VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1380546
Sex: U
Age:
State: TX

Vax Date:
Onset Date: 05/03/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: no additional adverse events; Expired dose administered; This spontaneous report was received from an other health professional and refers to a 34-year-old patient. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided. On 03-MAY-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA), 0.5 milliliter, non-valid lot # T01590 with expiration date 14-APR-2021, for prophylaxis. There was no previous temperature excursions. There was no additional adverse events reported.

Other Meds:

Current Illness:

ID: 1380547
Sex: U
Age:
State: NM

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: No AE reported; The vaccine was administered 17 days after expiration; This report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On approximately 14-MAY-2021, also reported as 17 days after vaccine expiration, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot number R027946 with expiration date 27-APR-2021, 0.5 milliliter for prophylaxis (expired vaccine used). No product quality complaint or adverse effects were reported. At the reporting time, the patient's outcome was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1380548
Sex: F
Age: 69
State: MD

Vax Date: 05/24/2021
Onset Date: 05/24/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: No additonal adverse event or product quality concern reported/ No addittional adverse events were experienced by the patient; an expired dose of VAQTA was admnistered on 24-MAY-2021; This spontaneous report was received from a register nurse via a company representative and refers to a 69 year old female patient. The patient's pertinent medical history and drug reactions or allergies were unknown. There was no concomitant therapies. The nurse reported that on 24-MAY-2021, one of the medical assistants vaccinated the patient with of an expired dose of hepatitis a vaccine, inactivated (VAQTA) second dose, lot # T014590 expiration date 15-APR-2021 for prophylaxis (dosage, route of administration and anatomical location were not reported). No additional adverse event were experienced by the patient. No prescription drug treatment was required. The patient did not required emergency room (ER) doctor visit. The vaccine has not had a temperature excursion (TE). The vaccine was evaluated and found to be supported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1380549
Sex: U
Age:
State: OR

Vax Date: 05/24/2021
Onset Date: 05/24/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: No additional AE reported; an expired dose of PROQUAD was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On 24-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S030210 with an expiration date on 25-MAR-2021) for prophylaxis. Strength, dose, anatomical location, and route of administration were not reported. The suspect vaccine did not experience any prior temperature excursi?n. No additional adverse events had been reported.

Other Meds:

Current Illness:

ID: 1380550
Sex: U
Age:
State: MD

Vax Date: 05/24/2021
Onset Date: 05/24/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: no adverse event; Expired vaccine used; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 24-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) (lot # S015428, expiration date 20-MAY-2021) for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No further information provided. No additional adverse events reported. No product quality complaints.

Other Meds:

Current Illness:

ID: 1380551
Sex: U
Age:
State: TX

Vax Date: 05/25/2021
Onset Date: 05/25/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: no additional AE/no additional information; PROQUAD that underwent a temperature excursion had been administered to the patient; This spontaneous report has been received from a healthcare business professional referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported. On 25-MAY-2021, the patient was vaccinated with the improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) for prophylaxis (lot # T028298, expiration date 16-FEB-2022; strength, dose, and route were not reported), which underwent a temperature excursion at 6.96 Fahrenheit (F) for 15 min (product storage error). The temperature excursion was detected by a data logger. There was no previous temperature excursion. No additional adverse event or information was reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-2106USA001672:

Other Meds:

Current Illness:

ID: 1380552
Sex: M
Age: 56
State: CA

Vax Date: 03/01/2020
Onset Date: 03/01/2020
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: his throat feels "uncomfortable; he developed a sore throat that same day; first dose of GARDASIL 9 on an unspecified date in March 2020, his second dose on an unspecified date in June 2020, and his third dose on 11/3/2020.; received the GARDASIL 9 vaccine at the age of 57; This spontaneous report as received from a 57-year-old male patient who reported on himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in March 2020, at the age of 57, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) as Human papillomavirus (HPV) prevention (product administered to patient of inappropriate age). He received his second dose on an unspecified date in June 2020 and his third dose on 03-NOV-2020 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported for any of the doses); both as HPV prevention (inappropriate schedule of product administration). The patient additionally received the COVID-19 vaccine (SARS-COV-2 VACCINE); the first dose was received on an unspecified date in December 2020 and the second dose on an unspecified date in January 2021 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 22-MAY-2021, he engaged in intercourse with his girlfriend and he developed a sore throat that same day. The patient stated his throat felt "uncomfortable" and he wanted to receive a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unspecified date, he was tested for COVID-19 and the test results were negative. He wanted a "Merck Specialist" to call him back and tell him he can receive a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) GARDASIL 9. The outcome of the events was unknown. The causality assessment between the events and the suspect vaccines was not provided.

