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
2833687 03/28/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
suspected vccination failure; I had both vaccines and still got shingles; This serious case was repo... suspected vccination failure; I had both vaccines and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 vccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had both vaccines and still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 24-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had received both vaccines and still got shingles. It was painful for about 2 weeks. The reporter mentioned that he/she never got the rash which they believe was suppressed from the vaccine. He/she had nothing to compare it to but he/she thinks it would had been much worse if he/she had not been vaccinated. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, 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
2833688 03/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected Vaccination failure; shingles on face and head; This serious case was reported by a consum... Suspected Vaccination failure; shingles on face and head; 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. The patient's past medical history included shingles (years ago). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on face and head). 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. 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-MAR-2025 This case was reported by a patient via interactive digital media. The patient had shingles years ago, got the shingles vaccine and now have shingles on face and head. Truly was the worst pain patient have ever had. 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 for shingles and laboratory confirmation regarding shingles ) is considered unrelated to GSK vaccine Shingles vaccine More
2833689 03/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
painful; This non-serious case was reported by a consumer via interactive digital media and describe... painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: painful). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient just got his/her first Shingles shot and boy was it painful. More
2833690 03/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspeceted vaccination failure; I currently have shingles right side on my head and face; This serio... Suspeceted vaccination failure; I currently have shingles right side on my head and face; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I currently have shingles right side on my head and face). 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: 22-MAR-2025 The reporter reported that he/she currently had shingles right side on head and face but it was getting better after three days and it was painful, but the reporter had the vaccine because his/her doctor asked if the reporter had chicken pox and she recommended the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2833691 03/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
took the shingles vaccine andhad shingles 3 times since vaccine/ suspected vaccination failure; had ... took the shingles vaccine andhad shingles 3 times since vaccine/ suspected vaccination failure; had shingles 3 times since vaccine and each time it became worse; 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: took the shingles vaccine andhad shingles 3 times since vaccine/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 3 times since vaccine and each time it became worse). 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: 24-MAR-2025 This case was reported by a patient via interactive digital media. The patient took the shingles vaccine and had shingles 3 times since the vaccine and each time it became worse. 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 vaccine Shingles vaccine More
2833692 47 F TX 03/28/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 233FT
Underdose Underdose
adult patient received a pediatric dose of Engerix B; adult patient received a pediatric dose of Eng... adult patient received a pediatric dose of Engerix B; adult patient received a pediatric dose of Engerix B; 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 47-year-old female patient who received HBV (Engerix B pediatric) (batch number 233FT, expiry date 12-DEC-2025) for prophylaxis. On 14-MAR-2025, the patient received Engerix B pediatric. On 14-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult patient received a pediatric dose of Engerix B) and underdose (Verbatim: adult patient received a pediatric dose of Engerix B). The outcome of the adult use of a child product and 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: 18-MAR-2025 The nurse called to inform that on 14th March 2025 an adult patient received a pediatric dose of Engerix B which led to adult use of a child product and underdose. Should administer another pediatric dose? The vaccine administration facility is the same as primary reporter. More
2833693 F MD 03/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 X5J23
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient received first Shingrix vaccine about 10 months ago, and they receive their second now; This... patient received first Shingrix vaccine about 10 months ago, and they receive their second now; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) (batch number X5J23, expiry date 25-JAN-2026) for prophylaxis. Previously administered products included Shingrix (first Shingrix vaccine about 10 months ago). 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: patient received first Shingrix vaccine about 10 months ago, and they receive their second now). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 18-MAR-2025 The patient received their first Shingrix vaccine about 10 months ago, and they receive their second now which led to Drug dose administration interval too long. No further details were collected. More
2833694 AZ 03/28/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Product preparation issue Product preparation issue
Administration of only the liquid portion; Administration of only the liquid portion; This non-serio... Administration of only the liquid portion; Administration of only the liquid portion; 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 MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. In MAR-2025, the patient received Priorix. In MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of only the liquid portion) and inappropriate dose of vaccine administered (Verbatim: Administration of only the liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 18-MAR-2025 The pharmacist reported that they had a new pharmacist here the other day, she think she gave the Priorix the new MMR, and she do not think she add it the stuff that was inside the little vial to it. The pharmacist think she only gave the syringe liquid which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist mentioned that she was not sure that this was administer to a patient. The pharmacist mentioned that they just had the vaccine since 1 week ago, so in case that this was administer this happened just a few days ago. More
2833695 FL 03/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient had not received the 2nd dose yet; This non-serious case was reported by a pharmacist via ca... patient had not received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in SEP-2018). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient had not received the 2nd dose yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 20-MAR-2025 The pharmacist reported that they had a patient whose first Shingrix vaccine and had not received the 2nd dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2833696 82 F CA 03/28/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52Z52
Product preparation issue Product preparation issue
one of the powder vials (diluent) was not mixed; one of the powder vials (diluent) was not mixed; Th... one of the powder vials (diluent) was not mixed; one of the powder vials (diluent) was not mixed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis. On 20-MAR-2025, the patient received Arexvy. On 20-MAR-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: one of the powder vials (diluent) was not mixed) and inappropriate dose of vaccine administered (Verbatim: one of the powder vials (diluent) was not mixed). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 20-MAR-2025 The pharmacist reported that after mixing doses, he/she realized that after vaccination one of the powder vials (diluent) was not mixed and the patient was given an incomplete dose which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist does not know which of these patients was given the incomplete dose. No further information was obtained The Vaccine Administration Facility was the same as Primary Reporter. This case was linked with US2025034231, reported by same reporter.; Sender's Comments: US-GSK-US2025034231:same reporter different patient More
2833697 63 M MI 03/28/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
received Priorix vaccine intramuscularly; Out of recommended age range; This non-serious case was re... received Priorix vaccine intramuscularly; Out of recommended age range; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 63-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 13-MAR-2026) for prophylaxis. On 21-MAR-2025, the patient received Priorix (intramuscular). On 21-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: received Priorix vaccine intramuscularly) and inappropriate age at vaccine administration (Verbatim: Out of recommended age range). The outcome of the subcutaneous injection formulation administered by other route 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: 21-MAR-2025 The pharmacist reported that the patient received an intramuscular dose of Priorix which led to, subcutaneous injection formulation administered by other route. The reporter mentioned that aside from the administration error, it was also noted that the patient was outside of the age range described in the prescribing information which led to, inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter. More
2833698 M NM 03/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Intercepted product prescribing error Intercepted product prescribing error
Shingrix prescribed under age with shingles episode; This non-serious case was reported by a pharmac... Shingrix prescribed under age with shingles episode; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included shingles, tingling (tingling in trunk, legs and arms) and burning sensation. On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted drug prescribing error (Verbatim: Shingrix prescribed under age with shingles episode). The outcome of the intercepted drug prescribing error was not applicable. Additional Information: GSK Receipt Date: 24-MAR-2025 The pharmacist reported that they have a patient that was younger than 50 years of age but they had shingles and they are having tingling in trunk, legs and arms, and burning sensation in the skin, without rash. The doctor prescribed Shingrix but caller did not feel comfortable giving the vaccine if patient was having symptoms. More
2833699 03/28/2025 COVID19
 PFIZER\BIONTECH
Abdominal distension, Chills, Faeces discoloured, Pyrexia Abdominal distension, Chills, Faeces discoloured, Pyrexia
chills; fever; digestions feel like bloated, very gassy; stool is kind of yellowish color/gassy yell... chills; fever; digestions feel like bloated, very gassy; stool is kind of yellowish color/gassy yellow stool; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Mar2025 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: CHILLS (non-serious) with onset Mar2025, outcome "unknown"; ABDOMINAL DISTENSION (non-serious) with onset Mar2025, outcome "unknown", described as "digestions feel like bloated, very gassy"; PYREXIA (non-serious) with onset Mar2025, outcome "unknown", described as "fever"; FAECES DISCOLOURED (non-serious) with onset Mar2025, outcome "unknown", described as "stool is kind of yellowish color/gassy yellow stool". Additional information: the patient got a shot about a week ago, couple of days after he got it, the patient experienced chills and fever but did not take temperature. Started digestions feel like bloated, very gassy and stool was kind of yellowish color. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2833700 76 M IL 03/28/2025 COVID19
 PFIZER\BIONTECH
Dysphagia Dysphagia
had a lot of troubles swallowing; This is a spontaneous report received from a Consumer or other non... had a lot of troubles swallowing; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing). Concomitant medication(s) included: ALDACTONE [SPIRONOLACTONE] taken for hypertension; PREVACID. Vaccination history included: Bnt162b2 (Dose number unknown, Patient thought he had had three previous immunization with Pfizer covid-19 vaccine, but was not sure), for covid-19 immunisation. The following information was reported: DYSPHAGIA (non-serious) with onset Dec2024, outcome "recovered", described as "had a lot of troubles swallowing". The event "had a lot of troubles swallowing" required emergency room visit. Therapeutic measures were not taken as a result of dysphagia. Additional information: The patient did not receive any other vaccine administered on the same day as the Pfizer Covid-19 Vaccine. When probed if consumer took any vaccine 4 weeks prior taking the Pfizer Covid-19 Vaccine, patient stated that all the vaccines the patient took were from Pfizer. Patient mentioned that he took a shot of the COVID-19 (it was just a normal dose ) and then after that he had a lot of troubles swallowing in December of 2024 for about 6 hours and it did not go totally away for about 2 days. It got better over the next two days and it was totally gone after two days. Patient had had lab test but not for this. For this patient almost went for emergency room but now with no treatment. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2833701 F TN 03/28/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from... I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female 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 included: "lung cancer" (ongoing), notes: since patient had lung cancer. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacture Unknown, Lot: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), Manufacture Unknown, Lot: Unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Mar2025, outcome "unknown" and all described as "I tested positive for Covid". The event "i tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Mar2025) Positive. Clinical course: Wednesday (19Mar2025) patient tested positive for Covid for the first time. Patient had all the Covid booster shots. Patient's doctor prescribed Paxlovid and when patient's husband picked it up we had to pay dollar 735 out of pocket. That was half of patient's insurance check for the whole month. Patient felt the need to take it since patient had lung cancer but patient would never buy a Pfizer product again. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2833702 M TX 03/28/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Nasopharyngeal swab, SARS-CoV-2 test COVID-19, Drug ineffective, Nasopharyngeal swab, SARS-CoV-2 test
gotten Covid; gotten Covid/ they swabbed me for the Flu and they swabbed me for the COVID and it cam... gotten Covid; gotten Covid/ they swabbed me for the Flu and they swabbed me for the COVID and it came back positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 50-year-old male patient received BNT162b2 (BNT162B2 NOS), in Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Vaccination for the flu, administration date: Nov2023, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "gotten Covid"; COVID-19 (medically significant), outcome "unknown", described as "gotten Covid/ they swabbed me for the Flu and they swabbed me for the COVID and it came back positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: positive; Unknown Results; SARS-CoV-2 test: I have COVID. Clinical course: The Caller stated, "This is my second time I've gotten Covid." When asked if they had taken Paxlovid previously, the Caller stated, "No I didn't. I got it when it first came out and I didn't get sick at all. Nothing. But it's so weird cause I didn't get sick; the only thing that happened to me was that I lost my sense of smell and taste. I took the vaccination in Jan2024 and I got it again" "They said cause you got high blood pressure we're gonna put you on Paxlovid" "The only symptom I had was I was sneezing my nose was runny all days I can't have the Flu, there's no way that I can have the Flu because I got the vaccination for the flu last Nov2023" "And then, so when I went and got vaccinated for the COVID, they have me some home test kits, so I said I'm going to test myself here at the house, and I tested myself and I told my wife, it's showing that I have COVID, she said for real? Let's go to the doctor So yeah, they swabbed me for the Flu and they swabbed me for the COVID and it came back positive It was horrible yesterday, but then I have allergies, so I thought maybe it's my allergies I knew something was wrong yesterday, because I went to sleep because I started like, I mean, it wasn't even cold when I was laying down and I was shivering I was shaking". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2833703 03/28/2025 COVID19
 PFIZER\BIONTECH
Non-cardiac chest pain Non-cardiac chest pain
I had an unrelated health condition when I tried switching to pfizer but it caused chest pain (suppo... I had an unrelated health condition when I tried switching to pfizer but it caused chest pain (supposedly non cardiac); This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: NON-CARDIAC CHEST PAIN (non-serious), outcome "unknown", described as "I had an unrelated health condition when I tried switching to pfizer but it caused chest pain (supposedly non cardiac)". Additional information: The patient received the Comirnaty COVID-19 Vaccine; they wrote, in relation to Moderna vaccine: Patient had an unrelated health condition when patient tried switching to Pfizer but it caused chest pain (supposedly non cardiac) so I am never getting pfizer again if can avoid it. It was probably not caused by the vaccine but I am being cautious. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2833704 F 03/28/2025 COVID19
 PFIZER\BIONTECH
Faeces discoloured, Flatulence Faeces discoloured, Flatulence
gassy yellow stool; gassy yellow stool; This is a spontaneous report received from a Consumer or oth... gassy yellow stool; gassy yellow stool; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Mar2025 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: FAECES DISCOLOURED (non-serious), FLATULENCE (non-serious) all with onset Mar2025, outcome "unknown" and all described as "gassy yellow stool". Additional information: Caller, a patient got Pfizer Covid vaccine shot a week ago (Mar2025) and she was having gassy yellow stool, she wanted to know if that is a side effect of getting a shot. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2833705 F 03/28/2025 COVID19
 PFIZER\BIONTECH
Vaccination site pain Vaccination site pain
a little swore injection site; This is a spontaneous report received from a Consumer or other non HC... a little swore injection site; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An elderly female 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "a little swore injection site". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2833706 75 F 03/28/2025 COVID19
FLU3
RSV
 UNKNOWN MANUFACTURER
SANOFI PASTEUR
PFIZER\WYETH


Bursitis, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint swelling Bursitis, Joint swelling; Bursitis, Joint swelling; Bursitis, Joint swelling
Joint swelling; Bursitis; Initial information received on 25-Mar-2025 regarding an unsolicited valid... Joint swelling; Bursitis; Initial information received on 25-Mar-2025 regarding an unsolicited valid non-serious courtesy case received from a consumer/ Non-Healthcare Professional. This case involves a 75 year old female patient who experienced joint swelling and bursitis after receiving influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone High Dose], COVID-19 vaccine prot. subunit (NVX CoV 2373) [Novavax COVID-19 Vaccine] and RSV vaccine prot. subunit PreF 2v [Abrysvo]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rosuvastatin; Omeprazole; Chondroitin sulfate, Glucosamine hydrochloride (Osteo bi-flex) for Product used for unknown indication; Vitamins NOS; and Paracetamol (Tylenol) all for Product used for unknown indication. On 03-Jan-2025, the patient received an unknown dose 1 of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination, received an unknown dose 1 of Abrysvo not produced by Sanofi Pasteur Injection (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination and received an unknown dose 1 of Novavax COVID-19 Vaccine not produced by Sanofi Pasteur lot number not reported via intramuscular route in unknown administration site for COVID-19 immunization. On 18-Jan-2025 the patient developed joint swelling and bursitis (latency- 15 days). Information on the batch number cannot be requested corresponding to the one at time of event occurrence. Reportedly, swelling of elbow. Action taken was not applicable. The patient was treated methylprednisolone (MEDROL A) and Joint fluid drainage for both the events. At time of reporting, the outcome was Unknown for both the events. More
2833707 NY 03/28/2025 IPV
 SANOFI PASTEUR
 X1C891M
No adverse event, Product storage error No adverse event, Product storage error
administered a dose of IPOL MDV which was involved in a temperature excursion with no reported adver... administered a dose of IPOL MDV which was involved in a temperature excursion with no reported adverse event; Initial information received on 21-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an infant and unknown gender patient who was administered with a dose of IPV (VERO) [IPOL] which was involved in a temperature excursion of low temperature which reached 48๏ฟฝ fahrenheit with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Mar-2025, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot X1C891M, expiry date 31-Oct-2026; strength standard, frequency once) for Immunisation. On 15-Mar-2025, the patient was administered with a dose of Ipol MDV which was involved in a temperature excursion of low temperature which reached 48๏ฟฝ fahrenheit with no reported adverse event (poor quality product administered) (product storage error) (latency same day). Reportedly, the vaccine Program Manager reporting that a clinic possibly administered a dose of Ipol MDV which was involved in a temperature excursion. There is no extended stability data cover for the excursion. 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
2833713 NJ 03/28/2025 MMRV
 MERCK & CO. INC.
 Y015992
No adverse event, Product storage error No adverse event, Product storage error
No symptoms or side effects reported; Physician called to report a T/E on PROQUAD and one dose was a... No symptoms or side effects reported; Physician called to report a T/E on PROQUAD and one dose was administered to a patient today, 3/3/2025. No symptoms or side effects reported.; This spontaneous report has been received from a physician regarding 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 vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection, at a dose of 0.5 mL, administered as prophylaxis (lot number reported as Y015992, which has been verified as valid, expiration date reported and validated as 23-MAR-2026), with sterile diluent (BAXTER STERILE DILUENT). The administered dose was exposed to a temperature excursion of 40 Fahrenheit degrees (F) for 1800 hours. No symptoms or side effects reported.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02762610-02762603 , CLIC number : , ESTAR number : , IRMS number : 500UW00000V5aViYAJ|03032025230058|1370 , Central date : 2025-03-04 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02762610 , MNSC interaction number : 02762603 , Integration log UniqueID : 500UW00000V5aViYAJ|03032025230058|1370 , Service cloud CaseID : 500UW00000V5aViYAJ More
2833714 SC 03/28/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Product dose omission issue; Product dose omission issue Product dose omission issue; Product dose omission issue
no adverse event; patient ran out of medication; missed dose; This spontaneous report was received f... no adverse event; patient ran out of medication; missed dose; This spontaneous report was received from a physician and refers to multiple patients 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. From 29-Jan-2025 to 19-feb-2025 (exact dates were unknown), the patients had missed doses of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for prophylaxis (schemes, doses, routes of administration, anatomical locations, lot numbers, and expiration dates were not reported) due to a delay of shipment (missed dose) (patient ran out of medication). No other information was known or provided.; Reporter's Comments: More
2833715 F NJ 03/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Feeling abnormal, Frequent bowel movements, Gastrointestinal disorder, ... Fatigue, Feeling abnormal, Frequent bowel movements, Gastrointestinal disorder, Nausea More
nauseous; felt lousy/does not feel like herself; having frequent bowel movements; stomach bothering;... nauseous; felt lousy/does not feel like herself; having frequent bowel movements; stomach bothering; feeling very tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose on unknown date). On 18-MAR-2025, the patient received the 2nd dose of Shingrix (right arm). On 18-MAR-2025, less than a day after receiving Shingrix, the patient experienced tiredness (Verbatim: feeling very tired ). On an unknown date, the patient experienced nausea (Verbatim: nauseous ), feeling bad (Verbatim: felt lousy/does not feel like herself), frequent bowel movements (Verbatim: having frequent bowel movements) and stomach discomfort (Verbatim: stomach bothering). The outcome of the tiredness, nausea, feeling bad, frequent bowel movements and stomach discomfort were not resolved. It was unknown if the reporter considered the tiredness, nausea, feeling bad, frequent bowel movements and stomach discomfort to be related to Shingrix. It was unknown if the company considered the tiredness, nausea, feeling bad, frequent bowel movements and stomach discomfort to be related to Shingrix. Additional Information: GSK Receipt Date: 19-DEC-2024 Consumer was the reporter. Reporter stated that she received her second dose of Shingrix 18th March 2025 in her right arm. Consumer stated she began feeling very tired last night and was still feeling tired today. Consumer stated she felt lousy and does not feel like herself. Stated she was nauseous and having frequent bowel movements. Stated if she had known the second dose was going to make her feel like this she would not have had the dose administered. More
2833716 03/28/2025 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; got shingles a few weeks ago; This serious case was reported by a con... Suspected vaccination failure; got shingles a few weeks ago; 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: got shingles a few weeks ago). 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAR-2025 The case was received from the patient via interactive digital media. The patient had both shots and got shingles a few weeks ago. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(1st and 2nd dose). More
2833718 75 F MN 03/28/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 AE435
EK225
Rash; Rash Rash; Rash
PATIENT CALLED ROUGHLY 6 HOURS AFTER THE VACCINES WERE ADMINISTERED WITH A CC OF GENERALLIZED RASH O... PATIENT CALLED ROUGHLY 6 HOURS AFTER THE VACCINES WERE ADMINISTERED WITH A CC OF GENERALLIZED RASH ON THE TRUNK FROM BELOW THE BREASTS TO THE ABDOMEN More
2833719 62 F TX 03/28/2025 MENB
 PFIZER\WYETH
 HP9989
No adverse event, Wrong product administered No adverse event, Wrong product administered
WRONG VACCINE GIVEN. PATIENT HAD ZERO REACTIONS OR SIDE AFFECTS ONCE ERROR WAS FOUND AN HOUR LATER WRONG VACCINE GIVEN. PATIENT HAD ZERO REACTIONS OR SIDE AFFECTS ONCE ERROR WAS FOUND AN HOUR LATER
2833720 2 M CA 03/28/2025 MNQ
TYP
YF
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
SANOFI PASTEUR
 AMAB056A
X1A261M
UK134AA
Angioedema; Angioedema; Angioedema Angioedema; Angioedema; Angioedema
2yo Male presented to Immunization Clinic for travel vaccines with provider prescription. Vaccines ... 2yo Male presented to Immunization Clinic for travel vaccines with provider prescription. Vaccines were administered as follow IM Route: Typhoid (Typhim VI): 0.5 ml Lot# X1A261M Meningococcal ACWY (Menveo): 0.5ml Lot # AMAB056A Subcutaneous Route: Yellow Fever (YF-Vax): 0.5ml Lot# UK134AA Vaccines were administered around 1411. 24 minutes later, father of patient called for help because he believed the patient was having an allergic reaction. Upon assessment, he displayed signs of facial angioedema, watery eyes and cough. Epinephrine Autoinjector (0.15mg) lot # 3FE588 was administered immediately in the left vastus lateralis at 1435 and Rapid response team was activated. Initial set of vitals signs taken at 1438 BP: 139/91 RR :30 breaths per minute O2 :100% HR 117 bpm Rapid Response Team showed up at 1438 (within 3 minutes) and transferred patient to the Emergency Department for further treatment and observation. Father of patient denied any history of allergies or adverse events following vaccination. Prior to vaccine administration, he answered "no" to all relevant questions as listed in DD 3110 "Routine Immunization Screening Form: Pediatric" Routine Vaccine Screening Routine vaccine peds sick today : No Routine vaccine peds serious reaction : No Routine vaccine peds allergies : No Routine vaccine peds nervous system : No Routine vaccine peds health problem : No Routine vaccine peds immune system : No Routine vaccine peds immune system : No Routine vaccine peds blood products : No Routine vaccine peds intussusception : No Routine vaccine peds asthma : No Routine vaccine peds splenectomy : No Routine vaccine peds vasovagal : No Routine vaccine peds recent vaccines : No Routine vaccine peds pregnant : No More
2833721 1.67 F FL 03/28/2025 MMRV
 MERCK & CO. INC.
Pyrexia, Rash Pyrexia, Rash
Fever and full body rash Fever and full body rash
2833722 36 F GA 03/28/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4n222
No adverse event, Product preparation issue No adverse event, Product preparation issue
Injected sterile diluent into patient without mixing vaccine component. Realized error and correcte... Injected sterile diluent into patient without mixing vaccine component. Realized error and corrected error, injected vaccine correctly with a new syringe. No adverse effects seen. Patient aware of error and was understanding of situation. More
2833734 67 F WA 03/28/2025 COVID19
 MODERNA
Blood pressure increased, Injected limb mobility decreased, Nasopharyngitis, Qua... Blood pressure increased, Injected limb mobility decreased, Nasopharyngitis, Quality of life decreased, Stent placement More
Could not lift my right arm above my shoulder for nearly a year. Caught a horrible cold after the f... Could not lift my right arm above my shoulder for nearly a year. Caught a horrible cold after the first shot. I hadn't had a cold for a consecutive 15 years and only 3 colds (that lasted a day or less) within 30 years. Started having blood pressure issues. After the second shot, caught a cold that lasted a week. Blood pressure issues increased and affected quality of life tremendously. Difficulty finding a medication that I don't have adverse reactions to it More
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2833735 49 M KY 03/28/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 z53j4
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Adult patient, 49 y.o male administered dtap in error. Should have received TDAP Adult patient, 49 y.o male administered dtap in error. Should have received TDAP
2833736 16 M AZ 03/28/2025 MNQ
 SANOFI PASTEUR
 U8194AA
Hyperhidrosis, Pallor Hyperhidrosis, Pallor
Patient assessment after 10 minutes: Reaction: Patient requested bottled water. When this nurse cam... Patient assessment after 10 minutes: Reaction: Patient requested bottled water. When this nurse came back into room patient appeared pale, diaphoretic, and his eyes were closed. Patient woke with a sternal rub, remained pale, patient followed commands. RN at patient chair side Patients heart rate 64, pulse ox 98% rapid response called by Dr. Dr. and Rn visualized patient. Patient responded to RN however reamained pale and diaphortic patient eyes open, patient response to verbale stimuli. Guardian verbalized that patient passes out whenever he has labs drawn or receives injections. Dr. verbalzied to bring patient to ER if needed. Rn pivoted patient from chair to wheelchair. At that time pharmacy, security, laboratory started to depart and patient was brought over to the ER with guardian by RN assisted patient. More
2833737 53 F CA 03/28/2025 HEP
MMR
PNC20
 DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
PFIZER\WYETH
 944916
Y000225
LJ5284
Cough, Lip blister, Lip swelling, Swollen tongue; Cough, Lip blister, Lip swelli... Cough, Lip blister, Lip swelling, Swollen tongue; Cough, Lip blister, Lip swelling, Swollen tongue; Cough, Lip blister, Lip swelling, Swollen tongue More
Patient started to have swelling in her lips/tongue. Patient reports a blister appearing on the uppe... Patient started to have swelling in her lips/tongue. Patient reports a blister appearing on the upper part of her lip. Patient developed a cough. More
2833738 35 M CA 03/28/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 AK334
Syncope Syncope
pt fainted shortly after i gave Boostrix vaccine pt fainted shortly after i gave Boostrix vaccine
2833739 79 F FL 03/28/2025 PNC20
 PFIZER\WYETH
 lx4482
Dizziness, Fatigue, Injection site swelling, Liver function test increased, Sync... Dizziness, Fatigue, Injection site swelling, Liver function test increased, Syncope More
Patient felt fatigue, dizziness 3 days after receiving vaccine, Patient's left arm was swollen ... Patient felt fatigue, dizziness 3 days after receiving vaccine, Patient's left arm was swollen at the injection side. Patient had syncope episode 3 days after receiving vaccine. Patient was rushed to ER. Her Liver function tests were elevated at the hospital More
2833740 45 M CA 03/28/2025 UNK
 UNKNOWN MANUFACTURER
Magnetic resonance imaging head, Magnetic resonance imaging spinal, Pain in jaw,... Magnetic resonance imaging head, Magnetic resonance imaging spinal, Pain in jaw, Trigeminal neuralgia More
After receiving the second dose of the Pfizer COVID-19 vaccination, I started to have pain on the ri... After receiving the second dose of the Pfizer COVID-19 vaccination, I started to have pain on the right side of my job. The started about 2 days after receiving the dose. At first I thought it was tooth pain. I went to the dentist multiple times, but they didn't see anything. I was diagnosed with trigeminal neuralgia. I have had flares off and on ever since then. Currently I am in a flare that is unbearable. There has never been a way to tie it officially to the vaccine. However, this all started right after receiving it and I have never had these issues before I received the vaccine. I want to note that I am not someone who is against vaccines. But this needs to be known by people because my pain is intense and I don't think I am the only one who has had this effect from these vaccines. More
2833742 4 F MI 03/28/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 K003413
N019822
Herpes simplex test negative, Herpes zoster; Herpes simplex test negative, Herpe... Herpes simplex test negative, Herpes zoster; Herpes simplex test negative, Herpes zoster More
Seen 3/21/25 for apparent 3rd episode of Zoster this time different body location than the previous ... Seen 3/21/25 for apparent 3rd episode of Zoster this time different body location than the previous two. Cause felt to be related to post vaccination infection rather than naturally occurring chicken pox. More
2833743 17 M IA 03/28/2025 HEP
MMRV
TDAP
VARCEL
 DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 945664
X026409
PG3RP
X026319
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Patient had vaccination error at our clinic. He had got ProQuad and Varivax instead of MMR and Variv... Patient had vaccination error at our clinic. He had got ProQuad and Varivax instead of MMR and Varivax. Talked with pt.'s dad and pt has not had any adverse reactions at this time. Notified to call clinic if pt develops fever, redness or swelling at injection site or rash. Pt has no adverse reactions at this time. Public Health notified and was instructed to fill out this form in case he gets a reaction. More
2833791 62 F AK 03/28/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 2KJ34
Diarrhoea, Injection site mass, Pyrexia, Vomiting Diarrhoea, Injection site mass, Pyrexia, Vomiting
Fever of 101.4 for 4 days after injection. Gold ball size knot to Left deltoid for 10 days. Vomiting... Fever of 101.4 for 4 days after injection. Gold ball size knot to Left deltoid for 10 days. Vomiting and diarrhea for 4 days. Symptoms started 4 hours after injection. More
2833361 TN 03/27/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y011819
Y011819
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
Caller confirmed no side effects/symptoms reported at this time; Caller is a nurse who reports they ... Caller confirmed no side effects/symptoms reported at this time; Caller is a nurse who reports they had a patient that received a dose of CAPVAXIVE on 2/13/2025 and an additional dose on 3/14/2025.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-FEB-2025 and on 14-MAR-2024, the patient was vaccinated with the first and second dose respectively of pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), lot #Y011819, which has been verified to be valid lot number for pneumococcal 21-valent Conjugate Vaccine, expiration date reported and upon internal validation establish as 01-OCT-2025 (strength, exact quantity volume, route and anatomical site of administration were not reported), administered for prophylaxis (Inappropriate schedule of product administration). The reported confirmed no side effects or symptoms at this time (No adverse event). More
2833362 1 KS 03/27/2025 MMR
 MERCK & CO. INC.
 X011441
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous r... No additional AE reported; MMR II was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a 13-month-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 27-Aug-2024 at 09:56 AM, the patient was vaccinated with an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X0114411, expiration date expiration date was not reported, however upon internal validation determined as 19-Apr-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Administered dose of vaccine was exposed to the temperature excursion of 12.3 degrees Celsius for 6 hours and 23 minutes (product storage error). No previous temperature excursion occurred. There were no additional adverse events reported (no adverse event). This is one of several reports received from the same reporter. Follow-up information has been received from the reporting Nurse on 21-MAR-2025. The Nurse stated the following: "The Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was currently and had previously always been stored in a FREEZER (unknown temperature) throughout the out-of-range temperature times (previously reported) and not in a refrigerator." Additionally, the patient had no adverse effects. No more medical information has been reported.; Reporter's Comments: More
2833363 MD 03/27/2025 VARCEL
 MERCK & CO. INC.
 Y011712
No adverse event, Product storage error No adverse event, Product storage error
No symptomatic events reported; T/E for VARIVAX; This spontaneous report was received from a healthc... No symptomatic events reported; T/E for VARIVAX; This spontaneous report was received from a healthcare business professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-MAR-2025, the patient was administered Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 0.5 ml, lot #Y011712, expiration date: 02-JUL-2026 (route of administration was not provided) for prophylaxis. The suspect vaccine was stored at 14.65 Fahrenheit (F) for 13 hours 15 minutes (product storage error). No adverse events were reported (no adverse event). More
2833364 17 M MI 03/27/2025 HPV9
 MERCK & CO. INC.
 Y010656
No adverse event, Product storage error No adverse event, Product storage error
No additional AE/PQC.; HCP called and reported inadvertent administration of GARDASIL 9 after a temp... No additional AE/PQC.; HCP called and reported inadvertent administration of GARDASIL 9 after a temperature excursion that occurred on 18MAR2025. GARDASIL 9 was administered on 19MAR2025 to a patient. Limited demographics provided. No additional AE/PQC. No additional infor; This spontaneous report was received from a nurse and refers to a 17-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-MAR-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection, 0.5 mL per dose (valid lot number Y010656, expiration date 29-NOV-2026) (dose number, vaccination scheme, frequency, anatomical location, route of administration was not provided) for prophylaxis, after a temperature excursion of -0.6 degrees Celsius, with a time frame of 25 hours 0 minutes 0 seconds that occurred on 18-MAR-2025. No previous temperature excursion. No additional adverse event (AE) reported. More
2833365 M 03/27/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Vaccination failure, Varicella; Vaccination failure, Varicella Vaccination failure, Varicella; Vaccination failure, Varicella
Lack of efficacy 15-month old child developed a mild case of chicken pox; rash started around Friday... Lack of efficacy 15-month old child developed a mild case of chicken pox; rash started around Friday 3/21.; Lack of efficacy; This spontaneous report was received from a consumer regarding a 15-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). The vaccine was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported). On 21-MAR-2025, the patient experienced lack of efficacy as he developed a mild case of chicken pox (Varicella, Vaccination failure). The patient was in a daycare setting and his brother was also vaccinated. The outcome of varicella was not reported. The reporter considered the event of vaccination failure to be related to Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX). The causal relationship between the event varicella and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was not reported. More
2833366 03/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shot and still got shingles three times. 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, 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
2833375 65 F MP 03/27/2025 PNC20
 PFIZER\WYETH
 LG5575
Dyspnoea, Injection site pain, Pyrexia, Rash, Rash pruritic Dyspnoea, Injection site pain, Pyrexia, Rash, Rash pruritic
AT AROUND MIDNIGHT POST-VACCINATION PT DEVELOPED A FEVER, ITCHY RASHES IN THE ABDOMINAL AREA, UNDER ... AT AROUND MIDNIGHT POST-VACCINATION PT DEVELOPED A FEVER, ITCHY RASHES IN THE ABDOMINAL AREA, UNDER THE ARMS AND BREAST. PT STATED SHE HAD SOB, "ROLLING IN MY CHEST." PT THEN DRANK WATER TOTALING 4 GLASSES THAT MORNING AND 2 TBSP OF SUGAR "FOLK MEDICINE." PT ALSO DRANK (3) 250MG OF NAPROXEN FOR PAIN RELIEF AT INJECTION SITE. AFTER SHE WAS ABLE TO SLEEP THAT NIGHT. WHEN SHE WOKE UP SHE HAD NO PAIN, FEVER, SOB, BUT RASHES PERSISTED FOR THE NEXT 3 DAYS. PT TOOK MANY COLD SHOWERS TO RELIEVE THE PAIN. PT IS BETTER NOW. More
2833376 11 M 03/27/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 3CA10C1
3CA10C1
Disturbance in social behaviour, Emotional distress, Fatigue, Injury, Laboratory... Disturbance in social behaviour, Emotional distress, Fatigue, Injury, Laboratory test; Obsessive-compulsive disorder, Tic More
Developed new OCD complex motor tics-compelled to push up off the ground and jump up in the air, kic... Developed new OCD complex motor tics-compelled to push up off the ground and jump up in the air, kicking buttocks. Occurs multiple times an hour. Compelled to sniff objects and lick objects. Makes it difficult to engage in activities and creates social difficulties. Causes injury, exhaustion and distress. Symptoms are getting progressively worse and becoming disabling. Consulted with a tic doctor at Hospital. Receiving therapy with therapist specializes in tic disorder: combination of CBIT and ERP. Starting medication. More
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2833377 37 F IN 03/27/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0187
EW0187
EW0187
EW0187
EW0187
EW0187
EW0176
EW0176
EW0176
EW0176
EW0176
EW0176
Arrhythmia, Asthenia, Brain fog, Disturbance in attention, Dizziness; Fatigue, F... Arrhythmia, Asthenia, Brain fog, Disturbance in attention, Dizziness; Fatigue, Feeling abnormal, Gait disturbance, Heavy menstrual bleeding, Hypoaesthesia; Impaired work ability, Injection site paraesthesia, Laboratory test normal, Magnetic resonance imaging normal, Memory impairment; Pain, Paraesthesia, Post-acute COVID-19 syndrome, Seizure, Sleep apnoea syndrome; Sleep disorder, Somnolence, Spinal disorder, Tremor, Vertigo; Vision blurred; Arrhythmia, Asthenia, Brain fog, Disturbance in attention, Dizziness; Fatigue, Feeling abnormal, Gait disturbance, Heavy menstrual bleeding, Hypoaesthesia; Impaired work ability, Injection site paraesthesia, Laboratory test normal, Magnetic resonance imaging normal, Memory impairment; Pain, Paraesthesia, Post-acute COVID-19 syndrome, Seizure, Sleep apnoea syndrome; Sleep disorder, Somnolence, Spinal disorder, Tremor, Vertigo; Vision blurred More
At first I felt a tingling feeling from the vaccine, which to me created an image of very small meta... At first I felt a tingling feeling from the vaccine, which to me created an image of very small metal balls going into my body. They travelled along my arm and throughout my body, in a tingling sensation that spread. Then I sat and waited to make sure I was ok. I went to drive home, thinking everything was ok and as I was driving I began to get dizzy and felt a vertigo coming on. I went home and went to sleep. The first shot seemed to just cause a poor reaction, and a lot of sleepiness. Sadly after the second shot, the vertigo was much worse and I slept even more. The day after the second shot I fell asleep during a lunch break working remotely and I didn't wake up for several hours- I woke up and contacted my employer to let them know I was having a reaction to the vaccine. After that was all over, feeling a little better- I went on with my life assuming this was just an unexpected side effect and got a lot more rest. Sadly my period was then effected in the months following- and it became more and more severe. I had a very normal light period before that lasted only about 4 days. It was never heavy prior at all. My periods became regularly heavy, long, and lasting up to seven days. The pads could no longer contain the blood, and I had to wear adult underwear or change the style of pad to something that was almost a double pad. I tried period underwear, a cup, and anything that seemed useful including adult underwear. My periods changed completely, and were a lot more hormonal, lasted longer, came on with hormones for days before and days after. A year later, I started having seizures where I had never had seizures in my life at all- and my sister has had epilepsy my whole life. I eventually had to seek out a geneticist and neurology help- and they were not able to catch the seizures on any tests. I got long covid during that time, 2022, and it seemed to clear up gradually- but never completely go away. Currently I have been off of work on leave since Nov. 27th of 2024 and I haven't been able to concentrate enough to be working productively. I now have a very disrupted sleep cycle, and sleep apnea came on hard in long covid several times but I could not get a CPAP issued no matter how bad it was on the tests. Right now I am just very out of it with severe brain fog everyday, very disrupted sleep, can't wake up properly wether I have an alarm and get up early or sleep later into the morning. No matter how much sleep I get it, it's never quite enough, and nothing is working. My overall intelligence seems mostly intact, I am simply a lot more forgetful- and several MRI's have been done before and after covid. I'm bogged down with a lot of body pain, but most noteably the numbness always comes back really bad. Sometimes the numbness takes over my face, on the left, and sometimes it takes over my legs when trying to stand or walk- and my left leg will be slightly dragging. I have major spine problems I didn't have before. I have a lot problems I didn't have before covid or the vaccines. My memory and overall concentration are getting very bad. My balance is getting very bad, and I'm shaky for no reason sometimes now. My eyes are getting more and more blurry. I burn out much faster while working, even from home. Socially, I can only take so much interaction, and I get tired real easy now from normal interactions. I get vertigo very easily now from even the smallest triggers. I have arrythmia's that I just didn't have before the vaccine, including a potential heart problem that just wasn't a problem at all before. More
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2833383 4 M TX 03/27/2025 MMRV
 MERCK & CO. INC.
 Y010306
Injection site erythema, Injection site swelling, Laboratory test, X-ray Injection site erythema, Injection site swelling, Laboratory test, X-ray
patient developed redness and swelling at the injection site.; patient developed redness and swellin... patient developed redness and swelling at the injection site.; patient developed redness and swelling at the injection site.; This spontaneous report has been received from a nurse referring to a 4-year-old male patient. The patient's concurrent conditions and medical history were reported as none. Concomitant therapies were not provided. On 28-FEB-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA) (+) sterile diluent, 1 dose (route of administration not reported) with lot # y010306 which was verified to be valid and expiration date not reported but upon internal validation established as 01-DEC-2025, for vaccination. On the same date, the patient went to an emergency room (ER) because he developed redness and swelling at the injection site (Vaccination site erythema and vaccination site swelling). He was treated with Cefazolin 1000mg, Dexamethasone 4mg, Diphenhydramine 50mg and went home. Basic laboratory tests (unspecified) and X-ray were performed, however results were not provided. The patient was not admitted into the hospital. On 02-MAR-2025, the patient was fully recovered from both events. The causal relationship between vaccination site erythema and vaccination site swelling with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (+) sterile diluent was not reported. More
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