๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2855296 F NC 08/22/2025 COVID19
 PFIZER\BIONTECH
Pain in extremity Pain in extremity
her arm would hurt a lot more than 'mine'; This is a spontaneous report received from a Co... her arm would hurt a lot more than 'mine'; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune diseases" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm would hurt a lot more than 'mine'". More
2855297 F 08/22/2025 MNP
 PFIZER\WYETH
 LP7146
Hypoaesthesia Hypoaesthesia
Numbness in arm and hand; This is a spontaneous report received from a Consumer or other non HCP. A... Numbness in arm and hand; This is a spontaneous report received from a Consumer or other non HCP. A 16-year-old female patient (not pregnant) received meningococcal group abcwy vaccine (PENBRAYA), on 13Aug2025 at 15:00 as dose number unknown, single (Lot number: LP7146) for immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same date as the vaccine(s). The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). It was unknown if the patient was taking any other medications within 2 weeks of the event starting. The following information was reported: HYPOAESTHESIA (non-serious) with onset 13Aug2025 at 18:00, outcome "recovering", described as "Numbness in arm and hand". The events "numbness in arm and hand" required emergency room visit. Therapeutic measures were taken as a result of hypoaesthesia. More
2855298 86 TX 08/22/2025 TDAP
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Intentional Age Prescription by HCP with no reported adverse event; Initial information received on... Intentional Age Prescription by HCP with no reported adverse event; Initial information received on 20-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 86 years old and unknown gender patient who had an intentional prescription of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] by HCP (healthcare professional) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot number not reported) once via intramuscular route in unknown administration site to help protect against tetanus, diphtheria and pertussis (Immunization) and was an intentional prescription by HCP with no reported adverse event (off label use) (same day latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. More
2855299 16 F CA 08/22/2025 MEN
MENB
 UNKNOWN MANUFACTURER
PFIZER\WYETH
 U8558BA
No adverse event, Product preparation error; No adverse event, Product preparati... No adverse event, Product preparation error; No adverse event, Product preparation error More
menquadfi and trumenba were administered together (combined) in one syringe with no reported adverse... menquadfi and trumenba were administered together (combined) in one syringe with no reported adverse event; menquadfi and trumenba were administered together (combined) in one syringe with no reported adverse event; Initial information received on 19-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 16 years old female patient who was administered with Meningococcal vaccine B rfHbpA/fHbpB [Trumenba] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] together (combined) in one syringe with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Aug-2025, the patient received 0.5 ml of Trumenba not produced by Sanofi Pasteur with strength- standard (formulation, expiry date and lot number not reported) once and 0.5 ml of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection with strength- standard (expiry date- 30-SEP-2028 and lot U8558BA) once were together (combined) in one syringe and given via intramuscular route in the left deltoid for Immunization with no reported adverse event (product use issue) (extra dose administered) (latency- same day). Reportedly, the patient did not report any adverse reaction. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2855302 14 M NY 08/22/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

No adverse event, Underdose; No adverse event, Underdose No adverse event, Underdose; No adverse event, Underdose
No additional AE reported.; Patient received the less than recommended dose for the 2nd dose (human ... No additional AE reported.; Patient received the less than recommended dose for the 2nd dose (human user error-needle was not placed tightly on the GARDASIL 9 ) .; Patient received the less than recommended dose for the 2nd dose (human user error-needle was not placed tightly on the GARDASIL 9 ) .; Male patient received first dose of GARDASIL 9 at age 14 on 7/24/2024, 2nd dose was administered on 8/15/2025.; This spontaneous report was received from a Nurse Practitioner on 15-Aug-2025 and refers to a 15-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-Jul-2024 at age of 14-years old, the patient was vaccinated with a first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 1 dosage form total (lot # and expiration date were not reported) for prophylaxis. On 15-Aug-2025, the patient received a second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), the less than recommended dose, 1 dosage form , (lot # and expiration date were not reported) (underdose, Inappropriate schedule of product administration) (human user error-needle was not placed tightly on the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Wrong technique in product usage process)for prophylaxis. No additional adverse event reported. Lot # will be requested and will be submitted if received. More
2855303 47 F IL 08/22/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 H7RF2
Inappropriate schedule of product administration Inappropriate schedule of product administration
As of today, the patient received the second dose/ late second dose; This non-serious case was repor... As of today, the patient received the second dose/ late second dose; 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 47-year-old female patient who received HAB (Twinrix) (batch number H7RF2, expiry date 07-JAN-2026) for prophylaxis. Previously administered products included Twinrix (received first dose in September 2024). On 13-AUG-2025, the patient received the 2nd dose of Twinrix. On 13-AUG-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: As of today, the patient received the second dose/ late second dose). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-AUG-2025 The Vaccine Administration Facility was the same as Primary Reporter A pharmacist called to get guidance for the Twinrix vaccine series A female patient received the first dose back in September 2024 and as of today, the patient received the second dose which led to drug dose administration interval too long The pharmacist wanted to know how to proceed for the schedule of the third dose and when do they give her the third dose. More
2855304 62 F ID 08/22/2025 FLU3
 SANOFI PASTEUR
 TFAA2410
Arthralgia, Bursitis, Shoulder injury related to vaccine administration Arthralgia, Bursitis, Shoulder injury related to vaccine administration
Patient started having shoulder pain within 24 hours after receiving the shot. She took Ibuprofen by... Patient started having shoulder pain within 24 hours after receiving the shot. She took Ibuprofen by mouth as needed expecting it to get better. Pain continued so she sought medical attention on 12/31/2024 was diagnosed with bursitis (and was given a steroid shot in the left shoulder that helped for about 2 months then stared to ware off. Now her pain is back to being 10 /10 with no pain meds usually first thing in the morning after immobility for few hours. On good days with shoulder movement is 4/10. Patient has history of shoulder surgery but the pain experienced after the shot was sudden, severe and of a different nature suggesting it is SIRVA. More
โœ“
2855305 35 F OR 08/22/2025 HPV9
 MERCK & CO. INC.
 3048223
Hypoaesthesia, Paraesthesia Hypoaesthesia, Paraesthesia
Tingling/ numbness in right arm and fingers started 15 minutes after administration improved but per... Tingling/ numbness in right arm and fingers started 15 minutes after administration improved but persisted throughout day More
2855306 6 M MI 08/22/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.

Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
They put the wrong vaccines to my 6 year old boy they gave us the wrong paperwork and then applied o... They put the wrong vaccines to my 6 year old boy they gave us the wrong paperwork and then applied other kid?s vaccines to him. More
2855307 2 M WY 08/22/2025 DTAPIPV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 42Y93
Product administered to patient of inappropriate age, Wrong product administered... Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered More
MOC wanted to only vaccinate 2 vaccines, not a combo, and only wanted DTaP and PCV. MA inadvertantl... MOC wanted to only vaccinate 2 vaccines, not a combo, and only wanted DTaP and PCV. MA inadvertantly administered DTaP-IPV(Kinrix). Pt is 2 years old and Kinrix is not approved for this age group. More
2855308 79 M NY 08/22/2025 COVID19
FLU3
TDAP
VARZOS
 PFIZER\BIONTECH
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 lm2215
u8429ba
x357e
x4535
Anti-neutrophil cytoplasmic antibody positive vasculitis, Monoplegia, Neurologic... Anti-neutrophil cytoplasmic antibody positive vasculitis, Monoplegia, Neurological symptom; Anti-neutrophil cytoplasmic antibody positive vasculitis, Monoplegia, Neurological symptom; Anti-neutrophil cytoplasmic antibody positive vasculitis, Monoplegia, Neurological symptom; Anti-neutrophil cytoplasmic antibody positive vasculitis, Monoplegia, Neurological symptom More
ANCA-associated vasculitis, paralyzed left foot, stroke like symptoms (stroke was ruled out), hospit... ANCA-associated vasculitis, paralyzed left foot, stroke like symptoms (stroke was ruled out), hospitalized for multiple months More
โœ“ โœ“ โœ“
2855309 62 F CA 08/22/2025 PNC20
 PFIZER\WYETH
 LN4929
Aspiration joint, Joint swelling Aspiration joint, Joint swelling
Patient complained of knee swelling and had to go to ER for evaluation. 30cc of fluid was drained f... Patient complained of knee swelling and had to go to ER for evaluation. 30cc of fluid was drained from patient's knee and swelling subsided. Emergency room MD had suspected adverse reaction from vaccine. More
2855310 2 F 08/22/2025 DTAP
IPV
 SANOFI PASTEUR
SANOFI PASTEUR

Injection site erythema, Injection site induration, Injection site swelling; Inj... Injection site erythema, Injection site induration, Injection site swelling; Injection site erythema, Injection site induration, Injection site swelling More
Swelling, induration, & erythema at the site of injection that started about 24 hours after inje... Swelling, induration, & erythema at the site of injection that started about 24 hours after injection. Erythema is 4-5cm across. More
2855311 1.08 F NM 08/22/2025 DTAPIPV
HEPA
HIBV
MMRV
PNC21
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 42Y93
DN273
Y003145
Y019465
Y005351
Irritability, Poor quality sleep, Pyrexia, Rash; Irritability, Poor quality slee... Irritability, Poor quality sleep, Pyrexia, Rash; Irritability, Poor quality sleep, Pyrexia, Rash; Irritability, Poor quality sleep, Pyrexia, Rash; Irritability, Poor quality sleep, Pyrexia, Rash; Irritability, Poor quality sleep, Pyrexia, Rash More
Fever 99-103 began 3 days prior to vaccination per parent, rash began after vaccination spread on mo... Fever 99-103 began 3 days prior to vaccination per parent, rash began after vaccination spread on most of body, irritable, not sleeping well More
2855312 6 M GA 08/22/2025 DTAPIPV
HEP
HEPA
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.



Injection site erythema, Injection site mass, Injection site pruritus, Injection... Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth More
Red, hot, swollen, itchy, lump around injection site. Tennis ball size. Began small and spread withi... Red, hot, swollen, itchy, lump around injection site. Tennis ball size. Began small and spread within 24 hours. More
2855318 39 M LA 08/22/2025 COVID19
 MODERNA
 98974
Systemic lupus erythematosus Systemic lupus erythematosus
Auto immune disease lupus doctor has prescribed me, methotrexate, hydroxychloroquine, and clobetasol Auto immune disease lupus doctor has prescribed me, methotrexate, hydroxychloroquine, and clobetasol
โœ“
2855319 59 F 08/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ353
Injection site erythema Injection site erythema
Patient developed redness near site of administration. I recommended to get benadryl and is almost g... Patient developed redness near site of administration. I recommended to get benadryl and is almost gone after the next day. More
2855320 48 F CA 08/22/2025 VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Z006737
Z006737
Z006737
z006737
z006737
z006737
Injection site mass, Injection site pain, Injection site pruritus, Injection sit... Injection site mass, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth; Urticaria; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site mass, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth; Urticaria; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling More
On August 20, 2025, the injection site (right upper back arm) felt tender to touch with some slight ... On August 20, 2025, the injection site (right upper back arm) felt tender to touch with some slight itchiness. On August 21, 2005, I still felt tenderness and gently rubbed the site and noticed a mass-like lump under the skin so I immediately went in from of a mirror to observe my arm and noticed a red diamond shaped welt, measuring 2.5 inches in length and 1.5 inches in width. It was warm to touch and I immediately placed an ice pack on it. Today, August 22, 2025, I contacted the Pharmacy where I received the injection, and reported to a Pharmacist, who stated that the large red welt side effect was not normal and to monitor it. She also stated that if redness spread or worsened, to contact my Primary Physician. More
2855321 17 F CA 08/22/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 K7JY3
Extra dose administered Extra dose administered
Patient received an extra dose of Bexsero on 8/21/2025. She received first dose of Bexsero on 8/13/... Patient received an extra dose of Bexsero on 8/21/2025. She received first dose of Bexsero on 8/13/2024 and second dose of Bexsero on 03/18/25. More
2855322 5 M NY 08/22/2025 DTAP
DTAP
UNK
UNK
 SANOFI PASTEUR
SANOFI PASTEUR
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Aphasia, Asthenia, Diarrhoea, Diplopia, Dizziness; Gait inability, Malaise, Vomi... Aphasia, Asthenia, Diarrhoea, Diplopia, Dizziness; Gait inability, Malaise, Vomiting; Aphasia, Asthenia, Diarrhoea, Diplopia, Dizziness; Gait inability, Malaise, Vomiting More
Symptoms started slowly on july 25th,,,started throwing up and diarrea, was ill and regressed ...bec... Symptoms started slowly on july 25th,,,started throwing up and diarrea, was ill and regressed ...became week,,started complaining of diziness and double vision...became completely nonverbal and unable to walk on August 1st.. More
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2855323 66 F CA 08/22/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 m4b34
Skin reaction, Skin warm Skin reaction, Skin warm
Patient was getting second dose of Twinrix at pharmacy. First dose and third dose have no reaction ... Patient was getting second dose of Twinrix at pharmacy. First dose and third dose have no reaction but second dose gave her redness skin on whole body and worm to touch. More
2855324 69 F SC 08/22/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 F4AC3
Extra dose administered Extra dose administered
PATIENT RECEIVED A SECOND DOSE OF RSV VACCINE PATIENT RECEIVED A SECOND DOSE OF RSV VACCINE
2855325 0.5 M CO 08/22/2025 DTAPHEPBIP
HIBV
RV1
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 K25M5
Y015929
3Z34X
Infant irritability, Infantile vomiting; Infant irritability, Infantile vomiting... Infant irritability, Infantile vomiting; Infant irritability, Infantile vomiting; Infant irritability, Infantile vomiting More
This patient is 6 months old and mom was taking and is currently taking Stelara which is an immunosu... This patient is 6 months old and mom was taking and is currently taking Stelara which is an immunosuppressant. Due to the potential immunosuppression from Stelara crossing the placenta and the possible amount of the immunosuppressive medication crossing into breastmilk, he was not started on the rotavirus vaccination series. He was given the first dose in the series today when he was 6 months of age. Additionally, he received a 3rd Hib vaccine which was not required for his series. Approximately 7-8 hours after administration of the rotavirus vaccine, he developed vomiting and fussiness. He has not developed a fever. More
2855326 7 F 08/22/2025 FLU3
 SANOFI PASTEUR
 UT8779KA
Syncope Syncope
Pt fainted 10-15 minutes after receiving the vaccine Pt fainted 10-15 minutes after receiving the vaccine
2855327 84 F MN 08/22/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Arthralgia, Diarrhoea, Fatigue, Myalgia, Nausea; Pyrexia Arthralgia, Diarrhoea, Fatigue, Myalgia, Nausea; Pyrexia
fatigue, fever, nausea, diarrhea, muscle and joint pain. resolved on it own. fatigue, fever, nausea, diarrhea, muscle and joint pain. resolved on it own.
2855328 40 F AZ 08/22/2025 MENB
MNQ
VARZOS
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 DD72H
U8438AA
FT95N
Nausea, Paraesthesia, Retching, Syncope; Nausea, Paraesthesia, Retching, Syncope... Nausea, Paraesthesia, Retching, Syncope; Nausea, Paraesthesia, Retching, Syncope; Nausea, Paraesthesia, Retching, Syncope More
I got very nauseous, dry heaved, felt tingly all over (all within maybe 1-2 minutes) before ultimate... I got very nauseous, dry heaved, felt tingly all over (all within maybe 1-2 minutes) before ultimately fainting. More
2854948 16 F CA 08/21/2025 MENB
MNQ
 PFIZER\WYETH
SANOFI PASTEUR
 HP9989
U8438AA
Injection site erythema, Injection site swelling, Urticaria; Injection site eryt... Injection site erythema, Injection site swelling, Urticaria; Injection site erythema, Injection site swelling, Urticaria More
Teen developed urticaria, redness/swelling to B-upper arms, then hives on abdomen and BLE just over ... Teen developed urticaria, redness/swelling to B-upper arms, then hives on abdomen and BLE just over 24 hours after vaccines were administered. No associated facial swelling, tingling in mouth, vomiting, or other symptoms. More
2854981 SC 08/21/2025 MMRV
 MERCK & CO. INC.
 Y017208
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Custome called to report TE. She called this morning for prior TE, and later a day... No additional AE; Custome called to report TE. She called this morning for prior TE, and later a day and before TE she was calling now, PROQUAD was administered to two patients.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 01-Aug-2025, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017208, expiration date: 13-Apr-2026), 0.5 mL for prophylaxis, diluted with sterile diluent (strength, dose, frequency, lot#, and expiry date not provided) (Product storage error). Temperature excursion occurred at -10.1 C for 1 hour. A previous temperature excursion was reported. No additional adverse event was reported. This is one of two reports from the same reporter. More
2854982 8 MI 08/21/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
patient received their first dose of GARDASIL9 in another unknown country and their current state sh... patient received their first dose of GARDASIL9 in another unknown country and their current state shot record indicates that it was given at 8 years old instead of 9 years old; No additional AE reported.; This spontaneous report was received from a nurse and refers to an 8-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 an unknown date, at the age of 8 (instead of 9 years-old), the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) (lot # and expiration date were not reported) (Product administered to patient of inappropriate age) in another country for prophylaxis. On an unknown date, at the age of 10, the patient received a second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) (lot # and expiration date were not reported) for prophylaxis. Reporter was unsure if this was an error in the shot record or if the first dose was actually administered at 8 years old. No additional adverse event reported. Lot # is being requested and will be submitted if received. More
2854983 13 MI 08/21/2025 MMR
 MERCK & CO. INC.
 X019101
Expired product administered, No adverse event, Underdose Expired product administered, No adverse event, Underdose
No additional AE; dose administered of 5 mL, label dose recommended 0.5 mL; HCP called to report the... No additional AE; dose administered of 5 mL, label dose recommended 0.5 mL; HCP called to report the inadvertent administration of an expired dose of MMR II.; This spontaneous report was received from a physician, concerning to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-Jul-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 #X019101 has been verified to be valid for this product, expiration date reported and confirmed as 16-Jul-2025) 5 mL for prophylaxis (route of administration and anatomical site not provided); reconstituted with sterile diluent (BAXTER STERILE DILUENT), (dose, indication, route, expiration date, and lot # were not reported). Since the vaccine was expired, the event of expired product administered was captured. The dose administered was reported as 5 mL, per label the recommended dose was 0.5 mL (incorrect dose administered). No additional adverse event reported (No adverse event). More
2854984 F NJ 08/21/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Blood pressure immeasurable, Enanthema, Pallor, Rash, Respiratory arrest; Syncop... Blood pressure immeasurable, Enanthema, Pallor, Rash, Respiratory arrest; Syncope, Unresponsive to stimuli More
patient fainted and according to the doctor was "unresponsive for about 10 seconds"/patien... patient fainted and according to the doctor was "unresponsive for about 10 seconds"/patient was pale; not breathing; "some kind of mucosal rash" on the mouth and lips; Caller stated HCP reported patient "finally came around" and blood pressure was undetectable. HCP stated they "finally got a blood pressure reading of 50/30; glucocagon for possible low blood sugar; patient had a rash on her chest; This spontaneous report was received from a physician and refers to a 13-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, administered by unknown route (lot # and expiration date were not reported) as prophylaxis. On an unknown date, after receiving first dose, the patient fainted and according to the doctor was "unresponsive for about 10 seconds". 9-1-1 was called. She was pale and not breathing. The patient "finally came around" and blood pressure was undetectable. HCP stated they "finally got a blood pressure reading of 50/30". HCP gave patient glucagon for possible low blood sugar. HCP stated ambulance finally came, however mother refused her daughter to go to the emergency room, because the patient "seemed to be coming around". The patient's mother called the office and stated patient had a rash on her chest and "some kind of mucosal rash" on the mouth and lips. HCP sent the patient to emergency room where she was given steroids and Benadryl and was sent home. HCP stated both "eventually resolved" and stated that the patient was referred to a cardiologist. Dates of all events were unknown. No additional information provided. At the reporting time, the outcome of blood pressure decreased and sugar blood decreased was unknown. The action taken with the suspect vaccine was not applicable. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. The reporter considered the all of the events to be life-threatening. More
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2854985 F PR 08/21/2025 HPV9
 MERCK & CO. INC.
Cervicectomy Cervicectomy
GARDASIL 9 caused a removal of cervix for 2 daughters; This spontaneous report was received from a n... GARDASIL 9 caused a removal of cervix for 2 daughters; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (strength, dose, frequency, route of administration, site of administration, lot #, and expiration date were not provided) as prophylaxis. The nurse said that the physician showed her a document that between 2018 and 2019, 3 daughters from the same family experienced adverse event (AE) after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9). The physician told the nurse that Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) caused a removal of cervix (Hysterectomy) for 2 daughters (This report refers to one of them and the other female patient was captured in case # 2320738) and one daughter developed a "knot" on her breast (Captured in case # 2320739). At the reporting time, the outcome of hysterectomy was not provided. The reporter considered the event of hysterectomy to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9). Upon internal review, the event of hysterectomy was considered medically significant. This is one of three reports from the same reporter. More
2854986 F PR 08/21/2025 HPV9
 MERCK & CO. INC.
Cervicectomy Cervicectomy
GARDASIL 9 caused a removal of cervix for 2 daughters; This spontaneous report was received from a n... GARDASIL 9 caused a removal of cervix for 2 daughters; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (strength, dose, frequency, route of administration, site of administration, lot #, and expiration date were not provided) as prophylaxis. The nurse said that the physician showed her a document that between 2018 and 2019, 3 daughters from the same family experienced adverse event (AE) after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9). The physician told the nurse that Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) caused a removal of cervix (Hysterectomy) for 2 daughters (This report refers to one of them and the other female patient was captured in case # 2320735) and one daughter developed a "knot" on her breast (Captured in case # 2320739). At the reporting time, the outcome of hysterectomy was not provided. The reporter considered the event of hysterectomy to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9). Upon internal review, the event of hysterectomy was considered medically significant. This is one of three reports from the same reporter. More
2854987 F PR 08/21/2025 HPV9
 MERCK & CO. INC.
Breast mass Breast mass
one daughter developed a "knot" on her breast.; This spontaneous report was received from ... one daughter developed a "knot" on her breast.; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (strength, dose, frequency, route of administration, site of administration, lot #, and expiration date were not provided) as prophylaxis. The nurse said that the physician showed her a document that between 2018 and 2019, 3 daughters from the same family experienced adverse event (AE) after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9). The physician told the nurse that Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) caused a removal of cervix (Hysterectomy) for 2 daughters (captured in cases # 2320735 and 2320738) and one daughter developed a "knot" on her breast (Breast mass). At the reporting time, the outcome of breast mass was not provided. The reporter considered the event of breast mass to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9). This is one of three reports from the same reporter. More
2854988 IN 08/21/2025 HEPA
 MERCK & CO. INC.
No adverse event, Underdose No adverse event, Underdose
No additional AE; HCP called to report administering an adult dose of VAQTA to a 12 month old patien... No additional AE; HCP called to report administering an adult dose of VAQTA to a 12 month old patient. No symptoms reported. AE filed under 02857257. Consent provided for follow up with the HCP. Caller declined to report any further information including whether the; This spontaneous report was received from a healthcare professional (HCP) and refers to a 12-month-old patient of unknown gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 15-Aug-2025, the patient was vaccinated with an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA), suspension for injection (lot # and expiration date were not reported) as prophylaxis (Vaccine overdose). No symptoms reported. Lot # is being requested and will be submitted if received. More
2854989 08/21/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Adrenal insufficiency, Central vision loss, Raynaud's phenomenon, Retinal o... Adrenal insufficiency, Central vision loss, Raynaud's phenomenon, Retinal operation, Retinal tear; Rheumatoid arthritis, Sjogren's syndrome, Systemic lupus erythematosus More
retina tear; loss my center vision; Rheumatoid arthritis; sjogrens; lupus; adrenal deficiency; Rayna... retina tear; loss my center vision; Rheumatoid arthritis; sjogrens; lupus; adrenal deficiency; Raynauds; This serious case was reported by a consumer via interactive digital media and described the occurrence of retinal tear 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 retinal tear (Verbatim: retina tear) (serious criteria GSK medically significant and clinically significant/intervention required), central vision loss (Verbatim: loss my center vision) (serious criteria GSK medically significant), rheumatoid arthritis (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant), sjogren's (Verbatim: sjogrens) (serious criteria GSK medically significant), systemic lupus erythematosus (Verbatim: lupus) (serious criteria GSK medically significant), adrenal insufficiency (Verbatim: adrenal deficiency) (serious criteria GSK medically significant) and raynauds (Verbatim: Raynauds). The patient was treated with Steroids. The outcome of the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds were not reported and the outcome of the adrenal insufficiency was not resolved. It was unknown if the reporter considered the retinal tear, central vision loss and adrenal insufficiency to be related to Shingrix. The reporter considered the rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds to be related to Shingrix. The company considered the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and adrenal insufficiency to be unrelated to Shingrix. The company considered the raynauds to be related to Shingrix. Linked case(s) involving the same patient: US2021AMR198955 Additional Information: GSK Receipt Date: 06-AUG-2025 This case was reported by a patient via interactive digital media. The patient received shingrix vaccine a few years ago (from reporting date) that triggered rheumatoid arthritis, sjogrens, raynauds, lupus and at the time of reporting also had adrenal deficiency that he/she steroid dependent on to live. The patient also developed a retina tear that had three surgeries on and loss his/her center vision. The patient would never tell anyone not to get a vaccine but dang sure would say to do some deep research beforehand.; Sender's Comments: A case of Retinal tear, Central vision loss, Rheumatoid arthritis, Sjogren's syndrome, Systemic Lupus erythematosus and Adrenal insufficiency, unknown time after receiving Shingrix in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. US-GLAXOSMITHKLINE-US2021AMR198955:same patient More
2854990 TN 08/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered at inappropriate site Product administered at inappropriate site
Shingrix vaccination given in a gluteus muscle; This non-serious case was reported by a nurse via ca... Shingrix vaccination given in a gluteus muscle; This non-serious case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 14-AUG-2025, the patient received Shingrix (intramuscular, unknown gluteal). On 14-AUG-2025, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Shingrix vaccination given in a gluteus muscle). The outcome of the vaccine administered at inappropriate site was not applicable. Additional Information: GSK Receipt Date: 14-AUG-2025 The supervisor of a health department reported that a Shingrix vaccination was given to a patient in a gluteus muscle, which led to vaccine administered at inappropriate site. More
2854992 OH 08/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and... Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 14-AUG-2025 The reporter asked that he or she was trying to find recommendation for second dose of Shingrix when the time the first vaccination was greater than 6 months. This was not for specific patient, this was for all of my patients greater than age 50 who had a first dose greater than 6 months ago and come across several lately, at least 6 or 8 people. Till the time of reporting, the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination. More
2854993 F MD 08/21/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 NG9E2
Expired product administered Expired product administered
A female patient received an expired dose of Menveo; This non-serious case was reported by a other h... A female patient received an expired dose of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number NG9E2, expiry date 30-JUN-2025) for prophylaxis. On 14-AUG-2025, the patient received Menveo. On 14-AUG-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: A female patient received an expired dose of Menveo). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 14-AUG-2025 The reporter reported that the administration of an expired dose of Menveo (1 vial) to a 16 year old female patient. The vaccine expired on 30th June 2025, it was administered on 14th August 2025 which led to expired vaccine used. The reporter asked did the patient need to be revaccinated. More
2854994 08/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
had shingles/got them on the bottom of my feet/diagnosed with shingles; This non-serious case was re... had shingles/got them on the bottom of my feet/diagnosed 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 Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had shingles/got them on the bottom of my feet/diagnosed with 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: 03-AUG-2025 and 06-AUG-2025 This case was reported by a patient via interactive digital media. The patient talked to his/her doctor about it and he talked he/she into the Shingles vaccine. Two days later the patient had shingles. The patient got them (shingles) on the bottom of his/her feet. The patient went back and was told that it was impossible and showed them and was diagnosed with shingles. The patient has not came back and never got another vaccine. More
2854995 08/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Rash, Rash pruritic Rash, Rash pruritic
still very itchy bumps on the crease of my leg and lower stomach; This non-serious case was reported... still very itchy bumps on the crease of my leg and lower stomach; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced itchy rash (Verbatim: still very itchy bumps on the crease of my leg and lower stomach). The outcome of the itchy rash was not resolved. It was unknown if the reporter considered the itchy rash to be related to Herpes Zoster vaccine. It was unknown if the company considered the itchy rash to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 05-AUG-2025 This case was reported by a patient via interactive digital media. The patient enquired how long it takes for the bumps to scab over and mentioned that theirs were still just very itchy bumps on the crease of their leg and lower stomach. More
2854996 M 08/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 14-AUG-2025 This case was reported by the patient's relative via interactive digital media. The patient got the shot and get shingles anyway. The reporter stated that this happened to both brothers-in-law (patient) and sister-in-law. 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. This case is linked with US2025AMR105311, reported by same reporter.; 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 is an unlisted event which is considered unrelated to GSK Shingles vaccine US-GSK-US2025AMR105311:same reporter More
2854997 3 F OH 08/21/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Inappropriate schedule of product administration, Product administered to patien... Inappropriate schedule of product administration, Product administered to patient of inappropriate age More
patient's 2nd dose of DTaP and 2nd dose of IPV; 3-year-old child received Kinrix; This non-seri... patient's 2nd dose of DTaP and 2nd dose of IPV; 3-year-old child received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis. On 15-MAY-2025, the patient received the 1st dose of Kinrix. On 15-MAY-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: patient's 2nd dose of DTaP and 2nd dose of IPV) and inappropriate age at vaccine administration (Verbatim: 3-year-old child received Kinrix). The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JUL-2025 and 25-JUL-2025 Nurse called to report the administration of a shot of Kinrix and mentioned that she was aware that the vaccine is indicated for ages 4 to 6 years and wanted to know if a new vaccine is needed or if this dose. Upon callback, HCP stated that Kinrix was the patient's 2nd dose of DTaP and 2nd dose of IPV and that Prior to the administration of Kinrix vaccine, patient received Vaxelis (Dtap-ipv-hep b). More
2854998 16 F PA 08/21/2025 MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 343DD
LN75D
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Extra Dose Administered; Extra Dose Administered; This non-serious case was reported by a other heal... Extra Dose Administered; Extra Dose Administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 343DD, expiry date 30-SEP-2025) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number LN75D) for prophylaxis. Previously administered products included Meningococcal vaccine A/C/Y/W (1st dose received on 23rd July 2021, batch number U6951AA). On 17-JUL-2025, the patient received the 3rd dose of Menveo. On 20-SEP-2024, the patient received the 2nd dose of Menveo. On 20-SEP-2024, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: Extra Dose Administered). On 17-JUL-2025, the patient experienced extra dose administered (Verbatim: Extra Dose Administered). The outcome of the extra dose administered and extra dose administered were not applicable. Additional Information: GSK Receipt Date: 25-JUL-2025 It was reported that a patient who received a third dose of Menveo which led to Extra dose administered. The reporter wanted to confirm if there was any other contraindication. HCP states she was unsure if it was Menactra. She only knew it was a meningococcal ACWY vaccine. More
2854999 38 M KY 08/21/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 95R7C
Expired product administered, Underdose Expired product administered, Underdose
38 year old received a pediatric dose; 38 year old received a pediatric dose; pediatric dose that ha... 38 year old received a pediatric dose; 38 year old received a pediatric dose; pediatric dose that had been administered had expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 38-year-old male patient who received HAV (Havrix pediatric) (batch number 95R7C, expiry date 05-MAY-2025) for prophylaxis. On 25-JUL-2025, the patient received Havrix pediatric. On 25-JUL-2025, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: 38 year old received a pediatric dose), adult use of a child product (Verbatim: 38 year old received a pediatric dose) and expired vaccine used (Verbatim: pediatric dose that had been administered had expired). The outcome of the underdose, adult use of a child product and expired vaccine used 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: 25-JUL-2025 A pharmacy technician called to inform that earlier that day, a patient received two doses of Havrix, he received a pediatric dose and he was fine, and then another adult dose in the other arm, batch number 2345B, expiry date 02nd February 2026. Reporter realized during the call that the pediatric dose that had been administered had expired back which led to expired vaccine used, adult use of a child product and underdose. No further details provided by reporter. More
2855000 M TX 08/21/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 742G5
Product preparation issue Product preparation issue
patient received only the diluent portion; patient received only the diluent portion; This non-serio... patient received only the diluent portion; patient received only the diluent portion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 9-month-old male patient who received Hib (Hiberix) (batch number 742G5, expiry date 26-AUG-2026) for prophylaxis. On 02-AUG-2025, the patient received Hiberix. On 02-AUG-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: patient received only the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 05-AUG-2025 The reporter mentioned that a patient received only the diluent portion of Hiberix. The reporter was aware that the diluent is sterile saline solution. The patient received only adjuvant of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2855001 F NH 08/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5Y4TL
Inappropriate schedule of product administration Inappropriate schedule of product administration
Shingrix is valid as a patient received the first dose in 2018 and the second one in April 2025; Thi... Shingrix is valid as a patient received the first dose in 2018 and the second one in April 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 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 5Y4TL, expiry date 31-JAN-2027) for an unknown indication. Previously administered products included Shingrix (patient had 1st dose in 2018, with expiry 13 March 2019 and batch number G45LN.). On 30-APR-2025, the patient received the 2nd dose of Shingrix. On 30-APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix is valid as a patient received the first dose in 2018 and the second one in April 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 06-AUG-2025 Other HCP reported that a patient received the first dose in 2018 and the second one in April 2025, which led to drug dose administration interval too long. The patients was 73 years of age at the time of reporting, female. More
2855002 IA 08/21/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered at inappropriate site Product administered at inappropriate site
a patient was given Boostrix into the gluteal muscle on Friday; This non-serious case was reported b... a patient was given Boostrix into the gluteal muscle on Friday; This non-serious case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 08-AUG-2025, the patient received Boostrix (unknown gluteal). On 08-AUG-2025, an unknown time after receiving Boostrix, the patient experienced vaccine administered at inappropriate site (Verbatim: a patient was given Boostrix into the gluteal muscle on Friday). The outcome of the vaccine administered at inappropriate site was not applicable. Additional Information: GSK Receipt Date: 11-AUG-2025 Nurse reported that a patient was given Boostrix into the gluteal muscle on Friday which led to vaccine administered at inappropriate site. No patient or product details were available. The reporter did not have details regarding product so unsure of presentation. More
2855003 M CA 08/21/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect dose administered Incorrect dose administered
Maladministration of adult dose to a pediatric patient (potential First Dose); Maladministration of ... Maladministration of adult dose to a pediatric patient (potential First Dose); Maladministration of adult dose to a pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 2-year-old male patient who received HAV (Havrix adult) for prophylaxis. On 20-JUN-2025, the patient received the 1st dose of Havrix adult. On 20-JUN-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient (potential First Dose)) and overdose (Verbatim: Maladministration of adult dose to a pediatric patient). The outcome of the adult product administered to child and overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-AUG-2025 The registered nurse called to ask about safety concerns on five patients vaccination schedule with the maladministration of an adult dose of Havrix which led to adult product administered to child and overdose. They just noticed due to a billing review. The registered nurse called in behalf of another site where the incident happened. Vaccination dates and partial patient demographics were obtained in this call. No vaccine detail was obtained in this call. More
2855004 F NY 08/21/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
how to proceed with the dosing schedule; This non-serious case was reported by a pharmacist via call... how to proceed with the dosing schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (received 1st dose on 10-MAR-2025 with batch number T5D73 and lot expiry 10-APR-2027). On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, the patient had incomplete course of vaccination (Verbatim: how to proceed with the dosing schedule). 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: 19-AUG-2025 The pharmacist reported that the patient received the Engerix-B vaccine on 10-MAR-2025, that was her 1st an only dose, so the reporter to find out how to proceed with the dosing schedule. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Engerix B vaccine, which led to incomplete course of vaccination. More
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