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: 0957046
Sex: M
Age: 32
State: WA

Vax Date: 12/29/2020
Onset Date: 01/06/2020
Rec V Date: 01/18/2021
Hospital:

Lab Data: No

Allergies: No

Symptoms: Injection site swelling, redness, hardness, itching

Other Meds: Cephalexin

Current Illness: No

ID: 0957047
Sex: M
Age: 57
State: WA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/18/2021
Hospital:

Lab Data: None

Allergies: No

Symptoms: Muscle pain Pain at injection site

Other Meds: No

Current Illness: No

ID: 0957048
Sex: F
Age: 23
State: WA

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/18/2021
Hospital:

Lab Data:

Allergies: No

Symptoms: Chills Fatigue Fever Headache injection site redness swelling Pain Joint pain Muscle pain Nausea

Other Meds: No

Current Illness: No

ID: 0957049
Sex: F
Age: 49
State: WA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 01/18/2021
Hospital:

Lab Data: None

Allergies: Hydrocodone Sulfides

Symptoms: Chills Fatigue Pain & swelling at injection site

Other Meds: Effexor Trazedone

Current Illness: No

ID: 0957050
Sex: F
Age: 40
State: CA

Vax Date: 12/29/2020
Onset Date: 01/01/2021
Rec V Date: 01/18/2021
Hospital:

Lab Data: None

Allergies: NKDA

Symptoms: R arm pain lasting 3 weeks

Other Meds: TRAMADOL

Current Illness: NONE

ID: 0957939
Sex: F
Age: 48
State: WA

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/18/2021
Hospital:

Lab Data:

Allergies: peanuts Ibuprophen Penecillin Iodine Tylenol erythromycin gluten sensitive

Symptoms: Headache Nausea Injection site redness

Other Meds: hydrochlorothiazide hydroxyine potassium amitriptiline

Current Illness: No

ID: 0961872
Sex: F
Age: 1
State: GA

Vax Date: 12/17/2020
Onset Date: 12/27/2020
Rec V Date: 01/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever 102 last 24 grs - seizure

Other Meds:

Current Illness: 0

ID: 1279626
Sex: U
Age: 66
State: NJ

Vax Date: 01/06/2021
Onset Date: 01/15/2021
Rec V Date: 01/18/2021
Hospital:

Lab Data: Called pharmacy was told to report to this site the adverse reaction. I called my PCP who advised to take Benadryl and Tylenol for headache. Called 1/16/2021. O

Allergies: Latex allergy, egg sensitivity

Symptoms: Had bruised from injection. Arm was sore a couple of days. itching started yesterday 1/15/21. Today 1/16/21 arm is very swollen ( welted) hot to touch and itching. 10 days after injection. By morning large raised welt, hot to the touch and itching. Headache

Other Meds: Vitamins / and statin daily for clogged artery, Bentyl

Current Illness: Crohn ' s disease

ID: 0954286
Sex: F
Age:
State: PR

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong that I can't have my foot firmly on the floor; Fever; strong headache; muscle pain generalized; tiredness; This is a spontaneous report from a contactable other Health Professional. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, Cardiac arrhythmia, allergy to crustaceans. The patient's concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergies, and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 21Dec2020 09:30 AM at a single dose on left arm for COVID-19 immunization. The patient experienced fever, strong headache, muscle pain generalized, tiredness on 08Jan2021, and "muscle pain is so strong that I can't have my foot firmly on the floor" on 08Jan2021 07:00. No treatment was received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 0954287
Sex: M
Age:
State: PR

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: Fever; Result Unstructured Data: Test Result:38.5 Centigrade

Allergies:

Symptoms: Fever 38.5?C (101.3?F) 24 hours; This is a spontaneous report from a contactable other HCP. This 49-year-old male other HCP reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) at Left Arm at single dose for COVID-19 immunization on 07Jan2021. Relevant history and concomitant drugs were unknown. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) Intramuscularly at Left arm at single dose on 16Dec2020, 12:00 PM for COVID-19 immunization. The patient experienced Fever 38.5?C (101.3?F) for 24 hours since 07Jan2021, 04:00 AM. Treatment was received for the event (unspecified), outcome of event was resolved on unknown date in Jan2021. The patient was not COVID infected prior vaccination. The patient had not COVID tested post vaccination.

Other Meds:

Current Illness:

ID: 0954288
Sex: F
Age:
State: AZ

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0954289
Sex: U
Age:
State: PA

Vax Date: 08/12/2020
Onset Date: 08/12/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE/PQC reported; Improperly Stored PROQUAD was administered to patient.; This spontaneous report has been received from a medical assistant, referring about a patient of unknown gender and age. Information about the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions and allergies was not provided. On 12-AUG-2020, the patient was vaccinated with an improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), (therapy type: rHA), lot number S021326 with expiration date on 05-JAN-2021, administered for prophylaxis (dose and frequency were unknown by the reporter; strength, route of administration and anatomical location were not provided). The temperature or the timeframe for the improperly stored vaccine was unknown by the reporter. It was unknown if there was a previous temperature excursion or if the call was due to a Digital Data Loger. No additional AE/PQC reported (no adverse event).

