/2020 6pm Temp 102 chills body aches. 12/24/2020  8am Temp 100.4 12/24/20 11:30 am Temp 99.5improving,  body aches but no chills. 12/22/2020 12/23/2020 58 F
908625 Pt received vaccination and immediately afterwards syncoped.  Pt recalls receiving the inoculation and becoming acutely lightheaded before losing consciousness.  No preceding SOB or palpitations noted. 12/21/2020 12/21/2020 43 F
908626 Progress Notes PA-C (Physician Assistant) ? ? Orthopedics Cosigned by: MD at 12/22/2020  9:46 AM Expand All Collapse All        12/21/2020    Patient:                                                                                           Date:  12/21/2020                                                                                             Subjective Patient is a 58 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness/shakiness. This provider was notified of patient reaction and she was then transferred to the emergency bay via wheelchair where she was assessed. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, hypotension, dysrhythmia, chest pain and collapse.    She denied difficulty breathing, throat tightness and tongue swelling, nausea.    She reports a history of atrial fibrillation and states that she had a procedure in the past and the anesthesia provider questioned her about this diagnosis. She reports taking metoprolol and methimazole on a daily basis. She took all of her am medications today, including an 81 mg aspirin. Reports history of watery eyes and blurred vision, takes Zyrtec daily. Denies any worsening of these symptoms outside of her baseline. Denies use of anticoagulant use or diabetes.  Last ate and drank about 1130 or noon.    Review of Systems  Constitutional: Negative for diaphoresis.  HENT: Negative for congestion, drooling, facial swelling, rhinorrhea, sneezing and trouble swallowing.   Eyes: Positive for discharge. Negative for redness.  Respiratory: Negative for chest tightness and shortness of breath.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for nausea and vomiting.  Skin: Negative for color change, pallor and rash.  Neurological: Positive for dizziness and headaches. Negative for syncope.  Psychiatric/Behavioral: Negative for agitation and confusion. The patient is not nervous/anxious.          Objective Vitals There were no vitals filed for this visit.      Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is obese. She is not toxic-appearing or diaphoretic.  HENT:     Head: Normocephalic and atraumatic.     Nose: No rhinorrhea.  Eyes:     Comments: Watering of both eyes   Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Comments: At right radial pulse Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.  Skin:    General: Skin is warm and dry.     Coloration: Skin is not pale.     Findings: No rash.  Neurological:     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Stress reaction following vaccine administration.   Patient was transported to the emergency bay via wheelchair.   Treatment included no therapy, but did continue with vital checks at approximately 5 minute intervals.    1603-blood pressure using the large adult cuff was 154/60 with large adult cuff, heart rate 69 with regular rate and rhythm at right radial pulse, 96% O2 sat on room air.  Patient continues to feel slightly dizzy and shaky though denies any chest pain, shortness of breath, swelling of the lips or tongue.    1611 vital signs reassessed with blood pressure of 150/63, heart rate 64, 97 percent on room air, continues to feel slightly dizzy/shaky, though, reports not nearly as bad.  Patient continues to answer questions appropriately and is talking without any signs of further decompensation.   1618-reports feeling better. Vital signs rechecked with BP of 121/55, 59 hearty rate and 96% RA. No new complaints.   1624- patient reports a slight headache, but denies chest pain, shortness of breath, chest tightness, lip or tongue swelling.    Discharge vitals obtained at 1626-with blood pressure of 135/55, heart rate of 58, 95% on RA. No new complaints, except feeling a bit cold.  Patient reports feeling better and feels that she can safely discharge.  Discussed need for urgent evaluation at the emergency department or to call 911 if symptoms of chest pain, shortness of breath, angioedema present.  Patient expresses understanding and all questions were answered to her satisfaction today.   Follow up response to treatment:excellent.   Patient discharge:  Stable to go home and follow up with PCP.    Orders Placed This Encounter Procedures ? COVID-19 MRNA      PA-C Electronically Signed 12/21/2020 4:05 PM 12/21/2020 12/21/2020 58 F
908652 Nausea Vomiting shaking Chills Arm soreness 12/23/2020 12/23/2020 38 F
908668 Chills, myalgia, fever, syncope and vomiting 12/22/2020 12/23/2020 30 F
908696 Experienced syncope after receiving vaccine injection. Clinical Assessment Team called but declined going to emergency department. 12/24/2020 12/24/2020 41 F
908700 Developed tremor, dizziness, and chills almost immediately after vaccine.  She developed hives to her chest approximately 30 mins after the vaccine was given.  She did get IM benadryl in the office which resolved the hives.  She was transported to the hospital via ambulance as the dizziness and tremor worsened over the time she was in the clinic.  She was discharged from ER the same day. 12/23/2020 12/23/2020 23 F
908705 Patient awoke at 2 am and felt like she could not breathe.  felt hot, tight, and severely weak.  Had chills and shaking.  No fever.  Patient was transported by ambulance, observed in the Emergency department until 5 am and discharged home.  Patient received oral acetaminophen in the ED. 12/18/2020 12/19/2020 23 F
908771 12/22 7 pm, severe leg cramps; 12/23 7 am: diarrhea, abdominal pain. noon: nausea requiring medication; 5 pm, shaking chills, normal temperature. 9 pm: bloody diarrhea, and what looked more like sloughing nonpigmented tissue rather than stool, continued abdominal pain. Woke with diarrhea and pain 1 am. This morning, frequent stool and moderate abdominal pain.  No chills.   Recovered from diverticulitis around 12/3, scheduled for colonoscopy 1/6/21 and probably colectomy 1/8/2021. 12/22/2020 12/22/2020 62 F
908843 Pfizer-BioNTech Covid 19 Vaccine: Patient reports "indescribable" muscle pain beginning almost exactly 4 hours after vaccination which has persisted until time of this report (day 7).   She notes minimal pain at injection site.  Has had no fever, no nausea/vomiting/diarrhea.  She states that her entire body hurts, including hair, teeth, toenails, and fingernails - she describes as throbbing pain.  She also reports pain in back and thoracic muscles to the extent that she cannot bend down to put on shoes.  She notes that the back pain was not initially present but started around day 5 (12/22/20).  She describes this as muscle pain and does not have visceral pain.   She reports some relief with acetaminophen and ibuprofen.  She also describes alternating episodes of feeling "freezing cold" with shaking chills followed by profuse diaphoresis (describes sweat as pooling and dripping).  Acetaminophen and ibuprofen have not relieved or lessened the episodes of chills and sweats. 12/18/2020 12/18/2020 45 F
908863 It started with itching hands and feet and then spread over my whole body. It all turned red. I had shaking. 12/20/2020 12/20/2020 52 F
908877 He was fine ate lunch, in a room with a patient, felt light headed and dizziness, passed out, he became unresponsive, he was hypotensive, he is now in the ER. 12/24/2020 12/24/2020 25 M
908923 Patient was very anxious about getting her vaccination. After a couple minutes of receiving the vaccine, the patient went to stand up from the chair she was vaccinated in and became light headed. She then put her head on the table and began shaking. She was safely lowered to the floor and placed on her back. 911 was called and paramedics arrived within 10 minutes. The patient was lucid and responsive, but breathing quickly and shaking. She was taken to the hospital by paramedics and discharged shortly after arriving. 12/24/2020 12/24/2020 38 F
908942 Felt a rush in my arm 5 minutes after. Then one hour following the injection I started getting dizzy and vertigo. Driving home I felt like something was very wrong like impending doom. My heart started racing almost pounding out of my chest. I was extremely dizzy and almost fainted. Flushed feeling and tightness in my chest followed. Flushed feeling felt all day. Also had a rash on my neck and chest. 12/24/2020 12/24/2020 31 F
908952 Mild soreness at the injection site noted in the evening of 12/22 and felt chills at 11:50 pm 12/22 but no fever at that time. Woke up the morning of 12/23 at 5:30 am and had a fever of 104 general body aches and shaking rigors. Took Tylenol and the fever came down. I was extremely fatigued and was in sleeping for most of the day on 12/23 and had no appetite . I informed my place of employment on the afternoon of 12/23 that I may not be able to report to work as scheduled on 12/24. Stayed home 12/24 but noticed an erythematous rash on my trunk around 3pm 12/24. I continued to alternate Tylenol and Motrin on 12/23 and 12/24 for general aches. 12/22/2020 12/22/2020 65 M
908953 Severe muscle aches/pain throughout my entire body as well a consistent headache which I believe caused the nausea.  For a period of an hour, I was having muscle spasms which them subsided. My body hurt so badly that I had a very difficult time turning from side to side and getting out of bed. At one point, I felt so badly that I thought I would have to be hospitalized. I started feeling a bit better by 8am but then started feeling badly again around 10am or so.  I'm feeling better now, 4:25pm. 12/23/2020 12/23/2020 45 F
908958 Vasovagal syncopal episode, fainted within 10 minutes of vaccine, rapid returned to baseline after episode 12/23/2020 12/23/2020 46 M
908996 About 1-2 minutes after vaccination, I developed palpitations, tachycardia, tingling, and also a scratchy throat and full sensation in my throat. The palpitations, tachycardia, and sensations of a full throat lasted approximately 10 minutes and tingling several minutes. The scratchy throat lasted approximately 1.5 hours. Also, several minutes after the injection I developed twitching of my fave lasting several minutes as well. 12/23/2020 12/23/2020 34 F
909054 immediately after injection, facial flushing, then continuous waves of flushing and chills through body, from abdomen to toes, lightheadedness, cold hands and feet. This occurred for several hours and did not worsen nor did this improve. Tongue felt numb, and mouth was dry.  Tongue felt swollen, however, the tongue size was normal. No rash, no fever and no shaking. Blood pressure, Oxygen saturation were normal. No breathing difficulties. I was observed in the ER and administered iv Benadryl 25 mg and pepcid, and iv fluids. I woke up a few hours later. I still had the rushes of chills, numb tongue, and cold hands and feet. I was discharged to home. I still have the rushes of flushing and chills that flows through my body. 12/24/2020 12/24/2020 67 F
909079 within a few minutes  I became  overly warm and feeling  dizzy, my blood pressure went up to 189/80 and my pulse elevated to 99.  My normal levels are usually 120/70 and pulse 54-60.  I had acute anxious feeling and overall body shaking. I was taken down to the ED by stretcher, I received the vaccine in the hospital setting,  I stayed in the ED for 3 hours and was discharged home.  I felt fatigued and weak for 24 hours after. 12/23/2020 12/23/2020 59 F
909094 Site reaction. Red, swollen, hard and warm. Fever. Severe body aches, chills, shaking, cough, SOA, headache, fatigue. 12/23/2020 12/23/2020 39 F
909136 more than usual bowel movements and body tingling all over at random.  Body tingling would occur more during strenuous movements and would occur with presyncope sensations without having a syncope episode 12/21/2020 12/22/2020 38 M
909149 Received vaccine at about 0830 on 12/24/20, at about 0100 on 12/25/20 started feeling lethargic then developed nausea and vomiting, additionally had mild to moderate shaking chills and mild myalgias.  Went to sleep and resolved when woke up in AM. 12/24/2020 12/25/2020 29 M
909153 Approximately 10 hours after vaccination I developed sudden onset of fatigue, severe headache, lightheadedness, cyclical chills, tachycardia, bilateral conjunctival erythema, excessive tears and muscle spasm which lasted for about 4hours 12/23/2020 12/23/2020 37 F
909159 Pfizer-BioNTech COVID-19 Vaccine EUA: During vaccine administration patient complained of flushing, lightheadedness, dizziness, and arm tingling. No loss of consciousness, respiratory symptoms, or gastrointestinal symptoms reported. Inital vital signs: Blood pressure 147/84 mmHg, heart rate 115 beats per minute, oxygen saturation 95% on room air. Repeat vitals ten minutes later: blood pressure 123/60 mmHg, heart rate 77 beats per minute, oxygen saturation 98% on room air. Patient monitored for 30 minutes. Symptoms improved with time and snack. Patient was discharged in stable condition. 12/22/2020 12/22/2020 35 F
909165 At the time of the injection sharp pain across my back , then at about 5 mins after feelings of light headedness, progressing pain across my back, trouble feeling like I could get enough air in with breathing and dizziness and I tried to get to the floor to sit or lay  down but passed out. Then the next event I recall was a sharp pain in my thigh(apparently administered Eli pen) . I regained consciousness and was gasping andI was told I had been given a shot of epi. 12/21/2020 12/21/2020 35 F
909168 Pfizer-BioNTech COVID-19 Vaccine EUA:  Patient reports dizziness, lightheadedness, and mild skin reaction (redness) at injection site soon after receiving vaccination. No respiratory or gastrointestinal symptoms reported. No loss of consciousness reported.  Initial vital signs: blood pressure 141/72 mmHg, pulse 121 beats per minute, respiratory rate 24 breaths per minute, oxygen saturation 98% on room air. Repeat vital signs a few minutes later: pulse 105 beats per minute, respiratory rate 20 breaths per minute, oxygen saturation 94% on room air. Juice, snack, and ice pack provided. Vaccine administration site cleaned and patient monitored for one hour after vaccine administration and symptoms resolved. Patient left ambulatory in stable condition. 12/23/2020 12/23/2020 27 F
909205 On 12/24 I started having muscle twitching in my back, shoulders, eyes and my mouth are felt drawn up. It subsided after about 15 minutes. On 12/25 the same thing happened, bit twitching muscles also affected my arms and hands. It lasted about 35 minutes. 12/01/2020 12/16/2020 50 F
909207 Feeling that something was wrong, headache, racing heart beat, short of breath, dizziness, weakness, inability to stand, hot then cold, shaking, chills, 12/24/2020 12/24/2020 29 F
909275 shaking chills, sweats, fever 12/23/2020 12/23/2020 55 M
909292 Headache, nausea, dizziness, dehydration, weakness, shaking 12/21/2020 12/21/2020 55 F
909350 Dizziness, syncope, nausea, feeling of going to faint. 12/22/2020 12/24/2020 30 F
909367 Body aches and pains (started at 8PM), shaking chills and really cold(1:30 AM), nauseous (1:30 AM), fever 100.5 (8:45AM and throughout the day). The next day, some coughs cause my head hurts, aches and pains, low grade fever. Treatment:aspirin and benadryl. Doing better than the day before. 12/24/2020 12/24/2020 53 F
909379 near syncope, hypotension, nausea/vomiting, tachycardia (120-150) within 5 minutes of administration. did not resolve and worsened within 1 hour. Pt went to ER for workups. Received IV benadryl without improvement.  Admitted to hospital overnight for continuous cardiac monitoring. Improved overnight and discharged in the afternoon 12/24/20. 12/23/2020 12/23/2020 28 F
909411 Second day on December 21 had moderate arm pain extending up neck to base of head. Dec 22 pain was gone but began to have continuous twitching of left eyelid, Dec 23 eye pain.  Started prednisone dose pack on Dec 22.  Eye twitching gradually improved and am currently having minimal symptoms 12/20/2020 12/22/2020 43 F
909419 57 hours after vaccine, I woke up with stomach cramps, diarrhea, chills/sweats feeling awful and soon after had a sudden syncopal event while walking back from the bathroom. I recovered, laid in bed and then within 15-20 minutes had diarrhea again so went to the bathroom and had another syncopal episode on the toilet (both witnessed by my husband) with diarrhea during this episode. I then went to the ER and was treated with 3L IV fluids for hypotension, IV zofran and bentyl. I left the ER within about 3 hours. still have been fatigued but was up most of that night. my body all hurts but I fell into my bedframe face first during the first syncope so would relate that to those symptoms/injuries. 12/22/2020 12/25/2020 37 F
909422 Within grove minutes of receiving the injection my throat closed, my heart raced. My pulse was 107 my oxygen was low around 89-90 I believe. My neck became red with a rash and I was shaking. I was taken to the emergency room as the shot clinic was attached to the hospital and received Benadryl 25mg and Predinose 50mg. I have no known allergies that have ever caused an anaphylactic reaction. I have never had vaccine reactions in the past either. 12/23/2020 12/23/2020 34 F
909433 Pt began feeling flushed, tremulous, c/o weird sensation in throat. developed rash. Had near syncope. 1-2hrs of symptoms. 12/26/2020 12/26/2020 27 F
909455 Fever 102.8 Myalgia  Chili?s Muscle spasm Severe headche 12/24/2020 12/24/2020 54 F
909457 Day 1/2 - Headache, Pain at injection site/slight arm sweeping, tiredness Day 2 - nausea, tiredness, dizziness, shortness of breath, feeling hot/flushed, fainted (led to a 911 call / ED visit) 12/24/2020 12/24/2020 39 M
909460 After 5 minutes, tachycardia, lip tingling, tremors 12/22/2020 12/22/2020 36 F
909494 Eyes twitching, headache, and nausea. 12/22/2020 12/27/2020 34 F
909504 Extreme muscle twitching in the left wrist muscles 12/16/2020 12/24/2020 57 M
909511 Dizziness, syncope, nausea, fatigue 12/01/2020 12/27/2020 66 F
909523 passed out twice - at 5pm on 12/26 & 8:30am on 12/27 12/26/2020 12/26/2020 24 F
909533 High blood pressure  Pain in injection site  Light headed Fatigue  Headache Body aches shaking 12/26/2020 12/26/2020 59 F
909559 Attempted to sleep but could not focus and kept having problems all night not being able to sleep. Woke up sore and with a headache and a bit of nausea. Was shaking a little in the morning. 12/26/2020 12/27/2020 19 M
909563 Chest pain followed by syncope approximately 5 minutes after injection. 12/26/2020 12/26/2020 20 F
909590 Had the expected side effects of arm pain, body aches, headache and chills beginning several hours after vaccination. The morning after the vaccination, I felt like I would be okay to go to work, so got up to take a shower.  Felt very lightheaded in the shower and fainted.  Fell to the floor outside the shower, hitting my head on the tile floor.  Was later able to proceed with going to work.  No other ill effects or treatment. 12/23/2020 12/24/2020 55 F
909635 Palpitations, shortness of breath, chest tightness, presyncope, which led to New onset atrial fibrillation with rapid ventricular response and required synchronized cardioversion and hospitalization. Discharged on anticoagulation and beta-blocker. 12/21/2020 12/22/2020 46 M
909651 Severe headache, chills, sweating, stomach upset, altered mental state, vision impairment, shaking. Started 30 minutes after injection and increased in severity over the next 48 hours then began to decrease. Headache is still present 4 days after injection. 12/23/2020 12/23/2020 34 F
909680 Patient reported she had been feeling anxious about receiving the vaccine all day due to its newness.  About 10 minutes after receiving the vaccination she reported an elevated heart rate per her watch. Her hands were shaking mildly.  She denied chest pain, shortness of breath and/or dizziness.  Palpated radial pulse was 130s-140's. BP was 150's/70's.  She was taken to hospital emergency room; she declined any medications. Through  use of meditation techniques and calming practices, her heart rate lowered to 90's, then returned to 120's then lowered again to normal heart rate. 12/23/2020 12/23/2020 27 F
909691 Shortness of breath,  chest pain, itching, near syncope,  blood pressure spike 12/26/2020 12/26/2020 20 F
909703 Dizziness, shaking and Nausea 12/18/2020 12/18/2020 58 F
909741 Headache beginning two to three hours after the injection. Generalized malaise approximately 9 pm.  Awoke from sleep at 1 AM with severe chills and tremors lasting until 3 AM.  Temperature of 103. Back to sleep and awoke at 4:30 with severe headache and N/V.  Temperature 100.8. Muscle aches, headache extreme tiredness throughout the day on the 25th.  Chills again around 11:00, temp 100.1.  Generalized malaise, stomach cramping and headache lasted throughout the day.  Awoke on the 26th at approximately 2am  with night sweats. Went back to sleep and awoke at 8am on the 26ths with wet blankets and pajamas.  Felt better after showering. Still had a headache but didn?t really hurt unless sneezing or coughing.  Well enough to go to church.  After returning had diarrhea a couple of times. Now only a lingering heaviness in center of my chest and need to cough that I have had since a week before my Covid diagnoses in November 12/24/2020 12/24/2020 57 F
909778 8:27 Hives, itching all over chest and on tongue, tongue swelling, slight difficulty swallowing. 8:30 epi administered/ benedrly 8:32 pseudo seizures begin off and on till the 27th 12/26/2020 12/26/2020 20 F
909791 syncope, anxiety, nausea, vomiting, diarrhea, perceived tongue swelling although no visible swelling 12/27/2020 12/27/2020 F
909819 Excessive thirst 15mins post  Heart palpation with fluttering sensations 30mins post HTN 156/96, 80hr, 1hour post  Chills 1hour post  Muscle spasms with cramping throughout body 45mins post Muscle weakness to left side 2hour post Facial twitches Treated with tylenol and Gatorade and rest. Symptoms lasted 48hours post. 12/22/2020 12/22/2020 49 F
909909 12/23/2020 0200 Severe tremors and Chills. Nausea, dizziness, & near syncope. Headache. 0700 Softball size lump(edema), 6"x6" area erythema, hot to touch, and pain at injection site. Difficulty raising arm due to pain. Fatigue. 12/25/2020 0100 Awakened hot and sweating which lasted approximately 6 hours, fatigue. Arm issues continued. 12/26-27/2020 Arm slowly improving but fatigued and headache continued. 12/28/2020-Improved but headache continues. 12/22/2020 12/23/2020 64 F
909925 12/25/2020 08:00AM patient awoke with left eye twitching, mouth drawn to left side. Neck severely aching from right earlobe to the back of neck, severe headache. Unable to close left eye.   ER visit  12/26/2020 in the morning - discharge diagnosis, Bell's palsy. Prescription Valacyclovir hcl 1 gram tablet,  Butalbital, Acetaminophen, Caffeine Oral tablet 50-325-40mg , solution eye drops , Azithromycin cream 12/23/2020 12/25/2020 59 F
909946 pt received a COVID vaccine of moderna and within 15 minutes pt c/o throat feellng itchy and tight down low. Also, c/o of tingling in fingers and toes. Pt noticeably shaking. Pt has a hx of fainting with needles. Pt become more anxious and requested and ambulance to be called.  Color was flushed. B/P 169/99 P146 SPO2 99%. For pts comfort gave O2 at 2L/min via NC. Pt remained alert and oriented and talking. EMT administered Benadryl 50mg IM.  Ambulance escorted pt to ER where only observation was done. F/U with pt about 2 hours later. Pt states she believes she panicked and was doing fine right now. No other issues. 12/23/2020 12/23/2020 43 F
909989 Dizzy, nauseous, headache, body aches, fatigue, black tary stools., diaphoretic, near syncope 12/22/2020 12/24/2020 32 F
910052 1006:  received vaccine 1022: 15 min observation complete - no difficulties 1034;  lightheaded "wash" in my head lasting tremors were from the initial lightheadedness and numbness or additional side effects.  I was driving my car, alone and became nervous. 11:30 25mcg benadryl capsule taken ~13:00 numbness of face resolved. 12/21/2020 12/21/2020 55 F
910058 Vasovagal like reaction after a light 1 mile walk. lost consciousness. 12/17/2020 12/17/2020 33 M
910062 Diaphoresis, syncope, and hypotension. 12/28/2020 12/28/2020 28 F
910073 12/20/2020 WITHIN MINUTES,  I STARTED TO FEEL PINS AND NEEDLES. RADIATED LEFT TO RIGHT SIDE OF ARMS, AND THEN UP TO HEAD. NUMBNESS AND TINGLING. SEVERE PROFOUND WEAKNESS, DIZZINESS AND ORIENTATION. VISION FELT 'FAR AWAY'.  HR INCREASED, HX SVT. 3 MINUTES BP  WAS 'OK' BUT I BELIEVE IT BOTTOMED OUT. HR WAS 150. STRETCHER, TX TO ER. BLURRY, 'STAY WITH US'. ALERT, AWAKE, VERY IN AND OUT OF FOCUS. FEEL LIKE 'PTSD' FROM THIS EXPERIENCE. 'WHOLE BODY WAS BUZZING'.  IV STEROIDS, IV BENADARYL, IV FLUIDS, IV ATTIVAN (NO EPI AS NO DIFFICULTY BREATHING) STILL FEELING 'DAZED' *FLU SHOT REACTION 2013 - BRONCHOspasm, MILD. 2014 - BRONCHOspasm,  RINGING IN EARS, INCREASED HR, DRY HACKING COUGH, USED NEBULIZER AND TOOK BENADRYL. LASTED 4 HOURS.  ALLERGIST APPT 2020 - ADMINISTERED FLU SHOT UNDER GUIDANCE; SCRATCH TEST; BROKEN UP INTO 2 DOSES. INFORMED NOT ALLERGIC TO FLU SHOW 'GOOD TO GET COVID SHOT'.  *STILL HAVE TINGLING IN LEFT THUMB 12/20/2020 12/20/2020 52 F
910075 Uncontrollable shaking, muscle tremors, cramping of muscles in legs, calves and thighs,  generalized fatigue and body aches, fever 103, diarrhea, vomiting, extreme headache, extreme soreness in arm where injection was given with limited range of motion.  Egg size lump, bruising and rash at injection site.   Most all symptoms lasting 2 days. 12/23/2020 12/24/2020 56 F
910160 arm stiffness, cough, dizziness, ringing in ears, muscle aches and spasms.  Seeing Primary care for symptoms and dizziness has not improve and ringing in ears has worsen.  Recommend from to get a MRI. 12/23/2020 12/24/2020 51 F
910190 At 6 hours post vaccine (1400 on 12/26/2020), I woke up from a sound sleep  sneezing convulsively and experiencing a headache, nausea, and extremely runny (literally gushing) nose and eyes. Within several hours, I also experienced swollen eyes and face as well as scratchy throat and slight cough.  No effect: ibuprofen; ibuprofen; phenylephrine; loratadine; fexofenadine  Effective: benadryl 100mg. q6hr(I was unable to take this previously because it puts me to sleep; once I was pulled from the work schedule I was able to take this) I have now taken three doses of 100 mg- as it wears off, some of the symptoms return, but they are gradually lessening.   Since I am an RN, I am comfortable doing home treatment with my employer/employee health representative aware of the situation. 12/26/2020 12/26/2020 62 F
910202 Pediatrician working in the hospital. Was exposed the an office contact wo had covid.  Shoulder in soreness. At work on  Wednesday. Felt lightheaded had to sit in chair. That's all he reminders.  He workup to a CODE team putting oxygen on him. He has a seizure. Took the COVID test has COVID. Admitted to hospital for 2 days. Likely a syncopal  event. 12/18/2020 12/23/2020 39 M
910206 30 minutes after vaccine administered, pt had irregular heart beat (felt like it was going to come out of his chest through his neck). Lightheadedness, and terrible headache.   Skin of chest and stomach were red.   Pt received treatment in the ER, received IV benadryl, IV steroids, and anti-nausea medicine, and IV fluids.   Pt was cold and shaking, couldn't stay warm.  4 days later, patient is still cold and fatigued. 12/24/2020 12/24/2020 36 M
910237 23 y.o. male who arrived by to the emergency department for suspected allergic reaction.  Patient received his Covid vaccine 3 hours prior to ED arrival.  Initially he was asymptomatic however, as the morning progressed, he developed a redness around the injection site.  He then noticed a rash all over his face, that was mildly itchy in nature and felt warm.  He denies any associated wheezing, shortness of breath, facial swelling, throat swelling, severe abdominal pain, vomiting, lightheadedness, dizziness, or syncope.  He has not taken anything for his symptoms, and they continue to worsen.  He has no prior history of allergic reaction to vaccines or other known allergies in the past.   He states this is mildly itchy in nature.  Patient was given 50 mg of p.o. Benadryl and Pepcid for symptomatic control.  He was observed in the ED for 2 hours without any progression of his symptoms, no associated facial swelling, wheezing, shortness of breath, abdominal pain, vomiting, or hypotension to suggest anaphylactic reaction.  He was discharged home in stable condition 12/21/2020 12/21/2020 23 M
910273 On 12/27/2020, I woke up with body aches and a headache around 0530. At 1230, I began experiencing severe stomach pain. I went into the bathroom and began sweating profusely. I had a bowel movement and started dry heaving. I then fell on the floor, and felt extremely weak. I did not bare down when having a bowel movement, I do not believe this was a vagal response. At this point I was still sweating profusely, my body hurt all over, I couldn't catch my breath, and I was incredibly weak. I crawled down the hall way to get my phone as I was home alone. My arms then began to tingle and my hands completely spasmed, I couldn't move them.  My fingers locked completely straight but my palms closed. I activated Siri on my phone because I couldn't use my fingers, and had her call 911. I was having a very hard time catching my breath. By the time EMS arrived (about 20 minutes on the phone with 911), I had started feeling better. I had chills, and still felt out of it, but I was breathing better and my hands unlocked. My arms were still tingling. I let them check me out. My BP was normal, my O2 sat initially said 88% but was 98 by the time they left. EKG was normal. I didn't go to the hospital with them, I stayed home. I didn't move around much the rest of the day. I felt tired and had lack of appetite. Today on 12/28/20, I'm feeling better but I am still taking it slow, just in case. 12/26/2020 12/27/2020 25 F
910309 fainted right after taking the vaccine; This is a spontaneous report from a non-contactable consumer (Pfizer company representative).  A female patient of an unspecified age received the bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; Batch/lot number, NDC number, Expiry Date: Unknown), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced fainted right after taking the vaccine (medically significant) on 17Dec2020. It was unknown if the patient received other products, and any investigation assessment was unknown. The clinical course was reported as follows: The reporter stated they had seen quite a bit on social media and on the (site name), where people have been sending around a video regarding a healthcare worker who fainted. The caller was just wondering " if Pfizer has been made aware of this. "Apparently, this was on the news. This healthcare worker was taking the COVID-19 vaccine and as she was talking to the press, she apparently fainted. It looks as if she fainted as one would do when taking blood tests or faint from fear of a shot or being worried. However, this video has been sent all over social media, as seen as an AE, and telling people to not take the vaccine." The reporter further clarified the healthcare worker was in (city name) and received the COVID-19 vaccine. As the healthcare worker was talking to the press, she fainted right after taking the vaccine. The reporter further clarified she was sent a link via (site name) from the news channel where it had the video recording. The reporter did not have a specific reporter. The reporter explained it was a " whole group that was talking about it." The reporter clarified she was in a (state name) group on (site name) with friends and family. The reporter also saw it on social media. " People are sending it left and right." When probed to determine if the reporter had any patient details or further details regarding the event, the caller stated the only information she had was that on (News name), and click on (City name) news and find the video of the healthcare worker taking the vaccine and fainting. The reporter clarified the news article was dated as 17Dec2020 "so this event must have happened yesterday." From the reporter's understanding from the news, the patient was fine, she got up.  "However, people are sending out on social media that she is dead", which the reporter did not think was the outcome. According to the news, when the reporter opened the link, it was just a regular fainting, it was not a death.  The reporter felt obligated to report and make sure Pfizer was aware of this since she had been seeing it everywhere on social media. The clinical outcome of the event, fainted right after taking the vaccine, was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. 12/17/2020 12/17/2020 F
910311 Temperature up to 102.2; Numbness in fingertips; Chills; Nausea; Soreness in arm; shaking too badly; This is a spontaneous report from a contactable Registered Nurse (patient) and Consumer (Patient's husband). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot# EK5730), via an unspecified route of administration in Left deltoid on 17Dec2020 14:00 at single dose for COVID-19 immunization.  Vaccination Facility Type: Hospital. Vaccine administered at site: No. Medical history included cervical dystonia. The patient had COVID back in Mar2020.  Symptoms were similar but she doesn't remember having the numbness in her fingertips. Family medical history: None. The patient's concomitant medications were not reported.  Additional vaccines administered on same date of Pfizer suspect: None. The patient previously took povidone-iodine (BETADINE) and experienced allergy to betadine.  Prior Vaccinations within 4 Weeks: None. AES follow prior vaccinations: None. The patient experienced temperature up to 102.2 on 18Dec2020 11:00, chills on 18Dec2020 10:00, numbness in fingertips on 18Dec2020 10:45, nausea on 18Dec2020, soreness in arm on 17Dec2020, shaking too badly in Dec2020.  No AES require a visit. Relevant tests: None. The patient received shot at 2PM. Had a little soreness in arm and took paracetamol (TYLENOL, Acetaminophen 500mg, Product strength and count size dispensed: 500mg caplets; quantity 100,  Provided 0CE3259A above date of Jan2022, Provided 484782EF17 from bottle, NDC: 49035-308-78, Manufacturer is Unknown) as pain reliever before bed, Dose: 1000mg on 17Dec2020 at 9PM. Took Ibuprofen (Product strength and count size dispensed: 200mg tablets; quantity 100, Provided 0DE2612A above date of Feb2022, Provided 604782EF8 from bottle, NDC: 49035-308-78, Manufacturer is Unknown) at dose: 400mg on 18Dec2020 at 4AM this morning. Having chills, temperature up to 102.2, numbness in fingertips and a little nausea. Clarified she is referring to the COVID Vaccine. The patient was shaking too badly. Symptoms started with Chills around 10AM 18Dec2020. Temperature was checked at 11AM Central time 18Dec2020 and checked now during report. Temperature was the same. Numbness in fingertips began 10:45AM 18Dec2020. Nausea had been on and on due to chills. Chills were aggravating the nausea. Had not thrown up. Temperature was going up and she was worried about getting dehydrated. Clarified EK5730 is from CDC Patient Card. Indication: Front line worker; lead nurse in Intensive Care and is in front of COVID all day long. A sample of the product is available to be returned, if requested, notified of mailer. Packaging is sealed and intact. The patient underwent lab tests and procedures which included temperature: 102.2 in Dec2020 and on 18Dec2020. The outcome of all the events was unknown. Serious: Yes, Seriousness criteria-Other medically important condition: No (as reported). Reporter seriousness for Temperature up to 102.2, Chills, Numbness in fingertips, Nausea: Medically significant. Relatedness of drug to reactions/events: Reaction assessed: Temperature up to 102.2, Chills, Numbness in fingertips, Nausea; Source of assessment: Primary Source Reporter; Source of assessment: Global Introspection; Drug result: Related. Verbatim event relatedness: COVID-19 Vaccine: Temperature up to 102.2, Numbness in fingertips-Related.; Sender's Comments: Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events, temperature up to 102.2, chills, numbness in fingertips, nausea, soreness in arm, shaking, are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. 12/17/2020 12/01/2020 64 F
910329 Non-itchy slighlty raised rash that appeared about 24 hours after vaccine at location of shot that extended up to shoulder and down to elbow. It went away after another 24 hours.    1 week after vaccine, developed lip twitch on side of body that vaccine was administered. Still persists 1 week later, but is not as intense 12/15/2020 12/16/2020 42 F
910337 vaccine at 11:30 am on 12/18/20  and after 15 mins she felt the room started to spin, dizzy and tunnel vision.  nausea and dry heaves also  2-3 mins after.  persistent dizziness.  pruritic rash and was taken to the ER by wheel chair. About an hour after the vaccine, she felt something in the back of her throat, speech ok, able to swallow.  No sob. She was treated with benadryl, pepcid, zofran and fluid.  She felt very hot and shaking. In the ER, she noticed that the rash had progressed to her back.  Notes chest redness, back with erythematous, raised pruritic bumps on back and arm (smaller size of dime)  Within 4 hours of treatment, she had improved.  That night at 2am she had a rash -not as pruritic.  She took more benadryl.  No rash after. No new meds, no nsaids.  She has never had any medical problems or rashes before.      Her symptoms are concerning for anaphylaxis but it is reassuring that her vitals were ok and that she did not progress and improved with benadryl and pepcid - advised to not get 2nd vaccine dose - will plan on skin testing her in the future 12/18/2020 12/18/2020 28 F
910367 I got vaccine tonight ~1750. I felt fine immediately after and stayed for the recommended 15 minutes.  During my drive home, ~20 minutes, I had some expiratory wheezing and a sensation of something in my throat. No angioedema or swelling.  No skin symptoms.  This was mild but made me think twice so I drove back to the er.  The wheezing resolved, but I felt like I was going to faint with hot flushing and nausea in the parking lot.  I didn?t go in because things seemed better and my stomach was turning like I was going to have diarrhea.  Since the wheezing was gone, I decided against going in.  I stayed in the parking lot for ~ 15 minutes and feeling of unease and presyncope waxed and waned, but eased.  I continued with some nausea. I had waves of nausea, chills, flushing, and presyncope. The wheezing didn?t return. No tachycardia.  I had chills and nausea on the drive home and at home. Took Tylenol and Pepcid when I got home and feel absolutely fine now after ~2 hours of fluctuating nausea, chills and sense of unease/anxiety.  None were as severe as they were when I was in the parking lot.  Throughout, I didn?t have high or low heart rate.  After 8 pm or so, I feel just fine. I have zero symptoms now. 12/21/2020 12/21/2020 38 F
910383 Moderna COVID-19 Vaccine  Nausea/Vomiting/Diarrhea upon awakening on 12/24. Lightheaded, near-syncope, diaphoretic. Lasted approximately 3 hours. Vomited then nausea subsided after about 1hr.  Chills starting 12/26. Difficulty warming up after being outside in the cold. Prolonged effects that are not normal for me. 12/28 cold/clammy hands despite being in warm environment. 12/23/2020 12/24/2020 42 F
910547 I'm not sure this is entirely vaccine related, but I wanted you to be aware. I occasionally experience unexplained swelling of my lips. It has been investigated by an allergist, but the cause is unknown -- doesn't appear to be a food allergy (no trigger foods identified, and it has never appeared immediately after eating), and may not even be histamine related.     It could be something immune-system related, and my experience this weekend might support that.     I had normal, expected symptoms on Friday evening (chills, headache). Those resolved Saturday. Saturday night, my lower lip swelled dramatically. Swelling spread into the upper lip as well. I have seen this before, but this was one of the more severe instances I have experienced.     Lips remained swollen overnight. When I woke up Sunday morning and went to the restroom, I became suddenly lightheaded and passed out. That's a symptom I have never experienced before. I consulted with my primary care doctor and took it very easy the rest of Sunday. He and I will follow up to further asses what happened. No further light-headedness on Sunday or today. Lips eventually resolved late in the afternoon.     This is all about 72 hours after the vaccine, so I can't be sure it is related, but I do wonder if it is related to having my immune system revved up by the vaccine. I reported it on the CDC check-in app and my primary care physician is noting it on his side as well. 12/24/2020 12/26/2020 45 M
910574 Fever 103F, shaking Chills Responded to Tylenol.  Afebrile 12 hours later 12/24/2020 12/25/2020 56 M
910576 Fever 103F, shaking Chills Responded to Tylenol.  Afebrile 12 hours later 12/24/2020 12/25/2020 56 M
910585 Extremely painful legs; abdomen spasms; abdomen spasms and cramps; severe chills; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient (not pregnant at the time of vaccination) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 17Dec2020 04:00 PM Intramuscular in Right arm (also reported Arm Left) for Covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Medical history included hypothyroidism, hypotension, obesity, and allergies to onions. There were no other vaccines received in four weeks; however other medications received in two weeks. Patient experienced extremely painful legs and abdomen spasms and cramps, severe chills on 17Dec2020 09:00 PM. Patient applied arnica 35% on the affected area and it helped. Since the vaccination, patient had not been tested for COVID-19. Outcome of the events was resolving.  The events were reported as non-serious.       Information on lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of extremely painful legs, abdomen spasms and cramps, and severe chills cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/17/2020 12/17/2020 52 F
910587 I received my first dose of Moderna vaccine at around 9:45 am on Dec 24 and I was fine for like 4 hrs after receiving it, until I started feeling similarly to the way I felt when I tested positive for Covid and had it at the beginning of November (feverish, headache, body ache, stuffy mucusless nose, fatigue, hangover sensation like nauseated and weird, etc...) Things got a little bit worse when all of a sudden I started feeling feverish and my heart started beating so fast I could hear it myself. I had to stop doing what I was doing and called (my insurance/MCD) because I was getting anxious and started hyperventilating, which did not allow me to breathe normal. They told me to take Tylenol which I did and little by little my fever started decreasing; it must have been almost 100 F at that moment. Then once again like 5 hrs after I had taken Tylenol I started getting fever again and this time I got extremely cold also and I was shaking so much and felt so weak I had to lay down and call  once again; they told me to have someone take me to their urgent care center and I went there and they retested me for Covid but it was negative this time. Since I had taken Tylenol (2nd time same day, 6 hrs apart) just before I left, my fever was not that high when I showed up there. They told me studies have showed some people experience similar symptoms but when they get the 2nd not the 1st dose; however, they thought it could happen too. I had fever nonstop for almost 48 hrs; it was so high (101.7- highest reached). The rest of the time?at night when I was trying to sleep, obviously I could not take my temperature, I was half awake, half sleep hallucinating, shaking, cold, then hot and sweating a lot and speaking non sense in my sleep (according to my spouse)- this happened both nights. On Dec 26 I woke up feeling not great but definitely better but had a little headache and still felt somewhat nauseated. My last dose of Tylenol I took at 8 pm on Dec 25. I have been feeling better for the past two days but I still feel a little bit tired and not back to my normal self. 12/24/2020 12/24/2020 46 M
910600 Reporting on behalf of patient. He self reported to the Medication Safety Coordinator, that he was woken up from his sleep the night after receiving the vaccination, with his jaw moving side to side uncontrollably. This lasted for a couple seconds, would stop, and then would happen again. This occurred about 3 times total. He also felt twitching in his forehead a couple times. These episodes self resolved and did not happen again. 12/21/2020 12/22/2020 52 M
910620 freezing and could not get warm; shaking; sick; Chills; tired; lightheadedness; Redness at injection site; Believe the vaccine was given subcutaneous; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899 and expiration date: Mar2021, via subcutaneous route in the back of right arm where the fatty area far away from deltoid, first dose on 17Dec2020 18:15 at a single dose for routine vaccination. The patient's relevant medical history was none. There were no concomitant medications. The reporting nurse was reporting for herself for the covid vaccine. She received the vaccine and believed it was administered subcutaneously versus in her deltoid muscle on 17Dec2020. She had redness at injection site on 18Dec2020. She also reported chills, lightheadedness and was tired on 18Dec2020. She added that the symptoms did not happen until after Friday night (18Dec2020). She doesn't think she could have continued working as sick as she was that night. She did not know if it was medically significant though. She went between not serious and medically significant and then stated she guessed it would be medically significant. She was freezing and could not get warm and was shaking. She did not notice the redness until Friday night around 3pm. The redness has improved, but it was still there. Unknown time for when it first started, but the first that she noticed it was around 3pm. Lightheadedness started around 1pm on 18Dec2020. The tiredness started around 3pm on 18Dec2020. The chill started around 7pm on 18Dec2020. They all improved by Saturday, 19Dec2020. Part of this report is that the doctor said it was in her triceps muscle and she does not think it was. They pinched the skin and put it in. She said her muscle was not sore. As a nurse, she believed it was not in her triceps area.  It was not in the deltoid area and that was suggested from Pfizer. The reporting nurse's seriousness for 'believe the vaccine was given subcutaneous' was medically significant, while non-serious for 'Redness at injection site'. The patient had no ER nor physician visit required; she had no prior vaccines within 4 weeks. The patient does not have a positive test for SARS-CoV2. She does not have SARS-CoV2 antibodies at diagnosis as she has had blood test a couple of months ago, either end of Oct2020 or beginning of Nov2020, and there were No antibodies at that time. The patient was not hospitalized nor was she admitted to an Intensive Care Unit (ICU). The patient did not display clinical signs at rest indicative of severe systemic illness. She did not have supplemental oxygen (including high flow or ECMO) nor received mechanical ventilation. She did not receive any additional therapies for COVID-19. The events did not require the initiation of new medication nor other treatment or procedure. The outcome of the events chills, lightheadedness, tired and Redness at injection was recovering while unknown for believe the vaccine was given subcutaneous, freezing and could not get warm, shaking, and sick.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. 12/17/2020 12/17/2020 56 F
910629 Patient evaluated and monitored following vaccine. Developed nausea and lightheadedness approximately 20 minutes after dose given. Patient reports that she hadn't had anything to eat or much to drink in the hours leading up to vaccine as she and her husband were going to get lunch after the vaccination appointment. Patient has a history of syncope/presyncope after a blood draw in the past.  Patient had no other stx other than very transient nausea and lightheadedness, which improved significantly in the hour that she was monitored.   BP at time of discharge from clinic was 105/73; pulse 67 12/27/2020 12/27/2020 26 F
910630 the individual has had seizures that have lasted apprx 3 days; anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine on 19Dec2020. 12-15 mins after receiving the vaccine, the individual has had seizures that have lasted approximately 3 days, has had multiple seizures since then. The patient was taken to the Emergency department, given epipen (Epi pen), was without symptoms for 24 hours at some point, during the 3 day time period and as of 22Dec2020, the patient was continuing to have seizures. The patient started having issues again on 21Dec2020 and 22Dec2020 (yesterday and today). He had more issues with seizures last night on 21Dec2020 and had seizures this morning. The individual also had an anaphylactic reaction in Dec2020 but didn't not elaborate on this. The reporter was wondering if he can get information that this has happened before and wanted information on reversing the situation because the doctors need help. Outcome of the event seizures was not recovered, of other event was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events seizures and anaphylactic reaction cannot be excluded based on compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. 12/19/2020 12/01/2020 19 M
910636 Nurse that fainted after the vaccine; This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer.  A patient of unspecified age and gender received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was a nurse who received the vaccine and did a live press conference on TV 15 minutes later and, as a result, she fainted. The event outcome was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. 12/25/2020 U
910713 12/21 SITTING IN CHAIR, FELT TINGLING IN EAR, 'FEELING FAINT'. MOVED TO CHAIR AGAINST THE WALL, TOLD MEDICAL STAFF. fainted, SWEATING PROFUSELY, 'WANTED TO GO TO SLEEP'. MONITORED HR, BP. VOMITED. BP WAS STILL ELEVATED 136/100. 'FELT BETTER' AFTER VOMITING, COLOR CAME BACK, 'CAME TO'.  ER: BASAL EVENT ABOUT TO DISCHARGE, TINGLING CAME BACK. NOTHING ON MONITOR INDICATED ANY PROBLEMS. EVENTUALLY DISCHARGED AS SYMPTOMS DECREASED.  DIAGNOSED; syncope 12/21/2020 12/21/2020 38 F
910745 tachycardia, hand tremors 12/28/2020 12/28/2020 37 F
910791 11:33 Patient arrived to the observation area with nurse at side. Nurse observed upper body twitching and stated that patient voided in the chair.  Patient looks dazed and pale and requests to lie down.  Patient placed on stretcher with head down and feet up. Initials vitals taken. HR 38. Call was placed to EMS.  Patient states that she felt anxious while waiting and has a history of panic attacks.    11:40 Patient appearance has improved.  2nd set of vitals taken show improvement.  Patient states that she feels better and placed a call to her daughter. Awaiting EMS arrival.  11:45 Patient transported via EMS to ED for further treatment and follow up.  15:00 Follow up call placed to ED.  Patient stable and may be admitted for further observation 12/26/2020 12/26/2020 54 F
910823 Recipient received her vaccine  and was sitting for observation when she reported feeling light headed about 5 min after the administration. 30 seconds after recipient became unresponsive and stopped breathing for 15 seconds, legs were elevated Code blue was called, after about another 30 seconds recipient  become aroused and coherent. Vitals were taken- pt. was tachycardic- 120s- came down to 80s, BP 120/80, 90% O2-eventually went up to 98%.  Temp 97.3. Med cue was called and took over to evaluate Pt. Pt. did report has had hx of vasovagal syncope. 12/28/2020 12/28/2020 61 F
910844 Headache, lightheaded, nausea, dizziness, muscle aches, malaise, and chest "squeezing" prior to syncopal episodes x 3. This occurred in OR where she works. "I don't know when I passed out." Rapid Response called s/p sternal rub by MD not effective. Taken to ED via stretcher. In ED, had EKG, IV fluids, Benadryl, and Phenergan. Regained consciousness on arrival to ED. Cleared to return to work on 12/24 by MD in ED. Will follow up with PCP. 12/22/2020 12/23/2020 44 F
910879 Heart palpitations, shaking and feeling of adrenaline rush. 12/28/2020 12/28/2020 45 F
910900 Pfizer-BioNTech COVID-19 Vaccine: Approximately 90 minutes after receiving vaccine patient returned to clinic reporting dizziness, flushing, nausea, claminess, and hot flashes. Initial blood pressure 133/97 mmHg, other vital signs reported as stable. Patient provided with ice pack, water, and snack. Patient was observed for one hour and symptoms improved. No loss of consciousness or respiratory symptoms reported. Patient left clinic stable. 12/23/2020 12/23/2020 27 F
910959 33 y.o. male with no significant past medical history except for obesity who has been working as a nurse in the emergency room department in our hospital and today he received COVID-19 vaccine and 30 minutes later patient started having increased saliva, cold hands and feet, left-sided pressure-like headache and some numbness in his legs at the same time he suddenly started talking only in first language and lost his ability to speak in second language.  He understand second language but replying first language stating that he is talking in second language.  On exam he was alert oriented confused by people not understanding his second language stating that his numbness and cold feeling in the hands and feet have improved.  Initially patient received 10 mg of Decadron for possible allergic reaction he had a head CT scan that was negative and his labs were remarkable only for hypokalemia.  Patient had no prior history of any neurological symptoms he was advised admission to the hospital for observation     Patient symptoms resolved next day,he is alert oriented able to communicate in second language he had a head MRI and head neck MRA that came back negative and had an EEG that showed no seizure activities.  Patient was seen in neurology consultation who felt that patient most likely had an episode of migraine headache.  Patient is going to be discharged home and to have a follow-up with his primary care physician next week 12/23/2020 12/23/2020 33 M
910968 Pfizer-BioNTech COVID-19 Vaccine: Patient reported dizziness and shakiness upon arising 15 minutes after receiving vaccination. Vital signs: blood pressure: 115/78 mmHg, pulse 73 beats per minute, temperature 36.8 degrees Celcius, respiratory rate 16 breaths per minute, oxygen saturation 99% on room air. Patient waited five minutes, stated she felt much better, and left vaccine clinic in stable condition.  No respiratory symptoms or loss of consciousness reported. 12/23/2020 12/23/2020 44 F
910998 Vasovagal syncope episode occurred right after receiving the Pfizer COVID-19 vaccine injection, patient became pallor, not diaphoretic, no c/o CP nor SOB, patient felt dizzy, HR in the50's, BP 78/50, glucose = 91, pt given water and OJ. After fluids pulse was stronger, bounding in the 60's, color improved, patient was still feeling faint, taken to cardiac intervention area to lay down, patient refused to go to ER, RRT paged and came to pod - escorted patient to lay down. Of note the patient only had 1 egg for breakfast.  Patient continued to be pale, starting shaking and was escorted to the ED for IV fluids and monitoring. 12/28/2020 12/28/2020 28 F
911028 Became dizzy, warm, tachycardic. lost consciousness (fainted?), quickly regained consciousness and was taken to the Emergency Department. Before transfer, Benadryl IM 25mg administered. 12/28/2020 12/28/2020 53 F
911035 Approximately 7 hours after receiving the vaccine patient who is a L&D Nurse return to work in her area. She describes that after finishing with a C-section she felt burning in both of her eyes (she thought this feels like an allergic reaction, but I am not sweating and haven't rubbed my eyes). She went to the restroom to get a cloth to wash her eyes; afterwards she reports her vision went totally black in both eyes. She reports feeling frustrated that no one came to help and some panic in trying to figure out how to get out of the restroom. She did make it out of the bathroom. Her Staff reports she postured and turned arms inward, head going to one side and passed out. They also report ~ 10 minutes of incoherent conversation and stating "I got the vaccine, maybe I was given the wrong thing and now I'm blind". Upon waking, patient vision fully restored and patient does not remember incoherent conversation. Differential diagnosis- TIA vs. CVA >  seizure disorder>>> complex migraine 12/22/2020 12/22/2020 47 F
911037 Tachycardia 160-170bpm, anxious, carpal pedal spasm. States she took Zyrtec and inhaler this morning (for asthma). Transferred  to outpatient clinic for assessment. 12/28/2020 12/28/2020 37 F
911050 SHORTNESS OF BREATH,  TROUBLE BREATHING, CATATONIC STATE, POTENTIAL seizure 12/28/2020 12/28/2020 43 F
911064 patient started having dizziness when she got up to leave from the waiting room 15 minutes post vaccination, she also mentioned headache behind her right eye. She was taken to an exam room in a wheel chair as she was unsteady on her feet. She was laid down on an exam table and vitals checked. She states no previous vaccine reactions, has history of seizures and has had them with increased frequency recently. Patient was released to her friend to be driven back to work 1 hour and 27 minutes post vaccination 12/28/2020 12/28/2020 60 F
911071 fainted within a couple minutes of recieving injection. Rapid response team activated and I was lifted onto a bed. Very low blood pressure. And ultimately felt better after 30 to 45 minutes of monitoring by medical team. 12/28/2020 12/28/2020 37 F
911074 12/24 ! 13:15 - 15 min after vaccine was administered p t c/o dizziness and shaking. was monitoring for further 15 minutes by vaccine staff. Then apx 06:00 pm that night started c/o chills, N/V, tremors, Fatigue, headache, and feeling flushed. continued thru 12/26. then 12/27 woke up with headache, n/v, chills, tremors and body swelling. 12/28- c/o nausea and headache.  Treated with Tylenol OTC 12/24 and 12/26 only. 12/28 Completed rapid COVID 19 test- results negative.  EDD 07/30/2021. 12/24/2020 12/24/2020 36 F
911079 Reported headache and twitching of right cheek. Took Tylenol and headache resolved day of vaccination; twitching resolved day of vaccination (unknown duration).  12/23/20 (day after vaccination) he reported a slight headache upon awakening that worsened as the day passed. He took 2 extra strength Tylenol at 10:00 AM (12/23/20).  Tylenol partially effective - headache lessened but still present.  12/28/20 update - chills, nausea, and fatigue from 12/23 - 12/28. Improvement in symptoms but symptoms are not completely resolved as of 12/28/20 per patient. 12/22/2020 12/22/2020 61 M
911115 Left Shoulder pain that started as ?oh I slept funny? to not going away with ice/heat or rest. Worsening in severity daily and spreading towards base of skull and eventually into clavicle. The pain became excruciating and I was unable to turn my head at all to the left. So bad I had to use my hands to lift my head up. I eventually went to the ED on 12/27/20. And overnight the pain became so unbareable and functionality so limited I couldn?t go to work or take care of my toddler. I returned the to ED on 12/28/20. Was advised to file adverse event and contact my employee health and safety department. I was initially examined in the ER the first time with a neck spasm. Sent home with an RX which didn?t work. At all. When I returned to the ER th next day, the physician felt my entire neck, shoulder and clavicle an noted swelling and prominent spasm. He diagnosed with a trapezius strain and a vaccine reaction. Gave me an RX for Valium which seems to help take the edge off. 12/23/2020 12/24/2020 44 F
911151 Increased blood pressure; Rapid heart rate; Chills( shaking); Chills( shaking); Chest and neck tightness; Chest and neck tightness; Teeth tingling; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), via an unspecified route of administration on 19Dec2020 12:30 at single dose on left arm for COVID-19 immunization. Medical history included known allergies: Latex. Concomitant medications received within received within 2 weeks of vaccination included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL]); ibuprofen. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020 13:00 (01:00 PM), the patient experienced rapid heart rate, Increased blood pressure, Chills (shaking), Chest and neck tightness, Teeth tingling. The adverse events result in Emergency room/department or urgent care. The patient received ER monitoring, EKG (reported as "AE treatment") for the adverse events. The events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering. 12/19/2020 12/19/2020 41 F
911170 Caller states she cant focus/She just can't focus; this is horrible/I have a hard time focusing; I'm like you know fogged; I just want to sleep/I have been sleeping all weekend that was horrible; I have some headache; I just don't feel right this is terrible; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the arm on 18Dec2020 at single dose for covid-19 immunization. Medical history included seizure. Concomitant medication included celecoxib (CELEXA), levothyroxine sodium (SYNTHROID), phenobarbitone [PHENOBARBITAL] for seizure. The patient stated that she could not focus, this was horrible and had a hard time focusing on 18Dec2020, the patient also stated that "like you know fogged" on 18Dec2020, the patient just wanted to sleep and she had been sleeping all weekend that was horrible on an unspecified date in Dec2020, the patient had some headache on an unspecified date Dec2020, she just took some Ibuprofen for the headache, the patient just didn't feel right this was terrible on an unspecified date in Dec2020. The outcome of 'could not focus' was not recovered and the outcome of the other events was unknown. 12/18/2020 12/01/2020 58 F
911356 Headache; Chills; Body ache and little bit congested; Body ache and little bit congested; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included high blood pressure, seizure disorder. Concomitant medication included metoprolol, aripiprazole (ABILIFY). The patient experienced headache, chills, body ache and little bit congested on an unspecified date with outcome of unknown. No treatment was received for events.  Information about Lot/Batch number has been requested. 12/28/2020 F
911565 The day after getting the vaccine I started having an intermittent tremor in my lower lip. This has continued through 12/29/20. 12/23/2020 12/24/2020 47 M
911625 I had tingling/swelling in tongue and body itching for 30 minutes post vaccine, then felt light headed/dizzy and almost passed out. Then about 8 hours later I noticed my arm was swollen, hard, red, puffy and hot at injection site.  It continued to get worse the next day. I was extremely tired and felt " like I was hit by a truck " for almost 2 days later. Pain in arm continued for a couple days later. 12/26/2020 12/26/2020 32 F
911626 After having covid 4 weeks ago, I got the covid vax. After an hour, arm was sore. I went through my work day. Got home and was tired, showered, and was tired. I woke up at 1am and was shivering and shaking . It was intense. I had a better reaction with the actual virus. The CDC stated that I should be 10 days out from having covid, to get the vaccine, and I did so. My arm is swollen, there is a lump where the injection was. I did not take any thing for pain or symptoms. 12/28/2020 12/28/2020 52 F
911641 Achy body Extreme tachycardia (HR in the 180s). Unable to get below 90.  Uncontrollable shaking  Migraine 12/28/2020 12/28/2020 24 F
912061 chills all night and syncope; chills all night and syncope; This is a spontaneous report from a contactable other health professional (patient).  A 39-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Unknown), intramuscularly in the left arm (also reported as the right arm) on 22Dec2020 at 15:00 at 39-years-old at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as: other. Medical history included Penicillin allergy from an unknown date and unknown if ongoing.  Concomitant medications included estrogens conjugated (PREMARIN), progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date (all of which were received within two weeks of vaccination). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Dec2020 at 00:00, the patient experienced: chills all night and syncope. The event syncope was considered medically significant; and the event chills was non-serious. There was no treatment received due to the adverse events. It was reported that prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, chills all night and syncope, was recovering.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported event syncope. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/22/2020 12/23/2020 39 M
912930 Patient was monitored for >15 minutes after vaccination. Patient told a nurse that her knees felt weak. Patient then fainted and was laying on the floor when i arrived. Patient reported she felt like she was "floating" and she did not want to "fall". She was also nausea and wanted to vomit and did not end up vomiting anything up. Patient fainted several more times. Her BP was around 143/80 and unsure about the pulse. Patient then become unresponsive for 20-30 seconds. 12/29/2020 12/29/2020 29 F
913106 The morning after getting vaccine, patient had high BP 213/159, 92% on room air, shaking, chills, LCTAB with diminishment at bases, emesis. Admitted to hospital for pneumonia. 12/26/2020 12/27/2020 82 F
913221 I received my vaccine on 12/18/2020. The side effects I experienced were initially as expected. Mild headache, muscle pain at the injection site.   However, the muscle issues have not subsided, and have actually gotten worse. Day 3 I began having a burning sensation in my underarm area radiating back towards my triceps. Muscle spasms continued to increase and spread to include deltoid, trapezius, and SCM muscles. Yesterday I developed a fever and began having a burning sensation down my triceps muscles and radiating into my forearm (radial side). No visible rash noted. Slight weakness in left arm. 12/18/2020 12/21/2020 41 F
913243 syncope, severe bradycardia followed by 20+ hours of chills, fatigue, weakness, body aches 12/29/2020 12/29/2020 27 F
913246 On Dec 28th I received the shot & initially didn't feel anything. When I woke up on the morning of Dec 29th I had a really bad headache, felt burning up & cold at the same time. My right arm (shot arm) and my left hip were super soar. I couldn't keep liquids down. I passed out the first time between 6:55 A.M. & 7:05 A.M.  Later that morning I passed out a second time for 2 mins. I still plan to get the second dose on Jan 25th 2021. Since I'm a contact tracer I texted my supervisor. I was advised to take the day off & report it just in case  it was related to the vaccine. 12/28/2020 12/29/2020 27 M
913249 30 seconds following IM injection, felt warm, flushed, lightheaded, vision dimming., near syncope. Symptoms improved lying supine. Blood pressure measured to be 90's systolic, Heart Rate 60's. NO RASH, NO ANGIOEDEMA, NO Shortness of breath. Symptoms resolved completely within in 3 minutes. 12/22/2020 12/22/2020 35 M
914179 lips were tingly and swollen; lips were tingly and swollen; fatigued; allergic reaction; passed out; breathing fast; her brain felt like a rock, like she was there but not there; head was so heavy,wouldn't open her eyes; her throat started to tighten up; chest pain; nauseous; headache; felt a little lightheaded, a little wobbly; palpitations; sweaty; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program. A 48-year-old female patient (no pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administrationon 22Dec2020 on left shoulder at single dose for COVID-19 immunization. The patient's medical history included pernicious anemia and She had problems with B12 and Vitamin D like 10 years ago, she had none in her body, everyone said she was deficient and this year with her new primary care, they sent her to do some antibody tests, and found out she has pernicious anemia, allery to MRI and CT contrast. MRI and CT contrast NDC, lot, expiry unknown. Her CT contrast allergy happened when she was 9 and 12 years old. It turns out to be her dad has an allergy the same way, his airways close. Whenever she needs a CT, they do without contrast, if she does need, they prep and give her Benadryl and keep an eye on her. This only happened once, that she needed with contrast, and with prep she was ok. With the MRI, this happened 4 or more years ago, maybe like 5 years ago. She needed an MRI, they said she would be fine, they injected contrast, she felt pretty hot, then she doesn't know, 20 minutes into it, she couldn't handle her gown, she looked at her chest, her whole chest was red like a burn. They gave her the IV Benadryl, she guesses, and it went away, now she knows, she doesn't know if her dad is allergic to MRI dye, but she knows she got the allergy from him for the CT contrast. The concomitant drugs was not reported. The patient was taken to ER with a severe allergic reaction. She had an allergic reaction on 22Dec2020: she passed out, said her brain felt like a rock, like she was there but not there, she then received an Epi Pen shot, when she got to the ER, her throat started to tighten up, lips were tingly and swollen, she was breathing fast, she had chest pain, she scaled it from a scale of 1-10, as about a 3 to 4 for chest pain, she felt nauseous, sweaty, and had a headache. She went to bed last night, and woke up, feeling better but a little fatigued on 23Dec2020. She is wondering if she should take the second dose, and wants to be in the clinical trial for this type of reaction. She needs transfer to Regulatory Authority. Caller confirmed details. Caller states she works in a hospital, and all this happened at the hospital, and her doctor was not involved. Outcome of allergic reaction: asks what does lasting effects mean? Right now she has a little fatigue and headache, but she knows they are regular symptoms she can have with the vaccine, are those lasting effects? She was discharged from the ER to home. She mentioned to the nurse she has, she went to get the shot, she told the registration nurse, she said she has a severe allergic reaction to CT contrast, her airway closes and she has a severe reaction to MRI contrast, her skin burns, it turns red and feels like a horrible burn, she cannot handle anything to contact her skin, it burns, and she mentioned that to the nurse, she said, instead of staying 15 minutes, said to stay 30 minutes there to observe just in case. She got the vaccine, and 10 minutes after the vaccine, she felt a little lightheaded, a little wobbly, but she didn't think much, it was mild, and on the mark at 30 minutes, the nurse asked her to stand, and that is when she started feeling, like her head was so heavy, the only way to describe, was like her brain was like a rock, she had to lay down, and when they laid her down, she wasn't there, she was there but wasn't, and they didn't wait at all to give her the Epi Pen, she had a feeling of heaviness that got worse, she wouldn't open her eyes, she was able to answer questions, but it was not her there, it was weird, then she didn't have. she breathed fast, had palpitations, chest pain, so they called a Rapid Response team, they were keeping an eye on her breathing, which was super fast, and they rushed her to the ED, and the doctor did what they were doing, giving her IV of whatever medication, and she was also very nauseous, then at one point in the ED, she started feeling, like imagine if fists were on throat, pushing her throat, a  little bit, and she tried to tell to the ED doctor, but guessed she was calling everyone to give her things, and didn't catch it, but it didn't last long, at the same time, she started to feel her lips tingly, so she thinks that, because they gave the Epi Pen so quickly, they wasted no time, she didn't have the airways closing like she does when she gets the CT contrast, they were quick. NDC/lot/expiry: She reads from the card they gave her: states first dose COVID-19 EH9899, states it doesn't specify lot, but she can find that out, they just gave her a vaccine record card. EPi Pen: NDC, lot, expiry unknown, states everything happened so quickly, she didn't think to get this information before calling, but she can get it. There at the hospital, she went to see the occupational health doctor, and based on guidelines from the CDC, he read supposedly she cannot get the second dose, but the doctor said because it is so new, and she has to wait the 3 weeks she guesses, things can change, and she wanted to be proactive. The outcome of the events, allergic reaction, passed out, throat started to tighten up, lips were tingly and swollen, chest pain, nauseous, headache, lightheaded, palpitations, sweaty was recovering. The outcome of other events was unknown. 12/22/2020 12/22/2020 48 F
914473 Weakness, fatigue, decreased appetite, upper extremity shaking, sternal red blotchy rash, decreased mental status, non-verbal, decreased level of conscious, mottling, left side facial droop, hypertensive, fever, unable to follow commands 12/28/2020 12/29/2020 83 F
914521 Patient presents with ? Altered Mental Status ? Headache     HPI Patient presents to ER by EMS ambulance after family called 911 as patient was incomprehensible with slurred speech and moaning on the phone this evening. On arrival of EMS patient was asleep in bed and reportedly unresponsive other that to localize to pain. EMS transferred patient to ER. On arrival to ER patient had GCS 7. Reportedly patient is locum nurse who works in a Nursing Home and patient reportedly received COVID vaccination 2 days ago and that night reportedly began complaining to family on the phone of headache, nasal congestion, sore throat, cough, fever, chills, nausea, emesis, myalgias, and lethargy. Per the medical record patient has history of seizures, migraines, and sciatica. No other information is known on patient arrival to ER.  1. Peripheral IV right dorsal hand placed by EMS in route to ER. 2. On arrival to ER GCS 7 (E1M5V1) and roving eye movements with episodic lateral conjugate and at times disconjugate gaze concerning for seizure activity. Arms and legs with moderately increased tone but no clonic movements and patient able to localize bilaterally. 3. Ativan 1 mg IVP for seizure, then further 2 mg IVP for persistent seizure. 4. Fosphenytoin 1,000 mg IVPB in ER for loading dose of antiseizure medication.  5. Patient had significant improvement following completion of Ativan 3 mg IVP and GCS improved to 14 (E3M6V5) from GCS of 7 (E1M5V1). 6. Patient able to communicate after improvement as above and reports she has had headache or migraine for past several days as well as dysuria with bilateral CVA pain and has significant pain on percussion of bilateral CVA and moderate pain on palpation of bilateral flanks. No nuchal rigidity or pain with ROM of neck.  Additionally, she complains of severe headache and diffuse pain of back and abdomen/pelvis. She reports a history of seizures in the past and reports she had one last month and was treated at a hospital in her home state. She denies antiseizure medications. Additionally, patient reports nonproductive cough, sore throat, nasal congestion, fever, chills, myalgias, lethargy, nausea, and episodic emesis over the past 2 days. She has anterograde amnesia following seizure and does not recall events. 7. Normal saline 1,000 mL IV bolus, then 100 mL/hour in ER. 8. CT of head with and without contrast performed and negative for intracranial hemorrhage, lesions, stroke, or other acute pathology. 9. CT of chest/abdomen/pelvis with IV contrast shows no acute pathology or notable abnormalities. 10. Lactic acid drawn and normal. 11. UA and urine microscopy collected by straight catheterization and culture collected and pending. 12. Blood cultures x 2 collected and pending. 12. Rocephin 2 mg IVPB in ER after blood cultures collected.  13. Vancomycin 20 mg/kg (1,500 mg) IVPB following Rocephin.  14. Dexamethasone 10 mg IVP in ER. 15. Duoneb nebulizer in ER. 16. Called to discuss with patient's daughter and the family's preferred contact who is 23 years old. She reports patient had COVID vaccination 2 days ago and beginning that night patient has complained of headache, fever, chills, nonproductive cough, sore throat, nasal congestion, myalgias, and lethargy. Additionally, she reports patient has history of seizures on at least 1 occasion in the past a few months ago but is not on antiseizure medications. She reports patient had MRI and MRA of her brain at that time and reportedly and intracranial aneurysm was identified at that time. 17. Called to request transfer to another facility and spoke with hospitalist who states there is no neurologist there and suggests transfer to larger tertiary care facility with neurology.  18. Called to request transfer and accepted by ER provider. 19. Transfer by ALS ground ambulance with telemetry, pulse oximetry, O2 to keep > 02%, vitals every 30 minutes, normal saline at 100 mL/hour, Rocephin 2 grams IVPB, vancomycin 20 mg/kg (1,500 mg) IVPB in ER.    DISPOSITION Patient Stabilized and Transferred Data Unavailable Wed Dec 30, 2020  2:12 AM CST 12/28/2020 12/29/2020 39 F
914931 Moderna COVID?19 Vaccine EUA - Metalic taste - Lump in her throat- felt like swelling - Nausea and then vomiting - shaking and started to become unresponsive. 12/20/2020 12/30/2020 39 F
915216 Weakness, headache, high level myalgias, fever, nausea, cold intolerance, shaking 12/30/2020 12/30/2020 34 M
915478 erythema, tachycardia, tachypnea, headache, uncontrolled dystonic shaking 12/30/2020 12/31/2020 55 M
915480 Developed sudden onset of shaking chills and fevers as high as 103.0. She has developed a small circular 5 x 5 area of erythema and firmness at the injection site of her left upper arm. 12/29/2020 12/30/2020 75 F
916473 Patient complained of a headache, then patient was losing consciousness and gasp for air. EpiPen was utilized due to being unresponsive then began to seizing. Patient started to flatline and an AED was used while a paramedic came. Patient was put on her side then facility gave something for seizures. Lastly, ,ambulance took her to the hospital. 12/31/2020 12/31/2020 54 F
916538 15-20 mins after receiving the vaccine she reported she had difficulty swallowing and difficulty breathing and was ?shaking."  a PA wrote in her note that when she ran in to help, she found the patient to be tachypneic, diaphoretic, warm with some red blotchy patches on face, chest & neck. Able to speak easily c/o trouble breathing & sensation of throat swelling & extremities feeling abnormal. No stridor. No facial edema noted by that clinician. Administered epi-pen 0.3mg   - IV  started , Benadryl 50mg IVP and solumedrol 125mg IVP. Patient reports she subsequently arched her back and had rigidity of her arms/legs and tremors.  Clinic PA reports that while she was there, pt was never hypotensive. Initially hypertensive after epi as expected with some favorable response after 10-15 min Staff there gave her IM epinephrine, IV Solu-Medrol and 50 mg IV Benadryl.  EMS was contacted and transported to the emergency room.  She arrived at the ER, was monitored for 2 hours, was started on pepcid and benadryl and discharged from the ER. She had a diffuse itchy rash. The following day she again developed recurrence of throat swelling. Went back to a different ER. Developed dyspnea immediately prior to arrival at ER. There was again given solumedrol and benadryl and pepcid and developed muscle rigidity and arched back for 10 minutes. Symptoms of SOB and dyspnea resolved with epinephrine. Was discharged from the ER with prednisone after being monitored for 5 hours.  Is continuing to take prednisone and benadryl. Rash is still present but improving with scheduled benadryl. Has new redness at injection site today. Continues to feel some throat swelling but no tightness today. This information was gathered from talking with pt today for a phone appt and also from her medical chart regarding her vaccination visit and two ER visits. 12/28/2020 12/28/2020 39 F
916809 CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO twitch, FOLLOWED BY UNCONTROLLED shaking, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST.  TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS.  SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES.  TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020. 12/23/2020 12/23/2020 40 F
917042 I received the vaccine at 6:30pm on 12/27.  I worked atb7pm and took lunch at 2:00am. After lunch, I immediately felt sick to my stomache and threw up. I went home after my shift and went to bed. After 5 hours, I woke up and went to the couch to lay down while kids watched TV. Next, I woke to several people in my house. I had a seizure and my son had called 911. I was taken to emergency department. I was admitted and stayed 2 nights in the hospital. 12/27/2020 12/28/2020 43 M
917122 A little over ab hour after receiving the vaccine I noticed a burning sensation in my sinuses. By 130am 1/1/2021 I awoke from my sleep terribly dizzy, shaking violently and experiencing a fever of 101.3 F. I took advil and tylenol and fell asleep about an hour later. I woke up with similar symptoms at approximately 830am on 1/1/2021 took an additional dose of advil and tylenol and slept till 12p. I woke up with a bad headache and coughing fits similar to when I had covid back in March. I went to an urgent care who assessed me and ordered me to the ER. medical center administered IV fluids, an inhaler, steroids, epinephrine and benadryl and a few hours later my symptoms had subsided for the most part and a dose of IV antibiotics was administered. I am currently admitted for observation with likely discharge on 1/2/2021. 12/31/2020 12/31/2020 35 M
918078 4 hours after vaccine, sore arm, fatigue, headache, blurred vision 12 hours after vaccine, full body tremors, fever of 102, extreme muscle weakness, fatigue, deep chest cough, shortness of breath. fatigue, weakness and cough continued for three days after  vaccine before subsiding 12/31/2020 12/31/2020 44 M
918200 Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection.  She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness.  Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious.  Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious.  Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness.  Patient had tachycardia and self-reported palpitations.  Received IV fluids and observation on telemetry with no rhythm disturbance.  Patient discharged 1428 on 12/24.  On 12/29, patient returned to ED at 0326  for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation.  Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619 12/23/2020 12/23/2020 27 F
918217 Patient developed muscle twitching, fatigue, dizziness and headache minutes after vaccine was given. Day after vaccine given, patient developed small red area around injection site that also had swelling and was warm to touch. No fever or other complication. 12/28/2020 12/28/2020 55 F
918270 Chills and shaking consistent with flu-like symptoms began about 12 hours following vaccination.  The next morning, I had a headache and vomited about 5 times.  Over the next several hours, I began to feel better and by that evening, was feeling pretty much normal, except for some lingering fatigue. 12/29/2020 12/29/2020 39 F
918299 The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the injection but at 2AM on the 22nd I woke up from my sleep with chills, and shaking even my teeth were clacking. Took Tylenol and it got better around 30 min later. Felt very fatigued and still nauseated almost threw up. By the end pf the day it resolved itself. 12/18/2020 12/22/2020 58 F
918743 shaking uncontrollably/she was full of shakes to the point the bed was shaking; chills; Woke up in the middle of the night; body aches; as painful as a strep infection; sore throat that was as painful as a strep infection/throat feels sore to the point of Strep/Throat soreness: Felt like sharp razor blades; Feels like she is having an extreme immune response; Feels congestion; severe serum sickness/weird serum sickness; high fever/Had a fever over 101; This is a spontaneous report from a contactable nurse(patient). A 32-year-old female patient received BNT162B2(lot number EH9899) via an unspecified route of administration at Arm Left on 21Dec2020 (from 16:30 to 17:00) at the age of 32 years old at single dose for doesn't want to bring COVID home to her family. The medical history included Migraine headaches. The concomitant medications were not reported. The patient had so many immunizations for international travel, had Yellow Fever vaccine, all of the Guardasil vaccines, had MMR vaccine four times because she never developed immunity to it until the fourth round, got a flu shot yearly,got TDap vaccine every five years because she was an HCP, did Emgality shots( not done it this month. Emgality had a protein inhibitor, was supposed to get Emgality shot on 21Dec2020). On 22Dec2020 the patient experienced severe serum sickness, high fever, body aches to the point that she was shaking uncontrollably, sore throat that was as painful as a strep infection; Caller mentioned she was taking tylenl and benadryl for her symptoms. The patient was a Nurse Midwife. She got the vaccine on Monday evening at 4:30PM. Feeling like she was having a weird serum sickness. Woke up in the middle of the night and she was full of shakes to the point the bed was shaking. She had a fever over 101. Felt like she was having an extreme immune response. She was taking Tylenol and Benadryl around the clock. Woke up this morning and her throat feels sore to the point of Strep. Wondering if she need to distance and get some kind of test. Has been wearing a mask all of the time and doesn't know of anyone people who have COVID that she has been in contact with. Feels congestion and sore throat. Shakes and chills: Began at 02:30. Hard core chills and shakes. High fever over 101: same time as chills and shakes. Woke up from a dead sleep. Didn't have a working thermometer but knows her temperature must have been over 101 by the way she felt. She didn't feel that crappy unless her fever is over 101. She can gauge her own temperature. She experienced throat soreness: Felt like sharp razor blades. The patient was taking numbing throat lozenges. Seriousness: Would say serious. Didn't require hospitalization. She self-treated. Had she not had to work, she would probably have stayed in bed. Has been taking round the clock medicine. The outcome of the events was unknown.  The information on the batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported serious events including severe serum sickness, high fever, body aches, shaking uncontrollably, sore throat that was as painful as a strep infection, feels like having an extreme immune response, congestion, chills, woke up from a dead sleep and the administration of the COVID 19 immunization with BNT162B2, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to those, as appropriate. 12/21/2020 12/22/2020 32 F
918776 I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the  hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered. 12/24/2020 12/31/2020 40 F
918799 disoriented; hit her head and cut herself; hit her head and cut herself; passed out at night; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose at left arm for COVID-19 immunization. Medical history included Atrial fibrillation/heart problems diagnosed prior to the vaccine, got the COVID virus on 18Nov2020, disoriented in Nov2020. Concomitant medications included her heart medication every day and vitamins, nothing out of the normal. Caller stated she had heart problems. The heart problems were diagnosed prior to the vaccine. Caller also stated that she got the COVID virus this year before the vaccine as well and she was off, of work for like a month. On 23Dec2020 she got the vaccine. Then on Thursday 24Dec2020 and Friday 25Dec2020 she had a reaction. She had passed out in the night, hit her head and cut herself, she was then disoriented for 1 full day. Caller stated that the last time she was disoriented like this was when she had the COVID Virus, because she had heart problems. Caller stated that she was fine now. Caller stated that she had been off, of work so much. The heart problem she had was Atrial Fibrillation. Caller clarified that she had the COVID virus this year in Nov2020, it was before thanksgiving, on 18Nov2020 she had the virus, then on 19Nov2020 she got tested and it was positive. She got the vaccine on the 23Dec2020 Wednesday then on 24Dec2020 at night she passed out and on 25Dec2020 she was disoriented all day. Investigation Assessment: No. On 24Dec2020 she was going to bathroom, and found herself on the floor, then the following day 25Dec2020 was when she was disoriented. She knew this because when she had the actual COVID virus previous in Nov2020 this happened previously. When queried outcome of being disoriented she stated that she still felt a little weird but if getting better very, very slow. The Second dose was schedule for 13Jan2021. Caller confirmed that she did have a Positive Test for Covid Previously. Her treatment at the time was in the Emergency Room, they gave her an Antibody infusion, she had to schedule it because it was actually a clinical trial. Caller was asked if she knew the name of covid test, she stated that she does not know, she only recalled that she opened her mouth and they test her that way. The outcome of the event "disoriented" was recovering, of the other events was unknown. 12/23/2020 12/24/2020 67 F
919036 Patient with extreme nausea and vomiting that started soon after receiving the Moderna vaccine.  Patient with loss of consciousness, diaphoresis and garbled speech during a foley catheter exchange thought to be from dehydration.  Patient was admitted to Hospital for observation for 2 days 12/28/2020 12/28/2020 89 M
919373 noticed twitching in L arm shortly after receiving vaccine, numbness , weakness and pain in arm and shoulder girdle, diagnosed with parsonage turner syndrome by neurologist, currently taking neurontin for pain as steroids not tolerated 12/30/2020 12/30/2020 39 F
919559 Pt experienced nausea, shortness of breath, chest tightness and anxiety and then lost consciousness.  Vitals were obtained several times during the medical intervention. Respirations were within normal limits throughout, BP was 135/89 initially, then rose to 210/110, then declined to 180s/? prior to EMS assuming care. Heart rate was 47 initially, then rose to normal limits. Treated with epinephrine, Benadryl and ammonia smelling salts and transported by ambulance to hospital. 01/04/2021 01/04/2021 40 F
919624 Around 10 or 11 pm, arm pain, chills, fatigue, headache, nausea, swollen lymph nodes, lightheadedness, fainted in tub. Next day, fatigue all day, couldn't talk, or eat.  Went back to bed again. The following day hot flashes, weakness. went to ER. Felt like blood pressure was dropping, tingling in legs, difficulty lifting her head. 12/29/2020 12/29/2020 29 F
919818 Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole body. did not think much of it.  woke up once in middle of night at 4am with racing heart but went back to sleep.  Around 9 am next morning started getting chills, initially mild then severe and developed severe myalgias; could not get out of bed or lift arms or limbs.  having chest tightness and shortness of breath. pressing on chest wall hurts, hard to take deep breath.  Temps of 99.5 most of morning.  started taking tylenol total of 1 gram.  1 hour after tylenol shaking and rigors with sweating. had temp of 101 after tylenol. HR 110 at this time (my baseline is around 60s).  O2 sat remained normal.  Went to ER for testing for covid in case this was covid--test negative.   Felt a little better morning of 1/4--no fever.  tried to work 1/2 day; called out sick.  lots of brain fog, fatigue mental slowing.  still having intermittent chest tightness and sob; feel like i cannot expand my lungs.  deep breath makes me cough. had few small red bumps on left antecubital fossa that resolved.  i'm a physician, i'm concerned this was a severe reaction and was advised to report this. 01/02/2021 01/03/2021 33 F
920968 It looks like one of the ingredients may have an animal cell lipid; syncope; Dizziness; feeling faint; like going to pass out now and then; overall achiness, severe headaches, fever; overall achiness, severe headaches, fever; overall achiness, severe headaches, fever; This is a spontaneous report from a contactable nurse reporting for herself.  This A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EH9899), intramuscular at single dose in the left arm on 22Dec2020 09:00 for covid-19 immunisation. Medical history included reaction to pork, porsine and/or if she ever was exposed to exposed to heparin. There were no concomitant medications. On 23Dec2020, the patient experienced syncope (medically significant), dizziness (medically significant), feeling faint; like going to pass out now and then (medically significant), overall achiness, severe headaches, fever. The outcome of the events syncope, dizziness, feeling faint; like going to pass out now was recovering and outcome of overall achiness, severe headaches, fever was recovered on 24Dec2020. The patient ask: are there any animal products, pork gelatin or a lipid form of that contain in the vaccine?   The events were described as follows: She experienced a significant amount of syncope and dizziness, for greater than 4 or 5 days post-receiving the vaccination. Also feeling faint like she is going to pass out every now and then. Has a more important question, wondering along with the doctors if one of the ingredients may have an animal product, like pork gelatin or a lipid form of that. It looks like one of the ingredients may have an animal cell lipid and was wondering if she was having a reaction to that. Declines to provide primary care provider details. States she received this first dose at occupational health in her workplace. Received the vaccine on the 22Dec2020 at 9am. 24 hours post vaccination, 1 day after, the syncope, dizziness, feeling faint started. Also the other symptoms, overall achiness, severe headaches, and fever were also experienced, but they stopped after that 24 hours. Those were expected since it was listed as side effects that popped up, so she expected those and they stopped after 24 hours. The syncope, dizziness, and faint feeling are not any worse and are very slowly improving, but she still has it and had to call out of work today because of it. That's consistent. Mentions it takes her a while to get down the stairs when getting product details for the COVID-19 vaccine. Unable to provide the vaccine NDC or expiry, or dose. Did not have any other vaccines at time of this one and none 4 weeks prior. Had to call a (company withheld) doctor and has to go to occupational health tomorrow to be seen. Declines having COVID virus. No further details provided.; Sender's Comments: Based on the compatible time association, the events syncope and dizziness are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/22/2020 12/23/2020 30 F
920994 PATIENT VACCINATED AROUND 9AM.  SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH spasmS WITHIN ABOUT 4-5 MINS.  SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM:  FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING.  AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED.  SYMPTOMS REPORTED IMPROVED FOLLOWING EPI.  EMS ARRIVED 10:05AM.  PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL.  WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT. 01/04/2021 01/04/2021 55 F
921037 nauseous; weak; no appetite; numbness on the skin of my arms and legs; I was post Ictal for 2+ hours; seizures/having 2 non epileptic seizures; dizzy and lightheaded; This is a spontaneous report from a contactable nurse (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Batch/lot number: EK5730), intramuscularly on 28Dec2020 07:45 AM at right arm, at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient received vaccine around 7:45 AM. Within 2 minutes she felt extremely dizzy and lightheaded on 28Dec2020. She sat down and drank some Gatorade and took deep breaths. The feelings persisted 5 minutes later. She then woke up after having 2 non epileptic seizures while still in 15m waiting period, (This included posturing and color change) a rapid response was called and she was taken to the ER. She was post Ictal for 2+ hours. Dizzy and nauseous, weak and no appetite for the rest of the day. She had no history of epilepsy. She also have numbness on the skin of my arms and legs within 24 hours of the vaccine. Onset date of all events (except dizzy and lightheaded) was reported as 28Dec2020 08:00AM. Treatment fluids, Zofran was received for all events. All event resulted in emergency room. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovered with sequel.; Sender's Comments: A possible contributory effect of suspect BNT162BW on reported seizures cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. 12/28/2020 12/28/2020 21 F
921091 Pt received vaccination and left after 15 min. observation symptom free. He drove a short distance away from the clinical site when he felt profuse sweating and had syncope (seconds) crashing into curb. He was aroused from impact and was able to stop car. He then developed profuse nausea and sudden urge to defecate. He went to restroom. Given these events he returned to the clinical site in another vehicle. Upon arrival he denied chest pain, shortness of breath or ongoing nausea or abdominal pain. He reported his AM blood sugar was 72 and does not take insulin. No history of coronary disease or syncope. EMS was activated and assumed care. 12/31/2020 12/31/2020 54 M
921151 The resident who was known to have seizures, and under control for many yeas with Keppra 1000 mg twice a day, on the second day after vaccination developed recurrent seizures requiring hospitalization to an intensive care unit, with intubation and mechanical ventilation until 1/5/21 (to be extubated today). She is still at the hospital. 12/28/2020 12/29/2020 43 F
921786 tremors resident sent hospital facility. 01/03/2021 01/03/2021 75 M
922299 I was instructed to stay for 30min as i have been anaphylatic to cipro in past. at 30min was told i could leave. while driving home on rt 91 my cheekbones became numb. then slowly a few min later my cheeks became numb. a few min later my lips became numb. as i was driving off exit to rt 5 in longmeadow i developed a lump in my throat. i turned around at top of exit and went back to highway to go to ER. this was approx 1645-1650. i went to ER arrived approx 1655. i was shaking. my bp and pulse were elevated. no tingling or swelling in my face. nurse checked my pupils and my smile and were wnl. no history of bells palsy. i received iv fluids, solucortef 125mg ivp, pepcid 20mg ivp, and benedryl 25mg ivp approx 1840pm. approx 45 min after solucortef numbness better but not gone. it started to come back a little more before discharge, which i let md know. she discharged me with scripts for epi-pen, prednisone, and OTC pepcid and benedryl. follow up with my pcp's office in am 12/24 at 10am with his NP. total time with facial numbness/lip numbness 29 hours. 12/23/2020 12/23/2020 58 F
923412 she got tunnel vision; almost passed out; Blood pressure dropped to 70/50; heart rate went up to 140; whole body got cold and tingly; whole body got cold and tingly; This is a spontaneous report from a contactable pharmacist (patient) reported for herself. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biotech; lot number: EL0142) via an unspecified route of administration at left arm on 30Dec2020 at 12:45 PM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included premature ventricular contractions (PVCs). No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. No other vaccine in four weeks and no other medications in two weeks. The patient experienced adverse events included blood pressure dropped to 70/50, heart rate went up to 140, whole body got cold and tingly and she got tunnel vision and almost passed out. The events all started on 30Dec2020 at 12:45 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event tunnel vision with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. 12/30/2020 12/30/2020 25 F
923822 The day after the vaccine I had fatigue and body aches. Then on 12-23 fevers of 101.4, chills, body aches, diarrhea, vomiting, productive cough, and profuse sweating. Jan 1st I was in the shower and was dizzy with a headache. loss of consciousness almost happened and that is when i got out of the shower and laid down. Went to the ED and was diagnosed with bilateral pneumonia 12/21/2020 12/22/2020 36 F
923892 I did let the nurse know right after I got the vaccine It did feel like  a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work).  They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me.  After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of  like I had a hangover and of course my arm was really sore.  The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one. 12/23/2020 12/23/2020 49 F
924892 extremely lightheaded; like he was about to fall down; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the 1st of 2 reports.  An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL0140), intramuscular on the right arm on 30Dec2020 10:10 at single dose for vaccination.  Medical history included covid-19 on Jul2020 and had it fairly severe and almost died and he mentions he was overweight.  There were no concomitant medications.  The patient previously took flu shot (INFLUENZA VACCINE), a couple of months ago. He mentions he was in the military so he had a lots of shots in his life but he has never had a reaction like this.  The patient stated that on 30Dec2020 10:30, "he became extremely lightheaded, like he was about to fall down. He sat down and is currently sitting down. This lightheadedness started about 20 minutes after the injection. When probed for the outcome, the caller explains it might be improving a little. The lightheadedness is not still not gone, but it has not worsened.  When probed for seriousness criteria, the caller explains he is just resting and sitting. He would say its not serious but it could be medically significant. He states he isn't sure if this is something that happens to just people who have had COVID before. He states none of his friends or relatives have this type of reaction. He lives in a retirement home and everybody is getting the injection. This is the second day of injections. He doesn't know if anybody had a reaction to the COVID-19 vaccine here". The outcome of the events were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of lightheadedness and pre-syncope due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520862 same reporter/drug, similar event, different patient. 12/30/2020 12/30/2020 89 M
925633 her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID.  The patient medical history included Primary Essential tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it.  The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020.  The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/30/2020 12/30/2020 54 F
925637 jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/22/2020 12/22/2020 46 F
925649 It sounds like to be an allergic reaction; She passed out; Tachycardia; Nausea; Lightheadedness; This is a spontaneous report from a non-contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 at single dose to be vaccinated for her protection. Medical history was none. The patient's concomitant medications were not reported.  Patient took the Pfizer COVID-19 vaccine and next day she had a very serious reaction. She did not know that if it was due to the vaccine. But she had tachycardia requiring her to go to the emergency room and she passed out and she had nausea and lightheadedness as well. It sounds like to be an allergic reaction. Given the seriousness of tachycardia and passing out as well as the lightheadedness and nausea it sounds too severe just to be a mild immune response. So, it was sort of rare immune response or it was unrelated it was unknown at this time. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the compatible time association, the contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/01/2020 12/01/2020 F
925755 feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship.   The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 01/02/2021 01/02/2021 50 F
925925 1 day after the vaccine he had a low grade fever... 1 week later he had a seizure and then multiple ones in the ER... 12/28/2020 01/04/2021 52 M
926755 Vaccine Candidate received vaccine approxat 2:30pm, was monitored for 15 min no complications at the time,  went home.  Around 5:30pm while walking into her home she became unresponsive, was assisted in a siting position, became incoherent, mumbling and started to convulse to the right side of her r upper extremity. Foaming at the mouth and stopped breathing, CPR was initiated for 1-2 min, EMS arrived was transported to Medical Center. She was admitted and  is currently hospitalized. MD reports this event is highly unlikely related to the vaccine given her medical history but suggested to report being its a new vaccine. Current status: stable. 01/05/2021 01/05/2021 70 F
926787 Resident had the COVID vaccine 12/30/2020. 12/31/20,  resident has been in bed all shift. Staff became concerned when resident was not easily aroused. Resident displayed signs of tremors, twitching, confusion, in and out of consciousness, low O2 sats, elevated pulse and fever, fatigue and weakness. Writer called NP. NP stated this is most likely a reaction d/t the COVID vaccine. She gave orders for Benadryl 25mg IM x1 now and Tylenol 1000 mg now. NP also stated resident will not be getting the second dose of vaccine. Will continue to monitor and update NP if worsening symptoms.   After receiving Benadryl and Tylenol at 145pm, resident began to appear as though she was feeling better and was talking to talk, fever had gone down. Tonight resident is not easily aroused, lethargic, continues to have tremors and twitches, almost appearing as convulsions. When asked if she knows where she is or what day it is, resident can properly answer. Resident denies SOB but staff has noted loud squeals while breathing. NP was updated and gave new orders to give Benadryl 25 mg IM x1 if needed and Ok to send resident to ED. Resident currently refuses to go to the hospital. Will continue to monitor. BP 152/112, P 116, T 99.1, O2 87-91. Resident's O2 at 1205am was 80% on 3LPM. Resident unable to be aroused from sleep by writer. NAR called to assist. NAR could not arouse resident. Writer and NAR attempted to reposition resident and resident's breathing became more labored. Resident turned back to previous position and writer called on call MD at approx. 1220am. MD returned call approx. 1235am with orders to send resident to ED. 911 called and ambulance arrived about 1245am. History of present condition given to EMTs and they stated resident would be going to Hospital. Writer has attempted to contact Hospital ED x3 but have been unable to get through. An EMT did just call to clarify when vaccine was given, what symptoms have been present and when they started. She said she has everything she should need and she will let Hospital ED staff know to call if they need anything else. Writer will again attempt to contact them though.  Resident's temp was 97.5 and BG 128. When EMTs arrived they got an O2 reading of 60%. Resident did open her eyes a couple times during transfer from bed to stretcher and while stretcher was going outside but no responses from resident were made. 12/30/2020 12/31/2020 53 F
927096 Day 2 (12/29/20): Fever (seizure at 4:30pm 12/28/2020 12/29/2020 60 M
927359 Patient alerted pharmacist to feeling light headed at 12:10pm. Patient was instructed to sit down on the floor. She stated she felt hot and hadn't eaten all day. She was given a few bites of apple sauce and some Dr. Pepper to drink in case of low blood sugar. She was also given 25mg of diphenhydramine in case of an allergic reaction after the vaccine adminstration at 12:15pm. A few minutes later, she began shaking and stated she thought she was having an anxiety attack.  At this time, the patient requested we call 911 because that would make her feel better and so we did. 01/06/2021 01/06/2021 31 F
927360 Symptoms started during bedtime and woke me up. Began with severe full body chills and full body muscle shaking and weakness during the night of 1/5 and early morning of 1/6, around 1000 to 0200. Slight headache began during that time as well.   Upon waking at 0900 on 1/6, chills and shaking decreased to mild severity, muscles still felt moderately weak and shaky, headache had increased in severity to a severe throbbing pain that worsened upon standing and walking, and moderate visual photosensitivity began. The headache persisted until I took 2 tablets of ibuprofen 200 mg, which is when the severity decreased to moderate after a few hours and then mild by bedtime. The photosensitivity persisted through the day and did not decrease much by bedtime.   Upon waking 1/7, there was only a mild headache and mild photosensitivity that faded completely within a few hours, no medication required. No more symptoms in the afternoon. 01/05/2021 01/05/2021 21 M
928662 On December 25th I had mild chest pain and then on January 1st, 2021 I had severe chest pain that persisted and on January 3rd I was admitted into the hospital.  My Ddimer was elevated and my Troponin levels were elevated.  An angiogram was performed and Dr. injected nitro into my arteries because they were constricted from Coronary spasms. 12/23/2020 01/01/2021 50 F
928757 Nausea/ dizzy, syncope 12 hours later. 01/07/2021 01/08/2021 34 M
928772 Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins & then returned to work. on 12/30/2020 patient was at work in Presurgical testing dept & experienced near syncope, dizziness & elevated BP. reported to ED & was admitted to telemetry unit. 12/22/2020 12/22/2020 52 F
929132 Patient fainted in the ICU setting.; dizziness; hypotension; This is a spontaneous report from a contactable Other HCP. A 25-year-old male patient received BNT162B2 (Lot number: eh9899) via an unspecified route of administration on 24Dec2020 13:00 at single dose for covid-19 immunisation. The patient did not have any known allergies or medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. On 24Dec2020, patient experienced dizziness and hypotension. Patient's blood pressure (BP) was 50/30 and heart rate (HR) 45. Patient fainted in the intensive care unit (ICU) setting. This happened during work hours while treating a patient. Patient was treated in the emergency department (ED). The adverse events resulted in emergency room/department or urgent care. It was unknown if treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. 12/24/2020 12/24/2020 25 M
930005 initial; swelling of tongue, tingling and numbness in legs, syncope. later; HA 12/22/2020 12/22/2020 26 F
930010 Resident displayed with confusion/shaking at 1400, condition worsens at time went.  Resident unable to state where he is, knows his name.  can tell you he does not feel right.   Temp 97.3, p 88, O2 91%, Bp 214/116  Transferred to ED with fever, temp of 103, and shortness of breath, admitted to ICU  Positive COVID-19 test at hospital. Diagnoses include acute COVID-19 pneumonia and hypoxia. PO had confusion,  fatigue, weakness, hypoxia, increased BP 01/05/2021 01/06/2021 87 M
930297 29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and nausea after receiving the second Pfizer COVID-19 vaccine around 10 AM.  Patient says that after her first dose of the vaccine she had mild sore throat and hoarse voice that resolved spontaneously.  She had her vaccine around 10, several hours later before coming to the emergency department between 2--230 she had the sudden onset of difficulty speaking with associated sore throat and nausea.  She has had dry heaving but no large amounts of vomiting.  She has not had stridor, wheezing, shortness of breath, syncope, or the development of a rash or hives.  She has not had a reaction to her prior vaccines she does not have any other allergies in general.  She has otherwise been well recently without infectious symptoms including fevers, chills, cough, and has not been exposed to Covid to her knowledge. Medications administered in ED included diphenhydramine 50 mg IV once, dexamethasone 10 mg IV once, famotidine 40 mg IV once, ondansetron 4 mg IV once. Had brief episode of shaking and R arm rigidity in the ED. Patient denies LOC during the episode, did not have a post ictal state, no tongue biting or episodes of incontinence. Given single event without LOC, less concern about episode being a seizure. Patient has had no further episodes of shaking since admission. CT brain was wnl, no FNDs noted on exam. 01/07/2021 01/07/2021 29 F
930348 I am breastfeeding. My daughter had seizure like episodes starting on Saturday 1/2, Sunday 1/3, Monday, 1/4 and 2 times on Tuesday 1/5. 12/28/2020 01/01/2021 33 F
930476 Acute allergic reaction Tongue swelling Facial swelling  Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness 01/05/2021 01/06/2021 40 F
931432 At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow and after time of wiping it a few times I went to look into the mirror and realized that nothing was there. about and hour later I got a drink and a snack to eat and I realized I had a numb sensation in the left corner of my lip.  As a nurse I went though the signs of a stroke with 2 other nurses I called. Everything was normal other than that sensation. Thinking I was just overly tired I went to bed. When I woke up the next day I felt okay until I went to drink some coffee and the numb sensation in my corner lip was still there. Now I was concerned and called employee health and was instructed to go to the ER to role out a stoke. I followed employee health's instructions and went to the ER. I was diagnosed with facial paresthesia and discharged with instructions to come back if symptoms got worse.  Symptoms persisted all day and around 7 I called my mom on video chat to show a visual facial twitch on the left side of my face. right after I got off the phone with her the left side of my face drooped and my fiance immediately drove me to the closest ER. I was seen immediately and they decided to admit me. The did labs and head CT. They admitted me to labor and delivery because there were no other rooms. The next day I was seen by a neurologist and many doctors. 01/05/2021 01/05/2021 34 F
931484 Patient was unresponsive in her room during the night, had gotten the vaccine this morning, 911 called. Had right arm pain and loss of consciousness. EMS got 180/104 BP and blood glucose was 122. Was transported to hospital. Returned to the facility the next day with no complications,  was just fatigued. 01/08/2021 01/08/2021 78 F
931774 After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring.  I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest.  Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure 01/06/2021 01/06/2021 49 F
932381 Headache, Myalgia, Arthralgia, Fever,  CoughWheeze & syncope 01/04/2021 01/04/2021 59 F
933261 Chills; Fever; loss of consciousness x 2; GI upset; Diarrhea; Difficulty sleeping; Pallor; Stomach flu; A spontaneous report was received from a nurse concerning a 31-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness (LOC) x 2, gastrointestinal (GI) upset, diarrhea, difficulty sleeping, pallor, stomach flu, chills and fever.   The patient's medical history, as provided by the reporter, included allergy to cefaclor and hereditary hemorrhagic telangiectasia. Concomitant medications reported included desvenlafaxine succinate, gabapentin and dexlansoprazole.   On 23 Dec 2020 at 11:30 am, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the morning of 23 Dec 2020, prior to receiving mRNA-1273, the patient felt "achy".  At 5:30 pm, the patient experienced chills, fever to 102, GI upset and diarrhea. At 11:00 pm, the patient reported difficulty sleeping, GI upset, LOC x 2 and pallor. The patient was transported to the emergency room via ambulance.  A COVID-19 polymerase chain reaction test and routine labs were collected; however, results were not provided. Treatment for the events included paracetamol, unspecified intravenous (IV) medications, ondansetron and ketorolac tromethamine. The emergency room discharge diagnosis was stomach flu.  Action taken with mRNA-1273 in response to the events was not reported.   The events, loss of consciousness (LOC) x 2, GI upset, diarrhea, difficulty sleeping, pallor, stomach flu, chills and fever, were considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a 31-year-old, male subject with a medical history of hereditary hemorrhagic telangiectasia, who experienced the unexpected events of loss of consciousness (LOC) x 2, gastrointestinal (GI) upset, diarrhea, difficulty sleeping, pallor, and stomach flu, and the expected events of chills and fever. The events of chills, fever occurred approximately 6 hrs. and the events of GI upset, loss of consciousness, difficulty sleeping occurred after 12 hrs. after the first dose of Moderna COVID-19 Vaccine. The time to onset for the events of GI upset and diarrhea were unknown. The reporter did not provide the causality assessment for the events. Due to the temporal association between the LOC and the administration of the vaccine, a causal relationship cannot be excluded, however, the subject's medical history of hereditary hemorrhagic telangiectasia and other concurrent conditions of GI upset, diarrhea, and stomach flu remain as confounders. 12/23/2020 12/23/2020 31 M
933755 Numbness and tingling bil upper extremities, seizure, temporary paralysis R arm. Started day after vaccine given, was observed overnight in hospital. 01/03/2021 01/04/2021 26 F
934099 Patient is a 41 y.o. female who presented to the ED with complaints of a reaction after she took the COVID vaccine.  Patient is an RN here and had earlier received COVID-19 vaccination (Moderna) around 0130 this afternoon. Soon after she experienced rash which was burning and itchy on her arms thighs and back. She reported to Occ health and was directed to the ED. While in the ED she experienced throat tightness and nausea. She had one episode of diarrhea.  No tongue, lip swelling, SOB or difficulty swallowing. Denies any chest pain, palpitations, pre-syncope/syncope.   No vomiting abdominal pain. H/o of allergy to fish mix and dust mite. 12/28/2020 12/28/2020 41 F
934745 Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli. 01/09/2021 01/10/2021 79 F
934910 chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital.  Medical history included asthma and  gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough.  The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate. 12/28/2020 12/28/2020 53 F
934919 syncope; diaphoresis; varying HR; blurred vision; This is a spontaneous report from a contactable physician (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Jan2021 as single dose for COVID -19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced syncope, diaphoresis, varying HR (heart rate) and blurred vision in Jan2021.  The patient underwent lab tests and procedures which included heart rate: varying in Jan2021. Details were as follows:   Patient received the vaccine in the morning.  He reported diaphoresis, syncope, varying HR, and blurred vision within 10 minutes of receiving the vaccine.  He was taken to the emergency room and therapeutic measures were taken as a result of the events; he was given fluids. The patient generally tolerated vaccines and has recovered from the episode. The events, syncope, diaphoresis, varying HR (heart rate) and blurred vision recovered in Jan2021.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. 01/05/2021 01/01/2021 M
934924 tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing.  The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown. 01/04/2021 01/04/2021 58 F
934936 experiencing an allergic reaction; Hives all over her face and neck/hives on face and neck; This is a spontaneous report from a contactable Physician (patient). A 30-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140, Expiry Date: 31Mar2021) via an unspecified route of administration in left upper arm on 31Dec2020 13:25 at single dose for COVID-19 immunisation. Medical history included crohn's disease from Jul2005 and ongoing, ongoing psoriasis, gastrooesophageal reflux disease (GERD), hand tremor. Concomitant medication included ongoing infliximab (REMICADE) for Crohn's, ongoing esomeprazole sodium (NEXIUM) for GERD, ongoing propranolol for hand tremor, copatsol topical steroid for Psoriasis, ongoing Multivitamin, ongoing vitamin B complex (B COMPLEX), ongoing biotin, ongoing iron, ongoing Calcium/Vitamin D, ongoing curcuma longa (TURMERIC). The patient had an allergic reaction after getting the COVID vaccine. She had an allergic reaction after getting the vaccine. She had hives all over her face and neck. She already had a Medrol Dose Pack at home and some Benadryl. She contacted her doctor who prescribed an Epi Pen for her, but she did not have to use the Epi Pen. She stated she used the Benadryl for three days. She started to get hives all over her face and neck the same date she got the vaccine. It started 2 hours after she got the vaccine (31Dec2020 15:25). She confirmed this was the first dose of the COVID Vaccine. She asked that if it is safe to take the second dose after experiencing an allergic reaction to the first dose. Symptoms include hives on face and neck. Patient had no trouble breathing. Took steroids and Benadryl for 3 days or until symptoms have been managed. No any of the events require a visit to emergency room. Reporter seriousness for hives all over her face and neck was reported as medically significant. Events outcome was recovered on 03Jan2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Allergic reaction and Hives cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/31/2020 12/31/2020 30 F
934940 shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/18/2020 12/19/2020 62 F
934950 She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown.   Information about lot/batch number has been requested. 12/30/2020 12/30/2020 59 F
935780 Extremely tired went to bed at 8:30. At 11:00, tossed and turned until 12:16 a.m. Did not think she could stand up. Walked in the bathroom had pain in stomach, was very hot and freezing at the same time, was shaking. Head hurt was hurting so bad. Tried standing up from toilet, was passed out. Eye, half of face is bruised and swollen , eye shut for two days. More than forty minutes passed before she could call her husband. Does not remember anything because she was passed out. Husband came in and grabbed her, to get her back into bed. she could not stand. Went to ER at  Hospital. Had CT scan, blood work , EKG, chest xray. Was still kind of out of it but was able to communicate with nurses. Face is still black and blue. Last night got up at 4:00 a.m. something was wrong with her throat. Felt like a walnut was in her throat. Went to doctor this morning. They said it was a reaction from the shot. Got an EpiPen, prednisone. Call them in 2 days to let them know how she's doing and also wear a heart monitor because they do not know how to take care of her, Has had vision blurriness in both eyes. Has not felt well at all. 01/05/2021 01/05/2021 61 F
936738 loss of consciousness Narrative:  Patient received COVID-19 vaccine dose #1 on 1/6/21 w/o complications. Per 1/6/21- 1/9/21 nursing notes, patient did not experience any injection site reactions, denied pain or tenderness at injection site, no dizziness, no n/v, remained afebrile. Around 1/9/21 @1810, patient became acutely nonresponsive after being helped to the edge of bed. Per nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency team called d/t patient's sudden change of condition. Emergency team helped patient into lying position. Per 1/9/21 ICU emergency team note, patient appeared comfortable w/ no palpable radial pulse and had minimal shallow agonal breathing. Pulse ox 94%, HR in 60s per machine. BP unmeasurably low by BP cuffx3. Resident passed at 18:20 pm. 01/06/2021 01/09/2021 89 M
938055 seizure; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient had a seizure. Clinical outcome of the adverse event was unknown at time of this report.   The information on the lot number has been requested.; Sender's Comments: A possible causal relationship between seizure and BNT162B2 cannot be completely ruled out considering the temporal relationship.  However, more information would allow for a full medically meaningful assessment, especially medical history, concomitant medications, concurrent illness and event details description including time lag between the onset of the event and vaccination date of BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 01/12/2021 F
938065 some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient).  A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported.  The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse.  The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate. 01/05/2021 01/05/2021 62 F
940708 Jan 1st, patient had a seizure after breakfast. Temperature was 98.5 Pulse 95. B.P. 160/70  Two hours later another seizure at the home, with emesis,  Sent to hospital at 2pm. Focal Status elepticus. seizure activity along with continuous persistent activity with emesis throughout the 12 hour time in the ED.  seizure during the CT scan. 12/30/2020 01/01/2021 79 F
940806 passed out; blood pressure was lowered; blood sugar high; weakened; feeling tired and her legs are heavy; feeling tired and her legs are heavy; This is a spontaneous report from a contactable consumer (Patient's Mother). A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 Monday at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced passed out 12 hours post injection (Jan2021). She specified that her daughter was therefore brought to hospital by ambulance. She continued explaining that her blood pressure was lowered, her blood sugar high and that she was weakened (Jan2021).  On 08Jan2021, "day 4", she said that her daughter had been feeling tired and her legs are heavy (Jan2021). The event outcome was unknown. She then asked if those side effects were experienced after the vaccine. It was not reported as serious.  Information on the batch number has been requested. 01/04/2021 01/01/2021 F
941499 Patient experienced a syncopal episode post vaccination, accompanied by feeling hot and tachycardic. Prior to the syncope, she reported hyperventilating. She remained unresponsive for about 10 minutes and was brought to the ED. There she became responsive, and reported chest pain and had sinus tachycardia episodes. She also had lower extremity weakness. This has improved per the latest neurology notes. She also had a negative EEG. Unsure if this is an allergic reaction or if the syncope was due to hyperventilation.  Patient is currently on day 3 of hospitalization. 01/11/2021 01/11/2021 36 F
941576 Employee was awaken at 5:30 am on 1/13/2021 by chills and a feverish feeling. She then became nauseous and faint. She passed out and was noted by her mother who is a RN to have a seizure. She remained out for several minutes  and then aroused. She has remained groggy the rest of today but has improved. She has a history of non-epileptic seizures since she was 14 and has been on medications for this. Employee stated she has not has any seizure activity in over a year. She did not see medical attention due to recovering quickly from this. 01/12/2021 01/13/2021 23 F
941834 about 14 hours after vaccination I experienced what appeared to be a severe case of Cytokine storm. I had a moderate case of COVID in May 2020 and had positive IgG AB in August. The symptoms started with heavy shaking chills, lasting 1 1/2 hours , fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of Vtach and complex ventricular dysrythmia, low BP, profound weaklness, head aches and joint and muscle pains ( similar to the experienced COVID symptoms ) 01/08/2021 01/08/2021 61 M
941992 Patient began having cramping of her upper extremities and subsequent swelling of her face and  neck and also shortness of breath, chest pressure and flushed appearance.  She denies any tongue or throat swelling.  She is also complaining of bilateral arm pain.  The initial reaction treatment was started in the conference room and then the patient was transferred to the emergency room.  She continued to has arm and chest pain in the emergency room.  She had muscle tension/rigidity in the upper extremity which caused significant pain.  She also developed a nonspecific rash on the chest and abdomen that  persisted  for through out he hospital stay. Treatment was started with epinephrine 0.5 mg IM x2 and diphenhydramine 50 mg  IM x1, prior to transfer to emergency room.  In the emergency room  treatment was dexamethasone  10mg  IV x 1, famotidine 20mg IV x1, Ketorolac 30mg IV x 1, lorazepam, 1mg IV x 2, morphine 4mg IV x 2, 1000ml Saline Solution.  As an inpatient  the treatment  included scheduled acetaminophen 500mg TID, as need morphine for pain after treatment  with fentanyl, scheduled diphenhydramine 25mg IV q8 and compazine  5mg  IV for nausea, cyclobenzapine 10mg as need for muscle spasms, dexamethasone as a scheduled dose started at 4 mg BID and tapered to 2 mg BID, Naproxen 500mg  BID and Norco 7.5/325 as need for pain. with famotidine 20mg BID . 01/05/2021 01/05/2021 25 F
942085 No adverse effects from vaccination seen on 1/2/21.   On 1/6/21 resident was seen by Dr and her baclofen pump was refilled with 20 ml Baclofen 4,000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous rate over 3 days.   On 1/8/21 at 0615 resident was shaking, lower extremities mottled, Sa02 70%, pulse 45. Oxygen started at 2 L/m per NC. At 0715  her primary physician was notified as well as her daughter. Oxygen increased to 4 L/min, sats at 83%. SOA noted, reported all over pain. At 0850 when they attempted to reposition the resident, she was not responsive. Licensed nurse assessed her and no heartbeat heard or pulse found. 01/02/2021 01/08/2021 62 F
942602 Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Fatigue; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on right deltoid on 05Jan2021 07:45 at single dose for covid-19 immunization. Family history included migraine (other family members). Medical history included mild blood pressure and kidney stones, reactive airway disease. Concomitant medication included colecalciferol (VITAMIN D), potassium, allopurinol and hydrochlorothiazide/valsartan for mild blood pressure and kidney stones, fluticasone propionate, salmeterol xinafoate (ADVAIR) for reactive airway disease, atorvastatin, and multivitamins. The patient previously took fluticasone propionate, salmeterol xinafoate (ADVAIR) and experienced dry mouth and lost sense of taste. The patient also previously took Tdap booster on Aug2020, Shingrix on 10Aug2020, and influenza on 12Oct2020; all for immunization; and tetanus injections for immunization and experienced localized tenderness. The patient had the first dose of BNT162B2 (lot number: EH9899) for COVID-19 immunization on 15Dec2020 and experienced localized tenderness at injection point. The received his second dose of COVID vaccine on 05Jan2021. With the first dose he had increased localized tenderness at injection site on 15Dec2020, and he rated it mild to moderate. He would say it was 80% resolved in 24 hours. It had completely resolved in 36 hours. He would say that he has recovered completely form the localized tenderness with the first dose. Then he noted his second dose was yesterday, in the context of not having much sleep the night before. The actual injection was uncommonly eerily painless. The other folks in his department had similar experience. Maybe it was the nurse who gave the injection. Maybe it was because it was the same area and sensitivity was decreased. They had to check the Band-Aid to make sure blood was there. The administration was painless. He was relieved when the arm started getting sore to know he actually received it. He had increased arm tenderness at injection site which he rated as moderate which has now resolved. It got to moderate where lifting the arm up was sore. He definitely knew that he had been vaccinated. He got the vaccine at 7:45AM and now it is 16 to 17 hours later and he would say the pain is mild now. It did persist. The first vaccine hurt a little more. He expects this to go away. Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias. He had unrelenting headache over night that was moderate to severe. He said it kept him awake. It was exacerbated by lying down. Sitting up helped him. It became a migraine which is something he doesn't often experience. Migraines are pretty rare for him. He took 800mg of Advil at 6AM that helped for headache and migraine. The weight of the patient was 250 to 255 pounds. shaking, sweats, hot and cold flashes, and augmentation of myalgias have resolved. Everything has resolved except for a little headache. In the background he literally had one or two hours of sleep. He thinks that likely precipitated a migraine was increased. Last night he slept literally an hour. He took 800mg of Advil and fell asleep. He is operating on 2 hours of sleep in 48 hours. Most of the stuff is gone except a little headache and expected fatigue. Headache Seriousness Criteria: he would say that it was relatively disabling. He would not have been able to carry on. He wouldn't have been able to operate last night. It would have interfered. It was dissimilar to others. He gets rare migraines. Everything was amplified with a migraine. He certainly felt that. It was fair to say the vaccine precipitated the migraine that was mild or severe. He doesn't want to falsely attribute these things to the vaccine. Causality Headache: precipitated by the vaccine. In the context that he had not slept the night before. He had a nasopharyngeal COVID test and it was negative. He has been in a COVID study where they are looking at combination. They developed a saliva test at (Name). There is a combination of saliva oropharyngeal and immunoglobins. He has been negative multiple times. The outcome of the events headache and fatigue was not recovered and recovered for the rest of the events.; Sender's Comments: A causal association between BNT162B2 and the reported event headache cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. 01/05/2021 01/01/2021 53 M
942659 Idiopathic trigeminal neuralgia; This is a spontaneous report from a contactable nurse (patient).  A 34-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular (right deltoid) first dose on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history included multiple sclerosis from 2015 (Diagnosed 5 year) and ear infection from 03Dec2020 prior to vaccination, she was seen in urgent care with an ear infection, states it was super painful and lasted about 7-10 days treated it with drops..  There were no concomitant medications. The patient requested guidance on whether or not she should get the second dose of the covid vaccine after being diagnosed with Trigeminal Neuralgia following the first dose. The patient stated that she received the first done on 21Dec2020 and on 27Dec2020 was diagnosed with Idiopathic trigeminal neuralgia. The patient was unclear if the vaccine played a part in the diagnosis and wonders if there is any data available about this as an adverse event as she read that Bells Palsy was reported and this was similar. The patient need guidance on whether to get second dose of the Covid vaccine scheduled for on Monday. Wondering if getting the second dose would be risking it flaring up, states she was now on anticonvulsant medication and gabapentin and they have increased the anticonvulsant medication. The patient experienced idiopathic trigeminal neuralgia (trigeminal neuralgia) (non-serious) on 27Dec2020 with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable. The outcome of the event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  Trigeminal Neuralgia due to temporal relationship.  However,  the event may possibly  represent concurrent medical condition in this patient with medical history of multiple sclerosis.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and viral serologies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/21/2020 12/27/2020 34 F
942886 Admission Note: ? Weakness - Generalized     Patient reports feeling weak prior to dialysis, but demanded clinic to perform dialysis. Had full tx done and brought to ER. Reports still feels weak after dialysis.    84 year old male comes in today after completing dialysis for evaluation of generalized weakness x 5 days. He has also lost his voice. He tells me he received his COVID vaccine yesterday, but he is concerned he may have COVID. He denies any fevers, cough, sore throat, NVD, abd pain.  Transfer Note:  HOSPITAL COURSE: Patient is a 84 y.o. male who presented with shaking chills and was found to have Gram-negative rods in the blood.  The source of infection was unclear.  Initially it was thought that it could possibly be cholecystitis but imaging was negative for that.  There was concern that it could be UTI but the patient is on dialysis and is an uric and therefore no urinalysis could be got.  Early this morning when I saw the patient the patient did have significant pain and tenderness in the right knee and is not able to put weight on that.  I.e. Consulted Dr. Today with per lumbar from Orthopedics who said that it would be in the best interest of the patient for him to be transferred to hospital where he could decide on aspiration and or washout of the right knee.   Transfer center has been called and we are trying to finalize a transfer of the patient hospital at this point of time   Please see problem list listed below.   REASON FOR ADMISSION/ ADMISSION DIAGNOSES   Sepsis cause unclear 01/06/2021 01/06/2021 84 M
942909 Chief Complaint Patient presents with ? Vomiting     pt reports dry heaving and nausea that started an hour ago    Patient is an 68 y.o. year old male with PMHx significant for HTN, BPH, who presents to the ED today with nausea and dry heaving for one hour PTA.  States that he was at work as a courier when he had onset of sensation of room spinning, nausea, and dry heaving.  Also having tinnitus which he thinks is b/l.  This happened once about two weeks ago and resolved spontaneously overnight when he was asleep.  No preceding illnesses, medication changes, or other associated symptoms.  Vertigo has no clear exacerbating or relieving factors.  Has not yet taken anything for symptoms.    The patient denies fevers, chills, headaches, syncope, chest pain, shortness of breath, rhinorrhea, sore throat, cough, abdominal pain, changes in usual bowel movements, changes with urination, back pain, pain anywhere else in body.  The patient has no sick contacts, recent travel history. 12/28/2020 01/12/2021 68 M
943095 Pt experienced 103.7 fever and muscle spasms. Hospitalized. 01/12/2021 01/12/2021 33 M
943359 Unprovoked seizure (clonic tonic) 13 days later, requiring hospitalization and testing 12/30/2020 01/12/2021 38 F
944244 She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; shake/her hands were shaking so hard; they took her temperature and it was 100/her fever went to 101/temperature had gone to 102.6; heart rate was elevated at 100/heart rate was 110/heart rate went to the high 120s; headache; backache; nauseated; chest was hurting; The initial case was missing the following minimum criteria: Invalid for unspecified adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration in deltoid left on 29Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included ongoing sleep apnoea (diagnosed about 3-4 years ago, wear her CPAP religiously), Hashimoto's hypothyroid, and chronic low vitamin d (lack of sunlight). Concomitant medication included levothyroxine sodium (SYNTHROID) from 2016 and ongoing for Hashimoto's hypothyroid, ergocalciferol (VIT D) from 2018 for chronic low vitamin d; lack of sunlight (She did not take it religiously, but was supposed to take it everyday). At 10:30 AM (29Dec2020), she started to get cold and shake. She thought that this was insane and it was in her head. It became so severe she could not use her computer her hands were shaking so hard. She went back up to where they were giving vaccines, they took her temperature and it was 100. It had been normal the morning before she got the vaccine. Her heart rate was elevated at 100. They put a blanket on her and said they wanted to watch her for 15 minutes. In that time her fever went to 101 and her heart rate was 110. They took her to the ER. She was there for 5 hours. Her heart rate went to the high 120s. They did a 12 lead EKG. Her temperature had gone to 102.6, which was the highest. They gave her a liter of Normal Saline. She also had a headache, backache, and felt nauseated. The liter of fluid helped, no doubt. She was not admitted. She was wiped out the next day (30Dec2020) with aches and pains still. Their concern was they said they did not give her epinephrine because her heart was too high. She had no breathing issues. Just extreme cold. At one point she had woke up in the ER (29 or 30Dec2020) and her chest was hurting, she knows from her heart rate being too fast. She was so cold. She had on 6 blankets. The next day (30Dec2020) she still had the aches and pains, she was tired, and had brain fog. It all went away on 30Dec2020. She had nothing after that. What scared her was the heart rhythm. The ER doctor says its not great, but felt that getting the second dose was better than her having COVID. The Electrophysiologist she saw, said she was unsure if she should get the second dose. The hospital said that for this next dose, they would give her the injection, wait 15 minutes, then send her home, expecting that she would have the same thing happen. When after the first dose, she was in the ER on a 12 lead EKG with an intravenous (IV). She had no arm pain the whole time. The reporter assessed all events related. She felt fine prior, walking in to get the vaccine. But she was much better the next day and recovered completely. She was just worried about the second dose. The outcome of events was recovered on 30Dec2020.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/29/2020 12/01/2020 54 F
944279 fever and chills; fever and chills; blood pressure was low, about 90/50; did not feel well; syncope episode; unconscious; This is a spontaneous report from a contactable other health professional.  A 27-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the left arm on 08Jan2021 at 12:00 at a single dose for COVID-19 immunization; received at a nursing home/senior living facility. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Medical history included COVID-19 from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included unspecified birth control taken for an unspecified indication from an unknown date to an unknown date; within two weeks of vaccination. The patient experienced the following events and outcomes: syncope episode in Jan2021 with outcome of unknown, unconscious in Jan2021 with outcome of unknown, fever and chills on 09Jan2021 with outcome of unknown, blood pressure was low, about 90/50  on 09Jan2021 with outcome of unknown, did not feel well in Jan2021 with outcome of unknown; all of which were assessed as medically significant. The clinical course was reported as follows: the fever and chills began about one hour after vaccination (as reported). About 18 hours after the vaccination, the patient was getting up to take more paracetamol (TYLENOL) and did not feel well. The patient had a syncope episode in the bathroom (no issues as she sat on the floor before hand). The patient was unconscious for about 1-2 minutes. The patient's blood pressure several minutes later was low, about 90/50; however, the patient took the blood pressure measurement herself, so it may not have been exactly accurate. The patient underwent lab tests and procedures which included blood pressure measurement: low, about 90/50 on 09Jan2021.  Therapeutic measures were taken as a result of fever. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported serious events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 01/08/2021 01/01/2021 27 F
944649 1/7/2021 @ 5:00 a.m. patient woke up and couldn't move her right side (neck, arm and leg).  Sister helped dress her and drove her to the hospital.  During the ride the hospital the patient had 2 seizures and a 3rd seizure in the ER at the hospital.  Patient states she has never had multiple, back to back seizures before.  States she hasn't had a seizure for 2 years. EEG was done. Was released from the hospital on 1/9/2021 and to have outpatient MRI of head, shoulder, c-spine.  Does not have full range of motion of right neck, and arm, hand and fingers and is painful. 1/14/2021 - full release back to work on 1/14/2021. 01/06/2021 01/07/2021 33 F
944663 Resident had been monitored and had shown no signs or symptoms of any kind until 2 pm on 1/14/2021. Resident was found in the floor of her room. She had fallen and was having a seizure, temperature was 99.7F and Oxygen saturation was 82%. 01/12/2021 01/14/2021 67 F
945934 It felt like a viral meningitis; arm soreness; feel some tension; migraine headache; body started shaking; chills/Rigors; temperature 104; I had sensitivity that I never had; headache; photophobia; Sinophobia; paresthesia/tingling sensation along my upper extremity; I felt like I was freezing; I didn't feel comfortable; vertigo; nausea; hard time to focus; This is a spontaneous report from a contactable other health professional (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  He didn't have any allergies. He was in good health, no underlying issue. He never had a surgery. In Jan2021, patient got the vaccine last night around. It started with arm soreness. Around 10:00 am he started to feel some tension, migraine headache. Around 11:00 he felt his body started shaking. He had chills, rigors and temperature 104. For 5-6 hours he had sensitivity that he never had. Patient had a headache, photophobia, sinophobia, paresthesia and tingling sensation along his upper extremity. he felt like he was freezing. He didn't feel comfortable. It resolved afterwards, he felt no weakness, no facial paralysis. It felt like a viral meningitis. He also had vertigo, nausea and hard time to focus. Outcome of events were unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event viral meningitis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. 01/01/2021 01/01/2021 M
946258 THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL seizure AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD WORK WAS DONE AND CT SCAN. SENT HOME AROUND 6:30 AM ON JAN 1ST. (I DO NOT REMEMBER MUCH JUST WHAT MY FAMILY HAD TOLD ME) . I DO REMEMBER BEING SEVERLY SICK WITH VOMITING IN THE ER. CURRENTLY FOLLOWING UP WITH MY FAMILY MD AND HAVE MRI AND EEG TESTS SCHECULED WITHIN THE NEXT COUPLE OF WEEKS. 12/31/2020 12/31/2020 52 F
946549 On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started sweating. She passed out. Her daughter was at home and she took her to the nearest hospital. Her BP was 60/34 and she had a temp of 100.3F on 1/8 during hospital admission. Her K was low. She received lot of fluids. She called our office on 1/10 and during the f/u she was still in the hospital. On 1/10 she has a temp of 98.4F and BP of 109/61. But she still has dizziness, nausea, anorexia and mild cough (Former smoker). COVID-19 test was done on 1/9, its negative. Dx was dehydration. Discharged from the hospital on 1/11, feels better but is tired. Will follow up with PCP on 1/16/21. 01/08/2021 01/08/2021 59 F
946732 Rash, swollen tongue and 2 seizures.  Admitted to hospital with diagnosis of seizure and allergic reaction., 01/14/2021 01/14/2021 51 F
947480 fainting spell; almost passed out; dizzy spells; weak; This is a spontaneous report from a contactable consumer (patient herself). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 07Jan2021 in right upper arm shoulder area at single dose for prevent covid. Medical history included ongoing acne. Concomitant medication included doxycycline from 2020 (taking it 6 months ago) and ongoing for acne. Patient stated that she got the Covid vaccine yesterday 07Jan2021 and almost passed out in her kitchen after a couple hours. Patient stated got in shower had dizzy spells and was weak 07Jan2021, she felt better now. Patient stated that she was a small girl of 105 pounds and the dose could have made her sick. She wanted to make sure she did not need to go and be seen. Patent had another spell in shower this morning and stated that the fainting spell and feeling weak started at 9:00 yesterday evening on 07Jan2021. Outcome of dizzy spells was recovering, and outcome of other events were unknown. 01/07/2021 01/07/2021 22 F
947506 Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization.  Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested. 01/05/2021 01/01/2021 44 F
947511 convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine  arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation.  Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation "Long haulers" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021. 01/05/2021 01/05/2021 54 F
947518 tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My hands became cold and numb; fatigue; sore arm, leg/thigh aching; sniffles; sore throat; brief dry cough; slight headache; neck ache; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included Mild ADHD/ADD. The patient's concomitant medications were not reported. Approximately 5 minutes after receiving vaccination, she was standing in the observation room (where they had all of them stay for at least 15 minutes to ensure no severe reactions) and experienced a sudden onset of vertigo, tunnel vision and pre-syncope. Her hands became cold and numb and she was trying to talk to another staff member who was arranging/scheduling her second vaccination dose at the same time when this event occurred, but it subsided quickly and she started to feel normal again. All these events occurred at 12:45 on 05Jan2021. She reported this event right away and they had her stay in the room longer. She was stable at that point but experienced these symptoms again but very mildly twice more while she walked back to her car to go home. Other side effects on 05Jan2021 that started in the evening and for the following 2-3 days included fatigue, sore arm, leg/thigh aching, sniffles/sore throat, brief dry cough and slight headache/neck ache. Very mild and tolerable symptoms. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of all events was resolved in Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 01/05/2021 01/05/2021 34 F
947528 Experienced vasovagal syncope after standing, resulting in fall; Experienced vasovagal syncope after standing, resulting in fall; Awoke with severe chills; nausea; body/muscle aches; body/muscle aches; left arm pain; extreme thirst; fatigue; This is a spontaneous report from a contactable consumer. A 44-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 08Jan2021 14:30 in left arm at single dose for covid-19 immunization. There was no medical history and concomitant medications. Allergies to medications, food, or other products was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered was in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Jan2021 01:30 am, patient woke with severe chills, nausea, body/muscle aches, left arm pain, nausea, extreme thirst. Patient experienced vasovagal syncope after standing, resulting in fall. Worst symptoms were lasted about 30 minutes, muscle aches and fatigue continue about 16 hours later. All events were reported as non-serious. No treatment was received for these events. Outcome of all events were recovering. 01/08/2021 01/09/2021 F
947549 partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate. 12/30/2020 12/31/2020 40 F
948243 Observed in her room having seizure activity and unresponsive to stimuli. BP of 200/120, oxygen level dropped to 86%,  HR was 116. She was transferred from Hospital A and later transferred to Hospital B and placed on a ventilator. This remains her current status 01/12/2021 01/13/2021 64 F
948380 1/5/2021 0718 Pt received 2nd COVID vaccine 1/4/21. Oral temp 100.6, near syncope, muscle aches and head aches. Per EMS NSR, denies SOB, and chest pain. 500 ml bolus received in route. In ED, Pt c/o nausea. Pt anxious, sweating and uncomfortable. 0855 Pt resting comfortably, reports decease in pain/body aches 4/10. 1043 Discharge disposition: home.  Accompanied By: self.  Mode:  walk. --Hospital 01/04/2021 01/05/2021 F
948471 5-6 HOURS AFTER VACCINATION.  convulsIONS/seizure, HIGH BLOOD PRESSURE, INCREASED HEART RATE, 01/08/2021 01/08/2021 50 F
949761 Patient information was reviewed. Patient was asked if they ever had any form of severe reaction to anything they had had in the past. Patient did not state yes to anything other than having a reaction that was managed at home to shellfish as a child. They stated their throat had swollen as a child during the event. Patient was told that it was an anaphylactic reaction and shouldn't have been managed at home as a child by nurse and should have been taken to the hospital. Patient was told they would be monitored for 30 minutes after receiving the vaccine. Within 2-3 minutes after receiving the vaccine the patient reported tingling or burning around the site of injections. Within 5 minutes they stated to be feeling tired and that their arm had felt numb. After this the patient began starring into the distance and was unresponsive. Called for help and advice by turning around as patient had syncoped. Got nurses and other team members attention and had an epi-pen ready just in case it was needed. Patient began having notable distress with respiration and administed an epi-pen. Advised for a nurse to call EMS for patient and crash cart/oxygen was also obtaine dby the facility. Oxygen was required. Patient was not responsive after the first dose and was given a second as they remained un-alert with notable distress. The patient became alert a while after receiving the second shot and not long after that the EMS arrived to the event. 01/15/2021 01/15/2021 49 F
950073 On 1/15/2021 at 1800, resident noted to be lethargic and shaking, stating "I don't care." repeatedly. C/O head and neck pain. T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening. Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T 99.4,  Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21. 01/15/2021 01/15/2021 63 M
950132 Patient had COVID-19 infection April 2020, ataxia and myoclonus developed, treated with IVIG and steroids at that time. June 2020 had full recovery after PT. Pt received Pfizer COVID-19 dose 1 on 12/22/20 and developed similar symptoms to above on 1/7/2021. Ataxia and tremor on examination, no myoclonus at this time. 12/22/2020 01/07/2021 58 M
950926 Remarkable Myalgia of extremities and back, interfering with rolling or sitting. spasmodic twitching of upper extremities, These resulted in Hospitalization. 12/30/2020 01/07/2021 72 M
951519 Narrative: Symptoms: Palpitations & syncope Treatment: EPINEPHRINE 1 MG ONCE ,EPINEPHRINE 1 MG ONCE ,SODIUM BICARBONATE 50 ML ONCE 01/05/2021 01/05/2021 78 M
951560 Severe Right sided chest pain, right sided muscle spasms and difficulty breathing two weeks after vaccine was administered Diagnosis of bilateral pulmonary embolism was made on presentation to ER. No personal or family history of clots in arteries or deep veins or any risk factors in patient.  Received heparin drip, pain medications, muscle relaxants inpatient. Pain progressively improved over days. Was discharged after 6 days on admission. Was discharged on oral anticoagulant (Rivaroxaban aka xarelto) 12/19/2020 01/03/2021 33 M
951972 I felt quite sick, like I had the flu; became very lightheaded and dizzy; passed out; felt quite sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included R.A.D., osteopenia, migraine with aura, the patient had previously suffered episodes of vasal vagal syncopy when she got the flu or other severe illnesses, and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included atenolol, atorvastatin, azelastine, and fluticasone. The patient previously took gramicidin, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced allergies. The morning after receiving the vaccine, she felt quite sick, like she had the flu. When she got up from bed and went to the bathroom to urinate, she became very lightheaded and dizzy. She attempted to return to bed, but passed out on the bedroom floor before she could get to the bed, and seized while she was unconscious. Once she came to, she was helped to bed and, after about 90 minutes, felt much better, and got up, and ate food and had coffee. All events occurred at 07:30 AM on 09Jan2021. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was resolved in Jan2021.   Information on the lot/batch number has been requested. 01/08/2021 01/09/2021 69 F
951973 Blacked out; fainted; Felt very unwell; Nauseous; Chills; Fell; Knocked out, hit her nose, started to bleed; Humongous scar on her nose; In her hand there's a rash with different dots/red; She has petechiae/rash on the forearm; hit her face; knocked out, hit her nose; This is a spontaneous report from a contactable physician. This physician reported that a 30-year-old female patient (daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blacked out, fainted, felt very unwell, nauseous, chills, fell, knocked out, hit her nose, started to bleed, humongous scar on her nose, in her hand there's a rash with different dots/red, she has petechiae/rash on the forearm, all on an unspecified date in Jan2021. The Caller wanted information on side effects specifically looking at platelet or clotting or bleeding issues. Her daughter, (female, age 29 date of birth) received the 2nd dose of Pfizer vaccine, received it at the (State name), last night. She felt very unwell, nauseous, chills, and then blacked out, fell, knocked out, hit her nose, started to bleed; fainted and hit her face, didn't stop bleeding for 2 hours. There's a humongous scar on her nose. It took 2 hours to stop bleeding. She's going to urgent care today. Her daughter was healthy, yesterday was 2nd dose. In her hand, there's a rash with different dots/red. She has petechiae/rash on the forearm. Thankfully it (bleeding) did stop. The outcome of events for 'knocked out, hit her nose, started to bleed' was resolved on an unspecified date, for other events was unknown. The case was reported as non-serious.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based solely on a chronological association a causal relationship between events blacked out  and fainted and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 01/08/2021 01/01/2021 30 F
952101 The day of vaccination, the patient presented to the emergency room with a complaint of dizziness and syncope. Reported that she became dizzy, presyncopal feelings, and had a witnessed syncopal event. The patient stated she does have vasovagal syncopal events after blood draws in the past. The patient was assigned an overnight admission for a potential post-vaccination adverse event, new onset atrial fibrillation, dehydration, and syncope. Patient was discharged the following day. 01/14/2021 01/14/2021 19 F
952704 Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021.  Patient sought care twice at  ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room.  1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues.  Medical Center  -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed.  Patient committed suicide in home. 01/14/2021 01/14/2021 79 M
953072 Syncopal event; Nausea; Vomiting; This is a spontaneous report from a contactable nurse.  A 29-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), via an unspecified route of administration on the right arm on 08Jan2021 12:15 at single dose for COVID-19 immunisation. The patient medical history was not reported.  Concomitant medication included influenza vaccine (INFLUENZA VACCINE) on 13Dec2020. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 18Dec2021 12:15. The patient experienced syncopal event, nausea and vomiting on 09Jan2021 05:00. The patient received no treatment. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the event syncope is possibly related to suspect drug BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 01/08/2021 01/09/2021 29 F
953077 couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 12/23/2020 12/23/2020 42 F
953249 injection site  became red & swollen, the size of  a softball.  Employee  started having seizure like symptoms on 1/14/21 and was admitted to hospital.  DC from hospital on 1/16/21 and on 1/17/21 started having seizures again and readmitted back to hospital.  Employee has no history of seizures. 01/12/2021 01/14/2021 37 F
953357 Resident had seizure like activity that was about 30 minutes in duration where her upper/lower extremities were shaking uncontrollably. Resident had to be admitted into hospital for observation. 01/16/2021 01/16/2021 86 F
953598 Started to have symptoms and fainted; Hit her nose and has a scar now; She blacked out; hit her nose, got the scar in the nose, …she was bleeding from  that scar; hit her nose, got the scar in the nose, …she was bleeding from  that scar; She started to feel unwell; Chills; Nausea; Rash in her arm; She had little red in her bumps; This is a spontaneous report from a contactable physician. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on arm on unspecified date at a single dose (2nd dose) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician stated, "she had no medical conditions, she was in very good you know very like standing with herself." Patient had her 1st dose of Covid vaccine on unspecified date for COVID-19 immunization. Physician (reporter) stated, "I am the parent of someone who got the COVID dose, the second dose yesterday. I am very concerned because my daughter yesterday (08Jan2021) started to have symptoms and fainted at 4:00 in the morning and hit her nose and has a scar now. She had her second dose yesterday (pending clarification), after the second dose last night she started to feel unwell, getting chills, nausea and when she got up to go to the bathroom, she fainted, she blacked out. She lives alone, she is an adult, she hit her nose, got the scar in the nose, and the bleeding wouldn't stop, she was bleeding from that scar. She told me it took two hours for bleeding to stop from that scar." When asked when the events started, Physician stated, "Last night (08Jan2021), at 4:00 am she took the shot during the day while she was at work. She said, she started to getting chills and then she was nauseated." When asked if patient was still experiencing the event, the parent reported no as patient was just resting. Also stated, "She didn't take any treatment but she said she took Tylenol." Physician further added, "I am concerned, we are going to be taking her to the urgent care now but I am concerned about what is going on with platelets and all of that because of what had happened, last night the bleeding wouldn't stop for two hours and she was alone at the night and weekends. She said, she had to lay down and then her dad is there now because he is closer, he is going to be taking care of the urgent care but I want Pfizer to know what my daughter has gone through last night after she took this second dose." Physician further added, "she is having a rash in her arm, she had little red in her bumps as well. I want her to go get checked up as soon as possible in urgent care." Patient was taking some Ibuprofen (later clarified that patient took Tylenol as treatment). She was not taking any other medication. Outcome of the events was unknown.   Information Requested on Lot/ Batch number.; Sender's Comments: The reported faint was most likely due to an accident, and less likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 01/08/2021 01/08/2021 29 F
953794 Individual felt fine except a sore arm until 1/5/2021 legs became weak and dizziness and light headed and did t" feel well" and passed out.  had general muscle weakness and went to ER.  She was given fluid for possible dehydration and went home and weakness increase and went back to ER and was admitted to hospital for testing. 12/30/2020 01/05/2021 23 F
953809 Individual had no side effect except sore arm for 5 days then on 1/5/2021 became weak and dizzy and passed out.  had not felt well in am.  she had continued weakness and extreme leg weakness and taken to ER for evaluation.  She states got IV fluids and sent home but weakness increase and went back to ER on 1/5/2021 and admitted to hospital. 12/30/2020 01/05/2021 23 F
953926 seizure 01/07/2021 01/12/2021 74 M
954996 Had severe body aches m, fever, headache, progressed into dizziness and "foggy memory", started to have some chest pain. Felt as if I was intoxicated, lasted the whole day. Woke up the next morning and still felt "out of it" and weak but thought it would get better, went to work (im a nurse). Started having continous vomiting, shortness of breath and chest pain at work. As well as severe tremors. I was taken to the hospital, given fluids and my QT was prolonged with my heart which i have never had before . Was given iv magnesium and waited for my heart rhythm to improve. Was told not to take anymore of my prescribed medications or nausea medications and follow up with my pcp the next day. Im still feeling horrible, nausea, body aches, low grade fever and I am 72 hours out. Now I have huge hospital bill to pay, can't work currently because I still feel bad and my heart has a weird rhythm. Hoping this helps as if this was what I was expecting I would have never got it. 01/16/2021 01/17/2021 34 F
955179 Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted.  She hit the tile floor. 01/02/2021 01/04/2021 79 F
955491 Systemic: Anaphylaxis-Severe, Systemic: seizure-Severe 01/15/2021 01/15/2021 48 F
955911 Approximately 3 days after my injection I began experience severe tremors Ib bilateral arms, bilateral legs, head, and vocal cord tremors as well as blurry vision and memory impairment. Unfortunately, the symptoms don't seem to be improving. My MD prescribed metoprolol, which I will begin today. 01/15/2021 01/17/2021 40 F
956506 1. shaking 2. Whole body tingling  3. Left arm tense (injection was provided in right arm) 4. Felt clammy  Walked over to hospital attached to the facility and was discharged the same day. All symptoms resolved. 01/12/2021 01/12/2021 34 M
957227 Hypotension, Prolonged seizure with bowel incontinence, cough, weakness and delirium, resulting in 911 transport and admission to hospital for intubation and mechanical ventilation for acute respiratory hypoxia. 01/08/2021 01/09/2021 63 M
958322 shaking and then became unresponsive 01/19/2021 01/19/2021 62 M
958470 Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had numbness loss of feeling to leg leg. Was admitted to Hospital for 5days.  Had intermittnet seizure type episodes. Has had labs and  imaging tests that have been neg Under the care of the A Neuro Group. MRI scheduled for 1/20/21.  As of 1/20/21 feeling better but still weak. 01/05/2021 01/05/2021 45 F
958841 passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP.    A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine  , intramuscular in the left arm  on 07Jan2021 11:00 at single dose for Covid-19 immunisation .  Medical history included rubber sensitivity (Latex).  The patient's concomitant medications were not reported.   On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out  with outcome of recovered , dizzy  with outcome of recovered , hit the ground  with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea   with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills  with outcome of recovered , tired with outcome of recovered , severe headache on  with outcome of recovered , vomiting twice   with outcome of recovered , cold  with outcome of recovered.    The reporter stated the patient  attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on  unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out  dizzy and  falling down and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. 01/07/2021 01/09/2021 65 F
958843 I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient).   This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot  EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot  EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation.  On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered.   The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. 01/09/2021 01/10/2021 58 F
959079 On 1/9/2021 observed  with elevated respirations of 38-42 per minute, BP manually 72/50. pulse is jumping rapidly between 110-16 bpm. oxygen sat 76% RA, resident refusing oxygen at first attempt, allowed oxygen to be placed, is now 84% on 4L. resident shaking head yes that he is hurting, and yes that he would take medication for pain. Dr. notified,   branch block.  Received order for morphine 2mg per hr as needed for elevated respirations and pain. Dr. also gave orders to D/C Tamsulosin and finasteride.  Resident continue with decreased O2 sats and elevated respirations. Absence of vital signs on 1/10/21 at 826PM. 01/06/2021 01/09/2021 91 M
959401 I was having episodes of dyspnea and non productive cough starting from 1/1/2021. On 1/13/2021 I experienced severe dyspnea and had loss of consciousness for 5 seconds and was found down.  I was rushed to the hospital and diagnosed with multiple pulmonary embolus  (about 9) which was treated with direct TPA via catheterization. I then recovered in the ICU and transitioned to oral anticoagulation and discharged home on 1/15/2021. 12/30/2020 01/01/2021 36 M
959665 3 days post = tremors; 4 days post= pneumonia; 6 days post= hospitalized 12/30/2020 12/30/2020 89 F
959929 Narrative:  Patient seen in ED 1-17-21 with c/c of "bloated with epigastric pain". Patient with complicated medical history including stage 1B pancreatic cancer (was currently on chemotherapy mFOLFIRINOX), and a leadless permanent pacemaker implantation on 1-11-21 for long episodes of SR with complete heart block following symptoms of syncope (other cardiac history: CAD s/p CABG 2009, PAF, and HTN). Regarding ER visit for epigastric pain, nothing notable was found on workup and patient was to discharge home to rest. There were available doses of COVID-19 Vaccine following a vaccine clinic that same day, and patient was offered and agreed to a dose of vaccine. Patient was monitored for 15 minutes post vaccine with no notable issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees and that he had been "feeling kind of bad all day". Patient was advise to seek urgent medical care and reported back to ED on 1-19-21 at 00:55. Patient wasd admitted for SIRS (tachycardia and febrile) -- patient also reported diffuse myalgia. WBC WNL, CXR unremarkable for infection, UA neg for bacteria, LFTs WNL, blood cultures negative. Procalcitonin elevated at 17.8 -- suggesting inflammatory response. Patient initially reported feeling better on the morning of 1-19-21, but around 13:00 began rapidly declining (confusion, unable to walk) and started experiencing EKG changes (9 beats of SVT). Patient then coded and resuscitation was attempted for approximately 30 minutes. Patient did not survive the code. Coroner has been notified and family is considering autopsy at time of this report. 01/17/2021 01/18/2021 70 M
963168 shaking, altered consciousness Narrative:  One day after pt received his first covid vaccine, pt experienced upper extremity shaking leading to ED visit and subsequent hospitalization with concern for seizure. Examination and labs were not consistent with seizure. He had features of lewy body disease and parkinsonism. Labs were significant for leukocytosis, but pt had no other signs/symptoms of infection or findings to indicate a source of infection. Pt referred to Neurology. 01/05/2021 01/06/2021 80 M
964641 Narrative: Temporary restriction on driving until further evaluation due to symptoms of seizures. 01/06/2021 01/06/2021 57 F
964653 loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well, on 12/16/2020, and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9 with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically, the presentation was most consistent with an aspiration pneumonia. 01/06/2021 01/07/2021 79 M