Other Meds:

Current Illness: Prophylaxis

ID: 1380553
Sex: U
Age:
State: OH

Vax Date: 05/26/2021
Onset Date: 05/26/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: No AE reported; expired dose of MMR II; This spontaneous report was received from the office manager referring to a 5-year-old patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported On 26-MAY-2021 , the patient was vaccinated with a expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S015427,expiry day 20-MAY-2021, 0.5 milliliter, intramuscular for prophylaxis; No other adverse event was reported.

Other Meds:

Current Illness:

ID: 1380554
Sex: U
Age: 1
State: NY

Vax Date: 05/24/2021
Onset Date: 05/20/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: no other adverse events; temperature excursion; This spontaneous report was received from a physician referring to a 11 month old patient of unspecified gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On 20-MAY-2021, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature excursion that lasted 84 hours, at a temperature of 43.7 degrees Fahrenheit (product storage error); no previous temperature excursions had occurred. On 24-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot number T037957, expiration date 09-MAY-2022, 1 dosage form (dose/frequency reported as "1 time dose") as prophylaxis (strength, route of administration and anatomical location were not provided). Digital data logger was involved. No signs, symptoms or adverse events were reported. The outcome of product storage error was unknown.

Other Meds:

Current Illness:

ID: 1380555
Sex: U
Age:
State:

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: No additional AE reported.; the vaccine expired on 15-APR-2021 and was administered to a patient on 21-MAY-2021; the vaccine had a temperature excursion on 07-APR2021 and was administered to a patient on 21-MAY-2021; This spontaneous report was received from a consumer referring to themselves, a patient of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 21-MAY-2021, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) lot # T014590, which has been verified to be a valid lot number, expiration date reported as 15-APR-2021 and upon internal validation established as the same (expired product administered) (dosage schedule, route and anatomical location were not reported) for prophylaxis. It was also reported that the vaccine had a temperature excursion on 07-APR-2021 (product storage error). There was no adverse effect reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds:

Current Illness:

ID: 1380556
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 05/27/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: no additional events; 1st dose of GARDASIL 9 series over one year and just returned for second dose; This spontaneous report as received from a pharmacist refers to a 24 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. In approximately 2020 (reported as about a year ago), the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series for prophylaxis. On 27-MAY-2021 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (Inappropriate schedule of vaccine administered). No product quality complaint or additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1380557
Sex: F
Age:
State:

Vax Date: 07/01/2016
Onset Date: 07/01/2016
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: No additional AE; Drug use for unapproved indication; This spontaneous report was received from an other reporter referring to a female patient of unknown age from an article found by the reporter's daughter who was a nurse. The patient's concomitant medication, pertinent medical history and drug allergies/reactions were unknown by reporter. The patient's concurrent conditions included check pain that occurred from the trigeminal neuralgia shocks. In July 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, frequency, lot# and expiration date were not provided) for trigeminal neuralgia shocks (product use in unapproved indication). The patient's check pain that occurred from the trigeminal neuralgia shocks had resolved within a week and had no pains. No additional adverse event was reported.

Other Meds:

Current Illness: Pain; Trigeminal neuralgia

ID: 1380558
Sex: U
Age:
State: VA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: A nurse reported PROQUAD was improperly stored and administered; This spontaneous report was received from a nurse referring to patient of an unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided. On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) (dosage regimen and route of administration were not provided), lot # T034823, expiration date 11-APR-2022, administered as prophylaxis. On that day, the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature of -5.3 degree Celsius (C) for 1 hours and 42 minutes, with no previous temperature excursion. The call because a digital data logger.

Other Meds:

Current Illness:

ID: 1380559
Sex: U
Age:
State: TX

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: No additional adverse events reported; nurse with credentials L.V.N. administered a dose of GARDASIL 9 that expired 5/30/2021; This spontaneous report as received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), dose reported as 1 dose, lot # R024259, expiration date: 30-MAY-2021 for prophylaxis (dose, and route of administration, were not reported) . It was reported that dose was properly stored.No additional adverse events reported. No product quality complaint.

Other Meds:

Current Illness:

ID: 1380560
Sex: F
Age: 1
State: TX

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: no further AEs occurred from the concomitant administration; they gave PROQUAD and VARICELLA together to a patient; This spontaneous report was received from a medical assistant referring to a 1-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided. On 28-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, one time, lot number T034613, expiraton date 10-APR-2021 (route of administration was not reported) for prophylaxis and varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, one time, lot number T031381, expiraton date 15-SEP-2022 (route of administration was not reported) for prophylaxis too (extra dose administered). Both vaccines were reconstitued with sterile diluent(STERILE DILUENT) 0.5 milliliters, lot number T020663 and U000171. No adverse event was reported.

