🏥 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 💀 🏥 🚑 ♿ ⚠️
2832741 16 M AZ 03/24/2025 VARCEL
 MERCK & CO. INC.
 Y013350
No adverse event, Product storage error No adverse event, Product storage error
The HBP stated patient did not experienced any adverse issues or side effects related to the adminis... The HBP stated patient did not experienced any adverse issues or side effects related to the administered VARIVAX dose.; A HBP (responsible for vaccine storage) called to report a TE for VARIVAX that occurred on 02/24/2025 and the vaccine was also inadvertently administered on 02/26/2025.; This spontaneous report was received from an other health professional and refers to a 16-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was reported a temperature excursion (TE) for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) that occurred on 24-Feb-2025. On 26-Feb-2025, the patient was inadvertently received Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y013350, expiration date: 02-Aug-2026, 0.5 mL / once as prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). Operator of device was health professional. It was stated patient did not experienced any adverse issues or side effects related to the administered Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) dose (No adverse event). More
2832742 IA 03/24/2025 MMRV
 MERCK & CO. INC.
 X021757
Expired product administered, No adverse event Expired product administered, No adverse event
Caller reported expired dose of PROQUAD was administered. No other information provided. No additi... Caller reported expired dose of PROQUAD was administered. No other information provided. No additional AEs/PQC reported.; No additional AEs/PQC reported; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-Mar-2025, the was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), formulation: injection, lot #X021757, expiration date: 23-Feb-2025, 0.5 mL, administered by subcutaneous route (anatomical location was not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided) (expired vaccine used). No additional adverse events reported (no adverse event). More
2832743 M OH 03/24/2025 MMRV
 MERCK & CO. INC.
No adverse event, Wrong product administered No adverse event, Wrong product administered
inadvertently received the PROQUAD vaccine instead of the MMR-II; No additional AE reported; Informa... inadvertently received the PROQUAD vaccine instead of the MMR-II; No additional AE reported; Information has been received from a nurse and referred to a 60-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis, instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) (Wrong vaccine administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot and expiration date were unknown). No other adverse event was reported. More
2832744 NJ 03/24/2025 MMR
 MERCK & CO. INC.
Expired product administered, No adverse event Expired product administered, No adverse event
No other AE; inadvertently administered an expired dose of MMR II; This spontaneous report was recei... No other AE; inadvertently administered an expired dose of MMR II; This spontaneous report was received from a physician and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-Mar-2025, the patient was inadvertently administered an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (expiration date: 02-Mar-2025) (dose, route, anatomical site, lot # was not reported) for prophylaxis (expired product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). No other AE was reported (No adverse event). This is a non-valid case due to lack of patient's identifies. Lot # is being requested and will be submitted if received. More
2832745 TX 03/24/2025 MMRV
 MERCK & CO. INC.
 X019557
Expired product administered, No adverse event Expired product administered, No adverse event
no adverse event; expired vaccine used; This spontaneous report was received from a medical assistan... no adverse event; expired vaccine used; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On 10-Mar-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #X019557, expiration date: 19-Jan-2025) for prophylaxis (expired vaccine used). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot #1950610, expiration date: 11-Oct-2025). Product had not experienced any temperature excursions through the date of administration. No side effects/symptoms were reported at this time (no adverse event). More
2832746 WV 03/24/2025 HEP
 MERCK & CO. INC.
No adverse event, Underdose No adverse event, Underdose
No adverse event; HCP/Medical Assistant called to report that 2 adults received pediatric doses of R... No adverse event; HCP/Medical Assistant called to report that 2 adults received pediatric doses of RECOMBIVAX HB. One was administered on 3/5/2025 and the other on 2/25/2025. No other information was available at the time of the call. No adverse effects were reporte; HCP/Medical Assistant called to report that 2 adults received pediatric doses of RECOMBIVAX HB. One was administered on 3/5/2025 and the other on 2/25/2025. No other information was available at the time of the call. No adverse effects were reporte; This spontaneous report was received from a physician assistant and refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On 05-MAR-2025, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) suspension for injection (RECOMBIVAX HB) 0.5 mL, administered as prophylaxis (strength, Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). It was reported that the patient received a pediatric dose of the previous mention vaccine (product administered to patient of inappropriate age) (underdose). No additional adverse event was reported (no adverse event). This is one of two reports received from the same reporter.; Reporter's Comments: More
2832747 17 F NH 03/24/2025 HPV9
 MERCK & CO. INC.
 X005044
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE reported; dose of GARDASIl-9 expired on 1/2/2025 and was administered on 3/18/2025 ... No additional AE reported; dose of GARDASIl-9 expired on 1/2/2025 and was administered on 3/18/2025 to a 17-year-old female consumer; This spontaneous report was received from a physician assistant and refers to a 17-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-Mar-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route, anatomical site, lot #X005044, expiration date: 02-Jan-2025) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event). Additional information is not expected. More
2832748 WV 03/24/2025 HEP
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age, Underdos... No adverse event, Product administered to patient of inappropriate age, Underdose More
No adverse event; HCP/Medical Assistant called to report that 2 adults received pediatric doses of R... No adverse event; HCP/Medical Assistant called to report that 2 adults received pediatric doses of RECOMBIVAX HB. One was administered on 3/5/2025 and the other on 2/25/2025. No other information was available at the time of the call. No adverse effects were reporte; HCP/Medical Assistant called to report that 2 adults received pediatric doses of RECOMBIVAX HB. One was administered on 3/5/2025 and the other on 2/25/2025. No other information was available at the time of the call. No adverse effects were reporte; This spontaneous report was received from a physician assistant and refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On 25-FEB-2025, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) suspension for injection (RECOMBIVAX HB) 0.5 mL, administered as prophylaxis (strength, Lot No., expiration date, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided). It was reported that the patient received a pediatric dose of the previous mention vaccine (product administered to patient of inappropriate age) (underdose). No additional adverse event was reported (no adverse event). This is one of two reports received from the same reporter.; Reporter's Comments: More
2832749 M 03/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Incomplete course of vaccination Herpes zoster, Incomplete course of vaccination
Breakthrough herpes zoster; This non-serious case was reported by a nurse via sales rep and describe... Breakthrough herpes zoster; This non-serious case was reported by a nurse via sales rep and described the occurrence of herpes zoster in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced herpes zoster (Verbatim: Breakthrough herpes zoster). The outcome of the herpes zoster was unknown. The reporter considered the herpes zoster to be related to Shingrix. The company considered the herpes zoster to be related to Shingrix. Additional Information: GSK Receipt Date: 12-MAR-2025 The patient received the shingrix first dose and experienced breakthrough herpes zoster. Patient received first dose of Shingrix and did not go back for second dose. Patient had breakthrough case of shingles after receiving only one dose. More
2832750 17 OK 03/24/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
17 yrs patint administered dose of kinrix; This non-serious case was reported by a other health prof... 17 yrs patint administered dose of kinrix; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 17-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis. On 10-MAR-2025, the patient received Kinrix. On 10-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 17 yrs patint administered dose of kinrix). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-MAR-2025 The patient was administered dose of Kinrix at not recommended age due to their facility not having supply of an appropriate vaccine for polio for the patient's age group which led inappropriate age at vaccine administration. The reporter confirmed the patient has not reported any medical concerns or symptoms after been administered the Kinrix. The reporter consented for follow up. More
2832751 03/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
had the vaccine but got shingles/ suspected vaccination failure; had the vaccine but got shingles, g... had the vaccine but got shingles/ suspected vaccination failure; had the vaccine but got shingles, got the vaccine milder case but still painful; 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: had the vaccine but got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the vaccine but got shingles, got the vaccine milder case but still painful). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine but got shingles, the patient was glad that patient got the vaccine milder case but was still painful. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2832752 03/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; got shingles; This serious case was reported by a consumer via intera... Suspected vaccination failure; 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: got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient received the Shingles vaccines and then got shingles. Agonizing, finally was given a nerve block after suffering for a month and a half. That was helpful finally helped with pain and although not immediate gave the relief. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2832753 03/24/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
suspected vaccination failure; am suffering with it no/horrible and I got both shots; This serious c... suspected vaccination failure; am suffering with it no/horrible and I got both shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: am suffering with it no/horrible and I got both shots). 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: Follow up information recived on 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she recived both shot of Shingles vaccine and suffering with it now and it was horrible.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2832754 03/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; awful experience second time with shingles; This serious case was rep... Suspected vaccination failure; awful experience second time with 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: awful experience second time with shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had awful experience second time with shingles after getting all the preventive shots. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2832755 17 F OK 03/24/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
patient needed a polio vaccine and they accidentally gave Kinrix; Wrong age/17 year old patient need... patient needed a polio vaccine and they accidentally gave Kinrix; Wrong age/17 year old patient needed a polio vaccine and they accidentally gave Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis. Co-suspect products included Polio vaccine for prophylaxis. Previously administered products included Pediarix (received in JAN-2008 from lot number AC21B125BB), Pediarix (received in MAR-2008 from lot number AC21B136CA), Pediarix (received in MAY-2008 from lot number AC21B136CA), Ipol (received in JAN-2008), Ipol (received in 16-MAY-2008), Daptacel (received in MAR-2008), Daptacel (received in MAR-2009), Adacel (received in FEB-2019) and Adacel (received in 19-OCT-2020). On 10-MAR-2025, the patient received Kinrix. On an unknown date, the patient did not receive Polio vaccine. On 10-MAR-2025, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: patient needed a polio vaccine and they accidentally gave Kinrix) and inappropriate age at vaccine administration (Verbatim: Wrong age/17 year old patient needed a polio vaccine and they accidentally gave Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-MAR-2025 and 12-MAR-2025 Manager explained that a patient needed a polio vaccine, and they accidentally gave Kinrix without noticing that it was not recommended for that age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient was administered a dose of Kinrix due to their facility not having a supply of an appropriate vaccine for polio for the patient's age group. The reporter confirmed the patient has not reported any medical concerns or symptoms after being administered the Kinrix. The patient received Prior doses of Diphtheria, Tetanus, Pertussis and Poliovirus vaccines: was received DTaP-Hib combined vaccine (unknown brand) in December 2011. No additional information provided. No additional AE/PQC (adverse event or product quality complaint provided). More
2832756 1 M WA 03/24/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
the 1.0 mL was given to a pediatric patient; the 1.0 mL was given to a pediatric patient; This non-s... the 1.0 mL was given to a pediatric patient; the 1.0 mL was given to a pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 15-month-old male patient who received HAV (Havrix adult) for prophylaxis. On 13-MAR-2025, the patient received the 1st dose of Havrix adult. On 13-MAR-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: the 1.0 mL was given to a pediatric patient) and overdose (Verbatim: the 1.0 mL was given to a pediatric patient). The outcome of the adult product administered to child and overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-MAR-2025 A Registered Nurse called just to have some information an adult Hepatitis A vaccine, and reported that the 1.0 milliliter of Havrix (adult dose) was given to a pediatric patient which led to adult product administered to child and overdose. She just wanted, kind of get more information, other than potential increase of local reactions is there anything else that we need to be aware of. More
2832757 16 M MN 03/24/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB043A
Product preparation error Product preparation error
supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the p... supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient; supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB043A, expiry date 31-JUL-2025) for prophylaxis. On 14-MAR-2025, the patient received Menveo. On 14-MAR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient) and inappropriate dose of vaccine administered (Verbatim: supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date:17-MAR-2025 The reporter stated that Menveo 2-vial was not reconstituted with the supplied diluent, but with another sterile diluent, and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. More
2832758 M NJ 03/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Inappropriate Schedule of Vaccine; This non-serious case was reported by a other health professional... Inappropriate Schedule of Vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 17-MAR-2025 Pharmacy Student requested data regarding patient who received 1st Shingrix vaccine in 2020 (date unknown), 2nd dose in 2023 (date unknown). The reporter asked if the patient needs to receive a 3rd dose to complete series or it the 2 Shingrix vaccines was a complete series. The reporter consented to follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. More
2832759 WI 03/24/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
Expired dose given; This non-serious case was reported by a other health professional via sales rep ... Expired dose given; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 13-year-old patient who received HBV (Engerix B Junior) (expiry date 09-MAR-2025) for prophylaxis. On 18-MAR-2025, the patient received the 2nd dose of Engerix B Junior. On 18-MAR-2025, an unknown time after receiving Engerix B Junior, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 18-MAR-2025 A field representative called in stating that had called in requesting data about the administration of a Engerix-B after an expired dose was administered with the dose having expired, which led to expired vaccine used. More
2832760 03/24/2025 FLUR4
 PROTEIN SCIENCES CORPORATION
Fatigue, Influenza like illness, Pain Fatigue, Influenza like illness, Pain
adult experienced flu like symptoms- tired/ achy; adult experienced flu like symptoms- achy; adult e... adult experienced flu like symptoms- tired/ achy; adult experienced flu like symptoms- achy; adult experienced flu like symptoms- tired; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves Adult and unknown gender patient who experienced flu like symptoms- tired/ achy after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok QIV]. The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided. On an unknown date, the patient received a unknown dose of suspect Influenza Quadrivalent Recombinant Vaccine lot number not reported via intramuscular route in unknown administration site for flu (Influenza) (strength, expiry date was unknown). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested. On an unknown date the patient developed flu like symptoms- tired/ achy (influenza like illness), (pain) and (fatigue) (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events. More
2832761 03/24/2025 FLUR4
 PROTEIN SCIENCES CORPORATION
Chills, Immediate post-injection reaction Chills, Immediate post-injection reaction
experienced chills immediately after injection for about 20 min; Initial information received on 19-... experienced chills immediately after injection for about 20 min; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves an unknown age and unknown gender patient who experienced chills immediately after injection for about 20 min, after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received (1 dosage form, once) dose of suspect Influenza Quadrivalent Recombinant Vaccine, Intravenous infusion (strength: not reported) (lot number, expiry date: not reported) via intramuscular route in unknown administration site for flu (Influenza). On an unknown date the patient developed chills immediately after injection for about 20 min (chills) (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine. No lab data reported. Action taken: not applicable. It was not reported if the patient received corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event (duration: 20 minutes) More
2832762 03/24/2025 IPV
 SANOFI PASTEUR
 W1C831M
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion for opened IPOL at 48 F for 10 minutes with no reported adverse event; Initial... temperature excursion for opened IPOL at 48 F for 10 minutes with no reported adverse event; Initial information received on 18-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age / gender patient who received (opened) IPV (VERO) [IPOL] exposed to temperature excursion at 48 f for 10 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of (opened) IPV (VERO) Suspension for injection (strength- unknown, expiry date- 21-NOV-2025 and lot W1C831M) via unknown route in unknown administration site for Immunization was exposed to temperature excursion for at 48 f for 10 minutes with no reported adverse event (poor quality product administered) (same day latency). Reportedly, human error was unknown. There was previous excursion. Reason for excursion was unknown, and the vaccine was administered. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2832763 0.33 M TX 03/24/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK167AA
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
administration of PENTACEL at an earlier than the recommended scheduled time with no reported advers... administration of PENTACEL at an earlier than the recommended scheduled time with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who was administered of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] earlier than the recommended scheduled time with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine Conj 20V (CRM197) [pneumococcal vaccine Conj 20V (CRM197)]; and diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3V (Vero), tetanus vaccine toxoid (pediarix)on 16-Jan-2025 both for Immunisation. On 28-Jan-2025, the patient received 0.5ml (Dose 1) (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) vaccine, Suspension for injection, Strength standard and lot UK167AA with expiry date 31-Oct-2025 via intramuscular route in the right thigh for Immunisation earlier than the recommended scheduled time with no reported adverse event (inappropriate schedule of product administration) (Latency Same day). Reportedly, Caller confirmed that the patient received Pentacel approximately one month too early. Treatment received: no. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2832764 1.25 F TX 03/24/2025 TDAP
 SANOFI PASTEUR
 3CA10C1
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
they have a patient who is 15 months and 18 days old who was given adacel instead of daptacel with n... they have a patient who is 15 months and 18 days old who was given adacel instead of daptacel with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months and 18 days old female patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Ada-Cel] instead of DaptaCel with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Varicella zoster vaccine live (Oka/Merck) (Varivax); and HIB vaccine (Hib) both for Immunisation. On 05-Mar-2025, the patient received 0.5ml (Dose 4) dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Strength standard, Frequency once and lot 3CA10C1 with expiry date 31-Dec-2025 via intramuscular route in the left thigh for immunization instead of daptacel with no reported adverse event (wrong product administered) (Latency Same day). Reportedly, A 15 months and 18 days old who was given ADACEL instead of Daptacel. The caller states that this was 4th dose in the tetanus-diphtheria-pertussis vaccination series for the patient and the other doses were given with Vaxelis. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2832765 1.5 M MO 03/24/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK109AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
partial administration of PENTACEL component, didn't get the Hib portion of the vaccine, they o... partial administration of PENTACEL component, didn't get the Hib portion of the vaccine, they only got the liquid portion with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 18 months old male patient who had partial administered pentacel component, didn't get the hib portion of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)], they only got the liquid portion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B vaccine and pneumococcal vaccine conj 15V (CRM197) for Prophylactic vaccination (Immunisation). On 13-Mar-2025, the patient had partial administered pentacel component, didn't get the hib portion of unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine , powder and suspension for suspension for injection (lot UK109AA) (Expiry date: 30-Sep-2025, Frequency: once, strength: standard) via unknown route in unknown administration site for immunization, they only got the liquid portion with no reported adverse event (single component of a two-component product administered) (Latency: same day). Reportedly, Caller would like to know does this count as the child being vaccinated or does the child need to be re-vaccinated. Call recording disclosed. Nurse stated that the situation did not happen in the office but in a daycare. They found out about the partial administration of PENTACEL when the parent gave a sheet that says patient received the product, but the Hib (Haemophilus influenzae type B) part was crossed out. For DTap:3rd and for IPV: 3rd dose Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2832766 1.25 M HI 03/24/2025 DTAP
 SANOFI PASTEUR
 2CA77C1
Exposure via skin contact, No adverse event, Underdose Exposure via skin contact, No adverse event, Underdose
vaccine didn't go into the patient and it was noted on outside of the patient's leg with n... vaccine didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event; vaccine didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient who was receiving diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] that didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event and vaccine didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Mar-2025, Caller reported that diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension of injection, (Unknown strength) lot 2CA77C1 with expiry date 30-Apr-2025, for immunization, which didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event (accidental exposure to product) (exposure via skin contact). Reportedly. They were using the VanishPoint needle, a needle that retracts into the syringe after injection.They ended up giving the patient another dose of DAPTACEL yesterday after she discussed it with the doctor. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2832767 27 F CA 03/24/2025 FLU3
 SANOFI PASTEUR
 UT8437AA
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
accidentally administered FLUZONE HD to a 27-year-old pregnant patient with no reported adverse even... accidentally administered FLUZONE HD to a 27-year-old pregnant patient with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 27 years old pregnant female patient who was exposed to influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] which was accidentally administered with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported accidentally administered FLUZONE HD to a 27-year-old pregnant patient with no reported adverse event .The reported event occurred at 32 weeks and 4 days of pregnancy. The date of last menstrual period was not reported. The estimated due date is May-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. Concomitant medications included RSV vaccine for Immunisation. On 19-Mar-2025, the patient accidentally administered 0.5 ml dose of suspect influenza usp trival a-b high dose subvirion vaccine, Suspension for injection in pre-filled syringe ,lot UT8437AA,expiry date:30-Jun-2025,Strength = High Dose and frequency:once, via intramuscular route in the right deltoid for influenza immunization [immunization] during pregnancy with no reported adverse event (exposure during pregnancy) (latency :same day) Reportedly there were no symptoms or adverse event during the call. Action taken was not applicable. Additionally, at time of reporting, the outcome of the pregnancy is unknown. More
2832768 4 M TX 03/24/2025 IPV
 SANOFI PASTEUR
 W1A191M
Expired product administered, No adverse event Expired product administered, No adverse event
patient administered expired IPOL with no reported adverse event; Initial information received on 20... patient administered expired IPOL with no reported adverse event; Initial information received on 20-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 4 years old male patient who administered expired IPV (VERO) [IPOL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) and Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck) (Proquad) for prophylactic vaccination (Immunisation). On 05-Mar-2025, the patient received a dose of 0.5 ml of expired IPV (VERO), suspension for injection (lot W1A191M, expiry date: 16-Feb-2025, strength: standard and frequency: once) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (expired product administered) (Latency: same day). Reportedly, They wanted to know the next steps that they needed to take with the patient's immunization. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2832779 F IL 03/24/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
Patient received Arexvy while she was pregnant; patient received Arexvy instead of Abrysvo; patient ... Patient received Arexvy while she was pregnant; patient received Arexvy instead of Abrysvo; patient received Arexvy instead of Abrysvo; This non-serious retrospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On an unknown date, the patient received Arexvy and did not receive Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Patient received Arexvy while she was pregnant), wrong vaccine administered (Verbatim: patient received Arexvy instead of Abrysvo) and drug use in unapproved population (Verbatim: patient received Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and drug use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Pregnancy Outcome: Live neonate with a congenital anomaly See case US2025AMR030558 for details regarding the baby case. Additional Information: GSK Receipt Date: 12-MAR-2025 A pharmacist mentioned that a patient received Arexvy instead of Abryvso while she was pregnant, which led to Wrong vaccine administered, Drug use in unapproved population and Vaccine exposure during pregnancy. The pharmacist asked if GlaxoSmithKline had any study showing a correlation of giving Arexvy to pregnant women and respiratory issues in newborns.; Sender's Comments: US-GSK-US2025AMR030558:Child case More
2832780 69 F 03/24/2025 RSV
 MODERNA
Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain, ... Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain, Pain in extremity More
vaccination at the left arm and the soreness still there/describes pain on the arm with a pain scale... vaccination at the left arm and the soreness still there/describes pain on the arm with a pain scale of 6 out of 10/ it is sore to the touch and soreness being 2-inch square/2-inch circle area from the pierced/punctured area; And if she touches right on the affected site, it's like a terrible bruise feeling right a little 2 inch circle; She maintains it hurts to move with a summary of description as "weakness and soreness"; She has trouble lifting it up and specifically adds the affected arm is not lifting up when she wanted to lift it; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (vaccination at the left arm and the soreness still there/describes pain on the arm with a pain scale of 6 out of 10/ it is sore to the touch and soreness being 2-inch square/2-inch circle area from the pierced/punctured area), VACCINATION SITE BRUISING (And if she touches right on the affected site, it's like a terrible bruise feeling right a little 2 inch circle), ASTHENIA (She maintains it hurts to move with a summary of description as "weakness and soreness") and MOVEMENT DISORDER (She has trouble lifting it up and specifically adds the affected arm is not lifting up when she wanted to lift it) in a 69-year-old female patient who received mRNA-1345 (mRESVIA) for Lower respiratory tract infection. Concurrent medical conditions included Sjogren's syndrome since 15-Jun-1995. On an unknown date, the patient received dose of mRNA-1345 (mRESVIA) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination at the left arm and the soreness still there/describes pain on the arm with a pain scale of 6 out of 10/ it is sore to the touch and soreness being 2-inch square/2-inch circle area from the pierced/punctured area), VACCINATION SITE BRUISING (And if she touches right on the affected site, it's like a terrible bruise feeling right a little 2 inch circle), ASTHENIA (She maintains it hurts to move with a summary of description as "weakness and soreness") and MOVEMENT DISORDER (She has trouble lifting it up and specifically adds the affected arm is not lifting up when she wanted to lift it). At the time of the report, VACCINATION SITE PAIN (vaccination at the left arm and the soreness still there/describes pain on the arm with a pain scale of 6 out of 10/ it is sore to the touch and soreness being 2-inch square/2-inch circle area from the pierced/punctured area), VACCINATION SITE BRUISING (And if she touches right on the affected site, it's like a terrible bruise feeling right a little 2 inch circle), ASTHENIA (She maintains it hurts to move with a summary of description as "weakness and soreness") and MOVEMENT DISORDER (She has trouble lifting it up and specifically adds the affected arm is not lifting up when she wanted to lift it) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment (1-10): 6 out of 10. The action taken with mRNA-1345 (mRESVIA) (Intramuscular use) was unknown. The concomitant medication was not reported by reporter. Patient experienced side effects post administration of the RSV vaccine but unsure if it was Moderna RSV/mRESVIA. She added that she had the vaccination at the left arm at least 6 weeks ago or maybe 2 months and the soreness was still there since the first 3 days for about 6 weeks now. She added that if she tried to lift the arm up over her head, did yoga or something, she hits that point where for a second she just can't make herself do it. And if she touched right on the affected site, it was like a terrible bruise feeling right a little 2 inch circle. The patient described pain on the said arm with a pain scale of 6 out of 10 (10 being the highest and 1 being the lowest). She had trouble lifting it up and specifically adds the affected arm was not lifting up when she wanted to lift it. She reiterated it was sore to the touch and soreness being 2-inch square/2-inch circle area from the pierced/punctured area. Caller clarified there was nothing excruciating but it was very, very noticeable. She mentioned she looked it up online and had not seen anything about a side effect of 6 weeks "going on and on". The patient did not experience any additional symptoms/events. The treatment medication was not reported by reporter. More
2832785 58 M CA 03/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PC5Y3
Injection site abscess Injection site abscess
Developed an injection site abscess Developed an injection site abscess
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2832786 64 F NC 03/24/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y011819
Y011819
Fatigue, Headache, Injection site erythema, Injection site pain, Injection site ... Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling, Local reaction, Nausea More
local skin reaction at vaccine site, left upper arm mild itchiness. Redness & swelling, mild nau... local skin reaction at vaccine site, left upper arm mild itchiness. Redness & swelling, mild nausea, head ache and fatigue. Cold compresses, Benadryl and Tylenol as needed upper arm pain. Began about 2 hours after vaccine given with symptoms peak 24 hours after. More
2832823 11 MO 03/24/2025 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
patient who received first dose of GARDASIL 9 at 11 years of age came to their facility at 20 years ... patient who received first dose of GARDASIL 9 at 11 years of age came to their facility at 20 years of age to complete the series; No additional AE details provided; This spontaneous report was received from Other health professional and refers to a 20-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date (reported as at 11 years of age), the patient was vaccinated with 1 dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, frequency, route of administration, site of administration, vaccination scheme, expiration date, and lot # were not reported). On unknown date (reported as at 20 years of age), the patient went to the facility to complete the series with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (strength, frequency, route of administration, site of administration, vaccination scheme, expiration date, and lot # were not reported) as a prophylaxis (Inappropriate schedule of product administration). No additional AE details provided was unknown. More
2832824 24 F FL 03/24/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 1780876
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
patient had not reported any adverse issues or side effects related to the administered dose; GARDAS... patient had not reported any adverse issues or side effects related to the administered dose; GARDASIL 9 (lot: 1780876 expiration: 11/09/2023) on 11/28/2022 needed to have the series restarted when she came into the clinic today; This spontaneous report was received from a physician and refers to a 26-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 28-Nov-2022, the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL, once strength, frequency, route of administration, site of administration, and vaccination scheme were not provided; lot # 1780876which has been verified as a valid number, and expiration date reported and validated as 09-Nov-2023) as a prophylaxis. On 04-Mar-2025, the patient was vaccinated with second dose (series restarted) with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, frequency, route of administration, site of administration, vaccination scheme, expiration date, and lot # were not reported) as a prophylaxis (Inappropriate schedule of product administration). The patient had not reported any adverse issues or side effects related to the administered dose. For the second dose lot # is being requested and will be submitted in received. More
2832825 OK 03/24/2025 RV5
 MERCK & CO. INC.
 Y009341
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported.; report T/E for ROTATEQ that was administered. T/E date was on 2/18/2025 ... No additional AE reported.; report T/E for ROTATEQ that was administered. T/E date was on 2/18/2025 and ROTATEQ was administered on 2/27/2025; This spontaneous report was received from a nurse concerning to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On 18-Feb-2025, doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent a temperature excursion at a temperature of 32.0 degrees Fahrenheit (F) during a timeframe of 2 hours, 12 minutes and 0 seconds without previous temperature excursions. On 27-Feb-2025, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #Y009341, expiration date 24-Nov-2025), dose number 1, 1 dosage form administered by Oral route (po) as prophylaxis (product storage error.) No additional adverse events were reported (no adverse event.) More
2832826 1.25 F NC 03/24/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 9m2r7
Wrong product administered Wrong product administered
Patient is 15 months olds. She was supposed to receive a Pedvax Hib but a Menveo was giving by accid... Patient is 15 months olds. She was supposed to receive a Pedvax Hib but a Menveo was giving by accident. More
2832827 1.25 F NC 03/24/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 9m2r7
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient is 15 months old and was supposed to receive a Pedvax Hib. They were given a menveo instead.... Patient is 15 months old and was supposed to receive a Pedvax Hib. They were given a menveo instead. The doctor and parents were informed. There have been no adverse reactions that we are aware of at this point. More
2832828 81 F MI 03/24/2025 COVID19
COVID19
 MODERNA
MODERNA
 049D22A
049D22A
Asthenia, COVID-19, Clostridium difficile infection, Clostridium test positive, ... Asthenia, COVID-19, Clostridium difficile infection, Clostridium test positive, Diarrhoea; Pleural effusion, Respiratory viral panel, SARS-CoV-2 test positive, White blood cell count increased More
Name: Medical Record #: Age: 83 y.o. DOB: 7/XX/1941 Admit date: 3/17/2025 Discharge date: 03/1... Name: Medical Record #: Age: 83 y.o. DOB: 7/XX/1941 Admit date: 3/17/2025 Discharge date: 03/18/25 Admitting Physician:, DO Attending Physician at the Time of Discharge: DO Primary Care Physician: MD Reason for Admission: C-diff, Covid Hospital Course: Patient presented to the emergency department for diarrhea and worsening generalized weakness. Upon admission, elevated white count was in the 60s. Zosyn and vanc was initiated. Imaging was relatively unremarkable other than bilateral pleural effusions. Patient did appear dry on initial exam and therefore 1 L bolus was given. GI PCR returned C difficile positive as well as RV P returned COVID positive. Patient was treated with oral vanc. White count down trended every day with patient feeling much better and having less stools per day. Patient was eating and tolerating diet well. Patient denied any chest pain, shortness of breath, abdominal pain. I called the patient's daughter who was amenable for patient's discharge back to facility. Patient was also amenable to this plan. We will discharge her with the total 10 day course of oral vanc. She is also instructed to take her Bumex for diuresis as well as as needed metolazone for extra diuresis. Patient will be discharged to facility in stable condition. She understands return precautions. Patient understands the importance of medication compliance and following up as told. All questions were answered. Discharged to Skilled Nursing Facility. More
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2832829 65 M TN 03/24/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient did not experience any adverse reactions. It was brought to our attention the next day by ou... Patient did not experience any adverse reactions. It was brought to our attention the next day by our corporate immunization claims review team that patient had already received this vaccination previously on 12/22/2023. This did not appear in the state immunization database as having occurred and did not trigger a DUR alert in our computer system as well. Pt was informed of duplicate vaccination and stated he was fine and was not angry. More
2832830 74 M NY 03/24/2025 COVID19
 MODERNA
 8080473
Balance disorder, Dizziness Balance disorder, Dizziness
Patient received vaccine on Thursday and felt fine. Woke up on Saturday AM with dizziness and balanc... Patient received vaccine on Thursday and felt fine. Woke up on Saturday AM with dizziness and balance problems. Could not think of a reason other than the vaccine that would cause the issue More
2832831 NY 03/24/2025 HPV9
 MERCK & CO. INC.
 1965046
No adverse event, Product storage error No adverse event, Product storage error
No adverse side effects were reported.; GARDASIL 9 that was out of range, unmonitored for an unknown... No adverse side effects were reported.; GARDASIL 9 that was out of range, unmonitored for an unknown amount of time at unknown temperatures. Lot number was provided, expiration date was unknown. Administered 2/3/2025; This spontaneous report was received from a physician assistant concerning to a 43-year-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On 03-Feb-2025, the patient was vaccinated with an improper stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), pre-filled syringe, lot #1965046, expiration date no provided but upon internal verification established as 22-Jan-2026, 1 dosage form (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis. The vaccine dose administered was out of range, unmonitored for an unknown amount of time at unknown temperatures (product storage error.) No adverse side effects were reported (no adverse event.) This was one of two reports received from the same reporter. More
2832832 78 F NC 03/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 MG5S9
Chills, Headache, Injection site erythema Chills, Headache, Injection site erythema
Patient states that she developed a headache around 8pm that night and chills. She states that she h... Patient states that she developed a headache around 8pm that night and chills. She states that she has a redness 2 inches around the injection site. More
2832833 25 F PR 03/24/2025 COVID19
 MODERNA
 011J20A
Arrhythmia, Electrocardiogram ambulatory, Endometriosis, Surgery Arrhythmia, Electrocardiogram ambulatory, Endometriosis, Surgery
Arritmias, Endometriosis Arritmias, Endometriosis
2832834 85 M CA 03/24/2025 PNC20
 PFIZER\WYETH
Nausea Nausea
Woke up the next feeling nauseous went away after eating, Woke up the next feeling nauseous went away after eating,
2832835 4 M OH 03/24/2025 DTAPIPV
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 34MF9
Y012054
Injection site erythema, Injection site swelling, Injection site warmth; Injecti... Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth More
PATIENT RECEIVED THE VACCINES ON 03/20/25, ON THE EVENING OF 03/21/25 THE PATIENTS RIGHT THIGH WAS W... PATIENT RECEIVED THE VACCINES ON 03/20/25, ON THE EVENING OF 03/21/25 THE PATIENTS RIGHT THIGH WAS WARM TO TOUCH RED AND SWOLLEN THE SIZE OF A GOLF BALL. THE OFFICE WAS CLOSED SO MOM TOOK HIM TO THE ER More
2832836 46 F OH 03/24/2025 HPV9
 MERCK & CO. INC.
 0006-4121-02
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Received Gardasil injection instead of Depo-Provera on 3/17/25. Received Gardasil injection instead of Depo-Provera on 3/17/25.
2832837 66 M FL 03/24/2025 PNC20
 PFIZER\WYETH
 LX4482
Extra dose administered Extra dose administered
Duplicate vaccine. First given 2/8/2023 Duplicate vaccine. First given 2/8/2023
2832838 1 M MD 03/24/2025 HEPA
MMR
PNC20
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 Y015027
Y004115
LK6651
Y007176
Body temperature increased, Fatigue, Febrile convulsion, Gaze palsy, Tremor; Bod... Body temperature increased, Fatigue, Febrile convulsion, Gaze palsy, Tremor; Body temperature increased, Fatigue, Febrile convulsion, Gaze palsy, Tremor; Body temperature increased, Fatigue, Febrile convulsion, Gaze palsy, Tremor; Body temperature increased, Fatigue, Febrile convulsion, Gaze palsy, Tremor More
febrile seizure with temp maximum 101.1F without any other signs of illness. Seizure lasted a few m... febrile seizure with temp maximum 101.1F without any other signs of illness. Seizure lasted a few minutes. involved eyes rolling back and jerking movements of arms and legs. patient with fatigue and clinginess immediately following seizure. then returned to baseline in ER More
2832839 11 F 03/24/2025 DF
DF
 SANOFI PASTEUR
SANOFI PASTEUR

Chest pain, Cough, Dizziness, Dyspnoea, Headache; Lymphangitis, Pyrexia, Rash, T... Chest pain, Cough, Dizziness, Dyspnoea, Headache; Lymphangitis, Pyrexia, Rash, Tachycardia, Vomiting More
Day of immunization: chest pain, vomiting, shortness of breath; went to ER. Day after immunization: ... Day of immunization: chest pain, vomiting, shortness of breath; went to ER. Day after immunization: cough, shortness of breath, fever (102.3), dizziness, headache, tachycardia; went to ER again. 2 days after immunization: rash with proximal streaking presumed to be lymphangitis; admitted to hospital for IV antibiotics More
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2832840 6 M TX 03/24/2025 MMR
 MERCK & CO. INC.
 Y014391
Heart rate decreased, Pallor, Vomiting Heart rate decreased, Pallor, Vomiting
Pale, pulse dropped 50, vomited a few minutes after standing. Pale, pulse dropped 50, vomited a few minutes after standing.
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