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: 1056741
Sex: F
Age: 68
State: NY

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

Lab Data:

Allergies: Penicillin

Symptoms: Covid arm

Other Meds: Omeprazole,clonidin,metrolpole,warfarin,gabapentin,flrxeril

Current Illness:

ID: 1056742
Sex: F
Age: 92
State: FL

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

Lab Data:

Allergies:

Symptoms: Error: Wrong Dose of Vaccine - Too Low

Other Meds:

Current Illness:

ID: 1056743
Sex: F
Age: 84
State: FL

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

Lab Data:

Allergies:

Symptoms: Error: Wrong Dose of Vaccine - Too Low

Other Meds:

Current Illness:

ID: 1056744
Sex: M
Age: 53
State: TX

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

Lab Data: No, just temperature.

Allergies: No.

Symptoms: Sore, achy headache , Unable to sleep at all and during the whent shivers to sweating thru my clothes. My temperatue. in the night was 101.6. Coordianation and balance are affeced the following morning as is my spatial awareness of whereI am in a room relative to a counter or chair. Sligj cognitive impact with spelling and typeing and forming thoughts which is taking a lot longer and my typin is slower by a third or more.

Other Meds: Copaxone 40 ml injectable Sanctura XR 60 mg Provigil 100 mg

Current Illness: No.

ID: 1056745
Sex: F
Age: 60
State: NY

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

Lab Data: None

Allergies: Sulfa, Penicillin, allergy to fragrance

Symptoms: Itchiness and Rash: Multiple body areas: between and under breasts, lower back area, under arms. It was also on my left arm around the injection site but that has gone away. Date of 1st dose: 1/8/2021 - ELO140 Date of 2nd dose: 1/29/2021 - EJ1686

Other Meds: Multi-vitamin, Vitamin D, Probiotic

Current Illness: None

ID: 1056746
Sex: F
Age: 76
State: FL

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

Lab Data:

Allergies:

Symptoms: Error: Wrong Dose of Vaccine - Too Low

Other Meds:

Current Illness:

ID: 1056747
Sex: F
Age: 34
State: OH

Vax Date: 02/18/2021
Onset Date: 02/20/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies: Blackberries

Symptoms: Approximately 36 hours after second dose- patient went into late preterm labor of 36w6d. Infant was born weighing 6lbs 3.8oz on 2/21/21. Due date was 3/14/21.

Other Meds: Omeprazole Prenatal vitamins

Current Illness: Shingles

ID: 1056748
Sex: F
Age: 55
State: IN

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

Lab Data: None

Allergies: None known

Symptoms: I was miserable . Was hard to walk from my bed to toilet. 20 feet. Couldn't eat. Felt like my eyes were exploding. Threw up. Muscles and joint pain 8/10. Weak. Could not sleep night of injection

Other Meds: Metoprolol Mvi Folic acid Colace Omega 3 Zinc Vit d3

Current Illness: None

ID: 1056749
Sex: F
Age: 94
State: FL

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Error: Wrong Dose of Vaccine - Too Low

Other Meds:

Current Illness:

ID: 1056750
Sex: F
Age: 93
State: FL

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

Lab Data:

Allergies:

Symptoms: Error: Wrong Dose of Vaccine - Too Low

Other Meds:

Current Illness:

ID: 1056751
Sex: F
Age: 69
State: WI

Vax Date: 02/19/2021
Onset Date: 02/22/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: received dose on 2-19 Friday. Saturday had body aches and 101.7 fever. Felt better Sunday. Rash at injection site started Monday March 22 and is still there today Friday March 26. It is red and itchy. Its size is comparable to a dollar bill.

Other Meds: Eliquis, Metoprolol, Hydrochlorothiazide, Simvastatin, Montelukast

Current Illness: none

ID: 1056752
Sex: F
Age: 35
State: RI

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

Lab Data:

Allergies: penecillin

Symptoms: red raised rash around injection site, swollen, itchy, hot to the touch, accompanied by headache

Other Meds: IUD

Current Illness: none

ID: 1056753
Sex: M
Age: 70
State: FL

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

Lab Data:

Allergies:

Symptoms: Error: Wrong Dose of Vaccine - Too Low

Other Meds:

Current Illness:

ID: 1056760
Sex: F
Age:
State: IL

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

Lab Data:

Allergies:

Symptoms: cut the HCP's middle finger; the rim (plastic collar) broke off / BROKEN FINGER FLANGE; This spontaneous report was received from a female nurse of unknown age referring to herself. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reaction or allergy were not reported. On 29-JAN-2021, the patient was administering a dose of hepatitis a vaccine, inactivated (VAQTA) (25U/0.5ML, lot # T020442, Expiration Date: 26-JAN-2022, 0.5 milliliter, route and indication was not reported) in a prefilled syringe this am to her patient. While the patient was just finishing administration, as the plunger was pushed fully into the syringe hub, the finger flange fell off, cutting her middle finger (unknown depth of injury, just stated cut) before it fell to the ground. The patient was able to maintain the hub of the syringe and plunger and withdraw it out of the patient without injury to her patient or affecting the administration. The full dose of hepatitis a vaccine, inactivated (VAQTA) was injected without a problem. The broken syringe would be obtained and the finger flange that broke off would not be returned as it was thrown in the sharp's container. The patient had a small cut to her middle finger that did not need any attention other than to be cleansed and bandaged. The outcome of finger injury was not recovered. The causality assessment was not provided. This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020442; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA002696:

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1056761
Sex: U
Age:
State: MD

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

Lab Data:

Allergies:

Symptoms: No additional AEs; patient received PROQUAD by intramuscular route, instead of subcutaneously; This spontaneous report was received from a nurse referring to a 4 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 15-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (0.5 ml, strength was not reported, lot #T027116 has been verified as valid, expiration date was 07-FEB-2022) intramuscularly instead of subcutaneously for prophylaxis (subcutaneous injection formulation administered by other route) with 5/8 inch needle. No additional adverse events were reported. The outcome of the events was unknown.

Other Meds:

Current Illness: Prophylaxis

ID: 1056762
Sex: U
Age:
State: KS

Vax Date: 11/02/2015
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: multiple outbreaks of herpes zoster; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and unknown gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 02-NOV-2015 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination), the patient suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As the result of vaccine live(ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of herpes zoster and postherpetic neuralgia was considered as not recovered. The reporter considered the events to be disabled and related to Zoster Vaccine Live(ZOSTAVAX).

Other Meds:

Current Illness:

ID: 1056763
Sex: U
Age:
State: VA

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

Lab Data:

Allergies:

Symptoms: No other AE's reported; temperature excursion/Varivax administered to a patient during a temperature excursion .; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 15-FEB-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength and route of administration were not reported, lot # T021821, expiration date was 25-JUN-2022) 0.5 milliliter for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to a temperature of minus 7.4 degree Celsius for a time frame of 3 hours and 54 minutes, as recorded by the digital data logger. There were no previous temperature excursions. No further adverse event (AE) information was provided. This is one of the several reports reported by the same reporter.; Sender's Comments: US-009507513-2102USA008793:

Other Meds:

Current Illness:

ID: 1056764
Sex: M
Age:
State: SC

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

Lab Data:

Allergies:

Symptoms: no additional AE; the physician administered an expired dose of PNEUMOVAX 23 to the patient; This spontaneous report was received from a physician and refers to a 64-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-FEB-2021, the physician vaccinated the patient with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) expiration date reported as December 2020 (exact dose, route of administration, anatomical location and lot # were not provided) for prophylaxis. The reporter stated that according to his knowledge, the administered vaccine did not experience a prior temperature excursion. No adverse event (AE) was reported.

Other Meds:

Current Illness:

ID: 1056765
Sex: F
Age: 70
State: OK

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: tiny scabby spot on part of the rash / entire rash has been scabby; rash on abdomen approx 3/4 inch wide, 3 inches long, about 3 inches above navel; This case was reported by a consumer and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number FY5H2, expiry date unknown) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 22nd December 2020, the patient received the 2nd dose of Shingrix. On 23rd December 2020, 1 days after receiving Shingrix, the patient experienced rash. On 27th December 2020, the patient experienced scab. On an unknown date, the outcome of the rash and scab were not recovered/not resolved. It was unknown if the reporter considered the rash and scab to be related to Shingrix. Additional details were provided as follows: The patient reported for herself. The patient received 1st dose of Shingrix on 8th October 2020 and had no adverse reaction. After 2nd dose patient had a rash on abdomen approximately 3/4 inch wide, 3 inches long, about 3 inches above navel. Rash was smooth as rest of skin, no itching or pain. The patient had a tiny scabby spot on part of the rash. Ever since 28th December 2020, the entire rash had been scabby. Still had no itching or pain. The patient was concerned that this might affect her ability to obtain the Covid vaccine. The reporter wanted to know if this kind of adverse reaction to the Shingrix vaccine was something she should be concerned about when she would be able to get the Covid vaccine. The patient was in the high risk group, due to age and underlying medical conditions.

Other Meds: Shingrix

Current Illness:

ID: 1056766
Sex: U
Age:
State:

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Soreness / Pain; Swelling; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were not recovered/not resolved. It was unknown if the reporter considered the pain and swelling to be related to Shingrix. Additional details were provided as follows: The patient reported for herself/himself. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced side effects of soreness, swelling and pain. The patient asked what could be done to calm this reaction.

Other Meds:

Current Illness:

ID: 1056767
Sex: F
Age: 69
State: GA

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210101; Test Name: Body temperature; Result Unstructured Data: (Test Result:99.9,Unit:degree F,Normal Low:,Normal High:)

Allergies:

Symptoms: headache; fever; fatigue; This case was reported by a consumer and described the occurrence of headache in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on an unknown date and patient experienced fatigue, fever and headache refer case US2021000494). On 31st December 2020, the patient received the 2nd dose of Shingrix. On 1st January 2021, 1 days after receiving Shingrix, the patient experienced headache, fever and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, fever and fatigue were not recovered/not resolved. It was unknown if the reporter considered the headache, fever and fatigue to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient herself. The patient received dose 2nd of Shingrix and reported that she experienced fatigue, headache, and fever of 99.9 degree Fahrenheit. The patient also reported that the events from the 2nd dose were more severe after the 2nd dose than the 1st. The reporter did not consent to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021000494:same patient, 1st dose

Other Meds:

Current Illness:

ID: 1056768
Sex: F
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: Redness / at the injection site; Swelling / at the injection site; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included covid-19 (had COVID in September 2020). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported but it could be 63 or 64 years. The patient received the first dose in either October or November of 2020. The patient had redness, swelling and pain at the injection site. For tolerence with 2nd dose refer case US2021005929. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021005929:Same reporter

Other Meds:

Current Illness:

ID: 1056769
Sex: F
Age:
State: NJ

Vax Date: 10/01/2020
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: genital herpes infection / major flare up 2 days post vaccination; genital herpes infection / major flare up 2 days post vaccination; This case was reported by a physician and described the occurrence of genital herpes in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included genital herpes. In October 2020, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced genital herpes and condition aggravated. On an unknown date, the outcome of the genital herpes and condition aggravated were unknown. It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Shingrix. Additional details were provided as follows: The patient was over 50 years of age. The patient was immunized at physician's recommendation with Shingrix in late October 2020. The patient had previously been diagnosed with genital herpes infection, and had major flare up 2 days post vaccination. The reporter did not consent to follow up.

Other Meds:

Current Illness: Genital herpes

ID: 1056770
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Both shots hurt; face was hot all the time; Major body aches; mixed with a sudden sense I might vomit right then and there; when the vaccine was pushed in, it was a different kind of pain; This case was reported by a consumer and described the occurrence of injection site pain in a 50-year-old male 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 a year after receiving Shingrix, the patient experienced injection site pain, feeling hot, general body pain, nausea and injection site pain. On an unknown date, the outcome of the injection site pain, feeling hot, general body pain, nausea and injection site pain were unknown. It was unknown if the reporter considered the injection site pain, feeling hot, general body pain, nausea and injection site pain to be related to Shingrix. Additional details were provided as follows: The patient received the 1st shots of Shingrix and it hurt Around 36 hours after 1st dose, the patient was afflicted with major body aches and face was hot all the time. When the needle actually punctured to flesh, yowza then, when the vaccine was pushed in, it was a different kind of pain, mixed with a sudden sense that the patient might vomit right then and there. For tolerance in 2nd dose refer case US2021AMR015447.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR015452:same reporter

Other Meds:

Current Illness:

ID: 1056771
Sex: M
Age:
State:

Vax Date: 01/12/2021
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Both shots hurt / needle actually punctured my flesh, yowza. And, then, when the vaccine was pushed in, it was a different kind of pain; face was hot all the time; major body aches; sense I might vomit; upper arm hurt for days, again, more than after any other shot I've gotten; fever; This case was reported by a consumer and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date refer case US2021AMR015401). On 12th January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, feeling hot, general body pain, nausea, pain in arm and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the feeling hot, general body pain, nausea and fever were unknown. The reporter considered the injection site pain, feeling hot, general body pain, nausea, pain in arm and fever to be possibly related to Shingrix. Additional details were provided as follows: The patient received the 2nd shot of Shingrix and it hurt. When the needle actually punctured his flesh and the vaccine was pushed in, it was a different kind of pain, mixed with a sudden sense of vomit right then and there. Afterward, his upper arm hurt for days, again, more than after any other shot the patient have gotten in his life. Around 36 hours after 2nd dose, the patient was afflicted with major body aches and his face was hot all the time.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR015452:same reporter

Other Meds:

Current Illness:

ID: 1056772
Sex: U
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: shivering; This case was reported by a consumer via interactive digital media and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th January 2021, the patient received the 2nd dose of Shingrix. On 21st January 2021, 1 days after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved. It was unknown if the reporter considered the shivering to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingles shot on Wednesday and since Thursday been experiencing shivering episodes at least 2 a day. The reporter asked was that normal.

Other Meds:

Current Illness:

ID: 1056773
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: pain, redness, and swelling at the injection site; pain, redness, and swelling at the injection site; swelling at the injection site; fever; muscle pain,; tiredness; upset stomach; GI problem is the worst; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old patient who received Herpes zoster (shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, tiredness, upset stomach and gastrointestinal disorder to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient had most common side effects after vaccination. The patient experinced pain, redness, and swelling at the injection site, muscle pain, tiredness, fever, and upset stomach. According to patient gastrointestinal problem was worst but also had other events.

Other Meds:

Current Illness:

ID: 1056774
Sex: U
Age:
State:

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

Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: (Test Result:100.0,Unit:degree F,Normal Low:,Normal High:)

Allergies:

Symptoms: fever of 100.0; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. In January 2021, the patient received the 2nd dose of Shingrix. In January 2021, 28 hrs after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the vaccine 28 hours ago from date of reporting and ran into a fever of 100 degree F. The patient took some Tylenol.

Other Meds:

Current Illness:

ID: 1056775
Sex: U
Age:
State: NE

Vax Date: 10/01/2020
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arms at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (mild case of shingles experienced in 2008). In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had sore arms at the injection site. The patient commented that patient was glad to receive the dose. For tolerance of 2nd dose, refer case US2021AMR025883. This case has been linked with US2021AMR025887 and US2021AMR025893, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR025887:same reporter US-GLAXOSMITHKLINE-US2021AMR025893:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same patient, same reporter, 1st dose

Other Meds:

Current Illness:

ID: 1056776
Sex: U
Age:
State: NE

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

Lab Data:

Allergies:

Symptoms: sore arms at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (mild case of shingles in 2008). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October 2020, refer case US2021AMR025865). In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had sore arms at the injection site. The patient commented that patient was glad to receive the dose. This case has been linked with US2021AMR025887 and US2021AMR025893, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR025887:same reporter US-GLAXOSMITHKLINE-US2021AMR025893:same reporter US-GLAXOSMITHKLINE-US2021AMR025865:same patient, same reporter, 1st dose

Other Meds:

Current Illness:

ID: 1056777
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: arm is red and swollen at the injection site; arm is red and swollen at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 2nd February 2021, the patient received Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix. Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient's arm was red and swollen at the injection site. The patient asked if an ice pack can be put on arm to help the swelling go down.

Other Meds:

Current Illness:

ID: 1056778
Sex: F
Age:
State: AZ

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

Lab Data:

Allergies:

Symptoms: sore arm; pain / at injection site; swelling at injection site; shivering; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female 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 arm, injection site pain, injection site swelling, shivering and fatigue. On an unknown date, the outcome of the pain in arm, injection site pain, injection site swelling, shivering and fatigue were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site pain, injection site swelling, shivering and fatigue to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix recently and at the time of reporting the patient experienced sore arm, pain and swelling at injection site, shivering, and fatigue. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1056779
Sex: F
Age:
State: IN

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

Lab Data:

Allergies:

Symptoms: Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female 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 diarrhea. On an unknown date, the outcome of the diarrhea was unknown. It was unknown if the reporter considered the diarrhea to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter was mother-in-law of patient. The patient experienced diarrhea after receiving what they believe was the Shingrix vaccine. The reporter did not consent to followup. This case linked with US2021005930 and US2021005937, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021005930:Same reporter US-GLAXOSMITHKLINE-US2021005937:Same reporter

Other Meds:

Current Illness:

ID: 1056780
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 2nd October 2020). On 7th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, 12 hrs after receiving Shingrix, the patient experienced vomiting and diarrhea. On an unknown date, the outcome of the vomiting and diarrhea were recovered/resolved. It was unknown if the reporter considered the vomiting and diarrhea to be related to Shingrix. Additional information was provided as follows: The case was reported by member of public (patient). The age at vaccination was not reported. The patient experienced gastrointestinal symptoms (diarrhea and vomiting) The symptoms during night. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1056781
Sex: F
Age: 80
State: TX

Vax Date: 11/06/2020
Onset Date: 12/01/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 202012; Test Name: covid-19; Result Unstructured Data: (Test Result:diagnosed with COVID-19,Unit:unknown,Normal Low:,Normal High:)

Allergies:

Symptoms: First dose on 06-Nov-2020 / diagnosed with COVID-19 later December; This case was reported by a pharmacist via and described the occurrence of covid-19 in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 6th November 2020, the patient received the 1st dose of Shingrix. In December 2020, less than 2 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with monoclonal antibody (nos) (Monoclonal Antibodies). On an unknown date, the outcome of the covid-19 was unknown. It was unknown if the reporter considered the covid-19 to be related to Shingrix. Additional details were reported as follows: The patient received 1st dose of Shingrix and in later December 2020, the patient was diagnosed with COVID-19, which was treated with monoclonal antibodies. There was no other problem with 1st dose. The pharmacist wanted to know that could this patient receive the 2nd dose of Shingrix. No further information provided. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 1056782
Sex: F
Age:
State: WI

Vax Date: 10/22/2020
Onset Date: 10/23/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: injection site / redness; pain in the injection site; injection site, swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 22nd October 2020, the patient received the 1st dose of Shingrix. On 23rd October 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site swelling. On 26th October 2020, the outcome of the injection site erythema, injection site pain and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose in left arm and the day after she had pain in the injection site, swelling and redness that lasted for 3 days. The vaccines lot number and expiration date was not provided. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 1056783
Sex: F
Age: 76
State: NY

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Feeling hot, with no temperature / events have not resolved; Sniffles and runny nose / events have not resolved; Stomach discomfort / events have not resolved; Experienced chills and shivering; This case was reported by a consumer via call center representative and described the occurrence of chills in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 28th December 2020, the patient received the 2nd dose of Shingrix. On 28th December 2020, 12 hrs after receiving Shingrix, the patient experienced chills. On 13th January 2021, the patient experienced feeling hot, sniffles and stomach discomfort. On 29th December 2020, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the feeling hot, sniffles and stomach discomfort were not recovered/not resolved. It was unknown if the reporter considered the chills, feeling hot, sniffles and stomach discomfort to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient stated that there were no events after 1st dose. The patient received the 2nd dose and about 12 hours after the patient experienced chills and shivering, which resolved on the next day. The patient reported that 2 weeks later, she began to experience feeling hot, with no temperature. The patient reported sniffles and runny nose. The patient also experienced stomach discomfort. These events were not resolved. The reporter did not consent to followup.

Other Meds: Shingrix

Current Illness:

ID: 1056784
Sex: M
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: erythema on upper half of injected extremity (left arm).; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved. It was unknown if the reporter considered the erythema of extremities to be related to Shingrix. Additional details were provided as follows: The patient who was a radiologist reported the case for himself. The age at vaccination was not reported but could be 53 or 54 years. Lot and expiry date were not provided. The patient developed erythema on the upper half of the injected extremity (left arm). The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1056785
Sex: F
Age: 64
State: NJ

Vax Date: 07/01/2018
Onset Date:
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: First dose July 2018 and never received her second dose; Severe hives from her neck to her waist; This case was reported by a consumer and described the occurrence of hives in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hives and incomplete course of vaccination. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the hives was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the hives to be related to Shingrix. Additional details were provided as follows: The patient reported for herself. The patient received the 1st dose of Shingrix on right arm. The patient experienced severe hives from her neck to her waist that lasted about a week. The patient did not receive the 2nd dose till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1056786
Sex: F
Age: 61
State: FL

Vax Date: 11/20/2020
Onset Date: 11/01/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Right arm / have been hurting severely; Shoulder have been hurting severely; She is unable to sleep on it (right arm); This case was reported by a consumer and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, immediately after receiving Shingrix, the patient experienced pain in arm, shoulder pain and difficulty sleeping. On an unknown date, the outcome of the pain in arm, shoulder pain and difficulty sleeping were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, shoulder pain and difficulty sleeping to be related to Shingrix. Additional details were reported as follows: This case was reported by patient herself. The patient stated that since receiving the vaccine, her right arm and shoulder had been hurting severely, to the point that she was unable to sleep on it. The reporter consented to follow-up.

Other Meds:

Current Illness:

ID: 1056787
Sex: F
Age: 61
State: FL

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

Lab Data:

Allergies:

Symptoms: Liquid began leaking down arm; Liquid leaked down arm; Shot was given in top layer of skin; A spontaneous report was received from a consumer, concerning a 61-years-old, female patient who was administered Moderna's COVID-19 vaccine and reported that Liquid began leaking down arm (Vaccination site discharge), Liquid leaked down arm (Underdose) and Shot was given in top layer of skin (Incorrect route of product administration). The patient's medical history included asthma. Concomitant medications were not provided. On 10-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection. Patient reported that the shot did not feel intramuscular, patient thinks the shot was given in the top layer of skin. After patient received the dose immediately liquid began leaking down her arm, which the patient believes was the Moderna Dose that should have gone in her arm. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, Liquid began leaking down arm, Liquid leaked down arm and Shot was given in top layer of skin was considered as resolved; Reporter's Comments: This report refers to a case of vaccination site discharge, underdose, and incorrect route of product administration for mRNA-1273 (lot # unknown), with no associated AEs.

Other Meds:

Current Illness: Asthma

ID: 1056788
Sex: F
Age: 32
State: NC

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

Lab Data:

Allergies:

Symptoms: A lot of leakage as dose was being administered/ dripped up to her fingers; Syringe was cracked; A spontaneous report was received from a consumer, concerning 32-year-old of old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and where a lot of leakage as dose was being administered/ dripped up to her fingers as syringe was cracked. The patient medical history was not reported. Concomitant medication was not reported. On an unspecified date, prior to onset of events the patient received first of two planned doses of vaccine (batch: unknown) for prophylaxis of COVID-19 infection. On17-Feb-2021, the patient received second of two planned doses of vaccine (batch no unknown) for prophylaxis of COVID-19 infection. On 17-Feb-2021 the patient experienced a lot of leakage happened in second dose. It dripped up to her fingers as syringe was cracked. Treatment taken information was not reported. Action taken in to (mRNA-1273) COVID-19 in response to events were not reported. The outcome of events a lot of leakage as dose was being administered/ dripped up to her fingers as syringe was cracked were considered resolved on 170-Feb-2021.; Reporter's Comments: This report refers to a case of Product administration error - Incorrect dose administered and Syringe issue for mRNA-1273, lot # unknown, with no associated AEs.

Other Meds:

Current Illness:

ID: 1056789
Sex: F
Age: 17
State: MN

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 17 years old and was mistakenly given the Moderna vaccine; A spontaneous report was received from a consumer, concerning a 17 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced product administered to patient of inappropriate age. The patient's medical history was not provided. No concomitant medications were reported. On 28 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown), in left non-dominant arm for prophylaxis of COVID-19 infection Caregiver said that daughter got the vaccine at her workplace and now they refusing to give her the second dose because she is under 18 years old. The workplace had the second dose on 25Jan2021. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, product administered to patient of inappropriate age, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old female who experienced nonserious unexpected event of Product administered to patient of inappropriate age for mRNA-1273 (lot # unknown) without associated adverse events. The event occurred the same day as the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056790
Sex: M
Age: 16
State: NC

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

Lab Data:

Allergies:

Symptoms: 16 Year old boy accidentally got Moderna shot; A spontaneous report was received from consumer, concerning her son, a 16 years old male patient who accidentally received Moderna's covid-19 vaccine (mRNA-1273). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Feb 2021, the patient received first of two planned doses of mRNA-1273 (lot no:024M20A) intramuscularly for prophylaxis of covid-19 infection. On 22 Feb 2021, a 16-year-old boy accidentally got Moderna vaccine shot. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event 16-Year-old boy accidentally got Moderna shot was considered recovered on 22 Feb 2021.; Reporter's Comments: This report refers to a case of a 16-year old male patient who accidentally received Moderna's covid-19 vaccine (mRNA-1273) lot # 024M20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1056791
Sex: M
Age: 33
State: CA

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

Lab Data:

Allergies:

Symptoms: Vaccination card says use the vaccine by 2/18/2021; A spontaneous report was received from a consumer concerning a 33-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and vaccination card says use the vaccine by 18 Feb 2021. No relevant concomitant medications were reported. On 19 Feb 2021, approximately 1 day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (007M20A) intramuscularly for prophylaxis of COVID-19 infection. Vaccination card says use the vaccine by 18 Feb 2021 (expired vaccine used). No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event vaccination card says use the vaccine by 18 Feb 2021 was considered resolved.; Reporter's Comments: This report refers to a case of Expired product administered for mRNA-1273 (lot # 007M20A), with no associated AEs.

Other Meds:

Current Illness:

ID: 1056792
Sex: F
Age: 94
State: OH

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

Lab Data:

Allergies:

Symptoms: nausea; takes an anticoagulant; A spontaneous report was received from a consumer concerning a 94-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea and contraindicated product administered. The patient's medical history was not provided. Concomitant medications included warfarin. On 24-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot unknown) in the right arm for prophylaxis of COVID-19 infection. On 25-Jan-2021, the patient experienced nausea. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, nausea, was unknown. The outcome of the event, contraindicated product administered, was considered recovered/resolved.; Reporter's Comments: This case concerns a 94-year old female patient who received mRNA-1273 and experienced non-serious event nausea and contraindicated product administered. Based on the current available information and temporal association between the use of the product and the start date of nausea, a causal relationship cannot be excluded. The event contraindicated product administered is assessed as not applicable.

Other Meds: WARFARIN

Current Illness:

ID: 1056793
Sex: F
Age: 77
State: MA

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

Lab Data: Test Name: body temeperature; Result Unstructured Data: 92. 1 degrees Fahrenheit

Allergies:

Symptoms: patient had hypothermia, with a temperature of 92.1 degrees Fahrenheit; trouble in breathing; she was freezing inside out; immediately got sick; Based on information previously received, the following information [Event hypothermia upgraded to serious from non-serious (Medically significant as per important medical event (IME) list)] has been amended. Initial information received on 15-Feb-2021 regarding an unsolicited valid serious case from non-healthcare professional. This case involves a 78 years elderly female patient who got immediately sick (illness), hypothermia, with a temperature of 92. 1 degrees Fahrenheit (hypothermia), trouble in breathing (dyspnoea) and was freezing inside (feeling cold), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date in December 2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed hypothermia, with a temperature of 92. 1 degrees fahrenheit (hypothermia) (serious event), immediately got sick (illness) (on the same day), trouble in breathing (dyspnoea) and was freezing inside (feeling cold) (non-serious events) (exact latency unknown), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Hypothermia was assessed as medically significant. Other relevant laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome is unknown for the reported events.; Sender's Comments: This case involves a 78 years elderly female patient who had hypothermia, illness, dyspnoea and feeling cold after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible. However, concomitant medication, family history, patient's medical condition at the time of vaccination and other relevant laboratory tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1056794
Sex: F
Age: 70
State: FL

Vax Date: 02/12/2021
Onset Date: 02/20/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: none

Allergies: penicillin cephalosporins biaxin robaxin prednisone

Symptoms: Eight days after receiving the Moderna vaccine, I developed a rash on my left arm, and it remained for 6 days. It encircled the arm, was hot to the touch, and tender at the injection site. The rash grew from a circular (approx 1.5 inch diameter) rash at first, to a band approximately 2-2.5 inches wide, encircling the arm.

Other Meds: aspirin 81 mg rosuvastatin 40 mg metoprolol 50 mg hydrochlorothiazide 12.5 mg ibuprofen 325 mg

Current Illness: total knee replacement January 6, 2021

ID: 1056795
Sex: F
Age: 76
State: TX

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

Lab Data:

Allergies:

Symptoms: Error: Wrong Dose of Vaccine - Too Low

Other Meds:

Current Illness:

ID: 1056796
Sex: F
Age: 82
State: NM

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Error: Wrong Dose of Vaccine - Too Low

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm