VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.







Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 1030005
Sex: U
Age:
State: TX

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE reported; Caller is a HCP reporting an AE for VARlVAX. Caller states the vaccine was administered after a temperature excursion; Information has been received from a other health professional, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T012551, expiration date on 10-APR-2022, 0.5 milliliter (anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccine had a temperature excursion of -13.8 Celsius degrees (C), during 41 minutes. It was confirmed that no previous temperature excursions occurred and a digital data logger was involved.

Other Meds:

Current Illness:

ID: 1030006
Sex: U
Age:
State: LA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No further AE details; PROQUAD was stored in the refrigerator instead of thee freezer; PROQUAD administered concomitantly with VARIVAX; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported. It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator instead of the freezer since 01-DEC-2020. On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Product storage error) (dose number, strength, anatomical location and route of administration were not reported, lot # T025221, expiration date 19-JAN-2022, therapy type: recombinant Human albumin (rHA)) at a dose of 0.5 milliliter for prophylaxis, administered concomitantly with a properly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose number strength, anatomical location, route of administration, lot # and expiration date were not reported) at a dose of 0.5 milliliter for prophylaxis (Inappropriate schedule of product administration). It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine was exposed to a temperature of 44 Fahrenheit (F) for a time frame of 1506 hours. There was no previous temperature excursion and the call was not due to a data logger. No further adverse event (AE) details were provided. This is one of the several reports reported by the same reporter.; Sender's Comments: US-009507513-2102USA001266: US-009507513-2102USA001044: US-009507513-2102USA000941: US-009507513-2102USA001248: US-009507513-2102USA001301:

Other Meds:

Current Illness:

ID: 1030007
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: her arm getting sore and stiff along with a painful sensation; her arm getting sore and stiff along with a painful sensation; This spontaneous report was received from a currently 80 year old female consumer concerning herself. Current conditions include: Allergy to pills, dust, mold and mildew; leukemia, congestion (unspecified). There was no information about the patient's concomitant medication. On an unknown date, the patient was vaccinated with a dose of vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her right arm for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced a reaction to it. It was reported that her reaction consisted of her arm getting sore and stiff along with a painful sensation (PT: pain in extremity, injected limb mobility decreased). No treatment was given for the events. A blood work was performed, on an unspecified date (data not showed).The outcome of pain in extremity and injected limb mobility decreased was reported as recovered, on an unknown date, reported as "4 or 5 days after she received the injection" . It was mentioned that the patient seek unspecified medical attention. The reporter considered pain in extremity and injected limb mobility decreased to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).

Other Meds:

Current Illness: House dust allergy; Hypersensitivity; Leukaemia; Mycotic allergy; Nasal congestion

ID: 1030008
Sex: U
Age:
State:

Vax Date:
Onset Date: 01/01/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: They are only 30% effective; I have been "overdosed" with the PREVNAR and PNUEMOVAX shots. I am 68 and have been getting then since I was 50; I have been "overdosed" with the PREVNAR and PNUEMOVAX shots. I am 68 and have been getting then since I was 50; Pneumonia; This spontaneous report was received from a 68-year-old patient of an unknown gender concerning to themself via Pfizer. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not provided. On an unknown date, since the patient was 50-year-old, the patient had been getting vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported) and with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) (indication, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported) (inappropriate schedule of product administration). The patient was certain the she had been "overdosed" with the vaccines shots(overdose). In January 2021 (reported as last January), she got pneumonia and went to the urgent care, where, the patient explained to the physician she was diligent with the vaccines and the physician stated that vaccines were only 30 percent effective (therapy partial responder). The outcome of pneumonia and therapy partial responder was unknown. The causal assessment between the events and the suspect vaccines were not reported. Upon internal review, pneumonia had been considered a medically significant event.

Other Meds:

Current Illness:

ID: 1030009
Sex: F
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient passed out; patient became stiff; This spontaneous report was received from a nurse via company representative regardin a 11-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 09-FEB-2021, the patient was vaccinate with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and other dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) in the opposite arm (dose, route, anatomical location, lot number and expiration date were not reported for both vaccines); all for prophylaxis. On the same day immediately after received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient became stiff and passed out (stiffness and loss of consciousness). The patient was monitored in the office for about 30 minutes and then released home. The did not seek medical attention and no treatment was given for the events. At the time of the report, the patient had recovered from the events on 09-FEB-2021. The relatedness between the events of stiffness and loss of consciousness and therapy with received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported. Upon internal review, loss of consciousness was determined to be medically significant event.

Other Meds:

Current Illness: Prophylaxis

ID: 1030010
Sex: U
Age:
State: VA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: vaccines were administered to patients prior to having them evaluated/does not have complete temperature excursion; Information has been received from an office manager concerning a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/drug allergies and concomitant medications were not reported. It was reported that on 18-JAN-2021, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot # T003707 and expiration date 30-JAN-2022), subcutaneous for prophylaxis. Other suspect vaccine given on the same day included a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, frequency, route, Lot # and expiration date not provided). It was reported that the vaccines were administered to patients prior to having them evaluated and the reporter still did not have cumulative and complete temperature excursion information to have them evaluated. This is one of several cases from the same source (US-009507513-2102USA004608).; Sender's Comments: US-009507513-2102USA004608:

Other Meds:

Current Illness:

Date Died:

ID: 1030011
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: taking Eliquis who died after receiving the Pfizer-BioNtech Covid-l9; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-014171), license party for apixaban (ELIQUIS). This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (taking Eliquis who died after receiving the Pfizer-BioNtech Covid-l9) in patient of an unknown age and gender who received apixaban (Eliquis) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine. On an unknown date, the patient started Eliquis (unknown route) and Covid-19 Vaccine (unknown route). DEATH occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The doctor died after taking Eliquis with Covid-19 Vaccine. For Eliquis(Unknown), the reporter did not provide any causality assessments. This case was linked to US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-012621 (Linked Report).; Sender's Comments: BMS Medical Evaluation Comment: This patient died after receiving apixaban therapy. Patient also received COVID-19 vaccine. Based on the limited information available regarding the cause of death and autopsy details, it cannot be ascertained with the reasonable possibility that the apixaban could have caused the event.; Reported Cause(s) of Death: Unknown cause of death

Other Meds: ELIQUIS

Current Illness:

ID: 1030012
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: skin become red; skin became / hard; 4 months baby received her second dose of Bexsero; nurse did not administer the injection at 90 degree angle in my baby's leg.; 4 months baby received her second dose of Bexsero; This case was reported by a consumer via media and described the occurrence of skin red in a 4-month-old patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 9 hrs after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced skin red, skin induration, inappropriate age at vaccine administration, wrong injection technique and inappropriate age at vaccine administration. On an unknown date, the outcome of the skin red, skin induration, inappropriate age at vaccine administration, wrong injection technique and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the skin red and skin induration to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported for 1st dose. The patient received 2nd dose of Bexsero and the reporter noticed the nurse did not administer the injection at 90 degree angle in baby's leg. About 9 hrs. post vaccination, baby's skin became red and hard not at the injection site but close to it. Upon internal reveiw the following corrections were made on 10th February 2021: The device problem for suspect Bexsero Pre-Filled Syringe Device was updated to Adverse Event Without Identified Device or Use Problem.

Other Meds:

Current Illness:

ID: 1030014
Sex: M
Age:
State: NJ

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Upper frequency hearing loss; Ringing in my ears; Really tired; Little bit spaced out; A spontaneous report was received from a consumer concerning a 75-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced "ringing in my ears", upper frequency hearing loss, really tired and little bit spaced out. The patient's medical history was not provided. Concomitant medication included Clopidogrel bisulfate, Bromelain, Pantoprazole sodium, Atorvastatin, low dose aspirin and Vitamin C. On 28 Jan 2021, approximately 2-3 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient reported that after the injection he noticed ringing in his ears with upper frequency hearing loss. He felt tired and a little bit spaced out. Treatment information was not provided. On 29 Jan 2021, the patient reported ringing was a little better, but the upper frequency hearing loss was still there along with feeling spaced out. Action taken with mRNA-1273 in response to the events was not provided. On 29 Jan 2021, the patient was recovered from really tired. The outcome of the events "ringing in my ears", upper frequency hearing loss, and little bit spaced out was unknown.; Reporter's Comments: This case concerns a 75-year-old, male, who experienced serious unexpected event of deafness, non-serious unexpected event of tinnitus, feeling abnormal and, non-serious expected event of fatigue. The events occurred 1 days (2-3 hrs) after mRNA-1273 (Lot# Unknown). Concomitant medications included Clopidogrel bisulfate, Bromelain, Pantoprazole sodium, Atorvastatin, low dose aspirin and Vitamin C. Treatment details were not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

Other Meds: PLAVIX; BROMELAIN; PANTOPRAZOLE SODIUM; ATORVASTATIN; ASPIRIN 81; VITAMIN C ACID

Current Illness:

ID: 1030015
Sex: F
Age: 31
State: MA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Cellulitis; A spontaneous report (United States) was received from a consumer regarding a 31 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced cellulitis. The patient's medical history was not provided. Concomitant medication use was not provided. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021 the patient experienced cellulitis. Treatment for the event included intravenous antibiotics. Action taken with mRNA-1273 in response to the event was not provided. The outcome for the event , cellulitis, was considered unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1030016
Sex: M
Age:
State: AR

Vax Date: 01/30/2021
Onset Date: 01/31/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Faint; Shortness of breath; Dizzy; Headache; A spontaneous report was received from a consumer who is a 34-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainting, dizziness, shortness of breath and headache. The patient's medical history was not provided. Concomitant medications were not reported. On 30 Jan 2021, the patient received their second dose of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly in his right arm for the prophylaxis of COVID-19 infection. On 31 Jan 2021, 14 hours after the second dose, the patient experienced fainting, dizziness, shortness of breath and headache. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, fainting, dizziness, shortness of breath and headache, were unknown.; Reporter's Comments: This case concerns a 34-year-old male patient, who experienced medically significant unlisted event of Syncope, non-serious listed event of Headache, and non-serious unlisted events of Dyspnea and Dizziness. The events occurred approximately 14 hours after receiving their second of two planned doses of mRNA-1273 (Lot #029L20A). Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 1030017
Sex: M
Age: 73
State: IL

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 02/15/2021
Hospital: Y

Lab Data: Test Date: 20201231; Test Name: Chest x-ray; Result Unstructured Data: Pneumonia confirmed by chest x-ray.; Test Date: 20210103; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptoms: Pneumonia; COVID-19; Fever of 100.4; A spontaneous report was received from a health care professional concerning a 73-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fever, pneumonia, and COVID-19. The patient's medical history, as provided by the reporter, included a previous COVID-19 infection diagnosis. Concomitant medications were not reported. On 29 Dec 2020, the patient received their first dose of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient experienced fever of 100.4 and was given paracetamol. On 31 Dec 2020, the patient had a chest x-ray and was admitted to the hospital for pneumonia. On 03 Jan 2021 the patient tested positive for COVID-19. The patient had previously tested positive for COVID-19 in November. No additional treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, fever, pneumonia, and COVID-19, was unknown.; Reporter's Comments: This case concerns a 73-year-old, male patient, with a previous COVID-19 infection prior to vaccination, who experienced a serious event of Pneumonia and non-serious events of Covid-19, and Pyrexia after receiving first dose of mRNA-1273 (Lot# 039K20A). Based on the mechanism of action of mRNA-1273, the event of Covid-19 is assessed as unlikely related to mRNA-1273. Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1030018
Sex: M
Age:
State: MA

Vax Date: 12/29/2020
Onset Date: 01/26/2021
Rec V Date: 02/15/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Myocarditis; Acute onset of chest pain; Soreness of the arm; A spontaneous report was received from a physician concerning a 20-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of the arm, acute onset of chest pain, and myocarditis. The patient's medical history, as provided by the reporter, included asthma, and allergy to egg, peanut and tree nuts. Concomitant medications reported included dupilumab, montelukast, budesonide / formoterol, cetirizine, albuterol and epinephrine. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 26 Jan 2021, after receiving the second dose of the vaccine, the patient reported soreness of the arm for 3 to 4 days. On 30 Jan 2021, the patient presented to the hospital with acute onset of left sided chest pain. The physician reported that the patient developed myocarditis. Consent for Safety to follow up was received. Treatment for the events, as reported, included patient's concomitant medications of dupilumab, montelukast, budesonide / formoterol, cetirizine and albuterol. No additional treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, soreness of the arm, was resolved on unknown date. The event acute onset of chest pain and myocarditis was not resolved at the time of this report.; Reporter's Comments: This case concerns a 20 year old male with medical history of multiple allergies, who was hospitalized with serious unexpected events of chest pain and myocarditis and a non-serious unexpected event of pain in extremity. The chest pain and myocarditis occurred 33 days after first dose and 4 days after last dose of mRNA-1273. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.

Other Meds: DUPIXENT; SINGULAIR; SYMBICORT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]; Epi-pen

Current Illness: Allergy to nuts (Tree nuts); Asthma; Egg allergy; Peanut allergy

ID: 1030019
Sex: F
Age: 67
State: PA

Vax Date: 01/20/2021
Onset Date: 01/25/2021
Rec V Date: 02/15/2021
Hospital: Y

Lab Data: Test Date: 20210126; Test Name: Temperature; Result Unstructured Data: High; Test Date: 20210126; Test Name: SatO2 low; Result Unstructured Data: Low

Allergies:

Symptoms: feeling much worse; Bloodwork with elevated parameters (troponins); Couldn't take food; Couldn't get up from bed; Fever (101?F); Atrial fibrillation; Pericarditis; A spontaneous report was received from a non-healthcare professional concerning a 67-year-old, female patient who developed a fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Pentasa, metformin, insulin, Zoloft and atorvastatin. The patient received their first of two planned doses of mRNA-1273 (lot number 028L20A) on 20 Jan 2021 in the right arm for prophylaxis of COVID-19 infection. The patient developed a fever on 25 Jan 2021, and it got up to 101 degrees Fahrenheit on 26 Jan 2021. On 26 Jan 2021 she felt must worse, couldn't take food, and couldn't get up from bed. On 27 Jan 2021, she was taken to the emergency room where her oxygen saturation was low, but the fever was gone. She was placed on oxygen, and blood work had elevated troponin. The patient was diagnosed with pericarditis and she was kept overnight. On 28 Jan 2021 she had atrial fibrillation and the medical team couldn't convert her chemically. She was stabilized on 30 Jan 2021 and she was feeling much better. Treatments of these events included oxygen and ibuprofen. The events, fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation were considered Recovering.; Reporter's Comments: This case concerns a 67 year old female who experienced serious unexpected events of feeling abnormal, decreased appetite, bedridden, elevated troponin, pericarditis, and atrial fibrillation, and a serious expected event of fever. The events began 6 days after first dose of mRNA-1273. Treatment with ibuprofen. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.

Other Meds: PENTASA; METFORMIN; ZOLOFT; ATORVASTATIN

Current Illness:

ID: 1030020
Sex: F
Age: 73
State:

Vax Date: 01/01/2021
Onset Date: 02/01/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Name: MRI; Result Unstructured Data: Cerebral atrophy with 6th nerve palsy.

Allergies:

Symptoms: sixth nerve palsy of the right eye; A spontaneous report was received from a healthcare professional concerning a 73-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed sixth nerve palsy of the right eye. The patient's medical history was not provided. Concomitant product use was not provided. On an unknown date, approximately two weeks prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 01 FEB 2021, she was seen at an ophthalmologist office and diagnosed with sixth nerve palsy of the right eye. An MRI was performed on an unknown date for the patient's condition which revealed there was mild generalized cerebral atrophy, prominent enlargement of the lateral and 3rd ventricles out of proportion to degree of cerebral atrophy. 4th ventricle is non dilated. There is patchy bilateral cerebral white matter flares. Hyperintensity is noted likely representing findings of chronic microvascular ischemic change. No obstructive lesion identified. No contiguous band of flare/T2 hyperintensity along the surface of the ventricles to suggest the presence of transependymal CSF flow. Impression was that in the setting of potential 6th nerve palsy, this constellation of findings may potentially represent underlying increased intracranial pressure. Normal pressure hydrocephalus was an alternative consideration in the appropriate clinical context. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, developed sixth nerve palsy of the right eye, was not reported.; Reporter's Comments: This case concerns a 73 year old, female patient who experienced a serious event of Ophthalmoplegia after receiving second dose of mRNA-1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1030021
Sex: M
Age: 27
State: TX

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 02/15/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Diabetic Ketoacidosis (nausea, heavy breath, could not form words, PH dropping); Increase of resting heart rate 114 to 120 to 130 and max 150; Terrible Migraine; Extreme nausea; A spontaneous report was received from a consumer, concerning her son, who is 27-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced diabetic ketoacidosis (DKA), terrible migraine, nausea, heavy breathing and increased heart rate. The patient's medical history, as provided by the reporter, included Asperger syndrome and Diabetes. No concomitant products were reported. On 14 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 15 Jan 2021, at 10:30 AM, the patient had terrible migraine and extreme nausea. He experienced DKA as he could hardly breath and breathing was heavy. At 6 PM, as stated by the reporter, the patient went to the emergency room and tests were done which confirmed DKA. The patient stayed there for 2 hours but his PH level was decreasing, couldn't form words and heart rate was 150 beats per minute(bpm) and was transferred to bigger hospital where he stayed in ICU. He was discharged in the afternoon on 17 Jan 2021. On 20 Jan 2021, the reporter stated that the patient again went back into DKA and was sent to hospital. On 23 Jan 2021, all symptoms were resolved, and the patient was discharged. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, diabetic ketoacidosis (DKA), terrible migraine, nausea, heavy breathing and increased heart rate, were considered resolved on 23 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Asperger's syndrome; Diabetic ketoacidosis

ID: 1030022
Sex: M
Age:
State: TX

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Date: 20210113; Test Name: Covid-19 test; Result Unstructured Data: positive

Allergies:

Symptoms: Hallucination; Feeling sick; High blood pressure; Oxygen was low; Covid-19; Fever; A spontaneous report was received from a consumer regarding a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced malaise, having fever, high blood pressure, abnormal, hallucination, oxygen being low/ oxygen saturation decreased, and COVID-19. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 05 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date after the mRNA-1273 vaccine was given, the patient experienced being sick, having fever, high blood pressure, hallucination, and oxygen being low. On 13 Jan 2021, the patient tested positive for COVID-19. Treatment included azithromycin. Action taken with mRNA-1273 was not reported. The outcome of the events, being sick, having fever, high blood pressure, hallucination, and oxygen being low, was not reported.; Reporter's Comments: Fever is consistent with the known safety profile of the product and temporarily associated with the administration. Hence, a causal association cannot be excluded. Based on the known etiology for COVID-19 the other events are including COVID-19 are considered unlikely associated with product use and can be attributed to COVID-19 infection.

Other Meds:

Current Illness:

ID: 1030023
Sex: F
Age: 42
State: NY

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 02/15/2021
Hospital: Y

Lab Data: Test Date: 20210130; Test Name: CT; Result Unstructured Data: Narrow spine; Test Date: 20210130; Test Name: MRI; Result Unstructured Data: Narrow spine

Allergies:

Symptoms: couldn't move her face and all the left side of her body/ Drooping Face/ Bell's Palsy; couldn't move her face and all the left side of her body; palm went numb; hip pain; lower leg pain; heart racing; really low blood pressure; arm was itching, her whole body was itching; Tongue and roof of the mouth numb; really bad headache; rash on both arms; nausea; vomiting; freezing; chills; Severe allergic reaction/Allergic symptoms; diarrhea; low grade fever; A spontaneous report was received from a healthcare professional who is a 43-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, arm pain, arm itched, whole body itching, rash on both arms, nausea, really bad headache, vomiting, freezing, low blood pressure, hip pain and lower leg pain and a bad headache. The patient's medical history included helicobacter pylori, two cervical spinal fusions, allergies to shellfish, strawberry leaves and dust. No concomitant product use was reported. On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) in the right arm intramuscularly for prophylaxis of COVID-19 infection. On 26 Dec 2020, approximately 20 minutes after receiving the Moderna COVID-19 vaccine, the patient reported she experienced a headache, body aches, chills, had a low-grade fever, diarrhea and arm pain. The headache and arm pain resolved after 4 days. On 23 Jan 2021, after the patient received her second dose of the Moderna COVID-19 vaccine, she reported her arm itched, then had whole body itched, a rash on both arms, was nauseated with a bad headache and vomiting. She stated she went to the emergency care unit and was given diphenhydramine 50 milligrams intramuscularly, a steroid injection and intravenous fluids. She stated, her legs and arms were shaking, she was freezing, and her teeth were chattering. Everything disappeared 2 hours later. The patient stated she went home but continued to vomit, had fevers, headaches, chills and body aches for two more days. On 30 Jan 2021, the patient reported she had a rash, was nauseated and her heart was racing. She road in an ambulance to the emergency room. She stated her palm went numb, she could not mover her face or the left side of her body. She stated, "they thought I was having a stroke". She also reported her blood pressure was low. The patient reported, they gave her Tissue Plasminogen Activator (TPA) and diphenhydramine. She reported she was able to mover her arm a little better. On unknown date, the patient reported that she was in the Coronary Care Unit (CCU) on bed rest with monitors. The patient reported she had hip pain and lower leg pain that was making her limp and a bad headache. On unknown date, the patient reported she had a magnetic resonance imaging (MRI) and computed tomography scan (CT) and stated, "it only showed a narrow spine". The patient stated she had a spinal fusion (date not provided). Treatment for the event included diphenhydramine, a steroid injection, intravenous fluids, and Tissue Plasminogen Activator (TPA). Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, headache and arm pain, were considered resolved on 30 Dec 2020. The outcome of the events, arm itched, whole body itching, freezing, rash on both arms, were considered resolved on 23 Jan 2021. The outcome of the events, couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, rash, nausea, really bad headache, vomiting, low blood pressure, hip pain and lower leg pain, were considered unknown.; Reporter's Comments: This case concerns a 43-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, arm pain, arm itched, whole body itching, rash on both arms, nausea, really bad headache, vomiting, freezing, low blood pressure, hip pain and lower leg pain and a bad headache.Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness: Shellfish allergy

ID: 1030024
Sex: F
Age: 61
State: PA

Vax Date: 01/13/2021
Onset Date: 01/21/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Facial paralysis; Shaking all over her body/shaking for 8 days; Can not sleep; Whole body hurts and it does not go away; Terrible chills and shivers; A spontaneous report was received from a consumer who is a 61-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain). The patient's medical history was not provided. Concomitant medications were not reported. On 13 Jan 2021, the patient received their first two planned doses of mRNA-1273 intramuscularly in her left arm for the prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient experienced terrible chills, shaking for 8 days, shivers and cold all the time, cannot sleep and whole-body hurts. On 28 Jan 2021, the patient experienced facial paralysis which was getting worse more on right side then moved to the middle of her face. The patient was given steroids. Treatment for the events included steroids. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain), were considered unknown.; Reporter's Comments: This case concerns a 61-year-old female who experienced a serious unexpected event of facial paralysis, the non-serious unexpected events of tremors, insomnia and pain, and a non-serious expected event of chills. Events began on 21-Jan-21 after the first dose of mRNA-1273 on 13-Jan-21. Treatment with steroids. Outcomes unknown. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Date Died:

ID: 1030025
Sex: M
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Death; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient was died. The patient's medical history was not provided. Concomitant product use was not provided. On an unknown date, the patient received his first dose of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection. On an unknown date, the patient was died. Treatment of this event was not provided. The patient was died. The cause of death was not provided. Autopsy details were not provided.; Reporter's Comments: This case concerns a male patient (unknown age), who experienced event of death (cause unknown). The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Autopsy and cause of death were not reported. Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.; Reported Cause(s) of Death: Death

Other Meds:

Current Illness:

ID: 1030026
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hallucinations/ Have seen ghosts; A spontaneous report was received from a consumer who is a male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hallucinations and seeing ghosts. The patient's medical history, as reported, included problem in eye that caused patient to see weird things some years ago. Concomitant medications were not reported. On an unspecified date, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced hallucinations and seeing ghosts. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, hallucinations and seeing ghosts, was unknown.; Reporter's Comments: This case concerns a 72-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of hallucinations. Based on the current available information and temporal association between the use of the product and the onset of the event after vaccination, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1030027
Sex: M
Age: 40
State: VA

Vax Date: 01/16/2021
Onset Date: 01/19/2021
Rec V Date: 02/15/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Spontaneous splenic hemorrhage and rupture; Spontaneous splenic hemorrhage and rupture; A spontaneous report was received from a consumer who is a 40-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a spontaneous splenic hemorrhage and rupture. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 16 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:013L20A) for prophylaxis of COVID-19 infection. On 19 Jan 2021, at approximately 8 am, the patient suffered a spontaneous splenic hemorrhage and rupture. He went to the hospital and was admitted. On 21 Jan 2021, a splenectomy was performed. On 22 Jan 2021, he was discharged from the hospital after four days. Pathology was performed on the ruptured spleen and nothing pathological was found. All blood tests and virus tests came back negative. Cause of spleen hemorrhage and rupture was unknown. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events spontaneous splenic hemorrhage and rupture was unknown.; Reporter's Comments: This case concerns a 40-year-old male subject, who experienced serious unexpected event of Splenic hemorrhage and splenic rupture. The events occurred 3 days after the first dose of the mRNA-1273 (Lot number:013L20A) administration. Cause of events were unknown. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1030028
Sex: M
Age: 75
State: IL

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Both eyes with Keratoconjunctivitis virus; A spontaneous report was received from a pharmacist concerning a 75 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced both eyes with keratoconjunctivitis virus. The patient's medical history was not provided. No relevant concomitant medication was reported. On an 07 Feb 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 026L20A and expiery date 28 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient experienced irritated eyes, problems with vision, sensitivity to light, didn't sleep the night, and felt like someone put acid in his eyes. On 09 Jan 2021, the patient was seen by his eye doctor and diagnosed with immune response to vaccine with keratoconjunctivitis virus with no infection. Treatment included an unspecified drug. Action taken with the mRNA-1273 in response to the event was not reported. On 15 Jan 2021, the outcome of the event keratoconjunctivitis virus was resolved.; Reporter's Comments: This case concerns a 75-year-old, male, who experienced a serious unexpected event of Keratoconjunctivitis (bilateral). The events occurred 2 day after mRNA-1273 (Lot# 026L20A). Treatment information was not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1030029
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: One case of anaphylaxis, after an individual received Moderna's vaccine; A spontaneous report was received from other manufacturer Pfizer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced one case of anaphylaxis, after an individual received Moderna's vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On an undisclosed date, the patient received their dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. Other manufacturer forwarded article posted via social media regarding COVID-19 vaccines. The article contained a brief statement from the Center for Disease Control (CDC) that stated, ?they also noted one case of anaphylaxis, which can cause throat swelling and breathing difficulty, after individual received Moderna's vaccine'. No further information was provided regarding Moderna's COVID-19 Vaccine (mRNA-1273). No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1030030
Sex: M
Age:
State: CA

Vax Date: 12/18/2020
Onset Date: 12/01/2020
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: the swelling and extreme tenderness of the site of injection; the swelling and extreme tenderness of the site of injection; headache; I couldn't sleep last night because I have headache, thrombing headache and back pain; Nausea; I had like metallic taste; Dizziness; The initial case was missing the following minimum criteria: suspect drug. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. A 61-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685, expiration date Mar2021) on his left arm, intramuscular on 18Dec2020 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertensive, 2 stents in heart in 2016, Hyperlipidemia, hypothyroidism, coronary artery disease in 2016 and Allergic (Allergic rhinitis + Chronic sinusitis). Concomitant medication included acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX). It was reported that the patient had swelling and severe tenderness left his arm. He couldn't sleep last night because he had throbbing headache and back pain on 18Dec2020. Initially, he had nausea. Patient stated further stated that Headache and swelling and extreme tenderness of the site of injection, that is the swelling, no redness but the swelling and tender and painful. Initially, he had till now the mild back pain. He patient said she took Tylenol. She also mentioned that initially she had like metallic taste and then disappear. The patient also had dizziness a little bit. The outcome of the event vaccination site swelling, dysgeusia and tenderness was recovered on unspecified dates, headache and back pain was not recovered, recovering for nausea while unknown for the remaining events.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; PLAVIX

Current Illness:

ID: 1030031
Sex: F
Age:
State: NJ

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: had the worst backache; muscle soreness; muscle soreness at the injection site; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid. A contactable consumer (patient) reported that an 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration at the right arm on 21Jan2021 at single dose for COVID-19 immunization. Medical history included autoimmune haemolytic anaemia (reported as immune system attacks red blood cells). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Concomitant medications included prednisone for red blood cells from Dec2020 and ongoing, folic acid from Dec2020, and omeprazole from 05Nov2020. The patient did not have any symptoms the day she received it except for muscle soreness at the injection site on 21Jan2021. On the night of 26Jan2021, she had the worst backache. Her son went to the store and bought Lidocaine patches for it. Clinical outcome of the event muscle soreness at the injection site was recovered on 22Jan2021 while for the worst backache was not recovered.

Other Meds: PREDNISONE; FOLIC ACID; OMEPRAZOLE

Current Illness:

ID: 1030032
Sex: F
Age:
State: CA

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Left axillary lymph node swelling, pain, and tenderness; Left axillary lymph node swelling, pain, and tenderness; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 09Jan2021 (18:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the public health clinic/veterans administration facility. Medical history included asthma. Concomitant medication included etonogestrel (NEXPLANON). The patient was not pregnant at the time of vaccination. On 10Jan2021 (18:00), the patient had left axillary lymph node swelling, pain and tenderness. The patient did not receive any treatment for the reported events. The outcome of the events, 'left axillary lymph node swelling, pain and tenderness', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, had nasal swab test for COVID-19 on 12Jan2021 which was negative.

Other Meds: NEXPLANON

Current Illness:

ID: 1030033
Sex: F
Age:
State:

Vax Date: 01/24/2021
Onset Date: 01/01/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: Body temperature; Result Unstructured Data: Test Result:99 Fahrenheit; Test Date: 20210125; Test Name: Heart rate; Result Unstructured Data: Test Result:95

Allergies:

Symptoms: stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers. A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization. Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year). The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021), she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

Other Meds: LISINOPRIL; JUNEL FE; PANTOPRAZOLE

Current Illness:

ID: 1030034
Sex: F
Age:
State: NY

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; next day she felt fine, cold but it's cold; chills; headache; First dose was on 05Jan2021/ Received the second dose on 22Jan2021; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration in left arm (by injection) on 22Jan2021 17:00 (also reported as 16:30) at a single dose for COVID-19 immunization. Medical history included allergic to yellowjacket (anaphylaxis) and bee venom. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient experienced chills and headache on 23Jan2021, next day she felt fine, cold but it's cold on 24Jan2021, itching and a rash on his right arm up to her shoulder and between her legs and small bumps on 25Jan2021, the rash now is getting little bumps on an unspecified date. Patient received Pfizer-BioNtech Covid-19 vaccine on Friday 22Jan2021 around 4:30PM (as reported). On Saturday she experienced chills and headache, next day she felt fine, cold but it's cold in the city, she didn't take anything (Tylenol). Last night she started to get itching and a rash on his right arm up to her shoulder and between her legs and small bumps. She would like to know if this side effects have been reported for the vaccine. The patient reported she is getting a little concerned. She had her 2nd dose of the Pfizer COVID vaccine on Friday, 22Jan2021. She had the side effects that Pfizer submitted in the brochure. She had them starting on Saturday. She had chills and a headache. The headache left her by Sunday morning. She now she has a rash that started last night in her thighs between her legs. Then this morning it is on her arms in the folds. She does not know if that is normal. She is wondering if this is a normal side effect and what to do about it. She has had anaphylaxis from yellow jackets before. She hopes she does not go that direction. Received the second dose on 22Jan2021 at 5 pm. The chills is hard to tell if she still has it as it is cold in the city. She took Tylenol for her headache. She used anti itch cream after she showered. The rash now is getting little bumps. First dose was on 05Jan2021 (LOT: EL0142). No expiration date or NDC for first or second dose is written on her vaccination card. She thought maybe it was her detergent, or bleach, but that is not it. Therapeutic measures were taken as a result of headache which included Tylenol and itching which included anti itch cream. The outcome of the event headache was recovered on 24Jan2021, of event itching and a rash on his right arm up to her shoulder and between her legs and small bumps was not recovered, while for the other events was unknown.

Other Meds:

Current Illness:

ID: 1030035
Sex: F
Age:
State: NY

Vax Date: 12/30/2020
Onset Date: 01/03/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Date: 20210121; Test Name: Covid test; Test Result: Negative

Allergies:

Symptoms: severe low back pain; difficulty walking; difficulty standing; difficulty sitting; This is a spontaneous report from a contactable Other Health Professional. A 50-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140), intramuscularly in the left arm on 30Dec2020 at 15:30 at 50-years-old at a single dose for COVID-19 immunization; administered in a living facility. The patient did not have COVID-19 prior to the vaccination. The patient's medical history was reported as NONE. Concomitant medication included colecalciferol (VITAMIN D) taken for an unspecified indication from an unspecified date to an unspecified date; and an unspecified vaccine (SEQIRUS; Lot Number: P 100242861) taken for an unspecified indication on 01Dec2020. On 03Jan2021 at 10:00, the patient experienced severe low back pain (non-serious), difficulty walking (non-serious), difficulty standing (non-serious), difficulty sitting (non-serious); for which no treatment was given. Four days after the injection, the patient had severe low back pain. The patient had difficulty walking, standing, sitting. After the first injection the pain was bad for 3-4 days, and then was gone after 7 days. The patient underwent lab tests and procedures which included COVID test: negative on 21Jan2021. The clinical outcome of the events was recovered on an unspecified date (as reported). The patient received the second dose of the bnt162b2 (Lot Number: 123302), on 20Jan2021 in the left arm.

Other Meds: VITAMIN D

Current Illness:

ID: 1030036
Sex: F
Age:
State: CO

Vax Date: 12/31/2020
Onset Date: 01/05/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:no signs of common bile duct blockage or pancreati; Comments: no signs of common bile duct blockage or pancreatic issues; Test Name: Ultrasound; Result Unstructured Data: Test Result:no signs of common bile duct blockage or pancreati; Comments: no signs of common bile duct blockage or pancreatic issues

Allergies:

Symptoms: upper abdominal pain; Nausea; Vomiting; This is a spontaneous report from an Other Health Professional. A 48-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the right arm at 48-years-old on 31Dec2020 at 15:15 at a single dose for COVID-19 immunization; administered at a hospital. The patient did not receive any other vaccine within four weeks prior of receiving bnt162b2. Medical history included non-alcoholic steatohepatitis (NASH liver disease) from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, endometriosis from an unknown date and unknown if ongoing, penicillin allergy from an unknown date and unknown if ongoing, gluten sensitivity from an unknown date and unknown if ongoing, sulfonamide allergy from an unknown date and unknown if ongoing , hibiclens soap allergy from an unknown date and unknown if ongoing, pancreatitis from an unknown date and unknown if ongoing. Concomitant medications included colestipol (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC), levothyroxine sodium (UNITHROID), liothyronine (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took pregabalin (LYRICA), clindamycin (MANUFACTURER UNKNOWN), buprenorphine (BUTRANS) and experienced allergies from an unknown date and unknown if ongoing. On 05Jan2021 at 19:00, the patient experienced: upper abdominal pain (non-serious), nausea (non-serious), and vomiting (non-serious); with no treatment received. Adverse event: About five days after the first dose, the patient started to have upper abdominal pain, nausea and vomiting. The pain and gastrointestinal (GI) issues that took place were similar to when the patient had experienced pancreatitis. The patient then contacted her primary care physician (PCP) and GI/Liver doctor. The issues cleared up within about 4-5 days of being on a clear liquid diet and rest. The patient had an ultrasound and blood work one week later, both showing no signs of common bile duct blockage or pancreatic issues. The patient underwent lab tests and procedures which included blood work and ultrasound: no signs of common bile duct blockage or pancreatic issues on an unknown date. The clinical outcome of the events was recovered on an unspecified date. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.

Other Meds: COLESTIPOL; BYSTOLIC; UNITHROID; LIOTHYRONINE

Current Illness:

ID: 1030037
Sex: M
Age:
State: IL

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The patient "felt tired and ache"; The patient "felt tired and ache"; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 in Dec20202 for COVID-19 immunization. The patient did not receive 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 hasn't been tested for COVID-19. The patient "felt tired and ache" on Jan2021 The outcome of events was recovered. The patient did not received treatment due to the events. The events were considered as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1030038
Sex: F
Age:
State: MO

Vax Date: 01/21/2021
Onset Date: 01/01/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: fever; Result Unstructured Data: Test Result:99; Test Date: 20210123; Test Name: HR; Result Unstructured Data: Test Result:thinking her HR was up, but it wasn't; Test Date: 20210122; Test Name: Pulse rate; Result Unstructured Data: Test Result:Normal; Test Date: 20210123; Test Name: Pulse rate; Result Unstructured Data: Test Result:40; Test Date: 20210123; Test Name: O2 saturation; Result Unstructured Data: Test Result:92; Test Date: 20210125; Test Name: Rapid COVID-19 test; Test Result: Negative

Allergies:

Symptoms: red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient

Other Meds: TIZANIDINE; METOPROLOL TARTRATE; PRIMIDONE; CLONAZEPAM

Current Illness: Anxiety; Essential tremor; Hypertension; Tachycardia

ID: 1030039
Sex: F
Age:
State: VA

Vax Date: 01/21/2021
Onset Date: 01/24/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: headaches; Sore throat; This is a spontaneous report from a contactable consumer (reporting for a patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),lot number unknown, via an unspecified route of administration on 21Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included hypothyroidism. The patient did not receive 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 hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced headaches and sore throat on 24Jan2021 (also reported as "headaches days 3-6 post-vaccination, Sore throat starting day 6"). The outcome of events was not recovered. Patient did not receive any treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1030040
Sex: F
Age:
State: IL

Vax Date: 01/24/2021
Onset Date: 01/25/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: Fever; Result Unstructured Data: Test Result:Mild; Test Date: 20210125; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Uncontrolled itchiness - body; Headaches; Mild fever; Nasal congestion; This is a spontaneous report from a contactable other hcp. A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EL1283, intramuscular, in the left arm, on 24Jan2021 12:00 at SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus, asthma and hypothyroidism. The patient did not receive 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 hasn't been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EJ1685, intramuscular, in the left arm, on 03Jan2021, 12:00 for covid-19 immunization. The patient's concomitant medications were not reported. On 25Jan2021 19:00, the patient experienced uncontrolled itchiness - body, headaches, mild fever and nasal congestion. The patient underwent lab tests and procedures on 25Jan2021 which included fever: mild and nasal swab: negative. The outcome of events was unknown. Patient did not received treatment due to the events. The events were considered as non-serious. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

Other Meds:

Current Illness:

ID: 1030041
Sex: M
Age:
State: MA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Slight shoulder pain around injection sight; Mild discomfort; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 22Jan2021 (10:15) at a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. On 22Jan2021 (12:30), the patient had slight shoulder pain around the injection "sight" (site) and mild discomfort. The pain around the injection site had lasted roughly 48 hours, and then was getting more painful over time, then slowly getting better. The patient did not receive any treatment for the reported events. The outcome of the events, pain around the injection site and discomfort, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1030042
Sex: F
Age:
State: IL

Vax Date: 12/19/2020
Onset Date: 12/01/2020
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Date: 20201226; Test Name: Covid PCR; Test Result: Negative ; Comments: covid test type post vaccination=Nasal Swab

Allergies:

Symptoms: Lips tingling; tongue felt full 4 mins after 1st injection; 24 hours later facial swelling and redness; 24 hours later facial swelling and redness; This is a spontaneous report from a contactable other health professional (HCP). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at 13:00 at a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mild depression from an unknown date and unknown if ongoing. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), pantoprazole sodium sesquihydrate (PROTONIX) and levonorgestrel (MIRENA). The patient experienced lips tingling, tongue felt full 4 mins after 1st injection. Given IV steroids in ER. Twenty-four (24) hours later facial swelling and redness, more steroids given, symptoms resolved. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 26Dec2020 (covid test type post vaccination=Nasal Swab). Therapeutic measures were taken as a result of lips tingling, tongue felt full 4 mins after 1st injection, 24 hours later facial swelling and redness, 24 hours later facial swelling and redness. The outcome of the events was recovered on an unspecified date. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: TRINTELLIX; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; MIRENA

Current Illness:

ID: 1030043
Sex: M
Age:
State: MA

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: slight left armpit swelling and pain; slight left armpit swelling and pain; chills and slight aches 12 hours after 2nd injection; chills and slight aches 12 hours after 2nd injection; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 24Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously received first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 04Jan2021 07:45 AM at single dose for COVID-19 immunization. On 24Jan2021 22:30, the patient experienced chills and slight aches 12 hours after 2nd injection. On 25Jan2021, 24 hours after 2nd injection, the patient experienced slight left armpit swelling and pain. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1030044
Sex: F
Age:
State:

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chills; fever; muscle ache; headache; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 10:45 at a single dose for COVID-19 immunization. The first dose was received on an unspecified date. The patient medical history was not reported. Patient was not pregnant at the time of vaccination. Concomitant medication included celecoxib (CELEXA). The patient experienced chills, fever, muscle ache and headache on 26Jan2021 23:00. Outcome of the events was not recovered and no treatment was received for the events. Events were considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: CELEXA

Current Illness:

ID: 1030045
Sex: M
Age:
State: VA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Migraine Headaches; chills; body aches; sore arm; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), intramuscular in the left arm, on 26Jan2021 14:00, at single dose, for COVID-19 immunization, at the hospital. Medical history included migraine and diabetes mellitus (diabetic). The patient has no allergies to medications, food or other products. Concomitant medication included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-10 post vaccination. The patient experienced migraine headaches, chills, body aches and sore arm on 26Jan2021 at 14:00. No treatment was given for the events. The outcome of the events was unknown. The events were assessed as non-serious.

Other Meds: JANUMET

Current Illness:

ID: 1030046
Sex: F
Age:
State: NY

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Date: 20210126; Test Name: fever - 100.8 degrees; Result Unstructured Data: Test Result:108; Comments: fever

Allergies:

Symptoms: Body aches; fever - 100.8 degrees; chills; nausea; tired; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9263) on his left arm, via an unspecified route of administration on 25Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL) and covid. The patient's concomitant medications were not reported. The patient experienced Body aches, fever - 100.8 degrees, chills, nausea, tired; all on 26Jan2021 06:30 AM. No treatment was received for the events. The outcome of the events was recovered on unspecified dates. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1030047
Sex: F
Age:
State: GA

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Joint pain in hands; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 26Jan2021 at 11:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history included high blood pressure and depression. The patient was taking unspecified concomitant medications. The patient previously took codeine and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 at 01:30 AM (approximately 14 hours after injection), the patient experienced joint pain in hands. The event was considered non-serious. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on 27Jan2021. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1030048
Sex: F
Age:
State: NC

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; Severe headache; Body/joint aches; Body/joint aches; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL4238; Expiration date was not reported) on 25Jan2021 (14:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included hypertension (HTN), asthma and allergies. The patient had unspecified concomitant medications. The patient was not pregnant at the time of vaccination. On 26Jan2021 (09:00), the patient had nausea; severe headache; and body/joint aches. The patient did not receive any treatment for the reported events. The outcome of the events, nausea, severe headache and body/joint aches, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.

Other Meds:

Current Illness:

ID: 1030049
Sex: M
Age:
State: GA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chills; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (11:00) at a single dose on the left arm for COVID-19 immunization. Medical history included orthostatic hypotension. The patient had unspecified concomitant medications. On 26Jan2021 (16:00), the patient had chills. The patient did not receive any treatment for the reported adverse event. The outcome of the event, chills, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. No follow-up attempts are possible/needed; information about lot/batch number cannot be obtained.?

Other Meds:

Current Illness:

ID: 1030050
Sex: F
Age:
State: MI

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine arm is a little tired; Vaccine arm is a little sore; This is a spontaneous report from a contactable consumer. A non-pregnant 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 26Jan2021 at 14:45 (02:45 PM), at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient was taking quite a few unspecified concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a clinic facility. On 27Jan2021, the patient's vaccine arm was a little tired and sore - typical of a shot. No problem, however. No treatment was administered for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient was recovering from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds:

Current Illness:

ID: 1030051
Sex: F
Age:
State: NC

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: HR; Result Unstructured Data: Test Result:elevated; Comments: HR elevated by NSR 09:15; Test Date: 20210125; Test Name: monitored; Result Unstructured Data: Test Result:symptoms occurring on and off; Test Date: 20210125; Test Name: Oxygen sats; Result Unstructured Data: Test Result:100%

Allergies:

Symptoms: scratchy throat; Felt dizzy; jittery; flushed; HR elevated by NSR; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), intramuscularly at the right arm, on 25Jan2021 08:45, at single dose, for covid-19 immunization. Medical history included ongoing acne; no known allergies. Concomitant medication included a prescription medicine for acne. The vaccine was received in a workplace clinic. The patient felt dizzy, jittery, flushed and, heart rate (HR) elevated by normal sinus rhythm (NSR). All these adverse events happened on 25Jan2021 09:15. She was then monitored for greater than 1 hour with symptoms occurring on and off during that period. At 10:25 on 25Jan2021 she felt flushed again with report of scratchy throat. No distress noted; oxygen sats was 100% on 25Jan2021; no itching or hives noted; and no swelling of the face or airway. Since she continued to have symptoms, she was placed in a wheelchair and taken to the emergency room (ER). No treatment was received for these adverse events. At the time of the report, the patient recovered from the adverse events on Jan2021.

Other Meds:

Current Illness: Acne

ID: 1030052
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: my face started to get red; my cheeks were swollen; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262, expiration date May2021), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got her first injection yesterday at 5pm. At 7pm, her face started to get red and her cheeks were swollen. At 1:30AM, she took some Benadryl. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1030053
Sex: F
Age:
State: MN

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: chills; fever; aching arms; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK 4176) via an unspecified route of administration on the left arm on 22Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included allergies, high blood and cholesterol; and diagnosed with COVID-19 (prior to vaccination). The patient's concomitant medications were not reported. On 23Jan2021, the patient experienced chills, fever and aching arms. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1030054
Sex: F
Age:
State: MA

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration on 26Jan2021 at 02:30 PM in left arm at single dose for COVID-19 immunization in the workplace clinic. There was no other vaccine administered in four weeks. Medical history included gluten intolerant. No Known allergies. Concomitant medication included calcium, ergocalciferol (VIT D), ibuprofen (ADVIL), multivitamin. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient experienced soreness at site of injection and loose bowels on 27Jan2021 at 07:15 AM. No treatment was received for adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was not recovered. No follow-up attempts possible. No further information expected.

Other Meds: CALCIUM; VIT D; ADVIL [IBUPROFEN]

Current Illness:

ID: 1030055
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/15/2021
Hospital:

Lab Data:

Allergies:

Symptoms: red at the injection site; This is a spontaneous report from a contactable consumer who reported for her husband, a male patient of an unspecified age who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking if there had been percentages surfaced on adverse reactions or continued studies on that with why some people were reacting and some were not as far as getting anaphylactic shock. The reporter heard that one doctor had a severe anaphylactic reaction and a lot of her nurse friends were afraid to receive the vaccine after hearing about it. The reporter also stated her husband who received the vaccine also got really red at the injection site on an unspecified date. The reporter was asking if there have been studies on dosage for all body masses for all health conditions and where information on the list of ingredients were posted. The reporter also asked if Pfizer's COVID vaccine use lipids as a carrier for the mRNA just like Moderna, and how does that affect people with heart disease. The reporter also asked if there was any problem with mixing vaccines with other vaccines such as use with the shingles, pneumonia, or whooping cough vaccine. The outcome of the event was unknown. Information on Lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm