VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.






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: 1409002
Sex: F
Age: 53
State: OR

Vax Date: 06/11/2021
Onset Date: 06/12/2021
Rec V Date: 06/18/2021
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: None

Symptom List: Dysphagia, Epiglottitis

Symptoms: 1 small Blister near injection site and cluster of bisters on the nose. Painful and sore, started to heal and scab over after 6 days.

Other Meds: Ropinirole

Current Illness: None

ID: 1409003
Sex: F
Age: 33
State: MO

Vax Date: 05/20/2021
Onset Date: 05/24/2021
Rec V Date: 06/18/2021
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: Penicillin

Symptom List: Anxiety, Dyspnoea

Symptoms: I 'm on the 27 th day of my period. A lot lighter than I usually experience but not light enough to be considered spotting filling 2 regular sized tampons a day. Opposed to my usual periods having to change a regular tampon every hour or two. Also no usual cramps or back pain, no blood clots that I usually experience. in a lot of ways it's the easiest period I've ever had except for the fact that it is on day 27. I'm very tired all the time which is usual when on my period but not for 27 days.

Other Meds: None

Current Illness: None

ID: 1409004
Sex: F
Age: 40
State: CO

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 06/18/2021
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: Amoxicillin, adhesive

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

Symptoms: Rash appeared same day and is still there.

Other Meds: Metformin, levothyroxine, vitamin B, vitamin D, fish oil

Current Illness: None

ID: 1409005
Sex: F
Age: 60
State: CA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 06/18/2021
Hospital: Y

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: Back and body ache, legs groin chest, kidneys, throw up and fever. Went to emergency, Doctors took many many test

Other Meds:

Current Illness:

ID: 1409006
Sex: M
Age: 12
State: OR

Vax Date: 05/22/2021
Onset Date: 05/26/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies: none

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

Symptoms: Child developed a massive PANDAS OCD Flare and possibly cytokine storm. He ended up in the hospital asking to die because OCD thoughts became over whelming. Child has had PANDAS for 6 years and never had an incident like this.

Other Meds: Clonidine, Zen Gaba, Vitamin D, Iron, Fluoxetine

Current Illness:

ID: 1409007
Sex: F
Age: 67
State: CA

Vax Date: 02/14/2021
Onset Date: 02/24/2021
Rec V Date: 06/18/2021
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: Approx. 10 days after receiving my second dose of the Moderna vaccine, I noticed that I had developed Tinnitus and it has not gone away.

Other Meds: Levothyroxine, Risedronate, Simvastatin, multi-vitamin, calcium/vit D,

Current Illness:

ID: 1409008
Sex: F
Age: 44
State: MD

Vax Date: 01/12/2021
Onset Date: 03/08/2021
Rec V Date: 06/18/2021
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: Phenergan causes hallucinations

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: After experiencing left supraclavicular lymph node pain for a few days, on 3/8 I woke up with a noticeable goiter and severs left neck/throat pain. Swallowing was painful, and my neck ached only on the left side. I went to an urgent care center after work that day and was told to see my PCP. I was able to see her on 3/10, and had thyroid labs drawn and a thyroid ultrasound. The ultrasound showed two nodules > 3.5mm, one on each side of my thyroid. The left nodule was larger. I went for more labs on 3/17, and within two days I began experiencing tachycardia, tremors, anxiety, agitation, and palpitations. I was referred to an endocrinologist and saw her on 3/24. She prescribed me atenolol, which eliminated my symptoms. On 4/1 I underwent a radioactive nucleotide reuptake exam and was diagnosed with thyroiditis. I took the atenolol for about a month and had more labs drawn, which showed I was now hypothroidotic. I was taken off of the atenolol and started on levothyroxin 50mg qd. After taking that for two months I had repeat labs that were on the high side of normal, and my dose of levothyroxin was increased slightly. I am scheduled for a follow-up thyroid ultrasound in two weeks.

