🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2837519 48 F TX 04/23/2025 MMR
 MERCK & CO. INC.
Pruritus, Rash Pruritus, Rash
Rashes on arms & legs and itchiness started 2 days after vaccination, its been 3 wks and still... Rashes on arms & legs and itchiness started 2 days after vaccination, its been 3 wks and still have rashes & itchiness More
2837520 2 F CO 04/23/2025 VARCEL
 MERCK & CO. INC.
 X010536
Expired product administered Expired product administered
Patient came in for Well Child and was due for her Varivax. The Medical Assistant got the vaccine re... Patient came in for Well Child and was due for her Varivax. The Medical Assistant got the vaccine ready and had the second verifer check the vaccine. Both clinical staff signed off on the form. Medical Assistant noticed when she went to input vaccine into computer that the vaccine expired on 4/11/2025. This was a VFC vaccine and I will also report to them. Medical Assistant reached out to mom of patient and let her know what happened and notified the provider that patient was seeing that day. Medical Assistant did advise mom that patient will have to come back to get another Varivax, however there should be no negative effects of getting the expired vaccine. More
2837521 47 M TX 04/23/2025 COVID19
COVID19
 MODERNA
MODERNA
 Moderna
Moderna
Arthralgia, Asthenia, Blood test, COVID-19, Dyspnoea; Fatigue, Pulmonary pain Arthralgia, Asthenia, Blood test, COVID-19, Dyspnoea; Fatigue, Pulmonary pain
I experienced the usual side effects of the vaccine, which eventually subsided. However, several day... I experienced the usual side effects of the vaccine, which eventually subsided. However, several days after my initial reaction, I felt as if I had a severe case of COVID. My lungs burned, and breathing became difficult. I felt utterly drained, as if my body were aflame. My joints ached intensely. For two to three months after I began to improve, I needed to perform breathing treatments. I continued to feel fatigued for approximately six months. More
2837522 74 F FL 04/23/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 p2443
Dizziness, Gait disturbance, Nausea, Skin laceration, Vertigo Dizziness, Gait disturbance, Nausea, Skin laceration, Vertigo
Patient woke up at 4am this morning. She stood up from bed and had severe nausea & vertigo, stu... Patient woke up at 4am this morning. She stood up from bed and had severe nausea & vertigo, stumbling into a wall mirror. Mirror didn't break, but she received a minor cut from the edging. The high severity of the nausea and dizziness stayed from about 4 am until 8:30 am. She did not vomit. Between that time and reporting to this pharmacist (around noon today), patient states she is still having intermittent nausea and dizziness but at a quarter of the severity. I recommended meclizine over the counter to aid with the nausea and dizziness or reaching out to prescriber for a prescription anti-nausea med. Patient seemed content to rest the remainder of the day and take it easy. More
2837523 29 F MI 04/23/2025 RAB
TYP
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 FDP00530
X2A411M
Choking sensation, Dyspnoea; Choking sensation, Dyspnoea Choking sensation, Dyspnoea; Choking sensation, Dyspnoea
-Patient received vaccines for typhoid and rabies at 11:08am on 4/21/25; patient returned at 245pm o... -Patient received vaccines for typhoid and rabies at 11:08am on 4/21/25; patient returned at 245pm on 4/21/25 complaining of SOB: stating that she felt like she was breathing through a straw and someone was choking her; medications ordered by doctor and patient given: EpiPen 0.3mg, Cetirizine 10mg tab, and methylprednisolone acetate 40mg injection; patient's symptoms resolved within 90 minutes and back to baseline; patient discharged home with Rx for EpiPen 0.3mg and strict instructions to follow up with the ER if symptoms return; patient called by facility next day 4/22 to check on patient's status; and patient stated she is feeling better; facility scheduled appt for patient to return for in-person follow up at 330p, 4/23/25. More
2837524 77 M NH 04/23/2025 COVID19
 MODERNA
 3046714
Neck pain, Pain Neck pain, Pain
Patient felt like he had a "crick" in his neck the next morning with occasional shooting p... Patient felt like he had a "crick" in his neck the next morning with occasional shooting pain. More
2837525 4 F VA 04/23/2025 DTAPIPVHIB
DTAPIPVHIB
HEPA
HEPA
MMRV
MMRV
 SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 uk196aa
uk196aa
J4k4x
J4k4x
y09176
y09176
Cyanosis, Dyskinesia, Electrocardiogram normal, Fall, Pyrexia; Skin discolourati... Cyanosis, Dyskinesia, Electrocardiogram normal, Fall, Pyrexia; Skin discolouration, Skin warm, Somnolence; Cyanosis, Dyskinesia, Electrocardiogram normal, Fall, Pyrexia; Skin discolouration, Skin warm, Somnolence; Cyanosis, Dyskinesia, Electrocardiogram normal, Fall, Pyrexia; Skin discolouration, Skin warm, Somnolence More
Patient left the office after receiving her vaccines. Of note, she received 2 combination vaccines ... Patient left the office after receiving her vaccines. Of note, she received 2 combination vaccines but had received indidual components of the vaccine previously per her immunization record that was brought to the office. About an hour after receiving her vaccines, pt. was with mom at mom's doctor's appointment when pt. reportedly fell to the floor, and started having jerking movements. Mom stated that her face turned blue/purple and her lips turned black. Patient's vitals were obtained and she was taken to the ER via ambulance. Mom stated that the episode lasted about 1-2 minutes and by the time the ambulance arrived 20 minutes later she had returned to her baseline. Pt. was examined in the ER and an EKG was reportedly normal. Pt. was discharged home and mom states that she was sleepy and slept for about 2 hours. Pt. then woke up because she was hungry and ate. Mom noted at that time that pt. had a fever as she was hot to touch but she wanted a blanket on her. Patient followed up in the office on 04/23/2025 and was playing, eating and acting normal. More
2837612 51 M GA 04/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 M7G39
Heart rate increased, Loss of personal independence in daily activities Heart rate increased, Loss of personal independence in daily activities
Pt reports higher than normal heart rate when exercising. Usually experiences elevated heart rate w... Pt reports higher than normal heart rate when exercising. Usually experiences elevated heart rate when walking and when weight training. Last walking session, he experienced heart higher than normal elevation. For last weight training session, he also experienced a higher than normal heart rate. He skipped weight training today and will attempt tomorrow (4/24/25). More
2837613 51 M FL 04/23/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 L5229
L5229
Abdominal pain upper, Chills, Crying, Facial pain, Headache; Heart rate increase... Abdominal pain upper, Chills, Crying, Facial pain, Headache; Heart rate increased, Pain, Pain in jaw, Pyrexia More
Adverse Events: Fever of 101.1, Body aches, Chills, Headache, Jaw & Face pain, sharp stomach pai... Adverse Events: Fever of 101.1, Body aches, Chills, Headache, Jaw & Face pain, sharp stomach pain, high heart rate and involuntary crying. Treatment: 2 Advil, and 2 Tylenol about four to six hours apart. Outcomes: patient felt a bit better after Advil but is currently declining again. More
2837615 67 F FL 04/23/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 JB27A
Extra dose administered Extra dose administered
Patient put in for an appointment for RSV vaccine and came in and received vaccine, but later corpor... Patient put in for an appointment for RSV vaccine and came in and received vaccine, but later corporate office notified pharmacy that patient already received vaccine 12/7/2023. More
2837625 27 M CA 04/23/2025 HPV9
 MERCK & CO. INC.
Incomplete course of vaccination Incomplete course of vaccination
exposed to HPV following their first dose of GARDASIL 9; a patient who missed their second dose of ... exposed to HPV following their first dose of GARDASIL 9; a patient who missed their second dose of GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 27-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In October 2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (0.5ml/dose), administered by Intramuscular route (strength, lot # and expiration date were not reported) for prevention of human papillomavirus (HPV)-related disease. On an unknown date, the patient missed his second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Vaccine dose omission) and was exposed to HPV following his first dose of suspect vaccine. The reporter could not confirm if patient has contracted HPV following exposure. No symptoms reported. At the reporting time, the outcome of exposed to HPV was unknown. The action taken with suspect vaccine was not applicable (conflicting information: also reported as dose not changed). The causal relationship between the event of exposed to HPV and suspect vaccine was not provided. Lot# is being requested and will be submitted if received. More
2837626 MA 04/23/2025 VARCEL
 MERCK & CO. INC.
 Y011019
No adverse event, Product storage error No adverse event, Product storage error
No additional AE/PQC. No additional information; HCP called to report inadvertent administration of ... No additional AE/PQC. No additional information; HCP called to report inadvertent administration of VARIVAX after a temperature excursion. Vaccine was administered on 27FEB2025 to a patient.; This spontaneous report was received from a nurse (registered nurse [RN]) and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 27-Feb-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), injection (valid lot #Y011019, with provided and established expiration date: 18-Jun-2026) for prophylaxis (exact dose, dose number, anatomical location, and route of administration were not provided) reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: -12.13 Celsius degrees (C) for 0 hours 39 minutes 0 seconds (product storage error, onset date: 27-Feb-2025). Previous temperature excursion was reported as yes: -14.19 C for 9 minutes and -14.25 C for 16 minutes. There was no additional adverse event (AE) reported (no adverse event). More
2837627 04/23/2025 MMRV
 MERCK & CO. INC.
 Y011209
Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event, Underdose More
HCP called to report that during administration of PROQUAD the patient "moved". The HCP is... HCP called to report that during administration of PROQUAD the patient "moved". The HCP is unable to confirm if the patient received the full dose.; No additional adverse event; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL, lot #Y011209; which has been verified to be valid to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported and upon internal review establish as 18-DEC-2025, administered for prophylaxis and with sterile diluent (BAXTER STERILE DILUENT) (indication, expiration date, and lot # were not reported). It was reported that during the administration of the vaccine the patient moved so the nurse was unable to confirm if the patient received the full dose (Accidental underdose). No additional adverse event (No adverse event). More
2837629 1 GA 04/23/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y016874
Y015557
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AEs reported; PROQUAD and VARIVAX inadvertently administered at the same office visit... No additional AEs reported; PROQUAD and VARIVAX inadvertently administered at the same office visit.ion provided. No additional AEs or PQC reported.; This spontaneous report has been received from a nurse practitioner and refers to a 1-year-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided. On 13-MAR-2025, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, subcutaneously in left thigh, lot # Y015557, expiration date 16-SEP-2026 (dose number was not provided) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, 0.5 ml, subcutaneously in left thigh, lot # Y016874, expiration date 07-APR-2026 (dose number not provided), at the same office visit, for prophylaxis (Accidental overdose). Both vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date not provided). No symptoms and no additional adverse events were reported. More
2837630 M 04/23/2025 COVID19
MMR
MMR
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.


Fatigue; Fatigue; Fatigue Fatigue; Fatigue; Fatigue
Felt tired; This spontaneous report was received from a consumer and refers to a 66-year-old male pa... Felt tired; This spontaneous report was received from a consumer and refers to a 66-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. He also stated that he is unsure if he received the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) as a child. On 16-Mar-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection administered as prophylaxis by unknown route (lot # and expiration date were not reported) which was diluted with a sterile diluent, solution for injection administered by unknown route (expiration date and lot # were not reported) along with a Covid vaccine (unspecified) administered by unknown route (indication, expiration date, and lot # were not reported). On 16-Mar-2025 (also reported as after the vaccinations), the patient experienced felt tired. The patient recovered/resolved from the event on an unspecified day in March 2025. The causal relationship between the event and the suspect vaccines/sterile diluent was not provided. Lot # is being requested and will be submitted if received. More
2837631 GA 04/23/2025 HEP
HEP
HEP
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Hepatitis B surface antibody negative, Vaccination failure; Hepatitis B surface ... Hepatitis B surface antibody negative, Vaccination failure; Hepatitis B surface antibody negative, Vaccination failure; Hepatitis B surface antibody negative, Vaccination failure More
non-responder; This literature marketed report has been received from the authors of a published l... non-responder; This literature marketed report has been received from the authors of a published literature article concerning a patient of unknown age and gender with human immunodeficiency virus infection. Concomitant medications included cabotegravir;rilpivirine. On an unknown dates, the patient was vaccinated with 3 doses of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) at 0, 1 or 2, and 6 months administered intramuscularly for prophylaxis (dose, vaccination site, lot number and expiration date were not reported). On an unknown date, the patient's hepatitis B antibody surface was negative, it was considered that patient was a non-responder (vaccination failure). Subsequently, the patient was re-vaccinated. The outcome of the event was not provided. Per internal guidelines the event was determined to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). This case was classified as non-valid due to the lack of patient's identifiers. Lot # is being requested and will be submitted if received. More
2837632 16 M CA 04/23/2025 HPV9
 MERCK & CO. INC.
 X020725
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; TE for GARDASIL 9 that occurred on02/13/2025 and then was inadvertently administer... No additional AE; TE for GARDASIL 9 that occurred on02/13/2025 and then was inadvertently administered to apati ent on 02/19/2025.; This spontaneous report was received from a medical assistant and refers to a 16-year-old male patient. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported. On 19-FEB-2025, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9 SYRINGE (DEVICE)) (involved lot # was X020725, expiration date: 16-APR-2026 [verified to be valid]); 0.5 ml/once, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion was 1.2 C for 0 hours 30 minutes 0 seconds (On 13-FEB-2025). There was no previous temperature excursion nor report of adverse event or product quality complaint involved. More
2837633 NJ 04/23/2025 MMR
 MERCK & CO. INC.
 X022135
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported.; MMR II was administered after a temperature excursion.; This spontaneous... No additional AE reported.; MMR II was administered after a temperature excursion.; This spontaneous report was received from a medical assistant and refers to a(n) 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 17-Mar-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), once, lot #X022135, expiration date: 01-Jun-2025, administered for prophylaxis (strength, dose, route of administration and anatomical location were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The products were administered after a temperature excursion (Product storage error). The excursion temperature was 52.5 Fahrenheit with time frame of 1 hour. There was no previous temperature excursion. No additional adverse event (AE) was reported (No adverse event). This is one of four reports received from the same reporter. More
2837634 4 PA 04/23/2025 MMRV
 MERCK & CO. INC.
 Y006771
No adverse event, Product preparation error No adverse event, Product preparation error
no adverse event; Physician reported an AE for PROQUAD. The caller said a dose was reconstituted wit... no adverse event; Physician reported an AE for PROQUAD. The caller said a dose was reconstituted with normal saline and administered to a patient on 3/20/2025. Confirmed with caller no other AE occurred. Caller provided consent for follow up. No other AE. No PQC.; This spontaneous report was received from a physician and refers to a 4-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 20-MAR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y006771, expiration date: 24-Sep-2025) (1 dose), for prophylaxis. The reporter stated that a dose was reconstituted with normal saline (lot #HN2235, expiration date: 01-Oct-2025) and administered to the patient (product preparation error). The physician confirmed that no other adverse event occurred (no adverse event). More
2837635 F 04/23/2025 PNC21
 MERCK & CO. INC.
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
experienced diffuse redness around and below the injection site; the site was red and felt hot for a... experienced diffuse redness around and below the injection site; the site was red and felt hot for about 3 days; This spontaneous report was received from a consumer referring to a female patient, age was not provided. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On an unknown date, the patient was vaccinated with pneumococcal 21-valent conjugate (CAPVAXIVE) injection, administered intramuscularly as a dose of 0.5 ml for prophylaxis (anatomical location, lot number and expiration date were not reported). On an unknown date, reported as 1 day after vaccination, the patient experienced diffuse redness around and below the injection site (Redness), the site was red and felt hot (Vaccination site warmth) for about 3 days and then subsided without intervention or medication. At the time of the reporting, the outcome of the event was recovered. The causal relationship between the events and the suspect therapy was not provided.; Reporter's Comments: More
2837636 MD 04/23/2025 HEP
 MERCK & CO. INC.
 Y006602
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Medical assistant reported that a patient missed second dose of RECOMBIVAX today. The patient recei... Medical assistant reported that a patient missed second dose of RECOMBIVAX today. The patient received the first dose on 1/11/2025. No additional AEs were reported, no further information provided. No PQC.; No additional AE; This spontaneous report was received from a medical assistant and refers to a(n) 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 11-Jan-2025, the patient received the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), lot #Y006602, expiration date: 05-Feb-2026, administered for prophylaxis (strength, dose and rout e of administration were not provided). It was reported that the patient missed second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) today (Inappropriate schedule of vaccine administered). No additional adverse events (AEs) were reported, no further information provided (No adverse event). This is a non-valid case due to lack of patient's identifiers. More
2837638 KS 04/23/2025 MMRV
 MERCK & CO. INC.
 X023598
Expired product administered, No adverse event Expired product administered, No adverse event
No symptoms reported.; administration of PROQUAD on 3/26/2025 and product expired on 3/24/2025; This... No symptoms reported.; administration of PROQUAD on 3/26/2025 and product expired on 3/24/2025; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Solution for injection (lot #X023598, expiration date: 24-Mar-2025) 0.5 mL administered as prophylaxis (Expired product administered) which was diluted with a sterile diluent (lot #1950614, expiration date: 10-Dec-2025) both administered by unknown route. In addition, it was confirmed that the product did not experience a temperature excursion. No symptoms were reported (No adverse event). More
2837639 14 F IL 04/23/2025 UNK
UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER






Back pain, Blindness, Brain fog, Chest pain, Cognitive disorder; Cyanosis, Deafn... Back pain, Blindness, Brain fog, Chest pain, Cognitive disorder; Cyanosis, Deafness unilateral, Dizziness, Dysphagia, Fatigue; Fructose intolerance, Gastrointestinal microorganism overgrowth, General physical health deterioration, Headache, Hippus; Impaired gastric emptying, Insomnia, Loss of personal independence in daily activities, Mitral valve prolapse, Mobility decreased; Nausea, Neck pain, Pain in extremity, Palpitations, Paraesthesia; Peripheral coldness, Photophobia, Poor peripheral circulation, Postural orthostatic tachycardia syndrome, Serum ferritin decreased; Tachycardia, Temperature intolerance, Temperature regulation disorder, Tremor More
Gastroparesis / nausea; POTS/brain fog,nausea,HA,dizziness,fatigue,blood pooling in legs,palpitation... Gastroparesis / nausea; POTS/brain fog,nausea,HA,dizziness,fatigue,blood pooling in legs,palpitation,chest pain,tachycardia,tremors,temp dysregulation,cognitive issue,insomnia,vision blackout upon standing,cold hand&feet,blue fingers,temp intolerance,light sensitivity,pain; Mitral valve prolapse; small intestinal bacterial overgrowth (SIBO) / nausea; low ferritin / nausea, severe fatigue, dizziness, extreme cold hands and feet, severe chronic headaches; autoimmune injuries/autoimmune disorders; loss of hearing in her left ear; fructose malabsorption / nausea, severe fatigue; Hippus pupils; difficulty swallowing; pins and needles in her feet up to her knees; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age (adult at the time of report). The pt's concurrent conditions included Ehlers-Danlos syndrome (reported as an adverse event, conflicting information), medical history and concomitant therapies were not provided. On an unknown date, at the age of 14 years old, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact dose, route of administration, anatomical location, lot# and expiration date were not reported), for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), as recommended by the pt's physician (referred to as a doctor and also as a health care provider) and consented by the pt's mother. On unspecified dates following vaccination, the pt suffered severe chronic headaches, dizziness, vision blackout upon standing, loss of hearing in her left ear, palpitations, chest pain, tachycardia, difficulty swallowing, tremors, nausea, back and neck pain, pins and needles in her feet up to her knees, temperature intolerance, extreme cold hands and feet, blue fingers, temperature dysregulation, severe fatigue, severe leg pain, blood pooling in legs, light sensitivity, hippus pupils, gastroparesis, brain fog, cognitive issues and insomnia. The pt's deteriorating health following the human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination occurred in the beginning of her freshman year of high school. She could not get out of bed to go to school. The more she sat upright, the worse the symptoms became. She saw numerous specialists, including cardiologists, gastroenterologists, hematologists, neurologists, physical therapists, and urologists. At one point, she was taking 18 pills a day and only growing more ill with each passing day. The pt was diagnosed with gastroparesis, fructose malabsorption, Hippus Pupil, and postural orthostatic tachycardia syndrome (POTS). Due to her post- human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been unable to participate in activities that a typical young person would enjoy. She has always loved the outdoors, animals, and playing sports. Growing up, she had a variety of pets, including dogs, cats, birds, fish, a snake, a hamster, and a hedgehog. She began playing soccer around the age of five and started softball at age six. She excelled in every sport she participated in and was a standout in physical education classes at school. She was even invited to play on a softball team with kids two years older than her, where she often played first base, third base, or shortstop. She was also a starter on her basketball team, ran track, and played volleyball. A tough and determined kid, she did not let anything hold her back-even playing through broken fingers, broken toes, and tom muscles. She rarely complained and always pushed herself. Growing up, she had many friends. She was a quiet and caring person who was easygoing and low-maintenance, and always ready to help those in need. Unfortunately, her symptoms significantly impacted her ability to live a normal life. Based upon her chronic and severe post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to POTS, mitral valve prolapse, gastroparesis, small intestinal bacterial overgrowth (SIBO), fructose malabsorption and low ferritin. The pt contended her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries and a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to their human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorders. As a proximate result of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. She also had a substantial fear of suffering additional and ongoing harms, including but not limited to being at that time at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and they would continue to incur these losses and expenses in the future. The outcome of the events was considered as not recovered. The reporter considered all the events to be related to human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered all events to be disabling. More
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2837640 13 M FL 04/23/2025 UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Abnormal behaviour, Autoimmune disorder, Cognitive disorder, Dyskinesia, Eye pai... Abnormal behaviour, Autoimmune disorder, Cognitive disorder, Dyskinesia, Eye pain; Genital pain, Hallucination, Inappropriate affect, Motor dysfunction, Paranoia; Photophobia, Schizophrenia, Tic, Unresponsive to stimuli More
Catatonic Schizophrenia, unresposive, paranoia, hallucinations, loss of motor skills, behavioral ch... Catatonic Schizophrenia, unresposive, paranoia, hallucinations, loss of motor skills, behavioral changes, cognitive decline, laugh randomly, scrunch his face, tics that caused his arms to move in unusual ways; autoimmune injuries; genital pain; Eye pain; eye pain with light sensitivity; Information has been received from a lawyer, regarding a case in litigation and concerning a minor male patient (pt) of an unknown age. No information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, at the age of 13 years old, the pt received his first and only dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On an unspecified dates, following his Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, the pt sustained serious autoimmune injuries and began experiencing genital pain and eye pain with light sensitivity. He began to experience tics that caused his arms to move in unusual ways, laugh randomly at nothing and, sometimes, at inappropriate times, and scrunch his face almost as if he was wincing in pain. He began suffering from paranoia and was unresponsive during school. He began experiencing hallucinations. As the months progressed, so did pt's symptoms. He was seen by multiple physicians and specialists for his complaints which included loss of motor skills, tics, behavioral changes, cognitive decline, light sensitivity, genital pain, and hallucinations. On unknown dates, based upon his chronic and severe post- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, including but not limited to catatonic schizophrenia. The pt suffered and at the time of report continued to suffer severe and permanent physical injuries, and permanent emotional injuries, including pain and suffering. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his autoimmune disease and other injuries caused by Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL). As a direct and proximate result of his Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)-induced injuries, the pt have suffered and at the time of report continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and he would continue to incur these losses and expenses in the future. The outcome of the events was considered not recovered. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). All events were considered disabling.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-03-31 , MNSC number : , CLIC number : , ESTAR number : LEGCLAPOL , IRMS number : 68514 , Central date : 2025-03-27 , Classification : DMC, Attachment description : Legal , Safety case number : More
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2837641 ID 04/23/2025 VARCEL
VARCEL
HIBV
HIBV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y013350
Y013350
X022981
X022981
Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error More
No additional AEs were reported; The nurse is reporting that a patient received improperly stored va... No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-Mar-2025, the patient was vaccinated with 1 dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE) lot# Y013350 and expiration date reported as and upon internal review confirmed as 02-Aug-2026 (exact dose, route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). The nurse was reporting that the patient received improperly stored vaccine (temperature: 14.92F; time frame: 1 hour 40 minutes; previous temperature excursion: no) (product storage error). More
2837642 TX 04/23/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

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
No additional AE; patient received fi rst doseof GARDASIL 9 on July 19th 2021, second dose on March ... No additional AE; patient received fi rst doseof GARDASIL 9 on July 19th 2021, second dose on March 18th 2025 and would like to complete the series; This spontaneous report has been received from a healthcare student (Also reported as Nurse, conflicting information) referring to a 27-year-old patient of unspecified gender. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not provided. On 19-JUL-2021, the patient was vaccinated as prophylaxis with the first dose of HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration, lot #, and expiration date were not provided); and on 18-MAR-2025, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration, lot #, and expiration date were not provided) (Inappropriate schedule of vaccine administered). No additional adverse event (AE). More
2837643 16 M NC 04/23/2025 UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Abdominal pain upper, Anxiety, Arthralgia, Balance disorder, Confusional state; ... Abdominal pain upper, Anxiety, Arthralgia, Balance disorder, Confusional state; Diplopia, Dizziness postural, Fatigue, Feeling hot, Hypersomnia; Immediate post-injection reaction, Irritability, Loss of personal independence in daily activities, Malaise, Palpitations; Scan brain, Somnolence, Syncope, Thirst, Vitreous floaters More
Fainted; He did not feel well; Chronic fatigue; anxiety; irritability; confusion; his body temperatu... Fainted; He did not feel well; Chronic fatigue; anxiety; irritability; confusion; his body temperature was hot all the time; floaters; cramping; pain in his joints; stomach aches; double vision; He would sleep 15-17 hours a day but never felt rested.; dizzy; difficulty with his balance; Information has been received from a lawyer and refers to a 16-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 an unknown date, the patient was vaccinated with the first and only dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, lot#, and expiry date was not reported) for prophylaxis. Patient's mother was exposed that vaccine was safe, prevented cancer, and teenagers must got it. Immediately after the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccination, patient fainted and when he came to, he did not feel well. Also experienced complete exhaustion and developed chronic fatigue. He would sleep 15-17 hours a day but never felt rested. He could not stay awake. He developed pain in his joints and generally felt unwell. He complained of stomach aches and cramping, which caused him to use the bathroom often at school, and at home. He started drinking one and a half to three gallons of water daily. Everyday tasks became difficult, including picking out clothes, taking a shower, choosing foods to eat, and brushing his teeth. He started experiencing confusion, anxiety, and irritability. His body temperature was hot all the time. Upon standing, he got dizzy, he had difficulty with his balance, and his heart would race. His vision was affected, and he experienced floaters and double vision. Patient was evaluated and treated by numerous specialists, including gastroenterologists, internal medicine doctors, dermatologists, psychologists, psychiatrists, cardiologists, sleep medicine doctors, neurologists, chiropractors, acupuncturists, immunologists, and Ear Nose and Throat doctors. He also received brain scans to determine the cause of his symptoms. At the reporting time, the outcome of the events was not reported. Causality assessment was related. Upon internal review, the event of fainted was determined to be medically significant. More
2837644 57 F IL 04/23/2025 PPV
 MERCK & CO. INC.
Erythema, Pain in extremity Erythema, Pain in extremity
HCP calling to report an AE regarding the PNEUMOVAX 23 vaccine. HCP reported that a patient had a se... HCP calling to report an AE regarding the PNEUMOVAX 23 vaccine. HCP reported that a patient had a severe local reaction where their whole upper arm was very red and painful for a couple of days after administration of the PNEUMOVAX 23 vaccine. HCP st; HCP calling to report an AE regarding the PNEUMOVAX 23 vaccine. HCP reported that a patient had a severe local reaction where their whole upper arm was very red and painful for a couple of days after administration of the PNEUMOVAX 23 vaccine. HCP st; This spontaneous report was received from a pharmacist concerning a 57-year-old female patient. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On unspecified date in January 2020 (reported as ''5 years ago''), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), (strength, route, anatomical location, lot # and expiration date were not reported) for the treatment of prophylaxis. On unspecified date in January 2020 (reported as ''5 years ago''), the patient had a severe local reaction where their whole upper arm was very red and painful (vaccination site erythema and vaccination site pain) for a couple of days after administration of the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) vaccine. The patient did not develop any hives. At the reporting time, the outcome of the events was unknown. The causality was not provided. Lot # is being requested and will be submitted if received. More
2837645 F CA 04/23/2025 HPV9
 MERCK & CO. INC.
Flushing, Gaze palsy, Nausea, Skin warm Flushing, Gaze palsy, Nausea, Skin warm
flushng on her face; warmth in her hole arm; nausea; Headache; This spontaneous report has been rece... flushng on her face; warmth in her hole arm; nausea; Headache; This spontaneous report has been received from a consumer regarding a 10-year-old female patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 02-APR-2025, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, scheme, route of administration, anatomical site, lot number and expiration date not reported). On an unspecified day in April, 2025, the patient's mom has called stating that the patient has developed flushing on her face (flushing of face) , nausea, warmth in her whole arm (skin warm) and a headache. She states she is aware of all of the adverse events with the exception of flushing. At the time of the reporting, the outcome of the events is unknown. Causal relationship between the suspect vaccine and the events was unknown. More
2837647 F 04/23/2025 HPV4
 MERCK & CO. INC.
Human papilloma virus test positive Human papilloma virus test positive
tested positive for HPV; This spontaneous report was received from a Consumer or other non health pr... tested positive for HPV; This spontaneous report was received from a Consumer or other non health professional and referred to a female patient of unknown age. The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included Polycystic ovary syndrome (PCOS). On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient tested positive for human papillomavirus (HPV). At the reporting time, the outcome of tested positive for HPV was unknown. The causal relationship between the event of tested positive for Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not provided. More
2837648 F 04/23/2025 PPV
 MERCK & CO. INC.
Injection site cellulitis Injection site cellulitis
severe localized cellulitis reaction, at injection site; Information has been received from other co... severe localized cellulitis reaction, at injection site; Information has been received from other company on 09-Apr-2025. This spontaneous report was received from a pharmacy student calling on behalf of facility referring to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (reported as 5 to 10 years ago), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (also reported as Pfizer product, conflicting information), administered in the deltoid (unknown if left or right) for prophylaxis (strength, route of administration, dose, lot # and expiration date were not reported). On an unknown date after the vaccination (5 to 10 years ago), the patient had severe localized cellulitis reaction to the vaccine, at injection site in the deltoid, unknown if left or right (Vaccination site cellulitis). The treatment for the event was reported as unknown. The reporter was wondering if that was any information on that because they were looking to give Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) to her now. At the reporting time, the outcome of vaccination site cellulitis was unknown. The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was reported as not applicable. The reporter considered the event of vaccination site cellulitis to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). Additional information is not expected. More
2837649 11 NY 04/23/2025 VARCEL
 MERCK & CO. INC.
 Y015557
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; Improper storage of product in use; This spontaneous report was received from a/an... No adverse event; Improper storage of product in use; This spontaneous report was received from a/an Nurse and refers to a(n) 11-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-Mar-2025, the patient was vaccinated with improperly stored dose of with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015557, expiration date: 16-Sep-2026) administered by Unknown route, as Prophylaxis. No adverse event. The vaccine underwent a temperature excursion of -7.8 Celsius Degrees, during a timeframe of 36 minutes, The vaccine underwent previous temperature excursion, at -14.4 Celsius Degrees up to -10.4 Celsius Degrees during 13 minutes. No adverse event was reported. More
2837650 M IL 04/23/2025 PNC21
 MERCK & CO. INC.
 Y011819
Fatigue, Flushing, Headache, Paraesthesia Fatigue, Flushing, Headache, Paraesthesia
FLUSHING; FATIGUE; TINGLING; HEADACHE; This spontaneous report was received from a regulatory author... FLUSHING; FATIGUE; TINGLING; HEADACHE; This spontaneous report was received from a regulatory authority, CDC Wonder on 22-Apr-202, referring to a 59-year-old male patient. The patient's medical history included allergy to sulfa. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (reported as 27-Feb-2025, conflicting information), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y011819, expiration date: 01-Oct-2025), administered by intramuscular route in left arm as prophylaxis. On 01-Feb-2025, the patient experienced fatigue, tingling, flushing and headache. At the reporting time, the outcome of the events was unknown. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was reported as not applicable. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown. More
2837651 50 F NY 04/23/2025 PNC21
PNC21
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 Y011819
Y011819
Blood glucose normal, Dizziness, Feeling abnormal, Nausea, Skin warm; Syncope; B... Blood glucose normal, Dizziness, Feeling abnormal, Nausea, Skin warm; Syncope; Blood glucose normal, Dizziness, Feeling abnormal, Nausea, Skin warm; Syncope More
syncope; dizziness; feeling abnormal; blood glucose normal; nausea; skin warm; This spontaneous repo... syncope; dizziness; feeling abnormal; blood glucose normal; nausea; skin warm; This spontaneous report was received from a Regulatory Authority and refers to a 50-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included diabetic. Concomitant therapies were not reported. On 17-Nov-2024, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Injection (lot #Y011819, expiration date: 01-Oct-2025), dose number 1, administered by Intramuscular route in Left Arm. On an unknown date, the patient started therapy with . On 17-Nov-2024, the patient started therapy with ADACEL administered by Intramuscular route (indication, expiration date, and lot # were not reported). The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), for the treatment of prophylaxis. On 17-Nov-2024, the patient experienced dizziness. On 17-Nov-2024, the patient experienced feeling abnormal. On 17-Nov-2024, the patient experienced blood glucose normal. On 17-Nov-2024, the patient experienced nausea. On 17-Nov-2024, the patient experienced skin warm. On 17-Nov-2024, the patient experienced syncope. On an unknown date, Investigation showed Blood sugar (??-???-0000): 111 (unit not provided). The patient recovered/resolved from the event of dizziness on an unspecified date. The patient recovered/resolved from the event of feeling abnormal on an unspecified date. The patient recovered/resolved from the event of blood glucose normal on an unspecified date. The patient recovered/resolved from the event of nausea on an unspecified date. The patient recovered/resolved from the event of skin warm on an unspecified date. The patient recovered/resolved from the event of syncope on an unspecified date. The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable. The action taken with Pneumococcal 21-valent Conjugate Vaccine Solution for injection was reported as not applicable. The causal relationship between the event of dizziness and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of feeling abnormal and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of blood glucose normal and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of nausea and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of skin warm and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The causal relationship between the event of syncope and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided. The reporter considered the event(s) of syncope to be medically significant. This is an amended report. The patient's age was updated from 6 months to 50 years. More
2837652 F KS 04/23/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Vaccination failure Vaccination failure
I Did Not Have Any Immunity; Initial report received on 13-Mar-2025. A consumer reported that she... I Did Not Have Any Immunity; Initial report received on 13-Mar-2025. A consumer reported that she, an 84-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not have any immunity. The patient has an allergy to penicillin that results in swelling under tongue. No concomitant medications were reported. On an unknown date, the patient received 2 doses of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available). The patient stated that after having her hepatitis B vaccine, she did not have any immunity. She was not completely sure she was given HEPLISAV-B, but she thought it was a 2-dose vaccine. No other information was available. Company Comment: The company assessed the event as non-serious and not immunologically confirmed for vaccine failure. The dosing schedule and serological marker and time to testing were not reported.; Sender's Comments: The company assessed the event as non-serious and not immunologically confirmed for vaccine failure. The dosing schedule and serological marker and time to testing were not reported. More
2837653 04/23/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Ophthalmic herpes zoster Ophthalmic herpes zoster
shingles in eye; This serious case was reported by a consumer via interactive digital media and desc... shingles in eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster 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 ophthalmic herpes zoster (Verbatim: shingles in eye) (serious criteria GSK medically significant). The outcome of the ophthalmic herpes zoster was not reported. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. Patient got Shingles right after the shot, got them in eye.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. More
2837654 04/23/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Injection site pain Injection site pain
tiny bit of soreness at the injection site; This non-serious case was reported by a consumer via int... tiny bit of soreness at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: tiny bit of soreness at the injection site). The outcome of the injection site pain was not reported. It was unknown if the reporter considered the injection site pain to be related to RSV vaccine. It was unknown if the company considered the injection site pain to be related to RSV vaccine. Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The patient had a tiny bit of soreness at the injection site. More
2837655 F 04/23/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pruritus, Rash Pruritus, Rash
Severe rash on neck and chest; itchy; This non-serious case was reported by a consumer and described... Severe rash on neck and chest; itchy; This non-serious case was reported by a consumer and described the occurrence of rash in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included menopause and progesterone. Concomitant products included estradiol and trazodone. On 14-APR-2025, the patient received Shingles vaccine. On 15-APR-2025, 1 days after receiving Shingles vaccine, the patient experienced rash (Verbatim: Severe rash on neck and chest). In APR-2025, the patient experienced pruritus (Verbatim: itchy). The patient was treated with acrivastine (Benadryl). The outcome of the rash was not resolved and the outcome of the pruritus was not reported. It was unknown if the reporter considered the rash and pruritus to be related to Shingles vaccine. It was unknown if the company considered the rash and pruritus to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-APR-2025 The rash was mildly itchy and feels like a sunburn (Severe rash on neck and chest) The symptoms were treated. More
2837656 63 F PA 04/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Erythema, Injection site erythema, Injection site pain Erythema, Injection site erythema, Injection site pain
redness on the vaccinated arm; Injection site pain; Injection site redness; This non-serious case wa... redness on the vaccinated arm; Injection site pain; Injection site redness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 10-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 10-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain) and injection site erythema (Verbatim: Injection site redness). On 13-APR-2025, the patient experienced erythema of extremities (Verbatim: redness on the vaccinated arm). In APR-2025, the outcome of the injection site pain and injection site erythema were resolved. The outcome of the erythema of extremities was not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and erythema of extremities to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site erythema and erythema of extremities to be related to Shingrix. Additional Information: GSK Receipt Date: 16-APR-2025 The reporter was the patient. The reporter reported that a patient received Shingrix vaccine and experienced redness which was worsened. The patient also experienced injection site pain, injection site redness. Three days after injection, she developed redness on the vaccinated arm. This red area is about three or four inches from the injection site, on the inner arm, below the elbow. Nothing else was reported. More
2837657 79 F MS 04/23/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 Y5X9T
Inappropriate schedule of product administration Inappropriate schedule of product administration
Wrong schedule; This non-serious case was reported by a consumer via call center representative and ... Wrong schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 79-year-old female patient who received HBV (Engerix B adult) (batch number Y5X9T, expiry date 30-SEP-2026) for prophylaxis. Previously administered products included Engerix b adulto (received 1st dose on 22 Nov 2024) and Engerix b adulto (received 2nd dose on20 DEC 2024). On 14-APR-2025, the patient received Engerix B adult (intramuscular). On 14-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too short (Verbatim: Wrong schedule). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 16-APR-2025 The reporter was the patient who received her 3rd dose of Engerix-B outside of the prescribing information recommended schedule. Persons 20 years of age and older had a series of 3 doses (1 mL each) on a 0, 1, 6 month schedule. The patient was given doses on these dates, first dose on 22nd November 2024, second dose on 20th December 2024, and third dose on 14th April 2025. The patient did ask about efficacy of vaccine off schedule and recommendations. The reporter did not fit into any of the special populations listed in the PI. MI information was given for her physician reference. The patient received the 3rd dose of Engerix b adult esrlier than the recommended interval, which led to shortenings of vaccine schedule. More
2837658 F 04/23/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 54TF4
54TF4
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles on hip; This serious case was reported by a consumer and des... Suspected vaccination failure; Shingles on hip; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 54TF4) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) (batch number 54TF4) for prophylaxis. Concurrent medical conditions included blood pressure high. On 26-MAY-2022, the patient received the 2nd dose of Shingles vaccine. On 24-MAR-2022, the patient received the 1st dose of Shingles vaccine. In JUN-2022, less than 2 months after receiving Shingles vaccine and between 2 and 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on hip). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 18-APR-2025 Consumer reported that she took two dose shingles vaccine and she get shingles 1 to 2x monthly on the hip area in JUNE 2022. This case was considered as suspected vaccination failure as details regarding laboratory test confirming 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 clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2). More
2837659 M 04/23/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Asthenia, Chills, Diarrhoea, Headache, Pyrexia; Vomiting Asthenia, Chills, Diarrhoea, Headache, Pyrexia; Vomiting
Fever; Diarrhea; Headache; Vomiting; body weakness; chills; This non-serious case was reported by a ... Fever; Diarrhea; Headache; Vomiting; body weakness; chills; This non-serious case was reported by a consumer and described the occurrence of fever in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included acetylsalicylic acid (Several). On 11-APR-2025, the patient received Shingrix. On 12-APR-2025, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), diarrhea (Verbatim: Diarrhea), headache (Verbatim: Headache), vomiting (Verbatim: Vomiting), weakness generalized (Verbatim: body weakness) and chills (Verbatim: chills). On 18-APR-2025, the outcome of the fever was resolving and the outcome of the diarrhea, headache, vomiting, weakness generalized and chills were resolving (duration 6 days). It was unknown if the reporter considered the fever, diarrhea, headache, vomiting, weakness generalized and chills to be related to Shingrix. It was unknown if the company considered the fever, diarrhea, headache, vomiting, weakness generalized and chills to be related to Shingrix. Additional Information: GSK Receipt Date: 19-APR-2025 The reporter reported that a patient received Shingrix vaccine experienced fever, chills, body weakness, diarrhea, vomiting and headache. More
2837746 7 M CA 04/23/2025 HIBV
 SANOFI PASTEUR
Extra dose administered, Product administered to patient of inappropriate age Extra dose administered, Product administered to patient of inappropriate age
Patient received a dose of HIB which he was not due for. He has had 4 doses already. Patient received a dose of HIB which he was not due for. He has had 4 doses already.
2837748 63 M TX 04/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9L944
Extra dose administered Extra dose administered
After receiving the Shingrix and at home, patient's wife informed the patient that he had alrea... After receiving the Shingrix and at home, patient's wife informed the patient that he had already received 2 doses of Shingrix. This pharmacy only showed 1 dose of Shingrix in the patient imz profile and the patient verbally consented that he wished to receive the Shingrix immunization. Unable to confirm the validity of the patient's wifes claims that he had already received 2 doses. Patient waife concerned for patient receiving a third dose of Shingrix. More
2837749 51 M FL 04/23/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 l5229
Chills, Crying, Pain in jaw, Pyrexia Chills, Crying, Pain in jaw, Pyrexia
Excessive crying and febrile, jaw pain, chills x 1 day Excessive crying and febrile, jaw pain, chills x 1 day
2837750 61 F VA 04/23/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 M4b34
Diarrhoea, Dizziness, Loss of consciousness, Nausea, Peripheral coldness Diarrhoea, Dizziness, Loss of consciousness, Nausea, Peripheral coldness
After 3 minutes of administration, patient felt dizziness and passed out , loss of cosnsciuosness a... After 3 minutes of administration, patient felt dizziness and passed out , loss of cosnsciuosness approximately 2 minutes. Her extrmemities were wet and cold.She became alert and oriented later , still felt diziness, nausea and onset of diarrhea.-Patient refused EMS and left pharmacy with family member More
2837751 2 M CA 04/23/2025 IPV
 SANOFI PASTEUR
 X1D14LM
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
Patient was in office for their 2 year physical 02/17/2025 and received the third IPV (Polio) vacc... Patient was in office for their 2 year physical 02/17/2025 and received the third IPV (Polio) vaccine on right side of thigh at 11:00am. Mother states she noticed redness to injection site around 1:00pm and warm to touch with no other symptoms, Patient had a telemedicine apt. with an on call nurse practitioner later that evening as it worsened and spread to opposite side of leg. Patient was advised to start Benadryl and if anaphylaxis develops head to Emergency Department. Early am 02/18/2025 mother states it was clearing up and had gotten better. Patient returned to office 04/23/2025is doing much better and no other symptoms occurred since then. More
2837752 81 F PA 04/23/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 75GZ7
75GZ7
Computerised tomogram head, Dysarthria, Dysphagia, Facial paresis, Laboratory te... Computerised tomogram head, Dysarthria, Dysphagia, Facial paresis, Laboratory test; Magnetic resonance imaging head More
Bilateral facial weakness, right worse than left. Involved upper and lower face. Dysphagia (oral pha... Bilateral facial weakness, right worse than left. Involved upper and lower face. Dysphagia (oral phase). Speech was slurred. Sudden onset, progressed over the course of one week. Improved over the next 1-2 weeks. More
2837753 65 F MI 04/23/2025 PNC20
 PFIZER\WYETH
 LX4482
Injection site erythema, Injection site nodule, Injection site pruritus, Injecti... Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth More
The day after the injection (4/18), it felt like a big (several centimeter) knot but wasn't red... The day after the injection (4/18), it felt like a big (several centimeter) knot but wasn't red. Two days after the injection (4/19), the knot started to improve but redness started to spread. Redness started higher on the arm and spread downward while it cleared higher up. 4/20, noticed warmth and spreading redness. Started topical hydrocortisone and ibuprofen. Seen by PCP office on 4/21 and noted "Well-demarcated 15cmx17cm area of warmth and erythema of the left upper arm as shown in photos below. There is a 2-3cm mobile mass felt at the top center of the area of erythema that is likely the site of the injection." It was itchy but not painful. No fevers, chills, difficulty breathing. On 4/21, topical steroid was increased in strength to clobetasol 0.05% BID and home cetirizine was increased from 10mg daily to 10mg BID. By 4/23, symptoms were resolving. No antibiotics were required. More
2837755 26 M WA 04/23/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 PG3RP
Headache, Urticaria Headache, Urticaria
Hives on right arm, then other arm 30 min later fever on 4/23/25 about 99F headache. Took Atertec. Hives on right arm, then other arm 30 min later fever on 4/23/25 about 99F headache. Took Atertec.
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