Other Meds: STERILE DILUENT

Current Illness:

ID: 1380561
Sex: F
Age:
State: NC

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: pneumonia; arm swelled up; pocket fuid in her left arm; turned red; the injection, "the second" hurt a little more but not a big deal; This spontaneous report was received from a female patient via Pfizer (MFR# 2021616142) concerning herself. Patient stated she was not a healthcare professional, but was a caregiver to some older people. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unspecified date, she was administered with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot# and expiration date were not provided) for pneumonia prophylaxis and "ended up in the emergency room (ER) twice". the patient stated she states she had quite a reaction. On an unspecified date approximately in 2018 (reported as "2 or 3 years ago") (conflictive information), she went to a health conference center and it was set up so people were 6 feet apart and masked. She talked to the "same doctor before" and the second time. They told her which station she would go to. She talked to the nurse, told her the reactions she had had in the past and the nurse asked her if she was allergic to any of the items, she had no idea as she had no idea what was in the vaccine so the nurse explained what they usually are in and asked again, this time she answered she was not allergic. After a while talking the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). She stated the injection, "the second" hurt a little more but not a big deal (vaccination site pain). A couple months later, she went to the doctor because her chest was tight, she worked all week. She had a chest x-ray, and the doctor said she had "waking" pneumonia. She added that with the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) her arm swelled up (peripheral swelling) and she had a pocket of fluid in her left arm (oedema peripheral), it turned red (unspecified date). She went to the ER and they gave her unspecified medication. They sent her home and said if it gets worse, she had to come back. On "sunday morning", she got up and she did not believe it, it was worse than ever. She went back to the ER and said it was getting worse. She stated it was terrible. She stated she had it back right around 2017 or 2018 also, but she was not sure (conflictive information). She ended up telling the doctor she would never take that one again, never ever. The doctor said she would not have to. At the time of the report, the outcome of pneumonia and vaccination site pain was unknown. The causal relationship between the event and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided. Upon internal review, pneumonia was considered a medically significant event.

Other Meds:

Current Illness:

ID: 1380562
Sex: U
Age: 0
State: MI

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: No AE/ PQC reported at this time; Caller reported VAQTA (lot T033304 exp 4/2/2022) and ROTATEQ (lot 1741376 exp 3/6/2022) were administered to patients.; This spontaneous report was received from a healthcare professional, referring to a 4-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported. On 18-MAY-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number 1741376, expiration date 06-MAR-2022) as prophylaxis (product storage error). No adverse effect (AE)/product quality complaint (PQC) reported at this time. The vaccine experienced a temperature excursion between 36 degrees Fahrenheit (F) to 46F (48.2F) for 0 hours, 15 minutes and 0 seconds. There was a previous temperature excursion between 36F to 46F (46.2F) for 0 hours, 15 minutes and 0 seconds, as recorded by a data logger.

Other Meds:

Current Illness:

ID: 1380563
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 05/25/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: No AE/ PQC reported at this time.; VAQTA were administered with an imporperly temperature excursion; This spontaneous report was received from a health care professional referring to a 23 month old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAY-2021, the patient was vaccinated with an improperly stored temperature excursion dose of hepatitis a vaccine, inactivated(VAQTA) prefilled syringe, lot #: T033304 , expiration date:02-APR-2022 (dose, and route of administration, were not reported)., for prophylaxis . The administered dose of the vaccine experienced a temperature excursion 36 to 47 degrees Fahrenheit for 15 minutes, as recorded by a data logger. There was no adverse effect reported.No product quality complaint was involved. This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: VAQTA SYRINGE DEVICE

Current Illness:

ID: 1380564
Sex: M
Age:
State: MI

Vax Date: 05/27/2020
Onset Date: 10/06/2020
Rec V Date: 06/08/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: No PQC or additional AEs reported; 31 year old male patient received GARD ASIL 9 on following dates. # 5/27/2020 #2 7/17/2020 #3 10/6/2020. Dosing schedule not followed as in PI; This spontaneous report was received from an unspecified reporter referring to a 31-year-old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 27-MAY-2020, 17-JUL-2020 and 06-OCT-2020, the patient was vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration). One dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was reported as 0.5 ml, lot # 1659422, expiration date 04-SEP-2022. No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

Date Died:

ID: 1380565
Sex: M
Age:
State: IA

Vax Date:
Onset Date:
Rec V Date: 06/08/2021
Hospital: Y

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Acute hemorrhagic leukoencephalitis (AHLE); Information has been received from the authors of a published literature article, regarding a 14 year old male patient. The patient had no concurrent conditions, medical history as was reported to be a healthy boy. The concomitant therapies were not provided. On an unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, intramuscularly for prophylaxis. Three weeks after vaccination, the patient presented headache. Over the following 2 weeks, the patient's headache worsened, and he became increasingly fatigued. On the day of presentation (40 days post-vaccination), he developed left-sided weakness, urinary incontinence, and confusion, which prompted his family to bring him to a local emergency department. There, head computed tomography (CT) was normal and labs, including Complete blood count (CBC), complete metabolic panel, and urine toxicology screen, were unremarkable. He was then transferred to our tertiary hospital for further evaluation and management. Neurologic exam upon admission was notable for left sided extremity weakness, tremors of left extremities, and mild confusion. Brain magnetic resonance imaging (MRI) revealed diffuse hyperintensities on T2 and FLAIR sequences within the subcortical white matter, thalamus, and basal ganglia; also reported as neuroimaging findings. MRI scan of the brain revealed T1-weighted, T2 FLAIR, gradient echo sequence, and the images at the level of midbrain, basal ganglia and centrum semiovale. Bilateral asymmetric foci of increased T2-signals were demonstrated involving the thickened cortices, thalami, and globus pallidi but sparing the posterior fossa structures (not shown), brainstem or centrum semiovale. Gradient echo sequence images showed no hemorrhagic areas. The areas of T2-prolongation did not show diffusion restriction or contrast enhancement (not shown). Cerebrospinal fluid examination showed a lymphocytic pleocytosis with 56 WBC (reference range 0-5), 77% of which were lymphocytes, along with normal protein and glucose. Extensive serologic and nucleic acid amplification testing of his CSF for bacterial and viral pathogens was negative, as were blood cultures. CRP was normal. Given the combination of his clinical picture, neuroimaging, and laboratory results, the patient was diagnosed with acute disseminated encephalomyelitis (ADEM) and started on treatment with intravenous methylprednisolone, 1 gram daily. Despite this treatment, the patient's encephalopathy worsened, necessitating transfer to the Pediatric Intensive Care Unit (PICU) on the second day of hospitalization. Upon transfer to the PICU, the patient was non-verbal and only intermittently following commands. Exam at the time was notable for left sided facial weakness, increased tone in the left extremities, bilateral ankle clonus, and left patellar hyperreflexia. After an episode of bilateral shoulder twitching concerning for seizure, continuous video electroencephalogram monitoring was initiated and revealed severe multifocal disturbance of cerebral function, but no epileptiform activity. On the third day of hospitalization, the patient had a rapid deterioration in his neurologic exam and developed agonal breathing, emesis, tachycardia, and fixed and dilated pupils. Emergent non-contrast head CT showed severe cerebral edema with impending cerebral herniation, for which he was treated with hyperventilation, hypertonic saline and intravenous mannitol. An emergent right hemicraniectomy was performed. Post-operatively, 400 mg/kg of intravenous immunoglobulin (IVIG) daily was added as treatment for ADEM, but the patient had no neurologic recovery. Neurologic exam performed 3 days post-operatively was consistent with brain death. Following the patient's death, the family consented to autopsy. Neuropathologic examination revealed an acute vascular inflammatory process with fibrinoid vascular necrosis, marked macrophage infiltrates, parenchymal necrosis, numerous hemorrhages, and areas of myelin and axonal loss, and postmortem histology revealed perivenular sleeves of tissue damage, myelin loss surrounding small parenchymal vessels, and diffuse hemorrhagic necrosis; all consistent with acute hemorrhagic leukoencephalitis. The histopathologic findings from a biopsy specimen of the right parietal lobe showed: A section stained with ''H&E'' revealed that parenchymal vessels were surrounded by a marked mixed inflammatory infiltrate with fibrinoid necrosis and perivascular hemorrhage. A section stained with Luxol fast blue and ''H&E' revealed peri-vascular demyelination. A section immunohistochemically stained for CD68 antigen revealed a marked macrophage infiltrate. A section immunohistochemically stained for neurofilament revealed patchy axonal loss. Action taken was not applicable. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was a recombinant vaccine that included the major capsid (L1) protein of 9 HPV types in highly purified virus-like particles. Sequence homologies between astrocyte water channel aquaporin 4 and several of the HPV L1 capsid proteins have been identified,15 suggesting that molecular mimicry was a biologically plausible mechanism by which HPV vaccination could trigger demyelinating disease. Upon internal review the event of acute disseminated encephalomyelitis (ADEM) was considered medically significant. A copy of the published article is attached as further documentation of the patient's experience.; Reported Cause(s) of Death: ADEM; diffuse hemorrhagic necrosis; Autopsy-determined Cause(s) of Death: myelin loss surrounding small parenchymal vessels; perivenular sleeves of tissue damage

Other Meds:

Current Illness:

ID: 1380566
Sex: U
Age: 0
State: MI

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: No adverse event; Incorrect product storage; This spontaneous report was received from a health care professional referring to a 8-week-old patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported. On 11-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1741376, expiry date 06-MAR-2022 for prophylaxis (strength, dose, and frequency were not provided). Other vaccines improperly stored were hepatitis a vaccine, inactivated (VAQTA)lot number 1741376, expiry date 06-MAR-2022, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, strength, route of administration, lot number, indication and expiry date were not reported) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature frame between 36 and 46 Fahrenheit degrees for 15 minutes, recorded y a digital data logger (product storage error). No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1380567
Sex: F
Age:
State: OK

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: received the first dose 12 years ago; This spontaneous report as received from a physician refers to a 30 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. In approximately 2009 (reported as 12 years ago), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis. She did not complete the series (Inappropriate schedule of vaccine administered).

Other Meds:

Current Illness:

ID: 1380568
Sex: F
Age:
State: FL

Vax Date: 06/01/2016
Onset Date:
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: nerve damage; shingles; Information has been received from a lawyer and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. In or around June 2016, patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered shingles and nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, 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. As a direct and proximate result of company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The events were considered to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness: Routine health maintenance

ID: 1380569
Sex: U
Age: 1
State: MI

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: No adverse effects were reported; the patient was administered an improperly stored VAQTA vaccine / temperature: 32.1 degree Fahrenheit; This spontaneous report was received from a certified medical assistant and refers to a 21 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided. On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # T023914, expiration date 31-MAR-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 32.1 degree Fahrenheit (F) for 4 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No adverse event (AE) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023914; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: VAQTA SYRINGE

Current Illness:

ID: 1380570
Sex: F
Age:
State: IL

Vax Date: 02/20/2017
Onset Date:
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Interrupted vaccine schedule / The patient received her first dose of GARDASIL 9 on 20-FEB-2017 at the age of 17 years old and did not receive the second or third dose; No additional AE reported; This spontaneous report was received from a registered pharmacist and refers to a female patient, who was 21 years old at the time of the report. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided. On 20-FEB-2017, when she was 17 years old, the patient was vaccinated with her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. At the reporting time, she did not receive the second or third dose of the vaccine yet and the pharmacist was requesting information regarding interrupted vaccine schedules for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No adverse event (AE) was reported.

Other Meds:

Current Illness:

ID: 1380571
Sex: M
Age:
State: NC

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Choking; Loss of consciousness; Ageusia; Anosmia; Decreased appetite; Drooling; Feeling abnormal; Fatigue; Pyrexia; Chills; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CHOKING (Choking) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included High cholesterol. Concurrent medical conditions included Prostate cancer (Hormone shot taken 02-APR-2021 for prostate cancer) and Blood pressure high. Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CHOKING (Choking) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills). At the time of the report, CHOKING (Choking), LOSS OF CONSCIOUSNESS (Loss of consciousness), AGEUSIA (Ageusia), ANOSMIA (Anosmia), DECREASED APPETITE (Decreased appetite), DROOLING (Drooling), FEELING ABNORMAL (Feeling abnormal), FATIGUE (Fatigue), PYREXIA (Pyrexia) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were provided by the reporter Company comment: 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.; Sender'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: LISINOPRIL; ATORVASTATIN

Current Illness: Blood pressure high; Prostate cancer (Hormone shot taken 02-APR-2021 for prostate cancer)

ID: 1380572
Sex: F
Age:
State: CA

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Syncope; Unresponsive to stimuli; Asthenia; Confusional state; Diarrhoea; Dizziness; Hyperventilation; Hypotension; Injection site bruising; Lethargy; Headache; Pyrexia; Fatigue; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) and UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criterion medically significant), ASTHENIA (Asthenia), CONFUSIONAL STATE (Confusional state), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), HYPERVENTILATION (Hyperventilation), HYPOTENSION (Hypotension), INJECTION SITE BRUISING (Injection site bruising), LETHARGY (Lethargy), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue). At the time of the report, SYNCOPE (Syncope), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli), ASTHENIA (Asthenia), CONFUSIONAL STATE (Confusional state), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), HYPERVENTILATION (Hyperventilation), HYPOTENSION (Hypotension), INJECTION SITE BRUISING (Injection site bruising), LETHARGY (Lethargy), HEADACHE (Headache), PYREXIA (Pyrexia) and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient received vaccination at 10:45am and by 10:50am patient informed others she felt light headed. Nurse rushed to the patient with the Epi pen. They observed patient head tilted backward and unresponsive. The patient started to response and become confused. Nurse didn't administer the Epi Pen. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1380573
Sex: F
Age:
State: MA

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Anaphylactic reaction; Dysphagia; Orbital swelling; Swelling face; Swollen tongue; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B2121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), DYSPHAGIA (Dysphagia), ORBITAL SWELLING (Orbital swelling), SWELLING FACE (Swelling face) and SWOLLEN TONGUE (Swollen tongue). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), DYSPHAGIA (Dysphagia), ORBITAL SWELLING (Orbital swelling), SWELLING FACE (Swelling face) and SWOLLEN TONGUE (Swollen tongue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient stated that no treatment medication was taken.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1380574
Sex: M
Age:
State: FL

Vax Date: 03/15/2021
Onset Date: 03/22/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Granulomatosis with polyangiitis; Gait inability; Inflammation; Pain in extremity; Vasculitis; Arthralgia; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis with polyangiitis) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroid disorder NOS. Previously administered products included for an unreported indication: VACCINES (Shingles shot #2 and Fatigue for 1 week). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), CALCITRIOL, LEVOTHYROXINE (LEVOTHYROXIN 0.05 MG KSA), METOPROLOL SUCCINATE (METOPROLOL ACTAVIS [METOPROLOL SUCCINATE]), VITAMIN D3 and CETIRIZINE HYDROCHLORIDE (EQUATE ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis with polyangiitis) (seriousness criterion medically significant), GAIT INABILITY (Gait inability), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Pain in extremity). 22-Mar-2021, the patient experienced VASCULITIS (Vasculitis) and ARTHRALGIA (Arthralgia). At the time of the report, GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis with polyangiitis), GAIT INABILITY (Gait inability), INFLAMMATION (Inflammation), PAIN IN EXTREMITY (Pain in extremity), VASCULITIS (Vasculitis) and ARTHRALGIA (Arthralgia) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Blood test: inconclusive Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. metoprolo susccinate ER 25mg, Multi vitamin with iron, vascepra 1 GM two capsules twice daily was provided to the patient as concomitant drug. Blood test taken for gout indicated no gout. Wegener's disease was diagnosed The patient's past medical history included Heart, Vasculitus/Weginer's Disease, Thyroid disorder NOS. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The dates of 1st and 2nd doses of Moderna COVID-19 vaccine administration are inaccurately reported (same dates) in source document.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The dates of 1st and 2nd doses of Moderna COVID-19 vaccine administration are inaccurately reported (same dates) in source document.

Other Meds: ASPIRIN 81; CALCITRIOL; LEVOTHYROXIN 0.05 MG KSA; METOPROLOL ACTAVIS [METOPROLOL SUCCINATE]; VITAMIN D3; EQUATE ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1380575
Sex: M
Age:
State: AR

Vax Date: 03/03/2021
Onset Date: 03/05/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Extraocular muscle paresis; Facial pain; Vision blurred; Headache; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of EXTRAOCULAR MUSCLE PARESIS (Extraocular muscle paresis) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus, Hypertension, Hypertriglyceridemia and Hypothyroidism. Concomitant products included METFORMIN, TAMSULOSIN, ATORVASTATIN, PREGABALIN, LOSARTAN, LEVOTHYROXINE, TRAMADOL (AC TRAMADOL), CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD&COUGH) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced EXTRAOCULAR MUSCLE PARESIS (Extraocular muscle paresis) (seriousness criterion medically significant), FACIAL PAIN (Facial pain), VISION BLURRED (Vision blurred) and HEADACHE (Headache). At the time of the report, EXTRAOCULAR MUSCLE PARESIS (Extraocular muscle paresis), FACIAL PAIN (Facial pain), VISION BLURRED (Vision blurred) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Computerised tomogram normal: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: METFORMIN; TAMSULOSIN; ATORVASTATIN; PREGABALIN; LOSARTAN; LEVOTHYROXINE; AC TRAMADOL; TYLENOL COLD&COUGH; ASPIRIN 81

Current Illness: Diabetes mellitus; Hypertension; Hypertriglyceridemia; Hypothyroidism

ID: 1380576
Sex: F
Age:
State: GA

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Loss of consciousness; Fear of injection; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and FEAR OF INJECTION (Fear of injection). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness) and FEAR OF INJECTION (Fear of injection) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was ok during her vaccine. Only after I finished the shot she passed out. We called 911 to make sure she was o.k. even though she said not to call. It was unknown if the patient received any corrective treatment and concomitant medication. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1380577
Sex: F
Age:
State: TN

Vax Date: 04/07/2021
Onset Date: 04/09/2021
Rec V Date: 06/08/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Acute myocardial infarction; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health professional and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in April 2021 due to ACUTE MYOCARDIAL INFARCTION. At the time of the report, ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was hospitalized for approximately 3 days and was treated in the Cath lab. No concomitant medications was reported. No treatment details were provided Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1380578
Sex: M
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Vaccinated against flu three times / In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza)/Suspected vaccination failure; In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza); Really bad cold; High fever; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, cold and fever. On an unknown date, the outcome of the vaccination failure, influenza, cold and fever were unknown. It was unknown if the reporter considered the vaccination failure, influenza, cold and fever to be related to Flu vaccine. Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient got vaccinated against flu and in that year after that he had one really bad cold with a high fever and stated he could not tell if it was influenza. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming influenza were unknown at the time of reporting. The follow-up would not possible as no contact details were available. For tolerance of other 2 doses refer case US2021AMR118022 and US2021AMR118023, reported by same reporter. Note: As the patient was not sure for influenza, hence considering the worst case approach captured influenza along with vaccination failure as event.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR118022:Same reporter. US-GLAXOSMITHKLINE-US2021AMR118023:Same reporter.

Other Meds:

Current Illness:

ID: 1380579
Sex: M
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Vaccinated against flu three times / In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza)/ Suspected vaccination failure; In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza); Really bad cold; High fever; This case was reported by a consumer via media and described the occurrence of vaccination failure in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of vaccination failure (also experienced influenza and bad cold with a high fever after receiving on an unknown date, refer case US2021AMR117937). On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, cold and fever. Rechallenge with Flu vaccine was positive. On an unknown date, the outcome of the vaccination failure, influenza, cold and fever were unknown. It was unknown if the reporter considered the vaccination failure, influenza, cold and fever to be related to Flu vaccine. Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient got vaccinated against flu and in that year after that he had one really bad cold with a high fever and stated he could not tell if it was influenza. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming influenza were unknown at the time of reporting. The follow-up would not possible as no contact details were available. For tolerance of last dose refer case US2021AMR118023. This case is one of 3 cases, reported by the same reporter. Note: As the patient was not sure for influenza, hence considering the worst case approach captured influenza along with vaccination failure as event.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR117937:Same reporter. US-GLAXOSMITHKLINE-US2021AMR118023:Same reporter.

Other Meds:

Current Illness:

ID: 1380580
Sex: M
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Vaccinated against flu three times / In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza)/Suspected vaccination failure; In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza); Really bad cold; High fever; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of vaccination failure (also experienced influenza and bad cold with a high fever after receiving on an unknown date, refer case US2021AMR117937) and Flu vaccine with an associated reaction of vaccination failure (also experienced influenza and bad cold with a high fever after receiving on an unknown date, refer case US2021AMR118022). On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, cold and fever. Rechallenge with Flu vaccine was positive. On an unknown date, the outcome of the vaccination failure, influenza, cold and fever were unknown. It was unknown if the reporter considered the vaccination failure, influenza, cold and fever to be related to Flu vaccine. Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient got vaccinated against flu and in that year after that he had one really bad cold with a high fever and stated he could not tell if it was influenza. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming influenza were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case is one of 3 cases, reported by the same reporter. Note: As the patient was not sure for influenza, hence considering the worst case approach captured influenza along with vaccination failure as event. ; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR118022:Same reporter. US-GLAXOSMITHKLINE-US2021AMR117937:Same reporter.

Other Meds:

Current Illness:

ID: 1380582
Sex: U
Age:
State: CA

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

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: pediatric patients (children) were given the adult dose of Havrix.; pediatric patients (children) were given the adult dose of Havrix.; This case was reported by a physician via call center representative and described the occurrence of overdose in a child patient who received HAV (Havrix 1440) for prophylaxis. On an unknown date, the patient received Havrix 1440. On an unknown date, unknown after receiving Havrix 1440, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown. Additional details were provided as follows: The reporter was a pediatrician. The age at vaccination was not reported. The pediatric patient was given the adult dose of Havrix, which led to overdose and adult product administered to child. The pediatrician?s office was still trying to identify the patient. Patient identifiers was not available till the time of reporting. The reporter consented to follow up. This is 1 of the 9 link cases, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter

Other Meds:

Current Illness:

ID: 1380583
Sex: F
Age:
State: WA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Pediarix, single dose hepB / single dose Polio, all at 2 month visit / was human error; This case was reported by a other health professional via sales rep and described the occurrence of accidental overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hepatitis B vaccine for prophylaxis and POLIOMYELITIS VACCINE (POLIO VACCINE) for prophylaxis. On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Hepatitis B vaccine and POLIO VACCINE. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hepatitis B vaccine, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. This report is made without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Health care professional reported that the patient received single dose of Pediarix, Hepatitis B and Polio at 2 months visit, which led to accidental overdose. No other information was reported. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1380584
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Patient is 17 months out from 1st dose / 2nd dose still valid or should she restart; This case was reported by a other health professional via Shingrix GSK interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix, 17 months ago prior to reporting). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of vaccination, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter enquired if the second dose was still valid or the patient should restart the series.

Other Meds:

Current Illness:

ID: 1380586
Sex: U
Age:
State: CA

Vax Date: 12/18/2020
Onset Date: 04/01/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Suspected vaccination failure/ Had the vaccine on December 18, 2020 / breaking out with Shingles around April 1, 2021; Breaking out with Shingles around April 1, 2021; The outbreak was severe with pain; Permanent scars on my nose and face from the shingles; Damage to my face and body; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 18th December 2020, the patient received Shingrix. On 1st April 2021, 104 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, scar and injury. On an unknown date, the outcome of the vaccination failure, shingles, pain, scar and injury were unknown. It was unknown if the reporter considered the vaccination failure, shingles, pain, scar and injury to be related to Shingrix. Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient had the Shingrix vaccine on the recommendation of the physician and started breaking out with Shingles around 1st April 2021. The outbreak was severe with pain. The patient has permanent scars on the nose and face from the shingles. The patient stated that he/she could send the pictures of the scars and damage to the face and body for review. The patient stated he/she would prefer to deal directly with GlaxoSmithKline on a settlement, instead of dealing with outside counsel with thousands of clients and being just a number. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.

Other Meds:

Current Illness:

ID: 1380587
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: got the shingle shot but I still had a light case of the shingles years later/ suspected vaccination failure; had a light case of the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the shingle shot but still had a light case of the shingles years later but the patient did recommend to get the shot. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.

Other Meds:

Current Illness:

ID: 1380588
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: got the vaccine and some years later got a mild case/ suspected vaccination failure; got a mild case.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the vaccine and some years later got a mild case of shingles. The patient stated if that was mild he/she cannot even imagine what a full blown case would be like. The patient recommended to get the vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles were unknown.

Other Meds:

Current Illness:

ID: 1380589
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Three to four years after vaccines, the first case / the second was / 5 months after the first/Suspected vaccination failure; First case was near my tail bone / second was / 5 months after the first; Second was a mere 5 months after the first, less painful, but lingered longer; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient experienced 2nd case of shingles a mere 5 months after the 1st case of shingles and stated shingles was less painful, but lingered longer. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. For 1st outbreak of shingles refer linked case US2021AMR118138, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR118138:Same reporter, same patient, 1st shingles outbreak

Other Meds:

Current Illness:

ID: 1380590
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Got the shots / Oral shingle in my mouth and lips/Suspected vaccination failure; Shingles; Oral shingle in my mouth and lips; Nerve pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles in 2012). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, oral herpes and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, oral herpes and nerve pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles, oral herpes and nerve pain to be related to Shingles vaccine and Shingles vaccine. Addition details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles shots couple of months before the reporting and as a side effect of the shots, the patient had oral shingles in mouth and lips and at present the patient on 2 kinds of medication to prevent the nerve pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1380591
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Wife had the shot and has the Shingles/Suspected vaccination failure; Shingles right now, really bad / going thru living HELL; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient got the shingles shot and right now she was going through living hell. The shingles was not preventable and it was really bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1380592
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Had shingles three times...even after the shot/Suspected vaccination failure; Had shingles three times...even after the shot; Best thing for pain is lidocaine patch; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with lidocaine (Lidocaine Patch). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. Even after receiving Shingles vaccine, the had Shingles three time. The patient stated that best thing for pain was lidocaine patch for immediate relief. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1380593
Sex: M
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: I got the shingles shot and had a few on my right side/ Suspected vaccination failure; I got the shingles shot and had a few on my right side; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had a few shingles on his/her right side. The patient stated that he/she did not had any pain and they were gone in a few days. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1380594
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: I had both shots WELL I have the shingles/suspect vaccination failure; I have the shingles; RED SPOTS; BUT SOME PAIN; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red spotty rash and pain. On an unknown date, the outcome of the vaccination failure, shingles, red spotty rash and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles, red spotty rash and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both the doses of Shingles vaccine and had shingles, red spots and some pain. The patient stated that the vaccine sure did not help him/her. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1380595
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: I got the vaccine with the booster last year. I now have shingles/despite the shot/ Suspected vaccination failure; I now have shingles on my back and side; Worst pain ever; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. In 2020, last year, the patient received Shingles vaccine with the booster and at the time of reporting, he/she had shingles on back and side. The patient stated that he/she had worst pain ever. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1380599
Sex: F
Age:
State: FL

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Administered the / vaccine to a child that was under the age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter administered the Kinrix vaccine to the patient that was under the age to receive the vaccine which led to inappropriate age at vaccine administration. The reporter provided all information and stated, there were no reported adverse events with the patient at the time of reporting. The reporter stated that she knew the patient was due for the DTaP and Polio vaccines. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1380602
Sex: F
Age:
State: WI

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 06/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: 11 month old patient had been given Kinrix; Kinrix 3rd dose in the DTaP series and the 3rd dose in the polio series; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included HEPATITIS B VACCINE (received prior 3 doses of series on an unknown date) and DTPa-IPV (received prior 3 doses of series on an unknown date). On 2nd June 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient received Kinrix at 11 months of age, which led to inappropriate age at vaccine administration. The patient received Kinrix to provide the 3rd dose in the DTaP series and the 3rd dose in the polio series, which led to inappropriate schedule of vaccine administered. The Pediarix was to be given but patient had completed 3 doses of Hepatitis B already. At the time of reporting, the dose was given and after realizing age recommendations on health care professional called for safety and composition information. Health care professional did not have all information at hand and provided limited data, initials not shared. The reporter consented to follow up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm