VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
43,092
AK1,300
AL3,149
AR2,058
AS39
AZ9,406
CA39,628
CO7,602
CT5,085
DC1,047
DE1,055
FL21,388
FM3
GA8,373
GU58
HI1,442
IA3,170
ID1,698
IL12,688
IN18,820
KS3,018
KY3,991
LA2,939
MA9,611
MD8,258
ME2,162
MH7
MI11,615
MN7,807
MO5,920
MP13
MS1,547
MT1,569
NC9,913
ND866
NE1,921
NH2,141
NJ10,441
NM2,506
NV2,483
NY21,032
OH12,246
OK3,130
OR5,610
PA14,687
PR1,402
QM1
RI1,440
SC3,714
SD804
TN5,425
TX20,857
UT2,841
VA9,728
VI31
VT1,241
WA9,465
WI7,223
WV1,535
WY573
XB5
XL1
XV2

ID: 1309509
Sex: F
Age:
State: CT

Vax Date: 04/23/2021
Onset Date: 04/24/2021
Rec V Date: 05/12/2021
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Symptoms: extreme soreness in the area of uterus; sore arm; has fibroid tumors and on Saturday night, she experienced very severe cramping from them; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 23Apr2021 at 11:30 AM (at the age of 51 years old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included chronic pain, fibromyalgia, ongoing fibroid tumors, and penicillin allergy. Concomitant medications included pregabalin (LYRICA); diazepam; ibuprofen; morphine; and multivitamins. The patient received the shot on Friday on 23Apr2021. The patient experienced sore arm on Saturday (24Apr2021), which is expected. The patient also has pre-existing fibroid tumors, and on Saturday night (24Apr2021), she experienced very severe cramping from them. On Sunday (25Apr2021) and Monday morning now (26Apr2021), the patient is experiencing extreme soreness in the area of uterus. 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 was not tested for COVID post vaccination. The patient had not yet recovered from the events. Information on the lot/batch number has been requested.

Other Meds: LYRICA; DIAZEPAM; IBUPROFEN; MORPHINE; MULTIVITAMINS [VITAMINS NOS]

Current Illness: Fibroma

ID: 1309510
Sex: F
Age:
State: NC

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 05/12/2021
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Symptoms: she ended up on the floor at the store; Whole left side; radial pulse and everything was gone; Whole left side; radial pulse and everything was gone; Freezing, could not get warm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05Feb2021 12:30 (Lot Number: EL9269) 1ST DOSE, single for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) and asthma. There were no concomitant medications. The patient not received prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. The patient reported that she received her first vaccine dose on 05Feb2021 and initially was instructed to get the second dose 2 weeks later. 30 minutes after getting the first dose she experienced a reaction, she thought she was having a stroke and she was transported to the ER for evaluation and found out it wasn't a stroke. Reports that because of her reaction, her ER doctor advised her not to get the second dose. But her primary doctor advised her to get the second dose at 3 weeks instead of 2 weeks after the first. She was planning to get her second dose 3 weeks after the first dose but her son died and she missed her appointment. Since then she has relocated to other state. It was further reported as follows: she waited 15 minutes after the vaccine and felt fine. She then went to the store and ended up on the floor at the store and had to be taken out of the store by ambulance. Her whole left side; her radial pulse per the Emergency Medical Technicians, was gone. She thought she was having a stroke but all of her tests at the hospital were negative. She was freezing and could not get warm. They put warming blankets on her. They did an MRI and a CT Scan and everything was fine. Symptoms lasted a couple of hours, then were gone. Emergency Room Nurses and Paramedics said she should get the second dose of the vaccine. The patient wants to be fully vaccinated. From the time she got her vaccine to the time they had to call the ambulance, it was about an hour. The patient missed her appointment for her second dose of the vaccine and still has not gotten it. Outcome of events recovered on 05Feb2021.

Other Meds:

Current Illness: Asthma (Verbatim: Asthma); COPD (Verbatim: COPD)

ID: 1309511
Sex: M
Age:
State: FL

Vax Date: 04/19/2021
Onset Date: 04/24/2021
Rec V Date: 05/12/2021
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Symptoms: Bells Palsy; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 19Apr2021 at 14:30 (Batch/Lot Number: EW0161) as SINGLE DOSE for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for Covid-19 since the vaccination. Medical history included Anxiety, depression and known allergies: Tree nuts. Concomitant medication included duloxetine (DULOXETINE), mirtazapine (MIRTAZAPINE), lamotrigine (LAMICTAL) and gabapentin (GABAPENTIN) all taken for unspecified indications, start and stop dates were not reported. The patient experienced bells palsy on 24Apr2021 at 19:00. Therapeutic measures were taken as a result of bell's palsy which included Prednisone and Valyacyclovir. The patient received first dose of BNT162B2 on 29Mar2021 (lot ER8730) at 15:30 administered to right arm. Outcome of the event was recovering. Follow up attempts needed. Further information is expected

Other Meds: DULOXETINE; MIRTAZAPINE; LAMICTAL; GABAPENTIN

Current Illness:

ID: 1309512
Sex: M
Age:
State: NY

Vax Date: 04/22/2021
Onset Date: 04/01/2021
Rec V Date: 05/12/2021
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Symptoms: Headache has continue and got much worse last night, left side of head and eyes hurting this morning; fever; chills; nausea; felt like he couldn't move; a sore arm; Headache has continue and got much worse last night, left side of head and eyes hurting this morning; This is a spontaneous report received from a contactable consumer (Calling on behalf of her son) reported for a 32-year-old male patient that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Apr2021 (Lot Number: EW0162) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 31Mar2021 (at age of 32 years old, Lot Number: EP7533) as a single dose for covid-19 immunization. The patient developed headache, fever, chills nausea, felt like he couldn't move, and a sore arm on Apr2021. Fever ended on Saturday (24Apr2021). Headache had continue and got much worse last night, left side of head and eyes hurting this morning (26Apr2021). He took two Advil this morning. The reporter asked how long will it last, if any info on severity, if Left side of the head- is that more of a migraine and what about eye pain. The outcome of event was "Fever" was recovered on 24Apr2021, outcome of "Headache aggravated" was not recovered and other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1309513
Sex: M
Age:
State: IN

Vax Date: 01/11/2021
Onset Date: 04/24/2021
Rec V Date: 05/12/2021
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Symptoms: received both doses of vaccine/he tested positive for COVID; received both doses of vaccine/he tested positive for COVID; This is a spontaneous report from a contactable nurse. A 32-year-old male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on left arm on 11Jan2021 13:10 (Batch/Lot Number: EL3246) as 2nd dose, single and dose 1 on 21Dec2020 (Batch/Lot Number: EJ1685) as 1st dose, single at the age of 31 years old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had tested negative for COVID-19 on Jul2020. The patient received both doses of vaccine and had symptoms started on 22Apr2021 and he tested positive for COVID on 24Apr2021. The patient would like to know what should he do or how to proceed, if he needs to get a booster or get the vaccine series again. He did take 400 mg of Ibuprofen. Seriousness criteria: The reporter adds that he does not think this is that serious, his symptoms are fine. Caller clarifies all symptoms reported are not serious. If it would not have been for loss of taste or smell, he would not have gotten tested but he thought it was weird. He was going to be traveling soon so he wanted to double check. The patient was not hospitalized,. The patient had no multiorgan failure, respiratory, cardiovascular, gastrointestinal/Hepatic, vascular, renal, neurological, hematological and dermatological disorders. The outcome of the events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.

Other Meds:

Current Illness:

ID: 1309514
Sex: F
Age:
State:

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 05/12/2021
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Symptoms: difficulty breathing; headache; headache effects her vision; She has asthma; blood pressure had been going up and down; blood pressure has been down (running low); feeling like her throat was closing; difficulty swallowing food; coughing; She experienced soreness in her arm & feeling off balance; feeling off balance; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, about five minutes after the injection she started coughing and feeling like her throat was closing. She continued to have difficulty swallowing food at this time. She experienced soreness in her arm and feeling off balance. She experienced a headache the following morning on 19Mar2021 that also continues and effects her vision. Her blood pressure has been down (running low). Her blood pressure had been going up and down. She has asthma and has had difficulty breathing since receiving the vaccine. The events feeling like her throat was closing, difficulty swallowing food and blood pressure has been down (running low) were considered medical important. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1309515
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 03/15/2021
Rec V Date: 05/12/2021
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Symptoms: revealed Breast cancer biomarkers 3 fold elevated (81) and CEA was 3.0 which was doubled; revealed Breast cancer biomarkers 3 fold elevated (81) and CEA was 3.0 which was doubled; This is a spontaneous report received from a contactable physician. This physician (patient) reported for herself that a 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration in left arm on an unspecified date (reported as on 19Dec2020, pending clarification) at single dose for COVID-19 immunization, in hospital. Medical history included breast cancer survivor-Stage 1A, grade 1; was treated with surgery and radiation in 2017 and opposite side in 2018 with surgery and radiation; sulfa allergy and cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included anastrozole and atorvastatin (LIPITOR). The patient historically received first single dose of BNT162B2 (lot number: EJ1685) via intramuscular in left arm on 19Dec2020 10:00 for COVID-19 immunization. Patient reported that she had breast cancer and was treated with surgery and radiation in 2017 and opposite side in 2018 with surgery and radiation. Currently on anastrozole. On routine surveillance test 2 months after the vaccine revealed Breast cancer biomarkers 3 fold elevated (81) and CEA was 3.0 which was doubled. 5 weeks later repeat tests showed CA marker 77 and CEA 2.6. Normally her markers run between 22 and 30 and CEA between 1.5 and 2.2. Should she worried about this and recurrence. She was in a very good health otherwise post cancer treatment. The adverse event occurred on 15Mar2021 08:00, resulted in doctor or other healthcare professional office/clinic visit, no treatment was received. Outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events. The reported events likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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.

Other Meds: ANASTROZOLE; LIPITOR [ATORVASTATIN]

Current Illness: Radiation therapy (opposite side in 2018); Surgery (opposite side in 2018)

ID: 1309516
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 05/12/2021
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Symptoms: she cut her hand; Sore arm; This is a spontaneous report received from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient cut her hand and had sore arm on an unspecified date with outcome of unknown. The event cut her hand was considered an Important Medical Event. The patient got stitches, a tetanus vaccine and was prescribed cephalexin as a result of the event. The patient is wondering if she can take the 2nd dose as scheduled. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1309517
Sex: M
Age:
State: WI

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 05/12/2021
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Symptoms: having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; nausea; lightheadedness; fatigue; dizziness; shortness of breath; cold sweats; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 09:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Relevant medical history included type 2 diabetes and high blood pressure. The patient had allergy to some nuts. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, 24 hours after his first Pfizer shot, the patient thought that he was having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats. These events were resulted in a visit to the Emergency Room. The Hospital Emergency Room diagnosis was "anti-viral reaction to vaccine" for the adverse event. The patient received with IV treatment. As of 24Apr2021, the clinical outcomes of the events "having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats" were resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1309518
Sex: F
Age:
State: LA

Vax Date: 04/23/2021
Onset Date: 04/24/2021
Rec V Date: 05/12/2021
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Symptoms: Almost passing out; Very short of breath/Had trouble breathing; Coughing to the point of seeing black; Could not walk from one room to the next with out being out of breath; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 23Apr2021 16:30 (Batch/Lot Number: EW0170) as UNKNOWN, SINGLE for covid-19 immunisation. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Medical history included asthma and sarcoidosis, drug hypersensitivity, allergies to cycline antibiotics. Concomitant medication included meloxicam (MELOXICAM) and omeprazole (PROTONIX [OMEPRAZOLE]). No Covid prior vaccination. Adverse event was reported as: Vaccine at 4:30 pm on Friday. Felt fine until later in the a.m. had trouble breathing. Very short of breath. Coughing to the point of seeing black and almost passing out. Could not walk from one room to the next without being out of breath. Adverse event start date: 24Apr2021, adverse event start time: 04:00 AM. Treatment received for events included nebulizer, rescue inhaler and Breo inhaler. The event outcome was recovering. No Covid tested post vaccination.

Other Meds: MELOXICAM; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1309519
Sex: M
Age:
State:

Vax Date: 04/12/2021
Onset Date: 04/01/2021
Rec V Date: 05/12/2021
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Symptoms: felt a cold and then hot burning mostly at night; like his legs were heavy; bad bruising on the deltoid muscle and bleeding; bad bruising on the deltoid muscle and bleeding; This is a spontaneous report from a non-contactable consumer reported for his son. A male patient in his 30's received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Apr2021 (at age of 30's, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter stated that his son had the first dose of the Covid-19 vaccine on 12Apr2021 and ten days later he presented "something like burning feet, felt a cold and then hot burning mostly at night, felt like he ran a marathon and felt like his legs were heavy". Stated that the side effects resolved after 24 hours. Added that his son was in his 30s. Stated that the vaccine administrator had a poor technique and his son presented bad bruising on the deltoid muscle and bleeding. He had no preexisting condition and would like to find out if this event has been reported. Reporter would like to consult if his son should get the second dose of the Pfizer Covid-19 vaccine if he presented side effects after the first dose. The outcome of the events "Feeling hot and cold/ Heaviness in limbs" was recovered on 23Apr2021. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1309520
Sex: M
Age:
State: CT

Vax Date: 01/22/2021
Onset Date: 03/05/2021
Rec V Date: 05/12/2021
Hospital: Y

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Symptoms: chest pains; cough; rash; This is a spontaneous report from contactable consumer (patient) via Medical information Team. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 22Jan2021 at 14:15 (Lot Number: EL3248) as single dose; dose 2 via an unspecified route of administration, administered in right arm on 12Feb2021 at 14:30 (Lot Number: EN6201) at the age of 79 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 the patient experienced chest pains, and cough, which required hospitalization from 05Mar2021 to 08Mar2021. The patient informed that he had some stress with son and daughter to point where he had some chest pains. After a week or two of conversation involving patients son and granddaughter culminated into this. The patient informed that when he went to the hospital because of chest pains, patient was already use to that and wasn't worried about it. The patient stated he didn't want to go to the hospital, called the doctor but because of Covid, the doctor wouldn't see the patient. The patient stated he shouldn't have been in the hospital at all. In terms of the cough, he simply called the doctor because the patient wanted cough medicine or something for that, temporary thing coming on. Patient stated the cough did not linger, and it was never treated. The hospital got into the chest pain and jumped on the heart situation and patient thinks they saw dollar signs or something. The patient wasn't very happy with them. The patient informed that he was given a blood thinner, Heparin IV during time hospitalized. The hospital decided to hold the patient over and they gave the patient Heparin IV for a good part of three days. The patient reported that he was discharged on 08Mar2021, and on 10Mar2021 the patient noticed the rash. The patient reporting experiencing rash after receiving both doses of the Pfizer covid-19 vaccine. The patient was thinking the combination of Plavix and heparin only three weeks after having the Pfizer Covid Vaccine could possibly be a side effect of rash. Therapeutic measures were taken as a result of rash. The doctor gave the patient Clobetasol Propionate and patient did treat rash with that. The doctor said to apply for 2 weeks and come in on one week. It has already improved. The patient mentions that he was also taking Calamine lotion and some spray and they all seem to be working. Patient didn't want to keep taking Clobetasol because it is a steroid and he had been using for a month and didn't want to do that. The clinical outcome of rash was recovering. The clinical outcome of the remaining events was unknown.

Other Meds:

Current Illness:

ID: 1309521
Sex: M
Age:
State:

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 05/12/2021
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Symptoms: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EW0150) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on unspecified date after getting the first dose of PFIZER-BIONTECH COVID-19 MRNA VACCINE. He added he has completed his 10-day quarantine yesterday. He explained that he should receive a confirmation email for the completed isolation today. He asked if he could get the second dose of the vaccine tomorrow, as initially scheduled. He then stated since a lost smell persists longer than other symptoms, is it included in the interim considerations from the CDC under their no symptoms criteria. The patient's second shot was scheduled on 27th of April. The outcome of the event was unknown. No further information is expected; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1309522
Sex: F
Age:
State: CO

Vax Date: 03/20/2021
Onset Date: 03/01/2021
Rec V Date: 05/12/2021
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Symptoms: The first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards; The first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in the left arm on 20Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included etonogestrel (IMPLANON) taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; ashwagandha (ASHWAGANDHA) taken for an unspecified indication, start and stop date were not reported. The patient was also taking unspecified multivitamins. No other vaccines were administered within four weeks of vaccination. On an unspecified date in 2021, the patient noted with the first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards. Details were as follows: patient noted that she never had period due to birth control methods. Following the first shot, she had a slight headache hours after the shot, and then got light embryos bleeding a few day afterwards. No treatment was given for the events. No COVID infection was noted prior to the vaccination, no COVID test was performed post vaccination. The outcome of events was unknown.

Other Meds: IMPLANON; ADDERALL; ASHWAGANDHA

Current Illness:

ID: 1309523
Sex: M
Age:
State: OH

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 05/12/2021
Hospital:

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Symptoms: allergic to something in the shot./systemic histamine reaction; swollen lips; lips were flaking, skin flaking; lips were flaking, skin flaking; massive facial angioedema/complete relapse of allergy/angioedema; fatigue; penis redness/penis was also "sheet red" and swollen; penis was also "sheet red" and swollen; itching; very very red face; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 50-year-old, dose 1 via an unspecified route of administration, administered in right arm on 25Mar2021 19:00 (Lot Number: ER8730; Expiration Date: 31Jul2021) as 1st dose, single for COVID-19 immunisation. Medical history included known allergies to spring pollen, oak birch, and ash. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and levocetirizine dihydrochloride (XYZAL) taken as allergy medication. On 25Mar2021, the patient got the shot, waited 15 minutes, no problems. On 26Mar2021, woke up to a very very red face. On 27Mar2021, massive facial angioedema, fatigue, itching, notable penis redness, his penis was also "sheet red" and swollen. The patient started 4mg prednisolone on 27Mar2021, kept facial swelling and allergies at bay, mostly, but a very close rate to not keeping up. On 02Apr2021, swelling subsided and mostly was getting back to "normal", however lips were flaking, skin flaking. On 04Apr2021-week of, things got better, very swollen lips but everything reasonably in check. On 12Apr2021, the face re-firing red at approx 1pm, slept until 6pm, and complete relapse of allergy/angioedema. Trip to Emergency room (ER), given shot of Kenelog in the arm, released. On 13Apr2021, no improvement, steroids ended 6 days after the patient started taking them, 2nd trip to ER with epinephrine shot, no improvement; blood taken, white blood cell count normal. On 14Apr2021, allergist appointment and he was told that he was allergic to something in the shot triggers pollen allergies, rosacea, etc. 50mg prednisone 5 days, 40mg 5 days, etc. He states that it was a systemic histamine reaction. On 26Apr2021 starts up again, mild, contact me. The patient doesn't know what to do with the second vaccine in general and he had called and they say no on him getting number 2. He was terrified of vaccines now because of his reaction. He also says that he was not hospitalized but he went to the emergency room twice. The patient would like to know if there have been any reports of those who had a similar reaction to this getting the second dose of the vaccine and how they reacted. He states that he has been told that he should not get the second dose but wonders if he were to get another COVID-19 vaccine other than Pfizer, if he would have the same reaction. The event allergic to something in the shot/systemic histamine reaction resulted to doctor or other healthcare professional office/clinic visit. The event massive facial angioedema/ complete relapse of allergy/angioedema resulted to emergency room/department or urgent care. The patient was treated with steroids for the events. The outcome of the event massive facial angioedema/complete relapse of allergy/angioedema was not recovered while for the rest of the events was recovering.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; XYZAL

Current Illness:

ID: 1309524
Sex: M
Age:
State: PA

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Onset Date: 04/16/2021
Rec V Date: 05/12/2021
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Symptoms: Shingles; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on 16Apr2021 with outcome of unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1309525
Sex: F
Age:
State: NJ

Vax Date: 04/05/2021
Onset Date: 04/09/2021
Rec V Date: 05/12/2021
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Symptoms: and had pain; The caller thought the patient had allergies,; SEVERE hearing loss; ringing and pressure in her ears; ringing and pressure in her ears; This is a spontaneous report from contactable consumers (including patient herself and her mother). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left deltoid on 05Apr2021 (Batch/Lot Number: ER8733) as 1st dose, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had no health issues and was "perfectly healthy." The patient didn't want to get the vaccine but her mother said she needed to get it, so the patient got the shot. On 09Apr2021, four days after receiving the vaccine, the patient had ringing in her ears, then it was hard to hear, and had pain out of nowhere. She started having ringing and pressure in her ears, then lost hearing in one year. She went to the doctor and had a hearing test. She had 50% hearing loss in her left ear. The doctor ordered an MRI with contrast and without contrast and came out negative. Patient's mother thought the patient had allergies, although the patient never has allergies, so the patient took some Afrin nose spray and saline spray. They waited. Then it was the other ear. Patient started having trouble hearing/ can't hear out of ear. The patient's ears got worse then the patient started losing her hearing. Today, the patient felt that something was not right so she went to see and Ear, Nose and Throat doctor diagnosed the patient with severe hearing loss. The doctor kept asking the patient when she received the COVID vaccine because he had seen this in other patients who have received the vaccine. The doctor believes that the hearing loss was because of the vaccine because it started right after the patient received the vaccine. The doctor prescribed the patient a high dose of cortisone for 12 days and now he wants an MRI of the patient's brain with and without contrast. There was not a question that loss of hearing is a side effect of the vaccine. The doctor had seen this before and mother just wanted to know if she has to spend thousands of dollars, what happens? Does she need to go to the news? She wants to know what to do. Is the hearing loss temporary? What percentage had the reaction recovered from it? The patient's insurance was going to run out at the end of April and she will not be able to afford the treatment of this. What is going on? The event was so bad that the patient said she will not live like this- its a ringing and pressure in the patient's head and its driving the patient crazy, now its gone but she can't hear. The doctor had seen this before and patient's mother just wanted to know if the patient has to spend thousands of dollars, what happens? Does the caller need to go to the news? The caller wants to know what to do. She stated "I did my own research. Every time I googled hearing loss, it's everywhere about ringing in the ears. My daughter left her job and now we have medical bills and she has no insurance. Pfizer has not been very good with getting back to me. I need help for my daughter. I need financial help. They're thinking about killing themselves because of the noise in their head. This should really be out there to say that there's a good chance that you may lose your hearing and have sounds in your head that drive you crazy. People need to be educated to make the right decision for them. This should really be out there to say that there's a good chance that you may lose your hearing and have sounds in your head that drive you crazy. People need to be educated to make the right decision for them. My daughter left her job and now we have medical bills and she has no insurance." There has not been a new event. Patient had a MRI of the brain with and without contrast and it was negative. She used steroids and was not better. Outcome of hearing loss was not recovered, of ringing and pressure in her ears recovered on an unspecified date, of remaining events was unknown. The patient had not been tested for COVID-19 since the vaccination.

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Current Illness:

ID: 1309526
Sex: F
Age:
State: NV

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 05/12/2021
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Symptoms: chest heaviness/very strong heaviness in her chest; restricted breathing; more breathless with any activity; breathing was difficult; difficult for his wife to talk and walk (because of her breathing).; difficult for his wife to talk and walk (because of her breathing).; allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband) A 44 year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ), intramuscular, administered in Arm Left on 21Apr2021 at 13:30 (at the age of 44 years old)(Batch/Lot Number: EW0162; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. Historical Vaccine includes Dose 1 on 23Mar2021 administered left arm, Lot Number: ER8727 and Expiration Date: 01Jul2021 for covid-19 immunisation ('had no problem'). The patient medical history was not reported. Concomitant medication(s) included phenylephrine hcl (PHENYLEPHRINE HCL) CVS brand NDC Number: 59779-094-68, Lot Number: 0EE3081 Expiry: Jan2022, taken for nasal decongestion therapy from Apr2021 and ongoing.No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. On 22Apr2021, The patient experienced chest heaviness/very strong heaviness in her chest, restricted breathing, allergic reaction, difficult for his wife to talk and walk, more breathless with any activity, breathing was difficult. The patient underwent lab tests and procedures which included electrocardiogram normal: results normal on 24Apr2021. Therapeutic measures were taken as a result of chest heaviness/very strong heaviness in her chest, restricted breathing. The clinical course was reported as follows Husband Reported on behalf of his wife got her first COVID-19 Vaccine dose 1, and had no problem, and was fine. He said when his wife got her second COVID-19 Vaccine dose on Tuesday, 21Apr2021, the first day she was fine, but towards the second day (22Apr2021), she had a very strong heaviness in her chest, and her breathing was restricted. His wife thought she may be having a severe allergic reaction to the COVID-19 Vaccine. Reporter made a few calls to the doctor, and the doctor told him to continue to monitor his wife, and maybe in a day, or 2, her symptoms would go away. On Saturday, 24Apr2021, his wife still had the chest heaviness, and it was very difficult for his wife to talk and walk (because of her breathing). On Saturday, 24Apr2021, the patient went to an urgent care. The doctor (clarified as a PA-physician assistant) looked for other symptoms his wife might have, and told his wife she did not have the COVID-19 Virus. He said his wife was told there were reports that the Pfizer COVID-19 vaccine was known for thickening the blood and for causing inflammation of the heart, said that she had an allergic reaction so an EKG was done at the time, and the EKG was normal. The PA (physician assistant) prescribed Ibuprofen 600mg (Lot Number: DE2607, Expiration Date Feb2022) by mouth daily. Also reported as (' 3 Ibuprofen 200mg tablets a day (600mg total),', and told his wife to return in 3 days if her symptoms were not better. It was also Reported his wife's chest heaviness had gone away, but the came back. Chest heaviness was not worse, but it had not gone away. The caller stated the doctor (PA) concluded that the Pfizer COVID-19 Vaccine produced too many antibodies in his wife, and the antibodies made his wife's blood thick. He said the doctor (PA) prescribed the Ibuprofen to help with his wife's blood flow. Subsequently the patient's husband had called Pfizer to report his wife's experience, but to also to find out how long his wife needed to continue taking the Ibuprofen. Reporter's wife, entered the call. She said the doctor (PA) suggested the Ibuprofen for inflammation. She stated she was more breathless with any activity (if she spoke or moved around). She said if she sat still, her breathing was fine. She said she was not physically tired at all, but her breathing was difficult. She said her chest heaviness was OK yesterday (25Apr2021), but when she woke up this morning, she had the chest heaviness again. She said her chest heaviness was better, but persisting. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected

Other Meds: PHENYLEPHRINE HCL

Current Illness:

ID: 1309527
Sex: M
Age:
State: AR

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 05/12/2021
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Symptoms: have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6 (lbs) pounds/Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight; falling; felt super strong; dizziness; failed all the tests for motor skills for his arms and legs; Fell and hit elbow and 3 ribs on left side; Fell and hit head; Sensory nerves are all gone; Fatigue; scabs; delusional; tore tendons in between ribs; They are tender(ribs); hurting all over; Cannot walk or lift anything; chest pain; his arm was sore a little; Left arm injection site pain; Disoriented; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 03Feb2021 (batch/lot number and expiration date not reported) at the age of 49 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date, vascular disease, bilateral stents placement, cataracts since he was born. Concomitant medication included gabapentin taken for an unspecified indication from an unspecified start date and ongoing. On 04Feb2021, the patient experienced left arm injection site pain. The patient experienced dizziness, falling, and couldn't go to work on unspecified date. He was treated by his (MD) physician, was given a CT scan, echocardiogram, and found to have some clots. He stated he has a history of vascular disease and had bilateral stents placed a year ago. He was placed back on an aspirin/Plavix regimen and referred to a neurologist because he has no motor skills anymore. He stated he failed all the tests for motor skills for his arms and legs. He was advised not to take the second dose of the vaccine and was diagnosed with neuropathy and autoimmune disorder (caller does not specify which disorder). He reported being positive for Covid-19 in Dec2020. He wanted to know what else he can do for his symptoms and is offering to be tested by Pfizer for treatment. The symptoms come in really hard seven days later. He actually had to go to the (ER) emergency and they worked on him and a whole string of doctors. He went to the emergency room and something was going on and wanted him to go to a family practitioner. They sent him to vascular, neurological and now they want to send him to a research center. It was a whole week after receiving vaccine before he began having symptoms. With the neuropathy and autoimmune, he cannot work like he did. He can hardly walk. Unspecified autoimmune was diagnosed last week. He can't remember the name of it. They told him not to take second one because the first one did what it did to him. It hurt a little and it was quick. The next day (04Feb2021), he said his arm was sore a little. He is only taking 4 medications and they looked it up. He did not think they were relevant. He was disoriented and fell and hit his head a couple of times. They ran an MRI on his head trying to figure that part out. That was done last week. He doesn't know the date and said it may have been on Friday. Results were good. The date he was disoriented was Wednesday 03Feb2021, when he took the shot. He has been disoriented and has been that way ever since. They kept him for 15 minutes to make sure no one passed out. He has been disoriented since then. He could not think clearly, and he could not do his job. He tore tendons in between ribs. He first thought he actually broke his ribs, but did not. There were two different falls. He cannot feel feet or anything. His motor skills are OK but when they did neuropathy test, they put needles in and shocked him to make his motor fire. His reflexes were really bad. He fell and hit elbow to keep from falling on face and twisted going down hitting 3-4 ribs on left side. It has been over 3 weeks now for his ribs. They are tender but they are not like the initial blow. It feels like they are healing. He fell and hit head a week ago. He was unsure of the exact date. He did not go to the emergency room with this one because the bed caught him. He fell and hit his head. All he has left is scabs. He cannot walk or lift anything (11Feb2021). That next Wednesday, he got ready to go to work and was so delusional and could not go in. He slept from 5:30 all that day and all that night. Then Thursday, he gets up and goes to work and goes slower, just to see what happened on Wednesday. He had fatigue and was disoriented. He did not provide start date or outcome for fatigue. He walked in and said either call an ambulance or he would go home. He went home and that was the last day of work. He then stated he laid in the car for 30 minutes and he said he is going to the emergency room. He went straight there that day. He had stents put in lower part of his body a year before. The neuropathy and the autoimmune kicked in 7 days later after the shot. The reason he went to the ER is because he thought it was his stent. He had bilateral, 4 of them. He was having chest pain and hurting all over on 11Feb2021. He thought he was having a heart attack. He was seen in the emergency room and released. It depends on how far he goes, how the chest pain worsens. Right now, he is ok, but when he gets up and moves around, it does the same thing. Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight. He was about 200 something and was kind of built and now is skin and bones. He lost 6 (lbs) pounds within a week and is eating like crazy. Sensory nerves are all gone. If hit with a baseball bat and he would not feel it. It came on slowly almost that he did not know it was happening. That is why they want to send him to Privacy for a research center and he does not want to go. He never had this happen before. ER or physician's office required: 1st date was on Thursday, 11Feb2021, when he went to Privacy. He was having chest pain and hurting all over. He thought he was having a heart attack. He was released. The patient stated he wanted to change the information he had provided since he was not in his right mind since he had taken the wrong medication dose than the doctor had given him. He stated the medication dosage he wanted to change was for Amiripyin. He stated he wanted to say he told the representative the symptoms he had experienced was enhanced which they were yesterday because he was trying to fight everything and stay awake. COVID 19 vaccine: he stated the doctor did not want him to take the second dose of the vaccine. He stated one of the symptoms he had experienced after the vaccine that he wanted to change the outcome for is the neuropathy. He stated he is back to where he used to be and yesterday it was bad he could hardly walk or talk. He stated also the other symptoms he wanted to change the outcome for is the autoimmune. The patient has not recovered from neuropathy, autoimmune disorder, disoriented, can't walk or lift anything, chest pain, and sensory nerves all gone; while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.

Other Meds: GABAPENTIN

Current Illness:

ID: 1309528
Sex: F
Age:
State: CA

Vax Date: 04/16/2021
Onset Date: 04/01/2021
Rec V Date: 05/12/2021
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Symptoms: blisters in her mouth; exhausted and winded; exhausted and winded; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; Metallic taste, hives on face and neck, shortness of breath walking; cold sore; super red and itchy; super red and itchy; tongue started to get itchy; the lymph nodes in her neck were really swollen; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0153, first dose, expiration date 31Jul2021) solution for injection intramuscular in the left arm on 16Apr2021 at 15:45 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included acid reflux, latex (allergy), sulfa based medicine (allergy), and pineapple (allergy). Concomitant medications included ongoing lansoprazole (PREVACID) for acid reflux, ongoing montelukast sodium (SINGULAIR) for seasonal allergy, ongoing fluticasone propionate (FLONASE) for seasonal allergy. 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 16Apr2021, the patient experienced metallic taste (5 seconds after vaccination), hives on face and neck (45 minutes after), shortness of breath walking resulting on doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care which included treatment with steroid shot and BENADRYL shot. On 17Apr2021, the patient experienced exhausted and winded. In Apr2021, the patient experienced cold sore, was super red and itchy, tongue started to get itchy, the lymph nodes in her neck were really swollen that included unspecified treatment. On 24Apr2021, the patient experienced blisters in her mouth and used hydrogen peroxide 3% to clean. The outcome of the events metallic taste, hives on face and neck, shortness of breath walking was recovering. The outcome of the events cold sore, super red and itchy, exhausted and winded, tongue started to get itchy, the lymph nodes in her neck were really swollen was unknown. The outcome of the event blisters in her mouth was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: PREVACID; SINGULAIR; FLONASE [FLUTICASONE PROPIONATE]

Current Illness:

ID: 1309529
Sex: M
Age:
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Rec V Date: 05/12/2021
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Symptoms: Flu coming on; Sore arm; Did not feel quite right/feeling funny; This is a spontaneous report from a contactable consumer via Medical Information Team. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for COVID-19 immunization. Patient stated that he received the first dose of the PFIZER BIONTECH COVID-19 mRNA VACCINE 3.5 weeks ago and the second dose last Wednesday (21Apr2021). Patient stated that after the first dose he had a sore arm, stated did not feel quite right, nothing major, like the flu coming on but no fever, stated feeling funny. Patient stated that nothing happened to him on the first, second or third day after the second dose of the vaccine side effect wise noting nothing like on the first dose. Patient stated he was concerned about the second dose not going in because he is not having any side effects. Patient stated the nurse stung him the first time and said nothing is coming out and the nurse stung him again and the patient stated he felt wetness on his arm. Patient stated the nurse did not squeeze up his arm and put it right in. Patient stated the nurse said to him she did not like the "syringes" and the patient is thinking that the needle was bent. Patient stated he asked the nurse did everything go in and the nurse told him yes and sent him on his way. Patient stated his wife and mother had the second dose and had the same symptoms but stronger than the first dose. Patient stated his wife had the second dose Saturday and reported soreness stronger than the first time and body ached a little bit, not feeling ok, nothing major, patient stated yesterday her arm was still a little sore but today she is better. Patient reported his mother got the second dose on Saturday and reported about the same as his wife noting soreness in the arm and pain in the legs stating it is gone now. Patient stated he is not happy about the answer he received and stated he did not want to report anything to DSU. Patient hung up on agent before any demographics could be obtained, side effect reports verified and survey offered. Patient asked is there a test for antibodies to see if his vaccine worked. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1309530
Sex: F
Age:
State: MO

Vax Date: 02/12/2021
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Rec V Date: 05/12/2021
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Symptoms: minor hallucinations; metallic taste; horrible smell that she experiences in which it makes her not want to eat or drink; chills; joint pain; tissue tender; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in deltoid right on 12Feb2021 (at the age of 80-years-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation. The reporter stated that since then (having both doses of the vaccine), she has been to the emergency room 4 different times experiencing side effects. She has a metallic taste and horrible smell that she experienced in which it made her not want to eat or drink. She has minor hallucinations, chills, joint pain, and her tissue is tender. Her joint pain has improved. Then stated, "I'm afraid I'm going to die from it." She asked if anyone has reported these reactions previously and what should she do about them. Her family physician's nurse looked up a study in which 11% of the patients were experiencing a metallic taste. Also stated, "This is very discouraging and depressing." The outcome of the event joint pain was recovering while of the rest was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of minor hallucinations cannot be excluded 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.

Other Meds:

Current Illness:

ID: 1309531
Sex: F
Age:
State: TX

Vax Date: 02/04/2021
Onset Date: 04/21/2021
Rec V Date: 05/12/2021
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Symptoms: blood pressure drop; nearly fainted; chest pain; jaw pain; loss of vision; Multiple bilateral pulmonary embolisms in my lungs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 39 years of age), via an unspecified route of administration, administered in arm left on 04Feb2021 (Batch/Lot Number: EN6202) as 2nd dose, single for COVID-19 immunisation. Medical history included MTHFR blood clotting gene mutation. Concomitant medications included citalopram, metoprolol, omeprazole and minastein fe24, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EN9581) dose 1 on an unknown date (also reported as 04Feb2021) 01:00 PM in left arm for COVID-19 immunisation. The patient was not pregnant. The patient did not have any other vaccine within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 prior since vaccination. It was reported that 6 weeks after the second dose on 21Apr2021 12:00, the patient had a blood pressure drop, nearly fainted, chest pain, jaw pain, loss of vision. She went to emergency room (ER), they did tests and found multiple bilateral pulmonary embolisms in her lungs. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events, Eliquis (reported as 'Eloquis') blood thinners given. The patient was hospitalized for the events for one day. The outcome of the events was not recovered. Information on the batch lot/batch number has been obtained.

Other Meds: CITALOPRAM; METOPROLOL; OMEPRAZOLE

Current Illness:

ID: 1309532
Sex: F
Age:
State: MO

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/12/2021
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Symptoms: Vomiting; chills; sweating; fever; extreme joint pain (especially in my knees); extreme skin inflammation pain; pain; restlessness; nausea; gassiness; piercing headache; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 11:00 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included bipolar 2, allergies to red dyes, and detergents. The patient is not pregnant at time of vaccination. Concomitant medication included lamotrigine (LAMICTAL); trazodone; fluoxetine and multiv. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 11:00 (Batch/Lot Number: ER2613) for covid-19 immunisation. The patient experienced vomiting, chills, sweating, fever, extreme joint pain (especially in her knees), extreme skin inflammation pain, restlessness, nausea, gassiness, piercing headache, muscle aches all on 15Apr2021 19:00. Symptoms onset 8 hours post second dose, went away by hour 20 post second dose, except for splitting headache which lingered for several days. Tylenol taken on regular schedule didn't kill pain. Alternated rosin salt bath/hot shower through the night. No treatment was received for other events. All events were serious. Prior to vaccination, no patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The outcome of event headache was unknown, while other outcomes of events were recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: LAMICTAL; TRAZODONE; FLUOXETINE

Current Illness:

ID: 1309533
Sex: F
Age:
State: NJ

Vax Date: 04/11/2021
Onset Date: 04/14/2021
Rec V Date: 05/12/2021
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Symptoms: weakness; Right arm sore at injection site; Body started shaking uncontrollably; she felt faint; she felt like she was going to pass out; feeling off kilter; nauseous; a stiffness in the back of her neck; she checked her blood pressure and it elevated; Felt jumpy; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0153) via an unspecified route of administration, administered into right arm on 11Apr2021 as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications include vitamins and supplements (unspecified). On 14Apr2021, patient felt jumpy. On 15Apr2021, patient felt faint, she felt like she was going to pass out as she was feeling off kilter, she was nauseous, had a stiffness in the back of her neck, she checked her blood pressure and it was elevated. On an unspecified date, she experienced weakness, right arm sore at injection site and her body started shaking uncontrollably. Outcome of events was unknown. No follow-up attempts are needed. No further information expected.

Other Meds:

Current Illness:

ID: 1309534
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 05/12/2021
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Symptoms: post menopausal vaginal bleeding; vaginal hemorrhage; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Apr2021 as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 24Mar2021 for COVID-19 immunization. Patient stated she had already reported this, did not confirm a reference, did not provide her age or prescribing physician's information. She asked if there were reports of "post menopausal vaginal bleeding or vaginal hemorrhage". She received Pfizer-BioNTech COVID-19 Vaccine. She stated "I found it reported online, I researched it, post menopausal vaginal bleeding/ vaginal hemorrhage. I'm in a terrible situation." The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1309535
Sex: F
Age:
State: NJ

Vax Date: 04/09/2021
Onset Date: 04/18/2021
Rec V Date: 05/12/2021
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Symptoms: not feeling well; received the first dose of the Pfizer vaccine on 19Mar2021. I received the second dose of the vaccine on 09Apr2021. I tested positive for COVID on 18Apr2021.; received the first dose of the Pfizer vaccine on 19Mar2021. I received the second dose of the vaccine on 09Apr2021. I tested positive for COVID on 18Apr2021.; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 09Apr2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Mar2021. The patient stated that she received the first dose of the Pfizer vaccine on 19Mar2021. She received the second dose of the vaccine on 09apr2021. She tested positive for COVID on 18Apr2021 (also reported as 21Apr2021, pending confirmation). The patient was not feeling well on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 18Apr2021. The outcome of the events was unknown. The patient wanted to know if she can et the COVID-19 infection from the vaccine. She also wanted to know if the vaccine can cause a false positive result. The patient was questioning if she tested positive due to the vaccine. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1309536
Sex: F
Age:
State: AL

Vax Date: 02/18/2021
Onset Date: 04/25/2021
Rec V Date: 05/12/2021
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Symptoms: autonomic dysreflexia; vomiting; chills; sweating; muscle pain/I still have muscle pain in my shoulders and neck; my head and heart were pounding; my head and heart were pounding; felt bad; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received second dose of BNT162B2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Lot Number: EN6201) at age of 31 years as single dose for covid-19 immunisation. Medical history included spinal cord injury due to MVA in 2012, neurogenic (incontinent) bladder and bowel, bladder augmentation and mitrofanoff, chronic neuropathic pain, dependent of wheelchair. Patient had no known allergies. Concomitant medications included lavender oil (lavender, helichrysum, jasmine). Historical vaccine included first dose of BNT162B2 administered in Arm Left on 28Jan2021 01:45 PM (Lot Number: EL8982) at age of 31 years as single dose for covid-19 immunisation and no reaction on previous exposure to drug. With first menstrual period after receiving vaccine patient had vomiting, chills, sweating, muscle pain, and her head and heart were pounding. It felt bad enough to go to emergency room but she waited it out at home and it lasted a few hours. Patient had a spinal cord injury so the symptoms were similar to what she got with autonomic dysreflexia, but this was the worst case of it she had ever had. She hadn't vomited in 10 years (or before her spinal cord injury). Patient still had muscle pain in her shoulders and neck. Adverse event start date was on 25Apr2021 12:00. No treatment received. No covid prior vaccination. No covid tested post vaccination. Outcome of events was recovered.; Sender's Comments: Based on the current available information, the event Autonomic dysreflexia is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history of spinal cord injury due to MVA in 2012 may provide a plausible explanation for the event. 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 Committees and Investigators, as appropriate.

Other Meds: LAVENDER OIL

Current Illness:

ID: 1309537
Sex: M
Age:
State: CA

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Rec V Date: 05/12/2021
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Symptoms: developed bell palsy after the first covid vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's parent) reported a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed bell palsy after the first covid vaccine on an unspecified date. The reporter was inquiring how to receive the second dose. The outcome of the event was unknown. Information on batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1309538
Sex: F
Age:
State: MI

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 05/12/2021
Hospital: Y

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Symptoms: major stroke; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was in the hospital due to a major stroke on an unspecified date. She can't move her right arm, right leg and she cannot talk. Patient's 2nd dose was due on 27Apr2021 and she can't continue to have the vaccine. Outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1309539
Sex: F
Age:
State: CA

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/12/2021
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Symptoms: mildly dizzy; heart palpitations; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0161), via an unspecified route of administration in the left arm, on 26Apr2021 at 10:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estradiol (ESTROGEN) (reported as low dose), acetylsalicylic acid (BABY ASPIRIN), and omeprazole (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8734), in the left arm, on 05Apr2021 at 10:15 (at the age of 51-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations on 26Apr2021 at 10:35 and mildly dizzy on 26Apr2021 at 10:40, which were reported as serious and medically significant. The clinical course was reported as: The patient experienced heart palpitations five minutes after receiving the vaccine, which went on for three minutes. Then, five minute later, she got mildly dizzy and was then fine for 10 minutes. This was reported to have repeated this cycle for two hours. The patient did not receive any treatment as a result of the events. The clinical outcome of heart palpitations and mildly dizzy was recovered on 26Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Other Meds: ESTROGEN; BABY ASPIRIN; OMEPRAZOLE

Current Illness:

ID: 1309540
Sex: F
Age:
State: CT

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 05/12/2021
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Symptoms: patient started her period the day of the vaccination and has not stopped bleeding since; This is a spontaneous report from a non-contactable consumer, reporting for herself. A 32-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2), via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 at a single dose for covid-19 immunisation. The patient received the vaccine in the hospital. The medical history was not reported. Concomitant medications included ergocalciferol/retinol palmitate (VITAMINS A & D) taken for an unspecified indication from 09Apr2021 to an unspecified stop date; cetirizine hydrochloride (ZYRTEC R) taken for an unspecified indication from 09Apr2021 to an unspecified stop date; rhamnus cathartica/rhamnus purshiana/senna spp. (HERBAL) taken for an unspecified indication start and stop date were not reported. No other vaccinations received in the last four weeks. On an unspecified date, the patient started her period the day of the vaccination and has not stopped bleeding since. It has been 18 days now. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.

Other Meds: VITAMINS A & D; ZYRTEC R; HERBAL

Current Illness:

ID: 1309541
Sex: F
Age:
State:

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 05/12/2021
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Symptoms: Stated that she can hardly walk and she does not know what she has.; possibly having cellulitis; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer Covid-19 on 31Mar2021, and she is scheduled for the second dose today at 9:40, but she had CT scan yesterday and she is taking antibiotics for possibly having cellulitis. Stated that she went to see two doctors and one of them just told her that it was inflammation and the other one prescribed her the antibiotics. Stated that she can hardly walk on an unspecified date in Apr2021 and she does not know what she has. She would like to know if there are any similar reports for the vaccine. Patient would like to know if she should reschedule the second dose of the Pfizer Covid-19 if she is currently taking antibiotics for possibly having cellulitis. The outcome of the events was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1309542
Sex: M
Age:
State: MI

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 05/12/2021
Hospital: Y

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Symptoms: Vision problems (partial loss of vision for a few seconds, unfocused spots in vision, double vision for minutes); Vision problems (partial loss of vision for a few seconds, unfocused spots in vision, double vision for minutes); Vision problems (partial loss of vision for a few seconds, unfocused spots in vision, double vision for minutes); Dizziness, Giddiness, lightheadedness; This is a spontaneous report from a contactable Other Health Professional. A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the right arm on 12Feb2021 at 10:00 (Batch/Lot number was not reported) at 69-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. Medical history included blood pressure high (HBP) from an unknown date and unknown if ongoing, atrial fibrillation (A-fib) from an unknown date and unknown if ongoing; and relevant past drug history: Yes, as reported (no details provided). Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; losartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; and others as reported. On 12Feb2021 at 14:00, the patient experienced: vision problems (partial loss of vision for a few seconds, unfocused spots in vision, double vision for minutes) (hospitalization, medically significant), and dizziness, giddiness, lightheadedness (hospitalization). The patient was hospitalized for the events for 3 days. The patient underwent lab tests and procedures which included computerised tomogram (CT): result was not provided on an unspecified date, echocardiogram: result was not provided on an unspecified date, Nasal Swab: negative on 24Apr2021 (post vaccination). Therapeutic measures were taken as a result of the events, which included CT and echocardiogram (as reported). The clinical outcome of the events: vision problems (partial loss of vision for a few seconds, unfocused spots in vision, double vision for minutes) was recovered on an unspecified date. The clinical outcome of the events: dizziness, giddiness, lightheadedness 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 a temporal association, a causal relationship between the reported events partial vision loss for a few seconds, unfocused spots in vision, double vision and dizziness, and the vaccine BNT162B2 cannot be completely excluded. The causality was confounded by the patients preexisting cardiovascular conditions including hypertension and atrial fibrillation and multiple concomitant medications. 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.

Other Meds: BYSTOLIC; HYDROCHLOROTHIAZIDE; LOSARTAN

Current Illness:

ID: 1309543
Sex: F
Age:
State: MN

Vax Date: 03/26/2021
Onset Date: 04/14/2021
Rec V Date: 05/12/2021
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Symptoms: Diagnosis of Bells Palsy on 14Apr2021; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in the left arm on 26Mar2021, at 11:00 as single dose for covid-19 immunization. Medical history included hypertension from an unknown date . No known allergies were noted. There were no concomitant medications. The patient had diagnosis of Bells palsy on 14apr2021 on 14Apr2021, at 06:00. The event resulted in Emergency room/department or urgent care visit. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of diagnosis of bells palsy on 14apr2021, and included treatment with predisone (x 5 days) and anti-viral (x 10 days). The outcome of diagnosis of Bells palsy on 14apr2021 was not recovered.

Other Meds:

Current Illness:

ID: 1309544
Sex: F
Age:
State: VA

Vax Date: 04/06/2021
Onset Date: 04/13/2021
Rec V Date: 05/12/2021
Hospital: Y

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Symptoms: Hypotension; weakness right side of the body, arm and leg; Paresthesia; Probably post vaccinal mild Brachial Neuritis; probably with autonomic neuropathy component, producing orthostatic hypotension; probably with autonomic neuropathy component, producing orthostatic hypotension; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hypotension, weakness right side of the body, arm and leg; paresthesia, probably post vaccinal mild brachial neuritis, probably with autonomic neuropathy component, producing orthostatic hypotension on 13Apr2021 16:00. The patient was hospitalized for a day on unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Apr2021. The outcome of the event was recovering. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1309545
Sex: F
Age:
State: DC

Vax Date: 03/01/2021
Onset Date: 03/15/2021
Rec V Date: 05/12/2021
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Symptoms: chills; sore arm; nausea; acid reflux causing extreme damage to the esophagus; cannot eat or sleep; cannot eat or sleep; rapid weight loss; Eosinophilic Esophagitis; cripeling upper back pain; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283), via an unspecified route of administration on 01Mar2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283) on 08Feb2021 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications was received within 2 weeks of vaccination. On 15Mar2021, the patient experienced chills, sore arm, nausea, acid reflux causing extreme damage to the esophagus, cannot eat or sleep, rapid weight loss, eosinophilic esophagitis, cripeling upper back pain. Therapeutic measures were taken as a result of the events and included PPI's, diet and lifestyle changes. The events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events chills, sore arm, and nausea was unknown; and the outcome of the other events was unknown. Events were serious due to disability (as reported). Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1309546
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 05/12/2021
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Symptoms: Extreme swelling and pain in both hands; Extreme swelling and pain in both hands; numbness; Left eyelid swelling; Hives on head and stomach; not feeling well; headache; This is spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on an unspecified date in 2021 (pending clarification) as 2ND DOSE, SINGLE for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient has no medical history. Concomitant medication included birth control (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme swelling and pain in both hands, and numbness. The patient also experienced left eyelid swelling, hives on head and stomach, generally not feeling well, and non-stop headache. The event onset date was not reported (pending clarification). There was no treatment received for the adverse event. The adverse events resulted in disability or permanent damage. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1309547
Sex: M
Age:
State: MI

Vax Date: 04/13/2021
Onset Date: 04/25/2021
Rec V Date: 05/12/2021
Hospital: Y

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Symptoms: Stroke; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151), via an unspecified route of administration, administered in Arm Right on 13Apr2021 12:30 as 2nd dose, single for COVID-19 immunization in a pharmacy/drugstore. Medical history included allergies: sulfa from unspecified date. Concomitant medications included hydrochlorothiazide and metoprolol succinate (TOPROL) both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot number: ER8727) on 22Mar2021 9:00 AM at 42 years of age in the right arm for COVID-19 immunization. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 25Apr2021 18:00 the patient had a stroke. The event required emergency room and physician's office visit and the patient was hospitalized for 1 day. The patient was treated with unspecified blood thinners. The outcome of the event was recovering.

Other Meds: HYDROCHLOROTHIAZIDE; TOPROL

Current Illness:

ID: 1309548
Sex: F
Age:
State:

Vax Date: 04/16/2021
Onset Date:
Rec V Date: 05/12/2021
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Symptoms: blisters inside and outside the mouth; hives; metallic taste; This is a spontaneous report received from a contactable consumer, the patient. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as a single dose (at the age of 44 years-old) for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced blisters inside and outside the mouth, hives, metallic taste all on an unspecified dates. Therapeutic measures were taken as a result of hives and included the patient received a steroid shot. The outcome of the events blisters inside and outside the mouth, hives, and metallic taste was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1309549
Sex: F
Age:
State: TX

Vax Date: 04/06/2021
Onset Date: 04/08/2021
Rec V Date: 05/12/2021
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Symptoms: Tinnitus - 24 hours a day, 7 days a week. I believe I have hearing loss and an scheduled for ent visit this week.; Tinnitus - 24 hours a day, 7 days a week. I believe I have hearing loss and an scheduled for ent visit this week.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-regnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left leg on 06Apr2021 09:30 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Vaccine facility type was pharmacy/drug store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced tinnitus - 24 hours a day, 7 days a week. that started on 08Apr2021 at 09:00. The patient believed she had hearing loss and was scheduled for ENT visit this week. The patient will have a hearing test (do not know next steps). The outcome of the events was not recovered. Events were reported as non-serious. Information on the batch/lot number has been requested.

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ID: 1309550
Sex: F
Age:
State: TX

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 05/12/2021
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Symptoms: leg formed a blood clot above knee; Severe pain; Numbing in arm and leg; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Batch/Lot Number: unknown) as 1ST DOSE, SINGLE for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included complications from bladder mesh and mitral valve prolapse. The patient's concomitant medications included Vitamins (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 06:00, the patient experienced severe pain followed by numbing in arm and leg, and leg formed a blood clot above knee. The patient tried to make doctor appointment but 40 days out. The patient took aspirin daily for clot and will see doctor in 2 weeks. No treatment was received for severe pain and numbing in arm and leg. The patient has not been tested for COVID-19 since the vaccination. The outcome of events severe pain and numbing in arm and leg was recovering; outcome of event leg formed a blood clot above knee was recovered on an unspecified date. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1309551
Sex: F
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Rec V Date: 05/12/2021
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Symptoms: the hives on her face; This is a spontaneous report received from a contactable consumer (patient herself). This female patient of unspecified age received first dose of bNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiry date was not reported) via unspecified route of administration as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives on her face. Caller would like to know whether the hives on her face will go away and what she can do to treat them. Caller stated now she wish she had not taken the shot. The clinical outcome of the event was unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1309552
Sex: M
Age:
State: NC

Vax Date: 03/23/2021
Onset Date: 04/01/2021
Rec V Date: 05/12/2021
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Symptoms: Sustained, rapid heart rate; This is spontaneous report from a contactable consumer (patient) . A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 23Mar2021 (Lot Number: ER8727) as single dose , dose 2 via an unspecified route of administration, administered in right arm on 13Apr2021 14:00 (Lot Number: EW0151) as SINGLE dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing, arrhythmia many years ago from an unknown date and unknown if ongoing. The patient's concomitant medications were unspecified. 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. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient sustained, rapid heart rate in Apr2021 "02:00 PM". The event occurred after dose one and dose two. The event after dose one required treatment by Urgent Care Clinic, EMS, and hospital emergency department. Treatment included adenosine in hospital. Outcome of the event sustained, rapid heart rate was recovering. No follow-up attempts are needed. No further information is expected.

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Current Illness:

ID: 1309553
Sex: M
Age:
State: NY

Vax Date: 04/23/2021
Onset Date: 04/24/2021
Rec V Date: 05/12/2021
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Symptoms: blood clot in one of his leg; leg became red; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 23Apr2021 (at the age of 73 years old) (Lot Number: EW0169, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient received his first dose of COVID-19 vaccine on 23Apr2021. In the night of 24Apr2021, his leg became red and he spoke to his doctor. The experienced a blood clot in one of his leg on 25Apr2021. The patient received Eliquis for the events to be taken for 45 days. He would like to consult if he should receive the second dose after the side effect from the first dose. Patient would like to know if there have been reports of blood clots after receiving the COVID-19 vaccine. The patient is scheduled to receive his second dose on 14May2021. The patient underwent lab tests and procedures which included blood test and ultrasound on leg: unknown results on 26Apr2021. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

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Current Illness:

ID: 1309554
Sex: F
Age:
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Vax Date: 04/21/2021
Onset Date: 04/24/2021
Rec V Date: 05/12/2021
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Symptoms: Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received BNT162B2 for COVID-19 immunization on 31Mar2021 (Lot unknown=True, Lot unknown reason=Unable to locate or read the details, Administration date=31Mar2021, Administration time=02:00 PM, Dose number=1, Vaccine location=Left arm, No reaction.) On 24Apr2021, Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs. The patient did not receive treatment for the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1309555
Sex: F
Age:
State: LA

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 05/12/2021
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Symptoms: headache; Fever was reported as worsened.; low grade fever; allergic reaction redness, warmth and itching at the injection site; allergic reaction redness, warmth and itching at the injection site; nodule/ bump; allergic reaction redness, warmth and itching at the injection site; nausea; This is a spontaneous report received from a contactable Nurse (patient) via medical information team. A 56-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Arm Right on 22Apr2021 at 10:00 (at the age of 56-year-old) as single dose for covid-19 immunization. Medical history included hair dye, allergy vaccines. The patient's concomitant medications were not reported. The patient previously took polyethylene glycol 3350. The patient experienced allergic reaction redness, warmth and itching at the injection site on 24Apr2021, nodule/ bump on 24Apr2021, low grade fever on 26Apr2021, headache on an unspecified date, nausea on 23Apr2021, fever was reported as worsened on an unspecified date. The events were reported non-serious. Patient stated she had delayed reactions, 3 days after the vaccine. She experienced "allergic reaction redness, warmth and itching at the injection site, a nodule/ bump, low grade fever, headache, nausea". She said she is allergic to the hair dye and she feels similar to after taking the vaccine. It could be due to the PEG in it. Patient stated that she was having symptoms that began on day 4 after the vaccine, a red circle around the vaccine site, it's warm and there is a hard knot under the skin. She still has a fever this morning and nausea, bad headache. She stated my concern was the amount of itching right at the site which reminded me of a true allergy not just a side effect. She experienced the same as when she was young. She had allergy vaccines and would react the same. The reaction she had is the same as with this vaccine reaction. She had a bad reaction to hair dye, and I started reading about the ingredient PEG that is sometimes found in that. The ingredient Polyethylene glycol, she had a question asked about the ingredient before the vaccine, she stated I guess that's in the diluent, and she never thought about the bad reaction she had to hair dye. When she put it together, and she understands it is in the vaccine. She was screened before the vaccine and she did have a pretty good reaction to hair dye at the end of last year. Her reaction started 2-3 days ago. Today, the redness is pretty much gone and the itching is gone, but it is still itching slightly. Confirmed that red circles, itching, and warm hard not started on 24th. Her fever was a little bit higher today, but still low grade. She stated when looking at her vaccine card that she may be wrong when it started after. She stated it would have been about 3 days ago so the 25th when the symptoms started. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the Pfizer Suspect. The adverse events required to go to Emergency Room and Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events allergic reaction redness at the injection site was recovered on 27Apr2021, events allergic reaction warmth and itching at the injection site, nodule/ bump was recovering, events low grade fever and Nausea was not recovered while for the events headache and Fever was reported as worsened was unknown. No follow-up attempts are needed. No further information is expected.

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Current Illness:

ID: 1309556
Sex: F
Age:
State: NY

Vax Date: 02/13/2021
Onset Date: 04/02/2021
Rec V Date: 05/12/2021
Hospital: Y

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Symptoms: breathing labored while walking or doing activity; swollen lymph nodes/ lymph nodes were enlarged slightly; fluid built up around heart and lungs; fluid built up around heart and lungs; white blood count was elevated; heart was weak and only working at 29% percent; heart was weak and only working at 29% percent; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Feb2021 at 18:00 (at the age of 43 years old) (Lot Number: EM9809, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient also received first dose of BNT162B2 on 23Jan2021 at 18:00 (at the age of 43 years old) (lot number: EL3247, unknown expiration) in left arm for COVID-19 immunization. After the second shot, the patient did notice swollen lymph nodes on 02Apr2021 for several days. She noticed her breathing labored while walking or doing activity on 02Apr2021 after getting the second shot. In 8 weeks, the patient went to the ER and found that she had fluid built up around heart and lungs which started on 02Apr2021. They also found in a CT scan that lymph nodes were enlarged slightly and that the patient's white blood count was elevated on 02Apr2021. After an echocardiogram on 02Apr2021, they determined that the patient's heart was weak and only working at 29% percent. The patient has had no prior history of heart problems or was taking any medications. The patient was given many heart medications to strengthen the heart and treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID and was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab on 10Apr2021 with negative result. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown. The events were assessed as serious (hospitalization) for 8 days. No follow-up attempts are needed. No further information is expected.

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Current Illness:

ID: 1309557
Sex: F
Age:
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Vax Date: 02/24/2021
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Rec V Date: 05/12/2021
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Symptoms: blood clot in her left calf; This is a spontaneous report from a contactable consumer, the patient. A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6203) on 02Feb2021 for COVID-19 immunization. On an unspecified date, the patient experienced pain and on 15Mar2021 it was confirmed that the patient had a blood clot in her left calf via ultrasound performed on 15Mar2021 with positive results. The patient was treated for the blood clot. The clinical outcome of "blood clot in her left calf" was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1309558
Sex: M
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Rec V Date: 05/12/2021
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Symptoms: developed 2 DVTs post Pfizer COVID vaccine; This is a spontaneous report from a non-contactable physician communicated to a Pfizer sales representative. A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) unknown dose number, via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed 2 DVTs post Pfizer COVID vaccine. Patient was put on apixaban (ELIQUIS). Event took place after use of product. Outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information expected.; Sender's Comments: The causal relationship between BNT162B2 and the reported deep vein thrombosis cannot be completely excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.

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Total 2021 VAERS Injuries: 392,839

Page last modified: 03 October 2021 5:28pm