๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • 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
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

โš ๏ธ 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
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2858592 0.08 F CA 09/13/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Autism spectrum disorder, Constipation, Erythema, Gastrointestinal disorder, Gas... Autism spectrum disorder, Constipation, Erythema, Gastrointestinal disorder, Gastrooesophageal reflux disease; Screaming, Speech disorder, Vasodilatation, Vomiting More
I did not enter vaccine information for all vaccines I believe caused damage because I believe *all*... I did not enter vaccine information for all vaccines I believe caused damage because I believe *all* - every - single - vaccine pt received was bad. She had a terrible reaction to all of them despite (or because of) following the doctor s orders for care after each vaccine administered. Permanent damage to the gut and brain. Intense vomiting as infant. Intense constipstion. Did every type of therapy possible but Autism is not a behavioral problem; it is a medical problem and the CDC knows this but continues to maim children and destroy families. Child sacrifice is what it is. You have ruined my child?s life, you are trying to ruin the entire world by way of your poison. More
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2858593 75 F WA 09/13/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 na0587
u8800ba
Neck pain; Neck pain Neck pain; Neck pain
severe left neck pain developed at 9:30-10pm the same evening severe left neck pain developed at 9:30-10pm the same evening
2858594 8 F MI 09/13/2025 COVID19
 PFIZER\BIONTECH
 NA0846
Immediate post-injection reaction, Lip pain, Syncope Immediate post-injection reaction, Lip pain, Syncope
Fainted immediately after receiving shot, lips were pale Fainted immediately after receiving shot, lips were pale
2858595 10 M TX 09/13/2025 UNK
 UNKNOWN MANUFACTURER
Rash Rash
Small raised bumps up and down both arms. Noticed at 10:30pm, about 5 hours after injection. Bumps ... Small raised bumps up and down both arms. Noticed at 10:30pm, about 5 hours after injection. Bumps are not red, do not itch or hurt. Patient said he feels normal. Bumps were mainly raised and slightly discolored from skin. Hard to see without brighter light. Mainly noticed when feeling his arms. Thought it was just dry skin bumps but he did have them before going to bed. This is still ongoing, but it's only been 30 min between reporting and he's gone back to bed. We are unsure of the exact flu vaccine used. More
2858259 TX 09/12/2025 RV5
 MERCK & CO. INC.
 Y018378
No adverse event, Product storage error No adverse event, Product storage error
TE for ROTATEQ, after being improperly stored.; No reported adverse effects; This spontaneous report... TE for ROTATEQ, after being improperly stored.; No reported adverse effects; This spontaneous report was received from a healthcare 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 an unknown date, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Y018378, expiration date: 10-May-2026) (strength, dose, and frequency not reported), vial dose, administered for prophylaxis (Product storage error). No reported adverse effects. More
2858260 4 M AZ 09/12/2025 UNK
 UNKNOWN MANUFACTURER
 Y017062
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Freezer temperature out of range; This spontaneous report was received from a Phys... No additional AE; Freezer temperature out of range; This spontaneous report was received from a Physician Assistant and refers to a 4-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (Hollister-Stier STERILE DILUENT). On 21-Jul-2025, the patient was vaccinated with dose 2 of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Y017062, expiration date: 11-Oct-2026, administered by Subcutaneous route in the right thigh as prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported). The freezer temperature where the vaccine was stored was out of range for 45 minutes on the same day (product storage error). More
2858261 09/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
It has been almost a year since first dose of Shingrix; This non-serious case was reported by a cons... It has been almost a year since first dose of Shingrix; 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 received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: It has been almost a year since first dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 03-SEP-2025 It has been almost a year since first dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2858262 1.25 F LA 09/12/2025 HIBV
 SANOFI PASTEUR
 UK201AC
No adverse event, Product preparation error No adverse event, Product preparation error
Wrong diluent was used to mix the vaccine (hib) live vaccine diluent used with no reported adverse e... Wrong diluent was used to mix the vaccine (hib) live vaccine diluent used with no reported adverse event; Initial information received on 27-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient (6.35 cm and 10.45 kg) who received Hib (Prp/T) Vaccine [Act-HIB] in which wrong diluent was used to mix with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Aug-2025, the patient received 0.5 ml (dose 1) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection, lot UK201AC, expiry date:30-Apr-2026 via intramuscular route in unknown administration site for Immunization which was mixed with wrong diluent to mix to used with no reported adverse event (product preparation error) (latency: same day). Reportedly, a patient received the HIB vaccine, but one of the diluents was missing. Office manager reported that they are trying to narrowit down to which patient received the vaccine without the diluent. Sales rep assumes that it was the ACTHIB. Vaccine will be readministered at 18-month wellness appointment. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information was received on 08-Sep-2025 received from other health professional: case was upgraded from non valid to valid case: patient demographics, batch number, expiry date has been added and event verbatim and LLT has been updated, text amended accordingly. More
2858274 77 M NC 09/12/2025 PPV
 MERCK & CO. INC.
Urticaria Urticaria
Urticaria to chest, back, L arm Urticaria to chest, back, L arm
2858277 95 M MI 09/12/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 957D4
Extra dose administered Extra dose administered
pharmacist gave him a 2nd shot; This non-serious case was reported by a pharmacist via call center r... pharmacist gave him a 2nd shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 95-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 957D4, expiry date 27-NOV-2026) for prophylaxis. Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY). On 13-AUG-2025, the patient received the 2nd dose of Arexvy. On 13-AUG-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: pharmacist gave him a 2nd shot). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date :14-AUG-2025 and 15-AUG-2025 Pharmacist reported that a patient did not realize that he already had an RSV Arexvy 15th May 2025 and the day before reporting, the pharmacist gave him a 2nd shot, which led to extra dose administered. No further details were provided. The reporter was consented to follow up. More
2858280 74 F 09/12/2025 FLU4
UNK
 SANOFI PASTEUR
UNKNOWN MANUFACTURER
 UNK
UNK
Cardiac pacemaker insertion, Colectomy, Computerised tomogram abdomen, Diverticu... Cardiac pacemaker insertion, Colectomy, Computerised tomogram abdomen, Diverticulitis intestinal haemorrhagic, Sinus node dysfunction; Cardiac pacemaker insertion, Colectomy, Computerised tomogram abdomen, Diverticulitis intestinal haemorrhagic, Sinus node dysfunction More
Tachycardia/bradycardia syndrome; Diverticulitis intestinal hemorrhage; This 74-year-old female subj... Tachycardia/bradycardia syndrome; Diverticulitis intestinal hemorrhage; This 74-year-old female subject was enrolled in an open label study. The subject received the 1st dose of Fluzone Quadrivalent (intramuscular, unknown deltoid) .7 ml on 01-NOV-2022, for prophylaxis. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) .5 ml on 06-DEC-2022, for prophylaxis. The subject's past medical history included arrhythmia. On 27-MAY-2023 08:00, 207 days after receiving Fluzone Quadrivalent and 172 days after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 diverticulitis intestinal hemorrhagic (Verbatim: Diverticulitis intestinal hemorrhage). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 bradycardia-tachycardia syndrome (Verbatim: Tachycardia/bradycardia syndrome) on 29-MAY-2023 08:00 with serious criteria of hospitalization. The outcome of diverticulitis intestinal hemorrhagic was resolved on 07-JUN-2023. The outcome(s) of the additional event(s) included bradycardia-tachycardia syndrome (resolved on 11-JUN-2023). Relevant Tests: On 30May2023 CT angio showed possible active arterial extravasation in sigmoid colon. Diagnostic results (reference ranges are provided in parenthesis if available): Laparoscopy- 07-JUN-2023 sigmoid colectomy. The investigator considered that there was no reasonable possibility that the diverticulitis intestinal hemorrhagic and bradycardia-tachycardia syndrome may have been caused by Fluzone Quadrivalent and RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the diverticulitis intestinal hemorrhagic and bradycardia-tachycardia syndrome may have been caused by Fluzone Quadrivalent and RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2023085179 GSK receipt date: 16-Jun-2023 required interventional radiology and surgical intervention; outside medical records requested; subject was admitted to hospital 27May2023 and was discharged after pacemaker placed, exact date unknown as medical records were not released. Regarding tachycardia/bradycardia syndrome: PCP records reviewed which indicate pacemaker placed 11Jun2023. Will consider that to be end date as it is date it was effectively treated. Reqarding diverticulitis intestinal bleeding: hospital records will not be released. Review of PCP/oncology records indicates the diagnosis of "diverticulosis of colon with hemorrhage" Also notes CT angio 30May2023 showing possible active arterial extravasation in sigmoid colon. It notes laparscopic sigmoid colectomy performed on 07Jun2023. Will list recovery date as surgery date as that is date bleeding stopped. No pre-existing gastrointestinal conditions and no known contributing cardiac or gastrointestinal medications Follow-up information received on 26-JUN-2023 The case US2023085179 was identified as a duplicate of US2023085180. All correspondence will be added in the case US2023085180(case of record) Summary of changes: event Tachycardia/bradycardia syndrome and narrative updated, deletion merging case performed. Follow-up information received on 25-JUL-2023. Summary of changes: SAE term (From diverticular bleeding to Diverticulitis intestinal hemorrhage) updated. Follow-up information received on 28-AUG-2023 Summary of changes: Event outcome and event outcome date, lab data and narrative updated. Follow-up information received on 31-AUG-2023 Summary of changes: Narrative and historical condition updated.; Sender's Comments: A case of Diverticulitis intestinal haemorrhagic and Sinus node dysfunction, 207 days after receiving the 1st dose of Fluzone Quadrivalent and 172 days after receiving the 1st dose of RSVPreF3 vaccine + AS01E, in a 74-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factor for Sinus node dysfunction (past medical history included arrhythmia). US-GSK-US2023085179: More
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2858281 60 M 09/12/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Atrial fibrillation, Atrial flutter, Cardiac ablation, Condition aggravated, Imp... Atrial fibrillation, Atrial flutter, Cardiac ablation, Condition aggravated, Implantable cardiac monitor insertion; Atrial fibrillation, Atrial flutter, Cardiac ablation, Condition aggravated, Implantable cardiac monitor insertion More
New Onset Atrial Fibrillation; This 62-year-old male subject was enrolled in a blinded study. The su... New Onset Atrial Fibrillation; This 62-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 12-SEP-2022, for prophylaxis. Concurrent medical conditions included hypercholesterolemia, hypertension, atrial flutter and type ii diabetes mellitus. Concomitant products included amlodipine, rosuvastatin calcium (Crestor) and carvedilol. On 18-AUG-2023, 340 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: New Onset Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with apixaban (Eliquis). The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation was not resolved. Diagnostic results (reference ranges are provided in parenthesis if available): Heart rate-In AUG-2023 240 (maximum) bpm. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023115567 GSK receipt date: 21-AUG-2023 Visit 5NH 21AUG2023 - Per PI: subject reported being diagnosed, hospitalized, and treated via Ablation around a year ago despite office visit in SEP 2022 and a year of phone contacts. He was just now reporting this diagnosis because of another Ablation performed on 18AUG2023. Subject had very little details, records requested for these details into diagnosis and treatment. Would update upon record receipt Subject was a 62 year old male with a history of diabetes mellitus type 2, hypertension, and hypercholesterolemia who presented to the office for visit 5 on 21AUG2023. At that time, he informed the site that he had been treated for atrial fibrillation since spring of 2022. On review of requested medical records, he was diagnosed with atrial flutter by a cardiac electrophysiologist. No treatment started secondary to arrythmia spontaneously converted. Through July and August of 2023, subject was evaluated for recurrent symptoms with placement of intracardiac loop recorder. This demonstrated numerous atrial fibrillation and atrial flutter events with 30 events of greater than 6 hours, maximum heart rate 240 bpm. The decision was made to perform an ablation for atrial fibrillation on 18AUG2023. Subject was admitted overnight for monitoring. Discharge medications updated to include Eliquis 5 mg BID, Carvedilol 12.5 mg BID, Crestor 20 mg QD, and Amlodipine 5 mg BID. Discharged 19AUG2023 Update per query 25JUN2024 - Subject was still taking the above medications started 19AUG2023, no further intervention needed as of end of study visit on 06MAY2024. Because ongoing medication, condition was considered not recovered/ not resolved. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 24-Aug-2023. Summary of changes: Subject age updated. Vaccination date and dose number updated. TTO updated. Lab data and narrative updated. Follow up information received on 28-Aug-2023, 29-Aug-2023. Summary of change: Event onset date and TTO updated, concomitant and treatment medications added. Current medical conditions added. Discharge date added, narrative updated. Follow up information received on 31-Aug-2023. Summary of changes: medical history, Lab data and narrative updated. Follow up information received on 14-sep-2023 Summary of change: Start date of Carvedilol updated. Follow up information received on 25-JUN-2024 Summary of change: General narrative were updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation, 718 days after receiving 1st dose of RSVPreF3 in a 62-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (h/o atrial flutter, hypertension, type ii diabetes mellitus, acute kidney injury and hypercholesterolemia) based on medical historyk and as per linked cases. US-GSK-US2023115565: US-GSK-US2023115567: More
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2858282 61 M 09/12/2025 UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER





Acute kidney injury, Atrial flutter, Blood creatinine increased, Blood glucose i... Acute kidney injury, Atrial flutter, Blood creatinine increased, Blood glucose increased, Cardiac ablation; Cardiac telemetry abnormal, Chest pain, Condition aggravated, Diabetic ketoacidosis, Dizziness; Palpitations; Acute kidney injury, Atrial flutter, Blood creatinine increased, Blood glucose increased, Cardiac ablation; Cardiac telemetry abnormal, Chest pain, Condition aggravated, Diabetic ketoacidosis, Dizziness; Palpitations More
Acute Kidney Injury; Diabetic Ketoacidosis; Worsening Atrial Flutter; Worsening Atrial Flutter; This... Acute Kidney Injury; Diabetic Ketoacidosis; Worsening Atrial Flutter; Worsening Atrial Flutter; This 61-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 12-SEP-2022, for prophylaxis. Concurrent medical conditions included atrial flutter, hypertension and type ii diabetes mellitus. On 29-NOV-2022, 78 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 acute kidney injury (Verbatim: Acute Kidney Injury). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 diabetic ketoacidosis (Verbatim: Diabetic Ketoacidosis) on 29-NOV-2022 with serious criteria of hospitalization, moderate - grade 2 atrial flutter (Verbatim: Worsening Atrial Flutter) on 29-NOV-2022 with serious criteria of hospitalization and moderate - grade 2 condition aggravated (Verbatim: Worsening Atrial Flutter) on 29-NOV-2022 with serious criteria of hospitalization. The subject was treated with sodium chloride and insulin nos (Insulin, Regular). The action taken with RSVPreF3 vs Placebo was no change. The outcome of acute kidney injury was resolved on 03-DEC-2022. The outcome(s) of the additional event(s) included diabetic ketoacidosis (resolved on 03-DEC-2022), atrial flutter (not resolved) and condition aggravated (not resolved). Diagnostic results (reference ranges are provided in parenthesis if available): Blood creatinine- 29-NOV-2022 2.43 mg/dL, (0.70-1.20). Blood glucose- 29-NOV-2022 640 mg/dL, (70.00-90.00). Cardiac telemetry-In NOV-2022 atrial flutter/atrial fibrillation at 2.91 %. Heart rate-In NOV-2022 135 - 178 with maximum interval of 18 hours bpm. The investigator considered that there was no reasonable possibility that the acute kidney injury, diabetic ketoacidosis, atrial flutter and condition aggravated may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the acute kidney injury, diabetic ketoacidosis, atrial flutter and condition aggravated may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023113435, US2023115567 GSK receipt date: 24-AUG-2023. Subject is a 61 year old male with a history of diabetes mellitus type 2 and hypertension who presented to the office for visit 5 on 21AUG2023. At that time, he informed the site that he has been treated for atrial fibrillation since spring of 2022. On review of requested medical records, he was diagnosed with atrial flutter by a cardiac electrophysiologist. No treatment started secondary to arrhythmia spontaneously converted. On 29NOV2022, subject presented to hospital with palpitations, light headedness, and chest pain. He was admitted to the hospital with worsening atrial flutter, diabetic ketoacidosis, and acute kidney injury. Mobile cardiac telemetry revealed atrial flutter/atrial fibrillation at 2.91% with a heart rate range of 135 - 178 bpm with maximum interval of 18 hours. Electrophysiologist diagnosed/interpreted these results as atrial flutter and Subject underwent intracardiac radio-frequency ablation on 02DEC2022. He was treated with IV fluids and insulin for the diabetic ketoacidosis. Glucose was corrected and the diabetic ketoacidosis was resolved. He was also treated with IV fluids for his acute kidney injury with resolution. Subject discharged in stable condition 03DEC2022. This episode of atrial flutter was resolved 02DEC2022. However, this was a chronic condition, so this is not recovered/ not resolved at end of study. Follow up information received on 31-Aug-2023. Summary of changes: Lab data and narrative updated. Follow up information received on 05-SEP-2023. Summary of changes: medical history updated. Follow up information received on 26-SEP-2023. Summary of changes: Treatment medication 0.9 % sodium chloride and Insulin regular added. Follow up information received on 25-JUN-2024. Summary of changes: General narrative updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Acute kidney injury, Diabetic ketoacidosis, Atrial flutter and Condition aggravated ,456 days after receiving 2nd dose of RSVPreF3 ,in a 61-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility, alternative risk factor (diabetes mellitus type 2) based on medical history for the event Diabetic ketoacidosis and alternate etiology (previous known atrial flutter) based on medical history for Atrial flutter event. US-GSK-US2023113435: US-GSK-US2023115567: More
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2858283 60 FL 09/12/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Inappropriate vaccination schedule (Late third dose); Inappropriate vaccination schedule (Late secon... Inappropriate vaccination schedule (Late third dose); Inappropriate vaccination schedule (Late 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 60-year-old patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose of vaccine on 7th November 2024). On an unknown date, the patient received the 3rd dose of Twinrix. On 09-MAR-2025, the patient received the 2nd dose of Twinrix. On 09-MAR-2025, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate vaccination schedule (Late second dose)). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate vaccination schedule (Late third dose)). The outcome of the incomplete course of vaccination 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: 28-AUG-2025 The pharmacist called to ask about a sixty-year-old patient's vaccination schedule (revaccination or schedule restart) for the Twinrix vaccine. The pharmacist reactively stated, he/she was going to administer the third dose of Twinrix today (date of reporting). More
2858285 67 M FL 09/12/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Back pain, Chills, Feeling abnormal, Impaired driving ability, Pain; Pyrexia, Tr... Back pain, Chills, Feeling abnormal, Impaired driving ability, Pain; Pyrexia, Tremor More
I received the Fluzone HD 65+ yesterday from Pharmacy. Within one to two minutes while driving, I ex... I received the Fluzone HD 65+ yesterday from Pharmacy. Within one to two minutes while driving, I experienced the sudden and severe onset of almost disabling back pain to the point where I had to pull over to the side of the road and I thought for a few minutes about calling an ambulance. I waited for about 15 minutes and it slowly started to resolve. About one and a half hours later, I developed shaking chills, with teeth rattling, low-grade temperature and generalized body aches. Advil got me through the next 18 hours. Today, the following day, I feel beat up but generally OK. I wonder if the back pain has been reported as an acute side-effect, within 1 to 2 minutes! I'm not an anti-vaxxer. I was just concerned. o returned physician. Thank you. I did not seek medical help. More
2858286 M CA 09/12/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Contusion, Diarrhoea, Dizziness, Fall, Headache; Impaired driving ability, Injur... Contusion, Diarrhoea, Dizziness, Fall, Headache; Impaired driving ability, Injury, Lethargy More
Adverse reaction to flu shot. Fluzone High-Dose 0.5 ML INJ, NDC 49281-0125-65. Administered 09/07/20... Adverse reaction to flu shot. Fluzone High-Dose 0.5 ML INJ, NDC 49281-0125-65. Administered 09/07/2025 at Pharmacy. Less than 24 hours later, I was lethargic with extreme dizziness and light-headedness. I fell once and injured myself. I am bruised but have not required medical treatment. Because of the dizziness I am absolutely unable to drive. I also developed a headache and diarrhea. I am currently resting and drinking water to avoid dehydration. I have never had an adverse reaction to an injection of any kind. I regularly get a flu shot every year and remain current on all vaccines appropriate to my age (74) and overall health (very good.) I have had seasonal tree allergies in the past but no longer, following allergies shot about 10 years ago. More
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2858287 55 F NY 09/12/2025 FLU3
FLU3
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8523AA
U8523AA
U8274AA
U8274AA
Asthenia, Balance disorder, Choking, Dysarthria, Dysphagia; Fall, Gait disturban... Asthenia, Balance disorder, Choking, Dysarthria, Dysphagia; Fall, Gait disturbance, Mobility decreased, Muscular weakness, Tongue biting; Asthenia, Balance disorder, Choking, Dysarthria, Dysphagia; Fall, Gait disturbance, Mobility decreased, Muscular weakness, Tongue biting More
3 weeks after Flu vaccine I began having slurred speech. This progressed to difficulty with drinking... 3 weeks after Flu vaccine I began having slurred speech. This progressed to difficulty with drinking, eating and swallowing abilities causing frequent choking and lip, tongue and cheek biting. By early April I began experiencing growing weakness of ankles and knees. This has progressed to generalized weakness, resulting in initial buckling of the knees, then frequent falls, due to worsening gait and imbalance. I can no longer manage stairs not steps. I cling to whatever is in available to move at home. More
2858288 49 F 09/12/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 5EF45
5EF45
Blood glucose normal, Chest discomfort, Dizziness, Dyspnoea, Erythema; Malaise, ... Blood glucose normal, Chest discomfort, Dizziness, Dyspnoea, Erythema; Malaise, Pallor More
Person received Flulaval vaccine. One minute after administration, was reported that person "do... Person received Flulaval vaccine. One minute after administration, was reported that person "doesn't feel well she feels like passing out saying 'I don't feel well' her face turned so red and can't breathe. We checked her BP it was 170's HR 127 she feels numbness too. Then she became pale. We called the supervisor and medicine doctor right away. Blood sugar 92." Person went to emergency department because of continued complaints of chest tightness and shortness of breath. More
2858347 TX 09/12/2025 RVX
 UNKNOWN MANUFACTURER
 2142136
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs were reported; The healthcare worker is reporting that a patient received improper... No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-Aug-2025, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2142136, expiration date: 28-May-2026) as prophylaxis, the vaccine received by the patient was improperly storred with temperature of 8.8 C for 30 minutes and 8.5 C for 15 minutes (product storage error). There was no previous temperature excursion. No additional adverse events (AEs) were reported. More
2858348 65 F FL 09/12/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019158
Y019158
Arthralgia, Influenza like illness, Injection site pain, Pain, Rash; Rash macula... Arthralgia, Influenza like illness, Injection site pain, Pain, Rash; Rash macular More
Arthralgia; rash macular; injection site pain; pain; Influenza like illness; rash; Information has b... Arthralgia; rash macular; injection site pain; pain; Influenza like illness; rash; Information has been received from the Food Drug Administration (FDA) (agency number 2844372-1) on 20-Aug-2025. This spontaneous report refers to a 65-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 01-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (lot #Y019158, expiration date: 20-May-2026), dose number 1, administered by Intramuscular route in Left Arm for prophylaxis. On 01-Jun-2025, the patient experienced rash macular, injection site pain, arthralgia, pain, influenza like illness, and rash. At the reporting time, the patient had not recovered from rash macular, injection site pain, Arthralgia, pain, Influenza like illness and rash. The causal relationship between the events of rash macular, injection site pain, arthralgia, pain, influenza like illness, rash and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : (withheld)@merck.com , Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2844372 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2858349 F TX 09/12/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Z005765
Z005765
Cellulitis, Chills, Fatigue, Headache, Induration; Injection site pain, Pain in ... Cellulitis, Chills, Fatigue, Headache, Induration; Injection site pain, Pain in extremity, Peripheral swelling More
CHILLS; FATIGUE; HEADACHE; INDURATION; INJECTION SITE PAIN; PAIN IN EXTREMITY; PERIPHERAL SWELLING; ... CHILLS; FATIGUE; HEADACHE; INDURATION; INJECTION SITE PAIN; PAIN IN EXTREMITY; PERIPHERAL SWELLING; Information has been received from Food and Drug Administration (FDA) and refers to 57-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and ibuprofen . On 02-Jun-2025, the patient was vaccinated with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Z005765, expiration date: 23-Nov-2026), administered by intramuscular route in right arm as prophylaxis. The patient messaged in stating: It hurt quite a bit at the time of vaccination, but did not think anything of it. On 03-Jun-2025 (approximately 24 hours after vaccination), the patient experienced fatigue (Severe), chills, headache, induration, injection site pain, pain in extremity and peripheral swelling. The patient's arm has continued to hurt since, is swollen and hard and is red 1/4 down my arm now. She was advised to be seen for potential cellulitis. She had office visit at walk-in clinic on 05-JUN-25 for cellulitis, and emergency room (ER) visit on 06-JUN-25 for concerns this is worsening. The patient was placed on antibiotics. At the reporting time, the patient had not recovered from the events. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.; Sender's Comments: Priority : 5 , Is case serious : No Index date : 2025-08-20 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2844223 , Central date : 2025-08-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2858350 09/12/2025 UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER




Condition aggravated, Diarrhoea, Drooling, Endotracheal intubation, Enlarged uvu... Condition aggravated, Diarrhoea, Drooling, Endotracheal intubation, Enlarged uvula; Epiglottic oedema, Epiglottitis, Full blood count abnormal, Gastroenteritis, Intensive care; Laryngoscopy abnormal, Mechanical ventilation, Obstructive airways disorder, Pancytopenia, Paralysis; Pyrexia, Stridor, Swelling, Tachypnoea, Vaccination failure; Vomiting More
rapidly progressing acute epiglottitis despite being fully vaccinated; rapidly progressing acute epi... rapidly progressing acute epiglottitis despite being fully vaccinated; rapidly progressing acute epiglottitis despite being fully vaccinated; This spontaneous report was received from the authors above and refers to a(n) 3-year-old patient of unknown gender. On an unknown date, the patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Oral liquid administered by Oral route (lot # and expiration date were not reported) for prophylaxis. On an unknown date the patient was evaluated in the emergency department (ED) for fever, diarrhea and emesis for 2 days. They were discharged with the diagnosis of gastroenteritis 12 hours later the patient re-presented to the ED with new bilateral neck swelling. On evaluation by ear nose and throat (ENT) the patient was stable on blow by oxygen with mild tachypnea. However, over the next 20 minutes stridor developed. racemic epinephrine was started and beside laryngoscopy was performed which revealed diffuse airway swelling of the uvula, epiglottis and supraglottic structures with near occlusion of the airway (rapidly progressing acute epiglottitis and vaccination failure). The patient was transferred to the operation room (OR) for intubation. A Complete blood count was performed which reveal severe pancytopenia. The patient entered in the OR on a stretcher on 10 liters of oxygen via facemask, sitting in a tripod position. At this time oxygen saturation was 95% with increased breathing, stridor and drooling. At intubation the ENT surgeon encountered a sever swollen epiglottis with complete obstruction of the glottic opening. The patient was paralyzed, mechanically ventilated and transported to UCI. At the reporting time the outcome of the events was not provided. The events were considered to be related with suspect therapy. Upon internal review, the event(s) of rapidly progressing acute epiglottitis despite being fully vaccinated was/were determined to be medically significant. More
2858351 UT 09/12/2025 VARCEL
 MERCK & CO. INC.
 X021281
Expired product administered, No adverse event Expired product administered, No adverse event
there were no symptomatic events reported; expired vaccine administration AE for VARIVAX.; This spo... there were no symptomatic events reported; expired vaccine administration AE for VARIVAX.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (Hollister-Stier STERILE DILUENT) . On 09-Sep-2025, the patient was vaccinated with an expired Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) with lot #X021281 and expiration date: 20-Aug-2025 as prophylaxis (dose and route of administration were not reported). No symptomatic events reported. The reporter also inquired about potency of dose provided to the patient. More
2858352 F CA 09/12/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.

Biopsy brain abnormal, Death, Encephalitis, Magnetic resonance imaging head abno... Biopsy brain abnormal, Death, Encephalitis, Magnetic resonance imaging head abnormal, Measles; Metagenomic analysis, Multipathogen PCR test, Positron emission tomogram abnormal More
Measles Encephalitis; This literature report has been received from the authors of the published art... Measles Encephalitis; This literature report has been received from the authors of the published article and refers to a 1-year-old female patient The patient's medical history was not reported. The patient's concurrent conditions included acute myeloid leukemia, diffuse morbilliform rash, and paternal haploidentical stem cell transplant. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), dose number 1, (lot # and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported). On an unknown date, the patient experienced Measles Encephalitis. On an unknown date, metagenomic RNA sequencing showed Acquired 50.7 million reads, 190,303 of which aligned to Edmonston-Enders (Moraten) measles vaccine (MV), 500๏ฟฝ coverage over 98.2% of the whole MV genome with mean coverage of 1,540๏ฟฝ reads. It was identified no known hyperfusogenic fusion gene mutations. However, 38.0% (68/179) of uracil-containing codons in the matrix (M) gene contained >1 uracil-to-cytosine mutation at levels =5%. M-gene hypermutation; multiplex quantitative reverse transcription PCR showed positive for measles vaccine (MV) RNA. 3 genomic targets: the nucleoprotein, hemagglutinin, and large protein genes. The carboxyl-terminal nucleoprotein typing sequence was identical to the MV component of the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) vaccine; magnetic resonance imaging showed abnormal signals; positron emission tomography showed hyperperfusion involving the insula and thalamus; mesial temporal lobe biopsy showed deep gray and white matter with astrogliosis but without notable inflammation, neoplastic cells, or definite inclusions. On an unspecified date, the patient died because of the event of measles encephalitis. An autopsy was not performed. The causal relationship between the event and the suspect vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), reconstituted suspect sterile diluent (Hollister-Stier STERILE DILUENT) was related (also reported as fatal case of vaccine-associated measles encephalitis). Reported Cause(s) of Death: vaccine-associated measles encephalitis More
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2858353 11 F NJ 09/12/2025 MNP
UNK
 PFIZER\WYETH
UNKNOWN MANUFACTURER
 LJ0077
Y014305
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AE/PQC reported.; HCP calling to report an AE regarding the PROQUAD vaccine. HCP repor... No additional AE/PQC reported.; HCP calling to report an AE regarding the PROQUAD vaccine. HCP reported that the PROQUAD vaccine was improperly stored and administered to multiple patients. HCP provided limited pertinent information and demographic data. HCP had no further clarific; This spontaneous invalid report was received from a registered nurse and refers to an 11-year-old female patient. The patient's concurrent conditions and medical history were not reported. Concomitant therapies were not reported. On 07-Mar-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (reported as MMR/VAR) (also reported as M-M-R II but lot # Y014305 was confirmed to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) with expiration date of 18-Feb-2026) (dose was not reported) administered intramuscularly in the left deltoid reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). On the same day, she was also vaccinated with a dose of Meningococcal vaccine A/B/C/W/Y (PENBRAYA) administered intramuscularly in the left deltoid. A monitor temperature logs regularly for temperature excursions. The vaccines were improperly stored and administered to multiple patients. No adverse events were reported. This was one of several cases received from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , number : 02792855-02792844 , number : , number : , number : 500UW00000Z5KJlYAN|19082025230024|1380 , Central date : 2025-08-20 , Classification : , Attachment description : Call , Safety case number : 2278777 , case number : 02792855 , interaction number : 02792844 , Integration log UniqueID : 500UW00000Z5KJlYAN|19082025230024|1380 , Service cloud CaseID : 500UW00000Z5KJlYAN More
2858354 12 F NJ 09/12/2025 MMRV
MNP
 MERCK & CO. INC.
PFIZER\WYETH
 Y014305
LJ0077
Product storage error; Product storage error Product storage error; Product storage error
No additional AE/PQC reported.; HCP calling to report an AE regarding the PROQUAD vaccine. HCP repor... No additional AE/PQC reported.; HCP calling to report an AE regarding the PROQUAD vaccine. HCP reported that the PROQUAD vaccine was improperly stored and administered to multiple patients. HCP provided limited pertinent information and demographic data. HCP had no further clarific; This spontaneous invalid report was received from a registered nurse and refers to a 12-year-old female patient. The patient's concurrent conditions and medical history were not reported. Concomitant therapies were not reported. On 26-Feb-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (reported as MMR/VAR) (also reported as M-M-R II but lot # Y014305 was confirmed to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) with expiration date of 18-Feb-2026) (dose was not reported) administered intramuscularly in the left deltoid reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) for prophylaxis. On the same day, she was also vaccinated with a dose of Meningococcal vaccine A/B/C/W/Y (PENBRAYA) administered intramuscularly in the left deltoid. A monitor temperature of vaccines storage regularly was noted. The vaccines were improperly stored and administered to multiple patients. No adverse events were reported. This was one of several cases received from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02792855-02792844 , CLIC number : , ESTAR number : , IRMS number : 500UW00000Z5KJlYAN|19082025230024|1380 , Central date : 2025-08-20 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2278777 , MNSC case number : 02792855 , MNSC interaction number : 02792844 , Integration log UniqueID : 500UW00000Z5KJlYAN|19082025230024|1380 , Service cloud CaseID : 500UW00000Z5KJlYAN More
2858355 F 09/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Syncope Syncope
Fainted; This serious case was reported by a consumer via call center representative and described ... Fainted; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 13-MAR-2024, the patient received the 1st dose of Shingrix. On 14-MAR-2024, 1 days after receiving Shingrix, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant). On 14-MAR-2024, the outcome of the fainting was unknown. It was unknown if the reporter considered the fainting to be related to Shingrix. The company considered the fainting to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 16-MAR-2024 The reporter reported this adverse event experienced by her neighbor over one year ago. 1 day after vaccination, in the morning, the patient fainted. This was all the information known at this time.; Sender's Comments: A case of Syncope, 1 day after receiving 1st dose of Shingrix in a female 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
2858356 77 F VA 09/12/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 55TH4
55TH4
55TH4
Ear pain, Herpes zoster, Herpes zoster oticus, Influenza like illness, Malaise; ... Ear pain, Herpes zoster, Herpes zoster oticus, Influenza like illness, Malaise; Musculoskeletal stiffness, Night sweats, Oropharyngeal pain, Pain, Pain in extremity; Paraesthesia, Rash, Tenderness, Urticaria More
flu like symptoms; night sweat; shingles in ear; facial herpes zoster; Sore arm; Sore throat; This s... flu like symptoms; night sweat; shingles in ear; facial herpes zoster; Sore arm; Sore throat; This serious case was reported by a consumer via call center representative and described the occurrence of herpes zoster otitis externa in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 55TH4) for prophylaxis. On 18-AUG-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). In AUG-2025, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms), night sweat (Verbatim: night sweat) and sore throat (Verbatim: Sore throat). On 18-AUG-2025, the patient experienced pain in arm (Verbatim: Sore arm). On 29-AUG-2025, the patient experienced herpes zoster otitis externa (Verbatim: shingles in ear) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: facial herpes zoster). The patient was treated with valaciclovir hydrochloride (Valtrex) and doxycycline. In AUG-2025, the outcome of the pain in arm, influenza-like symptoms and night sweat were resolved. The outcome of the herpes zoster otitis externa, facial herpes zoster and sore throat were not resolved. The reporter considered the herpes zoster otitis externa, facial herpes zoster, pain in arm, influenza-like symptoms, night sweat and sore throat to be related to Shingrix. The company considered the herpes zoster otitis externa to be unrelated to Shingrix. The company considered the facial herpes zoster, pain in arm, influenza-like symptoms, night sweat and sore throat to be related to Shingrix. Additional Information: GSK receipt date: 29-AUG-2025 The patient stated that she experienced a sore arm the same evening after receiving the vaccine, and the soreness persisted throughout the following day but had resolved by the time of reporting. Additionally, the patient reported waking up one night wet with sweat, which had since subsided. All these adverse events reportedly lasted for a couple of days and began during the week after receiving the vaccine, although no specific dates were provided. The patient stated that she experienced achiness, which was still ongoing at the time of reporting on 29-AUG-2025. She also reported feeling unwell on that day and described herself as just sitting and doing nothing. Over the weekend (specific dates not provided), the patient stated that she began feeling like pins were sticking in her head and she also reported the appearance of welts and bumps in her hair on the left side of her head, which she described as very sore to touch. According to the patient, there were big lumps on her head that stung when touched, and she was still experiencing these symptoms on 29-AUG-2025. The patient further stated that she developed a rash over the weekend (specific dates not provided), which first appeared on the left side of her neck, then spread to her left jaw and the inside and outside of her left ear. She also reported feeling like she had a stiff neck, which she noted began around the same time as the appearance of the welts on her head. Additionally, the patient reported experiencing an earache and a sore throat, she expressed feeling very upset by these symptoms. On 29-AUG-2025, the patient visited the emergency room and was diagnosed with shingles by the physician there, and she stated that the physician attributed her symptoms to the Shingrix vaccine. The physician also prescribed Gabapentin, although the patient stated that she did not intend to take this medication. Prior to receiving the shingles diagnosis, the patient reported taking one dose of Doxycycline, as she initially suspected her symptoms might have been due to a tick bite.; Sender's Comments: A case of Herpes zoster oticus, 11 days after receiving 1st dose of Shingrix in a 77-year-old female subject. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2858357 71 F 09/12/2025 UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Asthenia, Atrial fibrillation, Cardioversion, Echocardiogram, Echocardiogram abn... Asthenia, Atrial fibrillation, Cardioversion, Echocardiogram, Echocardiogram abnormal; Electrocardiogram ST-T segment abnormal, Fatigue, Left atrial enlargement; Asthenia, Atrial fibrillation, Cardioversion, Echocardiogram, Echocardiogram abnormal; Electrocardiogram ST-T segment abnormal, Fatigue, Left atrial enlargement More
atrial fibrillation; This 72-year-old female subject was enrolled in a blinded study. The subject re... atrial fibrillation; This 72-year-old female subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 15-AUG-2022, for prophylaxis. Concurrent medical conditions included weakness and fatigue. On 22-AUG-2023, 372 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: atrial fibrillation). Serious criteria included hospitalization. The subject was treated with rivaroxaban (Xarelto). The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation was not resolved. Relevant Tests: On 22 AUG 2023 12 Lead electrocardiogram (ECG) showed PR UNK, QRS 93, QTc 394 Ventricular Rate 115- Atrial fibrillation with RVR, nonspecific ST and T-wave abnormality, abnormal rhythm ECG. On 22 AUG 2023 Transesophageal echocardiogram (TEE) performed which revealed severely enlarged left atrium but no other vascular issues or clot formation, and underwent successful cardioversion back to sinus rhythm. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. GSK receipt date: 30-Aug-2023 Subject admitted 8/22/23 with symptoms of fatigue and weakness and discharged 8/24/2023. Atrial Fibrillation will continue no stop date expected. Atrial Fibrillation continues. Atrial continues as of 05 Dec 2023. Atrial Fibrillation continues as of 9 Feb 2024. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on: 05-Sep-2023 Summary of changes: Hospitalization details and Narrative updated. Follow-up information received on: 11-Sep-2023 Summary of changes: Concomitant drug, medical history, lab data added, narrative updated. Follow-up information received on 12-SEP-2023. Summary of changes: Type of drug was updated from concomitant to treatment. Follow-up information received on 14-SEP-2023. Summary of changes: Narrative updated. Follow-up information received on 20-NOV-2023. Summary of changes: Action taken not applicable changed to dose not changed. Follow-up information received on 30-NOV-2023 and 05-DEC-2023 Summary of changes: General narrative comments were updated. Follow-up information received on 19-FEB-2024. Summary of changes: General narrative comment updated. Follow up information received on 04-Jul-2024, End of study Unblinding completed; Sender's Comments: A case of Atrial fibrillation, 795 days after receiving 2nd dose of RSVPreF3 in a 72-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset. More
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2858358 4 F AZ 09/12/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 Z53J4
Expired product administered Expired product administered
patient was given expired infanrix; This non-serious case was reported by a nurse via sales rep and ... patient was given expired infanrix; This non-serious case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa (Infanrix) (batch number Z53J4, expiry date 07-JUN-2025) for prophylaxis. On 07-AUG-2025, the patient received the 1st dose of Infanrix (intramuscular, left deltoid). On 07-AUG-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient was given expired infanrix). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-Aug-2025 Provider of the record realized Infanrix was expired after administration to patient. No adverse event had been reported to date. More
2858359 12 F VA 09/12/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 Z92L4
Extra dose administered Extra dose administered
Second dose was administered on August 12th, 2025; This non-serious case was reported by a other hea... Second dose was administered on August 12th, 2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Z92L4, expiry date 31-JAN-2026) for prophylaxis. Previously administered products included Menveo (received first dose on 07-AUG-2024 of batch number NG9E2 and expiry date of 30-JUN-2025). On 12-AUG-2025, the patient received the 2nd dose of Menveo. On 12-AUG-2025, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: Second dose was administered on August 12th, 2025). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 14-AUG-2025 Practice manager needs to ask that it looks like they had given a Menveo. They had given it to a patient too early, the second dose and so, the reporter asked that need to give the information and could respond with any contraindications that the reporter need to document. Both doses were Menveo 1-vial presentation. More
2858360 CT 09/12/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
late 3rd dose; This non-serious case was reported by a nurse via call center representative and desc... late 3rd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Pediarix (Patient received 1 st dose on 03-DEC-2022) and Pediarix (Patient received 2 nd dose on 17-FEB-2023). On 28-SEP-2023, the patient received the 3rd dose of Pediarix. On 28-SEP-2023, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: late 3rd dose). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-AUG-2025 Nurse reports patient received Pediarix at 2, 4, and 12 months of age and Infanrix at 15 months of age. The patient received 3rd dose of Pediarix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 4th DTaP dose was Infanrix on 27-DEC-2023. More
2858361 5 M TX 09/12/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 A32BB
Expired product administered Expired product administered
Expired Product Used; This non-serious case was reported by a other health professional via call cen... Expired Product Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis. On 14-AUG-2025, the patient received the 1st dose of Pediarix. On 14-AUG-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-AUG-2025 The Vaccine Administration Facility was the same as Primary Reporter. A Medical Assistant called to get guidance on how to proceed for a patient who was administered an expired dose of Pediarix. More
2858362 49 F AZ 09/12/2025 HEP
HEP
HEP
HEP
HEP
HEP
HEP
HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 9K34M
9K34M
9K34M
9K34M
9K34M
UNK
UNK
UNK
UNK
UNK
Arthralgia, Burning sensation, Chest discomfort, Discomfort, Dizziness; Electroc... Arthralgia, Burning sensation, Chest discomfort, Discomfort, Dizziness; Electrocardiogram normal, Fatigue, Headache, Hemiparesis, Hepatitis B antibody negative; Injection site swelling, Joint swelling, Laboratory test normal, Myalgia, Nausea; Oropharyngeal pain, Pain, Peripheral swelling, Pruritus, Pulmonary function test; Rash, Throat irritation; Arthralgia, Burning sensation, Chest discomfort, Discomfort, Dizziness; Electrocardiogram normal, Fatigue, Headache, Hemiparesis, Hepatitis B antibody negative; Injection site swelling, Joint swelling, Laboratory test normal, Myalgia, Nausea; Oropharyngeal pain, Pain, Peripheral swelling, Pruritus, Pulmonary function test; Rash, Throat irritation More
left side weakness; muscle pain; left fingers swollen compared to the right fingers; Sore throat; Sw... left side weakness; muscle pain; left fingers swollen compared to the right fingers; Sore throat; Swollen joints; Dizziness; Joint pain; Itchy throat; Chest tightness; Rash/patient presented the rash on the next day/a rash on her neck; Itching/itching all over her body; Headache; Nausea; Fatigue; Injection site swelling; left side of body feels heavy; left side of body feels sore; rashes that come and go (described in the neck along with a "burning" sensation); titer low (3) after previous vaccination with unknown hepatitis b vaccine; This serious case was reported by a nurse via call center representative and described the occurrence of weakness left or right side in a 49-year-old female patient who received HBV (Engerix B adult) (batch number 9K34M, expiry date 05-SEP-2027) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. Concurrent medical conditions included fruit allergy (only known allergy was tomatoes). On 26-AUG-2025, the patient received Engerix B adult (intramuscular, left deltoid) 1 ml. On an unknown date, the patient received Hepatitis B vaccine. In AUG-2025, not applicable after receiving Engerix B adult and an unknown time after receiving Engerix B adult and Hepatitis B vaccine, the patient experienced therapeutic response decreased (Verbatim: titer low (3) after previous vaccination with unknown hepatitis b vaccine). On 26-AUG-2025, the patient experienced pruritus (Verbatim: Itching/itching all over her body), headache (Verbatim: Headache), nausea (Verbatim: Nausea), fatigue (Verbatim: Fatigue), injection site swelling (Verbatim: Injection site swelling), sensation of heaviness (Verbatim: left side of body feels heavy), pain (Verbatim: left side of body feels sore) and burning sensation (Verbatim: rashes that come and go (described in the neck along with a "burning" sensation)). On 27-AUG-2025, the patient experienced rash (Verbatim: Rash/patient presented the rash on the next day/a rash on her neck), itchy throat (Verbatim: Itchy throat) and chest tightness (Verbatim: Chest tightness). On 28-AUG-2025, the patient experienced dizziness (Verbatim: Dizziness) and joint pain (Verbatim: Joint pain). On 02-SEP-2025, the patient experienced swollen joints (Verbatim: Swollen joints). On an unknown date, the patient experienced weakness left or right side (Verbatim: left side weakness) (serious criteria GSK medically significant), muscle pain (Verbatim: muscle pain), swelling of fingers (Verbatim: left fingers swollen compared to the right fingers) and sore throat (Verbatim: Sore throat). The patient was treated with acrivastine (Benadryl). The outcome of the weakness left or right side, muscle pain, swelling of fingers, sore throat and burning sensation were not reported and the outcome of the rash was resolving and the outcome of the pruritus, itchy throat, dizziness, joint pain, swollen joints, sensation of heaviness and pain were not resolved and the outcome of the headache, nausea and fatigue were unknown and the outcome of the chest tightness and injection site swelling were resolved and the outcome of the therapeutic response decreased was not applicable. It was unknown if the reporter considered the weakness left or right side, rash, pruritus, headache, nausea, fatigue, itchy throat, chest tightness, dizziness, joint pain, swollen joints, injection site swelling, sensation of heaviness, pain, muscle pain, swelling of fingers, sore throat and burning sensation to be related to Engerix B adult. The company considered the weakness left or right side to be unrelated to Engerix B adult and Hepatitis B vaccine. It was unknown if the company considered the rash, pruritus, headache, nausea, fatigue, itchy throat, chest tightness, dizziness, joint pain, swollen joints, injection site swelling, sensation of heaviness, pain, muscle pain, swelling of fingers, sore throat and burning sensation to be related to Engerix B adult. Additional Information: GSK Receipt Date: 04-SEP-2025 The nurse reported that the adult patient was seen in the clinic after a needle stick. A hepatitis B titer was low. The patient received a booster dose of Engerix-B adult vaccine and in the evening, she had injection site swelling, a rash on her neck, itching all over her body, headache, nausea, fatigue and her whole left side of body felt heavy and sore. The patient was seen in the clinic the next day after vaccination, for the above effects and itchy throat and chest tightness. She started Benadryl for the rash and itching. Pulmonary function tests and electrocardiogram were normal. On 28-AUG-2025 her rash was improving with Benadryl. She developed dizziness and joint pain all over. On 02-SEP-2025 the joint pain continued, the rash comes and goes. She developed swollen joints in the fingers of her left hand. Nothing else was reported. The health care professional mentioned that the patient presented the rash on the next day. The health care professional described more reactions presented by the patient, rashes that come and go (described in the neck along with a burning sensation), dizziness, muscle pain, left side weakness, left fingers swollen compared to the right fingers and sore throat.; Sender's Comments: A case of Hemiparesis, 1 day after receiving unknown dose of Engerix B adult and Hepatitis B vaccine in a 49-year-old female subject. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2858363 09/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Rash pruritic, Rash vesicular Rash pruritic, Rash vesicular
broke out into a rash that looked like shingles; just itched really bad; This non-serious case was r... broke out into a rash that looked like shingles; just itched really bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of vesicular rash 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 vesicular rash (Verbatim: broke out into a rash that looked like shingles) and pruritus (Verbatim: just itched really bad). The outcome of the vesicular rash and pruritus were not reported. It was unknown if the reporter considered the vesicular rash and pruritus to be related to Shingles vaccine. It was unknown if the company considered the vesicular rash and pruritus to be related to Shingles vaccine. Additional Information: GSK receipt date: 18-AUG-2025 The patient reported case for himself/ herself. Patient got the 1st shot and broke out into a rash that looked like shingles but was not painful just itched really bad. More
2858364 09/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Product preparation issue Product preparation issue
vaccine was given part 2 with a sterile diluent and not part one; vaccine was given part 2 with a st... vaccine was given part 2 with a sterile diluent and not part one; vaccine was given part 2 with a sterile diluent and not part one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced wrong solution used in drug reconstitution (Verbatim: vaccine was given part 2 with a sterile diluent and not part one) and inappropriate dose of vaccine administered (Verbatim: vaccine was given part 2 with a sterile diluent and not part one). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 19-AUG-2025 This case was reported by a patient via interactive digital media. The second part of the zoster vaccine was administered with a sterile diluent instead of the first part. To proceed, part one needed to be given separately, and it required reconstitution with the appropriate sterile diluent before administration. More
2858365 09/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
missed the time for my 2nd shot; This non-serious case was reported by a consumer via interactive di... missed the time for my 2nd 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 received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (Received 1st dose of Shingles vaccine on an unknown date). The patient did not receive the 2nd dose of Shingles vaccine. The patient had incomplete course of vaccination (Verbatim: missed the time for my 2nd shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 20-AUG-2025 This case was reported by a patient via interactive digital media. The patient missed the time for the second shot. The reporter wanted to know if he/she need to start all over. More
2858366 09/12/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; Had the shot, still caught Respiratory syncytial virus infection; Thi... Suspected vaccination failure; Had the shot, still caught Respiratory syncytial virus infection; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Had the shot, still caught Respiratory syncytial virus infection). 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 RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 28-AUG-2025 This case was reported by a consumer via interactive digital media. The patient had the shot, still caught respiratory syncytial virus infection. This case was considered as suspected vaccination failure as details regarding time to onset for Respiratory syncytial virus infection and laboratory confirmation regarding Respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving RSV 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
2858367 09/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
The shingles shot was in my left arm , my pain is in my right arm; This non-serious case was reporte... The shingles shot was in my left arm , my pain is in my right arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: The shingles shot was in my left arm , my pain is in my right arm). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 29-AUG-2025 The patient reported that he/she received Shingles (Shingrix) shot and the patient had pain in his/her right arm More
2858368 09/12/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; we got RSV; This serious case was reported by a consumer via interact... Suspected vaccination failure; we got RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a unspecified number of patients who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patients received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patients experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: we got RSV). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved (duration 1 month). It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 30-AUG-2025 This case was reported by a patient via interactive digital media. Patient stated that when he/she read said that the vaccine will not prevent you from getting it; but it was 86 percent effective at kept from being in the hospital with pneumonia. Patient did not got pneumonia. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding respiratory syncytial infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving RSV 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
2858369 09/12/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Chest discomfort, Malaise, Respiratory syncytial virus infection, Vaccination fa... Chest discomfort, Malaise, Respiratory syncytial virus infection, Vaccination failure More
Suspected vaccination failure; I did get the shot before the second time; i was breaking all my ribs... Suspected vaccination failure; I did get the shot before the second time; i was breaking all my ribs and truly wanted to die; I was very ill for a month both times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included respiratory syncytial virus infection and illness. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: I did get the shot before the second time), illness (Verbatim: I was very ill for a month both times) and chest pressure sensation (Verbatim: i was breaking all my ribs and truly wanted to die). The outcome of the vaccination failure, respiratory syncytial virus infection and chest pressure sensation were not reported and the outcome of the illness was resolved (duration 1 month). It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, illness and chest pressure sensation to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection, illness and chest pressure sensation to be related to RSV vaccine. Additional Information: GSK Receipt Date: 30-AUG-2025 This case was reported by a patient via interactive digital media. The reporter reported that he /she had it (RSV infection) twice. The reporter stated that it was no fun, thought it was breaking all ribs and truly wanted to die. The reporter was very ill for a month both times and still had some issues after. He/she did get the shot before the second time, but not sure it was RSV the second time as he/she didn't do a test. The reporter mentioned get the shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving unknown dose of RSV 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
2858370 F 09/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Rash, Vaccination failure Herpes zoster, Pain, Rash, 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 female patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster 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 was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 02-SEP-2025 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The shingles were on left shoulder, under arm and on left breast and it was excruciatingly painful. Lukewarm to cool water provides some. The patient stated it was impossible to wear a bra on that area. That alone makes felt the isolation of this painful rash. This case was considered as suspected vaccination failure as details regarding completion of primary 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 Herpes Zoster vaccine, in a female 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
2858371 09/12/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Myalgia, Rash, Vaccination failure; Herpes zoster, Myalgia, Rash,... Herpes zoster, Myalgia, Rash, Vaccination failure; Herpes zoster, Myalgia, Rash, Vaccination failure More
Suspected vaccination failure; severe shingles rash and muscle aches in my right arm; This serious c... Suspected vaccination failure; severe shingles rash and muscle aches in my right arm; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In MAR-2024, the patient received the 2nd dose of Shingrix. In DEC-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: severe shingles rash and muscle aches in my right arm). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 29-AUG-2025 Patient received Shingrix shots two years ago and on Tuesday developed a severe shingles rash and muscle aches in right arm. This case was considered as suspected vaccination failure as details regarding laboratory confirmation and time to onset of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingrix (dose 1) and Shingrix (dose 2), 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
2858372 09/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Mobility decreased Mobility decreased
could not move their hand and arm; This non-serious case was reported by a consumer and described th... could not move their hand and arm; This non-serious case was reported by a consumer and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced mobility decreased (Verbatim: could not move their hand and arm). The outcome of the mobility decreased was resolved (duration 1 week). It was unknown if the reporter considered the mobility decreased to be related to Shingrix. It was unknown if the company considered the mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 29-AUG-2025 The reporter stated Shingrix shot was terrible. The patient could not move her/his hand and arm for a week. The patient stated still better than shingles though. More
2858373 09/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; have shingles right now; This serious case was reported by a consumer... Suspected vaccination failure; have shingles right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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: have shingles right now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-SEP-2025 This case was reported by a patient via interactive digital media. The patient had shingles vaccination shots and had shingles right now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: 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
2858374 09/12/2025 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 52-year-old patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the facial herpes zoster to be related to Herpes Zoster vaccine. Additional Information: GSK receipt date: 07-SEP-2025 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 Herpes Zoster vaccine in a 52-year-old 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
2858375 F 09/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site vesicles Injection site vesicles
blisters in a circle around my right arm where the patient had the vaccine given both times; This no... blisters in a circle around my right arm where the patient had the vaccine given both times; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of injection site blisters in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Covid-19 vaccine (vaccine received on an unknown date), Rosuvastatin (received 5 milligrams of Rosuvastatin daily) and Shingrix (1st dose received in December 2019). 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 blisters (Verbatim: blisters in a circle around my right arm where the patient had the vaccine given both times). The outcome of the injection site blisters was not reported. It was unknown if the reporter considered the injection site blisters to be related to Shingrix. It was unknown if the company considered the injection site blisters to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR110480 Additional Information: GSK receipt date: 26-AUG-2025 The patient took the second shot and had blisters in a circle around the right arm which is where the patient had the vaccine given both times. More
2858376 09/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; had a mild of shingles; This serious case was reported by a consumer ... Suspected vaccination failure; had a mild of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 78-year-old patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had a mild of 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 Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 06-SEP-2025 This case was reported by a patient via interactive digital media. Consumer reported that had a mild of shingles and they just trying to understand it. Consumer mentioned that it put them at a higher risk. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Herpes Zoster vaccine in a 78-year-old patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2858377 24 F MN 09/12/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 73BN2
73BN2
Discharge, Dyspnoea, Injection site erythema, Injection site urticaria, Injectio... Discharge, Dyspnoea, Injection site erythema, Injection site urticaria, Injection site warmth; Oropharyngeal pain, Respiratory tract congestion More
Hives around injection site lasting about 24 hours but were relieved with benadryl. Redness and warm... Hives around injection site lasting about 24 hours but were relieved with benadryl. Redness and warmth at the site of injection still present 48 hours later. Additionally experiencing severe congestion, making it difficult to breathe and a sore throat from the drainage, still present 24 hours after the onset of original symptoms. More
2858378 80 F SC 09/12/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
Patient has requested and now have received 3 doses of RSV vaccine, when a single dose is all that i... Patient has requested and now have received 3 doses of RSV vaccine, when a single dose is all that is indicated. 1/8/24, 8/21/24, 9/10/25 More
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