πŸ₯ VAERS Vaccine Data Browser

πŸ”’ 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.

πŸ“– Help & Search Guide

Column Icons Legend

πŸ’€ Death
πŸ₯ Hospitalized
πŸš‘ Emergency Room
β™Ώ Disability
⚠️ Life Threatening

How to Search

πŸ’‘ 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 "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ 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:

  • βœ… Early warning system for potential safety signals
  • βœ… Open and transparent - publicly accessible
  • βœ… Accepts all reports regardless of likelihood of causation
  • βœ… 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
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2840519 0.17 F MA 05/12/2025 DTAPHEPBIP
HIBV
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
MERCK & CO. INC.
 2G273
uk208aa
LN4928
2052022
Apnoea, Hypotonia, Lethargy, Pallor; Apnoea, Hypotonia, Lethargy, Pallor; Apnoea... Apnoea, Hypotonia, Lethargy, Pallor; Apnoea, Hypotonia, Lethargy, Pallor; Apnoea, Hypotonia, Lethargy, Pallor; Apnoea, Hypotonia, Lethargy, Pallor More
patient received vaccinations. Within 5-8 minutes of administration, patient had an episode of apnea... patient received vaccinations. Within 5-8 minutes of administration, patient had an episode of apnea. This episode was prolonged requiring supplemental oxygen. Once patient was breathing, she appeared awake from with poor color, hypotonia and lethargy until she arrived at the emergency department about 15minutes later. More
βœ“
2840520 7 M OH 05/12/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4l454
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
patient was out of age range for kinrix vaccine, no adverse reactions. patient was out of age range for kinrix vaccine, no adverse reactions.
2840521 4 F MI 05/12/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y014307
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
HCP called to report a patient may have inadvertently received a dose of PROQUAD that was beyond exp... HCP called to report a patient may have inadvertently received a dose of PROQUAD that was beyond expiration on 04/02/2025. The HCP stated the PROQUAD's expiration date was "short-dated" after a temperature excursion on 01/02/2025 with a "short-date; The patient did not report any adverse issue or side effect; This spontaneous report was received from a Medical assistant and refers to a 4-year-old female patient. The patient's concurrent conditions, medical history, Concomitant medications, drug reactions or allergies were not reported. On 02-Jan-2025, a dose of Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y014307, expiration date: 18-Feb-2026) underwent a temperature excursion at 69 Fahrenheit (F) for 4 hours 20 minutes (product storage error). Therefore, the site shortened the expiration date of the vaccine to 02-Apr-2025. On this date, the patient was inadvertently vaccinated with the dose of Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y014307, expiration date: 18-Feb-2026) 0.5 mL (route of administration, anatomical location not provided) as prophylaxis (discrepant information, as the reporter stated that the dose was given beyond shortened expiration date). The patient did not report any adverse event issue or side effect from the administrated dose. No previous temperature excursions were reported.; Reporter's Comments: More
2840522 63 F 05/12/2025 HEPA
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 z003701
EK225
Injection site erythema; Injection site erythema Injection site erythema; Injection site erythema
redness around injection site redness around injection site
2840523 37 M AZ 05/12/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00015
No adverse event No adverse event
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto... The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported. More
2840524 45 M AZ 05/12/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00016
No adverse event No adverse event
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom... The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported. More
2840525 0.5 F 05/12/2025 DTPPVHBHPB
PNC20
 MSP VACCINE COMPANY
PFIZER\WYETH

Nodule; Nodule Nodule; Nodule
1 inch x 0.5in nodule over the right anterolateral thigh. There is no overlying erythema or warmth.... 1 inch x 0.5in nodule over the right anterolateral thigh. There is no overlying erythema or warmth. Range of motion intact More
2840526 1 F TX 05/12/2025 HEPA
HEPA
MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y015027
Y015027
Z003308
Z003308
Cough, Diarrhoea, Injection site reaction, Rash, Rash erythematous; Rhinorrhoea;... Cough, Diarrhoea, Injection site reaction, Rash, Rash erythematous; Rhinorrhoea; Cough, Diarrhoea, Injection site reaction, Rash, Rash erythematous; Rhinorrhoea More
On 5/9/25, Hep A vaccine given on left vastus lateralis and MMRV given on the right vastus lateralis... On 5/9/25, Hep A vaccine given on left vastus lateralis and MMRV given on the right vastus lateralis. She developed an evanescent pink rash on face, trunk and extremities on 5/10/25 and seen at ER where she was prescribed cetirizine 2 ml once daily. Rash is improving but still intermittent. She had 1-2 loose stools on Saturday but now stooling normally. Has a mild cough and runny nose. She does attend daycare. She has no fever, vomiting, or irritability. She is eating and sleeping well. More
2840527 53 M NC 05/12/2025 HEPAB
MMR
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 P2443
4N222
Dizziness, Feeling hot, Flushing; Dizziness, Feeling hot, Flushing Dizziness, Feeling hot, Flushing; Dizziness, Feeling hot, Flushing
patient became lightheaded/dizzy and felt flushed/hot after receiving immunizations patient became lightheaded/dizzy and felt flushed/hot after receiving immunizations
2840528 68 M AZ 05/12/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00016
No adverse event No adverse event
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto... The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported. More
2840529 58 F MA 05/12/2025 PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH


Chills, Diarrhoea, Fatigue, Headache, Injection site erythema; Injection site pa... Chills, Diarrhoea, Fatigue, Headache, Injection site erythema; Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Nausea; Oedema peripheral More
PCV21 adverse reactions: injection day 0, day 1 soreness, swelling, heat and redness at injection s... PCV21 adverse reactions: injection day 0, day 1 soreness, swelling, heat and redness at injection site in the morning. By noonish, chills, nausea, diarrhea, headache, fatigue in addition to original symptoms. Day 2 fatigue, redness, heat, soreness, swelling and pruritis at site. Day 3 Redness, swelling, heat, pruritis, axillary edema. Day 4 (Today) Redness, swelling, heat, pruritis and axillary edema at injection site. More
2840530 14 F OR 05/12/2025 HPV9
IPV
TDAP
VARCEL
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 Y009051
Y1A201M
LX494
X021283
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered More
Patient is an underimmunized otherwise healthy child who came in for WCC and to update immunizations... Patient is an underimmunized otherwise healthy child who came in for WCC and to update immunizations. Originally, TDaP, Meningitis ACWY, polio, and varicella were ordered. It was planned that two weeks later patient would return for HPV, Hepatitis A, Hepatitis B. Gardisil/HPV was given accidentally in place of Menveo. The next day when PCP (reporter) was informed, patient's guardian was notified and this was reported via clinic reporting system. On 5/12, PCP was notified that VAERs also needed to be reported to, and so this report was filed More
2840531 42 M AZ 05/12/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00017
No adverse event No adverse event
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom... The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported. More
2840532 53 M AZ 05/12/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00016
No adverse event No adverse event
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto... The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported. More
2840533 5 M CA 05/12/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 X9EP5
Arthropod bite, Immunisation reaction Arthropod bite, Immunisation reaction
Pt went to emergency room. Unknown if vaccine reaction or spider bite as patient was playing outside... Pt went to emergency room. Unknown if vaccine reaction or spider bite as patient was playing outside. More
2840534 33 M AZ 05/12/2025 SMALLMNK
 BAVARIAN NORDIC
 96867
No adverse event No adverse event
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom... The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported. More
2840535 85 M TX 05/12/2025 PNC21
 MERCK & CO. INC.
 y019158
Injection site erythema Injection site erythema
redness at injection site lasting 5 days. I advised patient to consult with physician and I called t... redness at injection site lasting 5 days. I advised patient to consult with physician and I called the physician, leaving message to advise of reaction. More
2840536 22 M AZ 05/12/2025 SMALLMNK
 BAVARIAN NORDIC
 96867
No adverse event No adverse event
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom... The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported. More
2840537 50 F OK 05/12/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 lk6650
93kk4
Erythema, Swelling; Erythema, Swelling Erythema, Swelling; Erythema, Swelling
swelling/redness patient said it didn't hurt when and it resolved spoke with patient 5/12/25 swelling/redness patient said it didn't hurt when and it resolved spoke with patient 5/12/25
2840538 24 M WI 05/12/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 X024178
X024178
Arthralgia, Injection site erythema, Injection site induration, Injection site r... Arthralgia, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling; Injection site warmth More
Redness and rash around the injection site, with warmth and redness. These symptoms were present ap... Redness and rash around the injection site, with warmth and redness. These symptoms were present approximately 4-5 hours after injection. The next day a red circle around the injection site appeared, similar to a bullseye an area was hard and raised. Frank left shoulder joint pain began on Wednesday, May 5/7 and has been present since. More
2840540 NJ 05/12/2025 VARCEL
 MERCK & CO. INC.
 y014868
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous repo... No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a certified medical assistant (C.M.A.) 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 15-APR-2025, the was vaccinated with improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection (lot #y014868, expiration date: 03-SEP-2026) (exact dose, dose number, route of administration and anatomical location was not provided), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiry date were not reported). On an unknown date, the vaccine underwent a temperature excursion of 5.5 Fahrenheit degrees up to 14.4 Fahrenheit degrees for 40 minutes and 14.5 Fahrenheit degrees up to 46.4 Fahrenheit degrees/15.8 Fahrenheit degrees for 10 minutes. There was no previous temperature excursion. No additional adverse events were reported. More
2840541 NM 05/12/2025 HPV9
 MERCK & CO. INC.
 Y012508
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported.; patient was administered GARDASIL9 during a temperature excursion.; This... No additional AE reported.; patient was administered GARDASIL9 during a temperature excursion.; This spontaneous report was received from a non-health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-Apr-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) 1 dose (route of administration, vaccination site, and vaccination scheme were not provided; lot #Y012508 which has been verified to be a valid number, expiration date reported and validated as 01-Jan-2027) as a prophylaxis. The vaccine administered was stored at temperature of 0 degrees Celsius (C) for a time frame of 1 hours. It was unknown if a data logger was used. There was no previous temperature excursion. No additional AE details were reported. More
2840542 05/12/2025 HEPA
 MERCK & CO. INC.
 X025908
Expired product administered, No adverse event Expired product administered, No adverse event
No other AE; inadvertent administration of an expired dose of VAQTA to a patient; This invalid spont... No other AE; inadvertent administration of an expired dose of VAQTA to a patient; This invalid spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-May-2025, the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot #X025908, expiration date reported as and upon internal validation confirmed to be: 24-Apr-2025) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. On that day, an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) was inadvertently administered to the patient (expired product administered). No symptoms were reported and no additional details were provided. No other adverse event (AE) and no product quality complaint (PQC) was reported (no adverse event). This case was considered to be invalid due to lack of patient's identifiers. More
2840543 20 F NJ 05/12/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.








Cardiac arrest, Cardiac pacemaker insertion, Cardiomyopathy, Catheterisation car... Cardiac arrest, Cardiac pacemaker insertion, Cardiomyopathy, Catheterisation cardiac, Death; Heavy menstrual bleeding, Loss of consciousness, Myocarditis, Peripheral swelling, Resuscitation; Syncope, Tachycardia; Cardiac arrest, Cardiac pacemaker insertion, Cardiomyopathy, Catheterisation cardiac, Death; Heavy menstrual bleeding, Loss of consciousness, Myocarditis, Peripheral swelling, Resuscitation; Syncope, Tachycardia; Cardiac arrest, Cardiac pacemaker insertion, Cardiomyopathy, Catheterisation cardiac, Death; Heavy menstrual bleeding, Loss of consciousness, Myocarditis, Peripheral swelling, Resuscitation; Syncope, Tachycardia More
cardiac arrest; autonomic injuries; heart attack; cardiomyopathy/myocarditis/swelling in her legs/ta... cardiac arrest; autonomic injuries; heart attack; cardiomyopathy/myocarditis/swelling in her legs/tachycardia; Autoimmune injuries; heavy periods; neurological injuries; Information has been received from a lawyer regarding a case in litigation and referred to a 20-year-old female patient (pt). Prior to receiving quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), the pt was happy and healthy. Her other medical history, concurrent conditions and concomitant therapies were not provided. On 22-Mar-2022 (at the age of 20 years old), the pt was vaccinated with the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), as recommended by her doctor, with her consent, for prophylaxis. Following her first vaccination, pt experienced swelling in her legs but assumed this was due to standing while nursing. On dates of 31-May-2022 and 26-Sep-2022 (at the age of 20 years old), the pt was vaccinated with the second and third doses of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact doses, route of administration, anatomical locations, lots # and expiration dates were not provided). Following her second quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine, pt began having very heavy periods which had never occurred previously. The morning following her third vaccination, pt went to school and then to a restaurant for lunch. Pt collapsed in the doorway leaving the restaurant. A waitress began cardiopulmonary resuscitation (CPR) immediately, but pt never regained consciousness before being pronounced deceased. She was taken by ambulance to a local hospital and then flown to a regional hospital. During the flight, she went into extreme tachycardia, which the medical personnel could never get under control. Later that night, pt was taken for heart catheterization and pacemaker insertion. Shortly thereafter, her parents were notified that she had passed away. The doctors told the parents that they were baffled as to what caused pt's death. Based up on her medical records, pt was diagnosed with various medical conditions, including but not limited to, heavy menstrual bleeding and myocarditis before her death. The death certificate listed cause of death as cardiac arrest due to cardiomyopathy/ myocarditis. It was unknown whether the autopsy was done. Pt's parents contended that their daughter's quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating injuries, including but not limited to heavy menstrual bleeding and cardiomyopathy/myocarditis causing a heart attack and her death. It was contended that her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused pt to sustained serious and debilitating autoimmune, autonomic and neurological injuries (Autoimmune disorder; Neurological disorder NOS; Autonomic dysfunction), as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), the pt had suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his autoimmune disease and other injuries caused by quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of events of Heavy periods, Autoimmune disorder, Neurological disorder NOS, Heart attack and Autonomic dysfunction was considered to be not recovered. The lawyer considered all events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). The lawyer considered all events to be disabling / incapacitating. This is one of several reports received from same reporter.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user :, Index date : 2025-05-07 , number : , number : , number : , number : , Central date : 2025-05-05 , Classification :, Attachment description : Legal , Safety case number :; Reported Cause(s) of Death: cardiac arrest; myocarditis More
βœ“ βœ“
2840544 14 F NJ 05/12/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.









Abdominal pain upper, Adrenal disorder, Arthralgia, Autoimmune disorder, Blood t... Abdominal pain upper, Adrenal disorder, Arthralgia, Autoimmune disorder, Blood test; Brain fog, Chronic fatigue syndrome, Crying, Dizziness, Eating disorder; Educational problem, Erythema, Fibromyalgia, Food intolerance, Gait disturbance; Gluten sensitivity, Hypoacusis, Hypothyroidism, Loss of personal independence in daily activities, Memory impairment; Pain, Pyrexia, Visual impairment; Abdominal pain upper, Adrenal disorder, Arthralgia, Autoimmune disorder, Blood test; Brain fog, Chronic fatigue syndrome, Crying, Dizziness, Eating disorder; Educational problem, Erythema, Fibromyalgia, Food intolerance, Gait disturbance; Gluten sensitivity, Hypoacusis, Hypothyroidism, Loss of personal independence in daily activities, Memory impairment; Pain, Pyrexia, Visual impairment More
fibromyalgia, joint pain, hip pain, dizzy; autoimmune injury; chronic fatigue syndrome, brain fog, s... fibromyalgia, joint pain, hip pain, dizzy; autoimmune injury; chronic fatigue syndrome, brain fog, short term memory problem; hypothyroidism; chronic pain; adrenal gland dysfunction; gluten intolerance, stomach pain, trouble eating; corn intolerance, stomach pain, trouble eating; fever; red arm; Information has been received from a lawyer, regarding a case in litigation, and refers to an adult female patient (pt). The pt's medical history, current conditions and concomitant therapies were not reported. On 15-OCT-2020, at the age of 14 years old, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis (reported as recommended by the pt's health care provider for preventing cervical cancer). On unspecified date (reported as shortly after receiving the first GARDASIL injection), the pt experienced fever, a red arm, joint pain, hip pain, and began feeling dizzy. After practicing on the ice rink, the pt began to experience extreme pain to the point of not being able to complete her session. On 23-APR-2021, the pt received second dose of GARDASIL (no more details provided). On unspecified date (reported as after receiving the second GARDASIL injection), the pt experienced horrible pain, and her pain progressed. While at school, the pt would frequently call her parents weeping because she had difficulty walking due to the pain. Despite not dancing or skating as was her normal routine, The pt's hip and joint pain became worse. The pt had trouble walking from class to class at school. She was taken to see an orthopedic surgeon at university to examine her hip where she underwent multiple exams, including blood work. The orthopedic surgeon suspected that the pt's suffering was due to an autoimmune disorder. By this time, the pt had already received two cortisone shots in her hip that, unfortunately, did not relieve her symptoms entirely. The pt's primary care physician diagnosed her with fibromyalgia. A rheumatologist subsequently confirmed that diagnosis. The pt was later diagnosed with chronic fatigue syndrome (CFS). She would sleep 18 hours straight and not feel rested. In addition to these symptoms, she developed brain fog, short term memory problems, vision and hearing problems, stomach pain and trouble eating. 281. Thereafter, the pt was diagnosed with hypothyroidism. As the months progressed, so did the pt's symptoms. She was seen by multiple physicians and specialists for her complaints which now included: fibromyalgia, CFS, chronic pain, hypothyroidism, adrenal gland dysfunction, gluten and corn intolerance, extreme brain fog, short term memory problems, vision and hearing problems, stomach pain and trouble eating. As a result of her post-GARDASIL symptoms, the pt has been unable to engage in activities that a normal young person would enjoy. Post-GARDASIL injections, her academic performance plummeted from once having a 4.0 GPA to a 3.3 GPA. Her dreams of going to college and becoming a doctor now feel impossible. The pt was still unable to participate in the daily activities she previously did before she received the GARDASIL injections. Based upon her chronic and severe post-GARDASIL symptoms, the pt has been diagnosed with various medical conditions, including but not limited to, fibromyalgia, CFS, chronic pain, hypothyroidism, adrenal gland dysfunction, and gluten and corn intolerance. The pt contended her GARDASIL injections caused her to develop serious and debilitating autoimmune injuries, including but not limited to fibromyalgia, CFS, chronic pain, hypothyroidism, adrenal gland dysfunction, and gluten and corn intolerance, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by GARDASIL or otherwise linked to her GARDASIL-induced autoimmune disorder. It was stated that as a proximate result of the Company's misleading statements and omissions concerning the safety and efficacy of GARDASIL, the pt had suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The pt also have a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by the suspect vaccine. As a direct and proximate result of her GARDASIL-induced injuries, the pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of all events was not recovered/not resolved/ongoing. All events were related to the suspect vaccine. All events were considered to be disabling/incapacitating by the reporter. More
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2840545 15 M TN 05/12/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.






Acute psychosis, Alanine aminotransferase increased, Arrhythmia, Arthralgia, Asp... Acute psychosis, Alanine aminotransferase increased, Arrhythmia, Arthralgia, Aspartate aminotransferase increased; Blood albumin decreased, Blood potassium increased, Brain fog, Burning sensation, CSF protein increased; Chest pain, Depression, Disturbance in attention, Fatigue, General physical health deterioration; Headache, Heart rate increased, Hypertension, Hypothyroidism, Insomnia; Loss of personal independence in daily activities, Lumbar puncture, Malaise, Memory impairment, Peripheral coldness; Photophobia, Pyrexia, Suicidal ideation, Tachycardia, Visual impairment; Vitamin D decreased, Vitreous floaters, Weight decreased, White blood cell count increased More
acute psychosis; depression; condition worse; white blood cell counts elevated; potassium levels wer... acute psychosis; depression; condition worse; white blood cell counts elevated; potassium levels were elevated; Autoimmune Injuries; autonomic dysfunction/headaches, insomnia/ chest pain/ high blood pressure/high heart rate/ severe arrhythmia, tachycardia, hypertension/ chronic fatigue, insomnia, chronic headaches, vision change; protein in the central spinal fluid; low vitamin D; low albumin; AST were elevated; lost 30 pounds over a month's time/extreme weight-loss; fever; ALT were elevated; low thyroid functioning; joint pain; suicidal thoughts; Information has been received from a lawyer regarding a case in litigation and referred to a male adolescent/minor patient (pt). His other medical history, concurrent conditions and concomitant therapies were not provided. On 11-Dec-2019 (at the age of 15 years old), the pt was vaccinated with the first and only dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), as recommended by his health care provider/doctor, with his mother's consent, for prophylaxis (also reported as for preventing cervical cancer). Shortly after receiving the quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection, pt started having severe headaches, insomnia, and depression. He was taken back to the pediatrician who had administered the vaccination and was told that he would be fine. Instead of being fine, his condition deteriorated. Pt started to experience chest pain and acute psychosis. He did not feel well enough to play with his friends or play his video games. Pt was taken to the emergency room (ER) and was sent to two different psychiatric hospitals and placed on antipsychotic medications, but the medications made his condition worse. His white blood cell counts and potassium levels were elevated. A lumbar puncture was done that showed protein in the central spinal fluid, low vitamin D, low albumin, his liver aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were elevated and steadily rising, and he had low thyroid functioning. He experienced high blood pressure and a high heart rate. Pt also suffered severe arrhythmia, tachycardia, hypertension, and lost 30 pounds over a month's time. He developed chronic fatigue. Although extremely fatigued, he had difficulty sleeping/insomnia and, as a result, lost the ability to complete day-to-day activities. Pt also developed chronic headaches, vision changes, including "floaters" and light sensitivity. He developed feelings of cold and then burning sensations in his arms and legs as well as joint pain. Following the quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection, pt spent two months in the hospital. He was unable to attend school in person and he had to be homeschooled. As the months progressed, so did pt's symptoms. He was seen by multiple physicians and specialists for his complaints which now included: headaches, insomnia, depression, chest pain, acute psychosis, suicidal thoughts, fever, elevated white blood cell counts, elevated potassium, low vitamin D, low albumin, elevated liver AST and ALT, low thyroid functioning, high blood pressure, high heart rate, severe arrhythmia, tachycardia, hypertension, extreme weight-loss, chronic fatigue, insomnia, chronic headaches, vision changes, light sensitivity, feeling of coldness and burning sensations in arms and legs, joint pain, brain fog, inability to concentrate, and memory troubles. As a result of his post-Gardasil symptoms, pt had been unable to engage in activities that a normal young person would enjoy. Based upon his chronic and severe post- quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt has been diagnosed with various medical conditions, including but not limited to, autonomic dysfunction, chronic fatigue, and neuropsychiatric complications. Pt contended that his quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection caused him to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to autonomic dysfunction, chronic fatigue, and neuropsychiatric complications, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to his quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. It was contended that his quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused pt to sustain serious and debilitating autoimmune, autonomic and neurological injuries (Autoimmune disorder), as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), the pt had suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his autoimmune disease and other injuries caused by quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of all events was considered to be not recovered. The lawyer considered all events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). The lawyer considered all events to be disabling / incapacitating. This is one of several reports received from same reporter.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-05-07 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-05-05 , Classification : DMC, Attachment description : Legal , Safety case number : More
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2840546 11 IL 05/12/2025 HIBV
 MERCK & CO. INC.
 Y011267
Extra dose administered, No adverse event Extra dose administered, No adverse event
No symptoms reported as of now; inadvertently administered an extra dose of the PEDVAXHIB Vaccine. ... No symptoms reported as of now; inadvertently administered an extra dose of the PEDVAXHIB Vaccine. This patient was already fully vaccinated; Patient 11 years old; This spontaneous report was received from a nurse and refers to a(n) 11-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 07-May-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y011267, expiration date: 08-Nov-2026) as prophylaxis. On 07-May-2025, the patient experienced inadvertently administered an extra dose of the PEDVAXHIB Vaccine (Extra dose administered). This patient was already fully vaccinated . The patient was 11 years old (Product administered to patient of inappropriate age). No symptoms reported as of now (No adverse event). At the reporting time, the outcome of the events was reported as unknown. The action taken with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) was reported as not applicable. More
2840547 F 05/12/2025 HPV9
 MERCK & CO. INC.
Dyspnoea, Hot flush, Syncope, Urticaria, Vomiting Dyspnoea, Hot flush, Syncope, Urticaria, Vomiting
Consumer to report their child experienced vomiting; Consumer to report their child experienced hot ... Consumer to report their child experienced vomiting; Consumer to report their child experienced hot flashes; Consumer to report their child experienced syncope; Consumer to report their child experienced shortness of breath; Consumer to report their child experienced hives; This spontaneous report was received from a consumer or other non health professional and refers to a 21-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date (also reported as when the patient was 14-years-old), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL, intramuscularly, for the treatment of routine vaccination. (scheme, strength, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient hot flashes, syncope, vomiting, shortness of breath and hives. At the reporting time, the outcome of the events was unknown. The causal relationship between the events and the suspect vaccine was unknown. Upon internal review, the event of syncope was determined to be medically significant. More
2840548 F OR 05/12/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y007197
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, S... Immediate post-injection reaction, Syncope; Immediate post-injection reaction, Syncope More
the patient experienced immediate syncope; This spontaneous report was received from a Physician Ass... the patient experienced immediate syncope; This spontaneous report was received from a Physician Assistant (medical assistant) and refers to a 16-year-old female patient. The patientοΏ½s concomitant therapies included meningococcal vaccine (reported as οΏ½meningococcal [GFK]οΏ½). The patient's medical history, concurrent conditions, past drug reactions and allergies were reported as none. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered as prophylaxis (dose, formulation, anatomical site of injection, route of administration, lot number and expiration date were not provided). On 06-MAY-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL, administered by Intramuscular route for HPV prevention (lot number Y007197 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 18-AUG-2026; vaccination scheme frequency and anatomical site of injection were not provided). On that same date, the patient experienced immediate syncope. The patient laid down and the syncope resolved within 15 minutes (recovered). The reporter stated the patient was also vaccinated with meningococcal vaccine (reported as meningococcal οΏ½[GFK]οΏ½) a few minutes before the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) vaccination and did not experience any immediate symptoms with that vaccine nor the syncope until the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was administered. It was reported the patient sought medical attention for the event. The reporter stated this was a brand-new box of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and so far, they have given 3 doses out of this box and have had the same issue with each patient. They were told to discontinue the use of the product with this lot number. Additionally, they said they have been giving this vaccine for 8 years and have never seen a lot so consistently cause a reaction like this. Patient has not experienced any other issues. The causal relationship between the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and the event was not provided. The reporter considered the event of syncope to be related to the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (reported as have never seen a lot so consistently cause a reaction like this). Upon internal review, the event of Syncope was considered to be medically significant. This is one of three reports from the same reporter. More
2840549 M OR 05/12/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
Y007197
Syncope; Syncope Syncope; Syncope
syncope; This spontaneous report was received from a Certified Medical Assistant and refers to a 17-... syncope; This spontaneous report was received from a Certified Medical Assistant and refers to a 17-year-old male patient. The patient had no pertinent medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient received the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9), for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported). On 08-MAY-2025, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9), pre-filled syringe, 0.5ml, intramuscularly, lot #Y007197 expiring on 18-AUG-2026, for prophylaxis. On 08-May-2025, the patient experienced syncope. The patient sought medical attention. As treatment, the patient laid down and the syncope resolved within 15 minutes. The reporter states this was a brand new box of Human Papillomavirus 9-valent Vaccine, Recombinant Injection, (GARDASIL 9) and so far they have given 3 doses out of this box and have had the same issue with each patient. The reporter said they have been giving this vaccine for 8 years and have never seen a lot so consistently cause a reaction like this. The reporter considered the event of syncope to be related to Human Papillomavirus 9-valent Vaccine, Recombinant. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant and Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable. Upon internal review, the event of syncope was determined to be medically significant. This is one of several reports received from the same reporter. More
2840550 7 M NV 05/12/2025 DTAP
IPV
MMR
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 3ca20c1
y1a201m
Y013172
Y014181
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Nop side effects or symptoms have been reported. No additional AE; HCP called to report a patient re... Nop side effects or symptoms have been reported. No additional AE; HCP called to report a patient received extra doses of MMR II, VARIVAX, IPOL, and Daptacel after series completions; This spontaneous report was received from a Consumer and refers to a 7-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter. On 02-APR-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, 0.5 mL (lot number Y013172 has been verified to be valid for Measles, Mumps, and Rubella [Wistar RA 27-3] Virus Vaccine, Live [M-M-R II], expiration date 31-JUL-2026), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (expiration date, and lot number were not reported); with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, 0.5 mL (lot number Y014181 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date 20-AUG-2026), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (expiration date, and lot number were not reported); with Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid (DAPTACEL) (lot number reported as 3ca20c1, expiration date 28-FEB-2026; formulation not provided); and with Polio vaccine inact 3v (Vero) (IPOL) (lot number reported as y1a201m, expiration date 31-JAN-2027; formulation not reported). All doses were administered as vaccination (dose, vaccination scheme frequency, route of administration and anatomical site of injection were not provided for any of the vaccines). The patient received extra doses of all the previously reported vaccines after series completions (Extra dose administered). No side effects or symptoms have been reported and no additional adverse event was reported for the patient. No additional information provided. More
2840551 OH 05/12/2025 MMR
 MERCK & CO. INC.
 X012616
Expired product administered, No adverse event Expired product administered, No adverse event
No side effects/symptoms reported.; Nurse reports MMR II with expiry date of 5/2/2025 was administer... No side effects/symptoms reported.; Nurse reports MMR II with expiry date of 5/2/2025 was administered to a patient today 5/8/2025.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-May-2025, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X012616, expiration date: 02-May-2025) as prophylaxis (Expired product administered). The vaccine was reconstituted with sterile diluent (lot #W037058, expiration date: 27-Jun-2025). The nurse confirmed no temperature excursions occurred through the date of administration. No side effects/symptoms reported (No adverse event). More
2840552 64 F AR 05/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 L995Y
Burning sensation, Hypoaesthesia, Injection site swelling, Paraesthesia, Pruritu... Burning sensation, Hypoaesthesia, Injection site swelling, Paraesthesia, Pruritus More
swelling at the injection site; Patient experienced burning in her arm after receiving Shingrix; Pat... swelling at the injection site; Patient experienced burning in her arm after receiving Shingrix; Patient experienced tingling in her arm after receiving Shingrix; Patient experienced itching in her arm after receiving Shingrix; Patient experienced numbness in her arm after receiving Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number L995Y) for prophylaxis. Concurrent medical conditions included diabetes, blood pressure high and tension headache. Concomitant products included rizatriptan benzoate, semaglutide (Ozempic), amlodipine, hydrochlorothiazide and pravastatin. On 13-AUG-2024, the patient received Shingrix. On 13-AUG-2024, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at the injection site), burning sensation (Verbatim: Patient experienced burning in her arm after receiving Shingrix), tingling of extremity (Verbatim: Patient experienced tingling in her arm after receiving Shingrix), itchy upper limbs (Verbatim: Patient experienced itching in her arm after receiving Shingrix) and numbness of upper extremities (Verbatim: Patient experienced numbness in her arm after receiving Shingrix). The outcome of the injection site swelling, burning sensation, tingling of extremity and itchy upper limbs were resolved and the outcome of the numbness of upper extremities was not resolved. It was unknown if the reporter considered the injection site swelling, burning sensation, tingling of extremity, itchy upper limbs and numbness of upper extremities to be related to Shingrix. It was unknown if the company considered the injection site swelling, burning sensation, tingling of extremity, itchy upper limbs and numbness of upper extremities to be related to Shingrix. Additional Information: GSK receipt date: 01-MAY-2025 The reporter reported that the patient received Shingrix vaccine and experienced burning, tingling, itching and numbness in her arm. The patient also reported swelling at the injection site. More
2840553 60 M WI 05/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
Inappropriate schedule/had his second dose administered approximately 8 months later; This non-serio... Inappropriate schedule/had his second dose administered approximately 8 months later; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on 21 Apr 2016, intramuscular). 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 drug dose administration interval too long (Verbatim: Inappropriate schedule/had his second dose administered approximately 8 months later). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 01-MAY-2025 The patient had his first dose of Shingrix administered 21 APR 2016 (unknown site of administration.) Consumer stated he had his second dose administered approximately 8 months later (exact date unknown) which led to Drug dose administration interval too long. No further information was provided/obtained. More
2840554 F 05/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Neuralgia, Oral pain, Toothache Neuralgia, Oral pain, Toothache
This appears to be nerve pain; tooth pain; Mouth pain; This non-serious case was reported by a consu... This appears to be nerve pain; tooth pain; Mouth pain; This non-serious case was reported by a consumer and described the occurrence of toothache in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 12-OCT-2024, the patient received Shingrix. On 23-NOV-2024, 42 days after receiving Shingrix, the patient experienced toothache (Verbatim: tooth pain) and oral pain (Verbatim: Mouth pain). On an unknown date, the patient experienced nerve pain (Verbatim: This appears to be nerve pain). The outcome of the toothache and oral pain were not resolved and the outcome of the nerve pain was not reported. It was unknown if the reporter considered the toothache, oral pain and nerve pain to be related to Shingrix. It was unknown if the company considered the toothache, oral pain and nerve pain to be related to Shingrix. Additional Information: GSK Receipt Date: 02-MAY-2025 The reporter reported that she had been experiencing excruciating pain in mouth and teeth. The reporter seen her dentist twice and there was no visible signs of tooth damage. This appears to be nerve pain that began after she was vaccinated with Shingrix. The reporter understanding was that trigeminal neuralgia could be a side effect of shingles. The reporter would like to speak with someone in medical information regarding this and know if there were any reports of this in the clinical trials or if it was looked for in the clinical protocols. The reporter had no history of having shingles. The symptoms were treated. More
2840555 54 F 05/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 445TK
Chills, Pain, Pyrexia Chills, Pain, Pyrexia
body aches; 7 nights of fevers; chills; This non-serious case was reported by a consumer and describ... body aches; 7 nights of fevers; chills; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 445TK, expiry date 09-AUG-2026) for prophylaxis. Concurrent medical conditions included anxiety. Concomitant products included sertraline hydrochloride (Sertraline). On 25-APR-2025, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In APR-2025, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches), fever (Verbatim: 7 nights of fevers) and chills (Verbatim: chills). The outcome of the general body pain, fever and chills were not resolved. It was unknown if the reporter considered the general body pain, fever and chills to be related to Shingrix. It was unknown if the company considered the general body pain, fever and chills to be related to Shingrix. Additional Information: GSK receipt date: 05-MAY-2025 The patient experienced 7 nights of fever, chills and body aches. More
2840556 05/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; still had a repeat of the virus; This serious case was reported by a ... Suspected vaccination failure; still had a repeat of the virus; 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: still had a repeat of the virus). 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: 05-MAY-2025 This case was reported by a patient via interactive digital media. I had gotten vaccinated and still had experienced a repeat of the virus three times in total. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2840557 05/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
lived with outbreaks ever since; This non-serious case was reported by a consumer via interactive di... lived with outbreaks ever since; 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 (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 shingles (Verbatim: lived with outbreaks ever since). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by a patient via interactive digital media. Patient took the first shot and have lived with outbreaks ever since. More
2840558 05/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Nasal congestion Nasal congestion
congestion after Shingrix vaccine; This non-serious case was reported by a consumer via interactive ... congestion after Shingrix vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nasal congestion 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 nasal congestion (Verbatim: congestion after Shingrix vaccine). The outcome of the nasal congestion was not reported. It was unknown if the reporter considered the nasal congestion to be related to Shingrix. It was unknown if the company considered the nasal congestion to be related to Shingrix. Additional Information: GSK Receipt Date: 02-MAY-2025 The patient asked was it normal to had congestion after Shingrix vaccine. More
2840559 05/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
1st made me sick; This non-serious case was reported by a consumer via interactive digital media and... 1st made me sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: 1st made me sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR056756 Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that first dose of Shingles vaccine made him/her sick. For tolerance to second dose refer case US2025AMR056756.; Sender's Comments: US-GSK-US2025AMR056756: More
2840560 05/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspeceted vaccination failure; I thought of it got vaccinated and still got it!; This serious case ... Suspeceted vaccination failure; I thought of it got vaccinated and still got it!; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I thought of it got vaccinated and still got it!). 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: 06-MAY-2025 This case was reported by a patient via interactive digital media. The reporter thought of it got vaccinated and still got it. 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: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2840561 05/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Pruritus Herpes zoster, Pain, Pruritus
3rd week for me with shingles; This non-serious case was reported by a consumer via interactive digi... 3rd week for me with shingles; 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 (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 shingles (Verbatim: 3rd week for me with shingles). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-MAY-2025 The patient had one shot of Shingles vaccine and was going for second the week he/she broke out. The patient reported 3rd week for her/his with shingles. The patient had incredible itching, pain over. Those first 2 days and nights back hurt so bad. More
2840562 F OH 05/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
we didn receive our second dose until 12/11/2021; This non-serious case was reported by a consumer v... we didn receive our second dose until 12/11/2021; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 19-JUN-2018). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: we didn receive our second dose until 12/11/2021). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 06-MAY-2025 The reporter reported that a patient received first dose of the Shingrix vaccine on 19-JUN-2018. The reporter understand the next dose is recommended to be 2 to 6 months apart. For some reason that it might have been availability and then forgetfulness, did not receive our second dose until 11-DEC-2021. The reporter was ask the effectiveness of the timing of these two doses. This case is linked with US2025AMR057409, reported by same reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: US-GSK-US2025AMR057409:same reporter different patient More
2840563 M TX 05/12/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 Y49BZ
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Administration to an patient under the age (3 YO); This non-serious case was reported by a nurse via... Administration to an patient under the age (3 YO); 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 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On 10-APR-2025, the patient received Kinrix. On 10-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to an patient under the age (3 YO)). The outcome of the inappropriate age at vaccine administration 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: 02-MAY-2025 The reporter reported on 02-May-2025 a the nurse gave an 8 month old baby the Kinrix. The Vaccine Administration Facility is the same as Primary Reporter. The Healthcare professional reported that the patient was 8 month at the moment of the vaccination, but as we escalated this to 2nd line, HCP mentioned to my coworker that the real age of the patient was 3 years old which led to the inappropriate age at vaccine administration. More
2840564 M CA 05/12/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 A3X2K
Extra dose administered Extra dose administered
received an extra Hep A/Extra Dose Administered; This non-serious case was reported by a nurse via c... received an extra Hep A/Extra Dose Administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-year-old male patient who received HAV (Havrix) (batch number A3X2K, expiry date 07-SEP-2026) for prophylaxis. Previously administered products included havrix (Patient received first dose on an unknown date) and Havrix (Patient received booster dose and completed the schedule for the first time on 06-SEP-2022). On 01-MAY-2025, the patient received the 3rd dose of Havrix. On 01-MAY-2025, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: received an extra Hep A/Extra Dose Administered). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-MAY-2025 Nurse stated that they had a patient that received a vaccine error. The patient received Hep A vaccine, Havrix and the patient had already received a Hep initial doses, the patient actually received an extra Hep A. Patient completed the schedule for the first time on September 6th, 2022. Patient received third dose of Havrix , which led to extra dose administered. More
2840565 F MA 05/12/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 Y3Z9P
Incorrect dose administered Incorrect dose administered
Boostrix incomplete dose administration; This non-serious case was reported by a nurse via call cent... Boostrix incomplete dose administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 47-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number Y3Z9P, expiry date 27-AUG-2027) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: Boostrix incomplete dose administration). The outcome of the incomplete dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-MAY-2025 The registered nurse reported that the patient received incomplete dose of Boostrix. The nurse wanted to know how to proceed (like repeat the dose in two or four weeks or wait at al) after a patient received an incomplete dose of Boostrix. The vaccine administration facility was the same as primary reporter. More
2840566 F WA 05/12/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4n222
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administration of Priorix via intramuscular route in a 61 year old; administration of Priorix via in... administration of Priorix via intramuscular route in a 61 year old; administration of Priorix via intramuscular route; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 61-year-old female patient who received MMR (Priorix) (batch number 4n222, expiry date 13-SEP-2026) for prophylaxis. On 02-MAY-2025, the patient received the 1st dose of Priorix (intramuscular). On 02-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Priorix via intramuscular route in a 61 year old) and subcutaneous injection formulation administered by other route (Verbatim: administration of Priorix via intramuscular route). The outcome of the inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route 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: 02-MAY-2025 The pharmacist contacted GlaxoSmithKline to request information about the administration of Priorix via intramuscular route in a 61 year old patient, which led to the inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route. The Vaccine Administration Facility is the same as Primary Reporter. More
2840567 NY 05/12/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
it had been four years does this patient need third vaccine; This non-serious case was reported by a... it had been four years does this patient need third vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (patient received 1st dose on an unknown date) and Bexsero (patient received 2nd dose on an unknown date). On an unknown date, the patient did not receive the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: it had been four years does this patient need third vaccine). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 02-MAY-2025 Other HCP reported that a patient who according to the former guideline got two BexseroοΏ½s 2021, and it had been four years does this patient get a third vaccine? Reporter indicated that at age twenty five was a cut-off and donοΏ½t want to give a third dose. Till the time of reporting patient did not receive 3rd dose of Bexsero which led to incomplete course of vaccination. More
2840568 47 M 05/12/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration Incorrect route of product administration
A 47 years old male patient received Priorix IM instead of subcutaneous; A 47 years old male patient... A 47 years old male patient received Priorix IM instead of subcutaneous; A 47 years old male patient received Priorix; This non-serious case was reported by a consumer via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 47-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 23-APR-2025, the patient received Priorix (intramuscular, unknown deltoid). On 23-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A 47 years old male patient received Priorix IM instead of subcutaneous) and inappropriate age at vaccine administration (Verbatim: A 47 years old male patient received Priorix). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-MAY-2025 On 23rd April 2025, a 47 year old male received Priorix intramuscularly in the deltoid instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route and Inappropriate age at vaccine administration. The patient/reporter was not certain if he had received prior MMR injections in the past as a child, though he assumed that he had. However, since he was preparing for international travel, it was recommended that he receive a Priorix dose before his departure. More
2840569 F FL 05/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93KK4
Inappropriate schedule of product administration Inappropriate schedule of product administration
the second dose on February 2025; This non-serious case was reported by a pharmacist via call center... the second dose on February 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 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 93KK4, expiry date 31-JAN-2027) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine in 2018). In FEB-2025, the patient received Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: the second dose on February 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 06-MAY-2025 The pharmacist called to verify if an extra Shingrix dose would be needed if patient received the first dose on 2018 and the second dose on February 2025, which led to drug dose administration interval too long. The Vaccine Administration Facility is the same as Primary Reporter. More
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