๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2851891 07/30/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Post herpetic neuralgia, Vaccination failure; Herpes zoster, Post... Herpes zoster, Post herpetic neuralgia, Vaccination failure; Herpes zoster, Post herpetic neuralgia, Vaccination failure More
still dealing with the post herpetic neuralgia (nerve pain) right now; Suspected vaccination failure... still dealing with the post herpetic neuralgia (nerve pain) right now; Suspected vaccination failure; shingles in August 2024; 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. In AUG-2024, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles in August 2024). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: still dealing with the post herpetic neuralgia (nerve pain) right now). The patient was treated with gabapentin. The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia 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 and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 22-JUL-2025 This case was reported by a patient via interactive digital media. The patient mentioned he/she had both shots of Shingles vaccine in 2019 and was diagnosed with shingles in August 2024. The patient is still dealing with the post herpetic neuralgia (nerve pain) right now in July 2025. The patient was put on Gabapentin in October 2024 and was still on it, so it helped some but not much. The patient mentioned the shots did seem to be helped. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2851892 07/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I had shingles when I'm 75; This serious case was reported by a ... Suspected vaccination failure; I had shingles when I'm 75; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In JUL-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had shingles when I'm 75). 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: 23-JUL-2025 This case was reported by a patient via interactive digital media. The patient had shingles when he/she was 75 years old how he/she had the shot. It was not that bad his/her left hand, wrist to shoulder. He/she just got about 10 days ago and it was all dry now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2851893 07/30/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 7MN4C
Pain, Pain in extremity Pain, Pain in extremity
throbbing pain/pinching pain; arm hurts during the day/burning pain in arm; This non-serious case wa... throbbing pain/pinching pain; arm hurts during the day/burning pain in arm; This non-serious case was reported by a consumer and described the occurrence of throbbing pain in a patient who received Men B NVS (Bexsero) (batch number 7MN4C, expiry date 29-FEB-2028) for prophylaxis. In JUL-2025, the patient received Bexsero. In JUL-2025, an unknown time after receiving Bexsero, the patient experienced throbbing pain (Verbatim: throbbing pain/pinching pain) and pain in arm (Verbatim: arm hurts during the day/burning pain in arm). The outcome of the throbbing pain and pain in arm were not resolved. It was unknown if the reporter considered the throbbing pain and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the throbbing pain and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-JUL-2025 The patient's mother reported that case. Two weeks post vaccination of Bexsero vaccine the mom reported that the patient was still experiencing throbbing pain when sleeping, arm hurts during the day and when she lifts it. The patient was seen in office for examination and four days later mom called to report that the arm was still experiencing a pinching or burning pain More
2851894 M WI 07/30/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 9JT4S
Device connection issue, Underdose Device connection issue, Underdose
issue the plastarea on which we turn the needle into to tighten the hub down, both had cracked; Medi... issue the plastarea on which we turn the needle into to tighten the hub down, both had cracked; Medication Dispensing Error; one dose was not fully administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9JT4S, expiry date 21-FEB-2027) for prophylaxis. This case was associated with a product complaint. On 01-JUL-2025, the patient received Boostrix. On 01-JUL-2025, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: one dose was not fully administered). On an unknown date, the patient experienced syringe issue (Verbatim: issue the plastarea on which we turn the needle into to tighten the hub down, both had cracked) and pharmaceutical product complaint (Verbatim: Medication Dispensing Error). The outcome of the underdose, syringe issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the syringe issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 09-JUL-2025,10-JUL-2025 Other HCP reported that a Product Quality Complaint, because two vials of the Boostrix vaccine had an issue the plastic area on which we turn the needle into to tighten the hub down, both had cracked. The medication was squirted everywhere. Also mentioned one dose was not fully administered, and we had to poke the patient again. Reporter reported a PQC because two Boostrix vaccine had an issue the plastic area on which we turn the needle into to tighten the hub down, both have cracked. The medication was squirted everywhere. HCP also mentioned one dose was not fully administered, and they had to poke the patient again. On the other dose, they noticed this issue before administering to the patient. Both suspect syringes were saved. A picture will be sent because when they hold it up to the light we can see a hairline crack at the plastic sheath hub round base with threads/Luer Lock Adaptor. Suspect product was administered for one syringe and no for the other. Luer Lock compatible needle was used. The actual needles that were used on these two syringes have been put in the sharps container however the reporter was willing to send GSK an unopen needle of the same type that was used. It leaked at Luer Lock Adaptor. The one that was being injected into the patient sprayed out in every direction rather than into the patient. The other suspect syringe the leaking was noticed during the removal of the air bubble step, prior to insertion of the needle into he patient. No syringe was pre-assembled with needle some time before administration. Tray and/or box/carton was not damaged. No damage/breakage on the syringe barrel. The leak was not from the plunger stopper. Luer lock was damaged, both syringes LLAs had a hairline crack. If so, describe in detail the needle connection procedure applied: she twists it on until snug she does not force it. Then, she removed the air bubble. Monoject hypodermic safety needle 25-gauge, 1 inch was used. More
2851895 0.58 F CA 07/30/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
given Kinrix to a 7-month-old; This non-serious case was reported by a other health professional via... given Kinrix to a 7-month-old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis. On 11-JUL-2025, the patient received Kinrix. On 11-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: given Kinrix to a 7-month-old). 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: 14-JUL-2025 Physician reported that he/she had given a Kinrix to a 7-month-old, which led to inappropriate age at vaccine administration. More
2851896 FL 07/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
administration of only the adjuvant; administration of only the adjuvant; This non-serious case was ... administration of only the adjuvant; administration of only the adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. In JUN-2025, the patient received Shingrix. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administration of only the adjuvant) and inappropriate dose of vaccine administered (Verbatim: administration of only the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 15-JUL-2025 Reporter stated that they have had several reports of the Shingrix vaccine being administered incorrectly across their organization. Often times, the nurse was giving the patient the adjuvant vial and not reconstituting prior with the adjuvant. The issue was being caused by the way the product was stocked in their medication dispensing cabinets. Because the 10-count box were purchased, the vials were loaded into the cabinet and box discarded, therefore nursing does not had the barcode to be able to scan. Given the structure of the records in their EHR, the barcodes on the individual vials do not scan because the system was expecting the barcode on the outer kit. Because of this, nursing can't scan anything, contributing to them just scanning the adjuvant vial and administering that thinking it's the whole product (they have to bypass the scan so are not getting any sort of trigger that they need to scan the correct vials). The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2851897 F CA 07/30/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 32YB4
Incorrect route of product administration Incorrect route of product administration
administered as IM instead of Subcutaneous; This non-serious case was reported by a other health pro... administered as IM instead of Subcutaneous; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received MMR (Priorix) (batch number 32YB4, expiry date 01-DEC-2026) for prophylaxis. On 15-JUL-2025, the patient received Priorix (intramuscular). On 15-JUL-2025, an unknown time after receiving Priorix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered as IM instead of Subcutaneous). The outcome of the intramuscular formulation administered by other route 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: 16-JUL-2025 Other HCP reported regarding to the immunization Priorix, the MMR vaccine. Reporter just wanted to get information in regard because, they administered as IM instead of Subcutaneous and reporter wanted to know if there was going to be any complications for the patient or anything that should the patient know about it. The patient was administered with Priorix vaccine Intramuscularly, which led to Intramuscular formulation administered by other route. More
2851898 24 M TX 07/30/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3N2ND
Underdose Underdose
adult patient that inadvertently received the pediatric dose; adult patient that inadvertently recei... adult patient that inadvertently received the pediatric dose; adult patient that inadvertently received the pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 24-year-old male patient who received HBV (Engerix B pediatric) (batch number 3N2ND, expiry date 16-JAN-2027) for prophylaxis. On 16-JUL-2025, the patient received Engerix B pediatric. On 16-JUL-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult patient that inadvertently received the pediatric dose) and accidental underdose (Verbatim: adult patient that inadvertently received the pediatric dose). The outcome of the adult use of a child product and accidental underdose 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: 17-JUL-2025 Pharmacist wanted to know if she could give a second pediatric dose to complete a full dose of Engerix-B in an adult patient that inadvertently received the pediatric dose. Adult patient received pediatric of dose of Engerix B, which led to adult use of a child product and accidental underdose. More
2851899 62 M NC 07/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3334Y
Extra dose administered Extra dose administered
got a 3rd dose of Shingrix; This non-serious case was reported by a nurse via call center representa... got a 3rd dose of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 3334Y, expiry date 21-MAR-2027) for prophylaxis. Previously administered products included Shingrix (patient had the 1st dose of Shingrix in 20-JAN-2022) and Shingrix (2rd dose was received by patient in 21-MAR-2022). On 10-MAR-2025, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: got a 3rd dose of Shingrix). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 18-JUL-2025 On 18/Jul/2025, Nurse called to informed that a patient accidentally got a 3rd dose of Shingrix, which led to Extra dose administered. They have had 3 Shingrix injections total. Reporter informed that patient had the 1st dose of Shingrix in 20/Jan/2022,2nd dose in 21/Mar/2022, and the 3rd dose was received by patient in 10/Mar/2022. No further details were provided. The reporter was Consented to follow up. More
2851900 16 M KY 07/30/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB056A
Product preparation error Product preparation error
Boostrix administration with lyophilized powder reconstituted with saline water; Boostrix administra... Boostrix administration with lyophilized powder reconstituted with saline water; Boostrix administration with lyophilized powder reconstituted with saline water; 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 AMVB056A, expiry date 31-AUG-2025) for prophylaxis. On 14-JUL-2025, the patient received Menveo. On 14-JUL-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Boostrix administration with lyophilized powder reconstituted with saline water) and inappropriate dose of vaccine administered (Verbatim: Boostrix administration with lyophilized powder reconstituted with saline water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 21-JUL-2025 The health care provider wanted to know the timeframe to repeat the dose of Menveo 2 vial after administering the lyophilized component with saline water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. More
2851901 49 M AZ 07/30/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 7NX57
Underdose Underdose
accidental administration of a pediatric dose of Engerix-B to a 49 year old; accidental administrati... accidental administration of a pediatric dose of Engerix-B to a 49 year old; accidental administration of a pediatric dose of Engerix-B to a 49 year old; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 49-year-old male patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. On 19-JUL-2025, the patient received the 1st dose of Engerix B pediatric. On 19-JUL-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: accidental administration of a pediatric dose of Engerix-B to a 49 year old) and accidental underdose (Verbatim: accidental administration of a pediatric dose of Engerix-B to a 49 year old). The outcome of the adult use of a child product and accidental underdose 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: 23-JUL-2025 The nurse reported that the accidental administration of a pediatric dose of Engerix B to the adult patient, with the 10 mcg dose administered, which led to adult use of a child product and accidental underdose. The vaccine administration facility was the same as primary reporter. More
2851902 79 F SC 07/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 E5JY2
Expired product administered Expired product administered
Arexvy expired dose administration (less than 30 days); This non-serious case was reported by a phar... Arexvy expired dose administration (less than 30 days); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number E5JY2, expiry date 10-JUL-2025) for prophylaxis. On 21-JUL-2025, the patient received Arexvy. On 21-JUL-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Arexvy expired dose administration (less than 30 days)). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 25-JUL-2025 The pharmacist wanted to get information regarding a maladministration of an expired dose of Arexvy (less than 30 days between the expiration and the administration date) which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. More
2851903 M CA 07/30/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A male patien... COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 included: Paxlovid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2851904 F VA 07/30/2025 COVID19
 PFIZER\BIONTECH
 GH9702
Atrial fibrillation, Cardiac disorder, Heart rate abnormal, SARS-CoV-2 test Atrial fibrillation, Cardiac disorder, Heart rate abnormal, SARS-CoV-2 test
they were diagnosed with AFib; had issues with heart racing; cardiology issues; This is a spontaneou... they were diagnosed with AFib; had issues with heart racing; cardiology issues; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 1, single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (Had received the , Moderna vaccine 3 times prior), for Covid-19 Immunization. The following information was reported: CARDIAC DISORDER (caused and prolonged hospitalization) with onset 2022, outcome "unknown", described as "cardiology issues"; HEART RATE ABNORMAL (caused and prolonged hospitalization) with onset 2022, outcome "unknown", described as "had issues with heart racing"; ATRIAL FIBRILLATION (caused and prolonged hospitalization, medically significant) with onset 2022, outcome "unknown", described as "they were diagnosed with AFib". The events "they were diagnosed with afib", "had issues with heart racing" and "cardiology issues" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: never tested positive for COVID at any time. Therapeutic measures were taken as a result of atrial fibrillation, heart rate abnormal, cardiac disorder. Clinical course: Patient received the Pfizer vaccine on 16Sep2022. Had received the withheld vaccine 3 times prior. This was their first Pfizer vaccine. Patient claims they soon after had issues with heart racing and cardiology issues. Upon seeing an electrophysiologist, medications and monitoring they were diagnosed with AFib. No family history of AFib prior. Patient apparently never tested positive for COVID at any time. Events treatment included medication, three ablation procedures, pacemaker. More
2851906 0.75 F GA 07/30/2025 IPV
 SANOFI PASTEUR
 X1C891M
Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event More
while administering a dose of IPOL to a patient, only one-fourth of the dose was given, and the rest... while administering a dose of IPOL to a patient, only one-fourth of the dose was given, and the rest was partially wasted due to the patient moving with no reported adverse event; Initial information received on 23-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 months 5 days old female patient who was administered IPV (Vero) [IPol] but only one-fourth of the dose was given, and the rest was partially wasted due to the patient moving 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] for Immunisation. On an unknown date in Nov-2025, the patient received dose 1 of suspect IPV (Vero) (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation. On 23-Jul-2025, the patient was administered dose 2 of suspect IPV (Vero) (once) Suspension for injection, Strength Standard, lot X1C891M and expiry date Oct-2026 via intramuscular route in the right thigh for immunization but only one-fourth of the dose was given, and the rest was partially wasted due to the patient moving with no reported adverse event (incorrect dose administered) (Latency Same day). Reportedly, Patient had the first dose of IPol, and this was supposed to be second dose when she was 2 months old, the patient also received a full dose of Daptacel, today without any issues. Treatment - None, 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
2851907 0.5 F MI 07/30/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK174AB
No adverse event, Product preparation issue No adverse event, Product preparation issue
pentacel vaccine was administered to a child using only one vial, without mixing it with the powdere... pentacel vaccine was administered to a child using only one vial, without mixing it with the powdered vial with no reported adverse event; Initial information received on 28-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who had Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered to a child using only one vial, without mixing it with the powdered vial with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Jul-2025, the patient received a 0.5 ml (dose 2) dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (Frequency: once, strength: standard, expiry date: 30-Mar-2026 and lot UK174AB) via intramuscular route in right leg as immunization and administered to a child using only one vial, without mixing it with the powdered vial with no reported adverse event (single component of a two-component product administered) (latency: same day). Action taken: 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
2851908 4 M OH 07/30/2025 DTAPIPVHIB
 SANOFI PASTEUR
Extra dose administered, No adverse event Extra dose administered, No adverse event
inappropriate use due to a possible double dose of dtp-ipv from both quadracel and pentacel with no ... inappropriate use due to a possible double dose of dtp-ipv from both quadracel and pentacel with no reported adverse event; Initial information received on 29-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4-year-old male patient and is reported inappropriate use due to a possible double dose of dtp-ipv from both quadracel and diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] 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 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Quadracel) for Immunisation. On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection Frequency = Once (strength, dose, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization and is reported inappropriate use due to a possible double dose of dtp-ipv from both quadracel and pentacel with no reported adverse event (extra dose administered) (unknown latency).Information regarding batch number corresponding to the one at time of event occurrence is requested. 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
2851909 5 F 07/30/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Wrong product administered Wrong product administered
Tdap vaccine was given to patient, instead of DTap. Patients mother was made aware that there is les... Tdap vaccine was given to patient, instead of DTap. Patients mother was made aware that there is less immunity for pertussis in Tdap and that if she would like patient can be brought in for a booster later down the road. More
2851910 49 M CA 07/30/2025 COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
 1808952
1808952
1808952
Anxiety, Apathy, Asthenia, Brain fog, Confusional state; Dizziness, Fatigue, Hea... Anxiety, Apathy, Asthenia, Brain fog, Confusional state; Dizziness, Fatigue, Headache, Insomnia, Memory impairment; Tinnitus, Vertigo, Visual impairment More
Ever since about 7-10 days after 5/28/2021 vaccination, considerable persistent, unchanging and tinn... Ever since about 7-10 days after 5/28/2021 vaccination, considerable persistent, unchanging and tinnitus -- horrible high-pitched piercing noise that never changes or ends Throbbing headaches, dizziness and visual impairments, confused state, memory impairment, anxiety, vertigo, insomnia Constant fatigue, brain fog, lack of motivation, and have zero energy More
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2851911 M ID 07/30/2025 HEP
HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 GC3N4
GC3N4
GC3N4
GC3N4
Atrial septal defect, Cerebral ventricle dilatation, Chest X-ray, Echocardiogram... Atrial septal defect, Cerebral ventricle dilatation, Chest X-ray, Echocardiogram, Electroencephalogram; Endotracheal intubation, Feeding disorder, Intraventricular haemorrhage neonatal, Lumbar puncture, Magnetic resonance imaging; Neonatal seizure, Periventricular leukomalacia, Posthaemorrhagic hydrocephalus, Pyrexia, Swallow study; Swelling, Ultrasound head More
Initially patient developed symptoms with a fever and head swelling after 4-30-25 with no fever or s... Initially patient developed symptoms with a fever and head swelling after 4-30-25 with no fever or swelling initially after birth. By 5-4-25 he was diagnosed with Intraventricular hemorrhage of newborn Grade IV, Cerebral ventriculomegaly 5-4-25, Periventricular leukomalacia 5-12-25, seizures in newborn 5-18-25, post hemorrhagic hydrocephalus 5-23-25, patent foramen ovale 5-25-25, and feeding difficulties 6-5-25. More
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2851912 21 F WI 07/30/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 K7JY3
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Redness and Swelling around injection site Redness and Swelling around injection site
2851920 42 F TX 07/30/2025 HEP
HEP
 DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION

Acute stress disorder, Allergy test negative, Dermatitis contact, Food allergy, ... Acute stress disorder, Allergy test negative, Dermatitis contact, Food allergy, Skin burning sensation; Swelling face, Urticaria More
Within days, started having allergic reactions to foods and skincare that had never caused reactions... Within days, started having allergic reactions to foods and skincare that had never caused reactions before in 42 years. Burning in my face, swelling in my face, hives over my arms, neck and chest. Went to emergency room for second reaction, not stopped by Benedryl. Symptoms match Mast Cell Activation Syndrome. I now have allergic reactions to stress and certain foods (although allergy tests show no allergy to foods). Controlled mostly with diet, the doctors I have seen don?t know anything about MCAS, so no treatment so far. More
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2851921 42 F AZ 07/30/2025 MMRV
 MERCK & CO. INC.
 Z002991
Cold sweat, Dizziness, Dysgeusia, Palpitations Cold sweat, Dizziness, Dysgeusia, Palpitations
Pt called clinic informing us of the following symptoms: heart racing / weird taste in mouth / woozy... Pt called clinic informing us of the following symptoms: heart racing / weird taste in mouth / woozy/ lightheaded / clamy. The symptoms started approximately and hr after getting the vaccine. The pt has reported she took Benadryl to help with symptoms. More
2851922 90 F IA 07/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 35a77
Injection site erythema Injection site erythema
Significant redness to administration site; monitoring and otc pain relievers ; discussed if worsens... Significant redness to administration site; monitoring and otc pain relievers ; discussed if worsens to see pcp More
2851923 8 M TX 07/30/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Asymptomatic. Vaccine given at the wrong age. Asymptomatic. Vaccine given at the wrong age.
2851924 2 M MN 07/30/2025 DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH



Asthenia, Immunisation reaction, Injection site rash, Injection site scar, Letha... Asthenia, Immunisation reaction, Injection site rash, Injection site scar, Lethargy; Loss of personal independence in daily activities, Malaise, Pyrexia, Rash; Asthenia, Immunisation reaction, Injection site rash, Injection site scar, Lethargy; Loss of personal independence in daily activities, Malaise, Pyrexia, Rash More
Within 24 hours of receiving multiple vaccines (DTaP ? 1st dose, Pneumococcal ? 2nd dose, different ... Within 24 hours of receiving multiple vaccines (DTaP ? 1st dose, Pneumococcal ? 2nd dose, different product than prior), my child developed a severe adverse reaction. It began with an extremely bad rash at the vaccine site that quickly spread over his entire body. He developed a very high fever of 104?105๏ฟฝF and became so sick he could barely function ? lethargic, weak, and unable to engage in normal activity. I contacted his clinic immediately and provided photos. Nurses and staff expressed alarm, stating they had ?never seen anything like this,? and instructed me to monitor him closely at home. The reaction was severe enough to leave a permanent scar at the injection site, still visible one year later. More
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2851925 21 F CA 07/30/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Blood glucose normal, Syncope Blood glucose normal, Syncope
A few minutes after administering the vaccine, the patient fainted. I had stepped back into the phar... A few minutes after administering the vaccine, the patient fainted. I had stepped back into the pharmacy to retrieve some documents when I heard her mother call for help. Her mother was able to prevent her from falling out of the chair she was sitting in. She was unconscious just briefly as she regained consciousness by the time I looked into the vaccination room. We had her lay on the floor and I called 911 per protocol. Prior to the paramedics arriving, the patient started to feel better, sat up, and sipped some water. When the paramedics arrived, they took her blood pressure and blood sugar. After monitoring her, they cleared her and the mother and patient decided against going to the emergency room. More
2851926 1.08 M KY 07/30/2025 MMR
 MERCK & CO. INC.
Autism spectrum disorder, Cytogenetic abnormality, Developmental regression Autism spectrum disorder, Cytogenetic abnormality, Developmental regression
Patient started showing signs of regression 3 months after receiving MMR, pnuemonccal, and HEP A vac... Patient started showing signs of regression 3 months after receiving MMR, pnuemonccal, and HEP A vaccines at age 13 months on 4/25/24. On 7/25/24 he was there for a late 15 month well child follow up, where more vaccines were administered (HipB, Flu) a developmental test was completed and autism signs were given. At this appointment patient also was given a referral for OT, PT, and Speech. Before said appt on 4/25/25 he was attempting to walk, talk, sign, etc. He had stopped everything by this point. Patient has since been diagnosed with a rare genetic disorder & level 3 profound autism. Patient still is completely nonverbal. His life is altered in ways he will never get back. More
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2851927 67 F WA 07/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 pj353
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
Injection site red & hot to the touch Injection site red & hot to the touch
2851928 12 F AZ 07/30/2025 MENB
TDAP
 PFIZER\WYETH
SANOFI PASTEUR
 LL0637
U8389AA
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
pt received Men B injection on 07/29/2025 instead of MCV4 for childhood vaccines. pt came in today 0... pt received Men B injection on 07/29/2025 instead of MCV4 for childhood vaccines. pt came in today 07/30/2025 for reaction on right arm and back red rash. pt denied SOB/chest pain fevers or fatigue. Advised supportive care: acetaminophen or NSAIDs for discomfort, cold compress to the area, and observation over the next 48 72 hours. Instructed to monitor for any signs of progression. More
2852152 16 M GA 07/30/2025 MENB
MENB
MENB
MENB
MENB
MENB
MENB
MENB
MENB
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 5XA2J
5XA2J
5XA2J
5XA2J
5XA2J
5XA2J
5XA2J
5XA2J
5XA2J
U8508AA
U8508AA
U8508AA
U8508AA
U8508AA
U8508AA
U8508AA
U8508AA
U8508AA
Anion gap, Basophil count normal, Basophil percentage, Blood calcium normal, Blo... Anion gap, Basophil count normal, Basophil percentage, Blood calcium normal, Blood chloride increased; Blood creatinine increased, Blood glucose normal, Blood lactic acid abnormal, Blood potassium normal, Blood sodium normal; Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal, Computerised tomogram head normal, Differential white blood cell count abnormal; Electrocardiogram abnormal, Eosinophil count normal, Eosinophil percentage decreased, Eye movement disorder, Foaming at mouth; Full blood count abnormal, Haematocrit normal, Haemoglobin normal, Incontinence, Lip injury; Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal; Mean platelet volume normal, Metabolic function test abnormal, Moaning, Monocyte count normal, Monocyte percentage; Neutrophil count normal, Neutrophil percentage, Platelet count normal, Red blood cell count normal, Red cell distribution width; Sinus tachycardia, Vomiting, White blood cell count normal; Anion gap, Basophil count normal, Basophil percentage, Blood calcium normal, Blood chloride increased; Blood creatinine increased, Blood glucose normal, Blood lactic acid abnormal, Blood potassium normal, Blood sodium normal; Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal, Computerised tomogram head normal, Differential white blood cell count abnormal; Electrocardiogram abnormal, Eosinophil count normal, Eosinophil percentage decreased, Eye movement disorder, Foaming at mouth; Full blood count abnormal, Haematocrit normal, Haemoglobin normal, Incontinence, Lip injury; Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal; Mean platelet volume normal, Metabolic function test abnormal, Moaning, Monocyte count normal, Monocyte percentage; Neutrophil count normal, Neutrophil percentage, Platelet count normal, Red blood cell count normal, Red cell distribution width; Sinus tachycardia, Vomiting, White blood cell count normal More
16 y.o. male who presents for evaluation of a possible seizure. Earlier today around 13:30, he atten... 16 y.o. male who presents for evaluation of a possible seizure. Earlier today around 13:30, he attended a well check visit where he received required Meningitis A and optional Meningitis B vaccinations, one in each arm. After returning home around 16:00, his mother laid down and soon heard moaning and banging noises from the living room. She went into the living room where he was to find him lying on his side, foaming at the mouth, with his eyes rolled back and biting his lip. He was not violently shaking, though the banging she heard could have been from shaking. He experienced incontinence during the episode as well as emesis following the event. The episode lasted approximately 2-3 minutes. The patient recalls eve More
2851553 07/29/2025 PNC21
 MERCK & CO. INC.
 Y019158
Injection site rash, Lymphadenopathy, Rash erythematous Injection site rash, Lymphadenopathy, Rash erythematous
Reports swollen lymph node and raised irregular red rash i; raised irregular red rash in front of ar... Reports swollen lymph node and raised irregular red rash i; raised irregular red rash in front of armpit on left side approx 3 x 3 inches appeared the day after.; This spontaneous report was received from a consumer via company representative 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 07-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y019158 which has been verified to be a valid number, expiration date reported an validated as 20-May-2026), administered by Intramuscular route in left arm (deltoid), as a prophylaxis. On 08-Jul-2025 (the day after), the patient experienced swollen lymph node and raised irregular red rash in front of armpit on left side approx. 3 x 3 inches appeared. At the reporting time, the outcome of swollen lymph nodes and red rash was unknown. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. More
2851554 IL 07/29/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 X022985
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
No additional AEs were reported; Medical assistant reported that a patient received an expired MMR I... No additional AEs were reported; Medical assistant reported that a patient received an expired MMR II vaccine on 7/14/2025.; This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 14-JUL-2025, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered as the first dose for prophylaxis (lot number reported as X022985, which has been verified as valid, expiration date reported and validated as 08-JUN-2025) (dose, route of administration, and anatomical site of injection were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported) (Expired product administered). No additional adverse events were reported. More
2851555 FL 07/29/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, Incorrect dose administered, N... Inappropriate schedule of product administration, Incorrect dose administered, No adverse event More
first dose was administered (July 2, 2024). 2nd dose should have been administered 2 months later i... first dose was administered (July 2, 2024). 2nd dose should have been administered 2 months later in September 2024; No additional AE; 5 ML; This spontaneous report was received from a pharmacist, concerning to a 31-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-Jul-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), 5 mL (5 ML), (lot # and expiration date were not reported), as prophylaxis. (Incorrect dose administered) Since the second dose dose should have been administered 2 months later in September 2024, the doses would not entered in the recommended interval of 13 months. (Inappropriate schedule of product administration). No additional adverse event (No adverse event). More
2851556 6 F AL 07/29/2025 DTAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
UA8274AA
Product administered to patient of inappropriate age, Wrong product administered... Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered More
inadvertently administered ADACEL to a pediatric patient instead of the scheduled DAPTACEL with no r... inadvertently administered ADACEL to a pediatric patient instead of the scheduled DAPTACEL with no reported adverse event; administering adacel to a 6-year-old patient with no reported adverse event; Initial information received on 23-Jul-2025 (live follow up processed together) regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 years old pediatric female patient who was inadvertently administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] instead of the scheduled diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event and administering adacel to a 6-year-old patient 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 Polio vaccine (Polio vaccine) and Hepatitis a vaccine (Hepatitis a vaccine) for prophylactic vaccination (Immunisation). On 23-Jul-2025, the 6-year-old pediatric patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, suspension for injection (lot UA8274AA and expiry date: 30-Aug-2026) (strength not reported) via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation) instead of the scheduled diphtheria-15/tetanus/5 ac pertussis vaccine with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (Latency: same day). Reportedly, The patient's supposed to receive her 5th dose of DTaP, but was given with ADACEL instead. 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
2851557 M DE 07/29/2025 DTAPIPVHIB
 SANOFI PASTEUR
Expired product administered, No adverse event Expired product administered, No adverse event
patient received expired PENTACEL vaccine with no reported adverse event; Initial information receiv... patient received expired PENTACEL vaccine with no reported adverse event; Initial information received on 24-Jul-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves an unknown age male patient who received an expired diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] 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 expired suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (expired product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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
2851570 F 07/29/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Angioedema, Mastocytosis Angioedema, Mastocytosis
Giant hives; Mastosyposis; This serious case was reported by a consumer and described the occurrence... Giant hives; Mastosyposis; This serious case was reported by a consumer and described the occurrence of giant hives in a 78-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 14-JUL-2025, the patient received RSV vaccine. On 14-JUL-2025, less than a day after receiving RSV vaccine, the patient experienced giant hives (Verbatim: Giant hives) (serious criteria GSK medically significant). In JUL-2025, the patient experienced mastocytosis (Verbatim: Mastosyposis). The outcome of the giant hives was not resolved and the outcome of the mastocytosis was not reported. It was unknown if the reporter considered the giant hives and mastocytosis to be related to RSV vaccine. The company considered the giant hives to be unrelated to RSV vaccine. It was unknown if the company considered the mastocytosis to be related to RSV vaccine. Additional Information: GSK Receipt Date: 16-JUL-2025 The reporter reported that the patient had mastosyposis and giant hives.; Sender's Comments: A case of Angioedema, less than a day after receiving RSV vaccine, in a 78-year-old female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2851571 65 07/29/2025 VARZOS
VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Diarrhoea, Fatigue, Headache, Herpes zoster, Nausea; Vaccination failure; Diarrh... Diarrhoea, Fatigue, Headache, Herpes zoster, Nausea; Vaccination failure; Diarrhoea, Fatigue, Headache, Herpes zoster, Nausea; Vaccination failure More
Suspected Vaccination failure; mild case of shingles for the 2nd time on my thigh/have shingles now/... Suspected Vaccination failure; mild case of shingles for the 2nd time on my thigh/have shingles now/headache and fatigue; nausea; diarrhea; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 65-year-old 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), shingles (Verbatim: mild case of shingles for the 2nd time on my thigh/have shingles now/headache and fatigue), nausea (Verbatim: nausea) and diarrhea (Verbatim: diarrhea). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the nausea and diarrhea were resolved. It was unknown if the reporter considered the vaccination failure, shingles, nausea and diarrhea 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, nausea and diarrhea to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 21-JUL-2025 and 22-JUL-2025 This case was reported by a patient via interactive digital media. The patient had two Shingles shots and have shingles now and the patient got it last year in 2024. The patient stated that it was a mild case of the shingles for the 2nd time on his/her right outer thigh. The worse part was the nausea, diarrhea, headache and fatigue and lasted a couple days. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2851572 F 07/29/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Eye pain, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure Eye pain, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
suspected vaccination failure; twice in the eye; I have had shingles 3 times once on the body; This ... suspected vaccination failure; twice in the eye; I have had shingles 3 times once on the body; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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), ophthalmic herpes zoster (Verbatim: twice in the eye) (serious criteria GSK medically significant) and shingles (Verbatim: I have had shingles 3 times once on the body). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster 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: 20-JUL-2025 This case was reported by a wife of the patient via interactive digital media. She had received the shot a while ago and she had shingles three times once on her body and twice in her eye. This year was the third time. The episodes in her eyes were worse than the one on her body. It felt like someone was sticking a screwdriver in her eye. The reporter tried to get ointment this year, but it was over dollar 500 and her insurance did not cover it. She eventually got eye drops, which shea had to use four to six times a day. 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 ophthalmic herpes zoster and shingles were unknown at the time of reporting. This case was linked with US2025AMR094239 reported by same reporter.; Sender's Comments: A case of Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine, in a female patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. 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. US-GSK-US2025AMR094239:same reporter More
2851573 13 M 07/29/2025 DTAP
 SANOFI PASTEUR
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
Accidental administration of DTaP instead of Tdap with no reported adverse event; Initial informatio... Accidental administration of DTaP instead of Tdap with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 13 years old male patient who accidentally received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine 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 in July 2025, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site for Tdap vaccination series (immunisation), instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine, (unknown formulation strength and expiry date) lot number not reported with no reported adverse event (wrong product administered) (unknown latency) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. 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
2851630 49 F MI 07/29/2025 COVID19
 MODERNA
Vitiligo Vitiligo
Vitaligo, I have it on my hands legs arms face and lips. I went to get treatment from a dermatologis... Vitaligo, I have it on my hands legs arms face and lips. I went to get treatment from a dermatologist she said it was probably dormant and the shot made it activate. I tried creams and light therapy they didn't worm. More
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2851631 62 M MO 07/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chills, Injection site pain, Injection site swelling, Pyrexia Chills, Injection site pain, Injection site swelling, Pyrexia
Low grade fever up to 100.5F the next day and 1 afternoon low grade fever spike 2 days later with ch... Low grade fever up to 100.5F the next day and 1 afternoon low grade fever spike 2 days later with chills and localized pain and slight swelling at injection site.. Treated with advil and bed rest. More
2851632 76 M IA 07/29/2025 COVID19
 MODERNA
Death Death
Resident expired Resident expired
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2851633 13 F KS 07/29/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 Z005469
D2343
EB499
Fall, Tooth fracture; Fall, Tooth fracture; Fall, Tooth fracture Fall, Tooth fracture; Fall, Tooth fracture; Fall, Tooth fracture
Patient was given the immunizations patient was talking with nurse and mother for several minutes af... Patient was given the immunizations patient was talking with nurse and mother for several minutes after the vaccines were given. Nurse turned her back and was at the sink in the room when she heard patient's mother say something. Nurse turned around and patient was falling face first onto the floor. Patient was rolled over by her mother and the nurse. Patient was alert and oriented X3. Patient was assisted up and given a cup of orange juice and a cool washcloth to help cool her down, and an ice pack for her forehead. Patient did report that she chipped her bottom tooth. PA-C did come back in the room and did an assessment of the patient after the incident. More
2851634 61 F NC 07/29/2025 PNC21
PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Z006076
Z006076
Z006076
Asthenia, Chills, Decreased appetite, Feeling hot, Impaired work ability; Inject... Asthenia, Chills, Decreased appetite, Feeling hot, Impaired work ability; Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth, Pain, Sleep disorder More
The day after receiving the pneumonia vaccine, she developed a painful, swollen, and itchy area on h... The day after receiving the pneumonia vaccine, she developed a painful, swollen, and itchy area on her arm with a 'bull's eye' appearance. The area feels hot with a supraclavicular lump that she suspects is a swollen lymph node. The pain is significant, interfering with sleep and causing discomfort upon touch. She has been alternating ibuprofen and Tylenol every four to six hours initially, then as needed, but continues to feel weak with no appetite. She experiences chills and body aches but no fever. She feels too weak to work. She uses cool compresses for warmth and discomfort in the affected area and is concerned about infection, noting the area feels 'bumpy' and is unsure if it is hives. Cellulitis of left upper extremity Localized erythema, warmth, swelling, and pain at injection site. Differential includes localized erythema from injection site reaction versus cellulitis. Likely isolated skin reaction given worsening symptoms and warmth to palpation. - Prescribe doxycycline 100 mg orally twice daily for 7 days. - Advise cool compresses to affected area. - Instruct to use ibuprofen and acetaminophen as needed for pain. - Mark erythema border to monitor expansion. More
2851635 25 F TX 07/29/2025 DTAP
DTAP
 SANOFI PASTEUR
SANOFI PASTEUR

Chills, Dizziness, Fatigue, Headache, Pain; Pain in extremity, Peripheral swelli... Chills, Dizziness, Fatigue, Headache, Pain; Pain in extremity, Peripheral swelling, Pyrexia More
Low fever, chills, body aches, very bad headache, dizziness, fatigue, body pains, swollen upper arm,... Low fever, chills, body aches, very bad headache, dizziness, fatigue, body pains, swollen upper arm, immense pain in my upper arm. More
2851636 0.17 M TX 07/29/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.

No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Patient given the wrong set of vaccines. No adverse reaction occured. Infant was fine. No fever or ... Patient given the wrong set of vaccines. No adverse reaction occured. Infant was fine. No fever or reaction. Parents notified. More
2851637 38 F GA 07/29/2025 HEP
MMRV
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
 Y5X9T
Y004996
U8115AA
No adverse event, Underdose; No adverse event, Underdose; No adverse event, Unde... No adverse event, Underdose; No adverse event, Underdose; No adverse event, Underdose More
06/11/2025 -The patient did not experience any adverse event. No symptoms to be reported. The patien... 06/11/2025 -The patient did not experience any adverse event. No symptoms to be reported. The patient received the pediatric dose of MMR + Varicella for children <13 y/o age. No treatment was necessary. The outcome was the patient is doing well. More
2851638 59 F MA 07/29/2025 YF
 SANOFI PASTEUR
 UK133AB
Fatigue, Laboratory test normal Fatigue, Laboratory test normal
Pt received Yellow Fever on 4/15/25. Pt called facility on 7/29/25 to report that she feels she is h... Pt received Yellow Fever on 4/15/25. Pt called facility on 7/29/25 to report that she feels she is having an adverse reaction to the Yellow fever Vaccine. The patient states she began to experience extreme fatigue in June. Pt states she has been seen by her PCP and had labs completed by PCP, states all labs are WNL. Pt states that the fatigue is unrelenting and plans to follow up again with her PCP for further evaluation. More
2851639 12 M AL 07/29/2025 HPV9
 MERCK & CO. INC.
 Z002903
Blindness, Cold sweat, Lethargy, Loss of consciousness Blindness, Cold sweat, Lethargy, Loss of consciousness
The patient and his mother left our office on the second floor after receiving the vaccine. When the... The patient and his mother left our office on the second floor after receiving the vaccine. When they reached the first floor lobby, the mother states that the patient complained about being unable to see then immediately passed out. Mom dragged the patient back into the elevator and brought him back to the second floor. Our staff was called into the hall to assist. The patient was verbal and oriented, but lethargic and clammy. He was able to ambulate into the office and sit. Upon taking his blood pressure, it was initially 69/44. He was given a snack then escorted to lie down in an exam room. The patient confirmed that he was feeling better and his vision was back normal. We observed him for approximately 20 minutes, monitoring vital signs. The blood pressure came up to 103/75 sitting and 103/68 standing. Patient was assessed by Dr. then cleared to leave. More
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