Other Meds: Effexor 75mg qd, Women's Daily multivitamin

Current Illness: none

ID: 1409350
Sex: U
Age:
State: PR

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: I read on an App that DR. has 2 patients who have developed Lupus and after the Pfizer vaccine. He is still studying the cases closely to report them; This is a spontaneous report from a contactable consumer. A patient of unknown age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On unspecified date, patient has developed Lupus after the vaccine. Treatment received was unknown. Reporter informed that has 2 patients who have developed Lupus after the Pfizer vaccine and was still studying the cases closely to report them. The outcome of event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1409417
Sex: U
Age:
State: MO

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 06/18/2021
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 additional AEs; temperature excursion: -14.7 C; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 12-MAY-2021, the patient was vaccinated with incorrectly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, exact dose, route of administration were not reported; lot number reported as S03870 verified to be not valid, expiry date reported as 31-MAY-2022) for prophylaxis. The suspect vaccine was stored in the temperature from -50 degrees Celsius (C) to -15 C (-14.7C) for 45 minutes, in the temperature of -10.29 C for 45 minutes and in the temperature of -1.81 C for 3 hours and 30 minutes. There was previous temperature excursion of -14.7 C for 45 minutes. Digital data logger was involved. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1409418
Sex: M
Age: 1
State: CA

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 06/18/2021
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 adverse event reported; Administration of VARIVAX and MMR II (Stored in Freezer) that underwent a temperature excursion to a patient; This spontaneous report was received from a licensed vocational nurse and refers to a 1 year old male patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported. On 20-MAY-2021, the patient was vaccinated with an incorrect storage dose of varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously, 0.5 ml, lot # T027305, expiration date 12-AUG-2022 for prophylaxis. On the same date, the patient also received an incorrect storage dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II). subcutaneously, 0.5 ml, lot # S037497, expiration date 20-NOV-2021 for prophylaxis. The vaccines were exposed at 19.3 Fahrenheit (F) for 1 hour and 31 minutes. There was no previous temperature excursion. The call was made due to "data logger". No other adverse events were reported.

Other Meds:

Current Illness:

ID: 1409419
Sex: U
Age: 0
State: MI

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 06/18/2021
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 AE reported at this time; temperature excursion on ROTATEQ; This spontaneous report has been received from a health care professional referring to a 4 months old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 19-MAY-2021, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength and anatomical location were not provided; lot# 1741376 has been verified to be a valid lot number, expiration date reported as 06-MAR-2022), orally for prophylaxis (product storage error). The vaccine underwent temperature excursion at 48.2 Fahrenheit (F) for 15 minutes. The previous temperature excursion was at 46.2 F for 15 minutes. The digital data logger was involved in recording excursion details. At the time of report, there was no additional adverse event (AE) was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2106USA000779: US-009507513-2106USA000757: US-009507513-2106USA000712: US-009507513-2106USA000591: US-009507513-2106USA000663: US-009507513-2106USA000689: US-009507513-2106USA000988:

Other Meds:

Current Illness:

ID: 1409420
Sex: U
Age: 1
State: WA

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 06/18/2021
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 details were available; inadvertent concomitant administration of VARIVAX and PROQUAD to a patient; This spontaneous report has been received from a medical assistant referring to a 1-year-old patient of unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported. On 28-MAY-2021, the patient was inadvertent concomitantly vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 mL, lot # T025944, expiration date: 30-JUL-2022; strength and route were not reported) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rHA)) (PROQUAD) (0.5 mL, lot # T029099, expiration date: 23-FEB-2022; strength and route were not reported) for prophylaxis (inappropriate schedule of product administration). The reporter was requesting any information on what to look for with the patient. No additional adverse event details were available.

Other Meds:

Current Illness:

ID: 1409421
Sex: U
Age:
State: TX

Vax Date: 05/27/2021
Onset Date:
Rec V Date: 06/18/2021
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: product experienced a temperature excursion; no adverse event; This spontaneous report as received from a pharmacist (also reported as costumer) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 27-MAY-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S028737 expiration date 03-APR-2022 for prophylaxis (strength, dose, frequency, route, lot# and expiration date were not provided). No adverse effects were reported. Temperature excursion was registered by Digital Data Logger. 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: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1409422
Sex: U
Age:
State: VA

Vax Date: 06/03/2021
Onset Date: 06/03/2021
Rec V Date: 06/18/2021
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; administration of expired GARDISIL 9; This non-valid spontaneous report was received from a physician via office manager and refers to a patient of an unknown age and gender. On 03-JUN-2021, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, lot # R026716 was valid for formulation vial, expiration date 30-MAY-2021 (route of administration and anatomical location were not provided) for prophylaxis. The reporter inquired viability of administered dose. No additional adverse events reported. This case is non-valid due to lack of patient's identifiers. Follow up information was received form an unspecified source at the physician office on 15-JUN-2021. The reporter stated if they could get more information regrading the patient. However, more information was not able to be provided as it was not available.

Other Meds:

Current Illness:

ID: 1409423
Sex: U
Age: 18
State: SC

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 06/18/2021
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 adverse event; Vaqta and Gardasil 9 were administered to a patient on 6/2/21 prior to discovering temperature excursion; This spontaneous report was received from a medical assistant and refers to a 18-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 02-JUN-2021, the patient was vaccinated with an improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # T023914, expiration date 31-MAR-2022, at a dose of 0.5 milliliter, intramuscularly and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T025370, expiration date 01-DEC-2022, at a dose of 0.5 ml, intramuscularly for prophylaxis (anatomical locations were not provided). The temperature excursion was below 2 Celsius degrees (1,1 Celsius degrees) for 14 hours. There were no previous excursions reported. The digital data logger was involved. No additional adverse event.

Other Meds: VAQTA SYRINGE (DEVICE); GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1409424
Sex: U
Age:
State: IL

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 06/18/2021
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: No additional AE reported; an expired GARDASIL 9 was administered to a patient; This spontaneous report has been received from a pharmacist referring to a consumer, of unknown age and gender patient. No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were provided. On 04-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) of 0.5 milliliter for prophylaxis, lot # R021634, expiration date 08-MAY-2021. (anatomical location and route of administration were not provided). The reporter stated that the vaccine had no prior temperature excursions. No additional 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: R021634; expirationdate: 08-MAY-2021; 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:

ID: 1409425
Sex: U
Age:
State: CA

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 06/18/2021
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: additional adverse event reported; called about a temperature excursion and a improper storage; This spontaneous report has been received from a medical assitant, referring to a patient of unknown age and gender.The patient's concurrent medications, pertinent medical history, drug reactions or allergies were not reported. On 04-JUN-2021, the patient was vaccinated with an improperly stored the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) 0.5 milliliter , intramuscular , lot number S028738 , expiration date : 03-APR-2022 ,as prophylaxis The vaccine was exposed to a temperature excursion of 50.9 ?degree F for a time frame of 2 hours and 49 minutes, which were detected by the Digital Data Logger. There was no previous temperature excursion. 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: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; 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:

ID: 1409426
Sex: M
Age:
State: AL

Vax Date: 08/11/2020
Onset Date:
Rec V Date: 06/18/2021
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: who missed a dose of GARDASIL 9; No additional AE reported; This spontaneous report was received from a pharmacy technician and refers to a 17-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose, lot # 1621934, expiration date 29-JAN-2022 (exact dose, anatomical location and route of administration were not reported) for prophylaxis. On an unknown date, the patient missed a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse event was reported. The outcome of the event was unknown. The relatedness between the suspect therapy and the event was not provided This is one of 2 reports received from the same reporter. 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: 1621934; expirationdate: 29-JAN-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:

ID: 1409427
Sex: U
Age:
State: NJ

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/18/2021
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 other AE/PQC reported; an expired dose of RECOMBIVAX HB was inadvertently administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-JUN-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R031056, expiration date: 04-JUN-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse event was reported. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R031056; expirationdate: 04-JUN-2021; 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:

Current Illness:

ID: 1409428
Sex: F
Age:
State: PA

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/18/2021
Hospital:

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: full body cramping; numbness in limbs; extreme weakness; This spontaneous report as received from a registered nurse refers to a 14-year-old female patient. The patient's concomitant vaccine included unspecified Covid vaccine. There was no information about the patient's concurrent conditions or medical history provided. On 10-JUN-2021, 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 mg, intramuscularly, lot # T008151, expiration date: 21-JUN-2022 (anatomical location was not reported) for prophylaxis. On the same day, reported as 3 minutes after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient had full body cramping, extreme weakness and numbness in limbs. The patient sought medical attention and was transported to hospital via ambulance as a treatment. The outcome of the events was unknown. The causality assessment was not provided. 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: T008151; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: COVID-19 VACCINE; GARDASIL 9 SYRINGE (DEVICE)

Current Illness: Prophylaxis

ID: 1409429
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: received the first dose of GARDASIL 9 one year ago and did not complete the series at that time; No other AE/PQC reported; This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2020, reported as one year ago, 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) for prophylaxis. The patient did not complete the series at that time. Non-valid due to no patients identifiers.

Other Meds:

Current Illness:

ID: 1409430
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: heavy bleeding; female problems; became anemic; had hair loss; This spontaneous report as received from an office manager via a company representative refers to a 17-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (employee was unable to verify) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, reported as 1 month after receiving suspected vaccine, the patient started having female problems, heavy bleeding, became anemic and had hair loss. It was unknown if the patient sought medical attention or if she received any treatment. The outcome of the events was unknown. Causality assessment was not provided.

Other Meds:

Current Illness:

ID: 1409431
Sex: U
Age:
State: WI

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/18/2021
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: No additional AE reported; a consumer was inadvertently administered the PNEUMOVAX 23 vaccine/The consumer was not scheduled to receive this vaccine; This spontaneous report as received from an unspecified reporter, reported as other refers to a 53-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-JUN-2021, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, lot # T031820, expiration date: 10-MAY-2022 (route of administration and anatomical location were not reported) for prophylaxis. The patient was not scheduled to receive this vaccine and had not previously been vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T031820; expirationdate: 10-MAY-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: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1409432
Sex: U
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: The patient suffered herpes zoster. As a result of these symptoms, was seen and treated by medical providers and is still under their care.; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX). The event of herpes zoster was considered to be disabling.

Other Meds:

Current Illness: Herpes zoster

ID: 1409433
Sex: U
Age:
State: NY

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 06/18/2021
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: No AE reported; expired dose of PROQUAD was inadvertently administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided. On 14-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # S017256, expiration date 01-DEC-2020 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse event (AE) was reported.

Other Meds:

Current Illness:

ID: 1409434
Sex: U
Age:
State: ME

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 06/18/2021
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: No additional AEs; expired dose of RECOMBIVAX HB was administered on 11JUN2021; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JUN-2021, the patient was vaccinated with an expired dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) 1 time dose, lot # R034547, expiration date 09-JUN-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1409435
Sex: U
Age:
State: AL

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 06/18/2021
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: No further information is available; patient received an expired VAQTA; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JUN-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) 1 dose, lot # T008698, expiration date 04-JUN-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; 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: 1409436
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: measles; morbilliform rash over trunk, face and some extremities; This spontaneous report was received from a consumer via a company representative and refers to a 14 year old patient of unknown gender. The patient's medical history included stem cell transplant and it was reported the patient was well. No information regarding the patient's concurrent conditions, concomitant medications and previous drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, frequency, route and site of administration, lot number and expiration date were not provided). On an unknown date, 7 days after the vaccination, the patient developed morbilliform rash over trunk, face and some extremities. It was stated that it looked like measles. It was unknown if there was any treatment given for the adverse events. The patient was being seen by the dermatology team and would have a biopsy. The outcome of the events was not provided. The reporter was concerned that the events were related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Upon internal review, the event of measles was considered to be medically significant.

Other Meds:

Current Illness:

ID: 1409437
Sex: F
Age:
State: CA

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 06/18/2021
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: The physician told the field employee that a patient experienced syncope after receiving her second dose of GARDASIL 9; This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided. On 11-JUN-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) (route, strength, lot # and expiration date were not provided) for prophylaxis. The physician stated that, on the same date, the patient experienced syncope. The patient recovered on the same date after "seconds or a few minutes" later. The patient sought for medical attention, however it was unknown if any treatment was provided. The physician spoke with the patient's family on 14-JUN-2021 (reported as "yesterday"), and the informed the patient was doing fine. Causality between the reported event and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. Upon internal review, syncope was determined to be medically significant.

Other Meds:

Current Illness:

ID: 1409438
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: Congestive heart failure; Herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster and congestive heart failure. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter determined the events to be related to zoster vaccine live (ZOSTAVAX). The events of congestive heart failure and herpes zoster were considered to be disabling. Upon internal review, the event of congestive heart failure was determined to be medically significant.

Other Meds:

Current Illness: Routine health maintenance

ID: 1409440
Sex: U
Age:
State:

Vax Date: 06/09/2021
Onset Date: 06/01/2021
Rec V Date: 06/18/2021
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: SEVERE pain/ in shoulder , limp elbow; tiredness in shoulder , limp elbow; limp elbow and hand; I've waked at 3 am; This case was reported by a consumer and described the occurrence of shoulder pain in a 74-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 9th June 2021 21:00, the patient received Shingles vaccine. In June 2021, 6 hrs after receiving Shingles vaccine, the patient experienced shoulder pain, muscle fatigue, mobility decreased and sleep disturbance. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the shoulder pain, muscle fatigue, mobility decreased and sleep disturbance were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, muscle fatigue, mobility decreased and sleep disturbance to be related to Shingles vaccine. Additional information was provided as follows: On 9th June 2021, the patient had Shingles vaccination in evening about 9 pm. On 10th June 2021 about 3 am, the patient woke up in severe pain and tiredness in shoulder, limp elbow and hand. The patient applied ice and took two Tylenol. The patient asked what else should be done.

Other Meds:

Current Illness:

ID: 1409441
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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 induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: made my arm sore for days; I never felt good..; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine. Additional case was reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received a updated Shingle shot and had arm sore for days and never felt good and had receive another in 30 days, but it was better then shingles. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

Date Died:

ID: 1409442
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: got the shot 3 days later he was dead; This case was reported by a consumer via media and described the occurrence of death 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, 3 days after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by reporter for a friend's husband. The patient was in perfect shape but passed away 3 days after his shingles shot.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR131309:Same reporter.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1409443
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: Pt only received the diluent part of the mcv4; Pt only received the diluent part of the mcv4; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: The age at vaccination was not reported. The patient only received the diluent part of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine. The reporter consented to follow up. No other information was reported.

Other Meds:

Current Illness:

ID: 1409444
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: I am 48 years old / I have a prescription to get the shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of product prescribing error in a 48-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included shingles (Shingles on face). On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error. On an unknown date, the outcome of the product prescribing error was unknown. Additional details were provided as follows: This case was reported by patient himself/herself. Age at vaccination was not applicable for this report. The patient was 48 years old at the time of reporting and had a horrible case of shingles on face and had a prescription to get the shingrix vaccine, which led to intercepted drug prescribing error. The patient added that, he/she could not find anyone to give it since the patient was under 50 years of age had insurance and also insurance says they will not pay until the patient became 50 and the patient could not afford the vaccines The reporter did not consent to follow up.

Other Meds:

Current Illness: Shingles (Shingles on face)

ID: 1409445
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: Relapse of bipolar depression; feeling depressed; became tearful; joint pain/ burning pains in her small joints; joint pain/ burning pains in her small joints; aches and pains; myalgia; Ringing in her ears; This case was reported in a literature article and described the occurrence of bipolar depression in a 49-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. The patient's past medical history included bipolar depression and attention deficit hyperactivity disorder. Previously administered products included buspirone (15 mg twice/day), lurasidone (20 mg/day), oxcarbazepine (300 mg twice/day), trazodone (50 mg at bedtime) and lisdexamfetamine (30 mg in the morning). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, couple of hours after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced bipolar depression (serious criteria GSK medically significant), depressed mood, tearfulness, joint pain, burning sensation, pain, myalgia and ringing in ears. The patient was treated with celecoxib. On an unknown date, the outcome of the bipolar depression, depressed mood and tearfulness were recovered/resolved and the outcome of the joint pain, burning sensation, pain, myalgia and ringing in ears were unknown. The reporter considered the bipolar depression, depressed mood, tearfulness, joint pain, burning sensation, pain, myalgia and ringing in ears to be possibly related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follow: This case was reported in a literature article and described the occurrence of relapse of bipolar depression in a 49-years-old female patient who was vaccinated with unspecified seasonal Influenza vaccine (manufacturer unknown) for prophylaxis. This white female patient had history of bipolar depression well controlled on her regimen of medications, which included buspirone 15 mg twice/day, lurasidone 20 mg/day, oxcarbazepine 300 mg twice/day, trazodone 50 mg at bedtime, and lisdexamfetamine 30 mg in the morning (for comorbid attention-deficit/hyperactivity disorder), and was seen for a routine follow-up visit. At that time, her depression was in full remission, and she had scored 0 on the 9-item Patient Health Questionnaire (PHQ-9). No information on patient's family history was provided. On an unspecified date, a week earlier to clinic visit, the patient received unspecified seasonal Influenza vaccine (administration route and site unspecified; dosage unknown; batch number not provided). The age at vaccination was not reported. On an unspecified date, within a couple of hours after vaccination, the patient started feeling depressed and became tearful. These symptoms were followed a couple of days later with aches and pains, which escalated over the subsequent days. The patient complained of joint pain, burning pains in her small joints, and myalgia. The patient rated her pain as 6/10. The patient also noticed ringing in her ears for the previous 2 days. Two weeks later from routine visit, the patient returned to the clinic for an urgent, unscheduled visit due to escalating depression, which was rated as 18/27 on the PHQ-9 (a score of 15-19 considered moderately severe). The patient received celecoxib 200 mg twice/day, and was asked to return in a week if her condition did not improve. The patient returned to the clinic 8 weeks later for a previously scheduled appointment and reported having experienced a dramatic response to celecoxib. Her depression had remitted rapidly, and the patient scored 0/27 on the PHQ-9. The patient reported an additional benefit of improved interpersonal interactions. Her depression resolved when treated with celecoxib, and the patient continued to feel better on celecoxib. The authors commented that, "We discussed the possibility that her depression might be a reaction to the flu vaccine. On the assumption that her relapse of depression was related to an immune response, we agreed to a trial of celecoxib 200 mg twice/d, and she was asked to return in a week if her condition did not improve. This patient experienced a rapid relapse of her bipolar depression within a couple of hours after receiving a seasonal flu vaccine injection. Her depression resolved when treated with celecoxib, and she continues to feel better on celecoxib. This case seems to be consistent with a recent report of celecoxib improving treatment-resistant bipolar depression. Should our bipolar patients experience vaccination-induced relapse of depression, adding celecoxib to their treatment regimen could be helpful." The article corresponding to this case is not available for regulatory submission due to copyright restriction.

Other Meds:

Current Illness:

ID: 1409446
Sex: F
Age: 15
State: ME

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 06/18/2021
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: Three teenagers / received an adult dose / instead of a Pediatric dose; Three teenagers / received an adult dose / instead of a Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 2nd June 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, 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. 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 patient received an adult dose of Havrix instead of a Pediatric dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This is 1 of the 3 cases reported by the same reporter for different patients.; Sender's Comments: US-GLAXOSMITHKLINE-US2021130436:Same reporter. Patient #1 of 3. US-GLAXOSMITHKLINE-US2021130439:Same reporter. Patient #3 of 3.

Other Meds:

Current Illness:

ID: 1409447
Sex: F
Age: 13
State: ME

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 06/18/2021
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: Three teenagers / received an adult dose / instead of a Pediatric dose; Three teenagers / received an adult dose / instead of a Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 2nd June 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, 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. 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 patient received an adult dose of Havrix instead of a Pediatric dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This is 1 of the 3 cases reported by the same reporter for different patients.; Sender's Comments: US-GLAXOSMITHKLINE-US2021130437:Same reporter. Patient #2 of 3. US-GLAXOSMITHKLINE-US2021130439:Same reporter. Patient #3 of 3.

Other Meds:

Current Illness:

ID: 1409448
Sex: F
Age: 13
State: ME

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 06/18/2021
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: Three teenagers / received an adult dose / instead of a Pediatric dose; Three teenagers / received an adult dose / instead of a Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 2nd June 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, 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. 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 patient received an adult dose of Havrix instead of a Pediatric dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This is 1 of the 3 cases reported by the same reporter for different patients.; Sender's Comments: US-GLAXOSMITHKLINE-US2021130436:Same reporter. Patient #1 of 3. US-GLAXOSMITHKLINE-US2021130437:Same reporter. Patient #2 of 3.

Other Meds:

Current Illness:

ID: 1409449
Sex: U
Age:
State: IL

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 06/18/2021
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: Administration of an expired dose / to a patient / 3rd dose in the series; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 9794C, expiry date 13th June 2021) for prophylaxis. Previously administered products included Engerix B (1st dose and 2nd dose of Engerix B received on an unknown date). On 15th June 2021, the patient received the 3rd dose of Engerix B. On 15th June 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Engerix B which was already expired on 13th June 2021. The reporter did not feel completely comfortable sharing patient information but mentioned they would provide that in the follow-up. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1409450
Sex: M
Age:
State: MA

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 06/18/2021
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: a 29 year old male patient / inadvertently received the Shingrix vaccine; patient inadvertently received the Shingrix vaccine, the intended vaccine was the Moderna Covid-19; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 15th June 2021, the patient received Shingrix. On 15th June 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional details were provided as follows: The pharmacist reported that, the 29 year old male patient inadvertently received the Shingrix vaccine, the intended vaccine was the Moderna Covid-19, which led to inappropriate age at vaccine administration and wrong vaccine administered. No further information was reported.

Other Meds:

Current Illness:

ID: 1409452
Sex: U
Age:
State: NE

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: received the first dose of Shingrix / second dose six weeks after that.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 63-year-old patient who received Herpes zoster (Shingrix) (batch number DS754, expiry date 18th December 2022) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. The patient received 2nd dose 6 weeks after the 1st dose. The reporter consented to follow up.

Other Meds: Shingrix

Current Illness:

ID: 1409453
Sex: F
Age: 58
State: OH

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 06/18/2021
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: swelling; rash; redness; tenderness; pain; This case was reported by a physician via call center representative and described the occurrence of swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 20th May 2021, less than a day after receiving Shingrix, the patient experienced swelling, rash, erythema, tenderness and pain. On an unknown date, the outcome of the swelling, rash, erythema, tenderness and pain were recovered/resolved. It was unknown if the reporter considered the swelling, rash, erythema, tenderness and pain to be related to Shingrix. Additional details were provided as follows: The patient received first Shingrix shot and experienced swelling, rash, redness, tenderness, pain of which have now resolved. The reporter consent to follow up.

Other Meds:

Current Illness:

ID: 1409454
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: First dose 1 of shingrix in 2019 never got the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included shingrix (1st dose received in 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No other details of patient / vaccine/ health care professional was provided. The reporter consent to follow up.

Other Meds:

Current Illness:

ID: 1409455
Sex: F
Age:
State: TX

Vax Date: 10/20/2019
Onset Date: 10/20/2019
Rec V Date: 06/18/2021
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: On 11Mar2018/ received the first dose/ 20Oct2019/ receive the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 11th March 2018). On 20th October 2019, the patient received the 2nd dose of Shingrix. On 20th October 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose of Shingrix exceeding the recommending dosing schedule, which led to lengthening of vaccine schedule. The reporter consent to follow up.

Other Meds:

Current Illness:

ID: 1409456
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: first dose of Shingrix on 2019 / has not received the second dose yet.; This case was reported by a pharmacist via call center representative 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 (1st dose received in 2019). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consent to follow up.

Other Meds:

Current Illness:

ID: 1409457
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 06/05/2021
Rec V Date: 06/18/2021
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: SHAKING; CAN NOT STAND; DIZZY; SWEATING; HOT AND COLD; PAIN ALL IN BODY; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 200 pounds, and height was not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced shaking. On 05-JUN-2021, the subject experienced can not stand. On 05-JUN-2021, the subject experienced dizzy. On 05-JUN-2021, the subject experienced sweating. On 05-JUN-2021, the subject experienced hot and cold. On 05-JUN-2021, the subject experienced pain all in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, can not stand, dizzy, sweating, hot and cold, and pain all in body. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409459
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: PLATELET COUNT INCREASED; MIGRAINE; RED BLOOD CELL COUNT ABNORMAL; HAEMOGLOBIN ABNORMAL; HAEMATOCRIT ABNORMAL; MALAISE; FATIGUE; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythaemia vera. The patient was previously treated with hydroxycarbamide for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number was not reported) 10 mg, 2 times every 1 day, therapy dates were not reported, for polycythaemia vera. Concomitant medications included acetylsalicylic acid, ascorbic acid, oenothera biennis oil, sulfamethoxazole/trimethoprim, topiramate, and vitamin e nos. On an unspecified date, the platelets went to a critical level/had 800 000/uL platelets/platelets levels so high/ platelets went up/ platelets have been all over the map/ went up in to the 800s/plateIets going up (Platelet count increased). The patient was not feeling well (Malaise), Migraine headaches/ having migraines more often (Migraine), some issues with her red blood counts levels/ RBC 12/8 4.04, 1/5/21 4.15, 2117/21 4.34/4/20/21 4.40 (Red blood cell count abnormal), H/H 12/8 12.3/36.7, 115/21 12.1/36.9, 2/17/21 12.8/39.6 (Haemoglobin abnormal), I-UH 12/8 12.3/36.7, 1/5/21 12.1/36.9, 2/17/21 12.8/39.6 (Haematocrit abnormal). The patient had been feeling a little bit more tired (Fatigue) coincident with Jakafi (ruxolitinib). The reporting physician considered the events platelet count increased, malaise, migraine, and red blood cell count abnormal as not related to Jakafi. The events were considered related to stopping Hydroxyurea suddenly instead of weaning off while starting Jakafi. The units were not provided for all laboratory values. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ruxolitinib phosphate was not changed. The patient had not recovered from platelet count increased, migraine, and fatigue, and the outcome of malaise, red blood cell count abnormal, haemoglobin abnormal and haematocrit abnormal was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210617549-COVID-19 VACCINE AD26.COV2.S- Platelet count increased. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE.

Other Meds: ASPRIN; TOPAMAX; MAXOL; VITAMIN E NOS; VITAMIN C [ASCORBIC ACID]; PRIMROSE OIL

Current Illness: Polycythaemia vera

ID: 1409460
Sex: U
Age:
State: CO

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/18/2021
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: ADMINISTRATION OF EXPIRED VACCINE TO ONE PATIENT; LEFT LONGER THAN 2 HOURS OUTSIDE THE FRIDGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUN-2021, the subject experienced administration of expired vaccine to one subject. On 01-JUN-2021, the subject experienced left longer than 2 hours outside the fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine to one patient and left longer than 2 hours outside the fridge was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409461
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 05/19/2021
Rec V Date: 06/18/2021
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: ERRATIC HEARTBEAT AND PULSE, PULSE RATE VARIED; LOOSE BOWELS LIKE WATER, DIARRHEA; TIRED; This spontaneous report received from a consumer concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included loose bowels. Patient had no gallbladder and no known allergies The patient received covid-19 vaccine ad26.cov2.s by 2 paramedics (suspension for injection, route of admin not reported, batch number: 20SA61A and expiry: Unknown) dose was not reported, 1 total administered on 18-MAY-2021 14:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021 (after the vaccination), the patient felt tired. Patient always had loose bowels, now on 26-MAY-2021, the patient could not make it to the toilet, diarrhea and it came out like water. This had been ongoing for two weeks. On 08-JUN-2021, the patient had erratic heartbeat and on the same day at 12:45 pulse rate had been varied (erratic pulse). Patient could not keep anything in her. It was reported that nurse was in last week and informed loose bowels could be probably due to food. Patient did not had any medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 20-MAY-2021, and had not recovered from erratic heartbeat and pulse, pulse rate varied, and loose bowels like water, diarrhea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm