VAERS 2021 Database www.vaers.hhs.gov

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







Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1056046
Sex: F
Age: 39
State:

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

Lab Data:

Allergies:

Symptoms: Started to feel hot and "body on fire" 20 minutes post vaccination. Placed in supine position for about 10 minutes. Ice pack to chest and back of neck. Sat up, rechecked vital signs, Gave granola bar and powerade. Rechecked all vitals signs, Monitored an additional 30 minutes. Felt better and released to home.

Other Meds:

Current Illness:

ID: 1056047
Sex: F
Age: 66
State: IN

Vax Date: 02/17/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: N/A

Allergies: Penicillin

Symptoms: Vertigo and nausea

Other Meds: Coq10/pqq, memory protect, eye vitamins, hair skin and nails, magnesium threonate, magnesium citrate

Current Illness: None

ID: 1056048
Sex: F
Age: 51
State: IL

Vax Date: 02/03/2021
Onset Date: 02/06/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Hearing test, MRI of the brain

Allergies: Tetanus

Symptoms: Severe Loss of hiring in the right ear

Other Meds: Vitamin B, fish oil, garlic, vitamin C, vitamin D, vitamin mag/cal/zin, melatonin, Prevacid, singular

Current Illness: Secure Vitamin D deficiency, but I was not about it at the time of vaccine

ID: 1056050
Sex: M
Age: 70
State: NV

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Loss of appetite, general malaise for 2 days, some loss of balance, stuffed nose

Other Meds: Vitamin C, Beta Carotene, B Complex, Vitamin D

Current Illness: None

ID: 1056051
Sex: M
Age: 95
State: IL

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies: No known allergies

Symptoms: Confusion, nausea, vomiting, weakness

Other Meds: Januvia, omerperide, Flomax, Lipitor, gabapentin, low dose aspirin, vitamin D3

Current Illness: NA

ID: 1056052
Sex: F
Age: 31
State: TX

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies: Penicillin.

Symptoms: Sore at injection site 2 hours after the injection. The following day I had soreness, tightnes, red in the injection site, warm and tender to the touch. 48 hours later,I had a round lesion about 4 inches long and wide. Red, painful, warm to the touch and itchy. Resembles what they call ?Covid arm? but this was on the second dose. Still experiencing soreness, pain and itchy ness. Going onto day 3 since injection with the second dose of moderna.

Other Meds: No.

Current Illness: No.

ID: 1056053
Sex: F
Age: 74
State: CT

Vax Date: 02/17/2021
Onset Date: 02/24/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: None so far.

Allergies: Amoxicillin (Hives) Doxycycline (Hives) Quinolone /Fluoroquinolone group of antibiotics (Tendonitis) Mild allergy to Aleve (Flushing) Intolerance of Statins

Symptoms: Began with intense itching at injection site on the evening of February 24th (one week after first vaccination). Quickly progressed to hard, hot, red, swollen and painful area over top of arm, continued itching, and stiffness. It has been difficult to raise my left arm above shoulder level. Somewhat better today (February 26th), but injection site still hot and hard, and stiffness in muscle still present. Itching has subsided.

Other Meds: Losartan 100mg tablet 1 by mouth daily One a Day Proactive 65+ Multivitamin/Multimineral Supplement Vitamin D+K 2000

Current Illness: Polymyalgia rheumatica (moderate recurrence)

ID: 1056055
Sex: M
Age: 68
State: HI

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

Lab Data:

Allergies:

Symptoms: Patient felt lightheaded immediately after vaccination. Escorted to the post-vaccination waiting area. Mild inspiratory and expiratory wheeze on auscultation of lung sounds. No acute distress. Offered Powerade drink, patient declined. Patient recovered by 10:40 and was released.

Other Meds:

Current Illness:

ID: 1056056
Sex: F
Age: 54
State:

Vax Date: 02/01/2021
Onset Date: 02/07/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies: Hay fever, thrush with penicillium

Symptoms: Vaccine on Sunday morning. Monday woke feeling unwell, as day progressed, severe chills and freezing cold with body aches. Felt so bad thought Covid had returned. Literally teeth chattering, had to have hot bath to feel warm. Felt the same on Tuesday. Wednesday chills subsided and started to feel better. My arm was sore and aches for a full week.

Other Meds: Insulin, metformin, simvastatin, fexofenadine, sertraline, omeprazole, hrt, ibuprofen and paracetamol

Current Illness: Covid pneumonitis, tested positive 5/1/21, in hospital on oxygen for 5 days from 9/1/21

ID: 1056057
Sex: M
Age: 71
State: MA

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Cr 0.9, lactate 3.1, CRP 29.6, Keppra level therapeutic, pCXR unremarkable

Allergies: amlodipine

Symptoms: Within 24 hours of vaccination, pt developed soreness in R arm (where vaccine was given), generalized weakness and difficulty ambulating, and became nonverbal. Presented to BMC ED with temp 102.5, HR 119, BP 112/62, 97% RA.

Other Meds: acetaminophen, atorvastatin, clopidogrel, empagliflozin, levetiracetam, lisinopril, metformin, thiamine, trospium

Current Illness: COVID diagnosed 1/20/2021 (had mild symptoms)

ID: 1056058
Sex: U
Age: 27
State:

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever Nausea/Vomiting Cough Congestion Chest Pain Headache Vaccine #1 22JAN2021 Vaccine #2 19FEB2021

Other Meds:

Current Illness:

ID: 1056060
Sex: F
Age: 41
State: NJ

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

Lab Data:

Allergies: None

Symptoms: Fever 103 F, muscle aches, headache

Other Meds: None

Current Illness: Herpes sore on upper lip

ID: 1056061
Sex: M
Age: 70
State: CA

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: 2/24 - Consult with urgent care doctor ; consult with geriatric doctor 2/25 - PCP orders blood tests 2/26 - Will undergo 2 radiology studies today

Allergies: Penicillin

Symptoms: 2nd day - chills, fatigue numbness 3rd > 6th days - increasing numbness ... left face, left finger, left foot 4th & 5th days - stumbling on left side, all symptoms serious enough for me to get doctor consults (3 doctors)

Other Meds: Lisinopril

Current Illness: None

ID: 1056062
Sex: M
Age: 67
State:

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

Lab Data:

Allergies: none

Symptoms: Hive-type rash around the injection area. Not necessarily at the injection point but around a circle, centered at the injection point, about 2" - 3" away..

Other Meds: none

Current Illness: none

ID: 1056171
Sex: U
Age: 2
State: TX

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-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; Sender's Comments: US-009507513-2102USA004059:

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1056172
Sex: U
Age: 4
State: TX

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-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; Sender's Comments: US-009507513-2102USA004059:

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1056173
Sex: U
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: No additional adverse events; Expired dose of PNEUMOV AX-23 was inadvertently administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age. and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 16-FEB-2021, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, injected once, lot # S012246 with expiration date 10-FEB-2021, for prophylaxis (strength was not reported). No additional adverse events were reported. The product had never had a temperature excursion.

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1056174
Sex: F
Age:
State: WA

Vax Date: 01/29/2020
Onset Date: 02/04/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Not able to take her last dose on day 7; Spontaneous report received on 04FEB2020. A pharmacist reported that a female consumer was "not able to take her last dose on day 7" (PT: Product dose omission) while being on Vivotif for immunisation. The consumer took her first, second and third dose of Vivotif on 29JAN2020, 31JAN2020 and 02FEB2020 respectively. She was unable to take her last dose on 04FEB2020; instead, she would be able to take the last dose on 05FEB2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer was not able to her last Vivotif dose on day 7 (missed dose) as per the schedule. The consumer would be able to take her last dose on day 8. Vivotif doses should be taken on every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer was not able to her last Vivotif dose on day 7 (missed dose) as per the schedule. The consumer would be able to take her last dose on day 8. Vivotif doses should be taken on every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1056175
Sex: F
Age:
State: WA

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

Lab Data:

Allergies:

Symptoms: experienced a sore arm; redness at the injection site which resolved; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to Shingrix. Additional details were provided as follow: The age at vaccination was not reported. The patient reported that after 1st dose of Shingrix, on an unknown date, she experienced a sore arm and redness at the injection site which was resolved. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2021015599.; Sender's Comments: US-GLAXOSMITHKLINE-US2021015599:Same patent 2nd dose, same reporter

Other Meds:

Current Illness:

ID: 1056176
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: ARM PAIN; This case was reported by a consumer and described the occurrence of pain in extremity in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was not recovered/not resolved. It was unknown if the reporter considered the pain in extremity to be related to Shingrix. Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient asked if it was ok to take aspirin to help with arm pain from the Shingrix vaccine.

Other Meds:

Current Illness:

ID: 1056177
Sex: F
Age: 32
State: NY

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Name: Quad Screen; Result Unstructured Data: Quad screen (levels of alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), estriol and inhibin A in pregnant women's blood.; Test Name: Ultrasound; Result Unstructured Data: Normal

Allergies:

Symptoms: Bells palsy; Pregnancy; A spontaneous report was received from a physician, who was also a 32-year-old female patient who received Moderna's COVID-19 vaccine (mRNA- 1273) during pregnancy and the patient has been diagnosed with Bell's palsy after delivery. The patient's medical history included exercise induced asthma. Products known to have been used by the patient, within two weeks prior to the event, included ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide and omeprazole. On 23 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) for the prophylaxis of COVID-19 infection. On 20 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029L20A) for the prophylaxis of COVID-19 infection. On an unknown date, an ultrasound and quad screen (levels of alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), estriol and inhibin A in pregnant women's blood) were performed, and the results were normal. There were no complications during the pregnancy. On 01 Feb 2021, the patient delivered the baby. No other delivery or infant details were reported. On 10 Feb 2021, the patient was diagnosed with Bell's palsy. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the reported event, Bell's Palsy, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; OMEPRAZOLE

Current Illness:

ID: 1056178
Sex: F
Age: 16
State: TX

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: feeling cold; achy; feverish; they gave vaccine to my 16 year old daughter; A spontaneous report was received from a consumer concerning her daughter, a 16-year-old female patient that received the vaccine/product delivered to a patient of inappropriate age and experienced feeling cold, feverish/pyrexia and achy/pain. The patient's medical history was not provided. Concomitant medications were not provided. On 09 Jan 2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unreported) in the left arm for the prophylaxis of COVID-19 infection. On 09 Jan 2021, the patient experienced feeling cold, feverish and achy. Treatment for these events was not provided. Caregiver inquiring as to what to do about second dose. Caregiver REFUSED permission to contact and DOES NOT want the Centers for Disease Control notified. Action taken with mRNA-1273 was not reported. The outcome of the event, received the vaccine/product delivered to a patient of inappropriate age was considered resolved. The events, experienced feeling cold, feverish/pyrexia and achy/pain, was unknown.; Reporter's Comments: This report refers to a case of Product administration error ? Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with associated events of feeling cold, Pain ,Pyrexia .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: 1056179
Sex: M
Age: 17
State: CA

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Gave a 17 year old the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No concomitant medications were reported. On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, a health care professional gave a 17-year-old the Moderna COVID-19 vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, gave a 17-year-old the vaccine/product administrated to patient of inappropriate age, was considered resolved on 10 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number not provided) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1056180
Sex: U
Age:
State: MI

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

Lab Data:

Allergies:

Symptoms: Out of specification product administered; A spontaneous report was received from a physician concerning a "couple" of patients of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273), who reported the event of "Out of specification product administered"/MedDRA PT: expired vaccine used. The patients' medical histories were not provided. Concomitant medication use was not provided. On an unspecified date, a "couple of patients received a dose (unknown which dose) of two planned doses of mRNA-1273 ([LOT number, route and location unknown]) for prophylaxis of COVID-19 infection. A physician reported that "a couple of patients received their dose at 7 hours". Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The event of "Out of specification product administered" was considered recovered/resolved (date unspecified).; Reporter's Comments: This report refers to a case of Out of specification product administered for mRNA-1273, lot # unknown with no associated AEs.

Other Meds:

Current Illness:

ID: 1056181
Sex: F
Age: 17
State: IL

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: HCP administered the vaccine to a patient under the age of 18; A spontaneous report from USA was received from reporter concerning a under 18 year old female who received Moderna's COVID-19 vaccine (mRNA-1273) by a Health Care Profession. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 January 2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the unknown anatomical location for prophylaxis of COVID-19 infection. There are no recorded events of symptoms experienced by the patient. Laboratory details are unknown. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the given event is unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (under 18 year old female) for mRNA-1273 (lot number 013L20A) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1056182
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: 16 Year old patient inadvertently received vaccine; A spontaneous report was received from a pharmacist concerning a 16 year old patient who was administered a COVID vaccine at an inappropriate age. The pharmacist is concerned about 2nd dose recommendations. The patient's medical history was not provided. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on a date not provided intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, with no associated AEs.

Other Meds:

Current Illness:

ID: 1056183
Sex: F
Age:
State: CA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 20210119; Test Name: heart rate; Result Unstructured Data: 130-140

Allergies:

Symptoms: Severe allergic reactions; Tachychardia; Hypertensive; Blood pressure shut down; Dizzy; Weak; A spontaneous report was received from a consumer concerning a 46 year old, female patient who experienced severe allergic reactions, hypertension, blood pressure shut down, dizzy, weak and tachycardia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 19-JAN-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19-Jan-2021, the patient had tachychardia 130-140, was dizzy and weak, bp shut off. The patient said she was also hypertensive. Treatment for the event included IV fluids, nitroglycerin, aspirin and Benadryl. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event(s) was not reported.; Reporter's Comments: This case concerns a 46-year-old female hospitalized with serious unexpected events of severe allergic reaction, tachycardia, hypertension, dizziness, asthenia and blood pressure shut down. The events occurred the same day as the first dose of mRNA-1273. Treatment included IVF, nitroglycerin, aspirin and Benadryl. Based on 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: 1056184
Sex: M
Age:
State:

Vax Date: 02/06/2021
Onset Date: 02/09/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Swelling in the upper lip (angioedema); A Spontaneous report received from a non-health care professional concerning a unknown year of age male patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced angioedema. The patient had already known food and drug allergies. No relevant concomitant medications were reported. On 06 Feb 2021 prior to onset of events the patient received second of two planned doses of COVID-19 (mRNA-1273) vaccine, for prophylaxis of COVID-19 infection. On 09 Feb 2021 patient experienced swelling in upper lip (angioedema). He was in the hospital for a few hours and then discharged. The lip swelling has since subsided. Treatment information was not provided. Action taken in response to mRNA-1273 vaccine events the patient was not applicable. The outcome of event was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's history of known food and drug allergies remains confounding factor.

Other Meds:

Current Illness:

ID: 1056185
Sex: F
Age:
State: FL

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Next day lost hearing in left ear and getting worse; Feels pressure and ringing in her ear.; Feels pressure and ringing in her ear./ ringing was worsening; Next day lost hearing in left ear and getting worse; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL3246) at single dose at right arm on 03Feb2021 16:30 for covid-19 immunisation, because of her age and she had asthma and to protect her elderly and sick parents. Medical history included ongoing ongoing asthma all of her life, ongoing tinnitus 10 years approximately, allergies to everything, environmental allergies, medication, food allergies, contact allergies, ongoing fibromyalgia a decade, ongoing gastrooesophageal reflux disease (GERD) 10-15 years. Family history: father had bladder cancer and going through bowel resection surgery, mother was immunocompromised with polymyalgia rheumatica. Concomitant medication included gabapentin (GABAPENTIN) 200 mg, 1x/day at bedtime) for Fibromyalgia, famotidine (PEPCID) OTC dose in morning and night FOR GERD. After vaccination, towards 04Feb2021 evening, she started losing hearing in her left ear. That was late afternoon. It started with some pressure, and some loss of hearing. By 05Feb2021 it got worse. So she gave herself Sudafed because she was thinking it was normal allergies. By 06Feb2021, it wasn't better. The Sudafed did not seem to help. She went to the Urgent care on 06Feb2021, who told her to go to ENT. She has an ENT appointment on 09Feb2021. The Urgent care prescribed her a short dose of prednisone by mouth 10mg twice a day. She has looked, and not find loss of hearing as a side effect. She hasn't called the doctor yet. The hearing loss has persisted or worsened. It is not constant all day long, but it is there all day long. As of on 09Feb2021, it was pretty bad. On 04Feb2021 she was also experiencing ear ringing. It was a high pitched ring in the same ear. She had tinnitus in both ears, but it was usually low. This one since the pressure started building in her ear, the ringing was louder and bigger. The ringing was worsening. The outcome of events was not recovered.

Other Meds: GABAPENTIN; PEPCID [FAMOTIDINE]

Current Illness: Asthma (all of her life); Fibromyalgia (a decade); GERD (10-15 years); Tinnitus (10 years approximately)

ID: 1056186
Sex: F
Age:
State: MA

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

Lab Data: Test Date: 202102; Test Name: urine test; Result Unstructured Data: Test Result:unknown result

Allergies:

Symptoms: delirium; fell in the night/fallen; extreme fatigue; memory loss/memory problem prior to getting the vaccine, however, now it was worse; memory loss/memory problem prior to getting the vaccine, however, now it was worse; This is a spontaneous report from contactable other healthcare professionals. An 87-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EN5318), via an unspecified route of administration in the left arm on 01Feb2021 14:00 at a single dose for covid-19 immunization. Medical history included blood pressure abnormal, glaucoma, thyroid problems, mild cognitive impairment and memory problem. Concomitant medication included amlodipine, atorvastatin and carvedilol for blood pressure, donepezil for mild cognitive impairment, ezetimibe, levothyroxine for thyroid problems and ongoing latanoprost for glaucoma. The patient previously received first dose of bnt162b2 (lot number: EL3246) on 11Jan2021 for covid-19 immunization. On an unspecified date in Feb2021, the patient had fallen, did not hit her head, but she has extreme fatigue, memory loss (she has seen some improvement now) unable to be by herself now and take her medications. The patient had a mild case of memory loss and had delirium. The reporter cannot say these events occurred from the vaccine of course. However, the work up that has been done has been negative and reporter was worried. It was reported that the patient had a little memory problem prior to getting the vaccine, however, now it was worse. It was like the patient cannot be alone now. The patient did not have a stroke. However, this like sent the patient over a cliff. This is a life changing event. If patient gets better it's all good, but if she does not they are in big trouble. Patient was previously able to care for self and now she was not able too. Patient underwent lab test (unknown result) in Feb2021. Patient was taken to Urgent Care, was seen by a physician and basic blood work was done and a urine test was done (unknown result). The outcome of event delirium was recovering; all other events was unknown. Information on Lot/Batch has been requested.

Other Meds: AMLODIPINE; ATORVASTATIN; CARVEDILOL; DONEPEZIL; EZETIMIBE; LEVOTHYROXINE; LATANOPROST

Current Illness:

ID: 1056187
Sex: M
Age:
State: NJ

Vax Date: 01/05/2021
Onset Date: 01/07/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Name: heart monitoring; Result Unstructured Data: Test Result:unknown result; Test Name: Echocardiogram; Result Unstructured Data: Test Result:unknown result; Test Name: EKG; Result Unstructured Data: Test Result:unknown result

Allergies:

Symptoms: heart dysrhythmia; period of palpitations; This is a spontaneous report from a contactable nurse (reporting for himself). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number: EL3246, expiry date unknown), via an unspecified route of administration in the right arm on 05Jan2021, 10:30AM (at 46 years old), at single dose for COVID-19 immunization. The patient's medical history included high cholesterol (treated with statin medications) and seasonal allergies, both from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, ashwagandha, and ergocalciferol (VIT D). At 46 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number and expiry date unknown), via an unspecified route of administration in the left arm on 15Dec2020, 10:00AM at single dose for COVID-19 immunization. The patient has not received other vaccine in four weeks prior to vaccination. Patient did not have COVID prior to vaccination and has not tested for COVID after vaccination. In the morning of 07Jan2021 (approximately 9 am), the patient experienced a period of palpitations, and heart dysrhythmia lasting for approximately 1 hour. The episode resolved on its own and has not returned. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events; patient had echocardiogram, EKG, and 7 days heart monitoring from an unspecified date. The patient recovered from "heart dysrhythmia" on 07Jan2021, 10:00AM, and recovered from a period of palpitations an unspecified date. Information on lot/batch number (first dose) has been requested.; Sender's Comments: Based on the available information, a causal relationship between event heart dysrhythmia and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ATORVASTATIN; ASHWAGANDHA; VIT D

Current Illness:

ID: 1056188
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: I couldn't re stand; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history included multiple sclerosis (MS). The patient's concomitant medications were not reported. The patient stated she has MS and have both of her Pfizer vaccine doses. She called her doctor and he said it was ok to get the vaccine, even though it had only been 48 days since her IV Immunotherapy. Then the next day his office sent a letter stating to wait 60 days after IV immunotherapy. On an unspecified date, after the first dose, she sat and she couldn't re stand with her Multiple sclerosis. She had to call to help to her with her my wheelchair. She called her HCP and he said to take acetaminophen (TYLENOL) 4x/day and it would get better and it did get better. The dose was similar reaction per caller and she stated she has reported this information to the Pfizer safety dept. The patient stated, she was not even sure it was the vaccine that caused inability to stand for a few hours, with M.S. it could just flare up on it's own. Outcome of the event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1056189
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: neutropenia after first dose; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient developed neutropenia after first dose on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported neutropenia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1056190
Sex: F
Age:
State:

Vax Date: 01/24/2021
Onset Date: 02/05/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210205; Test Name: Blood pressure; Result Unstructured Data: Test Result:High

Allergies:

Symptoms: Bell's palsy; chest pains; high blood pressure; This is a spontaneous report from a contactable consumer (patient). A female consumer of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 05Feb2021, the patient had bad chest pains (she was not sure if she was having a heart attack, as reported), high blood pressure, and Bell's palsy. She was scheduled to have her second dose on 14Feb2021. On unknown date, blood pressure resulted high. The outcome of the events. Information on the LOT/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1056191
Sex: M
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: dehydration; diarrhea; chills; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 as a single dose for COVID-19 immunization. Medical history included Type2 Diabetes and hypertension. The patient's concomitant medications were not reported. On 20Jan2021, one hour after he received the first dose, he experienced chills and went to sleep. Hours later he started to experience diarrhea. The chills lasted for 3 days and the diarrhea lasted for 6 days. He tried taking loperamide hydrochloride (IMODIUM) and bismuth subsalicylate (PEPTO-BISMOL) to treat the diarrhea but it did not work. He went to the hospital and was admitted for dehydration on 25Jan2021. The patient reported that his primary care physician was not convinced that it was caused by the vaccine. He was to receive the second dose of the vaccine today but was wanting to know if that was ok based on his side effects. The clinical outcome of the event dehydration was unknown; chills was recovered on 23Jan2021; and diarrhea was recovered on an unknown date in Jan2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1056192
Sex: M
Age:
State: VA

Vax Date: 02/02/2021
Onset Date: 02/07/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Left side of face started to droop; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received their second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported), via an unspecified route of administration on the left arm on 02Feb2021 14:25 at 0.3 mL, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported) via an unspecified route of administration on the left arm on 14Jan2021 at 0.3 mL, single for COVID-19 immunization. The patient reported that when at work on Sunday 07Feb2021, the left side of his face started to droop at 23:00. No treatment was received for the event. The patient did not recover from the event.

Other Meds:

Current Illness:

ID: 1056193
Sex: F
Age:
State: NC

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210213; Test Name: BP; Result Unstructured Data: Test Result:121/75; Test Date: 20210213; Test Name: BP; Result Unstructured Data: Test Result:145/85

Allergies:

Symptoms: fainted twice while visiting the bathroom; BP was 145/85; arm was sore; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot_number m000007217771.CSN20 447277212), via an unspecified route of administration in left arm on 11Feb2021 16:45 at single dose for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included hypertension, blood cholesterol increased, anxiety, allergies, allergies to penicillin, Sulfa drugs and Crustacea. The patient previously took tetracycline and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Concomitant medication included olmesartan medoxomil (unknown manufacturer), diltiazem hydrochloride (unknown manufacturer) and sertraline hydrochloride (SERT). On 12Feb2021 her arm was sore but she was not really feeling anything more. On 13Feb2021 morning at 04:45 the patient fainted twice while visiting the bathroom. Upon checking of the BP it was 121/75. Later in the day the BP was 145/85. The patient was completely normal before the shot. It seems that the vaccine affected my BP. The outcome of the events was recovered in Feb2021. No treatment was performed. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.

Other Meds: OLMESARTAN MEDOXOMIL; DILTIAZEM HYDROCHLORIDE; SERT

Current Illness:

ID: 1056194
Sex: M
Age:
State: MN

Vax Date: 01/06/2021
Onset Date: 01/13/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 20210121; Test Name: Blood test; Test Result: Negative ; Test Date: 20210215; Test Name: Blood test; Test Result: Negative ; Test Name: INR; Result Unstructured Data: Test Result:in the range of 2.5-3.5; Test Date: 20210106; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: ventricular fibrillation; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for himself. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231) , intramuscular in right arm on 06Jan2021 at 08:15 (at 39 years) at single dose for COVID-19 immunization. Medical history included mechanical tricuspid valve (as reported) from 2008 and had surgery in 2008 for a tricuspid valve replacement, had a pacemaker, had known allergies to penicillin and contrast dye and unknown blood clotting disorder (as reported, always in therapeutic International normalised ratio (INR) range). Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), lisinopril and warfarin sodium (JANTOVEN). On 13Jan2021 at 09:45 the patient experienced ventricular fibrillation, serious as life threatening illness (immediate risk of death from the event) and due to hospitalization. Event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care . Nasal Swab on 06Jan2021 was negative. Blood tests done on 21Jan2021 and on 15Feb2021 were both negative. Clinical course was described as follows: Patient had an unknown blood clotting disorder. INR was always in the range of 2.5-3.5 and he took acetylsalicylic acid (BABY ASPIRIN) 3x/week. His heart was 100% paced via a pacemaker. He had surgery in 2008 for a tricuspid valve replacement. A week after he received the first dose of the vaccine, he had ventricular fibrillation that required 25 min of cardiopulmonary resuscitation (CPR) and 6 shocks via defibrillator. He was in the hospital to have a pacemaker replacement and replaced with a new pacemaker/ICD combo. Prolonged time in hospital related to significant trauma to heart, lungs, and liver from prolonged CPR and collapsed lung after initial procedure. Patient was hospitalized for 13 days. Final outcome of the event was not recovering.; Sender's Comments: Event ventricular fibrillation is more likely related to underlying heart disease and unrelated to BNT162B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: BABY ASPIRIN; LISINOPRIL; JANTOVEN

Current Illness:

ID: 1056195
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Extremely severe flu symptoms; terrible testing cough in his chest; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extremely severe flu symptoms, terrible testing cough in his chest, had to go to the emergency room (ER) on an unspecified date with outcome of unknown. The adverse event resulted in ER/ department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), hospitalization duration was 2 days. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.

Other Meds:

Current Illness:

Date Died: 01/19/2021

ID: 1056196
Sex: M
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/15/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; This is a spontaneous report from contactable pharmacist via Pfizer Sales Representative. A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Patient had a long history of congenital heart issues. He had been stable and closely monitored for the past 20 years. He had no history of arrhythmia. The patient's concomitant medications were not reported. Patient collapsed due to a cardiac arrest on Friday 15Jan2021 and passed away on 19Jan2021. The doctors feel that his cardiac arrest was caused by an arrhythmia. Reporter reported this through the v safe app. And received a message stating reporter would be contacted by the cdc. After patient passed away reporter replied stop to v safe. But still had not been contacted by anyone. This may or may not be related. Reporter have no way of knowing. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "collapsed due to a cardiac arrest", "cardiac arrest was caused by an arrhythmia" and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The patient's pre-existing long history of congenital heart issues might have provided alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan

Other Meds:

Current Illness:

ID: 1056197
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: General achiness all over and soreness in her arm after receiving the vaccine; General achiness all over and soreness in her arm after receiving the vaccine; This spontaneous case was received on 08-Feb-2021 from other non-health professional via Med Communications (reference number: SEQW21-00439) and concerned a female patient of unspecified age. At the time of initial reporting the patient was in her 70s. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, route of administration, indication and anatomical location: not reported). The batch number was not reported. On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced general achiness all over and soreness in her arm after receiving the vaccine. The outcome of the events was not reported. The reporter did not provide a causality assessment. The case was assessed as non-serious. The case is linked to the case 202101374 (the same patient). Company comment: A female patient of unspecified age was administered influenza virus vaccine polyvalent. On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced general achiness all over and soreness in her arm. Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding temporal relationship.; Sender's Comments: A female patient of unspecified age was administered influenza virus vaccine polyvalent. On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced general achiness all over and soreness in her arm. Causal role of the suspect vaccine is unassessable for both events, due to lack of information regarding temporal relationship.

Other Meds:

Current Illness:

ID: 1056198
Sex: M
Age:
State:

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

Lab Data: Test Name: Magnetic resonance angiography (MRA); Result Unstructured Data: MRA of the head and neck with and without IV contrast were unremarkable.; Test Name: Blood pressure; Result Unstructured Data: 112/67.; Test Name: Computed tomography (CT); Result Unstructured Data: CT of the head without contrast were unremarkable.; Test Name: Cerebrospinal fluid analysis; Result Unstructured Data: Normal.; Test Name: Complete blood count; Result Unstructured Data: Unremarkable.; Test Name: Hemoglobin a1c (HbA1c); Result Unstructured Data: Unremarkable.; Test Name: Lipid panel; Result Unstructured Data: Unremarkable.; Test Name: Magnetic resonance imaging (MRI); Result Unstructured Data: MRI of the brain with and without intravenous (IV) contrast were unremarkable.; Test Name: Comprehensive metabolic panel; Result Unstructured Data: Unremarkable.; Test Name: Cranial nerve exams/neurological and other system examinations; Result Unstructured Data: No abnormality was detected in other cranial nerve exams. Neurological and other system examinations were normal.; Test Name: Ophthalmic exam; Result Unstructured Data: Showed a dilated pupil in the right eye, mild ptosis, and diplopia with reduced adduction, elevation, and depression of the right eye but abduction and intorsion were fine.; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Unremarkable.

Allergies:

Symptoms: Transient oculomotor palsy; This literature case was received on 15-Feb-2021 and concerned a 23-year-old, male patient. The patient's concurrent condition included inflammatory bowel disease ulcerative colitis. The patient had no medical history of diabetes mellitus, hypertension, glucose intolerance, systemic vasculitis, hyperlipidaemia, smoking, or obesity. The patient had no significant family history of neurological disorders. The patient's concomitant medication included sulfasalazine for ulcerative colitis. On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand name not specified; route of administration, anatomical location, dose, indication: not reported). The batch number reported was not reported. On the same day, immediately after receiving influenza virus vaccine polyvalent, the patient experienced blurry vision. On an unspecified date, five days after receiving influenza virus vaccine polyvalent vaccine, the patient presented to the hospital with a complaint of blurry vision. He denied smoking cigarettes, drinking alcohol, using intravenous drugs and was sexually active with one female partner only. On a general physical exam, his blood pressure revealed 122/67. The ophthalmic exam revealed a dilated pupil in the right eye, mild ptosis, and diplopia with reduced adduction, elevation, and depression of the right eye but abduction and intorsion were fine. No abnormality was detected in other cranial nerve exams. Neurological and other system examinations revealed normal. On blood work, the complete blood count, comprehensive metabolic panel, erythrocyte sedimentation rate, lipid panel, and haemoglobin a1c (HbA1c) revealed unremarkable. Imaging of the brain that included computed tomography (CT) of the head without contrast, magnetic resonance imaging (MRI) of the brain with and without intravenous (IV) contrast, and magnetic resonance angiography (MRA) of the head and neck with and without IV contrast revealed unremarkable. The cerebrospinal fluid analysis was normal. The patient was diagnosed with transient oculomotor nerve palsy and was treated conservatively with lubricating eye drops. On an unspecified date, the patient recovered from the event since his symptoms resolved in two weeks. The reporters assessed the event as related to influenza virus vaccine polyvalent vaccine. Most of the possible causes of oculomotor nerve palsy, such as stroke, intracranial space occupying lesions, aneurysms, and infections, were ruled out by history, physical exam, blood work, and imaging studies, thus leading to the influenza vaccine as the most likely cause. The fact that this happened immediately after an influenza vaccination made this a plausible cause, and the rapid improvement of the symptoms in patient supported the rationale of demyelination for the pathogenesis of transient nerve palsy. The event of 'oculomotor nerve paralysis' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. Company Comment: A 23-year-old male patient developed IIIrd nerve paralysis on the same day after vaccination with the suspect product influenza virus vaccine polyvalent. The patient had no significant medical history. Comprehensive laboratory findings were unremarkable. Investigations included imaging of the brain with computed tomography (CT) and magnetic resonance imaging (with and without intravenous (IV) contrast), and magnetic resonance angiography (MRA) of the head and neck with and without IV contrast. All results were unremarkable. Based on lack of alternative aetiology and due to plausible time relationship, causality for the reported event is assessed as possibly related.; Reporter's Comments: The fact that this happened immediately after an influenza vaccination made this a plausible cause, and the rapid improvement of the symptoms in patient supported the rationale of demyelination for the pathogenesis of transient nerve palsy.; Sender's Comments: A 23-year-old male patient developed IIIrd nerve paralysis on the same day after vaccination with the suspect product influenza virus vaccine polyvalent. The patient had no significant medical history. Comprehensive laboratory findings were unremarkable. Investigations included imaging of the brain with computed tomography (CT) and magnetic resonance imaging (with and without intravenous (IV) contrast), and magnetic resonance angiography (MRA) of the head and neck with and without IV contrast. All results were unremarkable. Based on lack of alternative aetiology and due to plausible time relationship, causality for the reported event is assessed as possibly related.

Other Meds: SULFASALAZINE

Current Illness: Ulcerative colitis

ID: 1056315
Sex: M
Age: 67
State: KY

Vax Date: 02/12/2021
Onset Date: 02/23/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Itchy red round rash about the size of a tennis ball. Hard and warm to the touch

Other Meds: Metformin/carvediol/simvastatin/pioglitazone

Current Illness: None

ID: 1056316
Sex: F
Age: 25
State: NJ

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies: N/a

Symptoms: 2/25 after 10 hours I woke up with a lot of soreness at injection site and 99.3 body temperature; 3:30 99.6 temperature, chills, achy arm; 4:47 100.5 temp; 2/26 5:00 AM: chills, 100.0 temp, nausea.

Other Meds: Flonase, junel birth control pill

Current Illness: N/a

ID: 1056317
Sex: F
Age: 73
State: SC

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: None to date

Allergies: None

Symptoms: Increasing site soreness, increasing muscle soreness which is increasing in area involved, increasing warmth in muscle area, intermittent nausea, low grade fever (up to 100.9 F).

Other Meds: Shot given in upper arm, and became warm at site within a few hours. Muscle discomfort has been steadily increasing since, and low grade fever this evening 100.1 F and is relieved with tylenol. Tylenol was not taken until the next day and

Current Illness: On continual dosage of Niaspan, Losartin, Crestor and Salsalate (for many years) for hypertension and psoriatic an degenerative arthritis. No reactions to above meds.

ID: 1056318
Sex: M
Age: 77
State: OH

Vax Date: 02/22/2021
Onset Date: 02/24/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: None.

Allergies: Contrast dye

Symptoms: On 2/24/21 woke up around 10 AM due to the need to urinate. He was rigid (straight as a board) and unable to sit up in bed and barely able to move. After about 30 minutes he was able to sit up, stand and walk with a walker and assistance. generally has difficulty walking, but the concern was the rigidity and inability to bend for such a long period of time. After that he seems to be the same as he was prior to the vaccine. Also, on 2/22/21 shortly after getting his vaccine he had a tremor in his hand (not sure which one) which stopped shortly after getting the vaccine.

Other Meds: Carbodopa/Levodopa 150 mg, Finasteride 5 mg, Atorvastatin 20 mg, D3 25 mc, Docusate Sodium 100 mg, Viactiv 650 mg Vitamin C 250 mg MiraLAX 0.25 cap full 0.25 cap full every day , Myrbetriq 25 mg, Remeron 15 mg, Melatonin 5 mg See dosage o

Current Illness:

ID: 1056319
Sex: F
Age: 43
State:

Vax Date: 02/12/2021
Onset Date: 02/22/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Lung xrays, blood work, COVID 19 tests

Allergies: Sensitivity to penicillin

Symptoms: Extreme fatigue, chills, sensory nerve cold shooting sensation in upper chest, back, upper arms; tingling in face, numbness around mouth/lips; low grade fever, dizziness/nausea: Given prednisone and antibiotics for prior infection that presented 4 days after vaccination with continous, worsening cough (bronchitis), albuterol; following onset of extreme fatigue, change in appetite, chills, etc..., 4 days of worst symptoms, just beginning to improve slightly 2/26/21; given anti-nausea meds, IV fluids in ER, several days of continuous rest and sleep, and prayer; not fully recovered yet

Other Meds: zyrtec

Current Illness: Undiagnosed bronchitis

ID: 1056321
Sex: F
Age: 51
State: MI

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Haven?t gone yet

Allergies: Dilaudid

Symptoms: Red tiny bumps all over my body

Other Meds: Adderall XR Cymbalta

Current Illness: None

ID: 1056322
Sex: F
Age: 59
State: SC

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies: Morphine Codeine IVP dye Gentamycin

Symptoms: Fever, chills, vomiting, nausea on day #3 of not being able to work.

Other Meds: Avapro,trintellix, telismartin, wellbutrin, zetia, Actos, metformin, gemfibrozil, lantus, bydureon, omperzole, synthroid, metatoprol,

Current Illness:

ID: 1056323
Sex: F
Age: 64
State: MO

Vax Date: 02/24/2021
Onset Date: 02/25/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Normal arm soreness, very achy, tiredness

Other Meds: Meloxicam 7.5 my per day as needed Atorvastatin Calcium 10 mg per day Vitamin/mineral supplement

Current Illness: None

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm