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
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1106307
Sex: F
Age:
State: TN

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Patient felt like going to pass out and she did then, she was probably out less than in a minute; Severe headache; Nauseous; Throwing up/Vomiting; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient (weight: 81.65 kg, height 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder form an unspecified date. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder. On 22Feb2021, the patient experienced sore arm. On 25Feb2021, the patient developed severe headache, nauseous, and vomiting (throwing up) and the patient felt like going to pass out and she did then, she was probably out less than in a minute. The patient described as following: so, on 25Feb2021, the headache increased throughout the day and her nauseousness continued throughout the day and in the afternoon with the pain of the headache she thought she passed out, she vomited that gave her little bit of relief but then she took "two (not clarified) Advil and went to bed". Clinical outcome of the adverse events was unknown at time of this report. Patient asked if should be expected the same kind of reaction when she got her second shot.

Other Meds: SYNTHROID

Current Illness:

ID: 1106308
Sex: F
Age:
State:

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 03/16/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: confirmed appendicitis; This is a spontaneous report from a contactable Physician. A 34-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9269), via an unspecified route of administration on 04Feb2021 17:30 at SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30), bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) and folic acid. The reporter stated that abdominal pain that began at center of abdomen upon waking up at 8 am on 07Feb2021 and progressively got worse throughout the day. Developed nausea and multiple episodes of vomiting around 15:00. Abdominal pain then moved to RLQ, was persistent, dull and achy, worsened with movement (on 07Feb2021, 8:00). Pain was still present throughout the night and the next day, went to the ER for evaluation. There was concern for appendicitis. Labs were overall normal, CT abdomen was equivocal, abdominal and transvaginal ultrasound were normal but examination was concerning. Laparoscopic surgery was performed and confirmed appendicitis on an unspecified date. The patient was hospitalized for the event on an unspecified day. Outcome of the event was unknown.

Other Meds: BLISOVI FE 1.5/30; PROBIOTIC 10; FOLIC ACID

Current Illness:

ID: 1106310
Sex: F
Age:
State: PA

Vax Date: 02/26/2021
Onset Date: 03/01/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Bell's palsy; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on 01Mar2021. The event was reported to have resulted in emergency room/department or urgent care visit. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the known safety profile of the COVID-19 vaccine, and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported bell's palsy and the suspect administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 1106311
Sex: F
Age:
State:

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: double pneumonia and sepsis; double pneumonia and sepsis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history was chronic obstructive pulmonary disease (COPD). The patient previously took prednisone for COPD. She has a history of COPD and prior to getting her first Pfizer vaccine, she was on prednisone and antibiotics and was not feeling well. Concomitant medications were not reported. When she got her first vaccine on 30Jan2021, she started having problems breathing and a high fever and thought it was related to the vaccine. She was admitted to the hospital last Tuesday and was diagnosed with double pneumonia and sepsis. The doctor said it was not related to the vaccine. She got out of the hospital on Saturday. She is still on prednisone and antibiotics and now on oxygen all the time. She is getting mixed messages from her doctors on whether or not to get her second vaccine tomorrow. Some say yes, others no. She has not felt well for the last 5 weeks. The patient underwent lab tests and procedures which included body temperature: high fever on an unspecified date. The outcome of the events was unknown.; Sender's Comments: Based on the information available the reported events are considered not related to suspect drug.

Other Meds:

Current Illness:

ID: 1106313
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Bleeding; Pain; burning; Bruising; This is a spontaneous report from a Non-contactable consumer reporting for herself. A 53-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration, administered in right arm on Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced bleeding on Feb2021 with outcome of recovered , pain on Feb2021 with outcome of recovered with sequelae , burning sensation on Feb2021 with outcome of recovered with sequelae , bruising on Feb2021 with outcome of recovered with sequelae. Bleeding was considered an Important Medical Event. Course of the event: Pain, burning and bleeding immediately after injection. Bleeding stopped right away with a band-aid. Burning subsided within a few hours. Pain went away after 72 hours except it continues to hurt when sleeping on that side (right side). Bruising started about 3 days after the injection and took approximately 10 days to resolve. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1106314
Sex: F
Age:
State: NC

Vax Date: 02/13/2021
Onset Date: 02/15/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.

Other Meds: PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]

Current Illness:

ID: 1106315
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: headache/migraine; shoulder and neck pain; shoulder and neck pain; feeling tired; her stomach was not in the best shape; Digestive distress; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: unknown, via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history Guillain-Barre syndrome. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization and experienced 3 "rough days." The patient wanted information on some "residual" side effects that she is experiencing after receiving the COVID-19 vaccine, she received the second dose of the vaccine and presented the following side effects: headache/migraine that is diminishing, feeling tired, shoulder and neck pain or headache-type of reaction, her stomach was not in the best shape but she was tolerating food. She had been checked by two doctors and they can't find anything that could be causing this, she does not have a fever. The reporter is a patient with Guillain-Barre syndrome. She tried taking paracetamol (TYLENOL) but it did not make too much except for making blisters. She was a little concerned about her situation and stated that she wanted to make sure that she will be alright. During the call, she mentioned that one nurse told her that after receiving the vaccine she was on bed for 3 days and that other colleague of her was "not right" 6 days after receiving the vaccine she also knows that there are people who have some digestive distress after receiving the vaccine and she believes that her migraine/headache was causing her to have a digestive distress. She mentioned that after receiving the first shot of the vaccine she had 3 "rough days." The patient was recovering from the headache/migraine; while unknown for the rest of the events. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1106316
Sex: M
Age:
State: FL

Vax Date: 02/10/2021
Onset Date: 02/15/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: developed a rash in my back and groin that did not go away; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the second dose of bnt162b2 (Lot number was not reported), via an unspecified route of administration in the left arm on 10Feb2021 09:30 AM (at the age of 67-year-old) at single dose for COVID-19 immunization. Medical history included anxiety and some lactose intolerance. Concomitant medications included venlafaxine; fluoxetine hydrochloride (PROZAC); azelastine hydrochloride, fluticasone propionate (DYMISTA); amlodipine; and atorvastatin calcium (ATORVAS). The patient previously took lisinopril and experienced drug allergy. The patient previously received the first dose of bnt162b2 via an unspecified route of administration on the left arm on 22Jan2021 09:30 AM (at the age of 67-year-old) at single dose for COVID-19 immunization. Approximately 5 days after receiving the 2nd Covid 19 vaccine on 15Feb2021 12:00, the patient developed a rash in his back and groin that did not go away until 3 days ago when he was prescribed Prednisone 20 mg (2 a day) by an allergist. Prior to the Prednisone the rash was very persistent and increasing in intensity. The patient didnot know if it had to be with the vaccine, but five days later and did not respond to antihistamines or over the counter ointments for rash. No covid prior vaccination nor covid tested post vaccination. The event resulted in Emergency room/department or urgent care. The outcome of the event was unknown. Information on Lot/Batch number has been requested.

Other Meds: VENLAFAXINE; PROZAC; DYMISTA; AMLODIPINE; ATORVAS

Current Illness:

ID: 1106317
Sex: F
Age:
State: NY

Vax Date: 02/13/2021
Onset Date: 02/17/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.

Other Meds: EFFEXOR; SIMVASTATIN; D3

Current Illness:

ID: 1106318
Sex: F
Age:
State: NC

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: My muscle and nerve on both side of my face (especial jawline area) are uncomfortable; My muscle and nerve on both side of my face (especial jawline area) are uncomfortable; This is a spontaneous report from a contactable Consumer. This 66-years-old female Consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/exp. date unknown), via an unspecified route of administration on 23Jan2021 11:45 AM at single dose on left arm for covid-19 immunisation at a Clinic/ Administration facility. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Patient had no known allergies. Patient did not have any other vaccine in four weeks. Concomitant medication included metformin, thiamine hydrochloride (VITAMIN B-1), cyanocobalamin (VITAMIN B-12). After the 1st dose, her muscle and nerve on both side of her face (especial jawline area) are uncomfortable. The nerve of both of front elbows was uncomfortable "stronger" on an unspecified date with outcome of not recovered. Patient has not tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and has been requested.

Other Meds: METFORMIN; VITAMIN B-1; VITAMIN B-12

Current Illness:

ID: 1106319
Sex: M
Age:
State: OR

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: gradually increasing pain in upper chest, which became severe; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received BNT162B2 (BNT162B2; Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 25Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medications included acarbose (ACARBOSE), sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), metformin (METFORMIN) and losartan (LOSARTAN) all taken for unspecified indications, start and stop dates were not reported. The patient previously took denoral [risperidone] and darvon [betahistine mesilate] and experienced allergies. The patient experienced gradually increasing pain in upper chest, which became severe on 26Feb2021 at 20:00. It was reported that beginning in evening of day following vaccination: gradually increasing pain in upper chest, which became severe. Went to ER; tests there ruled out heart Involvement; referred to regular physician for follow-up (appointment booked for 03Mar2021). Pain slightly better when patient left ER, gradually subsided overnight and following day; pain gone on second following day. The patient underwent lab tests and procedures which included investigation: Test for heart involvement on an unspecified date (Tests there ruled out heart involvement). The outcome of the event was recovered. Information about lot/batch number has been requested.

Other Meds: ACARBOSE; JANUVIA [SITAGLIPTIN PHOSPHATE]; METFORMIN; LOSARTAN

Current Illness:

ID: 1106320
Sex: F
Age:
State:

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: 6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; 6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; This is a spontaneous report from a non-contactable consumer (patient herself). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on the left arm, on 26Feb2021 10:15, at a single dose, for covid-19 immunization. Medical history included allergies: bee stings and sulfa drugs, AFIB (not had AFIB for 3 years) and, had a confirmed case of COVID on Jan2021 (reported as 1 month before vaccination). Concomitant medication included unspecified medication for AFIB. The patient experienced 6 hours of AFIB on 27Feb2021 10:15, 24 hours after first dose. The patient was taking a medication for AFIB (concomitant medication) and have not had AFIB for 3 years. The patient recovered from the adverse event on 27Feb2021 16:15 with no treatment received for it. The patient was not covid-tested post-vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1106322
Sex: F
Age:
State:

Vax Date: 02/28/2021
Onset Date: 03/01/2021
Rec V Date: 03/16/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: bleeding from ileostomy; abdominal pain; This is a spontaneous report from a non-contactable pharmacist. An 80-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 28Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Iodine, Levaquin and Morphine and experienced allergies. It was unknown if the patient received other vaccines in four weeks. The patient experienced abdominal pain and bleeding from ileostomy on 01Mar2021 at 11:00PM. The events resulted in emergency room/department or urgent care and hospitalization. The patient had no COVID prior vaccination and had not tested post vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information available the events abdominal pain and bleeding from ileostomy are attributed to intercurrent medical conditions that were not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1106323
Sex: F
Age:
State: WA

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 03/16/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Sepsis; double pneumonia; This is a spontaneous report from a contactable consumer (patient's daughter). A 78-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included COPD from an unknown date. The patient's concomitant medications were not reported. Patient on tuesday (assessed as 2021) was hospitalized with double pneumonia and sepsis then was in the hospital until Saturday(assessed as 2021), when she was released. Patient is still on a breathing machine, which is not normal for her, and reporter is not sure if she should get the second dose of the vaccine which is scheduled for tomorrow since patient is still on antibiotics and Prednisone (assessed as treatment for sepsis and pneumonia). The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1106324
Sex: F
Age:
State: AZ

Vax Date: 02/18/2021
Onset Date: 02/28/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: hardness at injection site; has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site.; has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site; This is a spontaneous report from a contactable nurse reporting for her friend (patient). A 91-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration, administered in arm Right on 18Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included stage 3 kidney disease, colon cancer, breast cancer and radiation from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced hardness at injection site and has an area on her arm that is 3 inches in diameter that was red and swollen at the injection site on 28Feb2021. The nurse reported that her friend got the first injection of the Covid-19 vaccine on 18Feb2021. She was fine and did not have any reactions. Yesterday she showed the nurse an area on her arm that was 3 inches in diameter that was red and swollen at the injection site. The nurse adds that she told her friend to apply ice to the area but she did not do that last night. Her friend said the area did not hurt. The nurse adds that it is strange that it appeared 10 days later. The patient did not recover from the events. Information about lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile, causality between reported vaccination site reactions and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1106325
Sex: M
Age:
State: OK

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 03/16/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Acute Pancreatitis; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9267), via an unspecified route of administration in the right arm on 23Feb2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies. Concomitant medications included losartan, amlodipine and omeprazole. The patient was previously administered with the first dose of BNT162B2 (lot number: EN5318) on 26Jan2021 at 08:45 in the left arm for COVID-19 immunization. No other vaccine in four weeks. The patient experienced acute pancreatitis on 24Feb2021 07:00. The patient was hospitalized for acute pancreatitis for 2 days. The patient self-admitted into ER and was admitted into hospital for observation. On unspecified date in 2021, patient underwent FMP, complete blood count (cbc) and chem-20 labwork which determined that no history to contribute to chief complaint and diagnosis. Treatment administered for the events included IV fluids and unknown medications. No covid prior vaccination. Covid test post vaccination included covid test type post vaccination: Nasal Swab on 27Feb2021 with negative result. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: LOSARTAN; AMLODIPINE; OMEPRAZOLE

Current Illness:

ID: 1106326
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital: Y

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: acute severe ITP; The initial case was missing the following minimum criteria: literature report without causality. Upon receipt of follow-up information on 01Mar2021, this case now contains all required information to be considered valid. This is a literature report. A 22-year-old healthy male with no medication use received the Pfizer-BioNTech BNT16B2b2 mRNA vaccine through his work as an emergency department employee. On day three, post-vaccination, he experienced widespread petechiae and gum bleeding, which prompted his presentation. He was current on his vaccines, including yearly influenza, with no history of adverse reactions. He denied respiratory and gastrointestinal complaints or a history of infection. He had no personal or family history of bleeding or autoimmune dis-ease. Vital signs and the remainder of his exam were normal. Laboratory tests revealed normal white-cell count, hemoglobin, and severe thrombocytopenia with a platelet count of 2 x 109/L. Two months prior to receiving the vaccine, the patient was evaluated at an outpatient clinic for upper respiratory symptoms. His PCR assay returned negative for SARS-CoV-2, and complete blood count was unremarkable with a normal platelet count of 145 x 109/L (reference range, 140-400 x 109/L). The upper respiratory symptoms resolved within a few days, and the patient had no further complaints. However, as a precautionary measure, one-week post outpatient evaluation, he was again tested for SARS-CoV-2, which returned negative. At the emergency department on day 3, post-vaccination, the following labs were normal or negative: prothrombin time, partial thromboplastin time, fibrinogen, blood urea nitrogen, creatine, electrolytes, bilirubin, Lactate dehydrogenase, alkaline phosphatase, albumin, globulin, total protein, and haptoglobin. The aspartate aminotransferase (42) and alanine aminotransferase (90) were mildly elevated; however, they normalized the next day. Additionally, he tested negative for HIV, Hepatitis B, Hepatitis C anti-body, and Epstein-Barr Virus serology. A nasopharyngeal swab also returned negative for SARS-CoV-2 antigen. The patient was then admitted and given dexamethasone 40 mg daily for 4 days, a platelet transfusion, and intravenous immunoglobulin at 1 g/kg for 2 days. Immunologic studies performed on day 6 for Rheumatoid factor, antibodies for Cyclic Citrullinated Peptide, Anti Centromere, Chroma-tin IgG, dsDNA, Jo1, Ribosomal P Protein, Ribonucleoprotein, Scleroderma, Smith, Sjogren's Syndrome B, Sm/Rnp IgG, AntinuclearAntibody (<1:80, normal <1:80) were normal. However, Sjogren's Syndrome A antibody (2.8) was elevated (normal <1 AI). On day six, post-vaccination, petechiae and oral bleeding decreased, and the patient was discharged with a platelet count of 28 x 109/L. Based on the presentation, a platelet count <100 x 109/L, and the exclusion of alternative causes, a diagnosis of ITP wasmade. At follow up, on day 11, the patient's platelet count normalized to173 x 109/L, and the patient tested positive for plasma IIb/IIIa and Ia/IIa platelet autoantibodies. Sjogren's Syndrome A antibody decreased from 2.8 on day 6 to 1.5 (normal <1 AI). Moreover, complement C3 (94) was normal (reference range, 79-152 mg/dL), while complement C4(10.9 mg/dL) was low (reference range, 16-38 mg/dL). On day 34 a repeat of the patient's abnormal immunologic studies showed a normal value of both Sjogren's syndrome A antibody (SSAAB: <0.2) and Complement C4 (27.6 mg/dL). Additionally, SARS-CoV-2 IgG antibody testing was performed to rule out that a previous COVID-19 infection elicited the ITP experienced on day 3. However, SARS- CoV-2 IgG was negative. As of 16Feb2021, and since the patient's discharge on day6, he remains healthy without any evidence or symptoms of autoimmune disease. This is the first case published in the medical literature of an individual, with no other cause identified and no associated illness, experiencing ITP after receiving the Pfizer-BioNTech vaccine. The temporal relationship of the patient's presentation 3 days post-vaccine administration suggests, but does not prove, the vaccine may be linked to the patient's ITP. Additionally, the rapid and severe drop in platelet count to 2 x 109/L is reminiscent of the abrupt onset observed in drug-induced thrombocytopenia, which further suggests a recent etiology. However, it must be noted that the incidence of ITP is about 3.3 per 100 000 adults/year. Therefore, it is also plausible that this patient's diagnosis was purely coincidental, given that the country has administered over 12 million vaccines to date. Addition-ally, 43 448 participants were included in the Pfizer-BioNTech trial, and no ITP was reported. Moreover, considering the low complement C4 (10.9 mg/dL), mildly elevated SSA Ab (1.5), and 2 months prior, the platelet count (145 x 109/L) was near the lower limit, it is difficult to exclude alternative causes, such as an underlying autoimmune condition with pre-existing ITP. In this scenario, the ITP became clinically apparent following the vaccine, though this patient never manifested symptoms suggestive of autoimmune disease. This case was reported to the FDA's Vaccine Adverse Events Reporting System (VAERS) and is valuable both for post-approval pharmacovigilance and as a foundation for clinicians to evaluate future patients with suspected ITP. Rare vaccination events are important, but do not diminish the enormous utility of vaccination and the well-documented safety profile 2 of the Pfizer-BioNTech BNT16B2b2 mRNA vaccine. No follow-up attempts possible. No further information expected.; Sender's Comments: The young adult having extremely low platelet 3 days presented with skin/subcutaneous bleeding following vaccination, a contributory role of the vaccine use therefore cannot be fully excluded in triggering the event onset. Meanwhile, the adult experienced upper respiratory symptoms prior to the vaccination having positive autoimmunological biomarkers positive including Sjogren's Syndrome A antibody elevated, tested positive for plasma IIb/IIIa and Ia/IIa platelet autoantibodies, complement C4 low, a underlying autoimmune condition with pre-existing ITP might not be completely ruled out. 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: 1106327
Sex: F
Age:
State: UT

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Blood sugar was extremely high; This is a spontaneous report from Support. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), on 22Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband got the second dose today (22Feb2021) and after the patient checked her blood sugar, it was extremely high. The patient's husband was asking if this is the effect of the vaccine. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds:

Current Illness:

ID: 1106328
Sex: F
Age:
State: IA

Vax Date: 02/18/2021
Onset Date: 02/24/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: pneumonia; congestion; coughing; sore throat; This is a spontaneous report from a contactable consumer. This consumer reported for a 97-year-old female patient (mother). This 97-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6200), dose 1 , single dose via an unspecified route of administration in the right arm on 18Feb2021 for COVID-19 vaccination. Medical history included COVID-19 on an unknown date in Oct2020, colon cancer, congestive heart failure and had a pacemaker. Concomitant medications were not reported. On 24Feb2021 the patient had pneumonia, congestion, coughing and sore throat. She was on oxygen and does not use it all the time and guaifenesin (MUCINEX). Treatment was received for pneumonia, congestion, coughing and sore throat. The clinical outcome of pneumonia, congestion, coughing and sore throat was not recovered.

Other Meds:

Current Illness:

ID: 1106329
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), 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's medical history and concomitant medications were not reported. On an unspecified date, it was reported that a patient had an anaphylactic reaction following a single dose of the Pfizer BioNTech COVID-19 vaccine. Because it is contraindicated for the patient to take the second dose, she is finding the best way to protect the patient from COVID-19. She wants to know the duration of coverage of the vaccine. She said she knows that after a single dose, the vaccine is 92.6% effective. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known on available information and known drug profile, a possible causal relationship cannot be excluded between the suspect product and the event anaphylactic reaction. 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: 1106330
Sex: M
Age:
State: CA

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Pemphigus; Hives in the back; This is a spontaneous report from a contactable physician (patient). An 82-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 1284), via an unspecified route of administration, on the left arm, on 30Dec2020 at a single dose for Covid-19 immunisation. Medical history included glaucoma, age-related macular degeneration (AMD), arrhythmia. The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient has no Covid prior vaccination and not Covid tested Concomitant medications included nebivolol hydrochloride (BYSTOLIC), rosuvastatin calcium (CRESTOR), and timolol. On an unspecified date, the patient developed hives in the back within a week after 1st shot and broke out in blisters over upper body 3 wks after 2nd shot of vaccine. Skin biopsy (Bx) done to confirm Pemphigus. Treatment for the events was Kenalog 60 mg IM/ also 3 wks later prednisone po. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event Pemphigus cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: BYSTOLIC; CRESTOR; TIMOLOL

Current Illness:

ID: 1106331
Sex: M
Age:
State: SC

Vax Date: 02/04/2021
Onset Date: 02/19/2021
Rec V Date: 03/16/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: developed two blood clots in his right calf; pain in his leg; This is a spontaneous report from a contactable consumer reporting for himself. A 70-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN9581/expiration date: not provided), via an unspecified route of administration, on 04Feb2021 (at the age of 70 years old) as a single dose for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3249/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 (at the age of 70 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included was not provided. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), meloxicam, an allergy medication and anti-depressants. On 19Feb2021, the patient reported that he developed two blood clots in his right calf, one towards his ankle and one towards his knee and pain in his leg which required hospitalization on 22Feb2021. The patient was discharged on the same day, 22Feb2021. Relevant lab data included: blood test on 22Feb2021 were done to determine what medication to put him on. The results of the blood test was unknown. Treatment received for the event thrombosis included abixaban (ELIQUIS) tablets as a blood thinner. The patient reported he never had blood clots in his life. The outcome of the events thrombosis and pain in leg was unknown.

Other Meds: BABY ASPIRIN; MELOXICAM

Current Illness:

ID: 1106332
Sex: F
Age:
State:

Vax Date: 02/10/2021
Onset Date: 02/01/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: I was lethargic; had no energy; appetite was gone; nauseous; head was a little dizzy, especially when I lay down/dizzy spells; I also felt unbalanced; I was shaky; I was unable to sit or stand up by myself. I was so weak.; Whiplash; fainted or passed out; fallen down the whole flight of stairs; I had no recollection on how I got there.; acromioclavicular joint separation; right thumb fracture; thumb was very sore; back was sore; felt so sick; My right thumb was very sore and I could not move my left shoulder or arm.; temperature was high; felt terrible; pale; pain; I had bruises all over my shins, knees, right elbowand 2 bumps on my head; headache; chills; no idea when I will fully heal, or when I will be able to get back to normal activities; Concussion; imbalance in my inner ear from the fall and from the bangs I received on my head; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 10Feb2021 at 09:30 as a single dose for COVID-19 immunization. The patient's medical history included an unspecified immune system disorder from an unknown date and unknown if ongoing. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 20Jan2021 after her Remicaide infusion. The patient's concomitant medications were not reported. The patient experienced loss of consciousness on 11Feb2021, fall on 11Feb2021, joint dislocation on 11Feb2021, thumb fracture on 11Feb2021, concussion on an unspecified date in Feb2021, dizzy spells beginning on 13Feb2021, headache on 10Feb2021, chills on an unspecified date in Feb2021, fever on 11Feb2021, being unwell on 11Feb2021, being pale on 11Feb2021, pain beginning on 11Feb2021, contusions on 11Feb2021, decreased appetite on 14Feb2021, nausea on 14Feb2021, back pain on an 11Fev2021, sickness on 11Feb2021, pain in arm on 11Feb2021, memory deficit on 11Feb2021, weakness on 11Feb2021, balance difficulty on 13Feb2021, had no energy on 14Feb2021, being shaky beginning on 12Feb2021, whiplash injury on 11Feb2021, lethargic on 17Feb2021, inner ear disorder in Feb2021 and ADL impaired in Feb2021. Event descriptions were provided in the following first person account which was provided by reporter (the patient): "This is a chronological record of my experience after the Pfizer Vaccine 20Jan2021, I received my first shot of the Pfizer vaccine after my Remicade infusion in (hospital name) Wednesday, 10Feb2021, I received my second shot of the Pfizer vaccine at 9:30am at (hospital name). I started getting a headache before I went to bed at around 8pm. During the night, I got a severe headache and very bad chills. So bad my teeth were rattling and I had to pull an extra blanket over me. Thursday, 11Feb2021, I got up at 7.08am. I went into the bathroom and washed my face. I was very pale and I felt terrible. I went downstairs to the kitchen. I put the kettle on and took my temperature. I had three doctor appointments that morning in and I was worried I would not be able to get into them if my temperature was high. It was 100.1. I went into the ground floor bathroom. I left the bathroom when I heard the kettle was fully boiled. The next thing I remember was the feel of carpet on my left cheek. I knew the only floor in my house that had carpet, was the basement floor. I opened my eyes and to my horror, I was able to see the basement storage room. I had no recollection on how I got there. I knew straight away, that I had fainted or passed out, on the stairs landing and had fallen down the whole flight of stairs. I was afraid to move because I didn't know if I had broken my back or my neck. I was home alone. After laying there for a few minutes, I knew I had to try to get back up the stairs so I could get to a phone. If I didn't, I knew my husband would not find me there, until after 2:30pm. I tried to get up. I struggled but I got to my knees. The next thing I recall is waking up again on the carpeted floor. This time I was sprawled out in the opposite direction, this time my head was near the thread mill. I had obviously passed out again. Now this really frightened me, I was terrified to stand up in case I fell back down again. I literally crawled up the stairs on my hands and knees. I grabbed my cell phone and called my husband to come home from work. I made that call at 7.34am. I didn't move from the sofa until he came home. He made me a cup of tea. He then brought me into the bathroom to wash my teeth. When I was finished washing my teeth, I passed out again. I woke up this time to my husband tapping my face and calling my name. I had fainted again; he had caught me and had carried me into the sofa. I was unable to sit or stand up by myself. I was so weak. I felt so sick, I couldn't even drink the tea. My husband brought me up to bed. He checked on me every hour. I came back downstairs at 4pm. I hurt all over. I had bruises all over my shins, knees, right elbow and 2 bumps on my head. My back was sore. My right thumb was very sore and I couldn't move my left shoulder or arm. I put ice on my shoulder and thumb all night. I took Tylenol pm to help me sleep. Friday, 12Feb2021, my husband helped me to get dressed. I came down the stairs with him. I was very weak. I was shaky and did not trust myself to walk down the stairs. He was having knee surgery that morning. His friend took him to the hospital as I was not fit to drive. I did not move from the sofa until he came home at around 2pm. We talked about going to the ER but I really didn't want to go because of Covid. I was not steady on my feet and I would have to be dropped outside the hospital on my own. I took pain killers all day and iced down my left shoulder and right thumb. Saturday, 13Feb2021: I was still in a lot of pain and my head was a little dizzy, especially when I lay down. I went to Urgent care at 9am. I was seen by Dr. (Name provided). She sent me for 4 x rays and took my blood. My back and right shin were x rayed, I had no broken bones. My shins and knees were badly bruised. The other 2 x rays showed I had a fracture on my right thumb and there was something wrong with my left shoulder. She suggested I go to see an orthopedic doctor on Monday. I forgot to tell her about the dizzy spells and my neck been sore. She did not examine my head or neck. She found no other reason for my fainting, except that I got the Pfizer vaccine the day before. Sunday, 14Feb2021, I continued with the pain killers and ice on my shoulder and thumb. I continued to have dizzy spells. I also felt unbalanced. My appetite was gone and I felt nauseous sometimes when I was eating. I had no energy and I hurt all over. Monday, 15Feb2021, I got an appointment with an Orthopedist at 4.30pm. My husband dropped me off. Nurse and his assistant looked after me before I saw the doctor. I was told I have a separated bone in my left shoulder. It's called acromioclavicular joint separation. AC (collar bone) separates from the scapula (shoulder blade). So, I will have to wear a sling for a few weeks. I will also have to wear a temporary cast on my right hand for a few weeks to heal the fracture on my right thumb. No surgery is needed for either. They also put me on steroids for 2 weeks, Prednisone. Tuesday 16Feb2021, I rested all day. I was still having dizzy spells and I felt off balanced & very shaky. My husband, a close friend and a coworker thought I may have a concussion and advised me to get it checked out. I spent all day on the phone trying to get an appointment with a neurologist. I did get an appointment for the next day. Wednesday 17Feb2021, I still felt the same dizziness and I was lethargic. I had an appointment with the neurologist, Dr. (Name provided) at 2pm. I had a CAT scan and it was normal, no bleeding. The doctor said I had whiplash and a concussion. He did not find any other reason for my fainting, except for the side effects of the Pfizer vaccine. He told me, I just have to rest and the symptom from the concus

Other Meds:

Current Illness:

ID: 1106333
Sex: F
Age:
State: CA

Vax Date: 01/31/2021
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: pneumonia; This is a spontaneous report from a Pfizer-sponsored program, A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The patient was currently taking antibiotics for pneumonia, almost done with the treatment. The patient was scheduled to get her second COVID-19 vaccination tomorrow (at the time of report) and asked if it was safe for her to do so. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1106335
Sex: F
Age:
State: AL

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason; Vomiting; exhausted all day from being sick; exhausted all day from being sick; feeling slightly queasy/queasiness; diarrhea actually started before 1 AM/but was mild and escalated and by 1 AM it was extremely bad; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9264; Expiration Date: May2021), intramuscular, administered in Arm Left (left upper arm) on 25Feb2021 11:00 (at 70-year-old) at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Vaccination Facility Type was clinic. The patient previously took flu shot (she took the flu shot every fall and she has never had a reaction like this). It was reported that the patient started feeling queasy within 1 hour of the dose the same day. She confirmed by 1 AM 26Feb2021 she had diarrhea and vomiting which was about 14 hours after shot. She says the diarrhea actually started before 1 AM, so could have been 25Feb2021, but was mild and escalated and by 1 AM it was extremely bad. She confirmed the diarrhea was mild the same day as the vaccine and then got worse. She has also had a few heart quivers since this happened nothing constant but occasionally she feels like her heart is trembling. She thinks it was Saturday which would have 27Feb2021 because Friday, the day after the vaccine she was exhausted all day from being sick and maybe from the vaccine also but she thinks it was the next day, Saturday when she started occasionally feeling her heart jumping around a bit. She says occasionally her heart is still quivering for no rhyme or reason, just every once in a while she notices it. She says hopefully if she does take the second shot she will do better. The outcome of the event " few heart quivers/heart is trembling/occasionally feeling her heart jumping around a bit/occasionally her heart is still quivering for no rhyme or reason" was not recovered, "exhausted all day from being sick" was unknown, while for other events was recovered.

Other Meds:

Current Illness:

ID: 1106336
Sex: F
Age:
State: ME

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: anaphylaxis reaction to Prevnar 13; Prevnar 13: back of her throat was swelling; Prevnar 13: tongue was swelling; problem breathing; dizziness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know the ingredients in Covid vaccine and Prevnar 13 (pneumonia 13 vaccine). Wanted to know if any ingredients in pneumonia vaccine are in Covid vaccine. She had an anaphylaxis reaction to Prevnar 13. Stated that she does not think that her doctor's office reported the problem breathing and dizziness. She further stated that the back of her throat and tongue were swelling to Prevnar 13. Stated that she ended up going to the ER. She also stated that it resolved in an hour. Is checking to see if she can get the Covid vaccine. Clarified that she has not had the Covid vaccine yet. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1106337
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: prostate cancer; This is a spontaneous report from a contactable consumer reporting for himself. A 65-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on an unspecified date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced prostate cancer (medically significant) on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the event and included treatment with Lasix (not clarified over the call, reported as for his urine). Patient reported he had to underwent a surgery. The information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1106338
Sex: F
Age:
State: NY

Vax Date: 02/05/2021
Onset Date: 02/16/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 05Feb2021 (batch/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 got the 1st shot of vaccine on 05Feb2021. On 14Feb2021, the patient was not feeling well. On 16Feb2021, the patient tested positive for COVID-19. The patient wanted to know if she needs to be tested before the 2nd dose. She has been quarantined for 3 weeks in her home; even though the health department had said "quarantine for 14 days", but she did not go out because the weather was too cold. She had a problem of getting her second shot of the Pfizer COVID-19 Vaccine. She was supposed to get the second dose of the Pfizer COVID-19 vaccine on 26Feb2021 but could not due to being quarantined. She asked what is the timeframe that she should get the second dose is relative to having COVID. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1106339
Sex: M
Age:
State: VA

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: heart flutters; This is a spontaneous report from a Pfizer Sponsored, a contactable Nurse. A male patient of an unspecified age receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 on 03Feb2021 was the first dose. The patient experienced heart flutters, several times a day from an unspecified date. She is wondering if this is a normal reaction and what she should do about it. Outcome of the event was unknown. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1106340
Sex: F
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Kidney infections; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was scheduled to get her second dose of vaccine this Friday, but she said that after getting the first dose she had kidney infections on an unspecified date that's why she is taking antibiotics now and she wanted to know if she can still take second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1106341
Sex: F
Age:
State: MS

Vax Date: 02/26/2021
Onset Date: 02/01/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Very serious bacterial urinary tract infection; Rash; on face, underneath nose and underneath chin, aggravating rash; Bacterial infection; This is a spontaneous report from a contactable consumer (the patient). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration on 26Feb2021 (at the age of 91-years) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunization. The patient reported that she got her second COVID-19 vaccine Friday, and she has gotten a rash. It is just on her face, underneath her nose and underneath her chin. It is aggravating rash. She does not know what it is. She does not know what it could be or something else. The patient also reported "I had a very serious bacterial urinary tract infection, bacterial infection". The patient did not have any treatment for the rash. The clinical outcome of the events very serious bacterial urinary tract infection, Rash; on face, underneath nose and underneath chin, aggravating rash, and Bacterial infection was unknown.

Other Meds:

Current Illness:

ID: 1106342
Sex: F
Age:
State: NC

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; muscle and nerve on both side of her face and the area along the back of both ears on the back head are very uncomfortable; From thumb finger till middle figure of both hands are numb especially after getting up daily.; The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention); Both gums are very soreness and distention; Both gums are very soreness and distention; Stuffy nose; night sweats; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 66-year-old, on 20Feb2021, single dose for COVID-19 immunization. Relevant medical history included diabetes. The patient had no known allergies. Patient is not pregnant. Concomitant medications included metformin, thiamine hydrochloride (VITAMIN B1 [THIAMINE HYDROCHLORIDE]) taken for covid-19 immunisation; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (left arm), at the age of 66-year-old, on 23Jan2021, single dose for COVID-19 immunization and experienced muscle and nerve on both side of face (especial jawline area) are uncomfortable. On 21Feb2021 at 07:00 am, her muscle and nerve on both side of her face (especial jawline area, marionette line area, nasolabial folds, both temples and lower eyelid region) and the area along the back of both ears on the back head are very uncomfortable. From thumb finger till middle figure of both hands are numb especially after getting up daily. The nerve of both front elbows is uncomfortable a lot stronger (e.g. sensation of soreness and distention). Both gums are very soreness and distention. Stuffy nose and night sweats in the whole body happen a few times daily after the 2nd dose as well. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds: METFORMIN; VITAMIN B1 [THIAMINE HYDROCHLORIDE]; VITAMIN B12 [CYANOCOBALAMIN]

Current Illness:

ID: 1106343
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Viral pneumonia; This is a spontaneous report from two contactable consumers received by Pfizer from Merck & Co., Inc. manufacturer control number: 01872889. A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced viral pneumonia after vaccination. No further details were provided. The outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1106344
Sex: M
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 03/16/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: AFIB; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 01Feb2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced AFIB in Feb2021 with outcome of unknown. The patient was hospitalized for event in Feb2021 to an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1106345
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Patient was hospitalized for dysphasia after receiving 2nd dose of Pfizer COVID-19 vaccine.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), second dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was hospitalized for dysphasia after receiving 2nd dose of Pfizer covid-19 vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1106346
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Pneumonia; Pneumonia; I was tired; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program, PCV20 Adult Consumer Quant DTC Testing. A female patient of an unspecified age (reported as 70 unit of measure not provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had pneumonia once and was sick for months and was tired for a long time afterwards. Fortunately, the patient didn't have to go to the hospital, but felt badly enough to go. When her primary physician thought things were headed in that direction, the patient was treated with the strongest medications possible, and checked with her at home, with regularity. The patient had taken the (Prevnar) vaccine prior to this event. Outcome of the events was unknown. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1106347
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable Other Health Professional and a contactable consumer (patient). A 58-year-old female patient received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no event from vaccine. She tested positive for Covid after receiving vaccine and had another test performed that came back negative. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event tested positive for Covid after receiving cannot be excluded based on temporal association and limited information.

Other Meds:

Current Illness:

ID: 1106348
Sex: F
Age:
State: CA

Vax Date: 02/24/2021
Onset Date: 03/01/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Pancytopenia; This is a spontaneous report from a contactable Physician. A 78-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly at Left arm on 24Feb2021 (at the age of 78-year-old) for COVID-19 immunization at the Hospital. The patient medical history included Non-Hodgkin's lymphoma. Concomitant medications were none. The patient had received the first dose of vaccine on unknown date. The patient had not known allergies. The patient was not pregnant. Patient has not tested positive for COVID-19 since having the vaccine. Patient had not a COVID-19 prior vaccination. On 01Mar2021 the patient experienced pancytopenia. The outcome was reported as not recovered. No treatment received. The event was assessed as serious Life threatening Information on Lot/Batch has been requested.; Sender's Comments: Reported life threatening pancytopenia is considered unrelated to BNT162b2 but more likely associated with patient's medical history of Non-Hodgkin's lymphoma. 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:

Date Died:

ID: 1106349
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Resulted in the death; This is a spontaneous report from a Pfizer sponsored program: A contactable consumer reporting on behalf of the sister reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced an adverse effect that resulted in death on an unspecified date. Cause of death was unknown. It was unknown if an autopsy was done. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Resulted in the death

Other Meds:

Current Illness:

ID: 1106350
Sex: F
Age:
State: MA

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.

Other Meds:

Current Illness:

ID: 1106351
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Soreness in arm; tingling/numbness in lips; Soreness in arm; tingling/numbness in lips; Soreness in arm; tingling/numbness in lips; This is a spontaneous report from a contactable pharmacist. A 7-decade-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had allergy to bees. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and expiration date unknown) via an unspecified route of administration at single dose for COVID-19 immunization. The patient experienced soreness in arm; tingling/numbness in lips that started within 30 min of shot (2nd dose) and resolved on own about 15-20 min after tingling started. The outcome of the events tingling/numbness in lips was resolved on an unspecified date, while for event soreness in arm was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1106352
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Received first dose and got covid and wants to cancel her second dose; Received first dose and got covid and wants to cancel her second dose; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration, on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing cancer. Concomitant medications were not reported. The patient received first dose and got COVID and wants to cancel her second dose. The patient also had an infusion the day before reporting and is a cancer patient. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: Cancer

ID: 1106355
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: patient had anaphylactic reaction; labored breathing; Initial information received on 02-Mar-2021 regarding an unsolicited valid serious case from physician and consumer. This case involves a 56 years old female patient who had anaphylactic reaction with labored breathing (dyspnoea), after receiving INFLUENZA VACCINE. The patient's past medical history included other anaphylactic reactions but didn't clarify to what products. The patient's past medical treatment(s), vaccination(s) and family history were not provided and no Concomitant Medication(s). On an unknown date in 2014 at 3 in the evening, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date in 2014, the patient developed a serious anaphylactic reaction, while patient went to dinner at 5 in the evening with friends started having labored breathing (dyspnoea), (exact latency unknown) following INFLUENZA VACCINE. These events were assessed as medically significant. Patient states that the influenza vaccine that she had by Sanofi back in 2014 caused her to have an anaphylactic reaction and allergist was trying to find out what was in the flu shot to narrow down the reaction to what she was allergic to. Doctor office states that the patient received the Fluzone for under 65 years of age back in 2014 but that office did not have records of exactly what vaccine she used. Patient did not seek any medical care until the next day when she went to the office and physician subsequently sent her for test and to an allergist. Patient was not sure of any other details of the injection from 2014. In Dec 2020 her allergist gave her a skin test from Afluria and she had a "bad skin reaction" so then he gave her a "watered down" version of Afluria and she had redness with raised areas so he told her that she could not have further flu shots. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome is unknown for the reported events. Information regarding the batch number should be requested.; Sender's Comments: This case concerns a 56 years old female patient who presented with anaphylactic reaction and dyspnoea, after vaccination with INFLUENZA VACCINE .The time to onset is compatible. Past medical history included anaphylactic reactions. There is, however, no information regarding patient's condition at time of vaccination, past medical treatment, family history and other relevant laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1106356
Sex: F
Age: 76
State: CA

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: sulfa - 25+ year ago

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: 72 hours...exhaustion, super hot/icy cold within minutes, continued headache, diarrhea, nausea, could not eat for 2 days, 3rd day lost sense of taste and smell, 3rd day rash on arms and chest (4 hours), difficult to sleep soundly but needed to stay in bed or rest for the most part. 3/16 woke up feeling much better and able to eat, smell and taste about 75%. Spoke via text with doctors office personnel for advice 3/14 and 3/15...very supportive!

Other Meds: basic multi-vitamins

Current Illness: none

ID: 1106357
Sex: F
Age: 69
State: FL

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: Penicillin

Symptom List: Vomiting

Symptoms: Severe joint pain limiting mobility Minor fever Extreme chills/shaking lasting over 2 hours Extreme fatigue next day

Other Meds: Metformin Citalopram Atorvastatin Calcium Vitamin D Low dose aspirin Melatonin

Current Illness:

ID: 1106358
Sex: F
Age: 60
State: IN

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies: N/A

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Chills Joint ache

Other Meds: Gabapentin Meloxicam Magnesium capsules

Current Illness: N/A

ID: 1106359
Sex: F
Age: 45
State: CA

Vax Date: 01/29/2021
Onset Date: 01/31/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: Lisinopril

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Cough and wheezing starting about 48 hours after 2nd COVID vaccine (Moderna). Symptoms lasted approximately 1 week. Resolved after using Albuterol and Alvesco inhalers.

Other Meds: Isoniazid, Losartan, Propanolol, Multivitamin, Iron, Omega #, Vitamin B2 & B 6, Mag Ox, Zyrtec

Current Illness: None

ID: 1106360
Sex: F
Age: 44
State: VA

Vax Date: 03/14/2021
Onset Date: 03/15/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Allergic to Avocados.

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Fever, Chills, Body pain/ache, Muscle weakness/pain, Nausea, Loss of appetite, Dizziness, Sweating, Joint weakness/pain, High blood pressure

Other Meds: None.

Current Illness: None.

ID: 1106361
Sex: F
Age: 70
State: CA

Vax Date: 01/20/2021
Onset Date: 01/29/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: Acetone, walnuts, Belladonna, Feta cheese, chocolate, Codeine, darvon, other opiates-make me hyper, erythromycin, pestacides, perfume, shrimp, honey, Macrodantin, Miconazole, Mineral oil, nylon and chromic sutures,Pentazocine, Neomycin opthalmic, Omeprazole, adhesive tape

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: About 1/12-2 weeks s/p injection, my nervous system became extremely hyper. I was getting electric shocks down to my right three middle toes. I got the vaccine on my left side. I thought it was my back (sacro-iliac dysfunction), but it doesn't follow a dermatone. Then my R thumb started getting the shocks, with pain on one side, numbness on the other. This went on for a couple of weeks then calmed down. I got my second shot on 2/15/21 and a week or so after that the electric shocks came back even stronger and they are still doing it, only it appears to be slowing down now. I went to my pulmonary doc for an asthma check and asked her if I should report this, and she said yes.

Other Meds: vitamins B,C, E, multi, Biotin, B-12, CA+, aspirin 81mg, Lansoprazole, Cozaar, metformin, low dose Naltrexone, Cetirazine, tylenol 8-hr, probiotics

Current Illness: type 2 diabetes, asthma, reflex sympathetic dystrophy with chronic fatigue, fibromyalgia, gerd, depressin-not taking meds.

ID: 1106362
Sex: F
Age: 37
State:

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 03/16/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies: None known

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Swelling, intense itching and redness on face particularly around eyes and eyelids, cheeks, neck and back of ears. Also present in and around the bellybutton and on both arms (strong on right arm). Started day after injection and continued to intensify despite doses of benedryl and loratadine, and topical cortisone. Morning of 3/16 woke up to slight swelling in throat and overall intensified swelling in face and neck.

Other Meds: levothyroxine

Current Illness: None

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm