🏥 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:

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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)
VAERS ID: Search for specific report by ID number
Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
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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 10,001 to 10,050 of 34,052 reports (Page 201 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative
2857661		F		09/09/2025	HPV4	MERCK & CO. INC.		Postural orthostatic tachycardia syndrome Postural orthostatic tachycardia syndrome	Pt was diagnosed with POTS about 3-4 years ago. She attributes it to the GARDASIL vaccine.; This spo... Pt was diagnosed with POTS about 3-4 years ago. She attributes it to the GARDASIL vaccine.; This spontaneous report was received from a Consumer or other non-health professional and refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2021 (reported as "about 3-4 years ago"), the patient was diagnosed with Postural orthostatic tachycardia syndrome (POTS). The outcome of the event was unknown. The reporter attributed the Postural orthostatic tachycardia syndrome to the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccine, based on the book in her post and information they heard from other people before the book came out. The reporter did not know if a direct causal relationship between POTS and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was actually established by her doctor. Lot # is being requested and will be submitted if received. More
2857662	16	F	NC	09/09/2025	UNK UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration More	patient had completed the full quadrivalent HPV vaccination, administered at ages 16, 18, and 19 (sh... patient had completed the full quadrivalent HPV vaccination, administered at ages 16, 18, and 19 (she completed the full series); This literature report has been received from the authors of the published article and refers to a 18-year-old female patient (at the report time was 26-year-old). The patient's medical history included chronic tonsillitis. The patient's concurrent conditions included human papillomavirus (HPV)-associated pathology. Concomitant therapies were not reported. On an unknown date at the age of 16, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, dose number 1, (lot # and expiration date were not reported). On an unknown date at the age of 18, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, dose number 2, (lot # and expiration date were not reported). On an unknown date at the age of 19, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, dose number 3, (lot # and expiration date were not reported) as a prophylaxis. Therefore, the patient had completed the full quadrivalent HPV vaccination, administered at ages 16, 18, and 19 (she completed the full series) (Inappropriate schedule of product administration). A copy of the published article is attached as further documentation of the patient's experience. Literature report: More
2857663		F	TX	09/09/2025	VARCEL	MERCK & CO. INC.	Z004454	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	No other AE; VARIVAX was inadvertently administered today (2SEP2025) to a female child who is 4 mont... No other AE; VARIVAX was inadvertently administered today (2SEP2025) to a female child who is 4 months and 8 days old; This spontaneous report was received from a health professional and refers to a 4-month-old (reported as "4 months and 8 days old") female patient. Her medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 02-Sep-2025, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), batch/lot #Z004454 has been verified to be a valid batch lot number for Varicella Virus Vaccine Live (Oka-Merck), expiration date reported and upon internal validation confirmed as 13-Feb-2027, 0.5 mL, which was diluted with sterile diluent (BAXTER STERILE DILUENT) (batch/lot# 2053170, expiration date reported and upon internal verification confirmed as 20-Mar-2027) and administered as prophylaxis (dosage regimen, anatomical location and route of administration were not reported) (product administered to patient of inappropriate age.) No further information was provided. No other adverse events (AEs) were reported (no adverse event.) More
2857664			MA	09/09/2025	MMR	MERCK & CO. INC.	X014954	Expired product administered, No adverse event Expired product administered, No adverse event	Precautionary AE being filed as caller requested expiration date for MMR II lot X014954 and states s... Precautionary AE being filed as caller requested expiration date for MMR II lot X014954 and states she believes there was a "mis-documentation by a new employee". Precautionary AE for expired vaccine being administered. Caller abandoned call while; No additional AE/PQC reported.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X014954, which has been verified to be valid, expiration date: 24-May-2025, reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT, administered for prophylaxis (Expired product administered). No additional adverse event was reported (no adverse event). This is an invalid case due to the lack of patient's identifiers. More
2857665			WA	09/09/2025	MMRV	MERCK & CO. INC.	Y005919	No adverse event, Product storage error No adverse event, Product storage error	no adverse event; TE. PROQUAD was administered to one patient; This spontaneous report was received ... no adverse event; TE. PROQUAD was administered to one patient; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-Aug-2025, the patient was vaccinated with an improperly stored vaccine of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Powder and solvent for solution for injection (lot #Y005919, expiration date: 13-Mar-2026), 0.5 mL, total, (route of administration and anatomical location were not provided) as prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not provided) (Product storage error). The improperly stored vaccine underwent a temperature excursion of 5 degrees Fahrenheit (F) for 1 hour and 3 minutes without previous excursions. No adverse events were reported. More
2857666	39		NY	09/09/2025	VARCEL	MERCK & CO. INC.	Z008196	No adverse event, Product storage error No adverse event, Product storage error	No additional AE; HCP called to report a TE for VARIVAX. See TE Case 02867289. Caller reported that... No additional AE; HCP called to report a TE for VARIVAX. See TE Case 02867289. Caller reported that vaccine was administered to multiple patients on 8/21/2025 (see all AE cases below for reference). No additional patient information provided at the time of the call; This spontaneous report was received from a nurse practitioner and refers to a 39-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-Aug-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0,5 mL (lot #Z008196 with expiration date reported as and upon internal validation confirmed to be 30-Apr-2027) (route of administration and vaccination site were not reported) administered for prophylaxis. The reporter noted a temperature excursion (TE) for the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (temperature -11.8C; time frame: 0 hours 45 minutes 0 seconds; previous temperature excursion: no) (product storage error). The vaccine was administered to multiple patients. No additional patient information was provided at the time of the call. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). This was one of several reports received from the same reporter. More
2857667	1	F	NH	09/09/2025	MMRV VARCEL	MERCK & CO. INC. MERCK & CO. INC.	Z010729 Z008194	Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More	No symptomatic adverse events to report; A 13 month old female patient received PROQUAD and VARIVAX ... No symptomatic adverse events to report; A 13 month old female patient received PROQUAD and VARIVAX concomitantly together by accident.; This spontaneous report was received from a Registered Nurse and refers to a 13-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Sep-2025, the patient was accidentally vaccinated with both Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z010729, expiration date: 22-Dec-2026) 0.5 mL and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z008194, expiration date: 30-Apr-2027) 0.5 mL, both vaccines given as prophylaxis (accidental overdose). Both vaccines were reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (indication, expiration date, and lot # were not reported). No adverse event was reported. More
2857668			PA	09/09/2025	HEPA	MERCK & CO. INC.	Y017625	Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event	No additional AE/no PQC reported.; Nurse called and reported that an adult dose of VAQTA was inadver... No additional AE/no PQC reported.; Nurse called and reported that an adult dose of VAQTA was inadvertently administered to a pediatric patient. Caller stated no patient symptoms have been reported. Caller stated this also occurred for one other patient, see AE case #02866506. No addit; This spontaneous report has been received from an other health professional, regarding to a 13-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with an adult dose instead of a pediatric dose (Accidental overdose) of Hepatitis A Vaccine, inactivated (VAQTA), as prophylaxis, lot number Y017625 which had been verified to be a valid number; expiration date 11-JUL-2026 (route of administration, and anatomical site of injection were not reported). No additional adverse events were reported in the patient. More
2857669			VA	09/09/2025	MMRV	MERCK & CO. INC.	Y017512	No adverse event, Product storage error No adverse event, Product storage error	No additional AE; administering PROQUAD after experiencing a temperature excursion; This spontaneous... No additional AE; administering PROQUAD after experiencing a temperature excursion; This spontaneous report was received from a Physician Assistant (reported as medical assistant) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), administered for prophylaxis (lot number Y017512 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date 19-APR-2026; dose, formulation, route of administration, anatomical site of injection and dose number were not provided), which was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (expiration date, and lot number were not reported). The vaccine was administered after a temperature excursion (TE) at -13.4 degree Celsius (C) for 9 hours and 32 minutes, with a previous TE at -12.9 degree C for 2 hours and 22 minutes (Product storage error). No additional adverse event was reported for the patient. This is one of several reports received from the same reporter. More
2857670			CO	09/09/2025	MMRV	MERCK & CO. INC.	Y018161	No adverse event, Product storage error No adverse event, Product storage error	Nurse confirmed no reports of medical concerns regarding this report.; a dose of PROQUAD was exposed... Nurse confirmed no reports of medical concerns regarding this report.; a dose of PROQUAD was exposed to a temperature excursion today, 9/5/2025, and administered to a patient shortly after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported. On 05-Sep-2025, a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y018161, expiration date: 29-Apr-2026) was exposed to a temperature excursion. On that day (shortly after the excursion), this improperly stored vaccine was administered to a patient, 0.5 mL / Two dose series, as prophylaxis (product storage error). This vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (expiration date, and lot # were not reported). It was confirmed that there were no reports of medical concerns regarding this report (no adverse event). More
2857671			VA	09/09/2025	MMRV	MERCK & CO. INC.	Y017512	No adverse event, Product storage error No adverse event, Product storage error	administering PROQUAD after experiencing a temperature excursion.; no adverse event; This spontaneou... administering PROQUAD after experiencing a temperature excursion.; no adverse event; This spontaneous report was received from a health professional (other) and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient received Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017512, expiration date: 19-Apr-2026) (dose, route was not reported) for prophylaxis, which was reconstituted with sterile diluent (lot# and expired date was not reported). The administered vaccine was experiencing a temperature excursion with -13.4 degree C for 9 Hours 32 Minutes (Product storage error). There was a previous temperature excursion with -12.9 degree C for 2 hours 22 minutes. No adverse event was reported. This is one of several reports from the same reporter. More
2857672	80	F		09/09/2025	UNK	UNKNOWN MANUFACTURER	UNK	Atrial fibrillation Atrial fibrillation	Atrial Fibrillation; This 82-year-old female subject was enrolled in an open label study titled A ph... Atrial Fibrillation; This 82-year-old female subject was enrolled in an open label study titled A phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and above. The subject received the 2nd dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) .5 ml on 05-APR-2023, for prophylaxis. The subject's past medical history included pulmonary embolism. Concurrent medical conditions included alcohol use (twice weekly), hypothyroidism, chronic kidney disease stage 3, peripheral vascular disease, obesity and hypertension. On 01-AUG-2024, 484 days after receiving RSVPreF3 vaccine + AS01E, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included clinically significant/intervention required. The subject was treated with amlodipine. The outcome of atrial fibrillation was resolved on 01-AUG-2024. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2021107290, US2022GSK148516, US2024125639, US2024125641 GSK Receipt Date: 11-OCT-2024 On 01 AUG 2024 at Cardiologist appointment Doctor stated subject was in Atrial Fibrillation. Subject received prescription and cardiac catheterization was scheduled, which was pending. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 22-Oct-2024 Summary of changes: Past medical history and concurrent medical conditions added.; Sender's Comments: A case of Atrial fibrillation, 484 days after receiving 2nd dose of RSVPreF3 vaccine + AS01E in a 82-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor (Age, past medical history included pulmonary embolism, chronic kidney disease stage 3, peripheral vascular disease, obesity and hypertension). US-GSK-US2024125639: US-GSK-US2024125641: More
2857673	1	F	CO	09/09/2025	TDAP	GLAXOSMITHKLINE BIOLOGICALS	cx4hl	Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered	patient received Boostrix instead of DTaP; inappropriate age; This non-serious case was reported by ... patient received Boostrix instead of DTaP; inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number cx4hl, expiry date 09-NOV-2026) for prophylaxis. Co-suspect products included DTPa (DTaP vaccine) for prophylaxis. On 21-JUL-2025, the patient received Boostrix (intramuscular) .5 ml. On an unknown date, the patient did not receive DTaP vaccine. On 21-JUL-2025, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: patient received Boostrix instead of DTaP) and inappropriate age at vaccine administration (Verbatim: inappropriate age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 12-AUG-2025 The patient did not have any other conditions and did not receive any other products. The patient received a dose of Tdap (Boostrix) when DTaP should have been administered (medication error or inappropriate age), which led to wrong vaccine administered and inappropriate age at vaccine administration. No further information was provided or obtained. More
2857674	66	F	TX	09/09/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	2Xb45 2Xb45	Cold flash, Eye pain, Headache, Hot flush, Injection site pain; Injection site s... Cold flash, Eye pain, Headache, Hot flush, Injection site pain; Injection site swelling, Insomnia, Nausea, Neck pain, Pain More	Injection site pain; Injection site swelling; Nausea; Headache; Eye pain; Insomnia; neck pain exacer... Injection site pain; Injection site swelling; Nausea; Headache; Eye pain; Insomnia; neck pain exacerbated; hot/cold flashes; hot/cold flashes; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number SSDB9, expiry date 26-APR-2027) and (batch number 2Xb45, expiry date 26-APR-2027) for prophylaxis. Concurrent medical conditions included fibromyalgia, rheumatoid arthritis and chronic pain (Neck pain from 2 failed surgeries). Concomitant products included acyclovir, duloxetine, meloxicam, hydrochlorothiazide, valsartan (Valsartan Hctz), levothyroxine and ezetimibe (Zetia). On 23-AUG-2025 12:30, the patient received Shingrix (intramuscular, left deltoid). On 23-AUG-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site swelling (Verbatim: Injection site swelling), nausea (Verbatim: Nausea), headache (Verbatim: Headache), eye pain (Verbatim: Eye pain), insomnia (Verbatim: Insomnia), neck pain (Verbatim: neck pain exacerbated), hot flashes (Verbatim: hot/cold flashes) and cold flash (Verbatim: hot/cold flashes). In AUG-2025, the outcome of the hot flashes and cold flash were resolved (duration 4 hrs). On 24-AUG-2025, the outcome of the injection site swelling, nausea and eye pain were resolved (duration 1 day). The outcome of the injection site pain, headache, insomnia and neck pain were not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, nausea, headache, eye pain, insomnia, neck pain, hot flashes and cold flash to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site swelling, nausea, headache, eye pain, insomnia, neck pain, hot flashes and cold flash to be related to Shingrix. Additional Information: GSK receipt date: 25-AUG-2025 Most of the symptoms were resolved within 4 hours, but the headache, injection site pain and insomnia and neck pain are ongoing. The pharmacist did not provide the correct lot number from the Shingrix box, but provided lot numbers for the two separate components More
2857675		F		09/09/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK	Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete cours... Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete course of vaccination More	mild case of shingles; forgot to have the second dose administered in the recommended time of 2 to 6... mild case of shingles; forgot to have the second dose administered in the recommended time of 2 to 6 months later; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (prior to her first dose of Shingrix she did have a bout of Shingles). On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: mild case of shingles) and incomplete course of vaccination (Verbatim: forgot to have the second dose administered in the recommended time of 2 to 6 months later). The outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: Patient had her first dose of Shingrix administered in 2020 but forgot to have the second dose administered in the recommended time of 2 to 6 months later. Patient stated in the last couple of weeks she has had a mild case of shingles (lack of effect.) Consumer states she did not have a rash with the case of shingles but only had pain. More
2857676				09/09/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Malaise Malaise	Sick; This non-serious case was reported by a consumer via interactive digital media and described t... Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-AUG-2025 This case was reported by a patient via interactive digital media. The reporter reported it was a 2-part Shingles vaccine. The reporter reported the second dose of Shingles get anywhere from 2 to 6 months after the first. The patient got sick after the first dose of Shingles vaccine, and he/she really did not want to go back for the second one. More
2857677				09/09/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Its been ovet a year to get second shingles shot; This non-serious case was reported by a consumer v... Its been ovet a year to get second shingles shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose over a year ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Its been ovet a year to get second shingles shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a patient via (Shingrix GSK chatbot) interactive digital media. The patient received 1st dose dose and it had been over a year. The patient asked should get the second shingles shot. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2857678				09/09/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Rash, Rash erythematous, Rash pruritic Rash, Rash erythematous, Rash pruritic	developed little red, itchy bumps that started mainly on chest and belly; developed red, itchy bumps... developed little red, itchy bumps that started mainly on chest and belly; developed red, itchy bumps that started mainly on chest and belly; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of itchy rash 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 itchy rash (Verbatim: developed little red, itchy bumps that started mainly on chest and belly) and erythema (Verbatim: developed red, itchy bumps that started mainly on chest and belly). The outcome of the itchy rash and erythema were not reported. Additional Information: GSK receipt date: 27-AUG-2025 Reporter's doctor said that it was chi. More
2857679				09/09/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Malaise Malaise	Vaccine made me very sick for more than a week; This non-serious case was reported by a consumer via... Vaccine made me very sick for more than a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Vaccine made me very sick for more than a week). The outcome of the sickness was resolved. The reporter considered the sickness to be related to Shingles vaccine. The company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a patient via interactive digital media. The patient did not want shingles but the Shingles vaccine made him/her very sick for more than a week. The patient was afraid to get the second Shingles vaccine. More
2857680		F		09/09/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Injection site swelling Injection site swelling	Swelling about 4 inches around from the injection site; This non-serious case was reported by a phys... Swelling about 4 inches around from the injection site; This non-serious case was reported by a physician and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Swelling about 4 inches around from the injection site). The outcome of the injection site swelling was resolved. It was unknown if the reporter considered the injection site swelling to be related to Shingrix. It was unknown if the company considered the injection site swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 27-AUG-2025 The physician reported that with the 1st dose of Shingrix the patient did fine and with 2nd dose of Shingrix the patient had swelling about 4 inches around from the injection site. The patient recovered and was glad she got the Shingrix vaccine More
2857681		M		09/09/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected Vaccination failure; worse episode of the shingles; This serious case was reported by a co... Suspected Vaccination failure; worse episode of the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: worse episode of the shingles). 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. 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: 29-AUG-2025 This case was reported by a patient via interactive digital media. The reporter said one guy said he got the shingles and when he did get the shot, he had a worse episode of the shingles. 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: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2025AMR114106:Original Case Number : US2025AMR112713 More
2857682				09/09/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; Shingles; 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 shingles (Verbatim: Shingles). 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. 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: 03-SEP-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine and still got shingles and probably was not as bad as it could've been. The patient was landed at the doctors twice and the emergency department. The patient said thank goodness and said got the vaccine and did not think the patient could have survived This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2857683				09/09/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected vaccination failure; two years later got the Shingles; This serious case was reported by a... Suspected vaccination failure; two years later got the Shingles; 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, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: two years later got the Shingles). 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. 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-AUG-2025 This case was reported by a patient via interactive digital media. The patient stated that he/she was through no more vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, 2 years after receiving Shingles vaccine, in a subject. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2857684				09/09/2025	RVX	UNKNOWN MANUFACTURER	UNK	Extra dose administered Extra dose administered	took the RSV vaccination last year. And found out that I had taken it the previous year; This non-se... took the RSV vaccination last year. And found out that I had taken it the previous year; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Previously administered products included RSV vaccine (received 1st dose of vaccine in 2023). On an unknown date, the patient received the 2nd dose of RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced extra dose administered (Verbatim: took the RSV vaccination last year. And found out that I had taken it the previous year). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 30-AUG-2025 Patient took the RSV vaccination in 2024 (last year) and found out that patient had taken it the previous year. Patient was not told that it only was given once not yearly, which led to extra dose administered. More
2857685		M		09/09/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	UNK	Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure	Suspected vaccination failure; RSV; This serious case was reported by a consumer via call center rep... Suspected vaccination failure; RSV; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. It was unknown if the company considered the respiratory syncytial virus infection to be related to Arexvy. Additional Information: GSK receipt date: 01-SEP-2025 Reporter's husband and reporter had the RSV vaccine and did get RSV. Reporter asked if they should get an RSV booster. This case was considered as suspected vaccination failure as details regarding time to onset for RSV and laboratory confirmation regarding RSV were unknown at the time of reporting. This case was linked with US2025AMR114320 reported by same reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving unknown dose of Arexvy, in a male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. GSK-US2025AMR114320:same reporter /different patient More
2857686	1	F	MN	09/09/2025	DTAPHEPBIP DTAPHEPBIP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	39KS9	Extra dose administered, Inappropriate schedule of product administration; Extra... Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration More	Extra dose administered; received 3rd dose late; This non-serious case was reported by a physician v... Extra dose administered; received 3rd dose late; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 39KS9, expiry date 07-SEP-2025) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Pediarix (received 1st dose on 02-DEC-2020) and Pediarix (received 2nd dose on 07-FEB-2021). On 31-JUL-2025, the patient received the 4th dose of Pediarix. On 29-OCT-2021, the patient received the 3rd dose of Pediarix. On 29-OCT-2021, not applicable after receiving Pediarix and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: received 3rd dose late). On 31-JUL-2025, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered and drug dose administration interval too long were 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: 12-AUG-2025 The reporter had two pediatric patients in my clinic that received the Pediarix product on 31st July 2025 and when it was administered, after it was administered, the nurse figure out that neither of the patients that got that product, needed the Hep B and got actually a Fourth of the Hep B component, the Hepatitis B component which led to extra dose administered. So, the reporter wondering if there was any follow-up recommended from the manufacturer on that. They both completed the Hep B series and so they got a fourth dose of Hepatitis B what was not recommended. The patient received 3rd dose longer than recommended schedule which led to lengthening of vaccination schedule.; Sender's Comments: US-GSK-US2025104399:for 1 st patient More
2857687		F	AL	09/09/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	A patient received the 1st dose of Shingrix over a year ago and now she wants the second dose.; This... A patient received the 1st dose of Shingrix over a year ago and now she wants the second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose was received on 22-JUN-2024, batch number:9C514 and expiry date:26-OCT-2026). Additional patient notes included First dose Batch No.9C514 and Expiry date 26-OCT-2026. The patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time, the patient experienced incomplete course of vaccination (Verbatim: A patient received the 1st dose of Shingrix over a year ago and now she wants the second dose.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 25-AUG-2025 The patient got her first dose of Shingrix on 22-JUN-2024 and it had been over a year since the first dose. Pharmacist enquired if the patient could receive the second dose and she need to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. More
2857688		M	CA	09/09/2025	TDAP TDAP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	M2G3Z UNK	Incorrect dose administered, Incorrect route of product administration; Incorrec... Incorrect dose administered, Incorrect route of product administration; Incorrect dose administered, Incorrect route of product administration More	after administering Boostrix intravenously instead of intramuscularly to a patient; receive a double... after administering Boostrix intravenously instead of intramuscularly to a patient; receive a double dose of a Boostrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M2G3Z, expiry date 11-JUL-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix (intravenous) and Boostrix. On an unknown date, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: after administering Boostrix intravenously instead of intramuscularly to a patient) and overdose (Verbatim: receive a double dose of a Boostrix vaccine). The outcome of the intramuscular formulation administered by other route and overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. More
2857689	1	F	GA	09/09/2025	HIBV	GLAXOSMITHKLINE BIOLOGICALS	Z9Y95	Product preparation issue Product preparation issue	Administration without diluent.; Administration without diluent.; This non-serious case was reported... Administration without diluent.; Administration without diluent.; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 1-year-old female patient who received Hib (Hiberix) (batch number Z9Y95, expiry date 20-OCT-2026) for prophylaxis. On 27-AUG-2025, the patient received Hiberix. On 27-AUG-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Administration without diluent.) and inappropriate dose of vaccine administered (Verbatim: Administration without diluent.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-AUG-2025 The physician reported that the patient who were mistakenly given the Hiberix vaccine without diluent and they weren't given the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025111045:Same reporter, Different patient US-GSK-US2025111058:Same reporter, Different patient More
2857690				09/09/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	the vaccine was given on January, is it okey to give it eight months apart; This non-serious case wa... the vaccine was given on January, is it okey to give it eight months apart; This non-serious case was reported by a consumer 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 (received first dose in Jan 2025). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: the vaccine was given on January, is it okey to give it eight months apart). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 12-AUG-2025 Member of the public facility administrator call to ask if the vaccine was given on in Jan 2025 and asked if it was okey to give it eight months apart. No vaccination date, no vaccine detail and no patient demographics were obtained in this call. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2857691	59	M	WV	09/09/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	5J959	Product administered to patient of inappropriate age, Product preparation issue Product administered to patient of inappropriate age, Product preparation issue	A patient received only the adjuvant portion of Arexvy.; A patient received only the adjuvant portio... A patient received only the adjuvant portion of Arexvy.; A patient received only the adjuvant portion of Arexvy.; maladministration of the adjuvant portion of Arexvy alone to a 59 years old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5J959, expiry date 25-OCT-2025) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: A patient received only the adjuvant portion of Arexvy.), inappropriate dose of vaccine administered (Verbatim: A patient received only the adjuvant portion of Arexvy.) and inappropriate age at vaccine administration (Verbatim: maladministration of the adjuvant portion of Arexvy alone to a 59 years old patient). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were not applicable. Additional Information: GSK Receipt Date: 03-SEP-2025 The nurse reported that there was maladministration of the adjuvant portion of Arexvy alone to a 59 years old male patient, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration The reporter asked was there a time to revaccinate the patient More
2857692	64	F		09/09/2025	COVID19	MODERNA		COVID-19 COVID-19	covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ... covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in a 64-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Transplant. 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. In May 2023, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as none. No concomitant medication was reported. The patient received Moderna vaccines and boosters since 2021, initially received doses a month apart due to being immunocompromised. She underwent a transplant and was advised to get three Moderna vaccines post-transplant, which she received in Dec-2021, Jan-2022, and Feb-2022. She had consistently received boosters each fall but recently inquired about the new mRNA vaccines, mRNA-1273.815 (mNEXSPIKE) and mRNA-1273.214 (mSPIKEvax). Despite these precautions, she did contract COVID-19 once back in May 2023. Due to these reactions, she preferred a lower dosage of the vaccine and asked her healthcare provider if a lower dose would offer adequate protection. The patient seek assurance that a lower dose will protect her as effectively as a higher dose, though she did not receive a satisfactory response from her local healthcare provider. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. This case was linked to MOD-2025-789068 (Patient Link). Reporter did not allow further contact More
2857693	84	M		09/09/2025	COVID19	MODERNA	025L20A	Immunodeficiency, Inappropriate schedule of product administration, White blood ... Immunodeficiency, Inappropriate schedule of product administration, White blood cell count More	unsure if his low immune system was pre-existing since they just started checking it a year ago; Pat... unsure if his low immune system was pre-existing since they just started checking it a year ago; Patient received first dose on 01-Jan-2021 and second dose on 13-Jan-2021; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 025L20A, 024M20A, 041B21A and 007J21-2A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic leukemia and Breathing difficult. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Sep-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Feb-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 13-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 01-Jan-2021 and second dose on 13-Jan-2021). On an unknown date, the patient experienced IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 01-Jan-2021 and second dose on 13-Jan-2021) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: white count being so high (over 100,000) for 20 years. No concomitant medication was reported. The patient received every Moderna vaccine that had come out since it was all started and the last one, he had was on Sep-2024. The patient's doctor told him that he needed to get another COVID vaccine this year. His health problems - breathing problems and chronic leukemia were pre-existing before receiving the COVID vaccines but was unsure if his low immune system was pre-existing or not since they just started checking it a year ago. The patient needed infusions to bring his hemoglobin and IgG back up after every 3 months. Most of the patient's problems were on account of his chronic leukemia and his white count being so high (over 100,000) for 20 years. The patient never had any ill effects from any of his vaccines. This case was linked to MOD-2025-789067, MOD-2025-789069, MOD-2025-789070 (Patient Link).; Reporter's Comments: Advanced age and Concurrent medical condition Chronic leukemia are confounders for the event immunodeficiency. The benefit -risk relationship of product is not affected by this report. More
2857694	64	F		09/09/2025	COVID19	MODERNA		Body temperature, Nausea, Pyrexia, Tooth fracture, Vomiting Body temperature, Nausea, Pyrexia, Tooth fracture, Vomiting	she chipped her front tooth during this time; severe vomiting; a very high fever over 103degree F; n... she chipped her front tooth during this time; severe vomiting; a very high fever over 103degree F; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (she chipped her front tooth during this time), VOMITING (severe vomiting), PYREXIA (a very high fever over 103degree F) and NAUSEA (nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Transplant. Concurrent medical conditions included Cancer and Immunocompromised. In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In January 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In January 2022, the patient experienced TOOTH FRACTURE (she chipped her front tooth during this time), VOMITING (severe vomiting), PYREXIA (a very high fever over 103degree F) and NAUSEA (nausea). At the time of the report, TOOTH FRACTURE (she chipped her front tooth during this time), VOMITING (severe vomiting), PYREXIA (a very high fever over 103degree F) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 103degree F. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as none. No concomitant medication was reported. The patient received Moderna vaccines and boosters since 2021, initially received doses a month apart due to being immunocompromised. She underwent a transplant and was advised to get three Moderna vaccines post-transplant, which she received in Dec-2021, Jan-2022, and Feb-2022. The January dose resulted in the worst reaction she experienced, with severe vomiting, a very high fever over 103degree F, and she chipped her front tooth during this time. It was unknown if the patient experienced any additional symptoms/events. Following these reactions, she was given medication to help with nausea, which she was taking routinely a couple of hours after receiving her Moderna booster. Details of the medication was no provided. Reporter causality was not reported. This case was linked to MOD-2025-789078 (Patient Link). Reporter did not allow further contact More
2857695	77	F		09/09/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3046714	Oropharyngeal pain; Oropharyngeal pain Oropharyngeal pain; Oropharyngeal pain	sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHA... sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046714) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluzone high dose) for an unknown indication. No Medical History information was reported. On 22-Aug-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine inact split 3v (Fluzone high dose) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. It was reported that patient's all previous vaccines shots were Moderna. Patient did not had effect like this. It was the first time. Patient had a negative effect to where patient was in bed all day the following day, and don't know if it was the flu shot, or the extra COVID shot. Regarding whether patient was still experiencing symptoms it was reported that it was probably a phantom thing. Patient was so upset about it. Patient sometimes feel had a sore throat, when it's probably just normal. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. More
2857696		F		09/09/2025	COVID19 COVID19	MODERNA PFIZER\BIONTECH		Lymphoedema; Lymphoedema Lymphoedema; Lymphoedema	lymphedema; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOE... lymphedema; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (lymphedema) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema). At the time of the report, LYMPHOEDEMA (lymphedema) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient had been recently diagnosed with lymphedema and needed to get her covid vaccines within the next few weeks and wanted to know if it was safe to get the Spikevax vaccine since she had both Moderna and Pfizer. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. More
2857697	63	F	MN	09/09/2025	COVID19	UNKNOWN MANUFACTURER		Adverse event, Fatigue, Feeling abnormal, Malaise Adverse event, Fatigue, Feeling abnormal, Malaise	Usually tolerate just fine every immunization with Novavax; She may feel a little bit ill; She did n... Usually tolerate just fine every immunization with Novavax; She may feel a little bit ill; She did not feel completely normal; Just felt fatigue, not much; This non serious initial spontaneous report was reported by a Nurse via Contact Center (MI No. NOV25-00693) and concerns a 63-year-old Female who experienced "Usually tolerate just fine every immunization with Novavax, She may feel a little bit ill, She did not feel completely normal, and just felt fatigue, not much" on unknown dates after receiving Novavax COVID-19 Vaccine, Adjuvanted (2023- 2024 Formula) on an unspecified date in the Fall of 2023. At the time of the report, the outcome of the Adverse event, Malaise, Feeling abnormal, Fatigue was Unknown.; Sender's Comments: This Female of an unspecified age experienced Adverse event, Malaise, Feeling abnormal and Fatigue after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Adverse event was reported as non-serious. The event Malaise was reported as non-serious. The event Feeling abnormal was reported as non-serious. The event Fatigue was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Adverse event, Malaise, Feeling abnormal and Fatigue is considered Possible. More
2857698	64	F	MN	09/09/2025	COVID19	NOVAVAX		Adverse event, Fatigue, Feeling abnormal, Malaise Adverse event, Fatigue, Feeling abnormal, Malaise	Usually tolerate just fine every immunization with Novavax; She may feel a little bit ill; She did n... Usually tolerate just fine every immunization with Novavax; She may feel a little bit ill; She did not feel completely normal; Just felt fatigue, not much; This non serious initial spontaneous report was reported by a Nurse via contact center (MI No. NOV25-00693) and concerns a 64-year-old Female who experienced "USUALLY TOLERATE JUST FINE EVERY IMMUNIZATION WITH NOVAVAX", "SHE MAY FEEL A LITTLE BIT ILL", "SHE DID NOT FEEL COMPLETELY NORMAL" and "JUST FELT FATIGUE, NOT MUCH" after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on an unspecified date in the Fall of 2024. At the time of the report, the outcome of the Adverse event, Malaise, Feeling abnormal, Fatigue was Unknown.; Sender's Comments: This 64-year-old Female experienced Adverse event, Malaise, Feeling abnormal and Fatigue after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Adverse event was reported as non-serious. The event Malaise was reported as non-serious. The event Feeling abnormal was reported as non-serious. The event Fatigue was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Adverse event, Malaise, Feeling abnormal and Fatigue is considered Possible. More
2857699			ID	09/09/2025	RSV	PFIZER\WYETH	LL8396	Device connection issue, Needle issue, Soft tissue foreign body Device connection issue, Needle issue, Soft tissue foreign body	needle disengaged from the syringe when they it back and stayed on the patients arm; needle disengag... needle disengaged from the syringe when they it back and stayed on the patients arm; needle disengaged from the syringe when they it back and stayed on the patients arm; This is a spontaneous report received from a Pharmacist from medical information team. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Aug2025 as dose 1, single (Lot number: LL8396, Expiration Date: Apr2026), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (medically significant), INJURY ASSOCIATED WITH DEVICE (medically significant) all with onset Aug2025, outcome "unknown" and all described as "needle disengaged from the syringe when they it back and stayed on the patients arm". Clinical course: reporter explained that they had two Abrysvo vaccines that, when giving the injection, the needle disengaged from the syringe when they pulled it back and stayed on the patients' arm. Pharmacy had been giving the injections for a long time, switched from Arexvy to Abrysvo for RSV because could do pregnant patients and regular patients, so had been using Abrysvo for quite some time, and after numerous vaccinations this issue never happened until now. The issue happened for the first time two weeks before 26Aug2025, last Monday or Tuesday (in Aug2025) and then yesterday (on 25Aug2025). The needle did stick and stayed in the arm of the two patients involved. When withdrew, needle remained in the two patient's arms. They reconstituted the vaccine according to the instructions as usual but they didn't work well. They had a box of five vaccines. So far they used three and two out of them were faulty. There were 2 left in box and the other one was fine. She wanted to know why this issue might have happened. For 2nd Abrysvo: just had vial adapter, packaging discarded. Syringe used was not in packet of Abrysvo. Syringe that had to attach to inject medication was the BD precision glide needle 25g, 1 inch (Lot: 4178824, Expiry: 30Sep2029). One vial was available to be returned, some components were discarded, syringes were discarded. The reporter assessed event "When withdrew, needle remained in arm" as serious due to medically significant for going forward. Thought the patients were able to receive the vaccine, no ill affects, didn't want to have happen again. Re-went over everything as far as reconstitution and vaccine and everything that occurred was exactly as outlined as in package insert information, very weird. Causality for "needle disengaged from the syringe when they it back and stayed on the patients arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).; Sender's Comments: Based on the information given, the Company confirms that the event injury associated with device is unrelated to the suspected drug RSV VACCINE PROT.SUBUNIT PREF 2V and most likely to the device constituent of RSV VACCINE PROT.SUBUNIT PREF 2V (malfunction) wherein the needle disengaged from the syringe when they pulled it back it stayed on the arms of the patient.,Linked Report(s) : US-PFIZER INC-202500170819 Same reporter/drug/event for different patients; More
2857700			ID	09/09/2025	RSV	PFIZER\WYETH	LL8396	Device connection issue, Needle issue, Soft tissue foreign body Device connection issue, Needle issue, Soft tissue foreign body	needle disengaged from the syringe when they it back and stayed on the patients arm; needle disengag... needle disengaged from the syringe when they it back and stayed on the patients arm; needle disengaged from the syringe when they it back and stayed on the patients arm; This is a spontaneous report received from a Pharmacist from medical information team. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 25Aug2025 as dose 1, single (Lot number: LL8396, Expiration Date: Apr2026), in arm for immunisation, Device Lot Number: HN8587, Device Expiration Date: Sep2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (medically significant), INJURY ASSOCIATED WITH DEVICE (medically significant) all with onset 25Aug2025, outcome "unknown" and all described as "needle disengaged from the syringe when they it back and stayed on the patients arm". Clinical course: reporter explained that they had two Abrysvo vaccines that, when giving the injection, the needle disengaged from the syringe when they pulled it back and stayed on the patients' arm. Pharmacy had been giving the injections for a long time, switched from Arexvy to Abrysvo for RSV because could do pregnant patients and regular patients, so had been using Abrysvo for quite some time, and after numerous vaccinations this issue never happened until now. The issue happened for the first time two weeks before 26Aug2025, last Monday or Tuesday (in Aug2025) and then yesterday (on 25Aug2025). Yesterday a seasoned tech who gave injections had two incidents when giving Abrysvo vaccine where the needle disengaged from syringe when pulled back. The needle did stick and stayed in the arm of the two patients involved. When withdrew, needle remained in the two patient's arms. They reconstituted the vaccine according to the instructions as usual but they didn't work well. They had a box of five vaccines. So far they used three and two out of them were faulty. There were 2 other vial adapters left in box and the other one was fine. She wanted to know why this issue might have happened. For 1st Abrysvo: just had vial adapter, packaging discarded. Abrysvo diluent syringe: Lot: HN8587, Expiry: Sep2026. Syringe used was not in packet of Abrysvo. Syringe that had to attach to inject medication was the BD precision glide needle 25g, 1 inch (Lot: 4178824, Expiry: 30Sep2029). One vial was available to be returned, some components were discarded, syringes were discarded. The reporter assessed event "When withdrew, needle remained in arm" as serious due to medically significant for going forward. Thought the patients were able to receive the vaccine, no ill affects, didn't want to have happen again. Re-went over everything as far as reconstitution and vaccine and everything that occurred was exactly as outlined as in package insert information, very weird. Causality for "needle disengaged from the syringe when they it back and stayed on the patients arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).; Sender's Comments: Based on the information given, the Company confirms that the event injury associated with device is unrelated to the suspected drug RSV VACCINE PROT.SUBUNIT PREF 2V and most likely to the device constituent of RSV VACCINE PROT.SUBUNIT PREF 2V (malfunction) wherein the needle disengaged from the syringe when they pulled it back it stayed on the arms of the patient.,Linked Report(s) : US-PFIZER INC-202500170519 Same reporter/drug/event for different patients; More
2857701			MI	09/09/2025	RSV	PFIZER\WYETH		Product contamination physical Product contamination physical	One of the pieces like either broke off or broke into the bottle or something in the actual vial whe... One of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process; One of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process; This is a spontaneous report received from a Pharmacist from product quality group. This report involves rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE MATERIAL ISSUE (non-serious), outcome "unknown" and all described as "One of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process". Additional information: A pharmacist mentioned just in preparing that, for the Abrysvo vaccine that she has had like when she was preparing it, it was not administered to a patient but just when she was preparing it, and it's unknown that don't know how long ago this happened but she had to return two vaccines back to manufacturer because the, one of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process. So, she had returned two doses of the Abrysvo vaccine because of malfunction when she was trying to prepare it for administration. The pharmacist said she went to the process correctly. She had given this vaccine many times before, it was just the individual 2 doses of the vaccine that there was a problem with it. The reporter considered "one of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process" not related to rsv vaccine prot.subunit pref 2v. Causality for "one of the pieces like either broke off or broke into the bottle or something in the actual vial when she was doing the reconstitution process" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2857702	72	M	TX	09/09/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test	had covid twice/ First time got Covid was in May2021. It was the Pfizer COVID vaccines caller had pr... had covid twice/ First time got Covid was in May2021. It was the Pfizer COVID vaccines caller had prior to having Covid in May2021; had covid twice/ First time got Covid was in May2021. It was the Pfizer COVID vaccines caller had prior to having Covid in May2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Oct2023 as dose number unknown, 0.5 ml, single for covid-19 immunisation. The patient's relevant medical history included: "congestive heart failure" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "lost 80 pounds" (unspecified if ongoing); "Prediabetic" (unspecified if ongoing); "open heart surgery" (unspecified if ongoing). Concomitant medication(s) included: ZEPBOUND taken for weight abnormal, sleep apnoea syndrome. The patient also took other concomitant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2021, outcome "unknown" and all described as "had covid twice/ First time got Covid was in May2021. It was the Pfizer COVID vaccines caller had prior to having Covid in May2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: doesn't know if did culture in petri dish. Swabbed nose. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: The patient inquired about the availability of a specific COVID-19 vaccine formula recently approved by the FDA. The patient started to state he was immuno, then stated he was at risk, congestive heart failure and old. He states he takes a handful of drugs for heart. He was prediabetic and cardiologist was having him take Zepbound, lost 80 pounds thus far, prediabetes disappeared, and sleep apnea had gotten better. The patient got Covid twice and had received both the Pfizer COVID vaccines and Moderna COVID vaccine. Not sure when got Covid, if before or after getting which vaccine, then stated it was a sufficient amount of time after. First time got Covid was in May2021 just prior to him having open heart surgery and he had a Pfizer COVID vaccines prior to it. He does not believe that getting Covid was a result of the vaccine at all, just got it. Second time he had Covid was probably about May2023 or Jun2023 and was after having Moderna COVID vaccine. Then he had Pfizer COVID vaccine subsequently. He had a total of two or three of the Pfizer COVID-19 vaccines and one dose of Moderna COVID-19 vaccine. More
2857703	27	F	TX	09/09/2025	RSV RSV	PFIZER\WYETH PFIZER\WYETH		Blood pressure increased, Fatigue, Headache, Injection site pain, Muscle spasms;... Blood pressure increased, Fatigue, Headache, Injection site pain, Muscle spasms; Nausea, Pyrexia, Vomiting More	Headache; nausea; vomiting; cramping; fever; increased blood pressure; soreness at injection site; f... Headache; nausea; vomiting; cramping; fever; increased blood pressure; soreness at injection site; fatigue; This is a spontaneous report received from a Consumer or other non HCP. A 27-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 03Sep2025 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years, in right arm for maternal immunisation. The patient's relevant medical history included: "Bipolar" (unspecified if ongoing); "Allergy: Latex" (unspecified if ongoing); "Allergy: Iodine" (unspecified if ongoing). The patient was 34 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12Oct2025. Concomitant medication(s) included: LAMICTAL, start date: 22Aug2020. Past drug history included: Bactrim, reaction(s): "Allergy". The following information was reported: HEADACHE (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering"; MUSCLE SPASMS (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering", described as "cramping"; FATIGUE (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering"; PYREXIA (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering", described as "fever"; BLOOD PRESSURE INCREASED (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering", described as "increased blood pressure"; NAUSEA (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering", described as "soreness at injection site"; VOMITING (non-serious) with onset 03Sep2025 at 21:15, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, nausea, vomiting, muscle spasms, pyrexia, blood pressure increased, vaccination site pain, fatigue. More
2857704		F		09/09/2025	PNC20	PFIZER\WYETH		Cold sweat, Peripheral swelling, Rash Cold sweat, Peripheral swelling, Rash	experienced swelling and rash in her left arm; experienced swelling and rash in her left arm; cold s... experienced swelling and rash in her left arm; experienced swelling and rash in her left arm; cold sweats; This is a spontaneous report received from an Other HCP from a sales representative. A 40-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Unknown drug. The patient's concomitant medications were not reported. The following information was reported: COLD SWEAT (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "cold sweats"; PERIPHERAL SWELLING (non-serious), RASH (non-serious) all with onset Jun2025, outcome "recovered" (2025) and all described as "experienced swelling and rash in her left arm". Therapeutic measures were taken as a result of peripheral swelling, rash, cold sweat. Additional information: Treatment received for the adverse event was steroid pack. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2857705			NC	09/09/2025	COVID19 COVID19 COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH		COVID-19, Drug ineffective, SARS-CoV-2 test; Alopecia; COVID-19, Drug ineffectiv... COVID-19, Drug ineffective, SARS-CoV-2 test; Alopecia; COVID-19, Drug ineffective, SARS-CoV-2 test; Alopecia More	tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a C... tested positive for COVID; tested positive for COVID; 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 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), 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) all with onset 2022, outcome "recovered" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Additional Information: Patient received three COVID injections. The last was in Oct2021. In the Spring 2022, patient tested positive for COVID. Patient had it bad for one day. The information on the batch/lot number for BNT162B2 will be requested and submitted if and when received. Follow-up (03Sep2025): This is a spontaneous follow-up report received from same consumer, program ID [003110]. This consumer (patient) reported that: Updated Information: Product data (Dosage Regimens for dose 1 and 2 added) and Event data (event LLT updated to "Drug ineffective") More
2857706			NJ	09/09/2025	PNC20	PFIZER\WYETH	LN4932	Device connection issue Device connection issue	the luer lock piece broke off when preparing it; This is a spontaneous report received from a Nurse.... the luer lock piece broke off when preparing it; This is a spontaneous report received from a Nurse. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4932, Expiration Date: 31Aug2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the luer lock piece broke off when preparing it". Additional information: Caller said the luer lock piece broke off when preparing it, it was before reaching the patient. Caller was putting this one together, then snapped off, it was the last one in the box. Caller got another one and administered that one to the patient. Clarified and confirmed the Prevnar 20 where the luer lock piece broke off was not administered to a patient. NDC: 0005-2000-01. Causality for "the luer lock piece broke off when preparing it" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). More
2857707	38	F		09/09/2025	COVID19 COVID19 FLU3 FLU3	PFIZER\BIONTECH PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	NA0587 NA0587 73BN2 73BN2	Headache, Nasal congestion, Pain, Vaccination site erythema, Vaccination site in... Headache, Nasal congestion, Pain, Vaccination site erythema, Vaccination site inflammation; Vaccination site pain; Headache, Nasal congestion, Pain, Vaccination site erythema, Vaccination site inflammation; Vaccination site pain More	stuffy nose and headache on day 3; body aches and headache on day 2; body aches and headache on day ... stuffy nose and headache on day 3; body aches and headache on day 2; body aches and headache on day 2; Injection site sore, red, inflamed; Injection site sore, red, inflamed; Injection site sore, red, inflamed; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Sep2025 at 18:30 as dose 1, 0.3 ml single (Lot number: NA0587) at the age of 38 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 05Sep2025 (Lot number: 73BN2), in left arm for immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "walnuts allergy" (unspecified if ongoing); "nickel allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INFLAMMATION (non-serious) all with onset 05Sep2025 at 18:45, outcome "unknown" and all described as "Injection site sore, red, inflamed"; PAIN (non-serious), HEADACHE (non-serious) all with onset 06Sep2025, outcome "unknown" and all described as "body aches and headache on day 2"; NASAL CONGESTION (non-serious) with onset 07Sep2025, outcome "unknown", described as "stuffy nose and headache on day 3". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site inflammation, pain, headache, nasal congestion. No follow-up attempts are possible. More
2857708		F		09/09/2025	COVID19	PFIZER\BIONTECH		Chills, Pyrexia Chills, Pyrexia	received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; ... received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), 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 nos (Dose 1, single), for Covid-19 immunization, reaction(s): "Chills", "Fever"; Bnt162b2 nos (Dose 2, single), for Covid-19 immunization, reaction(s): "Chills", "Fever". The following information was reported: CHILLS (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever". Additional information: A consumer inquired whether the COMIRNATY (2025-2026 Formula) includes the new variant Stratus or the current variant. Another inquiry was made regarding the difference between the 2024-2025 and 2025-2026 formulations. Additionally, the consumer reported having received five prior COVID-19 vaccines with similar side effects, including chills and slight fever, and asked whether the current 2025-2026 formulation would cause the same side effects. In a separate inquiry, the consumer asked whether individuals aged 5 through 64 years who work as privacy are eligible to receive the vaccine or if a doctor's prescription is required. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500176826 same patient, different doses; More
2857709		F		09/09/2025	COVID19	PFIZER\BIONTECH		Chills, Pyrexia Chills, Pyrexia	received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; ... received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team. 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. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "Chills", "slight fever"; Bnt162b2 nos (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Chills", "slight fever"; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "Chills", "slight fever"; Bnt162b2 nos (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "Chills", "slight fever". The following information was reported: CHILLS (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever". Additional information: A consumer inquired whether the COMIRNATY (2025-2026 Formula) includes the new variant Stratus or the current variant. Another inquiry was made regarding the difference between the 2024-2025 and 2025-2026 formulations. Additionally, the consumer reported having received five prior COVID-19 vaccines with similar side effects, including chills and slight fever, and asked whether the current 2025-2026 formulation would cause the same side effects. In a separate inquiry, the consumer asked whether individuals aged 5 through 64 years who work as privacy are eligible to receive the vaccine or if a doctor's prescription is required. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500176826 same patient, different doses; More
2857711		M		09/09/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective, Illness COVID-19, Drug ineffective, Illness	he's got COVID/he got the Pfizer COVID shots and the booster; he's got COVID/he got the Pf... he's got COVID/he got the Pfizer COVID shots and the booster; he's got COVID/he got the Pfizer COVID shots and the booster; he got the Pfizer COVID shots and the booster and they made him extremely sick; This is a spontaneous report received from a Consumer or other non HCP. An 84-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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 (Primary Immunization completed), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "he's got COVID/he got the Pfizer COVID shots and the booster"; ILLNESS (non-serious), outcome "unknown", described as "he got the Pfizer COVID shots and the booster and they made him extremely sick". Clinical course: The reporter stated the patient was at home in bed. The physician's assistant told them that now they're treating Covid like cold. The patient said, "I think I'll just give him hot chicken soup and Tylenol and treat things like an ordinary cold. I'm just not paying dollar 200 for this drug. We'll just forget all about it, and I won't pick up the prescription. Oh, well then I think he better not take it because he got the Pfizer Covid shots and the booster and they made him extremely sick, so I'd be a little hesitant for him to take drug." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More

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