Other Meds:

Current Illness:

ID: 0954290
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: headache; vomiting; This spontaneous report was received from a nurse and refers to a 14 year old female patient. The patient's concurrent conditions included migraine and anxiety. No other information was given regarding the patient's concomitant medications or medical history. On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route of adminstration, lot number and expiration date were not reported). On an unknown date, after administration of the firs dose, the patient experienced headache and vomiting. The outcome of headache and vomiting and the causal relationship between vaccination and the events were not reported.

Other Meds:

Current Illness:

ID: 0954291
Sex: U
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: Leaking ODT vial during administration; Leaking ODT vial during administration; No AE reported; This spontaneous non-valid report as received from a medical assistant via a company representative refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: 1691304; expiration date not reported, but upon internal validation established as 22-DEC-2021, dose and route of administration were not provided). Oral Dosing Tube (ODT) vial was leaking during administration (product leakage, accidental underdose). No adverse event was reported. Product quality complaint (PQC) was filled. This report is non-valid due to the lack of the patient's identifiers.

Other Meds:

Current Illness:

ID: 0954292
Sex: U
Age:
State: KS

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE details; Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided. On 18-DEC-2020, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally, lot # 1684157 and expiration date 26-JUN-2021 administered as prophylaxis. The improperly stored dose of the suspect vaccine experienced a temperature excursion of below 2 degree Celsius (?C) for 24 minutes on an unknown date of 2020; a previous temperature excursion was reported of below 2 ?C (1.6?C) for 24 minutes. The call was made due to a digital data logger. No adverse symptoms were reported.

Other Meds:

Current Illness:

ID: 0954293
Sex: U
Age: 0
State: KY

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; Improperly stored ROTATEQ was administered to patient; This spontaneous report was received from a registered nurse and refers to a 3-months-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided. On 06-JAN-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dosage regimen was not reported), lot # 1691133 and expiration date 28-NOV-2021 administered as prophylaxis. The improperly stored dose of the suspect vaccine experienced a temperature excursion of 35.2 degree fahrenheit (?F) for 45 minutes on 06-JAN-2021 at 1:30 AM; no previous temperature excursion were reported. The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments: US-009507513-2101USA001927: US-009507513-2101USA003974:

Other Meds:

Current Illness:

ID: 0954294
Sex: U
Age: 4
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: administered after improper storage of product; This spontaneous report was received from a medical assistant referring to a 4-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 07-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T022314, expiration date 30-JUN-2022, at a dose of 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The vaccine was stored in a temperature of 7 degree Fahrenheit (?F) for 80 hours as recorded by a data logger. There was no previous temperature excursion reported.

Other Meds:

Current Illness:

ID: 0954295
Sex: F
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: immobility; swelling; insomnia; hives around the injection site; More pain than the average vaccines; This spontaneous report was received from a consumer referring to his wife a 58-year-old female patient.. Patient's concurrent conditions included cancer and allergy to sulfur based medications. Concomitant medications included, atorvastatin calcium (LIPITOR) and semaglutide (OZEMPIC). Information regarding patient's historical conditions was not provided. On an unspecified date in 2020 (reported as "roughly a month ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 dosage form in the right arm, to prevent pneumonia (prophylaxis) (strength, administration route, lot number and expiration date were not provided). On 01-DEC-2020 (reported as "6 weeks ago"), the patient experienced Immobility (paralysis), more pain than the average vaccine caused, swelling, insomnia and then she developed hives around the injection site. No treatment was given for the events, and a blood work was performed. The outcome of the events was reported as recovered/resolved. The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). Upon internal review, Immobility was determined to be a medically significant event.

Other Meds: LIPITOR; OZEMPIC

Current Illness: Allergic reaction to drug excipient; Cancer

ID: 0954296
Sex: U
Age:
State: MS

Vax Date: 12/01/2012
Onset Date: 12/01/2012
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: shingles; approximately 47-year-old pt administered zoster vaccine live (ZOSTAVAX); Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was approximately 47 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. In or about December 2012, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a physician at a family medical facility for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider at a family medical group for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event was not provided. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 0954297
Sex: F
Age:
State: AR

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional adverse events reported; The patient accidentally received an expired doseof VAQTA; This spontaneous report has been received from a nurse via office manager regarding on a 21-year-old female patient. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history. On 14-JAN-2021, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), at a dose of 1 milliliter (ml), intramuscularly (IM), as prophylaxis, lot number reported and validated as S036494, expiration date reported and validated as 09-JAN-2021 (strength, anatomical site of vaccination, and vaccination scheme frequency were not reported). It was reported that the patient was accidentally vaccinated with the expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (expired product administered) however, the vaccine was reported to be properly stored. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 0954298
Sex: F
Age: 62
State: CA

Vax Date: 10/27/2020
Onset Date: 10/27/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: minor sore arm; Early second dose / First dose on 21Sep2020 / Second dose on 27OCt2020; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 27th October 2020, the patient received the 2nd dose of Shingrix. On 27th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: The patient received 1st dose on 21st September 2020. The reporter stated that, the patient received 2nd dose early than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up. This was 1 of 2 linkied cases, reported by same reporter for different patient. Follow up information received from pharmacist on 23rd December 2020: The patient had no medical condition and or known allergies. Updated patient details. The patient received Shingrix by intramuscular route. Shingrix vaccine to be recommended to be administered 2 months apart, 2nd dose given at 5 weeks which led to drug dose administration interval too short. The patient experienced minor sore arm. The reporter considered minor sore arm to be related to Shingrix.; Sender's Comments: US-GLAXOSMITHKLINE-US2020213911: same reporter

Other Meds: Shingrix

Current Illness:

ID: 0954299
Sex: F
Age: 56
State: FL

Vax Date: 12/04/2020
Onset Date: 12/01/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Stomach cramps; This case was reported by a pharmacist and described the occurrence of stomach cramps in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 4th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, 1 week after receiving Shingrix, the patient experienced stomach cramps. On an unknown date, the outcome of the stomach cramps was unknown. It was unknown if the reporter considered the stomach cramps to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient who one week after receiving the dose of Shingrix experienced stomach cramps. The reporter consented to follow up. No other information provided.

Other Meds:

Current Illness:

ID: 0954300
Sex: F
Age: 67
State: TX

Vax Date: 12/27/2020
Onset Date: 12/27/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pain affected my shoulder; Arm swelled up; I had pain; Doubt if the shot was done intramuscularly; Electric shock; Burning in second and third finger; A spontaneous report was received from a 67-years-old, female patient, who was also a nurse, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm swelled up, had pain, affected her shoulder, had an electric shock, burning second and third finger, and doubt if the shot was done intramuscularly. The patient's medical history was not provided. Relevant concomitant medications reported included medication for blood pressure and diarrhea. On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) in the left arm for prophylaxis of COVID-19 infection and experienced an electric shock and burning in her second and third finger, and she doubted that the shot was administered in her deltoid. On 27 Dec 2020, about 6 hours later, the patient stated that her arm "was swelled up" and had pain. Later, on an unknown date, the patient stated that the pain got a whole lot worse and it also affected her shoulder. She mentioned that it was not the normal kind of pain. Treatment included paracetamol. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, experienced arm swelled up, had pain, affected her shoulder, had an electric shock, burning second and third finger, were considered unknown. The outcome of the event, doubt if the shot was done intramuscularly, was resolved on 27 Dec 2020.; Reporter's Comments: This case concerns a 67-years-old, female subject with medical history of hypertension, who experienced a non-serious unexpected events of product administration error, electric shock, burning sensation; a non-serious expected event of arthralgia, peripheral swelling, and pain in extremity. There were no reported AEs associated with product administration error. The event of electric shock, burning sensation, peripheral swelling, and pain in extremity occurred apparently 6 hours after mRNA-1273 administration. The time of onset was not provided for the event of arthralgia. The subject's concomitant medications included for hypertension and for diarrhea (details not provided). The event was treated with Tylenol. 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: 0954301
Sex: M
Age: 16
State: NM

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 16 year old male child received the first Moderna vaccine; A spontaneous report was received from a consumer concerning a 16-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) resulting in the event, 16 year old male child received the first Moderna vaccine. The patient's medical history was not provided. Concomitant medications were not reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient was 16 years of age when he received the mRNA-1273 vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, 16 year old male child received the first Moderna vaccine, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 0954302
Sex: M
Age:
State: IL

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chills; fever; muscle soreness; headaches; swollen lymphnodes; This is a spontaneous report from a contactable healthcare professional. A 32-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EV5730, intramuscular in right arm on 17Dec2020, at 12:00 PM (at the age of 32 years old) as a single dose for COVID-19 immunization and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL 3246, intramuscular in right arm, on 07Jan2021 at 11:00 (at the age of 32 years-old) as a single dose for COVID-19 immunization. The vaccinations were administered at a hospital. Medical history included an allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was not known if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks (date not reported) of the vaccination. On 08Jan2021 at 00:00, the patient experienced chills, fever, muscle soreness, headaches, and swollen lymph-nodes. The patient was not hospitalized for the events nor received treatment. The clinical outcome of the events of Chills, fever, muscle soreness, headaches, and swollen lymph-nodes was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0954303
Sex: F
Age:
State: MN

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: diarrhea; low appetite; felt achy/achiness; tired/fatigue; This is a spontaneous report from a contactable healthcare professional. A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek9231, via an unspecified route of administration, in right arm on 31Dec2020 at 17:30 (at the age of 32 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history includes type 1 diabetes, anxiety, and anemia. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included insulin lispro (HUMALOG), drospirenone, ethinylestradiol (GIANVI), propranolol (PROPRANOLOL), sertraline (SERTRALINE). Past drug history included an allergy to amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did take concomitant medications within 2 weeks prior to the vaccination. On 31Dec2020 and 01Jan2021, the patient was achy, tired, had diarrhea, low appetite. The clinical course was as follows: From 5 hours to about 24 hours after the vaccine she felt achy and tired. She felt fine after that. A week later (approximately 07Jan2021 at 18:00), she had diarrhea, low appetite, fatigue, and achiness. The patient was not hospitalized for the events nor received treatment. The clinical outcome of the events of achy, tired, had diarrhea, low appetite was recovering. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: HUMALOG; GIANVI; ;

Current Illness:

ID: 0954304
Sex: F
Age:
State: NY

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Loss of taste - things don't taste normal; Loss of taste - things don't taste normal; This is a spontaneous report from a contactable nurse. A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number=EK9231, intramuscular in right arm on 07Jan2021 at 08:45 (at the age of 62 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. There was no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included duloxetine (DULOXETINE), naproxen (NAPROXEN), ergocalciferol (VIT D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of the vaccine. On 08Jan2021, at 9:00, the patient experienced a loss of taste - "things don't taste normal". The patient was not hospitalized for the event nor received treatment. The clinical outcome of the events of loss of taste ? things don't taste normal, was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: ; ; VIT D

Current Illness:

ID: 0954305
Sex: F
Age:
State: TX

Vax Date: 12/21/2020
Onset Date: 01/05/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:99.9.; Test Date: 20210105; Test Name: COVID Test; Test Result: Positive

Allergies:

Symptoms: She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse (patient herself) reported that a 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date not reported), via an unspecified route of administration in the upper left arm on 21Dec2020 17:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing hypertension (blood pressure high). She was a former smoker, a teenage smoker. She has not smoked since the age of 19 years old. Concomitant medication included amlodipine for high blood pressure. The patient informed that she was vaccinated on 21Dec2020. On 05Jan2021, she had a positive COVID Test and she was wondering when she should have the second dose of the COVID Vaccine. She thought initially she just had a cold. She took the COVID test as a precaution. It started out with a stuffy nose. She had a congested cough, upper airway cough, nothing deep in the lungs. She had a low grade fever. It was like 99.9. It was possible it was higher, but she had taken Ibuprofen at night. She woke up soaking wet. She had sweats kind of. Her temperature however never registered a true fever if a fever was considered 100.4. She was not really having body aches any more unusual than one would have for a 64 year old. She has a very mild sore throat. Her stuffy nose had improved, it's still there slightly, but not like it was the first few days. The outcome of events was unknown.; Sender's Comments: Test positive for covid19 found 14 day following the first dose of COVID-19 vaccination, bnt162b2, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.

Other Meds:

Current Illness:

ID: 0954306
Sex: F
Age:
State: UT

Vax Date: 12/17/2020
Onset Date: 12/20/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sharp pain R side of neck along dermatome; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; minor shingles outbreak; skin irritation; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 10:15 at a single dose on the left arm for COVID-19 immunization. Medical history included Afib/ flutter, ablation, and total hysterectomy. Patient had allergies to food: grapes. Concomitant medications included fish oil, zinc, and estradiol (1 mg, 2x/week) transdermal patch. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. On 20Dec2020 at 09:00, the patient experienced sharp pain R side of neck along dermatome, vesicles break out R anterior chest with mild burning and itching consistent with a minor shingles outbreak. MD had examined it and his opinion was that the minor shingles outbreak was most likely triggered by the vaccine. Very mild but skin irritation was also present. No treatment was given for the events. Since the vaccination, the patient has not tested for COVID-19. The outcome of the events was recovering at the time of the report.

Other Meds: ; ;

Current Illness:

ID: 0954307
Sex: F
Age:
State:

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fatigue; This is a spontaneous report from a contactable consumer reported a 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 29Dec2020 at a single dose for Covid-19 immunization. Medical history included ongoing chronic fatigue and Epstein Barr. The patient's concomitant medications were not reported. The patient works in a nursing home, she received her first vaccine on 29Dec2020, she said since then has had fatigue. Inquiring if this is normal and if anyone else has reported this and asking if others have reported. She is due for second dose 19Jan2021. Outcome of the event was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness: Chronic fatigue (history of chronic fatigue and Epstein Barr)

ID: 0954308
Sex: F
Age:
State: IL

Vax Date: 12/18/2020
Onset Date: 01/01/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: Test Date: 20210101; Test Name: covid 19; Result Unstructured Data: Test Result:Positve

Allergies:

Symptoms: received the first dose of vaccine in a hospital on 18Dec2020/tested positive for COVID on 01Jan2021; received the first dose of vaccine in a hospital on 18Dec2020/tested positive for COVID on 01Jan2021; This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program, Pfizer First Connect. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK5730, expiration 31Mar2021) , via an unspecified route of administration in left arm, on 18Dec2020 at 15:00, at 0.3 mL, single, for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient received the first dose of vaccine in a hospital on 18Dec2020 at 15:00 as she works in emergency room and tested positive for COVID on 01Jan2021. The patient stated that the second dose is scheduled this afternoon (08Jan2021) and wants to know if she should proceed with the vaccine. The patient is looking for guidance on whether or not to get the second dose or wait. The patient has been directed to receive second COVID vaccine. No additional vaccines administered on the same date. The event required a visit to urgent care. The patient did not have prior vaccinations within 4 weeks. No events prior to vaccination. The patient underwent lab tests and procedures which included COVID 19: positive on 01Jan2021. Outcome of the events was unknown. The event was assessed as serious (medically significant). The event "Tested positive for COVID" was assessed as unrelated to COVID vaccine as her husband was COVID positive before her.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.

Other Meds:

Current Illness:

ID: 0954309
Sex: F
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe pain in the middle of her chest that was acid reflux/bad GERD; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ1686, expiry date: 31Mar2021), intramuscular in the left arm on 04Jan2021 11:00 (also reported as 12:00) at a single dose for COVID-19 immunisation. The patient's medical history included Gastrooesophageal reflux disease (GERD) which she has not had this since she was pregnant 36 years ago. There were no concomitant medications. 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 has not been tested for COVID-19. The caller stated she had the COVID vaccine on Monday (04Jan2021) at 11:00am. Later that day at 6:00pm she had severe pain in the middle of her chest that was acid reflux/bad GERD. She has not had this since she was pregnant 36 years ago. She stated that the sharp pain in her chest was really really bad, she thought she was having a heart attack. She stated the pain went away, but she has really bad acid. The caller asked if this is this normal? Additionally, how long do side effects in general last? She wanted to go lay down because her stomach was hurting. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 0954310
Sex: F
Age:
State: OH

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

Lab Data: Test Date: 20210108; Test Name: COVID; Result Unstructured Data: Test Result:unknown

Allergies:

Symptoms: Sore throat; congestion; headache; she will vomit; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program: Pfizer First Connect. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730, exp date: 31Mar2021), via an unspecified route of administration on 19Dec2020 for COVID-19 immunization. Medical history included being COVID positive on 16Nov2020. The patient had no other relevant history. There were no concomitant medications (no other products). She was working at a doctor's office. The patient mentioned she was due to receive the 2nd dose of the vaccine on 09Jan2021 at 9 am but currently has a sore throat, congestion and a headache (onset date: 05Jan2021). Her symptoms worsened. It started as just a headache. With the congestion now when she blows her nose, sometimes she will vomit (onset date: Jan2021). She was asking if it was okay for her to take the vaccine tomorrow and for any recommendations. She was tested for COVID the day of reporting (08Jan2021) but had no results with her; she hasn't received the COVID test result back (unknown). No investigation assessment performed. The outcome of she will vomit was unknown while the other events had not recovered.

Other Meds:

Current Illness:

ID: 0954311
Sex: F
Age:
State: PA

Vax Date: 12/23/2020
Onset Date: 12/28/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: Covid-19; Test Result: Positive

Allergies:

Symptoms: She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; She reported being exposed to her husband, who tested positive for COVID, and that she tested positive following her first vaccine dose; This is a spontaneous report from a contactable female nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. and expiry date unspecified) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if it is safe to get the second dose of the vaccine after being exposed to or having COVID? She reported being exposed to her husband (on an unspecified date), who tested positive for COVID, and that she tested positive following her first vaccine dose. She got her Covid-19 vaccine on the 23Dec2020 and tested positive for Covid-19 on the 28Dec2020. She was scheduled to get the next dose on Wednesday and wants to know if she should still get it. Outcome of the events drug ineffective, COVID-19 and Exposure to COVID-19 was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and COVID-19 test positive on 28Dec2020. 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 test was likely associated with being exposed to her husband, who had COVID-19. Further information is needed for full medical assessment.

Other Meds:

Current Illness:

ID: 0954312
Sex: F
Age:
State: OR

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: Test Date: 20201207; Test Name: COVID-19 Test; Test Result: Negative

Allergies:

Symptoms: she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.

Other Meds:

Current Illness: Asthma; Eczema; Osteoporosis; Psoriasis

ID: 0954313
Sex: F
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: odd feeling; dizziness; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FL3246, expiration date unknown), intramuscularly in left arm (also reported as subcutaneously in the left deltoid muscle) on 07Jan2021 at 10:00 at a single dose for COVID-19 immunisation. Medical history included osteoarthritis and depression on unknown dates and other unspecified conditions diagnosed in 2012 or 2014 and also needed glasses. Concomitant medication included bupropion as antidepressant for about six years. Family medical history was reported none. The patient experienced dizziness on 07Jan2021 following the first dose. The patient received the first dose on 07Jan2021 (yesterday) morning. She did not have any symptoms after the injection, but by the end of the afternoon/ late afternoon or early evening, she started feeling dizzy. She was not sure if it was because of her age. In the morning of 08Jan2021, when she woke up, she was feeling more dizzy. It was not to the point where she felt she was going to fall though. She would like to know if this has been reported as a common side effect. The patient asked when will it get better and if this will affect her second dose in 3 weeks. There was no prescriber and patient went to designated vaccine site which was not a military facility. The patient further reported that the dizziness was nothing notable last night. It was not better. In the morning of 08Jan2021, she walked around a bit and ate breakfast, thinking that would take away. When sitting, she as fine. When getting up to walk, she noticed it. The room was not spinning. It was just an odd feeling. When reading the vaccine card, she said she is looking for glasses and confirmed that she needed them prior to getting the vaccine. The patient also informed that one of the side effects of bupropion was dizziness and she did not take it on 08Jan2021. She did take the dose in the night of 07Jan2021. It was in a pharmacy vial with no lot or expiration. The patient had no previous history of previous immunizations with Pfizer vaccine. There were no additional vaccines administered on same date as the BNT162B2. The event did not require ER or physician's office. There were no prior vaccinations within 4 weeks. The event was considered non-serious by the reporter. There were no relevant tests. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 0954314
Sex: F
Age:
State: LA

Vax Date: 12/19/2020
Onset Date: 12/30/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data: Test Name: blood was tested; Test Result: Negative ; Comments: her blood was tested for the COVID-19 Virus antibodies, and her blood was negative for the virus antibodies; Test Date: 20210105; Test Name: COVID test; Test Result: Positive ; Comments: she received her 1st dose of the COVID-19 Vaccine on 19Dec2020 and tested positive for the COVID-19 Virus on 05Jan2021.

Allergies:

Symptoms: She had sniffles and post nasal drip; Got first dose then went to (Entertainment complex name) and contracted COVID/tested positive after getting the 1st dose; Tested positive after getting the 1st dose; She returned home with sniffles, fatigue, and no taste/She had sniffles and post nasal drip; This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program: IBCC (Inbound Call Center for HCPs). A 53-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, exp date not reported), via an unspecified route of administration on 19Dec2020 for given since patient works with COVID patients (COVID-19 immunisation). The patient had no relevant medical history. There were no concomitant medications. Nurse called asking if she can get the 2nd dose of the vaccine 6 days after the 21st day. She tested positive on 05Jan2021 after getting the 1st dose and was still in quarantine. The nurse works at a hospital. She received her first dose of the COVID-19 Vaccine on 19Dec2020, and afterwards donated blood on the same day. She got the vaccine through her place of work. She said when she donated blood on 19Dec2020, her blood was tested for the COVID-19 Virus antibodies, and her blood was negative for the virus antibodies. She lives about 30 mins from work, so she thought she would get both done in the same day. She gave blood right before she got the vaccine. She gave the blood then went and got the Vaccine. She said on 26Dec2020 she went to Entertainment complex as it was her vacation. Her and her family went for 4 days. On 30Dec2020 she returned home with sniffles, fatigue, and no taste. She said she tested positive for the COVID-19 Virus on 05Jan2021. On 30Dec2020 they got back, and on 02Jan2021 she had sniffles and post nasal drip. On 03Jan2021 she did not wanna get out of bed. She was profoundly fatigued. She also lost her smell. She had to go back to work on 07Jan2021, but did not want to go back in unless she was sure she was okay because she works with babies. She had no other symptoms after 03Jan2021, except no smell and no taste. She got tested for COVID and was positive on 05Jan2021 (also reported as 06Jan2021 [pending clarification]). Her and her husband were both positive, but her kids were not. The weird thing was she also on 06Jan2021 got her results back from giving blood and she was negative for COVID on 19Dec2020 prior to getting the vaccine. Caller clarifies that her COVID test was a nasal swab. Patient thought her age may have contributed to her feelings of fatigue. She had indicated she worked in either a hospital NICU or nursery, and that is why she had to quarantine for 14 days. She probably would not have even gotten tested for COVID if she was not a nurse and did not know that losing taste and smell were a sign. She feels fine. She said she was scheduled for her second dose of the COVID-19 Vaccine on 12Jan2021. She said she was now in quarantine for 14 days due to testing positive for the COVID-19 Virus, and her quarantine period ends on 14Jan2021. Since now she is in quarantine, she will miss her second dose which was supposed to be on 12Jan2021. She said she rescheduled her second dose of the COVID-19 Vaccine to 18Jan2021, which was 6 days later than when she was supposed to receive the 2nd COVID-19 Vaccine dose. She asked if getting the dose 6 days late was okay. The events were considered as non-serious by the reporter. The outcome of the events was unknown.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 0954315
Sex: M
Age:
State: SC

Vax Date: 12/17/2020
Onset Date: 12/18/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data: Test Date: 20201222; Test Name: Tested positive with COVID; Test Result: Positive

Allergies:

Symptoms: tested positive for COVID; tested positive for COVID; achiness; Chills; not feeling well; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient's wife) reported similar events for four patients. This is the first of four reports. A 48-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer-Biontech Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient received the vaccine last 17Dec2020. The following day, 18Dec2020, he was not feeling well. Clarified those side effects as achiness and chills. He had been working so hard and thought initially were getting side effects from the COVID Vaccine. He was tested positive for COVID on 22Dec2020. He was in bed basically until 31Dec2020. His wife wants to know if he should get the second dose. The outcome of events was recovered. Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021019513 same drug, similar events, different patient;US-PFIZER INC-2021019535 same drug, similar events, different patient;US-PFIZER INC-2021019534 same drug, similar events, different patient

Other Meds:

Current Illness:

ID: 0954316
Sex: F
Age:
State: CA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: migraine; weakness; itchiness, redness and swelling around the injection site; itchiness, redness and swelling around the injection site; itchiness, redness and swelling around the injection site; This is a spontaneous report from a contactable nurse. A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 30Dec2020 at SINGLE DOSE at left arm for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. On 30Dec2020, the patient reported migraine and became more severe on 31Dec2020, weakness, itchiness, redness and swelling around the injection site post vaccination. Caller wants to know if she can receive the second dose of the vaccine despite the redness and swelling around the injection site. The outcome of the event Itchiness, red and swollen injection site was recovered on 31Dec2020, the event migraine, weakness was recovered on 01Jan2021 Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0954317
Sex: F
Age:
State: FL

Vax Date: 01/06/2021
Onset Date: 01/08/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: redness and itchiness on the injection site; redness and itchiness on the injection site; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the COVID-19 vaccine on Wednesday (06Jan2021). Everything was fine, she sat there for fifteen to twenty minutes and then left. This morning (08Jan2021), patient woke up with redness and itchiness on the injection site where the shot was. Patient asked if her side effects are expected and will it go away, and should she be concerned. The outcome of the events was unknown. Information on lot number/batch number was requested.

Other Meds:

Current Illness:

ID: 0954318
Sex: F
Age:
State:

Vax Date: 12/22/2020
Onset Date:
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she had a metallic taste in her mouth; she couldn't taste anything half an hour after receiving the first dose; fatigue that made her fall asleep for 4-5 hours; tingling sensation in the top of her head/ tingling sensation on her right arm right after the shot; nausea; numb sensation on her right arm; sore sensation so bad she could not lift her arm; sore sensation so bad she could not lift her arm; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization. Medical history included two strokes. The patient's concomitant medications were not reported. On an unknown date, the patient experienced a metallic taste in her mouth, she couldn't taste anything half an hour after receiving the first dose, fatigue that made her fall asleep for 4-5 hours, tingling sensation in the top of her head/ tingling sensation on her right arm right after the shot, nausea, numb sensation on her right arm, and sore sensation so bad she could not lift her arm. The clinical outcomes of metallic taste in her mouth, couldn't taste anything, fatigue, tingling sensation, nausea, numb sensation on her right arm, and sore sensation so bad she could not lift her arm, were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0954319
Sex: F
Age:
State: PA

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore right arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: Mar2021), via an unspecified route of administration on the right arm on 04Jan2021 (between 16:00- 16:15) at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease about 7-8 years ago. She said she doesn't take medication all the time for the condition. Concomitant medication included azithromycin (Z-PAK), bifidobacterium infantis (ALIGN). Patient had nausea since 06Jan2021. Her sore arm started at around 3:00 AM on 05Jan2021 and lasted only one day. The caller asked if the nausea could be caused by the COVID-19 Vaccine, and if so, should she get the second dose of the COVID-19 vaccine. Reported the nausea is more of an annoyance, and she doesn't feel like she is going to throw up. Her nausea has been persisting since it started on 06Jan2021, but had worsened from 07Jan2021, to 08Jan2021. She said she woke up the morning of 08Jan2021 with a sore throat, and has had an off and on headache since the morning. Outcome of the event sore arm was recovered on 05Jan2021, for the remaining events was not recovered No prior vaccinations within 4 weeks. The reporter considered the event non-serious.

Other Meds: Z-PAK; ALIGN

Current Illness: Hashimoto's disease

ID: 0954320
Sex: F
Age:
State: NV

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

Lab Data:

Allergies:

Symptoms: hives, headache and fever; hives, headache and fever; hives, headache and fever; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were 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 patient experienced hives, headache and fever after receiving the first dose of the Pfizer COVID-19 vaccine. She wanted to know if she can receive the second dose of the vaccine. She took some Benadryl for it. She mentioned she is due soon for the second dose, later clarified as, due today (08Jan2021) for the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0954321
Sex: F
Age:
State: IL

Vax Date: 12/18/2020
Onset Date: 12/20/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data: Test Date: 20201220; Test Name: SARS-COV-2; Test Result: Positive

Allergies:

Symptoms: tested positive for SARS-COV-2; tested positive for SARS-COV-2; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable nurse (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 18Dec2020 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient received first dose of vaccine on 18Dec2020 and tested positive for SARS-COV-2 20Dec2020. She reported "las major symptom" on 27Dec2020 and asked if it was okay to take the second dose. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Positive SARS-COV-2 came back 2 days following the vaccine use is compatible with COVID 19 infection. No adequate effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.

Other Meds:

Current Illness:

ID: 0954322
Sex: M
Age:
State: AZ

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Normal pain at site; nause; diarrea; congestion; pain both ears; headache; dizziness; weakness; cough; joint and muscle aches; joint and muscle aches; chills; loss of appetite, taste and smell; loss of appetite, taste and smell; loss of appetite, taste and smell; fever; difficulty breathing; dehydration; throught swollen; This is a spontaneous report from a contactable Other Health Professional (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 30Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included covid from an unknown date and unknown if ongoing (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). Known allergies: no. Other medical history: no. Concomitant medication the patient received within 2 weeks of vaccination included bupropion, esomeprazole magnesium, lisinopril, magnesium citrate, magnesium oxide, riboflavin, tanacetum parthenium (MIGRELIEF), lisdexamfetamine mesilate (VYVANSE), Aller-itin. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Facility where the most recent COVID-19 vaccine was administered: Other. The patient experienced normal pain at site, nause, diarrea, congestion and pain both ears, headache dizziness, weakness. cough, joint and muscle aches, chills, loss of appetite, taste and smell, fever, difficulty breathing, dehydration, throught swollen, all on 31Dec2020 05:00 with outcome of recovering. The patient received treatment for the adverse event: cold medicine fluids paracetamol (TYLENOL) and sleep. Since the vaccination, has the patient been tested for COVID-19: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information about Lot/Batch number has been requested.

Other Meds: ; ; ; MIGRELIEF; VYVANSE

Current Illness:

ID: 0954323
Sex: F
Age:
State: VA

Vax Date: 12/16/2020
Onset Date: 12/17/2020
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events. No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.

Other Meds: SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BREO ELLIPTA

Current Illness:

ID: 0954324
Sex: F
Age:
State: MN

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: at the injection site, it is raised, warm and red; at the injection site, it is raised, warm and red; at the injection site, it is raised, warm and red; This is a spontaneous report from a contactable other health professional (HCP). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on her right arm, on 06Jan2021 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. Patient received the first vaccine 2 days ago (06Jan2021) and last night (07Jan2021) at the injection site, it is raised, warm and red. She has had no other symptoms and no fever. She was asking if it is normal for it to take time to occur and for how long will it last. On 08Jan2021, it was reported that she did see that it was normal but was asking if it is normal 48 hours later. Otherwise, she was completely fine. She works as a technician at the hospital. She just took a picture of it so she can keep track of it. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0954325
Sex: M
Age:
State: CA

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: body temperature; Result Unstructured Data: Test Result:fever

Allergies:

Symptoms: Fevers; Chills; he is suspecting that he got infected with the Covid-19 though he already received the 1st dose; he is suspecting that he got infected with the Covid-19 though he already received the 1st dose; Body aches; Patient suspected that he has gotten infected also from his spouse; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 (Tuesday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported body aches developing the evening of receiving the vaccine, and it has persisted for three days. Patient started to get the chills on Wednesday (06Jan2021). Patient said his wife has been tested positive after he took the 1st dose and he is suspecting that he got infected with the Covid-19 though he already received the 1st dose. Patient thought that he may have been infected by his spouse. He got the vaccine on Tuesday and on Wednesday had fever and chills and still has them. Stated that his spouse lost her sense of smell and taste and tested positive for Covid on Wednesday. Patient stated that this was the day after he received his vaccine. Patient suspected that he has gotten infected also from his spouse and was not aware when he got the vaccine. Stated that now that he is having expected side effects of fever and chills. The outcome events was not recovered. This case was reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and suspected got COVID-19 infection via exposure to COVID-19 living with his wife, who lost her sense of smell and taste and tested positive for COVID on 06Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Further information is needed for full medical assessment.

Other Meds:

Current Illness:

ID: 0954326
Sex: F
Age:
State:

Vax Date: 12/20/2020
Onset Date: 01/01/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: COVID-19 test; Test Result: Negative

Allergies:

Symptoms: Headache; Nausea; Vomiting; Diarrhea; Feeling ill; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable other health care professional (patient). A female (Age: 40; Unit: Unknown) patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration first dose on 20Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that today 08Jan2021, the patient started experiencing COVID symptoms: headache, nausea, vomiting and diarrhea. She did a COVID test today but did not get the results yet. The patient wanted to know if she should get her Dose 2, which was scheduled on 10Jan2021?. The first dose was on 20Dec2020, started feeling covid symptoms 08Jan2021, headache, nausea, vomiting, diarrhea. The patient did covid test today 08Jan2021 and expecting results on 11Jan2021, but second is scheduled for 10Jan2021. The patient was wondering if she should still have her second dose on 10Jan2021. Additionally, it was reported that o the past Friday 08Jan2021, started feeling ill (Jan2021) and got Covid-19 tested but negative results on 11Jan2021. Supposed to get a 2nd dose on Sunday, but since testing is still pending, the caller did not proceed with taking it. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0954327
Sex: F
Age:
State: NC

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/19/2021
Hospital:

Lab Data:

Allergies:

Symptoms: not feeling good (felt like crap); dizziness (really dizzy); weakness; shortness of breath (short of breath); arm feeling weak (arm felt weak); This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140, expiration date 31Mar2021) via an unspecified route of administration on 08Jan2021 at a single dose in the left arm as Covid-19 vaccine due to being a front line worker. Medical history included ongoing pre-diabetic from 2015. There were no concomitant medications. The patient received the vaccine today on 08Jan2021. Within 15 minutes (also reported as 15 minutes after the vaccine), she experienced not feeling good (felt like crap), dizziness (really dizzy), weakness, shortness of breath (short of breath), and arm feeling weak (arm felt weak) on the side where the injection was received. It's the weirdest thing, she never had issues with vaccines before. She was asking if this was normal. The outcome of the events was unknown. The nurse reported that the events were related to the suspect product.

Other Meds:

Current Illness: Pre-diabetic

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm