🏥 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 💀 🏥 🚑 ♿ ⚠️
2841830 0.33 M 05/20/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
patient presented for 4 month well child visit, immunization record was reviewed and deficiency of a... patient presented for 4 month well child visit, immunization record was reviewed and deficiency of age appropriate vaccines were detected, ordered placed for completion, and Kinrix vaccine was administered instead pediarix vaccine, no adverse events or reactions noted after vaccination upon chart review, issue was realized, spoke to health department, vaccine is safe and valid, no further action recommended, patient's family was contacted with no answer, will reach out to the family again for the incident. More
2841831 4 F CA 05/20/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 Y49BZ
Unevaluable event Unevaluable event
monitor monitor
2841832 54 F PR 05/20/2025 VARCEL
 MERCK & CO. INC.
 X026790
Audiogram abnormal, Deafness unilateral, Magnetic resonance imaging head normal Audiogram abnormal, Deafness unilateral, Magnetic resonance imaging head normal
Loss of hearing on the right side. Loss of hearing on the right side.
✓
2841833 67 F FL 05/20/2025 TDAP
 SANOFI PASTEUR
 3CA33C1
Rash, Rash erythematous Rash, Rash erythematous
Three days after receiving vaccination employee developed pink rash on both arms and legs. Three days after receiving vaccination employee developed pink rash on both arms and legs.
2841834 63 F TX 05/20/2025 DTAP
PPV
 SANOFI PASTEUR
MERCK & CO. INC.

Eyelid rash, Pruritus, Rash pruritic, Throat irritation; Eyelid rash, Pruritus, ... Eyelid rash, Pruritus, Rash pruritic, Throat irritation; Eyelid rash, Pruritus, Rash pruritic, Throat irritation More
My armpit on the left side started itching, later I had a few itchy bumps that came up on the left s... My armpit on the left side started itching, later I had a few itchy bumps that came up on the left side then my left eye started to itch and I rubbed it and it swelled a bit, which then caused a little itching in throat so I took a Zyrtec and 5mg of Benadryl which took care of it. More
2841835 4 M VA 05/20/2025 DTAP
DTAP
HEP
HEP
HIBV
HIBV
UNK
UNK
DTPPVHBHPB
DTPPVHBHPB
IPV
IPV
MMRV
MMRV
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MSP VACCINE COMPANY
MSP VACCINE COMPANY
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 1
1
2
2
2
2
2
2
U8335AA
U8335AA
X1D141M
X1D141M
Y017513
Y017513
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
Our son was scheduled to receive Hep B, Polio, and Hib vaccines and received 2 of each, plus DTAP. Our son was scheduled to receive Hep B, Polio, and Hib vaccines and received 2 of each, plus DTAP.
2841836 1.25 M MN 05/20/2025 DTAP
DTAP
VARCEL
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 3CA20C1
3CA20C1
X017484
X017484
Infant irritability, Musculoskeletal stiffness, Pyrexia, Rhinorrhoea, Seizure; S... Infant irritability, Musculoskeletal stiffness, Pyrexia, Rhinorrhoea, Seizure; Somnolence, Teething; Infant irritability, Musculoskeletal stiffness, Pyrexia, Rhinorrhoea, Seizure; Somnolence, Teething More
15mo here with observed seizure like activity at home Dad reports he was holding patient and patient... 15mo here with observed seizure like activity at home Dad reports he was holding patient and patient laid back in his arms and "went stiff" for 15-20 seconds Stiffness remitted without recurrence Patient was initially sleepy but is now awake and fussing Mom reports patient has had fever and fussing for the past 48 hours or so Patient received Daptacel and Varivax 6 days ago Mom reports patient has had a runny nose and is presently teething He had a fever 7d ago, but only that night and was afebrile for 4-5 days in the interim Patient has had some intermittent emesis per dad. No noted diarrhea. There has not been any noted cough, throat pain, difficulty breathing, rash, swelling, other noted symptoms or concerns. More
2841837 7 M OH 05/20/2025 COVID19
COVID19
 MODERNA
MODERNA
 3045059
3045059
C-reactive protein increased, Diarrhoea, Lip swelling, Malaise, Oral mucosal eru... C-reactive protein increased, Diarrhoea, Lip swelling, Malaise, Oral mucosal eruption; Rash, Urticaria, Vomiting, White blood cell count increased More
pt received the covid vaccine in our office on 5/12 at 4:24, mom called at 8:30 the next morning to... pt received the covid vaccine in our office on 5/12 at 4:24, mom called at 8:30 the next morning to report pt felt "crummy" & developed a rash on his face/mouth. called a bit later to say his lips swelled to twice their size, pt sent to ED, treated with epi & sent home. returened to our office the next day for a follow up, urticaria, later that day developed diarrhea & started vomiting, went to ED again where he was admitted More
✓
2841838 28 F MD 05/20/2025 CHIK
CHIK
 VALNEVA USA, INC.
VALNEVA USA, INC.

Abdominal pain, Adrenocortical insufficiency acute, Asthenia, Blood glucose decr... Abdominal pain, Adrenocortical insufficiency acute, Asthenia, Blood glucose decreased, Diarrhoea; Fatigue, Heart rate increased, Hypotension, Pyrexia, Vomiting More
Severe weakness, fatigue, abdominal pain, vomiting, diarrhea, low blood pressure, low blood sugar, f... Severe weakness, fatigue, abdominal pain, vomiting, diarrhea, low blood pressure, low blood sugar, fever, and rapid heart rate over several hours after vaccine, seen at ER, diagnosed with adrenal crisis, improved with hydrocortisone More
✓
2841839 1.08 M MI 05/20/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 Z92L4
Inappropriate schedule of product administration, No adverse event, Product admi... Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age More
Patient was given Menveo instead of MMR. The Menveo in stock was the one vial preparation which is n... Patient was given Menveo instead of MMR. The Menveo in stock was the one vial preparation which is not indicated for children under 10 years. This vaccine was also given incorrectly given outside of the schedule. Mother was contacted and informed of the situation, local health department was also contacted for recommendation's and mom was advised off these as well. to date, we are not aware of any adverse reactions to the vaccine given. More
2841841 21 F TX 05/20/2025 MMR
 MERCK & CO. INC.
 Y009430
Extra dose administered Extra dose administered
Client given MMR II on 5-15-25 and 5-20-25. No treatment. Client given MMR II on 5-15-25 and 5-20-25. No treatment.
2841842 81 M MI 05/20/2025 COVID19
 MODERNA
 B0001
Expired product administered Expired product administered
Vaccine was expired upon administration Vaccine was expired upon administration
2841843 77 F MI 05/20/2025 COVID19
 MODERNA
 B0001
Expired product administered Expired product administered
vaccine was expired upon administration vaccine was expired upon administration
2841844 1.25 M ID 05/20/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019465
Y017062
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
On 05/19/2025 patient presented to clinic for vaccination. Patient was to receive MMR & Varicel... On 05/19/2025 patient presented to clinic for vaccination. Patient was to receive MMR & Varicella. Patient was given Varivax and Proquad was mistakenly grabbed and administered rather than MMR II. No side effects have been reported by parent. Vaccines were administered at 09:37AM 05/19/2025. Discovered 1:00PM 05/19/2025. Provider notified. Manufacturer Merck & Co contacted and reported that adverse event according to product warning label likelihood is increased with the double dose of Varicella Vaccination. Parent notified of increased risk for fever, injection site reaction, rash. Advised on s/s to watch for. More
2841845 41 F WA 05/20/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA



Brain fog, Concussion, Contusion, Eye swelling, Fatigue; Haemorrhage, Headache, ... Brain fog, Concussion, Contusion, Eye swelling, Fatigue; Haemorrhage, Headache, Histamine intolerance, Hormone analysis, Lip swelling; Peripheral swelling, Photosensitivity reaction, Rash, Swelling face, Urticaria; Visual impairment More
Adverse histamine reactions, eyes swell up, rashes, abnormal bleeding/bruising, swollen lips, swolle... Adverse histamine reactions, eyes swell up, rashes, abnormal bleeding/bruising, swollen lips, swollen face leaving severe bruising, arm swelled in a rash the nigh of the shot, brain fog, concussion, eyesight changes, headaches-severe, extreme exhaustion, hives , sun allergy when I have never been allergic to the sun before, I have many pictures all dated and time stamped starting since the vaccination. More
✓
2841846 1 M PA 05/20/2025 VARCEL
 MERCK & CO. INC.
 1973325
Disseminated varicella, Skin lesion, Varicella virus test positive, Varicella zo... Disseminated varicella, Skin lesion, Varicella virus test positive, Varicella zoster viraemia More
Disseminated varicella - multiple cutaneous lesions and varicella viremia. Confirmed to be vaccine s... Disseminated varicella - multiple cutaneous lesions and varicella viremia. Confirmed to be vaccine strain via PCR. More
2841847 34 M WA 05/20/2025 MMR
 MERCK & CO. INC.
 Y011709
Extra dose administered, No adverse event Extra dose administered, No adverse event
There have been not side effects reported. It was determined after the vaccine was given that this w... There have been not side effects reported. It was determined after the vaccine was given that this was an extra dose. More
2841849 1 F AR 05/20/2025 MMR
 MERCK & CO. INC.
 Y015020
Rash Rash
Rash started on belly , chest and some on face. Rash started on belly , chest and some on face.
2841851 12 F NH 05/20/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5KR3R
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Pt was given DTaP instead of TDaP, no side effects reported at this time Pt was given DTaP instead of TDaP, no side effects reported at this time
2841852 59 F CA 05/20/2025 CHIK
 VALNEVA USA, INC.
 24B011
Arthritis reactive, Laboratory test, Oedema peripheral, Phlebitis, Ultrasound Do... Arthritis reactive, Laboratory test, Oedema peripheral, Phlebitis, Ultrasound Doppler More
generalized bilateral phlebitis, ankle edema, reactive arthritis of hands generalized bilateral phlebitis, ankle edema, reactive arthritis of hands
2841853 66 F 05/20/2025 COVID19
HEP
MMR
 MODERNA
DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
 3046714
944943
GE974
Systemic inflammatory response syndrome; Systemic inflammatory response syndrome... Systemic inflammatory response syndrome; Systemic inflammatory response syndrome; Systemic inflammatory response syndrome More
Patient was admitted to hospital and diagnosed with Systemic inflammatory response syndrome (sirs). ... Patient was admitted to hospital and diagnosed with Systemic inflammatory response syndrome (sirs). The exact date and time of event were not communicated to us nor was the length and duration of treatment More
✓
2841854 48 F WA 05/20/2025 MMR
 MERCK & CO. INC.
 Y014391
Cough, Hypoaesthesia oral, Muscle twitching, Rash macular, Throat clearing Cough, Hypoaesthesia oral, Muscle twitching, Rash macular, Throat clearing
The employee c/o coughing, trying to clear throat, numb lips, itching face and Left arm became splot... The employee c/o coughing, trying to clear throat, numb lips, itching face and Left arm became splotchy. Employee was treated i the ED with steroids' and antibiotics. More
2841855 81 M CA 05/20/2025 COVID19
 PFIZER\BIONTECH
 LN0590
No adverse event No adverse event
No adverse reactions reported. No adverse reactions reported.
2841860 3 CA 05/20/2025 VARCEL
 MERCK & CO. INC.
 Y015100
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; Inbound call from HCP regarding a T/E for VARIVAX and PROQUAD. See T/E case #02792... no adverse event; Inbound call from HCP regarding a T/E for VARIVAX and PROQUAD. See T/E case #02792544. HCP reported that only VARIVAX was administered to one patient. PROQUAD was not administered to anyone. No symptomatic events reported. HCP agrees to be correspond; This spontaneous report was received from a/an Nurse and refers to a(n) 3-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 15-Apr-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015100, expiration date: 06-Sep-2026) 0.5 mL administered by Unknown route. On 15-Apr-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), 0.5 mL administered by Unknown route (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of Prophylaxis. On 15-Apr-2025, the patient experienced Inbound call from HCP regarding a T/E for VARIVAX and PROQUAD. See T/E case #02792544. HCP reported that only VARIVAX was administered to one patient. PROQUAD was not administered to anyone. No symptomatic events reported. HCP agrees to be correspond. On an unknown date, the patient experienced no adverse event. At the reporting time, the outcome of Inbound call from HCP regarding a T/E for VARIVAX and PROQUAD. See T/E case #02792544. HCP reported that only VARIVAX was administered to one patient. PROQUAD was not administered to anyone. No symptomatic events reported. HCP agrees to be correspond and no adverse event was unknown. The action taken with Varicella Virus Vaccine Live (Oka-Merck) and sterile diluent was reported as not applicable. More
2841861 F GA 05/20/2025 PNC21
 MERCK & CO. INC.
Feeling hot, Injection site erythema, Malaise, Pyrexia Feeling hot, Injection site erythema, Malaise, Pyrexia
injected with a CAPVAXIVE injection a few weeks ago, that she had a large red area that took 1 to 2 ... injected with a CAPVAXIVE injection a few weeks ago, that she had a large red area that took 1 to 2 days to go away; fever; Vaccination site warmth; malaise; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 2025 (also report as a few weeks ago), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), (lot # and expiration date were not reported) for prophylaxis. On 2025, the patient had a large red area that took 1 to 2 days to go away. It also had fever and was warm, having a lot of warmth and fever. She had also a day or so of general malaise, after the injection. She recovered from the events (also reported as from the injection) on an unspecified date in 2025. No hospitalization or prolonged treatment was needed. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. More
2841862 NM 05/20/2025 HPV9
 MERCK & CO. INC.
 Y012508
Product storage error 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 an office manager 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 23-Apr-2025, the patient was vaccinated with an improperly storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y012508, expiration date: 01-Jan-2027) for prophylaxis. No additional adverse event was reported. More
2841863 M GA 05/20/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y012864
1965045
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
Nurse does not report any side effects/symptoms.; patient received GARDASIL 9 outside of the recomme... Nurse does not report any side effects/symptoms.; patient received GARDASIL 9 outside of the recommended dosing schedule/first dose 24OCT2024/second dose 21NOV2024. Patient has returned for dose 3 today but has not yet received it.; This spontaneous report was received from a nurse referring a 33-year-old male patient. His medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 24-Oct-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection pre-filled syringe (batch/lot number Y012864 has been verified to be a valid batch lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration reported as 19-Jan-2026 but upon internal validation established as 29-May-2026), dose number 1, 0.5 mL (anatomical location and route of administration were not reported). On 21-Nov-2024, he was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection pre-filled syringe (batch/lot number 1965045 has been verified to be a valid batch lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration reported and upon internal validation established as 19-Jan-2026), dose number 2, 0.5 mL (anatomical location and route of administration were not reported) (inappropriate schedule of product administration.) Both vaccine doses were administered as prophylaxis. Patient returned for dose 3 on 01-May-2025 (reported as "today"), but he had not yet received it. Nurse did not report any side effects/symptoms (no adverse event). No additional details were provided. More
2841864 VA 05/20/2025 HPV9
 MERCK & CO. INC.
No adverse event, Wrong product administered No adverse event, Wrong product administered
No Additional AE/PQC; Consumer calling to report that their child was given GARDASIL 9 instead of PR... No Additional AE/PQC; Consumer calling to report that their child was given GARDASIL 9 instead of PROQUAD. Consumer did not report any side effects. Permission to contact HCP was given. No Additional AE/PQC; This spontaneous report was received from a Consumer on 15-MAY-2025 and refers to a child 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-MAY-2025, the patient was vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (dose, dose number, frequency, anatomical location, route of administration, lot#, and expiration date were not reported) instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, dose number, frequency, anatomical location, route of administration, lot#, and expiration date were not reported) with Product sterile diluent Solution for injection (dose, dose number, frequency, anatomical location, route of administration, lot#, and expiration date were not reported) for prophylaxis. Consumer did not report any side effects. Lot # will be requested and will be submitted if received. More
2841865 FL 05/20/2025 HPV9
 MERCK & CO. INC.
 W010661
Expired product administered, No adverse event Expired product administered, No adverse event
no adverse event; patient received an expired dose of GARDASIL 9 today 05/15/2025; This spontaneous ... no adverse event; patient received an expired dose of GARDASIL 9 today 05/15/2025; This spontaneous report was received from a medical assailant on 15-MAY-2025 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 15-MAY-2025, the patient was vaccinated with an expired dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (lot #W010661, expiration date: 19-OCT-2024) , dose: 0.5 mL (0.5ml/ series) (dose number, route of administration and anatomical location were not reported) for prophylaxis (Expired product administered) No symptomatic events were reported. No additional information was provided. More
2841866 05/20/2025 HPV9
 MERCK & CO. INC.
 Y007843
No adverse event No adverse event
I have recently received a Gardasil 9 vaccine and would like to verify its authenticity; No addition... I have recently received a Gardasil 9 vaccine and would like to verify its authenticity; No additional AE; This spontaneous report was received from an other health professional on 19-May-2025 and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) (lot #Y007843, expiration date: 17-Nov-2026) as prophylaxis. The patient would like to verify its authenticity (Suspected counterfeit product). The patient wanted to confirm whether this batch was an original product manufactured by the company and intended for distribution. Also, if possible, the patient wanted to confirm which country it was distributed to. No additional AE (no adverse event). More
2841867 F CO 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Nausea Fatigue, Nausea
Generalized symptoms. Extreme tiredness; Generalized symptoms nausea; This non-serious case was repo... Generalized symptoms. Extreme tiredness; Generalized symptoms nausea; This non-serious case was reported by a other health professional via sales rep and described the occurrence of tiredness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 01-MAY-2025, the patient received Shingrix. On 02-MAY-2025, 1 days after receiving Shingrix, the patient experienced tiredness (Verbatim: Generalized symptoms. Extreme tiredness) and nausea (Verbatim: Generalized symptoms nausea). On 04-MAY-2025, the outcome of the tiredness was resolved and the outcome of the nausea was resolved (duration 2 days). It was unknown if the reporter considered the tiredness and nausea to be related to Shingrix. It was unknown if the company considered the tiredness and nausea to be related to Shingrix. Additional Information: GSK Receipt Date: 05-MAY-2025 The patient had generalized symptoms extreme tiredness and nausea after Shingrix vaccination. More
2841868 F 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Paraesthesia Paraesthesia
Tingling skin which travels from her arms, then to her back, then to her feet/legs; This non-serious... Tingling skin which travels from her arms, then to her back, then to her feet/legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling skin in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-MAY-2025, the patient received Shingrix. On 05-MAY-2025, 1 days after receiving Shingrix, the patient experienced tingling skin (Verbatim: Tingling skin which travels from her arms, then to her back, then to her feet/legs). The outcome of the tingling skin was not resolved. It was unknown if the reporter considered the tingling skin to be related to Shingrix. It was unknown if the company considered the tingling skin to be related to Shingrix. Additional Information: GSK Receipt Date: 06-MAY-2025 The patient self-reported this case. The patient received her Shingrix vaccine and on next day she began feeling a tingling sensation on her skin, which travelled from her arms, then to her back, then to her feet or legs. The patient refused to provide any additional information. More
2841869 F 05/20/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Chills, Dizziness, Headache, Heart rate irregular, Nausea; Rash Chills, Dizziness, Headache, Heart rate irregular, Nausea; Rash
Rash; Headache; Chills; Nausea; Dizziness; Irregular heart beat; This non-serious case was reported ... Rash; Headache; Chills; Nausea; Dizziness; Irregular heart beat; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On 05-MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash), headache (Verbatim: Headache), chills (Verbatim: Chills), nausea (Verbatim: Nausea), dizziness (Verbatim: Dizziness) and heart rate irregular (Verbatim: Irregular heart beat). The outcome of the rash, headache, chills, nausea, dizziness and heart rate irregular were unknown. It was unknown if the reporter considered the rash, headache, chills, nausea, dizziness and heart rate irregular to be related to Shingrix. It was unknown if the company considered the rash, headache, chills, nausea, dizziness and heart rate irregular to be related to Shingrix. Additional Information: GSK Receipt Date: 06-MAY-2025 The patient self-reported this case The patient received her first dose of Shingrix yesterday morning and after the dose, she experienced irregular heartbeat, rash, headache, chills, nausea, and dizziness. More
2841870 M KS 05/20/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 M77CC
Exposure via skin contact, Incorrect dose administered, Syringe issue Exposure via skin contact, Incorrect dose administered, Syringe issue
Product complaint; medication leaked out of the prefilled syringe around the plastic portion that at... Product complaint; medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle; underdose; vaccine leaked onto patient's arm; vaccine leaked onto patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis. This case was associated with a product complaint. On 07-MAY-2025, the patient received Boostrix. On 07-MAY-2025, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: underdose), exposure via skin contact (Verbatim: vaccine leaked onto patient's arm) and accidental exposure while administering drug (Verbatim: vaccine leaked onto patient's arm). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product complaint) and syringe connection issue (Verbatim: medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle). The outcome of the underdose, exposure via skin contact, accidental exposure while administering drug, pharmaceutical product complaint and syringe connection issue were not applicable. It was unknown if the reporter considered the syringe connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the syringe connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 09-MAY-2025 14-MAY-2025 Other HCP reported about a defective prefilled syringe. When she started to administer the injection the medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle. The medication leaked onto reporter's hand and the patient's arm, which led to Accidental exposure while administering drug and exposure via skin contact. Needle was securely attached to the syringe. Return of needle used was not available. This case is linked with US2025AMR059513 reported by same reporter.; Sender's Comments: US-GSK-US2025AMR059513:Same reporter/Diffrent patient More
2841871 M 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Suspected vaccination failure; Break through case; residual PHN; This serious case was reported by a... Suspected vaccination failure; Break through case; residual PHN; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a elderly male 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Break through case) and post herpetic neuralgia (Verbatim: residual PHN). The outcome of the vaccination failure was resolving and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix. It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. It was unknown if the company considered the post herpetic neuralgia to be related to Shingrix. Additional Information: GSK Receipt Date: 14-MAY-2025 The patient had been approximately 70 years old. The patient received subsequent dose of the Shingrix vaccine and experienced vaccine failure which was ongoing but in recovering state and it was not serious. It had been a breakthrough case (shingles), but very mild. The patient had been prescribed antivirals right away but had still experienced 2/10 pain and some residual postherpetic neuralgia (PHN). No other products received by 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.; 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 Shingrix More
2841872 66 F 05/20/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4n222
Incorrect route of product administration Incorrect route of product administration
66 years old patient received priorix; Drug administered via inappropriate route; This non-serious c... 66 years old patient received priorix; Drug administered via inappropriate route; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of subcutaneous injection formulation administered by other route in a 66-year-old female patient who received MMR (Priorix) (batch number 4n222, expiry date 13-SEP-2026) for prophylaxis. On 15-MAY-2025, the patient received the 1st dose of Priorix (intramuscular, left arm). On 15-MAY-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Drug administered via inappropriate route). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: 66 years old 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: 15-MAY-2025 The reporter reported that the 66 years old patient received 1st dose of Priorix intramuscularly which led to inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route. More
2841873 71 M TN 05/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 75GZ7
Hypersensitivity, Lethargy, Mobility decreased Hypersensitivity, Lethargy, Mobility decreased
Allergic reaction; Lethargic; Could not get up; This non-serious case was reported by a pharmacist v... Allergic reaction; Lethargic; Could not get up; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a elderly male patient who received Herpes zoster (Shingrix) (batch number 75GZ7) for prophylaxis. Concurrent medical conditions included parkinson's disease. On 14-MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular, right arm). In MAY-2025, less than a week after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Allergic reaction), lethargy (Verbatim: Lethargic) and mobility decreased (Verbatim: Could not get up). The outcome of the allergic reaction, lethargy and mobility decreased were resolving. The reporter considered the allergic reaction, lethargy and mobility decreased to be related to Shingrix. The company considered the allergic reaction, lethargy and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 16-MAY-2025 The reporter is a pharmacist called to report that the wife of a male patient stated that the patient had an allergic reaction, got lethargic, and could not get up (no specific date provided). The patient was taken to the emergency room, was checked at the emergency room, and was discharged (no specific date provided). The reporter did not know if the patient had an overnight stay at the Emergency Room. The patient was told at the emergency room that he was experiencing side effects from receiving the second dose of Shingrix. The patient was now back home and doing okay. The reporter had notified the patient's physician, and provided consent to follow up with the patient's physician. The reporter stated that they do not fill the patient's prescription medications, and he had no prescription history to provide. More
2841874 05/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Autoimmune disorder, Herpes zoster, Vaccination failure Autoimmune disorder, Herpes zoster, Vaccination failure
Suspeceted vaccination failure; had shingle twice and the autoimmune disease from the vaccine is wor... Suspeceted vaccination failure; had shingle twice and the autoimmune disease from the vaccine is worse; I have had shingle twice and the autoimmune disease from the vaccine is worse; 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), autoimmune disorder (Verbatim: had shingle twice and the autoimmune disease from the vaccine is worse) (serious criteria GSK medically significant) and shingles (Verbatim: I have had shingle twice and the autoimmune disease from the vaccine is worse). The outcome of the vaccination failure, autoimmune disorder and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The reporter considered the autoimmune disorder to be related to Shingles vaccine. The company considered the vaccination failure, autoimmune disorder and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingle twice and the autoimmune disease from the vaccine was worse. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, 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, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster and Autoimmune disorder are unlisted events which are considered unrelated to GSK Shingles vaccine. " More
2841875 05/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
shot hurt; This non-serious case was reported by a consumer via interactive digital media and descri... shot hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: shot hurt). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-MAY-2025 This case was reported by a patient via interactive digital media. Reporter stated that get the shingles vaccine, the shot hurt but it is better than shingles. More
2841876 05/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
they both made me sick; This non-serious case was reported by a consumer via interactive digital med... they both 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: they both 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. Additional Information: GSK receipt date: 06-MAY-2025 This case was reported by a patient via interactive digital media. Patient stated they both made them sick. This case is 1 of 2 cases created for both doses. More
2841877 67 05/20/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; had that 3 times; This serious case was reported by a consumer via in... Suspected vaccination failure; had that 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included covid-19. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: had that 3 times). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 08-MAY-2025 The case was received from the patient via interactive digital media. The reporter got an RSV vaccine. The reporter got it when he/she was 67 from his/her great granddaughters. The reporter reported that it was way worse than Covid and he/she had that 3 times. Plus the reporter lost his/her mother, brother and sister in law within 21 days to Covid. RSV was the last vaccine the reporter got but he/she glad he/she did. There were a few times the reporter thought he/she was going to die when he/she had RSV. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection 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 RSV vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK RSV vaccine." More
2841878 05/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I had it 3 times; This serious case was reported by a consumer via in... Suspected vaccination failure; I had it 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received 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: I had it 3 times). 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: 09-MAY-2025 The case was received from the patient via interactive digital media. The reporter had it 3 times but very mild because he/she had the vaccine. 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 vaccine Shingles vaccine. More
2841879 05/20/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pruritus, Rash, Vaccination failure; Herpes zoster, Pruritus, Ras... Herpes zoster, Pruritus, Rash, Vaccination failure; Herpes zoster, Pruritus, Rash, Vaccination failure More
Suspected vaccination failure; have shingles now; This serious case was reported by a consumer via i... Suspected vaccination failure; have shingles now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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: have shingles now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine 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: 12-MAY-2025 The case was received from the patient via interactive digital media. The reporter had both Shingles shots but had shingles now. It was a mild case with a rash and some itching. Hopefully would just go away soon. The reporter advice to get shots. He/she was convinced it helped. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2). More
2841880 KS 05/20/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 M77CC
Device leakage, Occupational exposure to product Device leakage, Occupational exposure to product
medication leaked out of the prefilled syringe around the plastic; Product complaint; medication lea... medication leaked out of the prefilled syringe around the plastic; Product complaint; medication leaked onto my hand; medication leaked onto my hand; This non-serious case was reported by a other health professional and described the occurrence of occupational exposure via skin contact with product in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Boostrix. On 07-MAY-2025, an unknown time after receiving Boostrix, the patient experienced occupational exposure via skin contact with product (Verbatim: medication leaked onto my hand) and inadvertent exposure to vaccine (Verbatim: medication leaked onto my hand). On an unknown date, the patient experienced syringe connection issue (Verbatim: medication leaked out of the prefilled syringe around the plastic) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the occupational exposure via skin contact with product, inadvertent exposure to vaccine, syringe connection issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the syringe connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 09-MAY-2025 Other healthcare professional reported about a defective prefilled syringe. When she started to administer the injection the medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle. The medication leaked onto reporter's hand and the patient's arm, which led to occupational exposure via skin contact with product, inadvertent exposure to vaccine and syringe connection issue. Needle was securely attached to the syringe. This case is linked with US2025057149 reported by same reporter for the patient.; Sender's Comments: US-GSK-US2025057149:Same reporter/Diffrent patient More
2841881 GA 05/20/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Underdose Underdose
inadvertently administered a pediatric dose of ENGERIX-B by GSK (GlaxoSmithKline) to an adult patien... inadvertently administered a pediatric dose of ENGERIX-B by GSK (GlaxoSmithKline) to an adult patient.; Underdose; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis. On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: inadvertently administered a pediatric dose of ENGERIX-B by GSK (GlaxoSmithKline) to an adult patient.) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 13-MAY-2025 Inadvertently administered a pediatric dose of Engerix-B to a patient, which led adult use of a child product and underdose. More
2841882 F SC 05/20/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Vaccination failure, Zoster sine herpete; Vaccination failure, Zoster sine herpe... Vaccination failure, Zoster sine herpete; Vaccination failure, Zoster sine herpete More
Suspected vaccination failure; recently developed internal shingles; This serious case was reported ... Suspected vaccination failure; recently developed internal shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, several years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: recently developed internal shingles). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was not resolved. It was unknown if the reporter considered the vaccination failure and zoster sine herpete to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the zoster sine herpete to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 15-MAY-2025 The patient had the multi dose at some point in time but have recently developed internal shingles. The got both doses of Shingrix probably 7 or more years ago and was right now dealing with internal shingles. So the patient wanted to know if the efficacy of the vaccine ran out in that 7 or so years so should she get another round of Shingrix. The patient also wanted to know if a booster dose/third dose required with Shingrix. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose). More
2841883 05/20/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; had the injection and still caught RSV; This serious case was reporte... Suspected vaccination failure; had the injection and still caught RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: had the injection and still caught RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 13-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the injection and still caught respiratory syncytial virus infection. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: 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 RSV vaccine. More
2841884 05/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
within 10 days got Shingles; This non-serious case was reported by a consumer via interactive digita... within 10 days got 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 Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: within 10 days got Shingles). 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 : 15-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had a friend who got the vaccine and within 10 days got Shingles. Read up on it. 1 out 10 could develop Shingles after the vaccine. More
2841885 05/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; friend who get their shingles shots and still get the shingles; This ... Suspected Vaccination failure; friend who get their shingles shots and still get the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: friend who get their shingles shots and still get the shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAY-2025 This case was reported by a patient's friend via interactive digital media. The reporter knew a friend (patient) who got their Shingles shots and still got the shingles and said so asked why to take it. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: 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
2841886 05/20/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles very badly; This serious case was reported by a consumer via... Suspected vaccination failure; shingles very badly; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 very badly). 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: 13-MAY-2025 The reporter know several people that still broke out with shingles very badly that got the vaccine so did not said if get the vaccine would not get shingles. 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 vaccine Shingles vaccine. More
📋 Privacy Policy & Data Disclaimer