🏥 VAERS Vaccine Data Browser

🔒 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.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • 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 "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 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:

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

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ 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?

⚠️ 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
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2823712 71 F IA 01/30/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 J5T9Z
Wrong product administered Wrong product administered
I grabbed the under 65 influenza vaccine from the fridge and administered the vaccine. It wasn'... I grabbed the under 65 influenza vaccine from the fridge and administered the vaccine. It wasn't until afterwards that I realized the patient should have gotten the over 65 influenza vaccine. More
2823713 1.5 F IL 01/30/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 X4T99
No adverse event, Product preparation issue No adverse event, Product preparation issue
18mo patient was seen here today for her well visit. Due to her sickle cell disease, due for a dose ... 18mo patient was seen here today for her well visit. Due to her sickle cell disease, due for a dose of MCV4. A Menveo 1-vial presentation was given instead of the Menveo 2-vial presentation. All parties involved in patient care aware of error. No immediate reactions noted for patient. More
2823714 65 M 01/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 GK2AZ
Extra dose administered Extra dose administered
Patient was unaware of previous doses. MD told patient at his most recent appointment that he needed... Patient was unaware of previous doses. MD told patient at his most recent appointment that he needed to get Shingrix. However when I went to document the vaccine in system, it shows that the patient received both doses via his primary care in 11/2023 and 01/2024 More
2823715 65 F OR 01/30/2025 FLU3
 SEQIRUS, INC.
Dizziness, Headache, Rash Dizziness, Headache, Rash
headache, dizziness, rash across the torso treated with Benadryl every 4 hours, ongoing headache, dizziness, rash across the torso treated with Benadryl every 4 hours, ongoing
2823716 0.83 M PA 01/30/2025 FLU3
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Product administered to patient of inappropriate age, Wrong patient received pro... Product administered to patient of inappropriate age, Wrong patient received product; Product administered to patient of inappropriate age, Wrong patient received product More
Hep A given to the wrong sibling, given to the 10 month old younger sibling of the patient it was in... Hep A given to the wrong sibling, given to the 10 month old younger sibling of the patient it was intended for More
2823717 17 F NC 01/30/2025 FLU3
MENB
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 A555J
LL0637
Injection site erythema, Injection site reaction, Pyrexia, Rash macular, Strepto... Injection site erythema, Injection site reaction, Pyrexia, Rash macular, Streptococcus test negative; Injection site erythema, Injection site reaction, Pyrexia, Rash macular, Streptococcus test negative More
Recieved Trumenba and Flulaval vaccine in left deltoid on 01/27/25. Patient returned to office on 01... Recieved Trumenba and Flulaval vaccine in left deltoid on 01/27/25. Patient returned to office on 01/29/25 reporting rash and fever. Patient/caregiver state sore throat (scratchy throat) and cough began 1-2days before given vaccines. Patient/caregiver report fever and rash began on 01/27/25 after vaccination. Rash: site of rash: (left deltoid with macular serpiginous rash/ +erythema/no signs infection otherwise) More
2823718 41 F FL 01/30/2025 YF
 SANOFI PASTEUR
 UK118AA
Chills, Dizziness Chills, Dizziness
PATIENT EXPERIENCED CHILLS ALONG WITH DIZZINESS, ALSO ACCORDING TO PATIENT HEART WAS BETEAING RAPIDL... PATIENT EXPERIENCED CHILLS ALONG WITH DIZZINESS, ALSO ACCORDING TO PATIENT HEART WAS BETEAING RAPIDLY . More
2823719 12 F OH 01/30/2025 HPV9
 MERCK & CO. INC.
 Y018389
Injection site mass, Injection site pain Injection site mass, Injection site pain
Patient's parent reported on 1/30/2025 at 3:23pm that patient developed a "golf-ball sized... Patient's parent reported on 1/30/2025 at 3:23pm that patient developed a "golf-ball sized knot" at approximately 12:00pm on 1/30/2025 at the injection site where she received her HPV vaccine the day prior. Patient also reports mild pain around the site. No other symptoms reported. Parent states that after her first HPV vaccine, the patient experienced only mild site pain. Parent was advised to contact primary care provider. More
2823720 76 M AZ 01/30/2025 PNC20
 PFIZER\WYETH
 LK6650
Condition aggravated, Gout Condition aggravated, Gout
Severe gout flare - pt is on allopurinol 100 mg for prevention and stated never had flares prior to ... Severe gout flare - pt is on allopurinol 100 mg for prevention and stated never had flares prior to vaccination. Currently prescribed indomethacin 50 mg to treat flares More
2823721 4 F TN 01/30/2025 DTAPIPV
HEPA
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 5g23d
22gp3
y014939
Loss of consciousness, Pallor; Loss of consciousness, Pallor; Loss of consciousn... Loss of consciousness, Pallor; Loss of consciousness, Pallor; Loss of consciousness, Pallor More
Pt briefly lost consciousness approx. 10-15 minutes post vaccination. Witnessed by mother and cleric... Pt briefly lost consciousness approx. 10-15 minutes post vaccination. Witnessed by mother and clerical staff. Medical staff called to lobby. Pt awake and alert appearing pale. No s/s of respiratory distress noted. O2 saturation 99%. Pulse:77. BP:108/82 with pt moving arm frequently. Pt assessed by APN. Pt ambulatory with steady gait, interactive with staff, and pallor greatly improved just a few minutes after incident. Dc'd home with mother. More
2823722 71 M NY 01/30/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Pruritus, Rash, Rash macular; Erythema, Pityriasis rosea, Skin lesion; Pruritus,... Pruritus, Rash, Rash macular; Erythema, Pityriasis rosea, Skin lesion; Pruritus, Rash, Rash macular; Erythema, Pityriasis rosea, Skin lesion More
Patient experienced the beginning of a rash starting on right side of tors on 1/10/25 which subseque... Patient experienced the beginning of a rash starting on right side of tors on 1/10/25 which subsequently spread to torso (abdomen, sides of torso and back, upper arms about 2 weeks after initial administration of the vaccine. Experienced moderately severe itching with the breakout of many red spots lesions. Sought treatment at dermatology office on January 28th for diagnosis and treatment (contact physician's office for full details). More
2823723 35 F GA 01/30/2025 TDAP
 SANOFI PASTEUR
 U7976AA-CP
Pruritus, Throat tightness Pruritus, Throat tightness
Patient began scratching lower left arm approximately 3 minutes after vaccine administration. At app... Patient began scratching lower left arm approximately 3 minutes after vaccine administration. At approximately 15 minutes post-injection, patient stated she felt like her throat was closing More
2823724 8 F VA 01/30/2025 HEP
HEPA
IPV
MMR
TDAP
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
 Y004552
Y012054
X1D141M
X026329
U8274AA
Y013346
Blood glucose normal, Immediate post-injection reaction, Incontinence, Seizure, ... Blood glucose normal, Immediate post-injection reaction, Incontinence, Seizure, Syncope; Blood glucose normal, Immediate post-injection reaction, Incontinence, Seizure, Syncope; Blood glucose normal, Immediate post-injection reaction, Incontinence, Seizure, Syncope; Blood glucose normal, Immediate post-injection reaction, Incontinence, Seizure, Syncope; Blood glucose normal, Immediate post-injection reaction, Incontinence, Seizure, Syncope; Blood glucose normal, Immediate post-injection reaction, Incontinence, Seizure, Syncope More
Following vaccination patient had an immediate episode of syncopy with some seizure activity. Also h... Following vaccination patient had an immediate episode of syncopy with some seizure activity. Also had incontinence.. Mom reported history of syncope with previous vaccines. This was not disclosed to clinic staff until after the episode. More
2823725 64 F TN 01/30/2025 PNC20
 PFIZER\WYETH
 lj5283
Lethargy, Limb mass, Pain in extremity, Pyrexia Lethargy, Limb mass, Pain in extremity, Pyrexia
Patient experienced a sore arm and bump on her arm for multiple days and felt lethargic and feverish... Patient experienced a sore arm and bump on her arm for multiple days and felt lethargic and feverish but reports no actual md office or er/urgent care visits. More
2823726 0.17 F MI 01/30/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 YJ4kc
No adverse event No adverse event
No adverse event, Revaccination as treatment, no outcomes at this time. No adverse event, Revaccination as treatment, no outcomes at this time.
2823727 5 M UT 01/30/2025 DTPPVHBHPB
IPV
 MSP VACCINE COMPANY
SANOFI PASTEUR
 U7536AA
X1D141M
Erythema, Pyrexia, Vomiting, Wrong product administered; Erythema, Pyrexia, Vomi... Erythema, Pyrexia, Vomiting, Wrong product administered; Erythema, Pyrexia, Vomiting, Wrong product administered More
Patient came in to clinic to get updated vaccines. He was due for Dtap and polio and is 5 years old.... Patient came in to clinic to get updated vaccines. He was due for Dtap and polio and is 5 years old. He was unintentionally given more vaccines than necessary at the time. He was given vaxelis which contains DTaP, IPV, HIB, and Hep B; it is intended for use from 6 weeks to 4 years of age. There was also a separate IPOL (polio/IPV) vaccine given. Reviewing this patients vaccine record, it appears he should have gotten either Kinrix (DTaP & IPV) which is for 4 years to 6 years of age or Infanrix (DTaP) and IPOL (polio/IPV). The MA in charge of the patient and asked (redacted) and (redacted) to perform the vaccines which they did. In the rush and because they just stepped in to help they accidentally gave him the wrong vaccine. The next day patients mom called asking why his vaccines weren't showing up as updated in his chart. As this was being looked into we realized the mistake of the incorrect vaccine. We contacted the state to see what needed to happen and what this all meant. Through this we discovered that all of his vaccines including the ones he was getting updated were still valid but just needed to inform the parents and check for adverse reactions to vaccines as we generally would with any vaccine. Mother was contacted and informed. Mother stated that both of patients arms were red, he had been vomiting and had some fever but confirmed that he was having no problems with breathing. We told her that we would recommend she brought her son in to a provider to be evaluated for his reaction. More
2823728 14 F VA 01/30/2025 HPV9
 MERCK & CO. INC.
Hyperventilation, Laboratory test normal, Loss of consciousness, Vomiting Hyperventilation, Laboratory test normal, Loss of consciousness, Vomiting
After 24 hours she passed out and when we could get her awake she started throwing up and was hyperv... After 24 hours she passed out and when we could get her awake she started throwing up and was hyperventilating More
2823729 4 U LA 01/30/2025 MMRV
 MERCK & CO. INC.
Contraindication to vaccination Contraindication to vaccination
No adverse event; HCP called and reported administration of PROQUAD to a patient while on a possible... No adverse event; HCP called and reported administration of PROQUAD to a patient while on a possible immunosuppressant. A 4-year-old patient is on Dupixent and received a dose of PROQUAD on 17JAN2025. No additional information was known by reporter. No additional AE/P; This spontaneous report was received from nurse concerns to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions included immunosuppression. Concomitant medications included dupilumab (DUPIXENT). On 17-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and anatomical route of administration were not provided) to patient while on a possible immunosuppressant (contraindicated product administered). No additional adverse event. Additional information is not expected. More
2823730 23 U IN 01/30/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y013469
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AE/no PQC reported.; CRT agent transferred nurse who called to report a 4th dose of GA... No additional AE/no PQC reported.; CRT agent transferred nurse who called to report a 4th dose of GARDASIL 9 was inadvertently administered to a patient. Caller stated patient received doses of GARDASIL 9 on 12/29/2023, 3/15/2024, 7/18/2024, and then received 4th dose on 11/1/2024. Ca; This spontaneous report was received from nurse and refers to a 23-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 29-DEC-2023, 15-MAR-2023 and 18-JUL-2024 the patient was vaccinated with first, second and third doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, exact doses, lot #, expiry dates, and anatomical routes of administration were not provided). In addition, on 01-NOV-2024, the patient received 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #Y013469 (who had been verified to be a valid number, expiration date reported as 10-OCT-2026) (Extra dose administered). No additional adverse event. More
2823731 U IL 01/30/2025 MMRV
 MERCK & CO. INC.
 Y010050
No adverse event, Product storage error No adverse event, Product storage error
No symptomatic adverse events were reported; HCP called to report a Temperature Excursion on case n... No symptomatic adverse events were reported; HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that PROPQUAD was inadvertently administered after suffering from a T; This spontaneous report as received from a registered nurse and refers to a patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown). On 14-JAN-2025, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # Y010050, expiration date: 25-NOV-2025, albumin status validated as rHA) (route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion with a temperature that reached -11.6 degrees Celsius (C) for 3 hours and 5 minutes (product storage error). Previous excursions could not be confirmed neither if product was still supported. No symptomatic adverse events were reported. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-2501USA008885: US-009507513-2501USA008877: More
2823732 U IL 01/30/2025 MMRV
 MERCK & CO. INC.
 Y013574
No adverse event, Product storage error No adverse event, Product storage error
No symptomatic adverse events were reported; HCP called to report a Temperature Excursion on case n... No symptomatic adverse events were reported; HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that PROQUAD was inadvertently administered after suffering from a Te; This spontaneous report as received from a registered nurse and refers to a patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown). On 02-DEC-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # Y013574, expiration date not provided but upon internal validation established as 03-FEB-2026, albumin status rHA) (route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion with a temperature that reached -11.6 degrees Celsius (C) for 3 hours and 5 minutes (product storage error). Previous excursions could not be confirmed neither if product was still supported. No symptomatic adverse events were reported. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-2501USA008885: US-009507513-2501USA008877: More
2823733 U IL 01/30/2025 VARCEL
 MERCK & CO. INC.
 Y004553
No adverse event, Product storage error No adverse event, Product storage error
No symptomatic adverse events were reported; temperature excursion vaccine; This spontaneous report ... No symptomatic adverse events were reported; temperature excursion vaccine; This spontaneous report was received from a nurse and refer to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history On 18-NOV-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # Y004553, expiration date not reported but upon internal validation established as 20-FEB-2026 which was exposed to temperature excursion with the sterile diluent(MERCK STERILE DILUENT), (dose, route, anatomical location were not reported) for prophylaxis. No symptomatic adverse events were reported. This is one of several reports from the same source.; Sender's Comments: US-009507513-2501USA008885: More
2823734 0.75 F OH 01/30/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.

Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; Prod... Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; Product origin unknown; This spontaneous report was received from a Physician via medical records (MR) regarding a case in litigation and refers to a 9-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies were not reported. On 11-JAN-2005, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufactured unknown) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). The vaccine could either be hepatitis b vaccine (recombinant) (RECOMBIVAX HB) or hepatitis b vaccine rhbsag (yeast) (ENGERIX B) (Product origin unknown). On 25-APR-2005, the patient received the second dose of hepatitis b vaccine (recombinant) (manufactured unknown) (Inappropriate schedule of product administration). On 26-AUG-2005, the patient received the third dose of hepatitis b vaccine (recombinant) (manufactured unknown) (Inappropriate schedule of product administration). This is one of the 3 cases referred to the same patient.; Sender's Comments: US-009507513-2412USA007989: US-009507513-2501USA009383: More
2823735 1.33 F OH 01/30/2025 MMR
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.


Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Inappropriate schedule of vaccine administered; Product origin unknown; This spontaneous report was ... Inappropriate schedule of vaccine administered; Product origin unknown; This spontaneous report was received from a Physician via medical records (MR) regarding a case in litigation and refers to a 16-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies were not reported. On 26-AUG-2005, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufactured unknown) administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided); which could either be measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection or measles vaccine live (schwartz), mumps vaccine live (rit 4385), rubella vaccine live (wistar ra 27/3) (PRIORIX) (Product origin unknown). On 30-JUN-2009, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided); and the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufactured unknown). On 21-JUL-2009, the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Inappropriate schedule of product administration). This is one of the 3 cases referred to the same patient.; Sender's Comments: US-009507513-2412USA007989: US-009507513-2501USA009376: US-009507513-2412USA007989: More
2823736 U CA 01/30/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

No adverse event, Product preparation error; No adverse event, Product preparati... No adverse event, Product preparation error; No adverse event, Product preparation error More
No additional AE/PQC; HCP called to report that MMR II and VARIVAX were inadvertently reconstituted ... No additional AE/PQC; HCP called to report that MMR II and VARIVAX were inadvertently reconstituted with the diluent for HIBRIX (0.9% NaCl) instead of the Merck diluent provided and administered to the same patient on the same day. No symptoms reported. No further inform; This spontaneous report was received from a other health professional referred to a patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported. On 27-JAN-2025, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1, 0.5 milliliter, intramuscular (strength, anatomical location, vaccination scheme, lot number and expiration date were not reported), for prophylaxis. On the same date, the patient was vaccinated with her/his first dose of varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 milliliter, intramuscular (strength, anatomical location, vaccination scheme, lot number and expiration date were not reported), for prophylaxis. Both vaccines were inadvertently reconstituted with sodium chloride (Manufacture Unknown) diluent for Haemophilus influenzae type b. (HIBERIX) (also reported as "HIBRIX" conflicting information), (product preparation error). No adverse event was reported. Lot number is being requested and will be submitted if received. More
2823737 U NJ 01/30/2025 HPV9
 MERCK & CO. INC.
 X005044
Expired product administered, No adverse event Expired product administered, No adverse event
No additional adverse event was reported; Nurse calling with a report of an adverse event regarding ... No additional adverse event was reported; Nurse calling with a report of an adverse event regarding an expired administration of GARDASIL 9. Nurse stated that a dose of GARDASIL 9 with a labeled expiration date of 1/2/2025 was inadvertently administered to a patient today, 1/27/2025. Nurse; This spontaneous report was received from a registered nurse 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 27-JAN-2025, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml / two or three dose series, lot #X005044, expiration date: 02-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported. More
2823738 U WY 01/30/2025 HPV9
 MERCK & CO. INC.
 X005044
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; Medical Assistant calling to report inadvertently administering an expired dose of... No additional AE; Medical Assistant calling to report inadvertently administering an expired dose of GARDASIL 9 to a patient.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 28-JAN-2025, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (lot number reported as X005044, which has been verified as valid, expiration date reported and validated as 02-JAN-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not provided) (Expired product administered). No additional adverse events were reported. The reporter also confirmed that the product did not undergo any temperature excursion and it was supported per Post-Expiry Memo. More
2823739 U GA 01/30/2025 HPV9
 MERCK & CO. INC.
 Y013712
No adverse event, Product storage error No adverse event, Product storage error
no symptoms reported; GARDASIL 9 administered to a patient after product experienced a temperature e... no symptoms reported; GARDASIL 9 administered to a patient after product experienced a temperature excursion; This spontaneous report was received from a nurse referring to a patient, age and gender was not reported. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided. On 28-JAN-2025, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis, 0.5 milliliter, lot number Y013712, which has been verified to be valid, expiration date reported and validated as 26-OCT-2026 (strength, scheme, route of administration and anatomical site not provided). The administered dose of the vaccine was stored at an unknown temperature during an unknown time frame. There were no symptoms reported. More
2823741 U NV 01/30/2025 VARCEL
 MERCK & CO. INC.
 X002100
Expired product administered, No adverse event, Product storage error Expired product administered, No adverse event, Product storage error
No additional AEs were reported; Nurse reported that an expired VARIVAX was administered today. No s... No additional AEs were reported; Nurse reported that an expired VARIVAX was administered today. No symptoms reported. She also mentioned that the vaccine had a temperature excursion on 4/1/2024 but did not know the excursion details. She will call back with temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided. On 28-JAN-2025 the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X002100 and expiration date 19-JAN-2025 for prophylaxis (exact dose, dose number (reported as "1 dose" which could indicate both, one dose and first dose), route and site of administration were not provided)) (expired product administered). No symptoms reported (no adverse event). More
2823742 U 01/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Oesophageal carcinoma Oesophageal carcinoma
diagnosed with stage four esophageal cancer; This serious case was reported by a consumer via intera... diagnosed with stage four esophageal cancer; This serious case was reported by a consumer via interactive digital media and described the occurrence of esophageal cancer in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced esophageal cancer (Verbatim: diagnosed with stage four esophageal cancer) (serious criteria GSK medically significant). The outcome of the esophageal cancer was not reported. It was unknown if the reporter considered the esophageal cancer to be related to Shingles vaccine. The company considered the esophageal cancer to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the shingles vaccine and six months later he/she was diagnosed with stage four esophageal cancer. The reporter mentioned that he/she could not prove any connection, but it did make them wonder.; Sender's Comments: Oesophageal carcinoma is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. More
2823743 49 M LA 01/30/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Abdominal pain upper Abdominal pain upper
Right upper quadrant pain; This non-serious case was reported by a physician via call center represe... Right upper quadrant pain; This non-serious case was reported by a physician via call center representative and described the occurrence of upper abdominal pain in a adult male patient who received HAB (Twinrix) for prophylaxis. On 14-AUG-2024, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced upper abdominal pain (Verbatim: Right upper quadrant pain). Rechallenge with Twinrix was positive. The outcome of the upper abdominal pain was not resolved. It was unknown if the reporter considered the upper abdominal pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the upper abdominal pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2024123891 Additional Information: GSK Receipt Date: 31-DEC-2024 The patient experienced right upper quadrant pain after Twinrix second dose. This pain persisted. Follow up by Safety Team was accepted to his personal email.; Sender's Comments: US-GSK-US2024123891:same reporter More
2823744 M SC 01/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Extra dose administered Extra dose administered
received the rsv vaccine now again in December of 2024; This non-serious case was reported by a cons... received the rsv vaccine now again in December of 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Arexvy (Received 1st dose on September of 2022). In DEC-2024, the patient received Arexvy. In DEC-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received the rsv vaccine now again in December of 2024). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 02-JAN-2025 The reporter reported that patient received Arexvy vaccine second dose again in December of 2024 which led to extra dose administered. It was in error. The patient wanted to know if there were any harmful side effects from double dosing. More
2823745 U 01/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Fatigue Fatigue
Recovering from the second vaccine now, it totally wipes you out; This non-serious case was reported... Recovering from the second vaccine now, it totally wipes you out; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of exhaustion in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced exhaustion (Verbatim: Recovering from the second vaccine now, it totally wipes you out). The outcome of the exhaustion was resolving. It was unknown if the reporter considered the exhaustion to be related to Shingles vaccine. It was unknown if the company considered the exhaustion to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-JAN-2025 The case was received from the patient via interactive digital media. Recovering from the second vaccine now, it totally wiped you out. More
2823746 U 01/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-JAN-2025 This case was reported by a patient via interactive digital media. Patient had shingles twice and patient had the shots after first shingles tie and then experienced second shingles that was not quite as bad but painful would not wish this on worst enemy. 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. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2823747 U 01/30/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Extra dose administered Extra dose administered
taken the rsv vaccine in September of 2022 and now again in December of 2024. It was in error; This... taken the rsv vaccine in September of 2022 and now again in December of 2024. It was in error; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Previously administered products included rsv vaccine (in September 2022). In DEC-2024, the patient received RSV vaccine. In DEC-2024, an unknown time after receiving RSV vaccine, the patient experienced extra dose administered (Verbatim: taken the rsv vaccine in September of 2022 and now again in December of 2024. It was in error). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 02-JAN-2025 The patient received RSV vaccine in September of 2022 and now again in December of 2024 it was in error, which led extra dose administered. The patient asked was there any harmful side effects from double dosing, were there harmful side effects from double dosing the RSV vaccine. More
2823748 U 01/30/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Blister, Herpes zoster, Vaccination failure; Blister, Herpes zoster, Vaccination... Blister, Herpes zoster, Vaccination failure; Blister, Herpes zoster, Vaccination failure More
Suspected vaccination failure; receive two doses shingles vaccine last year and came down with shing... Suspected vaccination failure; receive two doses shingles vaccine last year and came down with shingles 2 weeks ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: receive two doses shingles vaccine last year and came down with shingles 2 weeks ago). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date : 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the two doses of shingles vaccine last year and came down with shingles two weeks ago. The reporter mentioned that he/she almost through the blister stage. The reporter had a question did the body build an immunity against shingles after you have contracted it. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine 1 and Shingles vaccine 2. More
2823749 F PA 01/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Exposure during pregnancy, Product use issue, Wrong product administered Exposure during pregnancy, Product use issue, Wrong product administered
Gave Arexvy instead of Abrysvo; Gave Arexvy instead of Abrysvo; This non-serious prospective pregnan... Gave Arexvy instead of Abrysvo; Gave Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On an unknown date, the patient received Arexvy and Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Gave Arexvy instead of Abrysvo) and wrong vaccine administered (Verbatim: Gave Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown. Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Exposure (Abrysvo): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 16-JAN-2024 The reporter reported that a pregnant patient received Arexvy instead of Abrysvo, which led to vaccine exposure during pregnancy and wrong vaccine administered. But in the end baby were totally fine. The patient did not had a lot of time to decide on whether or not to get the maternal vaccine. The patient read there was a higher risk of a preterm labor so wanted to ask if that happened to anyone who got it or any other issues, also, thinking of doing the Beyfortus shot for baby. More
2823750 U 01/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. Patient reported that the shingles vaccines gave shingles to the patient. 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. The follow-up could not be possible as no contact details were available; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles. More
2823751 M 01/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; still got shingles again, on the opposite side; This serious case was... Suspected vaccination failure; still got shingles again, on the opposite side; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles again, on the opposite side). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 21-JAN-2025 The case was received from the patient's wife via interactive digital media. The patient has had the vaccine and he still got shingles again, on the opposite side. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2823752 U 01/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
down for a few days; This non-serious case was reported by a consumer via interactive digital media ... down for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose of vaccine on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: down for a few days). The outcome of the feeling unwell was resolved. It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine. It was unknown if the company considered the feeling unwell to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. Patient was the reporter. Patient had the Shingles vaccination, both of them. 2nd one was no joke. He/she was down for a few days. But it was definitely better than to get shingles. His/her mother in law had shingles. He/she heard all about it and the pain that came with it and she had residual pain in her left arm. The follow-up could not be possible as no contact details were available. More
2823753 U 01/30/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
suspected vaccination failure; Broke through; This serious case was reported by a consumer via inter... suspected vaccination failure; Broke through; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Broke through). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 21-JAN-2025 This case was reported by a patient via interactive digital media. The patient had a 2 shot vaccination. He/she broke through shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1) and Shingles vaccine (Dose 2). More
2823754 U 01/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
kicked their butt; This non-serious case was reported by a consumer and described the occurrence of ... kicked their butt; This non-serious case was reported by a consumer and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: kicked their butt). The outcome of the feeling unwell was not reported. It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter reported that a couple of people talked to said that the 2nd Shingrix dose kicked their butt. This case has been linked to the case US2025AMR006731 reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR006731:same reporter More
2823755 U 01/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Injection site reaction Herpes zoster, Injection site reaction
Shingles at injection site; This non-serious case was reported by a consumer via interactive digital... Shingles at injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles at injection site). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 26-JAN-2025 The patient self-reported this case for himself/herself. The patient had first shot and developed shingles at the injection site. The patient reported that it had been almost 4 months and he/she was still in a breakout stage. The patient asked should he/she get the 2nd shot. More
2823756 M IL 01/30/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 D4774
Inappropriate schedule of product administration Inappropriate schedule of product administration
the first dose was administered on August 12th 2024 and the second dose on January 2nd 2025.; This n... the first dose was administered on August 12th 2024 and the second dose on January 2nd 2025.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 43-year-old male patient who received HAB (Twinrix) (batch number D4774, expiry date 12-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 12-AUG-2024). On 02-JAN-2025, the patient received the 2nd dose of Twinrix. On 02-JAN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: the first dose was administered on August 12th 2024 and the second dose on January 2nd 2025.). The outcome of the drug dose administration interval too long was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-JAN-2025 The pharmacist called to verify when the 3rd dose of Twinrix should be administered if the first dose was administered on 12th August 2024 and the second dose on 2nd January 2025. the patient received the 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. The vaccine administration facility was the same as primary reporter.; Sender's Comments: US-GSK-US2025000316:Same reporter/ Different patient (Wife case) More
2823757 0.42 U NE 01/30/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
possibly underage; This non-serious case was reported by a nurse via call center representative and ... possibly underage; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. On 10-DEC-2024, the patient received FluLaval 2024-2025 season. On 10-DEC-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: possibly underage). The outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-JAN-2025 The register nurse stated that they were getting a billing error edit for age on a flu vaccine, Flulaval. The child was 24 weeks and 2 days when administered which led to inappropriate age at vaccine administration. The vaccine was given on 10th December 2024. The reporter did not collect any further information as it was uncertain based on PI if patient was underage as it just stated 6 months and depends on what the definition of 6 months. More
2823758 65 M FL 01/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52Z52
Extra dose administered Extra dose administered
received Arexvy twice, once in 2023 and the second dose was given on 26Dec2024; This non-serious cas... received Arexvy twice, once in 2023 and the second dose was given on 26Dec2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis. Previously administered products included Arexvy (received 1st dose in 2023). On 26-DEC-2024, the patient received the 2nd dose of Arexvy. On 26-DEC-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received Arexvy twice, once in 2023 and the second dose was given on 26Dec2024). The outcome of the extra dose administered was unknown. Additional Information: GSK Receipt Date: 03-JAN-2025 The patient received Arexvy twice, which led to an extra dose administered. More
2823759 1.17 M CA 01/30/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 C24B9
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient received the first dose on December 19th 2024; This non-serious case was reported by a other... Patient received the first dose on December 19th 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 2-year-old male patient who received HAV (Havrix) (batch number C24B9, expiry date 06-MAY-2026) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX). On 02-JAN-2025, the patient received Havrix. On 02-JAN-2025, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Patient received the first dose on December 19th 2024). The outcome of the drug dose administration interval too short was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 03-JAN-2025 Reporter stated that a patient were not transferred to the system and patient ended up receiving a dose of Pediarix, Priorix, Hiberix and Havrix on 02-JAN-2024. Later patient's mother provided the immunization records and it was realized that extra doses were administered. Patient received the first dose on 19-DEC-2024. Male patient, 2 years and 2 months old. Patient received booster dose within a month which led to shortening of vaccination schedule. For another vaccines received by patient please refer US2025000647, US2025000645 and US2025000650.; Sender's Comments: US-GSK-US2025000647:Same patient US-GSK-US2025000645:Same patient US-GSK-US2025000650:Same patient More
2823760 0.25 M PA 01/30/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 ZP72S
Expired product administered Expired product administered
Maladministration of Engerix-B after the expiration date; This non-serious case was reported by a ot... Maladministration of Engerix-B after the expiration date; 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 3-month-old male patient who received HBV (Engerix B Junior) (batch number ZP72S, expiry date 15-DEC-2024) for prophylaxis. On 03-JAN-2025, the patient received Engerix B Junior. On 03-JAN-2025, an unknown time after receiving Engerix B Junior, the patient experienced expired vaccine used (Verbatim: Maladministration of Engerix-B after the expiration date). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-JAN-2025 Certified medical assistant called to report the maladministration of an expired dose of an Engerix-B 10 micrograms dose to a patient just a few days after the expiration date, which led to an expired vaccine used. The reporter needs an advice on what to do with the patient. The vaccine administration facility was the same as primary reporter. More
2823761 74 F CA 01/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 5J959
Dizziness, Fatigue, Headache, Malaise Dizziness, Fatigue, Headache, Malaise
Fatigue; Headache; not feeling too good; Extreme dizziness; This non-serious case was reported by a ... Fatigue; Headache; not feeling too good; Extreme dizziness; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5J959, expiry date 25-OCT-2025) for prophylaxis. On 27-DEC-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue), headache (Verbatim: Headache), feeling bad (Verbatim: not feeling too good) and dizziness (Verbatim: Extreme dizziness). The outcome of the fatigue, headache, feeling bad and dizziness were not resolved. It was unknown if the reporter considered the fatigue, headache, feeling bad and dizziness to be related to Arexvy. It was unknown if the company considered the fatigue, headache, feeling bad and dizziness to be related to Arexvy. Additional Information: GSK Receipt Date: 03-JAN-2025 Pharmacist reported that he/she had a patient here who received the Arexvy vaccine a week ago from today, last Friday. They did experienced some side effects like fatigue, headache and not feeling too good, extremely dizzy and they were still experienced those side effects on the day of reporting. Consented to follow up. More
2823762 M IL 01/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Tinnitus Tinnitus
tinnitus; This non-serious case was reported by a pharmacist via sales rep and described the occurre... tinnitus; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2024, the patient received the 1st dose of Shingrix. In DEC-2024, 2 months after receiving Shingrix, the patient experienced tinnitus (Verbatim: tinnitus). The outcome of the tinnitus was unknown. It was unknown if the reporter considered the tinnitus to be related to Shingrix. It was unknown if the company considered the tinnitus to be related to Shingrix. Additional Information: GSK Receipt Date: 09-JAN-2025 Patient DOB (date of birth) and initials were not available. The patient developed tinnitus 2 months after receiving the Shingrix. More
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