🏥 VAERS Vaccine Data Browser

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This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

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Data Interpretation

The presence of a report does not mean the vaccine caused the adverse event.
Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
Serious adverse events must be reported by law, even if unrelated to the vaccine.
The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death

🏥 Hospitalized

🚑 Emergency Room

♿ Disability

⚠️ Life Threatening

How to Search

💡 Search Tips:

Select Year: Choose a specific year OR "All Years" to search across all data
All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
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Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
Lot Number: Search specific vaccine lot (works great with "All Years")
Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

Reports are unverified: VAERS accepts all reports without medical verification
Not proof of causation: A report does not mean the vaccine caused the event
Anyone can report: Healthcare providers, patients, and family members can submit reports
Multiple vaccines: One report may list multiple vaccines given at the same time
Blank fields: Not all fields are required, so some data may be missing

Using the Table

Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
Expand text: Click "More" to see full narrative or symptom text
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Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.

34,052

Total Reports (2025)

500

Deaths Reported

1,634

Hospitalizations

ER Visits

1,191

Disabilities

570

Life Threatening

Year: VAERS ID: Age: Sex: State: Vaccine Type: Manufacturer: Lot Number: Site: Symptom: Death: Hospitalized:

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Showing 12,601 to 12,650 of 34,052 reports (Page 253 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥	♿
2853683	0.33	F	WI	08/12/2025	DTAPIPVHIB	SANOFI PASTEUR	UK036AB	Expired product administered, No adverse event Expired product administered, No adverse event	had administered an expired PENTACEL with no reported adverse event; Initial information received on... had administered an expired PENTACEL with no reported adverse event; Initial information received on 07-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient received an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Aug-2025, the patient received 0.5 ml of an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength- standard, expiry date- 30-JUN-2025 and lot UK036AB) once via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853684			GA	08/12/2025	TD	SANOFI PASTEUR		No adverse event, Wrong product administered No adverse event, Wrong product administered	patient was incorrectly administered TENIVAC instead of ADACEL with no reported adverse event; Initi... patient was incorrectly administered TENIVAC instead of ADACEL with no reported adverse event; Initial information received on 08-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who was administered with incorrect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] Instead Of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient incorrectly received an unknown dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection, (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization instead of adacel with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, Manager mentioned that it was their mistake to administer TENIVAC instead of ADACEL. Nurse clarified that the doctor ordered the Tdap (for the Pertussis component) for the patient but instead, the TENIVAC was administered. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853698	17	F	VA	08/12/2025	MENB MENB	NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS	K7JY3 3R33K	Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered	Accidental overdose; This non-serious case was reported by a nurse via call center representative an... Accidental overdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number K7JY3, expiry date 31-AUG-2028) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) (batch number 3R33K, expiry date 31-AUG-2028) for prophylaxis. On 31-JUL-2025, the patient received the 2nd dose of Bexsero (left arm) .5 ml and the 1st dose of Bexsero (right arm) .5 ml. On 31-JUL-2025, an unknown time after receiving Bexsero and Bexsero, the patient experienced accidental overdose (Verbatim: Accidental overdose). The outcome of the accidental overdose was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-JUL-2025 The reporter was an licensed practical nurse (LPN) working at a pediatric office. The reporter called seeking guidance from medical information. The LPN reported that a dose of Bexsero had been given to a patient in the right arm. Then, immediately after, another dose of Bexsero had been given in the patient's left arm. The reporter stated that they had not seen correctly and had given the patient another dose of the vaccine, which led to Accidental overdose. More
2853699		M	CT	08/12/2025	MENB	NOVARTIS VACCINES AND DIAGNOSTICS	UNK	Incomplete course of vaccination Incomplete course of vaccination	but has yet to receive subsequent doses; This non-serious case was reported by a consumer via call c... but has yet to receive subsequent doses; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 18-year-old male patient who did not receive Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (1st dose received intramuscularly on 19-AUG-2024). The patient did not receive the 2nd dose of Bexsero. The patient had incomplete course of vaccination (Verbatim: but has yet to receive subsequent doses). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-AUG-2025 The reporter was the mother of the patient. The reporter's son (patient) received dose one of Bexsero but had yet to receive subsequent doses. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to an incomplete course of vaccination. More
2853700				08/12/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Headache, Herpes zoster, Vaccination failure Headache, Herpes zoster, Vaccination failure	Suspected vaccination failure; had them all over my face; This serious case was reported by a consum... Suspected vaccination failure; had them all over my face; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: had them all over my face). The outcome of the vaccination failure and facial herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-AUG-2025 This case was reported by a patient via interactive digital media. The patient said yes had the vaccine as well and had them all over on the face and even one side of head hurt. They were mild as well and thanks to the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2853701				08/12/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More	Suspected vaccination failure; dealing with a breakout of shingles now; This serious case was report... Suspected vaccination failure; dealing with a breakout of shingles now; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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 (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: dealing with a breakout of shingles now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 03-AUG-2025 This case was reported by a patient via interactive digital media. The patient had both shots in 2020 and dealing with a breakout of shingles now, it was so painful This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). More
2853734	11	F		08/12/2025	HPV9 HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.	Y000205 Y014059 R017134	Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More	No side effects reported. No additional information on AE/No PQC; did not receive her second and thi... No side effects reported. No additional information on AE/No PQC; did not receive her second and third doses until November 2024 and January 2025; did not receive her second and third doses until November 2024 and January 2025; This spontaneous report was received from a consumer and refers to her 16-year-old daughter. The patient's medical history, concurrent conditions, and cncomitant therapies were not reported. In 2019 (when 11 years old), the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (lot #R017134, expiration date: 29-Apr-2021). The second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (lot #Y000205, expiration date: 23-Sep-2026) was administered in November 2024; the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (lot #Y014059, expiration date: 01-Nov-2026) was administered in January 2025 (inappropriate schedule of vaccine administration). No adverse event was reported. More
2853735	4		VA	08/12/2025	MMRV	MERCK & CO. INC.	Z002990	No adverse event, Product storage error No adverse event, Product storage error	No additional AE; HCP reporting that a patient received a dose of improperly stored PROQUAD. Refere... No additional AE; HCP reporting that a patient received a dose of improperly stored PROQUAD. Reference TE case #02843001. HCP reported that she did not know the date the excursion occurred, but knows the PROQUAD was administered following the excursion. HCP reported; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 12-JUN-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Z002990 was valid, expiration date: 14-JUL-2026, 0.5 mL, route of administration and anatomical location were not provided) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis (Product storage error). Temperature excursion of 52.2 F was reported. No symptoms or side effects were reported (No adverse event). More
2853736		F	IL	08/12/2025	MMR	MERCK & CO. INC.		Measles antibody negative Measles antibody negative	patient had a titer for MMR-II done on 4/24/2025, which showed she was low, not consistent with immu... patient had a titer for MMR-II done on 4/24/2025, which showed she was low, not consistent with immunity, below 13.5.; This spontaneous report was received from a health business professional regarding a 65-year-old female patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On an unknown date (reported that it was assumed it was when the patient was a child), the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lyophilizate and solvent for solution for injection, reconstituted with sterile diluent (DSM STERILE DILUENT) solution for injection, as a vaccination (volume of injection, anatomical location, route of administration, lot #, and expiration date were not reported). On 24-Apr-2025, the patient had a titer for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) done, which showed she was low, not consistent with immunity, as it was below 13.5 (unit not reported). At the time of this report, she had not yet been re vaccinated, as she had concerns on receiving live virus, hence she had not recovered from the event. The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided. Lot# is being requested and will be submitted if received. More
2853738	66	F	NY	08/12/2025	VARZOS VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	UNK UNK UNK	Pain, Rash pruritic, Skin burning sensation, Vaccination failure, Zoster sine he... Pain, Rash pruritic, Skin burning sensation, Vaccination failure, Zoster sine herpete; Pain, Rash pruritic, Skin burning sensation, Vaccination failure, Zoster sine herpete; Pain, Rash pruritic, Skin burning sensation, Vaccination failure, Zoster sine herpete More	vaccination failure; internal shingles/burning of skin/pain; itchy rash; This serious case was repor... vaccination failure; internal shingles/burning of skin/pain; itchy rash; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Varicella zoster vaccine live (Oka/Merck) (Zostavax) for prophylaxis. The patient's past medical history included burning sensation. Concurrent medical conditions included blood cholesterol increased, ulcerative colitis and immunocompromised (her immune system was low due to medication HUMIRA). Concomitant products included risankizumab (Skyrizi), adalimumab (Humira) and rosuvastatin calcium (Crestor). Family history included shingles. On 14-SEP-2022, the patient received the 2nd dose of Shingrix. On 14-JUL-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received Zostavax. In NOV-2024, more than 2 years after receiving Shingrix and Shingrix and an unknown time after receiving Zostavax, the patient experienced itchy rash (Verbatim: itchy rash). On 20-MAY-2025, the patient experienced vaccination failure (Verbatim: vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: internal shingles/burning of skin/pain). The patient was treated with prednisone. The outcome of the vaccination failure was unknown and the outcome of the zoster sine herpete was resolved and the outcome of the itchy rash was not resolved. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and itchy rash to be related to Shingrix, Shingrix and Zostavax. It was unknown if the company considered the vaccination failure, zoster sine herpete and itchy rash to be related to Shingrix, Shingrix and Zostavax. Additional Information: GSK Receipt Date: 28-JUL-2025, 29-JUL-2025 Consumer stated that throughout her life she would have a burning feeling on her skin that did not develop into anything, and she does have a family history of Shingles. Also stated that her immune system was low due to medication Humira, and her PCP did lab work that confirmed the consumer had a case of shingles. Consumer did not have any blisters, only pain and burning on her side, therefore, she was diagnosed with internal shingles. Consumer states she had burning of skin around the left side of her trunk from her belly button to her back on the left side. Consumer stated this lasted a few weeks. She stated she was vaccinated in 2016 and the consumer stated she is not sure that she was vaccinated with Shingrix. Consumer wondered if she was vaccinated with Zostavax. Consumer stated in November she fell out of remission when on Humira and the PCP changed her medication to Skyrizi. She was put on prednisone for 6 weeks in November 2024. The consumer also stated since November 2024 she has had a itchy rash on the left side of her trunk and does not know what the rash is. Consumer stated she is unsure if she mentioned this rash to her PCP at the time she was diagnosed with internal shingles and the rash has not resolved and it unsure why the rash did not go away when she was given prednisone.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation of disease) is considered unrelated to GSK Shingrix. More
2853739		M	NE	08/12/2025	MNQ	NOVARTIS VACCINES AND DIAGNOSTICS	Amxb06	Product preparation issue Product preparation issue	Only the liquid portion of the 2 vial Menveo was given; Only the liquid portion of the 2 vial Menveo... Only the liquid portion of the 2 vial Menveo was given; Only the liquid portion of the 2 vial Menveo was given; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number Amxb06, expiry date 31-DEC-2026) for prophylaxis. On 30-JUL-2025, the patient received Menveo (left arm). On 30-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Only the liquid portion of the 2 vial Menveo was given) and inappropriate preparation of medication (Verbatim: Only the liquid portion of the 2 vial Menveo was given). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK receipt date: 30-JUL-2025 The reporter did not know which dose of Menveo but, only the liquid portion of the 2 vial Menveo was given, containing the CY&W component. which led to, inappropriate dose of vaccine administered and inappropriate preparation of medication. The lyophilized was not given. They wanted to know if they need to bring the patient back in to re vaccinate and when should they did this. More
2853740		F	NY	08/12/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	she did not receive the second dose; This non-serious case was reported by a consumer via call cente... she did not receive the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 18th May 2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: she did not receive the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 04-AUG-2025 The consumer was the reporter. The reporter stated that her first dose of Shingrix was administered on 18th May 2023. Consumer stated she did not receive the second dose but will schedule an appointment to have the second dose administered which led to incomplete course of vaccination. More
2853741		F	GA	08/12/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Erythema, Peripheral swelling Erythema, Peripheral swelling	swelling of arm; redness of arm; This non-serious case was reported by a nurse via sales rep and des... swelling of arm; redness of arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of swelling arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. In JUL-2025, the patient received Shingrix (unknown arm) and Pneumococcal vaccine (unknown arm). In JUL-2025, an unknown time after receiving Shingrix and Pneumococcal vaccine, the patient experienced swelling arm (Verbatim: swelling of arm) and erythema of extremities (Verbatim: redness of arm). The patient was treated with antihistamines and steroids. The outcome of the swelling arm and erythema of extremities were resolving. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix and Pneumococcal vaccine. It was unknown if the company considered the swelling arm and erythema of extremities to be related to Shingrix and Pneumococcal vaccine. Additional Information: GSK receipt date: 04-AUG-2025 During a routine customer interaction, it was informed about a patient had a severe swelling reaction to her shoulder and arm requiring antihistamine and oral steroid treatment after receiving her Shingrix immunization. She also reported that she had received a pneumonia immunization at the same time in her other arm. Patient was described as female, mid 60s and that this occurred within the previous month. No other information was provided. More
2853742				08/12/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	suspected vaccination failure; I have shingles now; This serious case was reported by a consumer via... suspected vaccination failure; I have shingles now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-JUL-2025 This case was reported by a patient via interactive digital media. Patient reported that he/she had shingles now but not half as bad when got the shots for it. Also stated that anyone who were having it or had it, get shots it would help. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2853743				08/12/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure	suspected vaccination failure; shingles/still managed to get a small outbreak; This serious case was... suspected vaccination failure; shingles/still managed to get a small outbreak; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/still managed to get a small outbreak). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 04-AUG-2025 This case was reported by a patient via interactive digital media. The patient had poison ivy and two Shingles vaccines and still managed to get a small outbreak. It was not as painful as many of have stated. The physician said that was probably because he/she had the Shingles shots. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Doses 1 and 2). More
2853744				08/12/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Fatigue, Herpes zoster, Pain, Vaccination failure; Fatigue, Herpes zoster, Pain,... Fatigue, Herpes zoster, Pain, Vaccination failure; Fatigue, Herpes zoster, Pain, Vaccination failure More	suspected vaccination failure; had both of my shots but I continue to get a new outbreak every eight... suspected vaccination failure; had both of my shots but I continue to get a new outbreak every eight weeks or so; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included fibromyalgia and autoimmune disorder. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had both of my shots but I continue to get a new outbreak every eight weeks or so). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 30-JUL-2025 This case was reported by a patient via interactive digital media. The reporter reported Shingles were no joke. The patient had both of Shingles shots but continue to get a new outbreak/shingles every eight weeks or so. Some think it's connected to her weakened auto-immune dusty. There was not much could do for either but endure the pain and tiredness. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). More
2853745				08/12/2025	VARZOS VARZOS	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	UNK UNK	Blepharitis, Eyelid ptosis, Herpes zoster, Skin burning sensation, Vaccination f... Blepharitis, Eyelid ptosis, Herpes zoster, Skin burning sensation, Vaccination failure; Blepharitis, Eyelid ptosis, Herpes zoster, Skin burning sensation, Vaccination failure More	suspected vaccination failure; got shingles about two weeks ago for the first time; eyelid inflamed;... suspected vaccination failure; got shingles about two weeks ago for the first time; eyelid inflamed; eyelid drooping; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (The patient received the dose about 10 years ago). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUL-2025, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: got shingles about two weeks ago for the first time). On an unknown date, the patient experienced inflammation of eyelids (Verbatim: eyelid inflamed) and eyelid ptosis (Verbatim: eyelid drooping). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster, inflammation of eyelids and eyelid ptosis were resolved (duration 10 days). It was unknown if the reporter considered the vaccination failure, facial herpes zoster, inflammation of eyelids and eyelid ptosis to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster, inflammation of eyelids and eyelid ptosis to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 04-AUG-2025 This case was reported by a patient via interactive digital media. The patient got a Shingles shot that first came out that he/she think was good for about 10 years. Then they came out with the lifetime Shingles shots where get one and then the second a few months later. It's been a few years till the time of reporting, and he/she got shingles about two weeks ago for the first time from reporting date. It affected face and a strip of it on face's left side. There was a hot burning sensation and right eyelid was inflamed and drooping, badly. Immediate care gave medication and cleared it up within a week. There was also itching. The patient never had it before. The patient had all the shots a few years ago. He/she caught it at its early onset, before 72 hours, and got help. Actually, it took almost 10 days to get it over. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2853746				08/12/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster Herpes zoster	several people who got this jab and got shingles a week later; This non-serious case was reported by... several people who got this jab and got shingles a week later; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patients received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: several people who got this jab and got shingles a week later). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-AUG-2025 This case was reported by a consumer via interactive digital media. The reporter knew several patients who got this Shingles jab and got shingles a week later. More
2853747		M		08/12/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Pain in extremity Pain in extremity	Our arm were quite sore for about a week; This non-serious case was reported by a consumer via inte... Our arm were quite sore for about a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Our arm were quite sore for about a week). The outcome of the pain in arm was resolved (duration 1 week). It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-AUG-2025 This case was reported by a patient via interactive digital media. The patient were at the doctor the minute the vaccine was available. The arm were quite sore for about a week. The patient would did it again in a heartbeat. This was 1 of the 3 cases, reported by the different reporter.; Sender's Comments: US-GSK-US2025AMR101934:same reporter different patient US-GSK-US2025AMR101941:same reporter different patient More
2853748				08/12/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Erythema, Herpes zoster, Ophthalmic herpes zoster, Pruritus, Vaccination failure Erythema, Herpes zoster, Ophthalmic herpes zoster, Pruritus, Vaccination failure	It affected my right eye; singles beginning 9/19/24 on my forehead on the right side; Suspected vac... It affected my right eye; singles beginning 9/19/24 on my forehead on the right side; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On 19-SEP-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: singles beginning 9/19/24 on my forehead on the right side). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: It affected my right eye) (serious criteria GSK medically significant). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 08-AUG-2025 This case was reported by a patient via interactive digital media. Patient had singles beginning 19th September 2024 on his/her forehead on the right side. It affected his/her right eye. It was nearly one year and he/she still had a red mark over his/her eyebrow and itching. If patient had not been vaccinated it would have been much worse. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. A case of Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2853749	13	M	FL	08/12/2025	MNQ	NOVARTIS VACCINES AND DIAGNOSTICS	E4A39	Expired product administered Expired product administered	A 13 years old male patient received an expired dose of Menveo (1 vial); This non-serious case was r... A 13 years old male patient received an expired dose of Menveo (1 vial); This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39, expiry date 30-JUN-2025) for prophylaxis. On 10-JUL-2025, the patient received Menveo. On 10-JUL-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: A 13 years old male patient received an expired dose of Menveo (1 vial)). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 15-JUL-2025 The reporter called to report the administration of an expired dose of Menveo (1 vial) to patient, which led expired vaccine used. The reporter asked what was the safety information, would the patient need another dose. Health care professional mentioned they called the parents of the patient and would repeat the dose at the time of reporting. The reporter consented to follow up. More
2853750	63	M	VA	08/12/2025	MNQ	NOVARTIS VACCINES AND DIAGNOSTICS	9X7CD	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	the administration of a shot of Menveo to a 63-year-old male patient and it was not appropriate for ... the administration of a shot of Menveo to a 63-year-old male patient and it was not appropriate for his age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 63-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 9X7CD, expiry date 31-JAN-2026) for prophylaxis. On 18-JUL-2025, the patient received the 1st dose of Menveo. On 18-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: the administration of a shot of Menveo to a 63-year-old male patient and it was not appropriate for his age). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 23-JUL-2025 On 23 July 2025, a pharmacist called to report the administration of a shot of Menveo to a 63-year-old male patient and it is not appropriate for his age. She wanted to know how to proceed because patient was seeking to have another vaccine in preparation for a travel to . Vaccine was administered on 18 July 2025, one dose. More
2853751	67	M	NE	08/12/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	G75S4	Expired product administered Expired product administered	Expired vaccine used/expired on 05 Jul 2025; This non-serious case was reported by a pharmacist via ... Expired vaccine used/expired on 05 Jul 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G75S4, expiry date 05-JUL-2025) for prophylaxis. On 24-JUL-2025, the patient received Arexvy. On 24-JUL-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Expired vaccine used/expired on 05 Jul 2025). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 25-JUL-2025 The pharmacist called to inform gave an Arexvy vaccine to a patient and realize after giving it that the antigen component of the vaccine expiration date was 05 Jul 2025 which led to Expired vaccine used, checked the adjuvant, and it was in date. According to reporter, the dose was given on 24 Jul 2025. More
2853752	17	F	MO	08/12/2025	MENB MNQ	NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS	5XA2U 9X7DC	Loss of consciousness; Loss of consciousness Loss of consciousness; Loss of consciousness	Patient passed out; This serious case was reported by a nurse via call center representative and de... Patient passed out; This serious case was reported by a nurse via call center representative and described the occurrence of passed out in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9X7DC, expiry date 31-JAN-2026) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) (batch number 5XA2U, expiry date 31-MAY-2028) for prophylaxis. On 31-JUL-2025, the patient received Menveo and Bexsero. On 31-JUL-2025, less than a day after receiving Menveo and Bexsero, the patient experienced passed out (Verbatim: Patient passed out) (serious criteria GSK medically significant). The outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the passed out to be unrelated to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-JUL-2025 The nurse reported that a patient received Menveo (1-vial) along with Bexsero on the day of reporting and she had a reaction, she passed out.; Sender's Comments: A case of Loss of consciousness, less than a day after receiving Menveo, Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE, in a 17-year-old female patient. Causal relation is indeterminate considering multiple vaccines given concomitantly. More
2853753		M	CA	08/12/2025	HEP	GLAXOSMITHKLINE BIOLOGICALS		Inappropriate schedule of product administration Inappropriate schedule of product administration	he didn't get the 2nd dose on time, he just got it a couple days ago; This non-serious case was... he didn't get the 2nd dose on time, he just got it a couple days ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (The 1st vaccination was received in 18-Mar-2025,). In JUL-2025, the patient received the 2nd dose of Engerix B. In JUL-2025, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: he didn't get the 2nd dose on time, he just got it a couple days ago). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-JUL-2025 Pharmacist reported that question was in regards Engerix-B,he/she had an adult patient, who had received primary vaccination. The 1st vaccination was received in 18-Mar-2025, he didn't get the 2nd dose on time, he just got it a couple days ago, which led to Drug dose administration interval too long. The reporter wants to be asked so, gone furthermore 4 months to get the 2nd dose and I'm curious about timing on the 3rd dose, should we still do it at 6 months from the 1st dose? or should we delay it? should he get a 4th dose? Just wondering if there was any data around how to provide the 3rd dose" The HCP didn't mention the 2nd dose vaccination date. More
2853754	56	F	FL	08/12/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	a patient that wants to get the second dose of Shingrix after receiving the first one back on 10.27.... a patient that wants to get the second dose of Shingrix after receiving the first one back on 10.27.2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on 27th October 2020, batch number CZ455, expiry date 16th September 2022). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: a patient that wants to get the second dose of Shingrix after receiving the first one back on 10.27.2020). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 01-AUG-2025 A pharmacist asked how to proceed with a patient that wanted to get the second dose of Shingrix after receiving the first one back on 27th October 2020. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2853755			NE	08/12/2025	MNQ	NOVARTIS VACCINES AND DIAGNOSTICS	UNK	Product preparation issue Product preparation issue	Diluent only; Diluent only; This non-serious case was reported by a other health professional via ca... Diluent only; Diluent only; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Diluent only) and inappropriate preparation of medication (Verbatim: Diluent only). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK receipt date: 01-AUG-2025 The reporter wanted to know what should be done if a patient was given just the liquid component of Menveo 2 vial which led to inappropriate dose of vaccine administration and inappropriate preparation of medication. They reported a mal administration within an hour of the question being asked through the adverse event website so it had already been reported and they were not using this system to report. She just needed to know if the patient needs to be alerted and revaccinated. More
2853756	24	F	CT	08/12/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS	57DD5	Incorrect route of product administration Incorrect route of product administration	Priorix intramuscular instead of subcutaneous administration; This non-serious case was reported by ... Priorix intramuscular instead of subcutaneous administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 24-year-old female patient who received MMR (Priorix) (batch number 57DD5, expiry date 01-DEC-2026) for prophylaxis. On 29-JUL-2025, the patient received Priorix (intramuscular). On 29-JUL-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix intramuscular instead of subcutaneous administration). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 04-AUG-2025 A Health Care Provider wanted to know how to proceed after administering Priorix intramuscularly instead of subcutaneously which led to subcutaneous injection formulation administration by other route. More
2853757		F		08/12/2025	HEP	GLAXOSMITHKLINE BIOLOGICALS		Wrong product administered Wrong product administered	Healthcare Provider did not read the name of the vaccine and gave her Engerix-B.; This non-serious c... Healthcare Provider did not read the name of the vaccine and gave her Engerix-B.; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On 04-AUG-2025, the patient received Engerix B. The patient did not receive Twinrix. On 04-AUG-2025, an unknown time after receiving Engerix B the patient experienced wrong vaccine administered (Verbatim: Healthcare Provider did not read the name of the vaccine and gave her Engerix-B.). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date : 05-AUG-2025 Patient explained she was given the wrong vaccine in the vaccine series, since the healthcare provider gave her the first dose of Twinrix in July, and yesterday on August 4th of 2025 the healthcare provider did not read the name of the vaccine and gave her Engerix-B which led to wrong vaccine administered. Patient wanted to know was there any guidance on what to do. Since Medical Information Specialist was not able to help because they could not give Medical Information to patient, caller abruptly hung up and agent was not able to get any additional details on the case or to ask for consent to follow up with Safety Team. Age of the patient, lot number and expiration date were not asked during the call. More
2853758		F	CO	08/12/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Incorrect route of product administration Incorrect route of product administration	Inappropriate Route of Administration (Subcutaneously instead of Intramuscularly); This non-serious ... Inappropriate Route of Administration (Subcutaneously instead of Intramuscularly); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 05-AUG-2025, the patient received Shingrix (subcutaneous). On 05-AUG-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Inappropriate Route of Administration (Subcutaneously instead of Intramuscularly)). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK Receipt Date: 06-AUG-2025 The pharmacist reported that a patient was administered Shingrix subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The pharmacist wants guidance on this situation. The Vaccine Administration Facility is the same as Primary Reporter More
2853759	12	F	KS	08/12/2025	MNQ	NOVARTIS VACCINES AND DIAGNOSTICS	342DD	Extra dose administered Extra dose administered	Vaccine extra dose; This non-serious case was reported by a nurse via call center representative and... Vaccine extra dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 342DD, expiry date 30-APR-2026) for prophylaxis. Previously administered products included Menveo (received 1st dose in June 2024). On 30-JUN-2025, the patient received the 2nd dose of Menveo. On 30-JUN-2025, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: Vaccine extra dose). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 30-AUG-2025 The nurse reported that the patient received two doses of Menveo one year apart, at age 11 and age 12, which led to extra dose administered. First dose was administered back in June 2024 and last one on 30 June 2025. The reporter was ask there any harm since it was not spaced correctly. The vaccine administration facility was the same as primary reporter. More
2853761	77	M		08/12/2025	COVID19	MODERNA		COVID-19 COVID-19	contracted COVID-19 despite being vaccinated; This spontaneous case was reported by a consumer and d... contracted COVID-19 despite being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19 despite being vaccinated) in a 77-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Cancer and Immunocompromised. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID-19 despite being vaccinated). At the time of the report, COVID-19 (contracted COVID-19 despite being vaccinated) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient didn't experienced symptoms following vaccination and mentioned that his immune system was somewhat compromised due to a past cancer diagnosis. Furthermore, he contracted COVID-19 despite being vaccinated but recovered without complications. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. More
2853762				08/12/2025	COVID19	PFIZER\BIONTECH		Diarrhoea, Neoplasm malignant, Systemic lupus erythematosus Diarrhoea, Neoplasm malignant, Systemic lupus erythematosus	lupus; cancer; diarrhea; The initial case was missing the following minimum criteria: Unidentifiable... lupus; cancer; diarrhea; The initial case was missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on (03Feb2025), this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853763				08/12/2025	COVID19	PFIZER\BIONTECH		Alopecia Alopecia	lose a ton of hair within a few days of getting it; This is a spontaneous report received from a Con... lose a ton of hair within a few days of getting it; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "lose a ton of hair within a few days of getting it". Additional information: Chat question Verbatim: If your covid 19 vaccine caused me to lose a ton of hair within a few days of getting it, what disorder do I have and what are the remedies? No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853764				08/12/2025	COVID19	PFIZER\BIONTECH		Autoimmune disorder Autoimmune disorder	I am suffering with an auto immune disease after my second covid vaccine, what should I do?; This is... I am suffering with an auto immune disease after my second covid vaccine, what should I do?; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "I am suffering with an auto immune disease after my second covid vaccine, what should I do?". Clinical course: AE description: Unique Identification number: NA, UTC Time stamp: 08Aug2025 7:20:30AM, Chat question Verbatim: I am suffering with an auto immune disease after my second covid vaccine, what should I do? No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853765		F		08/12/2025	COVID19	PFIZER\BIONTECH		Myelodysplastic syndrome Myelodysplastic syndrome	MDS; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old female p... MDS; This is a spontaneous report received from a Consumer or other non HCP. A 63-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELODYSPLASTIC SYNDROME (disability, medically significant), outcome "not recovered", described as "MDS". It was unknown if therapeutic measures were taken as a result of myelodysplastic syndrome. Clinical course: Patient self reports that, FMD that she has MDS as a result of the Covid vaccination. It was unknown that other vaccine was received on same date, other vaccine in four weeks and other medications in two weeks. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More		✓
2853766	37	F	PA	08/12/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH	FF2587 FF2587 FF2587 FF2587 FF2587 FF2587	COVID-19, Drug ineffective; Catheterisation cardiac, Dyspnoea, Echocardiogram, M... COVID-19, Drug ineffective; Catheterisation cardiac, Dyspnoea, Echocardiogram, Malaise, Muscle atrophy; Pulmonary arterial hypertension; COVID-19, Drug ineffective; Catheterisation cardiac, Dyspnoea, Echocardiogram, Malaise, Muscle atrophy; Pulmonary arterial hypertension More	3 weeks later got covid really bad; 3 weeks later got covid really bad; This is a spontaneous report... 3 weeks later got covid really bad; 3 weeks later got covid really bad; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose 1, single (Lot number: FC3180), in arm and on 10Sep2021 as dose 2, single (Lot number: FF2587), in arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "3 weeks later got covid really bad".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500160813 same patient, different dose/events; More
2853768		F	TX	08/12/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report received from a Consu... diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient have been taking the Pfizer vaccine for COVID every six months and today it was reported that patient was still diagnosed with COVID-19 on an unspecified date. She was prescribed with unspecified medication and was very expensive. Outcome of the events was unknown. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2853769				08/12/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	got covid vaccine from Pfizer but still ended up with covid; got covid vaccine from Pfizer but still... got covid vaccine from Pfizer but still ended up with covid; got covid vaccine from Pfizer but still ended up with covid; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got covid vaccine from Pfizer but still ended up with covid". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853770		F		08/12/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	it didn't work for her because she got covid now; it didn't work for her because she got c... it didn't work for her because she got covid now; it didn't work for her because she got covid now; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "it didn't work for her because she got covid now". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2853771			NY	08/12/2025	COVID19	PFIZER\BIONTECH		Vision blurred Vision blurred	after getting 3 shots with booster my eyes started to get blurry; This is a spontaneous report recei... after getting 3 shots with booster my eyes started to get blurry; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "after getting 3 shots with booster my eyes started to get blurry". Additional information: Patient read in the news that Pfizer covid vaccine causes eye damages and reported "after getting 3 shots with booster my eyes started to get blurry". More
2853772	0.42	M	NC	08/12/2025	DTAPIPV HIBV PNC20	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH	42Y93 Y013911 LK6653	No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More	No adverse event; patient was given Kinirix instead of Pediarix. This error was not noticed on the d... No adverse event; patient was given Kinirix instead of Pediarix. This error was not noticed on the date of administration it was noticed today 8/12/25 when patient is scheduled to come in for his 6 month well check. Vaccine was given on 7/10/25 by new staff CNA. More
2853773	3	F	AL	08/12/2025	DTAPIPV MMRV	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	3rt93 Z009075	No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More	Kinrix (DTAP-IPV) vaccination was administered on 8.7.25 in error to a 3 year 11-month-old child req... Kinrix (DTAP-IPV) vaccination was administered on 8.7.25 in error to a 3 year 11-month-old child requiring DTap and Polio vaccinations. Immunization registry accepted the vaccination as a valid dose. No adverse reactions noted. More
2853774	24	M	MA	08/12/2025	TDAP TDAP	SANOFI PASTEUR SANOFI PASTEUR		Arthralgia, Blood test normal, Exercise tolerance decreased, Injection site pain... Arthralgia, Blood test normal, Exercise tolerance decreased, Injection site pain, Sleep disorder; X-ray limb normal More	Pain and soreness in left shoulder coming from the site of the shot. Anti-inflammatories did not hel... Pain and soreness in left shoulder coming from the site of the shot. Anti-inflammatories did not help. Pain lasted for 2 months and impacted sleep and ability to exercise. X-ray showed no bone damage and blood tests showed no infection. More
2853775	69	F	FL	08/12/2025	COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19	MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA	040CF21A 040CF21A 040CF21A 040CF21A 040CF21A 040CF21A 004F21A 004F21A 004F21A 004F21A 004F21A 004F21A B4S1521 B4S1521 B4S1521 B4S1521 B4S1521 B4S1521	Acoustic stimulation tests, Alopecia, Anxiety, Blood test, Brain fog; Chest X-ra... Acoustic stimulation tests, Alopecia, Anxiety, Blood test, Brain fog; Chest X-ray, Chills, Cholecystectomy, Colonoscopy, Computerised tomogram abdomen; Computerised tomogram head, Decreased appetite, Depression, Electrocardiogram, Endoscopy upper gastrointestinal tract; Fatigue, Headache, Hepatobiliary scan, Hyperacusis, Inflammation; Insomnia, Laboratory test, Nausea, Palpitations, Parosmia; Pyrexia, Rash; Acoustic stimulation tests, Alopecia, Anxiety, Blood test, Brain fog; Chest X-ray, Chills, Cholecystectomy, Colonoscopy, Computerised tomogram abdomen; Computerised tomogram head, Decreased appetite, Depression, Electrocardiogram, Endoscopy upper gastrointestinal tract; Fatigue, Headache, Hepatobiliary scan, Hyperacusis, Inflammation; Insomnia, Laboratory test, Nausea, Palpitations, Parosmia; Pyrexia, Rash; Acoustic stimulation tests, Alopecia, Anxiety, Blood test, Brain fog; Chest X-ray, Chills, Cholecystectomy, Colonoscopy, Computerised tomogram abdomen; Computerised tomogram head, Decreased appetite, Depression, Electrocardiogram, Endoscopy upper gastrointestinal tract; Fatigue, Headache, Hepatobiliary scan, Hyperacusis, Inflammation; Insomnia, Laboratory test, Nausea, Palpitations, Parosmia; Pyrexia, Rash More	Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, inso... Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine More
2853776	13	F	TX	08/12/2025	UNK	UNKNOWN MANUFACTURER		Adverse reaction, Critical illness, Disorganised speech, Dysarthria Adverse reaction, Critical illness, Disorganised speech, Dysarthria	On the day patient received the vaccination and had a consultation with the nurse, she exhibited sev... On the day patient received the vaccination and had a consultation with the nurse, she exhibited severe physiological symptoms, including inability to articulate complete sentences and disorganized speech. She appeared critically ill, suggesting an adverse reaction potentially induced by the administered substance. Given that the facility is not our primary pediatric care provider and lacks access to patient's comprehensive medical history, appropriate medical assessment was unavailable. The severity of her condition indicated possible syncope or blackout. I contacted local law enforcement authorities to report the incident. More		✓
2853777	18	M	VA	08/12/2025	HEP HPV9	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.	4BX39 Z005055	Blood glucose, Dizziness, Loss of consciousness; Blood glucose, Dizziness, Loss ... Blood glucose, Dizziness, Loss of consciousness; Blood glucose, Dizziness, Loss of consciousness More	Patient went to sit down in lobby after vaccines were administered, stated he was feeling lightheade... Patient went to sit down in lobby after vaccines were administered, stated he was feeling lightheaded and passed out in chair for less than a minute after. We called hospital EMT service to look at the patient checked vitals, bp. blood sugar, gave juice. Patient was in good stable condition and went home. More
2853778	13	F	MS	08/12/2025	TDAP TDAP TDAP TDAP	SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR	U8122AA U8122AA U8122AA U8122AA	Basophil percentage decreased, Blood creatinine decreased, Blood glucose, Blood ... Basophil percentage decreased, Blood creatinine decreased, Blood glucose, Blood urea increased, Chest X-ray normal; Computerised tomogram head normal, Differential white blood cell count, Full blood count normal, Gaze palsy, Loss of consciousness; Mean cell volume decreased, Platelet count increased, Protein urine present, Red cell distribution width normal, Seizure; Somnolence, Unresponsive to stimuli More	Pt given vaccine according to protocol. Pt and mother went out of building to their car. Pt began se... Pt given vaccine according to protocol. Pt and mother went out of building to their car. Pt began seizing in passenger side of vehicle. Pt then lost consciousness for approximately 30-45 seconds. Two nurses went to assess pt and stated pt not breathing. Nurse performed sternal rub. Pt oriented, then 1st nurse went to pt and witnessed 2nd seizure. Nurse called 911 then fire and ambulance arrived. Took pt to hospital. BP 81/36 then 82/41. Per record review: CT Head - Impression: No CT evidence of acute intracranial hemorrhage or midline shift. Portable CXR - Impression: No active chest disease Glucose in ER - 85 CBC & Differential Abnormal. Notable for the following components: MCV 78.1 RDW 14.1 Platelets 416 Basophils 0.02 All other components WNL CMP Abnormal; notable for the following BUN 37 Creatinine 0.2 Urinalysis Reflex Culture Abnormal; Notable for the following components: Urine Protein Qual Random 1+ Bacteria Urine Rare Discharge VS B/P 121/50, Pulse 74, Temp 98.4, Resp 18, Oxygen Sat 95% Medications at time of Discharge DiazePAM 10 mg insert 10 mg into the rectum every 6 hours if needed for seizures up to 4 doses Discharge Disposition Routine MD Note: "Patient is a 13 y/o female presenting with a chief complaint of Seizures. Brought in by mom with chief complaint of seizure like activity. Otherwise healthy. No chronic medications. Was ate health department today receiving a tetanus update for school. She tolerated the immunization without difficulty. However on arrival to the car she became sleepy. Mother states she caught her out of the corner of her eye flapping her arms. Her eyse rolled back in her head and she was unresponsive. She did this twice. Each time lasted for about 1 minute. Mother states she has another child who has febrile seizures but reports that these were different because the patient was not postictal. Child denies alcohol, tobacco or illicit drugs. No recent falls or injuries. No recent illnesses. Takes occasional Benadryl for fluid on the ear. No over the counter medications. More
2853779	13	F	TX	08/12/2025	COVID19	MODERNA		Cerebrovascular accident, Neoplasm malignant, Thrombosis Cerebrovascular accident, Neoplasm malignant, Thrombosis	Two cancers, a stroke, blood clots Two cancers, a stroke, blood clots	✓	✓
2853780	16	M	ND	08/12/2025	MENB MNQ	PFIZER\WYETH SANOFI PASTEUR		Cyanosis, Nausea, Pallor, Respiratory rate decreased, Vomiting; Cyanosis, Nausea... Cyanosis, Nausea, Pallor, Respiratory rate decreased, Vomiting; Cyanosis, Nausea, Pallor, Respiratory rate decreased, Vomiting More	Seconds after vaccine administration PT became pale, lips blue, and slowed breathing. Pt laid his ... Seconds after vaccine administration PT became pale, lips blue, and slowed breathing. Pt laid his head back in the chair. He became sweaty, nurse applied cold packs to neck and forehead. Nurse reminded him to deep breath as he had very shallow breathing. He did state he felt like he was going to puke. Nurse moved garbage can close to him, he did vomit minutes later. Once he vomitted, color came back ,lips normal color, and Pt felt much better. Time course of his adverse event was about half an hour until he vomitted and felt better again. More

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