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**
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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: 1399636
Sex: F
Age: 41
State:

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache, Myalgia, Arthralgia, Fever, injection site pain, fatigue Narrative:

Other Meds:

Current Illness:

ID: 1399637
Sex: F
Age: 52
State:

Vax Date: 12/29/2020
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rash, UrticariaPruritus, pain and inflammation at injection site Narrative:

Other Meds:

Current Illness:

ID: 1399638
Sex: F
Age: 34
State:

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 1/6 injection site arm soreness, 1/7 red raised bump R foot great and second toe 1/8 red raised bump on R foot side next to pinky toe Narrative: 1/6 injection site arm soreness. 1/7 post vaccine day 1 noted great toe and second toe with red raised bump on R foot. 1/8 post vaccine day 2 noted new bump R foot on the side next to pinky toe. Instructed to call Covid hotline. 1/8 Covid result negative.

Other Meds:

Current Illness:

ID: 1399639
Sex: M
Age: 54
State:

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: L clavicular swollen gland, Local site discomfort, reness, swelling Narrative:

Other Meds:

Current Illness:

ID: 1399640
Sex: M
Age: 38
State:

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rash Narrative:

Other Meds:

Current Illness:

ID: 1399641
Sex: F
Age: 49
State:

Vax Date: 12/30/2020
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Erythema/enduration at injection site Narrative:

Other Meds:

Current Illness:

ID: 1399642
Sex: M
Age: 51
State:

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Myalgia, Arthralgia, Fever, Rash, Diarrhea, chills Narrative:

Other Meds:

Current Illness:

ID: 1399643
Sex: F
Age: 52
State:

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Myalgia, Arthralgia. injection site pain, fatigue, malaise Narrative:

Other Meds:

Current Illness:

ID: 1399644
Sex: F
Age: 54
State:

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Headache, Myalgia, Fever, L arm soreness, lump under skin, cold on the 3rd, arm pain, Narrative:

Other Meds:

Current Illness:

ID: 1402096
Sex: F
Age: 59
State:

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Myalgia bruising at injection site-size of a quarter Narrative:

Other Meds:

Current Illness:

ID: 1402098
Sex: M
Age: 53
State:

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Myalgia Narrative:

Other Meds:

Current Illness:

ID: 0936173
Sex: F
Age:
State: PR

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pain in the left armpit; a small protrusion in the area of the left collarbone which hurts to the touch; a small protrusion in the area of the left collarbone which hurts to the touch; feeling headache; tiredness; chills; bnt162b2 first dose on 15Dec2020 at 14:30 and then second dose on 04Jan2021 at 15:30; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK4176), intramuscularly on 04Jan2021 at 15:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization and had pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00, the next day (16Dec2020) the area was red and inflamed, the redness and the inflammation lasted three days. The patient experienced hours after receiving the second dose of the vaccine she began feeling headache, tiredness and chills on 04Jan2021 at 21:00. The next day of the vaccine on 05Jan2021 she began feeling pain in the left armpit and she had a small protrusion in the area of the left collarbone which hurts to the touch. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.

Other Meds:

Current Illness:

ID: 0936174
Sex: F
Age:
State: PR

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

Lab Data:

Allergies:

Symptoms: have pain in my left arm where it was administered the vaccine/the area was red and inflamed; have pain in my left arm where it was administered the vaccine/the area was red and inflamed; pain in my left arm where it was administered the vaccine; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient experienced started to have pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00. The next day (16Dec2020) the area was red and inflamed. The redness and the inflammation lasted three days. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events 'redness and the inflammation' was recovered on 19Dec2020, outcome of the other event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.

Other Meds:

Current Illness:

ID: 0936176
Sex: U
Age: 5
State: IL

Vax Date: 11/23/2020
Onset Date: 11/23/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE information provided; Caller reported temperature excursion/Temperature -13.3C; This spontaneous report was received from a registered nurse concerning to a 5-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided. On 23-NOV-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter (ml) for prophylaxis, lot number reported as T021642 and expiration date as 21-DEC-2021 (vaccination scheme, route of administration and anatomical site of vaccination were not provided). The administered vaccine had a temperature excursion of -13.3 degrees Celsius (?C) for a time frame of 4 hours and 15 minutes (product storage error) on an unspecified date, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion. No additional adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2012USA013501: US-009507513-2012USA013584: US-009507513-2012USA013596:

Other Meds:

Current Illness:

ID: 0936177
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Bell's palsy; Information has been received from a lawyer and an elderly patient of unknown age and gender, regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In or about 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX): Bell's palsy. The outcome of the event was unknown. Upon internal review, Bell's palsy was determined to be medically significant.

Other Meds:

Current Illness:

ID: 0936178
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: SHINGLES; Information has been received regarding a case in litigation from a lawyer referring to a currently 65 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a hospital for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event shingles was unknown.

Other Meds:

Current Illness: Prophylaxis

ID: 0936179
Sex: U
Age:
State: MI

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no other AE ocurred; VARIVAX was administered to a patient after improper storage/temperature excursion; This spontaneous report was received from a customer who was a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported. On 06-JAN-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection dose 1, (strength, dose, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T017686, expiration date: 21-MAY-2022) as prophylaxis. The vaccine administered experienced a temperature excursion of minus 12.5 degrees Celsius (C) for 11 hours and 10 minutes (product storage error), as recorded by a data logger. No other adverse effect (AE) occurred. Previous temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 12 degree Celsius) for 2 hours and 30 minutes was reported. .

Other Meds:

Current Illness:

ID: 0936180
Sex: M
Age:
State: FL

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The patient did not experience any adverse event during or aftere the injection; Patient who received a dose of MMRII on 06-JAN-2021 and it was realized later that the dose he received had expired 24-OCT-2020; This spontaneous report was received from a pharmacist concerning a 21 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 06-JAN-2021, the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (expired product administered) for prophylaxis ( lot # R030812 had been determined to be a valid lot number measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 24-OCT-2020) (strength, dose, route of administration and anatomical location were not provided). No adverse event reported.

Other Meds:

Current Illness:

ID: 0936181
Sex: M
Age:
State:

Vax Date: 12/08/2020
Onset Date: 12/01/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: yesterday I had my follow-up 2nd shot; minor soreness at the injection site; I?ve been feeling tired all day / tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in December 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional information was provided as follows: The age at vaccination was not applicable. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient had been unable to receive second dose Shingrix. The reporter consented to follow up. Consumer declined to provide mailing address and consumer declined to provide further information for safety report. Follow up information received from consumer on 9th December 2020: On 8th December 2020, the patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. In December 2020, the patient experienced minor injection site soreness and feeling of tiredness all day which was unusual for the patient. The reporter wanted to know was tiredness a possible side effect and how long should it lasts. It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.

Other Meds:

Current Illness:

ID: 0936182
Sex: F
Age:
State: KS

Vax Date: 10/23/2020
Onset Date: 10/29/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Redness at site of injection; Papule / persistent light pink 5x7cm rectangular papule; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 23rd October 2020, the patient received the 1st dose of Fluarix Tetra 2020-2021 season (intramuscular). On an unknown date, the patient started Fluarix Tetra Pre-Filled Syringe Device. On 29th October 2020, 6 days after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site erythema and papule. On an unknown date, the outcome of the injection site erythema and papule were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and papule to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra 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. The patient received Fluarix QIV and several days later, could not be specified by reporter, the patient presented a papule (5 by 7 cm) and some redness at site of injection it was not itchy. The papule was persistent and had not cleared up. The reporter consented to follow up. This case US2020230710 is duplicate of case US2020230712 and all information submitted in case US2020230710.; Sender's Comments: US-GLAXOSMITHKLINE-US2020230712:FU1 deleted

Other Meds:

Current Illness:

ID: 0936183
Sex: F
Age: 55
State: UT

Vax Date: 11/11/2020
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: worsening migraines since receiving her first Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of migraine aggravated in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included migraine. On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced migraine aggravated. On an unknown date, the outcome of the migraine aggravated was not recovered/not resolved. It was unknown if the reporter considered the migraine aggravated to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced worsening migraines since receiving her 1st Shingrix vaccine. The reporter did not consent to follow up.

Other Meds:

Current Illness: Migraine

ID: 0936184
Sex: F
Age:
State: MD

Vax Date: 12/19/2020
Onset Date: 12/21/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20201221; Test Name: c-reactive protien; Result Unstructured Data: (Test Result:high,Unit:unknown,Normal Low:,Normal High:); Test Date: 20201221; Test Name: Sedimentation rate; Result Unstructured Data: (Test Result:high,Unit:unknown,Normal Low:,Normal High:)

Allergies:

Symptoms: Results showing elevated / C-reactive protein; Results showing elevated sedimentation rate; This case was reported by a consumer via call center representative and described the occurrence of c-reactive protein increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 19th December 2020, the patient received the 1st dose of Shingrix. On 21st December 2020, 2 days after receiving Shingrix, the patient experienced c-reactive protein increased and elevated sedimentation rate. On an unknown date, the outcome of the c-reactive protein increased and elevated sedimentation rate were unknown. It was unknown if the reporter considered the c-reactive protein increased and elevated sedimentation rate to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced increased level of C-reactive protein and sedimentation rate. The reporter mentioned that, patient did previous test and results were normal. No additional information provided. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 0936185
Sex: M
Age: 73
State: FL

Vax Date: 12/21/2020
Onset Date: 12/01/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: redness of the shoulder / redness is about 5 inches by 3 inches; shoulder that is hot to the touch; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 4BA4A, expiry date 29th January 2022) for prophylaxis. On 21st December 2020 09:00, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2020, less than a week after receiving Shingrix, the patient experienced localized erythema and feeling hot. On an unknown date, the outcome of the localized erythema and feeling hot were not recovered/not resolved. It was unknown if the reporter considered the localized erythema and feeling hot to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in right deltoid and experienced redness of shoulder 5 inches by 3 inches and shoulder was hot to touch. The reporter mentioned that, events were still not resolved at the time of reporting. The reporter stated that the primary care physician had been seeing had retired, and that he currently has not had a primary care physician. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 0936186
Sex: F
Age: 61
State: RI

Vax Date: 12/27/2020
Onset Date: 12/27/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Did not get full dose; A spontaneous report was received from a pharmacist concerning a 61-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, did not get full dose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 27 Dec 2020, during vaccine administration, a portion of the vaccine dripped on the patient's arm due to an issue with the needle and the syringe, and the patient did not get full dose of vaccine. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event, did not get full dose, was considered resolved on 27 Dec 2020.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 011J20A. There were no reported AEs associated with this case of Incorrect dose administered.

Other Meds:

Current Illness:

ID: 0936187
Sex: F
Age:
State: NY

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient received 0.3mL; A spontaneous report was received from pharmacist concerning a 49-year-old female patient who received Moderna's COVID-19 vaccine and the patient received 0.3mL. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 28 Dec 2020, the patient was given 0.3 ml dose of the vaccine instead of 0.5 ml. No treatment information was provided. The patient had no adverse reactions. Action taken with mRNA-1273 in response to the event was not reported. The event, patient received 0.3mL, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 49 year-old, female patient, who experienced an event of incorrect dose administered after receiving her first dose of COVID-19 vaccine. No adverse events were reported.

Other Meds:

Current Illness:

ID: 0936188
Sex: U
Age:
State: CO

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: employees vaccinated from a vial that was punctured more than 6 hours ago; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, expired product administered. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the Moderna COVID-19 vaccine was given out this week with doses from a vial that had been punctured for more than 6 hours instead of being discarded. She stated that the punctured vials were placed in the fridge or on top of an ice pack or in the carton and used beyond 6 hours after it was first punctured. No other specific details were provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event, expired product administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# 011J20A; expiration date- unknown), reporting an expired product administered. The event occurred the same day of vaccine administration. The reporter did not provide the causality assessment. The event of expired product administered was assessed as not related to Moderna COVID-19 Vaccine.

Other Meds:

Current Illness:

ID: 0936189
Sex: U
Age:
State: CO

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: employees were vaccinated from a vial that was punctured more than 6 hours ago; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine and who experienced an expired product administered. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Dec 2020, a vial containing the Moderna COVID-19 vaccine was punctured. Instead of being discarded, the vial was placed in cold storage. On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT number 011J20A) for prophylaxis of COVID-19 infection. On 27 Dec 2020, the nurse reported that the patient had received the mRNA-1273 vaccine from the vial that was punctured more than 6 hours before administration. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event, expired product administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns an unidentified patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Expired product administered without any associated adverse events.

Other Meds:

Current Illness:

ID: 0936190
Sex: U
Age:
State: CO

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Employees were vaccinated from a vial that was punctured more than 6 hours ago; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine and who experienced an expired product administered. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Dec 2020, a vial containing the Moderna COVID-19 vaccine was punctured. Instead of being discarded, the vial was placed in cold storage. On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT number 011J20A) for prophylaxis of COVID-19 infection. On 27 Dec 2020, the nurse reported that the patient had received the mRNA-1273 vaccine from the vial that was punctured more than 6 hours before administration. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event, expired product administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient, who experienced an event of expired product administered after receiving the first dose of mRNA-1273 vaccine. No adverse events were reported.

Other Meds:

Current Illness:

ID: 0936191
Sex: U
Age:
State: CO

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Employees vaccinated from a vial that was punctured more than 6 hours ago; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, expired product administered. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) for prophylaxis of COVID-19 infection. On 27 Dec 2020, the nurse reported that the Moderna COVID-19 vaccine was given out on 23 Dec 2020 and 24 Dec 2020 with doses from a vial that had been punctured for more than 6 hours instead of being discarded. She stated that the punctured vials were placed in the fridge or on top of an ice pack or in the carton and used beyond 6 hours after it was first punctured. No other specific details were provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event, expired product administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns an unidentified patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Expired product administered without any associated adverse events.

Other Meds:

Current Illness:

ID: 0936192
Sex: F
Age:
State: NJ

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Passed out twice; Pain in the injection site; Slight headache; A spontaneous report was received from a consumer concerning a 24-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, passed out twice, pain in the injection site, and slight headache. The patient's medical history was not reported. No concomitant medications were reported. On 26 Dec 2020 at 1:58 pm, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L2DA) intramuscularly for prophylaxis of COVID-19 infection. On 26 Dec 2020, at 5:00 pm, the patient passed out. She also had pain in the injection site and a slight headache. On 27 Dec 2020, at 8:30 am, the patient passed out again. No treatment information was provided. The Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, passed out twice, pain in the injection site, and slight headache was unknown.; Reporter's Comments: This case concerns a 24 year old female patient, who experienced a serious unexpected event of loss of consciousness and non-serious expected event of injection site pain and headache. The event occurred apparently few hours after first dose of mRNA-1273 (Lot # 026L2DA) administration. 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: 0936193
Sex: F
Age: 34
State: CA

Vax Date: 12/27/2020
Onset Date: 12/27/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20201227; Test Name: Blood pressure; Result Unstructured Data: mmHg; Test Date: 20201227; Test Name: EKG; Test Result: Inconclusive ; Result Unstructured Data: Unknown results; Test Date: 20201227; Test Name: Pulse rate; Result Unstructured Data: heart beats per minute Tachycardia

Allergies:

Symptoms: Shortness of breath; Tingling; Numbness of body, face, neck; Tachycardia at 144; Palpitation; Elevated BP at 140/90; Chest tightness; Dizziness; Flushing of face; A spontaneous report was received from a physician, who was a 34-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated blood pressure (BP) at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Dec 2020, three to four minutes after receiving the mRNA-1273 vaccine, the patient experienced numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated BP at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face. The patient reported the elevated BP was not her usual blood pressure. She underwent an electrocardiogram (EKG)unknown results and was given oxygen for the events. No other treatments were administered. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated BP at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face, was considered resolving.; Reporter's Comments: This case concerns a 34 year old female patient, who experienced a serious unexpected event of hypoesthesia and paraesthesia and non serious unexpected events of dyspnea, tachycardia, palpitations, blood pressure increased, chest discomfort, dizziness and flushing. The event occurred within 3-4 min after first dose of mRNA-1273 (Lot# 025J20-2A) vaccine administration. The patient was treated with oxygen and no medication was administered. 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: 0936194
Sex: F
Age:
State: OR

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Soreness injection site; The initial case was missing the following minimum criteria: unspecified product and adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the arm on 23Dec2020 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy and anaphylaxis to a penicillin type drug. The patient's concomitant medications were not reported. The patient previously took ampicillin (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for an unknown indication and experienced drug allergy. On 23Dec2020, the patient experienced soreness at injection site. The patient did not receive any treatment for the event. The clinical outcome of the soreness at injection site was recovered in Dec2020 after about 48 hours. The reporter considered that there was a reasonable possibility that the soreness at the injection site was related to the vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0936195
Sex: M
Age:
State: NH

Vax Date: 12/23/2020
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: site soreness; arm is starting to get red with an induration under the injection site; arm is starting to get red with an induration under the injection site; The site was warm; This is a spontaneous report from a contactable other health professional. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EL0140, via an unspecified route of administration in the right deltoid from 23Dec2020 at a SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included atorvastatin (LIPITOR). The patient experienced site soreness. He also indicated that his arm was starting to get red with an induration under the injection site. The site was warm. Outcome of events was unknown. No treatment was required/received due to events. No follow-up attempts possible. No further information expected.

Other Meds: LIPITOR

Current Illness:

ID: 0936196
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: my throat is extremely painful; it hurts to swallow; my throat started feeling a little scratchy 2 hours after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left deltoid on 02Jan2021 at 10:00 as singe dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported " my throat is extremely painful " on 02Jan2021 with outcome of unknown; " it hurts to swallow on 02Jan2021 with outcome of unknown; " my throat started feeling a little scratchy 2 hours after receiving the vaccine " on 02Jan2021 with outcome of unknown. The events were detailed as follows: patient received her 1st vaccine, then described the following: I feel ok but my throat is extremely painful and it hurts to swallow. My throat started feeling a little scratchy 2 hours after receiving the vaccine. Therapeutic measures were taken as a result of the events and included ibuprofen (ADVIL) 400 mg orally at 2:30 pm, helped some and was also reported as hurting more now because she needed to take more medicine. The outcome of events was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .

Other Meds:

Current Illness:

ID: 0936197
Sex: F
Age:
State: WI

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.

Other Meds: ; ; ; ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAM

Current Illness:

ID: 0936198
Sex: F
Age:
State: MI

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

Lab Data:

Allergies:

Symptoms: I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left arm on 30Dec2020 at 11:00 as single dose for an unspecified indication. Medical history included penicillin allergy, sulfa allergy and allergy to nuts from an unspecified date. There were no concomitant medications. The patient experienced allergic reaction, throat pain, swollen uvula, itching in mouth and throat and shaking that was reported as "had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula" on 30Dec2020, at 11:15. The events were reported to have resulted in emergency room/department or urgent care. The events were reported as non-serious. Therapeutic measures were taken as a result of the events: treatment included antihistamine and steroids. Prior to vaccination, the patient had not diagnosed with COVID-19, not had she been tested for COVID-19 since the vaccination. The outcome of events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .

Other Meds:

Current Illness:

ID: 0936199
Sex: F
Age:
State: MI

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

Lab Data:

Allergies:

Symptoms: Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 31Dec2020 at 15:30 as a single dose for COVID-19 immunization. Medical history included allergy to tomatoes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 21:00, the patient experienced soreness in my arm, dizziness, tiredness and overall not feeling well. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness in my arm, dizziness, tiredness and overall not feeling well were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0936200
Sex: F
Age:
State:

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contactable nurse (patient) from a Pfizer-sponsored program. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 28Dec2020 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included possible exposure to COVID-19 patient on 22Dec2020 to 23Dec2020 (patient's patient tested positive on 24Dec2020 and saw the patient on 22Dec2020 and 23Dec2020). The patient's concomitant medications were not reported. The patient experienced fatigue on 28Dec2020, very mild sore arm on 29Dec2020, and body aches (just legs ache) on 02Jan2020. The clinical course was reported as: The patient felt fatigue on the day of vaccination and very mild sore arm the next day. The patient experienced body ache (just legs) on 02Jan2021, but it was less on 03Jan2021. The clinical outcome of fatigue and very mild sore arm was unknown and of body aches (just legs ache) was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.

Other Meds:

Current Illness:

ID: 0936201
Sex: F
Age:
State:

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Itchy everyday since then all over body; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included allergies to cilantro and iron. The patient's concomitant medications were not reported. The patient received vaccine on 28Dec2020 and reported she had been itchy every day since then all over body. Treatment for the event included diphenhydramine hydrochloride (BENADRYL). The outcome of the event, itchy, was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0936202
Sex: F
Age:
State: NY

Vax Date: 12/28/2020
Onset Date: 12/01/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.

Other Meds:

Current Illness:

ID: 0936203
Sex: F
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: fever; tachycardia; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age (pregnancy status not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 03Jan2021 as a single dose for COVID-19 immunization. Indication. Medical history and concomitant medications were not reported. I was not known if the patient received other vaccinations in last 4 weeks or if she took any medications in the past 2 weeks. It was not reported if the patient had been tested for COVID-19 prior to the vaccination. The patient reported fever, tachycardia following administration of vaccine. She was scheduled to receive second dose 30Jan2021 and was questioning safety of second administration. The clinical outcome of the fever and tachycardia was not reported. It was unknown if the patient was tested for COVID-19 after the vaccination. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0936204
Sex: F
Age:
State: MI

Vax Date: 12/24/2020
Onset Date: 12/27/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sensitive from left flank down toward mid buttocks slightly toward anterior area; This is a spontaneous report from the Medical Information Team. A contactable nurse reported that a 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via intramuscular route of administration in the left arm, from 24Dec2020 08:15 at a single dose for COVID-19 immunization. Patient had no other medical history (reported as "none"). Concomitant medication included melatonin, calcium and bupropion hydrochloride (WELLBUTRIN). The patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 27Dec2020 09:00, the patient experienced shingle type pain burning, tingling and very sensitive from left flank down toward mid buttocks slightly toward anterior area. The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of events included motrin, tylenol and lidocaine. Patient was unable to go to work for a few days. No follow-up attempts are possible. No further information is expected. Information on the batch number has been obtained.

Other Meds: ; ; WELLBUTRIN

Current Illness:

ID: 0936205
Sex: F
Age:
State: NY

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

Lab Data: Test Name: ANA; Test Result: Positive

Allergies:

Symptoms: She got her period two weeks early; This is spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is the first of 3 reports, reporting for one of the colleagues. A 41-year-old female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, exp: 31Mar2021, via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. She was ANA and double strand is positive for autoimmune but it is watch and see thing. Patient's other medical history and concomitant medications were not reported. Patient is not pregnant at the time of reporting. Reporter was wondering if other people were also reporting if they got their periods early. She got her period two weeks early (on 02Jan2021) and mentioned she also has two colleagues who had that as well on an unspecified date. The outcome of the event was reported as not recovered. Information on the lot/batch number has been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021004161 same reporter/drug/AE, different patient;US-PFIZER INC-2021004222 same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 0936206
Sex: F
Age:
State: CA

Vax Date: 12/27/2020
Onset Date:
Rec V Date: 01/12/2021
Hospital:

Lab Data:

Allergies:

Symptoms: swollen lymph nodes in the armpit; arm pit pain; This is a spontaneous report from the Medical Information Team. A contactable other health professional reported that a 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 27Dec2020 at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was having arm pit pain, it felt like a swollen lymph node. She saw that this was a side effect. Outcome of events was unknown. Information about lot/batch number requested

Other Meds:

Current Illness:

ID: 0936207
Sex: F
Age:
State: OK

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

Lab Data: Test Date: 20201226; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Positive

Allergies:

Symptoms: COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; arm pain; she felt like crap the night; chills; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date Mar2021), intramuscular on left arm, on 18Dec2020 at 0.3 mL, a single dose for vaccination. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she tested positive with Covid. She received the Pfizer Covid vaccine on 18Dec2020. She was exposed to the virus through close personal contact right around this same time-frame and did develop the virus herself. She wanted to know if there were any recommendations regarding her needing to get the second dose in series. She stated that her husband, who was not vaccinated, had the virus and developed more serious symptoms than she did. She is concerned about worsening side effects with the second dose and stated that she felt like crap the night after her first dose with chills and arm pain. The patient tested positive for COVID-19 on 26Dec2020. Specific test name was unknown, but she knows it was not a rapid test. She is scheduled to get the second dose of the Pfizer COVID-19 Vaccine on 08Jan2021. She called to ask if she should or should not get the second dose relative to the COVID-19 diagnosis. She has not been able to find the information she is asking about. The outcome of the event of Covid-19 was recovering while other events was unknown. The Covid-19 was assessed as unrelated to the suspect drug.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment. COVID-19 antigen test positive.

Other Meds:

Current Illness:

ID: 0936208
Sex: F
Age:
State: MO

Vax Date: 12/24/2020
Onset Date: 12/17/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: Rapid test; Test Result: Negative

Allergies:

Symptoms: welt on the injection site that was very hot and red; welt on the injection site that was very hot and red; welt on the injection site that was very hot and red; rash all over the body; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 24Dec2020 (as reported) at 07:45 at 43-years-old at a single dose for COVID-19 immunization. Medical history included fibromyalgia, hypertension, and shellfish allergy; all from an unknown date and unknown if ongoing. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), ergocalciferol (VIT D); all taken for an unspecified indication from an unspecified date to an unspecified date (received within two weeks of vaccination). The patient previously took iodine (MANUFACTURER UNKNOWN) and experienced iodine allergy, and codeine (MANUFACTURER UNKNOWN) and experienced codeine allergy; both from an unspecified date to an unspecified date. On 17Dec2020 at 13:15 (as reported), the patient experienced: welt on the injection site that was very hot and red, and rash all over the body. The patient also reported, "I have all the symptoms of COVID-19." It was unknown if the patient received treatment for the adverse events. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Rapid test (SARS-CoV-2 test): negative on 04Jan2021. The clinical outcome of the events was not recovered. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Other Meds: ; ; VIT D

Current Illness:

ID: 0936209
Sex: F
Age:
State: NJ

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

Lab Data: Test Date: 20201212; Test Name: A1C; Result Unstructured Data: Test Result:6.4; Test Date: 202004; Test Name: Covid-19 antibody test; Test Result: Negative ; Test Date: 20201231; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20201231; Test Name: Covid-19 rapid test; Test Result: Positive

Allergies:

Symptoms: tested positive for Covid-19 after receiving 1st dose; COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020; smell was gone/no sense of smell; no sense of taste; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) via unspecified route of administration in the left arm on 26Dec2020 at single dose for Covid-19 immunization. Medical history included cholesterol, blood pressure (controlled blood pressure), hypothyroidism. Concomitant medications included TELMISARTAN (MICARDIS) for blood pressure and ATORVASTATIN (LIPITOR) for cholesterol; both on unspecified date. The patient was asking if she was able to get the 2nd dose of vaccine, since she was tested positive for Covid-19 (31Dec2020) after receiving 1st dose. The patient was asking information about missing 2nd dose and when can she get it and wanted to know if it was still okay to get the second dose. The patient asked if she needed to have a test negative for covid-19 prior to receiving 2nd dose. The patient experienced no sense of taste and actually realized it on 29Dec2020 that her food was not tasting good. The patient didn't notice her smell was gone until she was cooking the chicken curry, she even tested it out by spraying some perfume, she has no sense of smell on 30Dec2020. The patient informed that both her taste and smell returned 02Jan2021 but was not recovered completely. The patient underwent lab tests and procedures which included A1C: 6.4 on 12Dec2020, COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020. The patient informed that she had no positive test before the Covid-19 vaccine, she took Covid-19 antibody test in Apr2020 and it was negative. The outcome of the events tested positive for Covid-19 after receiving 1st dose was unknown, no sense of taste and smell was gone/no sense of smell was recovered with sequel on 02Jan2021.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use.

Other Meds: MICARDIS; LIPITOR [ATORVASTATIN]

Current Illness:

ID: 0936210
Sex: F
Age:
State: AL

Vax Date: 12/31/2020
Onset Date: 01/04/2021
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20201231; Test Name: COVID; Test Result: Positive ; Comments: COVID Test resulted on 10:00 04Jan2021. Test was administered on 31Dec2020.

Allergies:

Symptoms: congestion; positive for Covid-19; positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (patient). A 61-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date not reported), via an unspecified route of administration on left arm on 31Dec2020 at 08:15 at a single dose for Covid-19 immunization/precaution because she works with hospice patients. Medical history included blood pressure (abnormal), diabetes, cholesterol (abnormal), and acid reflux, all are ongoing. The patient has no family medical history. Concomitant medications included amlodipine besilate, benazepril hydrochloride for blood pressure taking about 4-5 years, metformin for diabetes taking about 5 years, rosuvastatin for cholesterol Taking about 5 years, pantoprazole for acid reflux taking 5 years, and vitamin D as supplement taking for 3 years. No previous immunization nor vaccines administered on same date of the suspect drug. The patient was calling about the COVID vaccination, which she received on Thursday, 31Dec2020. Her husband tested positive on Thursday, so she took the test on Thursday after she took the vaccination and they just told her today, 04Jan2021, that she is positive for Covid-19. She wanted to know if that was going to mess up her vaccination in any way and if there are recommendations for second dose. She is a CNA. There was no prescriber. She received it because she works with hospice patients. Test was administered on 31Dec2020. COVID Test resulted on 10:00 04Jan2020 as positive. ER or physician's office required: She just went to get a COVID test when her husband tested and they gave her a azithromycin (Z-PACK) 250 mg because she had congestion. Take two tabs first day and then one daily for 4 more days. She is taking last one today (04Jan2021). Outcome of the events was unknown.; Sender's Comments: A causal association between reported events and BNT162B2 cannot be excluded.

Other Meds: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE; ; ; ; VITAMIN D [VITAMIN D NOS]

Current Illness: Acid reflux (esophageal); Blood cholesterol abnormal; Blood pressure abnormal; Diabetes

ID: 0936211
Sex: F
Age:
State: LA

Vax Date: 12/16/2020
Onset Date: 12/31/2020
Rec V Date: 01/12/2021
Hospital:

Lab Data: Test Date: 20201231; Test Name: body temperature; Result Unstructured Data: Test Result:98 degrees Fahrenheit; Comments: normal; all day until that night; Test Date: 20201231; Test Name: body temperature; Result Unstructured Data: Test Result:102 degrees Fahrenheit; Comments: later that night about 10:00 PM; Test Date: 20210101; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: slight sore arm; slight chest congestion; positive COVID-19 test after first dose of vaccine; positive COVID-19 test after first dose of vaccine; Fever; cold like symptoms; stuffy head; horrible headache; Cough; This is a spontaneous report from a contactable healthcare professional (patient) from a Pfizer-sponsored program, Pfizer First Connect. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 16Dec2020 as a single dose (reported as 0.3 mL) (at the age of 44-years-old) for COVID-19 immunization. Medical history included ongoing hypothyroidism, one thyroid gland removed due to a nodule on an unspecified date (years ago), ongoing acid reflux, ongoing hypercholesteremia, ongoing fluid retention, and ongoing history of headaches. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism and for one thyroid gland removed due to a nodule from an unspecified date and ongoing, dexlansoprazole (DEXILANT) taken for acid reflux from an unspecified date and ongoing, atorvastatin (LIPITOR) taken for hypercholesterolemia from an unspecified date to an unspecified date, and hydrochlorothiazide (MANUFACTURER UNKNOWN) taken for fluid retention from an unspecified date and ongoing. Additional concomitant medications included unspecified vitamins. The patient had a positive COVID-19 test after first dose of vaccine on 01Jan2021; cold like symptoms, stuffy head, horrible headache, cough, and fever on 31Dec2020; slight chest congestion on 02Jan2021; and slight sore arm on an unspecified date. The events, stuffy head and horrible headache, were reported as medically significant. The events, cough, fever, and slight chest congestion, were reported as non-serious. The clinical course was reported as follows: It was reported that the patient was vaccinated on 16Dec2020, became symptomatic on 31Dec2020, and tested positive for COVID-19 on 01Jan2021. The patient stated that she became symptomatic one day prior to testing positive for COVID-19, on 31Dec2020. She initially had cold-like symptoms with a stuffy head, cough and a horrible headache; the worst headache she had ever had. These symptoms occurred earlier in the day on the 31Dec2020. Then later that night about 10:00 PM, she had a fever with a body temperature of 102 degrees Fahrenheit. Her body temperature had been normal at 98 degrees all day that day until that night. She also had slight chest congestion and then was fever free for over 48 hours. The patient stated that she had a history of headaches and can tolerate a headache. The headache started 31Dec2020 and was significant. It was reported that after the vaccine, she had no other symptoms other than a slight sore arm, which lasted a day; maybe 24 hours after she received the vaccine. The patient stated that she does not think any of the other symptoms, other than the sore arm, have anything to do with the vaccine. The clinical outcome of positive COVID-19 test after first dose of vaccine and slight sore arm was unknown; cold like symptoms, horrible headache, and cough was recovering; fever was recovered on 02Jan2021; and stuffy head and slight chest congestion was not recovered. The reporter assessed the causality assessment between the events, positive COVID-19 test after first dose of vaccine, cold symptoms, stuffy head, cough, horrible headache, fever, and slight chest congestion, as unrelated. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: SYNTHROID; DEXILANT; LIPITOR [ATORVASTATIN]; HCTZ

Current Illness: Acid reflux (esophageal); Fluid retention; Headache; Hypercholesteremia; Hypothyroidism

ID: 0936212
Sex: M
Age:
State:

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

Lab Data: Test Date: 20210101; Test Name: body temperature; Result Unstructured Data: Test Result:103.1 Fahrenheit; Test Date: 202101; Test Name: oxygen saturation; Result Unstructured Data: Test Result:okay; Test Date: 2020; Test Name: COVID-19 IgG; Test Result: Positive ; Test Date: 20201228; Test Name: COVID-19 PCR nasal swab; Test Result: Negative ; Test Date: 202101; Test Name: COVID-19 PCR nasal swab; Result Unstructured Data: Test Result:pending

Allergies:

Symptoms: suspected COVID-19; suspected COVID-19; Fatigue; Body aches; Headache; chills; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left deltoid on 15Dec2020 at 21:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing hypertension from 2009 and COVID-19 from 10Jun2020 to an unknown date in 2020. Ongoing concomitant medications included fosinopril (MANUFACTURER UNKNOWN) taken for hypertension from 2017. The patient did not receive any other vaccines on the same day as the BNT162B2 vaccine. On 19Dec2020, shy of about 96 hours of getting the vaccine, the patient experienced fatigue, body aches, headache and chills. He did not have any fever. The patient stated that he recovered from the fatigue, body aches, headache and chills by 19Dec2020. The patient was fine from 19Dec2020 until 01Jan2021. On 28Dec2020, the patient had a COVID-19 PCR test that came back negative. On 01Jan2021, the patient suspected that he had COVID-19. He had a fever of 103.1 degrees Fahrenheit, body aches, chills like he was freezing to death, fatigue, diarrhea; however, he did not have nausea or loss of taste or smell. He had swollen lymph nodes, but no sore throat and his oxygen saturation was okay in Jan2021. He was also having chest pain but it was more like intercoastal pain. He stated that these current symptoms were significantly worse than the ones he had just after getting the vaccine and felt more like the symptoms he had when he had COVID-19 before on 10Jun2020 (positive IgG for COVID-19-tested in 2020). The patient had a COVID nasal swab (PCR) done at an urgent care (physician's office) on 02Jan2020 or 03Jan2020 and was awaiting the results. The clinical outcome of the suspected COVID-19 was not recovered.; Sender's Comments: A causal association between reported suspected COVID-19 cannot be excluded.

Other Meds:

Current Illness: Hypertension

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm