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
2852733 M IN 08/05/2025 FLUX
 UNKNOWN MANUFACTURER
Pruritus, Urticaria Pruritus, Urticaria
Reported Symptoms: 10037087:PRURITUS; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTIC... Reported Symptoms: 10037087:PRURITUS; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA More
2852734 F OK 08/05/2025 FLU3
 SANOFI PASTEUR
 UT8470BA
Arthralgia Arthralgia
Reported Symptoms: 10003239:ARTHRALGIA; 10023222:JOINT PAIN; Narrative: Other Relevant HX: Other: JO... Reported Symptoms: 10003239:ARTHRALGIA; 10023222:JOINT PAIN; Narrative: Other Relevant HX: Other: JOINT PAIN More
2852735 72 F CA 08/05/2025 FLU3
 SANOFI PASTEUR
 UT8463CA
Anaphylactic reaction, Chest discomfort, Dysphagia, Dyspnoea, Wheezing Anaphylactic reaction, Chest discomfort, Dysphagia, Dyspnoea, Wheezing
Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: per provider note: 72-year-old female who states... Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: per provider note: 72-year-old female who states that at about 9:00 a.m. this morning she got a flu shot and shortly after started having difficulty swallowing. She denies tightness in the chest, shortness of breath or wheezing. She denies inability to handle her own secretions. She denies diffuse itch or rash. Patient presented to ED and was offered treatment with Benadryl IV, steroids but patient refused. Also offered epi, patient refused. Patient's sx improved without treatment while in ED. She had not no respiratory involvement at this time and I believe the difficulty swallowing is probably esophageal/GI. There was no signs of angioedema or airway inclusion. No stridor. The lungs are clear to auscultation all fields and she was moving air well. Other Relevant HX: Other: ANAPHYLAXIS More
2852736 F DC 08/05/2025 FLUX
 UNKNOWN MANUFACTURER
Contraindication to vaccination Contraindication to vaccination
Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: A 69yo female with PMH of Osteopenia, Environmen... Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: A 69yo female with PMH of Osteopenia, Environmental Allergies, Osteoarthritis, Breast Cancer, long term use of anticoagulant, Atrial Flutter, Cardiomyopathy, Colonic Polyp and Cerebrovascular Accident s/p Arrhythmia. On February 8, 2025, PCC/WHC attending physician reported the patient had a historical ADR of Influenza vaccine induced Anaphylaxis classified as severe and updated the patient's ADR/Allergy profile. PCC attending physician also added an addendum note regarding influenza vaccine contraindication as "severe reaction in previous dose/contraindicated" No other detailed information was provided regarding reaction treatment, the product, when and where it occurred, who administered the vaccine, vaccine manufacturer, Expiration date, lot number etc. Unable to find on patient immunization profile. Other Relevant HX: Other: ANAPHYLAXIS More
2852737 85 M MN 08/05/2025 FLUX
 UNKNOWN MANUFACTURER
Malaise, Myalgia Malaise, Myalgia
Reported Symptoms: 10025482:MALAISE; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narrative: Other Releva... Reported Symptoms: 10025482:MALAISE; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: MALAISE; MUSCLE PAIN More
2852779 1 M MO 08/05/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 X019102
Y004554
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AEs/PQC reported; vaccines administered after temperature excursions.; This spontaneou... No additional AEs/PQC reported; vaccines administered after temperature excursions.; This spontaneous report was received from an other health professional and refers to unknown number of patients of unknown age and gender. The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported. On unknown dates, the patients started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X019102, expiration date: 16-Jul-2025) for the treatment of Prophylaxis. On unknown dates, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y013066, expiration date: 29-Jul-2026) for the treatment of Prophylaxis. On unknown dates, the patients started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y004554, expiration date: 20-Feb-2026) for the treatment of Prophylaxis. On unknown dates, the patients started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017514, expiration date: 19-Apr-2026) for the treatment of Prophylaxis. On unknown dates, the patients started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y019171, expiration date: 18-May-2026) for the treatment of Prophylaxis. On unknown dates, the patients started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y013582, expiration date: 03-Feb-2026) for the treatment of Prophylaxis. These vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported). On an unknown date, the patient experienced vaccines administered after temperature excursions. There was also previous temperature excursion. No other information provided. No additional AEs/PQC reported. At the reporting time, the outcome of the events was unknown. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. Varicella Virus Vaccine Live (Oka-Merck). Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and sterile diluent was reported as not applicable. Follow up was received from a nurse on 31-JUL-2025, regarding a 1-year-old male patient. On 29-MAR-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml injection (lot #X019102, expiration date: 16-Jul-2025) Intramuscularly via Left Thigh and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 0.5 ml injection (lot #Y004554, expiration date: 20-Feb-2026) Subcutaneously via Right Thigh for Prophylaxis with sterile diluent (MERCK STERILE DILUENT) (Product storage error). Temperature excursion occurred a result of a reading from a Digital Data Logger and both vaccines were given prior to known excursion. The patient did not receive Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). This is an invalid report due to provided identifiers (previously invalid case). The is one of several reports from the same reporter. More
2852780 F SC 08/05/2025 HEPAB
PNC21
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 M4834
Y019158
7KD58
Blood pressure decreased, Death, Palpitations; Blood pressure decreased, Death, ... Blood pressure decreased, Death, Palpitations; Blood pressure decreased, Death, Palpitations; Blood pressure decreased, Death, Palpitations More
BLOOD PRESSURE DECREASED; PALPITATIONS; Information has been received from a health authority (agenc... BLOOD PRESSURE DECREASED; PALPITATIONS; Information has been received from a health authority (agency # 2836036-1). This spontaneous report refers to a(n) 51-year-old female patient. The patient's medical history included Past Stroke and blood pressure control with triptans. The patient's concurrent conditions included Blood pressure control. Concomitant medications included Trazodone hydrochloride, Pantoprazole, Oxybutynin, Ropinirole, Famotidine, Meloxicam, Atorvastatin. On 26-MAR-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXVIVE) Injection, lot #Y019158, expiration date was not reported but upon internal validation was established as 20-MAY-2026, administered by Intramuscular route; Hepatitis a vaccine inact;Hepatitis b vaccine rHBsAg (yeast) (TWINRIX), lot #M4834, administered by Intramuscular route (expiration date was not reported); along with Diphtheria vaccine toxoid (+) Pertussis vaccine acellular 3-component (+) Tetanus vaccine toxoid (BOOSTRIX); all vaccines were administered for prophylaxis. On the same date, soon after vaccination but already at home, the patient experienced blood pressure went down and the hear stater racing (palpitations). On 09-APR-2025, the patient died due to the events. It was unknown whether an autopsy was performed. The causal relationship between the events of and the suspect vaccines were not reported. Executive summary received on 29-JUL-2025. Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of V116 0.5ML 1DOSE SYR Batch number 0001791496 material number 2017970 at MSD which could have impacted on product quality. No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch. Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product. Due to the nature of this AE-QIR, a drug substance (DS) review was performed by DS manufacturing site MSD. The investigation did not highlight any issues which would compromise the quality, safety, potency or efficacy of any of these Drug Substance batches. The investigation concluded that the Drug Substance batches conform to all release specifications. There have been no additional requests for information or additional testing relating to this Adverse Event.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-06-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2836036 , Central date : 2025-06-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :; Reported Cause(s) of Death: BLOOD PRESSURE DECREASED; PALPITATIONS More
โœ“
2852781 0.33 M OR 08/05/2025 RV5
 MERCK & CO. INC.
 X028882
Expired product administered, No adverse event Expired product administered, No adverse event
No symptoms reported; "ROTATEQ VIAL 2" dose frequency ".5 ml"; an expired dose o... No symptoms reported; "ROTATEQ VIAL 2" dose frequency ".5 ml"; an expired dose of ROTATEQ was administered to a patient on 7/7/2025. HCP reported that ROTATEQ expired 7/4//2025 (X028882 7/4/2025); This spontaneous report was received from a nurse and refers to a 4 month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-JUL-2025, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) solution, lot #X028882, expiration date: 04-Jul-2025, at a dose of ".5 ml" (suspect vaccine provided also as "ROTATEQ VIAL 2 frequency .5") administered for prophylaxis (inappropriate dose of vaccine administered, expired product administered). Potency of the dose was supported by the Post Expiry Memo. No symptoms reported at the time of the call (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-07-18 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2308432 , Central date : 2025-07-18 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number : More
2852782 FL 08/05/2025 VARCEL
 MERCK & CO. INC.
 Z004455
No adverse event, Product storage error No adverse event, Product storage error
No additional AE/no PQC reported; VARIVAX involved in temperature excursion has been administered; T... No additional AE/no PQC reported; VARIVAX involved in temperature excursion has been administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-Jul-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) (lot #Z004455, expiration date: 13-Feb-2027) 1 dosage form (1 dose), administered by unknown route as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). The vaccine was administered after being involved in the temperature excursion (Product storage error). No additional adverse events. At the reporting time, the outcome of the events was unknown. The action taken with the suspect vaccine was not reported but established as not applicable. More
2852783 M FL 08/05/2025 HPV9
 MERCK & CO. INC.
 W007026
Incomplete course of vaccination Incomplete course of vaccination
This pharmacist reported that a 40 year old male patient received his first dose of Gardasil on 23-F... This pharmacist reported that a 40 year old male patient received his first dose of Gardasil on 23-Feb-2024. His next doses were to be administered at 2 and 6 months but he did not get them. The pharmacist wondered if he has to restart his series.; This spontaneous report was received from a Pharmacist and refers to a 40-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 23-Feb-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, units and route of administration were not reported) lot #W007026, which was confirmed to be valid and the expiration date was verified to be 12-Apr-2024, for prophylaxis. It was reported that the patient's next doses were to be administered at 2 and 6 months but he did not get them. The pharmacist wondered if he had to restart his series (Inappropriate schedule of product administration). More
2852784 TX 08/05/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 W014513
Unknown
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
Pharmacist reported that a patient received first dose (w014513 exp 1/26/2025) of GARDASIL 9 on 7/1... Pharmacist reported that a patient received first dose (w014513 exp 1/26/2025) of GARDASIL 9 on 7/18/2024 and the second dose (z018414 exp 12/11/2025) on 7/15/2025. No additional AEs were reported, no further information provided. No PQC.; no additional adverse event; Information has been received from Business Partner/CRO on 15-Jul-2025. This spontaneous report was received from a pharmacist 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 18-Jul-2024, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), (lot #W014513, expiration date: 26-Jan-2025), dose number 1, for an unknown indication. On 15-Jul-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), (lot #Unknown), dose number 2, (indication and expiration date were not reported) (Inappropriate schedule of vaccine administered). No additional adverse event was reported. More
2852785 33 F CA 08/05/2025 HPV9
 MERCK & CO. INC.
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
No additional AE; a missed dose of GARDASIL 9; This spontaneous report was received from a Consumer ... No additional AE; a missed dose of GARDASIL 9; This spontaneous report was received from a Consumer o and refers to a 33-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 01-Oct-2024, the patient received the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) (strength, formulation, dose, route, lot # and expiration date were not reported) for prophylaxis. The patient missed following doses (Inappropriate schedule of product administration). No adverse event was reported. More
2852786 1 M OH 08/05/2025 MMR
 MERCK & CO. INC.
Diarrhoea, Measles post vaccine, Pyrexia, Rash Diarrhoea, Measles post vaccine, Pyrexia, Rash
Measles; diarrhea; This spontaneous report was received from a consumer and referred to a 1-year-old... Measles; diarrhea; This spontaneous report was received from a consumer and referred to a 1-year-old male patient. The patient's pertinent medical history included Asthma. The patient's concurrent conditions, drug reactions/allergies were not reported. Concomitant therapies were not reported. On 05-MAY-2025, the patient was vaccinated with dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (dose, strength, formulation, dose number, route, anatomical site, expiration date and lot # were not reported) for routine vaccination, which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (indication, expiration date, and lot # were not reported). On approximately 15-MAY-2025 (reported as approximately 10 days later), the patient broke out in a rash, had a high fever, and diarrhea. The patient was seen by the pediatrician who diagnosed him with measles. The patient was treated with steroids, antibiotics, naproxen (MOTRIN), and ointments and it eventually started clearing up. However, on 25-JUL-2025, the patient started to break out again in a full body rash and developed a high fever. The patient was currently being monitored outpatient by the pediatrician. Treatment did not change, and the symptoms were currently treated with unspecified steroids, antibiotics, ointments, and naproxen (MOTRIN). The outcome of the events measles and diarrhea was reported as not resolved. The causality between the events and the suspect products was not provided. More
2852787 16 F NY 08/05/2025 HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.

Incomplete course of vaccination, Maternal exposure before pregnancy; Incomplete... Incomplete course of vaccination, Maternal exposure before pregnancy; Incomplete course of vaccination, Maternal exposure before pregnancy More
HCP called regarding alternate dosing schedule for GARDASIL 9. See Request case 0284855. Caller re... HCP called regarding alternate dosing schedule for GARDASIL 9. See Request case 0284855. Caller reported a missed dose AE for GARDASIL 9. Caller stated a female patient received 2 doses of GARDASIL "18 years ago" and then became pregnant and misse; Caller stated a female patient received 2 doses of GARDASIL "18 years ago" and then became pregnant and missed the 3rd dose.; No additional AE; This spontaneous prospective pregnancy report was received from a pharmacist regarding a currently 34-year-old female patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, concomitant therapies were not reported, and obstetric history was not reported. On unspecified dates in 2006 (reported as 18 years ago), the patient was vaccinated with the first and second doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (conflicting information also reported as Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9]), suspension for injection, as prophylaxis (volume of injection, lot numbers, and expiration dates were not reported). On another unspecified date (reported as then), the patient became pregnant (last date of menstrual period, date of conception, among other information regarding this pregnancy was not provided) (Vaccine exposure before pregnancy). Therefore, she missed the third dose (Inappropriate schedule of vaccine administered). For this reason, she was advised to restart the series and received a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), suspension for injection 0.5mL, as prophylaxis in unspecified dates in December 2024 and February 2025 (lot numbers and expiry dates were not reported). At the time of this report the pregnancy and fetal outcome had not been reported. Lot # is being requested and will be submitted if received. More
2852788 F PA 08/05/2025 PNC21
 MERCK & CO. INC.
Injection site swelling Injection site swelling
two patients who received CAPVAXIVE and experienced "swelling at the injection site"; This... two patients who received CAPVAXIVE and experienced "swelling at the injection site"; This spontaneous report was received from a field-based employee (FBE) and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date (reported as "recently"), the patient experienced swelling at the injection site. The FBE stated that the physician originally reported it as "cellulitis" but then corrected herself and said "swelling" shortly after. No additional clarification was known by FBE. No additional information was known at that time. At the reporting time, the outcome of swelling at the injection site was not provided. The action taken with the suspect vaccine was assessed as not applicable. The causal relationship between swelling at the injection site and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) was not provided. Lot # is being requested and will be submitted if received. This is 1 of the 2 reports received from the same reporter (cross-reference with case #2316283).; Reporter's Comments: More
2852789 F PA 08/05/2025 PNC21
 MERCK & CO. INC.
Injection site swelling Injection site swelling
two patients who received CAPVAXIVE and experienced "swelling at the injection site"; This... two patients who received CAPVAXIVE and experienced "swelling at the injection site"; This spontaneous report was received from a field-based employee (FBE) and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date (reported as "recently"), the patient experienced swelling at the injection site. The FBE stated that the physician originally reported it as "cellulitis" but then corrected herself and said "swelling" shortly after. No additional clarification was known by FBE. No additional information was known at that time. At the reporting time, the outcome of swelling at the injection site was not provided. The action taken with the suspect vaccine was assessed as not applicable. The causal relationship between swelling at the injection site and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) was not provided. Lot # is being requested and will be submitted if received. This is 1 of the 2 reports received from the same reporter (cross-reference with case #2316262).; Reporter's Comments: More
2852790 F MO 08/05/2025 MMRV
 MERCK & CO. INC.
 X019102
No adverse event, Product storage error No adverse event, Product storage error
No additional adverse event; Vaccine involved in temperature excursion; This spontaneous report was ... No additional adverse event; Vaccine involved in temperature excursion; This spontaneous report was received from a nurse and refers to a 10-months-old female patient. The patient's medical history, concomitant therapies and current conditions was not reported. On 17-MAR-2025, the patient was vaccinated with an improper storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X019102, who had been verified to be a valid lot number, expiration date reported and validated as 16-JUL-2025) 0.5 mL administered by Subcutaneous route in Left Thigh as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). It was reported that the vaccine experienced temperature excursion of freezer. As determined by manufacturer- vaccine not supported for use-vaccine was given prior to known excursion (product storage error). Also, was storage in clinical practice. The vaccine was no available for return since was discarded after use. In addition, the vaccine was used according to instruction leaflet by health care professional. This event was already reported to doctor, heath department and manufacturer. The patient was vaccinated at private doctor's office with private funds. No additional adverse event reported. This is one of several reports received from the same reporter. More
2852791 08/05/2025 FLUX
VARZOS
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Erythema; Erythema Erythema; Erythema
Angry Red Shoulder; This non-serious case was reported by a pharmacist via sales rep and described t... Angry Red Shoulder; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of localized erythema in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patients received Shingrix (unknown arm) and Flu vaccine. On an unknown date, an unknown time after receiving Shingrix and Flu vaccine, the patients experienced localized erythema (Verbatim: Angry Red Shoulder). The outcome of the localized erythema was resolved. The reporter considered the localized erythema to be related to Shingrix. It was unknown if the reporter considered the localized erythema to be related to Flu vaccine. The company considered the localized erythema to be related to Shingrix. It was unknown if the company considered the localized erythema to be related to Flu vaccine. Additional Information: GSK Receipt Date: 18-JUL-2025 A Population Health Pharmacist at a top 200 healthcare system wanted to know if certain patients had a genetic predisposition to experience more severe local reactions with Shingrix. She shared that some patients experienced an angry red shoulder, while others could barely tell where the vaccination had been given. She had seen the same thing when patients received an adjuvanted flu vaccine. When asked about the age of the patients in whom she had noticed this difference more often, she shared that it was usually not the elderly, but patients in their 40s and 50s. More
2852792 51 F MO 08/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Blister, Injection site rash, Pruritus Blister, Injection site rash, Pruritus
Blisters; Itch; bulls eye rash around the injection site; This non-serious case was reported by a co... Blisters; Itch; bulls eye rash around the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 16-JUL-2025, the patient received Shingrix (right deltoid). In JUL-2025, less than a week after receiving Shingrix, the patient experienced injection site rash (Verbatim: bulls eye rash around the injection site) and pruritus (Verbatim: Itch). On 18-JUL-2025, the patient experienced blister (Verbatim: Blisters). The patient was treated with hydrocortisone. The outcome of the injection site rash, blister and pruritus were not resolved. It was unknown if the reporter considered the injection site rash, blister and pruritus to be related to Shingrix. It was unknown if the company considered the injection site rash, blister and pruritus to be related to Shingrix. Additional Information: GSK receipt date: 21-JUL-2025 The reporter was the patient. The patient received the first dose of Shingrix on Wednesday, 16 July 2025. The patient experienced a bulls eye rash around the injection site. This was a flat rash which has almost fully resolved. The patient treated this rash with Hydrocortisone cream. On Friday, 18 July 2025, the patient noticed a couple of blisters, which she thought was an insect bite, but it continued to worsen over the weekend. The blistering rash contains tiny blisters and they itch. Her arm, neck and upper chest are affected. More
2852793 M MN 08/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Paraesthesia, Skin lesion, Vaccination failure; Herpes zoster, Pa... Herpes zoster, Paraesthesia, Skin lesion, Vaccination failure; Herpes zoster, Paraesthesia, Skin lesion, Vaccination failure More
mild shingles outbreak two months ago; suspected vaccination failure/Lack of drug effect; This serio... mild shingles outbreak two months ago; suspected vaccination failure/Lack of drug effect; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included polymyalgia rheumatica (experienced 20 years ago, treated with one round of Prednisone and it resolved.). Previously administered products included Prednisone (polymyalgia rheumatica treated with one round of Prednisone). Concurrent medical conditions included hypercholesterolemia and atrial fibrillation. Concomitant products included lovastatin and apixaban (Eliquis). On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid) and the 1st dose of Shingrix (intramuscular, unknown deltoid). In MAY-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/Lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: mild shingles outbreak two months ago). In MAY-2025, the outcome of the shingles was resolved. The outcome of the vaccination failure was not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 23-JUL-2025 The patient reported that he had received both doses of Shingrix about 10 years ago, stating it had been confirmed to be "the new vaccine." He experienced a mild shingles outbreak two months prior. He had only a few lesions on his right back and side, accompanied by tingling on the right side and right front of his trunk. This was treated and resolved quickly. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2852794 F MD 08/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Burning sensation, Erythema, Fatigue, Pyrexia Burning sensation, Erythema, Fatigue, Pyrexia
burning on her neck; she developed redness on her neck; she experienced fatigue and a low grad fever... burning on her neck; she developed redness on her neck; she experienced fatigue and a low grad fever; she experienced fatigue and a low grad fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 18-JUL-2025, the patient received the 1st dose of Shingrix (left arm). On 18-JUL-2025, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: she experienced fatigue and a low grad fever) and fatigue (Verbatim: she experienced fatigue and a low grad fever). On 25-JUL-2025, the patient experienced burning sensation (Verbatim: burning on her neck) and red neck (Verbatim: she developed redness on her neck). The outcome of the burning sensation and red neck were not resolved and the outcome of the fever and fatigue were resolved. It was unknown if the reporter considered the burning sensation, red neck, fever and fatigue to be related to Shingrix. It was unknown if the company considered the burning sensation, red neck, fever and fatigue to be related to Shingrix. Additional Information: GSK Receipt Date: 25-JUL-2025 The reporter was the patient who received her first dose of Shingrix in her left arm last Friday. The day of the administration she experienced fatigue and a low grad fever. One week later she developed redness and burning on her necks. The reporter stated the redness and burning sensation starts on the left neck and goes all over toward the back. More
2852795 F 08/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain, Pain in extremity, Sleep disorder Injection site pain, Pain in extremity, Sleep disorder
arm has been hurting for almost a year; Pain at injection location; This non-serious case was report... arm has been hurting for almost a year; Pain at injection location; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included anxiety, depression, blood pressure high, thyroid disorder, allergy and weight. Concomitant products included bupropion hydrochloride (Bupropion), atorvastatin calcium propylene glycol solvate (Atorvastatin), escitalopram oxalate (Escitalopram), hydralazine hydrochloride (Hydralazine), levothyroxine sodium (Levothyroxine), cetirizine hydrochloride (Cetrizine) and semaglutide. On 14-AUG-2024, the patient received Shingrix. On 17-AUG-2024, 3 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection location). On an unknown date, the patient experienced pain in arm (Verbatim: arm has been hurting for almost a year). The outcome of the injection site pain and pain in arm were not resolved. It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix. It was unknown if the company considered the injection site pain and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 26-JUL-2025 The patient reported that her arm has been hurting for almost a year, more painful when it reaches above her head for a box and at times it almost drops on lifting. It also hurts during the night if the patient lays on the left side. The patient had a constant uncomfortable pain, but more painful in the events stated above. The patient reported that the symptoms was treated. More
2852796 90 M MI 08/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Rash, Vaccination failure; Herpes zoster, Rash, Vaccination failu... Herpes zoster, Rash, Vaccination failure; Herpes zoster, Rash, Vaccination failure More
suspected vaccination failure; Shingles; This serious case was reported by a consumer via call cente... suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 93-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 09-AUG-2022, the patient received the 2nd dose of Shingrix. On 12-MAR-2022, the patient received the 1st dose of Shingrix. On 21-JUL-2025, 1077 days after receiving Shingrix and 1227 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with mupirocin (Bactroban). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 30-JUL-2025 The patient received first and second dose of Shingrix and a week ago (Monday from reporting date), the patient developed shingles. The rash was on his left side near his hip and on his left side center back. His doctor prescribed an antiviral and Bactroban (mupirocin) ointment 2 percent. 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2852797 08/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
Sick; This non-serious case was reported by a consumer via interactive digital media and described t... 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 (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a consumer via interactive digital media. The patient had the shots got really sick off of the second one.; Sender's Comments: US-GSK-US2025AMR088828:same reporter different patient More
2852798 39 SC 08/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster, Product administered to patient of inappropriate age, Vaccination... Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure More
had two outbreaks of shingles since then and one in July; Suspected vaccination failure; had two out... had two outbreaks of shingles since then and one in July; Suspected vaccination failure; had two outbreaks of shingles since then One in March; 39 years patient received Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 39-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included renal disease. In DEC-2024, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 years patient received Shingrix). In MAR-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two outbreaks of shingles since then One in March). In JUL-2025, the patient experienced shingles (Verbatim: had two outbreaks of shingles since then and one in July). The outcome of the vaccination failure, shingles and shingles were not reported and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JUL-2025 The patient received the Shingrix vaccine in December and had two outbreaks of shingles since then which was one in March and one in July. The patient was very disappointed. The patient thought it was supposed to prevent future outbreaks and had to go on medication for them and was not supposed to take it because of his/her kidney disease. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration. 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2852799 08/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Hypersensitivity Hypersensitivity
I'm allergic; This non-serious case was reported by a consumer via interactive digital media an... I'm allergic; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy 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 allergy (Verbatim: I'm allergic). The outcome of the allergy was not reported. It was unknown if the reporter considered the allergy to be related to Shingrix. It was unknown if the company considered the allergy to be related to Shingrix. Additional Information: GSK Receipt Date: 22-JUL-2025 This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine and had allergy. More
2852800 08/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Swelling Swelling
taken me off that med because of swelling side effect.; This non-serious case was reported by a con... taken me off that med because of swelling side effect.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling 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 swelling (Verbatim: taken me off that med because of swelling side effect.). The outcome of the swelling was not reported. It was unknown if the reporter considered the swelling to be related to Shingles vaccine. It was unknown if the company considered the swelling to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-JUL-2025 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine and took medicine due to the swelling side effects. More
2852801 08/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Nerve injury, Neuralgia Nerve injury, Neuralgia
still have pain from nerve damage; still have pain from nerve damage; This non-serious case was repo... still have pain from nerve damage; still have pain from nerve damage; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: still have pain from nerve damage) and nerve damage (Verbatim: still have pain from nerve damage). The patient was treated with gabapentin. The outcome of the nerve pain and nerve damage were not resolved. It was unknown if the reporter considered the nerve pain and nerve damage to be related to Shingles vaccine. It was unknown if the company considered the nerve pain and nerve damage to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles shots and still have pain from nerve damage and was very painful even though the patient took gabapentin. More
2852802 08/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Sunburn, Vaccination failure Herpes zoster, Sunburn, Vaccination failure
suspected vaccination failure; I had the vaccine and still got them after a bad sunburn; This seriou... suspected vaccination failure; I had the vaccine and still got them after a bad sunburn; 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 the vaccine and still got them after a bad sunburn). 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: 29-JUL-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had the vaccine and still got them after a bad sunburn luckily there was no pain with it as physician said the vaccine saved him/her. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2852803 08/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I got the shot and still got shingles; This serious case was reported... Suspected vaccination failure; I got the shot and still got 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: I got the shot and still got 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: 29-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the shot and still got shingles. The shot did lessen the symptoms of shingles, but it still wasn't fun. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2852804 08/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; I got my shingles shot and still got the shingles; This serious case ... Suspected vaccination failure; I got my shingles shot and still got 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. In JUN-2025, 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 got my shingles shot and still got the shingles). The patient was treated with malus spp. vinegar extract (Apple Cider Vinegar). 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: 28-JUL-2025 This case was reported by a patient via interactive digital media. The patient got shingles about a month ago (from the date of reporting) and was still in pain. The patient used apple cider vinegar which did help and also said that put ice packs if you could take it. The patient mentioned that he/she got his/her Shingles shot and still got the shingles. 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 Shingles vaccine. More
2852805 08/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure
Suspected vaccination failure; Several of my friends got the shot and got shingles then later on got... Suspected vaccination failure; Several of my friends got the shot and got shingles then later on got the shingles again; 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 patients 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: Several of my friends got the shot and got shingles then later on got the shingles again). 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: 29-JUL-2025 This case was reported by a patient via interactive digital media. The reporter stated shingles was the horrible things to have and he/she got them last of January which ended in the last of May. The reporter had never felt anything so painful, burning and itching. The reporter stated, on TV it was said that it can last for weeks but do not say how many weeks. The shingles just took the life almost out of him/her. Further, he/she has heard about the shots they have for shingles. The reporter did not have the shot of Shingles vaccine and pray no one get those shingles they were awful. The reporter stated that several of their friends got the shot and got shingles then later on got the shingles again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2852806 67 F CA 08/05/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 957D4
Product preparation issue Product preparation issue
Only diluent administered.; Only diluent administered.; This non-serious case was reported by a phar... Only diluent administered.; Only diluent administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 957D4, expiry date 27-NOV-2026) for prophylaxis. On 22-JUL-2025, the patient received Arexvy. On 22-JUL-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered.) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 24-JUL-2025 The pharmacist reported that they did not mix it just gave the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Reporter mentioned it was administered on 22-JUL-2025. No further details provided. The vaccine administration facility was the same as primary reporter. More
2852807 0.17 M CA 08/05/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 D2343
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
patient received Menveo 1 vial rather than 2 vial dose yesterday; This non-serious case was reported... patient received Menveo 1 vial rather than 2 vial dose yesterday; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-week-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number D2343, expiry date 31-JAN-2026) for prophylaxis. On 24-JUL-2025, the patient received Menveo (right thigh). On 24-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: patient received Menveo 1 vial rather than 2 vial dose yesterday). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 25-JUL-2025 A registered nurse reported that a 2-month-old patient received Menveo 1 vial vaccine rather than 2 vial doses yesterday which led to inappropriate age at vaccine administration. More
2852808 F 08/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
first dose of Shingrix in 2023 and then a second dose was given in April 2025; This non-serious case... first dose of Shingrix in 2023 and then a second dose was given 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 female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (a patient received the first dose of Shingrix in 2023). In APR-2025, the patient received the 2nd dose of Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix in 2023 and then a second dose was given in April 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 25-JUL-2025 A pharmacist mentioned that a patient received the first dose of Shingrix in 2023 and then a second dose was given in April 2025, which led to drug dose administration interval too long. The healthcare professional (HCP) asked if the patient was 100 percent protected because today, the patient was at the clinic requesting a third dose. No further details were provided. The reporter was consented to follow up. More
2852809 16 M TX 08/05/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 E4A39
Expired product administered Expired product administered
patient received today (29-Jul-2025) a dose of the Menveo (1 vial) that expires on 30-Jun-2025; This... patient received today (29-Jul-2025) a dose of the Menveo (1 vial) that expires on 30-Jun-2025; 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 male patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39, expiry date 30-JUN-2025) for prophylaxis. On 29-JUL-2025, the patient received Menveo. On 29-JUL-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient received today (29-Jul-2025) a dose of the Menveo (1 vial) that expires on 30-Jun-2025). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 29-JUL-2025 The clinic coordinator reported that a patient received an expired dose of the Menveo (1 vial), which led to expired vaccine used The HCP asked for recommendations on this situation. More
2852810 73 M NC 08/05/2025 COVID19
 MODERNA
 3046734
Hypoaesthesia, Paraesthesia Hypoaesthesia, Paraesthesia
numbness and tingling in his fingers started this morning; numbness and tingling in his fingers star... numbness and tingling in his fingers started this morning; numbness and tingling in his fingers started this morning; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (numbness and tingling in his fingers started this morning) and PARAESTHESIA (numbness and tingling in his fingers started this morning) in a 73-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis. Concurrent medical conditions included Arthritis. Concomitant products included Cyclobenzaprine hydrochloride (Cyclobenzaprine), Duloxetine hydrochloride (Duloxetine), Tamsulosin hydrochloride (Tamsulosin), Tadalafil and Tadalafil (Cialis) for an unknown indication. On 31-Jul-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 01-Aug-2025, the patient experienced HYPOAESTHESIA (numbness and tingling in his fingers started this morning) and PARAESTHESIA (numbness and tingling in his fingers started this morning). At the time of the report, HYPOAESTHESIA (numbness and tingling in his fingers started this morning) and PARAESTHESIA (numbness and tingling in his fingers started this morning) had not resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. The HCP was not aware of any other vaccines administered 4 weeks prior to Spikevax. The patient received most of his vaccines and had some pain medications at the pharmacy. The HCP enquired about a side effect one of their patients experienced after receiving the COVID-19 vaccine the previous day. On the morning of 01-Aug-2025, a patient contacted the pharmacy to report experiencing numbness in their fingers following administration of the COVID-19 vaccine the previous day. The pharmacist spoke with the patient over the phone. The HCP believed the numbness and tingling in his fingers began that same morning and had not yet resolved. After conducting some research, the HCP was unable to find substantial information on this side effect and sought to learn whether similar cases had been reported. She was particularly interested in understanding the outcomes of those cases and whether there is a typical timeline for resolution. It was unknown if the patient experienced any additional symptoms or events. More
2852811 12 F MI 08/05/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9kb9g
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
There was no adverse reaction. A 12-year-old student was given Dtap vaccination instead of Tdap . There was no adverse reaction. A 12-year-old student was given Dtap vaccination instead of Tdap .
2852812 11 F MI 08/05/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 LT7c9
No adverse event, Wrong patient No adverse event, Wrong patient
No adverse effects noted. pt just rec' vaccine that was not meant for her but her sibiling No adverse effects noted. pt just rec' vaccine that was not meant for her but her sibiling
2852813 64 F FL 08/05/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 BG5J4
Extra dose administered, Pain in extremity Extra dose administered, Pain in extremity
Patient was administered Arexvy twice. Once in 2023 and now again in 2025. Patient had a little more... Patient was administered Arexvy twice. Once in 2023 and now again in 2025. Patient had a little more than usual arm pain. More
2852814 5 M OK 08/05/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 U8209CB
Z006282
Injection site abscess, Injection site erythema, Injection site induration, Inje... Injection site abscess, Injection site erythema, Injection site induration, Injection site warmth, Vomiting; Injection site abscess, Injection site erythema, Injection site induration, Injection site warmth, Vomiting More
Kinrix and Proquad were given on 8-1-25. Mother reported that child's left deltoid area became ... Kinrix and Proquad were given on 8-1-25. Mother reported that child's left deltoid area became red at site on the morning of 8-2-25 and then noticed the site became "rock hard" and "feverish" later in the evening of the same day. Reports child started vomiting on 8-3-25. Mother took child to Urgent Care on 8-3-25. Reports APRN-CNP there told her child had an "abcess" to left deltoid area. Mother denies arm having any drainage or visible puss pockets and denies the area being lanced. Child was prescribed Cephalexin 250 mg/5ml: to take 10ml BID x 10 days and Zofran 4mg: Take 1 every 6 hours x 4 days. More
2852815 74 M GA 08/05/2025 FLU3
 SANOFI PASTEUR
 u8764bb
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received Fluzone HD on 7/22/25 and again on 8/4/25. Patient reports no adverse events or sid... Patient received Fluzone HD on 7/22/25 and again on 8/4/25. Patient reports no adverse events or side effects. More
2852816 0.5 F MO 08/05/2025 DTAPHEPBIP
MNQ
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH


Vaccination error; Vaccination error; Vaccination error Vaccination error; Vaccination error; Vaccination error
MENQUAD GIVEN BY MISTAKE. PATIENT WAS NOT DUE FOR THIS VACCINE MENQUAD GIVEN BY MISTAKE. PATIENT WAS NOT DUE FOR THIS VACCINE
2852817 0.5 M MO 08/05/2025 DTAPHEPBIP
MNQ
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH


Vaccination error; Vaccination error; Vaccination error Vaccination error; Vaccination error; Vaccination error
PATIENT GIVEN MENINGOCOCCAL BY MISTAKE. NOT DUE TO VACCINE PATIENT GIVEN MENINGOCOCCAL BY MISTAKE. NOT DUE TO VACCINE
2852818 13 F FL 08/05/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 9JT4S
Electrocardiogram, Loss of consciousness, Posture abnormal, Syncope Electrocardiogram, Loss of consciousness, Posture abnormal, Syncope
A minute after the patient received the vaccination (3:01 PM EST), RN (vaccinator) saw the patient&#... A minute after the patient received the vaccination (3:01 PM EST), RN (vaccinator) saw the patient's head fall to her side. RN asked if she was okay. Nurse began to fan her and assisted her in inhaling and exhaling. The patient became conscious after a few seconds and started responding to nurses. The patient said she couldn't see, and the patient fainted again, while nurse was still fanning her. They proceeded to move the patient to the floor and decided to call 911. Now conscious again, nurse proceeded to fan and help the patient breathe. While on the floor, blood pressure was checked via pulse ox. After a couple of seconds, the patient started to feel better and asked not to be taken to the hospital. Father explained that this has happened in the past with other vaccinations. EMT arrived and nurse explained the situation, informed them of a possible vasovagal episode. EMT said they figured it was that and proceeded to recheck vitals and perform an EKG out of precaution. The patient's father and the patient declined transportation to the hospital. Nurse advised the patient's father to inform nurses if the patient has a history of fainting after vaccinations and to have the patient rest with legs elevated. The patient was also given a Coke. More
2852819 5 M 08/05/2025 TDAP
 SANOFI PASTEUR
 U8564AA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
None None
2852820 62 F IN 08/05/2025 PNC20
TDAP
 PFIZER\WYETH
SANOFI PASTEUR
 LN4932
u8264aa
Chills, Erythema, Pain in extremity, Peripheral swelling; Chills, Erythema, Pain... Chills, Erythema, Pain in extremity, Peripheral swelling; Chills, Erythema, Pain in extremity, Peripheral swelling More
Left arm swelling, pain, erythema. +chills. Left arm swelling, pain, erythema. +chills.
2852821 59 F TX 08/05/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UT8770KA
LN4932
Injection site erythema, Injection site mass, Injection site warmth, Peripheral ... Injection site erythema, Injection site mass, Injection site warmth, Peripheral swelling; Injection site erythema, Injection site mass, Injection site warmth, Peripheral swelling More
Patient describes waking up the next morning with a swollen arm, with two knots at the injection sit... Patient describes waking up the next morning with a swollen arm, with two knots at the injection site, the entire area red and hot to touch. She reports that the two knots when the injections were given disappeared the next day. This morning she contacted the pharmacy to report that her arm was still red from the shoulder to elbow and hot to touch. More
2852822 9 F TX 08/05/2025 COVID19
 PFIZER\BIONTECH
 LN6739
Wrong product administered Wrong product administered
Back to school event, 9 yr. old was given Pfizer (6 mths-4yrs) vaccine. Minor sent to post vaccinati... Back to school event, 9 yr. old was given Pfizer (6 mths-4yrs) vaccine. Minor sent to post vaccination observation and after 15 minutes monitoring minor was dismissed.Noticed the vial closely when entering vaccine information to database, wrong vaccine was given,notified clinic lead on site. More
2852824 14 F 08/05/2025 MMRV
 MERCK & CO. INC.
 Z007852
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
None None
๐Ÿ“‹ Privacy Policy & Data Disclaimer