🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2838344 04/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain, Product use in unapproved indication Pain, Product use in unapproved indication
shot was rough; doctor told me to get the shot because of my allergies; This non-serious case was re... shot was rough; doctor told me to get the shot because of my allergies; 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 Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot was rough) and drug use for unapproved indication (Verbatim: doctor told me to get the shot because of my allergies). The outcome of the pain was not reported and the outcome of the drug use for unapproved indication was not applicable. 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: 18-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that his/her doctor told to get the shot, because of allergies, which led to drug use for unapproved indication. Patient reported that shot was rough but he/she made it. More
2838345 F NC 04/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
I hurt on the first one too; This non-serious case was reported by a consumer via sales rep and desc... I hurt on the first one too; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included migraine headache (since child). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: I hurt on the first one too). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Linked case(s) involving the same patient:US2025048282 Additional Information: GSK Receipt Date: 21-APR-2025 The reporter was hurt on the first one too. For tolerance of 2nd dose of Shingrix, refer case US2025048282.; Sender's Comments: US-GSK-US2025048282:Same patient/Diffrent dose More
2838346 04/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
first dose of the Shingles vaccine 5 years ago and got second in february; This non-serious case was... first dose of the Shingles vaccine 5 years ago and got second in february; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included varicella zoster vaccine (Patient received first dose 5 years ago). In FEB-2025, the patient received the 2nd dose of Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: first dose of the Shingles vaccine 5 years ago and got second in february). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 20-APR-2025 This case was reported by a patient via interactive digital media. Patient had a first dose of the shingles vaccine about 5 years ago, and got second dose in February. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. This case is one of the multiple linked cases.; Sender's Comments: US-GSK-US2025AMR048644:same reporter different patient US-GSK-US2025AMR048648:same reporter different patient US-GSK-US2025AMR048653:same reporter different patient US-GSK-US2025AMR048658:same reporter different patient US-GSK-US2025AMR048644:same reporter different patient US-GSK-US2025AMR048648:same reporter different patient More
2838347 IN 04/28/2025 DTAPHEPBIP
IPV
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 UNK
W1C741M
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Extra dose administered She stated they received a dose of Pediarix, and IPOL, so they essentially r... Extra dose administered She stated they received a dose of Pediarix, and IPOL, so they essentially received 2 doses of the polio vaccine; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of overdose in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included Polio vaccine inact (Ipv) (batch number W1C741M, expiry date 17-NOV-2025) for prophylaxis. On 11-MAR-2025, the patient received Pediarix and Ipv (intramuscular) .5 ml. On 11-MAR-2025, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Extra dose administered She stated they received a dose of Pediarix, and IPOL, so they essentially received 2 doses of the polio vaccine). The outcome of the overdose 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: 21-APR-2025 The health care professional reported that a patient received a dose Pediarix and IPV (VERO) [IPOL] received, so they essentially received 2 doses of the polio vaccine with no adverse event. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 11-Mar-2025, the patient received an unknown dose of suspect IPV (VERO) [IPOL] via Intramuscular route in unknown administration site for vaccine dose schedule due and received an unknown dose of suspect diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid not produced by Sanofi Pasteur with (Unknown strength, formulation, lot and expiry date), via unknown route in unknown administration site for Prophylactic vaccination (Immunisation), so they essentially received 2 doses of the polio vaccine with no adverse event (extra dose administered) (latency same day), which led to overdose. The nurse was asked for additional adverse event information, and she agreed to it initially and when she was asked for the initials and date of birth of the patient she asked if this goes back to the patient. Then she declined to provide additional information at the time of her call and states that she would fill out any paperwork that was sent to her. More
2838348 04/28/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Cough Cough
still have the cough; This non-serious case was reported by a consumer via interactive digital media... still have the cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: still have the cough). The outcome of the cough was not resolved. It was unknown if the reporter considered the cough to be related to RSV vaccine. It was unknown if the company considered the cough to be related to RSV vaccine. Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient did had RSV vaccine and it helped and wasn't so severe but still had the cough and was still coughing but if didn't get the vaccine, sure it would be worse. More
2838349 F OR 04/28/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Loss of personal independence in daily activities, Pain in extremity Loss of personal independence in daily activities, Pain in extremity
Pain in arm; she is unable to continue daily activities; This non-serious case was reported by a phy... Pain in arm; she is unable to continue daily activities; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. In APR-2025, the patient received the 1st dose of Bexsero (left arm). In APR-2025, an unknown time after receiving Bexsero, the patient experienced pain in arm (Verbatim: Pain in arm) and activities of daily living impaired (Verbatim: she is unable to continue daily activities). The outcome of the pain in arm and activities of daily living impaired were not reported. It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the pain in arm and activities of daily living impaired 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: 23-APR-2025 Physician called to report that she has a 17.5-year-old female patient who received her first dose of Bexsero last week. Since then, the patient has had severe arm pain to the point where she is unable to continue daily activities. Patient stated that she was aware this is a side effect listed in the package insert but it is more severe than she has heard of in any patient and requested that report the incident. She would like any follow up and guidance of how to assist the patient. More
2838350 04/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Back pain, Fall, Pain in extremity Back pain, Fall, Pain in extremity
arm was very sore all week; I fell off my couch; hurt my back badly; This non-serious case was repor... arm was very sore all week; I fell off my couch; hurt my back badly; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In APR-2025, the patient received Shingles vaccine. In APR-2025, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm was very sore all week), fall (Verbatim: I fell off my couch) and back pain (Verbatim: hurt my back badly). The outcome of the pain in arm was resolved and the outcome of the fall and back pain were not reported. It was unknown if the reporter considered the pain in arm, fall and back pain to be related to Shingles vaccine. It was unknown if the company considered the pain in arm, fall and back pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself Patient had gotten the vaccine a week before, and his/her arm had been very sore all week. The other night, he/she had fallen off his/her couch and hurt his/her back badly, even though he/she had not been drinking. More
2838351 04/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Oral herpes zoster, Oral pain, Vaccination failure Oral herpes zoster, Oral pain, Vaccination failure
Suspected vaccination failure; I developed shingles in my mouth; This serious case was reported by a... Suspected vaccination failure; I developed shingles in my mouth; 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, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and oral herpes zoster (Verbatim: I developed shingles in my mouth). The outcome of the vaccination failure and oral herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and oral herpes zoster 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 oral herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Two months after patient had gotten the vaccine, he/she developed shingles in his/her mouth. Little was more painful than having massive ulcers in his/her gums and palate. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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 clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2838352 F 04/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Malaise Herpes zoster, Malaise
got shingles from the vaccine; This non-serious case was reported by a consumer via interactive digi... got shingles from the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female 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 shingles (Verbatim: got shingles from the vaccine). The outcome of the shingles was not reported. The reporter considered the shingles to be related to Shingles vaccine. The company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-APR-2025 The patient got shingles from the vaccine. Then she was so sick she did not get the second half. More
2838353 04/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
got the vaccine for shingles and got the shingles 10 days after that; This non-serious case was repo... got the vaccine for shingles and got the shingles 10 days after that; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got the vaccine for shingles and got the shingles 10 days after that). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. Reporter had a friend that got the vaccine for shingles and got the shingles 10 days after that. More
2838354 04/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; 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: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. Patient got the vaccine and still got them (shingles). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2838355 04/28/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Came down with RSV, spent 19 days in the hospital; Suspected vaccination failure; This serious case ... Came down with RSV, spent 19 days in the hospital; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Came down with RSV, spent 19 days in the hospital) (serious criteria hospitalization). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 24-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that at the suggestion of his/her pulmonologist patient had the RSV vaccine last fall in 2024. The patient came down with RSV (respiratory syncytial virus infection), spent 19 days in the hospital, and was told that if he/she had not been vaccinated it could have been fatal. This case was considered as suspected vaccination failure as details regarding time to onset for RSV and laboratory confirmation regarding RSV 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 details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine More
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2838356 F 04/28/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Blister, Chemotherapy, Herpes zoster, Herpes zoster oticus, Pain; Post herpetic ... Blister, Chemotherapy, Herpes zoster, Herpes zoster oticus, Pain; Post herpetic neuralgia, Vaccination failure More
Suspected vaccination failure; Ramsay Hunt Syndrome; PHN; This serious case was reported by a consum... Suspected vaccination failure; Ramsay Hunt Syndrome; PHN; 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. The patient's past medical history included knee replacement (had two total knee replacements), neck surgery (had neck surgery with titanium plates and screws) and cesarean section (had three children, one was a C-section). 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), ramsay-hunt syndrome (Verbatim: Ramsay Hunt Syndrome) (serious criteria GSK medically significant) and post herpetic neuralgia (Verbatim: PHN). The outcome of the vaccination failure was not reported and the outcome of the ramsay-hunt syndrome and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome and post herpetic neuralgia to be related to Shingles vaccine. The company considered the vaccination failure and ramsay-hunt syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that she was dealing with Ramsay-hunt syndrome and PHN (post herpetic neuralgia) right now (at the time of reporting) and she had never experienced pain like this in her life. Patient indicated that she had three children, one was a C section, two total knee replacements, neck surgery with titanium plates and screws and more but none of it compared to the pain she had been experiencing for two months. Patient stated that, in her case it was on the left side of her face and head with ear involvement and blisters all around her eye. Patient got the vaccine, but chemo treatments wiped out the vaccine, also she ask everyone to get vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding Ramsay-hunt syndrome 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2838357 04/28/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure; Burning s... Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure; Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure More
Suspected vaccination failure; going through shingles right now; This serious case was reported by a... Suspected vaccination failure; going through shingles right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 86-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) and shingles (Verbatim: going through shingles right now). 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 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: 22-APR-2025 This case was reported by a patient via interactive digital media. The patient had the 1 to 2 vaccines 2 years ago (from the date of reporting) and going through shingles right now (at the time of reporting), the patient just got medication from pharmacy salve was easing, the itching, burning and pain a good bit. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2). More
2838358 04/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Extra dose administered Extra dose administered
extra dose of vaccine adminstered; This non-serious case was reported by a consumer via interactive ... extra dose of vaccine adminstered; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: extra dose of vaccine adminstered). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 23-APR-2025 Patient received extra dose of Shingrix by accident, which led to extra dose of vaccine administered. More
2838359 04/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site erythema, Injection site pruritus, Pyrexia, Sluggishness Injection site erythema, Injection site pruritus, Pyrexia, Sluggishness
shot site was very itchy; shot site was very red; fever; felt a little sluggish; This non-serious ca... shot site was very itchy; shot site was very red; fever; felt a little sluggish; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In APR-2025, the patient received the 1st dose of Shingles vaccine. In APR-2025, less than 2 weeks after receiving Shingles vaccine, the patient experienced injection site itching (Verbatim: shot site was very itchy) and injection site erythema (Verbatim: shot site was very red). On an unknown date, the patient experienced fever (Verbatim: fever) and sluggishness (Verbatim: felt a little sluggish). The outcome of the injection site itching and injection site erythema were resolved (duration 1 week) and the outcome of the fever and sluggishness were resolved (duration 2 days). It was unknown if the reporter considered the injection site itching, injection site erythema, fever and sluggishness to be related to Shingles vaccine. It was unknown if the company considered the injection site itching, injection site erythema, fever and sluggishness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-APR-2025 The case was received from the patient via interactive digital media. The patient was 75 years old and about a week and a half ago had his/her first shingles shot of the two. The patient had a reaction for about a week. The shot site was very red and itchy, about the size of a lid on a jar of mayonnaise. The patient had a little fever felt a little sluggish for a day or two. The patient could not say that he/she was looking forward to the next one. More
2838360 F 04/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; shingles; 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) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-APR-2025 This case was reported by a patient via interactive digital media. The reporter mother never got shingles until she got the vaccine for it. 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 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
2838361 04/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
knocked patient out for a couple days; This non-serious case was reported by a consumer via interact... knocked patient out for a couple days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell 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 unwell (Verbatim: knocked patient out for a couple days). The outcome of the unwell was resolved. It was unknown if the reporter considered the unwell to be related to Shingles vaccine. It was unknown if the company considered the unwell to be related to Shingles vaccine. Additional Information: GSK receipt date: 22-APR-2025 This case was reported by a patient via interactive digital media. The patient took 1st dose of vaccine and it really knocked the patient out for a couple days. More
2838362 04/28/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Fatigue, Pain in extremity Fatigue, Pain in extremity
sore arm; tired; This non-serious case was reported by a consumer via interactive digital media and ... sore arm; tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in an unspecified number of patients who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm) and tiredness (Verbatim: tired). The outcome of the pain in arm was not reported and the outcome of the tiredness was resolved (duration 1 day). It was unknown if the reporter considered the pain in arm and tiredness to be related to RSV vaccine. It was unknown if the company considered the pain in arm and tiredness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 13-APR-2025 The reporter reported patients had very little reaction to all the vaccines, just to sore arm and tired for a day. This case was linked with case US2025AMR047722 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025AMR047722:case created for multiple patient, same reporter More
2838363 10 M CO 04/28/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Wrong product administered Wrong product administered
Infanrix administration instead of Boostrix; Infanrix administration out of the recommended age; Thi... Infanrix administration instead of Boostrix; Infanrix administration out of the recommended age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 10-year-old male patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number X449Y) for prophylaxis. On 17-MAR-2025, the patient received Infanrix. On an unknown date, the patient did not receive Boostrix. On 17-MAR-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix administration instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: Infanrix administration out of the recommended age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-APR-2025 Office Manager wanted to get safety information regarding the Infanrix administration to a patient that should have received Boostrix but received Infanrix which led wrong vaccine administered The received Infanrix in non-recommended age which led inappropriate age at vaccine administration The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. More
2838364 NH 04/28/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect dose administered Incorrect dose administered
Potential administration of Engerix-B 20 MGRS DOSE TO 19 YEAR-OLD PATIENTS; Potential administration... Potential administration of Engerix-B 20 MGRS DOSE TO 19 YEAR-OLD PATIENTS; Potential administration of Engerix-B 20 MGRS DOSE TO 19 years old patinets; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a patient who received HBV (Engerix B adult) for prophylaxis. On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Potential administration of Engerix-B 20 MGRS DOSE TO 19 YEAR-OLD PATIENTS) and adult product administered to child (Verbatim: Potential administration of Engerix-B 20 MGRS DOSE TO 19 years old patinets). The outcome of the overdose and adult product administered to child were not applicable. Additional Information: GSK Receipt Date:22-APR-2025 The reporter just noticed that Engerix-B 20 mgrs. dose was indicated for 20 years-old and older. She was not sure, but she believed that some 19 year-old patients could potentially receive Engerix-B 1 ml dose at her clinic, which led to overdose and adult product administered to child. She accepted a follow up to clarify. No further information available at the moment of the call. The Vaccine Administration Facility is the same as Primary Reporter. No further information available at the moment of the call. The reporter consented to follow up. More
2838365 F MO 04/28/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB056A
Product preparation error Product preparation error
Use of a Non-approved Diluent to Reconstitute and Administer the Lyophylized Meningococcal Group A C... Use of a Non-approved Diluent to Reconstitute and Administer the Lyophylized Meningococcal Group A Component of the 2-vial Presentation of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB056A, expiry date 31-AUG-2025) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Use of a Non-approved Diluent to Reconstitute and Administer the Lyophylized Meningococcal Group A Component of the 2-vial Presentation of Menveo). The outcome of the wrong solution used in drug reconstitution was not applicable. Additional Information: GSK Receipt Date: 22-APR-2025 The nurse colleague administered a Menveo reconstituted with sterile water to a patient which led to wrong solution used in drug reconstitution. The vaccine administration facility was the same as primary reporter. More
2838366 6 NY 04/28/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Wrong product administered Wrong product administered
received a dose of Boostrix instead of a DTap vaccine; This non-serious case was reported by a pharm... received a dose of Boostrix instead of a DTap vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included DTPa (DTPa vaccine) for prophylaxis. On an unknown date, the patient received Boostrix and DTPa vaccine. On an unknown date, an unknown time after receiving Boostrix and DTPa vaccine, the patient experienced wrong vaccine administered (Verbatim: received a dose of Boostrix instead of a DTap vaccine). The outcome of the wrong vaccine administered 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: 22-APR-2025 Other HCP reported that a 6-year-old patient had received a dose of Boostrix instead of a DTap vaccine (no brand name reported), which led to wrong vaccine administered. Reporter didn't have any more additional details on this event. More
2838367 F IA 04/28/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Exposure during pregnancy, Inappropriate schedule of product administration Exposure during pregnancy, Inappropriate schedule of product administration
Patient is pregnant; 3th dose: April 18th 2025: 28 weeks of gestation; 2nd dose: March 21st 2025: 24... Patient is pregnant; 3th dose: April 18th 2025: 28 weeks of gestation; 2nd dose: March 21st 2025: 24 weeks of gestation; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 27-year-old female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On 18-APR-2025, the patient received the 3rd dose of Engerix B. On 21-MAR-2025, the patient received the 2nd dose of Engerix B. On 21-MAR-2025, an unknown time after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose: March 21st 2025: 24 weeks of gestation). On 18-APR-2025, the patient experienced drug dose administration interval too short (Verbatim: 3th dose: April 18th 2025: 28 weeks of gestation). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Patient is pregnant). The outcome of the drug dose administration interval too short, drug dose administration interval too short and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Pregnancy Exposure (Engerix B): To mother in third trimester Pregnancy Exposure (Engerix B): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing 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 : 22-APR-2025 Registered nurse calleds to report an early third dose for a patient on ENGERIX-B. Patient was pregnant. The patient received 2nd and 3rd dose of engerix b earlier than recommended interval, which led to shortening of vaccination schedule. More
2838368 0.5 M CO 04/28/2025 HEPA
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 MZ474
Inappropriate schedule of product administration, Product administered to patien... Inappropriate schedule of product administration, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, Product administered to patient of inappropriate age More
Inappropriate Age at Vaccine Series Administration; Inappropriate schedule of vaccine; Inappropriate... Inappropriate Age at Vaccine Series Administration; Inappropriate schedule of vaccine; Inappropriate Age at Vaccine Series Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received HAV (Havrix 720) (batch number MZ474, expiry date 24-APR-2026) for prophylaxis. Co-suspect products included HAV (Havrix) for prophylaxis. In NOV-2024, the patient received the 2nd dose of Havrix 720. In OCT-2024, the patient received the 1st dose of Havrix. In OCT-2024, not applicable after receiving Havrix 720 and an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age at Vaccine Series Administration). In NOV-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age at Vaccine Series Administration) and drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and drug dose administration interval too short 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: 22-APR-2025 The nursing supervisor stated that the first dose of Havrix was administered to a 6-month-old patient in October 2024 which led to inappropriate age at vaccine administration. The patient also received the 2nd dose in November 2024 which also led to inappropriate age at vaccine administration and drug dose administration interval too short. More
2838369 2 M VA 04/28/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect dose administered Incorrect dose administered
2 years of age received 2/3 of an Infanrix vaccine, this situation happened 22-Apr-2025; This non-se... 2 years of age received 2/3 of an Infanrix vaccine, this situation happened 22-Apr-2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 2-year-old male patient who received DTPa (Infanrix) for prophylaxis. On 22-APR-2025, the patient received Infanrix. On 22-APR-2025, an unknown time after receiving Infanrix, the patient experienced incomplete dose administered (Verbatim: 2 years of age received 2/3 of an Infanrix vaccine, this situation happened 22-Apr-2025). The outcome of the incomplete dose administered 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: 22-APR-2025 Practice manager called and reported that patient received 2o/3 of an Infanrix vaccine, this situation happened on the day of reporting, which led to incomplete dose administered. The vaccine administration facility was the same as primary reporter. The reporter did not have the lot number nor expiry date of the vaccine. During the call, the reporter mentioned the vaccine as Boostrix, and then, she mentioned that actually it was the DTap Infanrix vaccine. More
2838370 0.17 M WV 04/28/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 PE24L
Expired product administered Expired product administered
Expired Drug Used; This non-serious case was reported by a nurse via call center representative and ... Expired Drug Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number PE24L, expiry date 11-APR-2025) for prophylaxis. On 22-APR-2025, the patient received Pediarix. On 22-APR-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used 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: 23-APR-2025 The nurse reported that an expired Pediarix was administered to a patient which led to expired vaccine used. The nurse asked data that allows use within a certain time after expiration. More
2838371 60 F MS 04/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
3rd dose administered.; This non-serious case was reported by a pharmacist via call center represent... 3rd dose administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 2nd dose on 07-SEP-2022) and Shingrix (received 1st dose on an unknown date). On 08-APR-2025, the patient received the 3rd dose of Shingrix. On 08-APR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered.). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 23-APR-2025 The pharmacist called to inform that back in 08th April 2025 somebody received an extra dose of a vaccine, such vaccine was Shingrix which led to extra dose administration. According to reporter, the Shingrix series was completed back on 07th September 2022. More
2838372 80 M CA 04/28/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 4H297
Expired product administered Expired product administered
Expired dose administered; This non-serious case was reported by a other health professional via cal... Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug administered in a 80-year-old male patient who received HBV (Engerix B) (batch number 4H297, expiry date 06-APR-2025) for prophylaxis. Concurrent medical conditions included hemodialysis. On 23-APR-2025, the patient received Engerix B. On 23-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired drug administered (Verbatim: Expired dose administered). The outcome of the expired drug administered 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: 23-APR-2025 Patient Supervisor called to inform that earlier that day, a dose of Engerix-B was given 15 days after expiration date which led to Expired drug administered. According to the reporter, the patient was under the hemodialysis schedule, so they receive 2 syringes (40 mcg) of Engerix-B. Reporter did not specify if in that visit the two syringes were administered, and if so, if it was only one of the two syringes that was expired. More
2838373 M CA 04/28/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
administration of a pediatric dose of Hep B vaccine to an adult patient; administration of a pediatr... administration of a pediatric dose of Hep B vaccine to an adult patient; administration of a pediatric dose of Hep B vaccine to an adult patient; 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 48-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis. On 22-APR-2025, the patient received the 3rd dose of Engerix B pediatric. On 22-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: administration of a pediatric dose of Hep B vaccine to an adult patient) and underdose (Verbatim: administration of a pediatric dose of Hep B vaccine to an adult patient). 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 : 23-APR-2025 A nurse called to reported the administration of a pediatric dose of Hep B vaccine to an adult patient which led to adult use of child product and underdose. The nurse mentioned this was the third dose of the Hepatitis B series. The nurse could not provide the brand name nor the lot number of the vaccine but confirmed it was a GSK vaccine. The nurse asked for recommendations on this situation. More
2838374 50 F CA 04/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 X5T42
Extra dose administered Extra dose administered
accidentally gave an extra dose of Shingrix to a patient not realizing she already completed the 2 s... accidentally gave an extra dose of Shingrix to a patient not realizing she already completed the 2 shot series in 2023..."; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number X5T42, expiry date 30-JAN-2027) for prophylaxis. Previously administered products included Shingrix (received 2 doses in 2023). On 23-APR-2025, the patient received the 3rd dose of Shingrix. On 23-APR-2025, not applicable after receiving Shingrix, the patient experienced extra dose administered (Verbatim: accidentally gave an extra dose of Shingrix to a patient not realizing she already completed the 2 shot series in 2023..."). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 23-APR-2025 The physician reported that a nurse accidentally gave an extra dose of Shingrix to a patient not realizing she already completed the 2 shot series in 2023, which led to extra dose administered. The vaccine administration facility was the same as primary reporter. More
2838375 IN 04/28/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administered Infanrix to a 12-year old patient; This non-serious case was reported by a pharmacist v... administered Infanrix to a 12-year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old patient who received DTPa (Infanrix) for prophylaxis. On 22-APR-2025, the patient received Infanrix. On 22-APR-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered Infanrix to a 12-year old patient). 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: 24-APR-2025 The reporter reported that he/she administered Infanrix to a 12-year-old patient, which led to Inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter. More
2838376 76 F 04/28/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19-2
COVID19-2
COVID19-2
COVID19-2
COVID19-2
COVID19-2
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH





FF2587
FF2587
FF2587
FF2587
FF2587
FF2587
Antibody test, Aphasia, Atrial fibrillation, Blood pressure measurement, Compute... Antibody test, Aphasia, Atrial fibrillation, Blood pressure measurement, Computerised tomogram; Confusional state, Decreased appetite, Depression, Dizziness, Dyspnoea; Electrocardiogram, Fall, Headache, Heart rate, Insomnia; Investigation, Loss of consciousness, Lymphoedema, Magnetic resonance imaging, Memory impairment; Mitral valve incompetence, Pyrexia, SARS-CoV-2 test, Visual impairment, Weight; X-ray; Antibody test, Aphasia, Atrial fibrillation, Blood pressure measurement, Computerised tomogram; Confusional state, Decreased appetite, Depression, Dizziness, Dyspnoea; Electrocardiogram, Fall, Headache, Heart rate, Insomnia; Investigation, Loss of consciousness, Lymphoedema, Magnetic resonance imaging, Memory impairment; Mitral valve incompetence, Pyrexia, SARS-CoV-2 test, Visual impairment, Weight; X-ray; Antibody test, Aphasia, Atrial fibrillation, Blood pressure measurement, Computerised tomogram; Confusional state, Decreased appetite, Depression, Dizziness, Dyspnoea; Electrocardiogram, Fall, Headache, Heart rate, Insomnia; Investigation, Loss of consciousness, Lymphoedema, Magnetic resonance imaging, Memory impairment; Mitral valve incompetence, Pyrexia, SARS-CoV-2 test, Visual impairment, Weight; X-ray More
My lymph nodes in my throat and ankles have been swelling since I got the bivalent vaccine dose ( th... My lymph nodes in my throat and ankles have been swelling since I got the bivalent vaccine dose ( the 4th Covid Vaccine dose); vision worsened; shortness of breath; Headaches; inability to sleep; A-fib; mitral valve leaking; loss of appetite; Fell in bathroom; confusion; depression; unable to remember names and common vocabulary; unable to remember names and common vocabulary; loss of consiousness; dizzy; fever; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (loss of consiousness), ATRIAL FIBRILLATION (A-fib) and MITRAL VALVE INCOMPETENCE (mitral valve leaking) in a 76-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Famtozinameran, Tozinameran (Pfizer BioNTech COVID-19 vaccine, bivalent (original and omicron BA.4/5)) for COVID-19 immunisation and Tozinameran (Pfizer BioNTech COVID-19 vaccine) for COVID-19 immunisation. The patient's past medical history included COVID-19 (No smell, no taste slight fever, cough, headaches recovered in 14days. On 21-Jan-2020, symptoms returned but recovered in 5 days) from 03-Jan-2020 to 17-Jan-2020, Dizziness (Hospitalized) in June 2020, Chest pain (hospitalized) in June 2020, Breathing difficult (trouble breathing at night that she elevated her head; hospitalized) in June 2020, Vein disorder NOS (Veins scuttered) on 03-Jan-2020, Respiratory syncytial virus infection, Escherichia coli infection, COVID-19 (had Covid for a week; In Mar-2022, patient had extreme fatigue and no appetite) from 06-Feb-2022 to February 2022, Pernio-like erythema (had Covid toe, all toes went blue, and it resolved except the blue stayed in 2 of toes) on 17-Feb-2022, Fatigue, Physical therapy and Anticoagulant therapy (Blood thinner). Previously administered products included for COVID-19 immunisation: BNT162b2 (Dose 1, single (Lot number: ER9231), in arm) in January 2021, BNT162b2 (Dose 2 (Lot number: EN6201) in arm and rash on arm and doctor office mentioned shingles) on 23-Jan-2021; for Immunization: Flu vaccine VII; for Herpes simplex: Valacyclovir (valacyclovir as needed and 2021 reactivated with 2nd Pfizer shot). Past adverse reactions to the above products included No adverse effect with BNT162b2 and Valacyclovir; Shingles with BNT162b2; and Vaccination failure with Flu vaccine VII. Concurrent medical conditions included Occipital neuralgia (Test concluded with cardiologist following Veins scuttered 03Jan2020; hospitalized. She was discharged to conjugate facility and recovery time was 2 weeks) since June 2020, Pernicious anemia (1996, Congenital; Verification test 1996, Extreme Fatigue) since 1954, Osteoarthritis (Joint pain; bone loss, Physical therapy) since 2009, Osteoporosis (valacyclovir as needed, 2021 reactivated with 2nd Pfizer shot) since 2021, Herpes simplex (valacyclovir as needed, 2021 reactivated with 2nd Pfizer shot) since 1983, Mitral valve prolapse (Test concluded with cardiologist following Veins scuttered 03Jan2020) since 2021, Blood pressure high and Drug allergy. Concomitant products included Acetylsalicylic acid (Aspirine) from 1996 to March 2023 for Anticoagulant therapy, Diphenhydramine hydrochloride (Benadryl) from 2020 to 2021 for Drug hypersensitivity, Atenolol from 2015 to an unknown date for Hypertension, Cyanocobalamin (Vitamin b12) from 1996 to an unknown date and Calcium from 1996 to an unknown date for Pernicious anaemia, Bupropion hydrochloride (Bupropion) for an unknown indication. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, fourth dose of Famtozinameran, Tozinameran (Pfizer BioNTech COVID-19 vaccine, bivalent (original and omicron BA.4/5)) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On 28-Dec-2022, the patient experienced LOSS OF CONSCIOUSNESS (loss of consiousness) (seriousness criterion medically significant). 28-Dec-2022, the patient experienced FALL (Fell in bathroom), CONFUSIONAL STATE (confusion), DEPRESSION (depression), APHASIA (unable to remember names and common vocabulary), MEMORY IMPAIRMENT (unable to remember names and common vocabulary), DIZZINESS (dizzy) and PYREXIA (fever). In March 2023, the patient experienced ATRIAL FIBRILLATION (A-fib) (seriousness criterion medically significant), MITRAL VALVE INCOMPETENCE (mitral valve leaking) (seriousness criterion medically significant), DECREASED APPETITE (loss of appetite), INSOMNIA (inability to sleep) and HEADACHE (Headaches). In April 2023, the patient experienced DYSPNOEA (shortness of breath) and VISUAL IMPAIRMENT (vision worsened). On an unknown date, the patient experienced LYMPHOEDEMA (My lymph nodes in my throat and ankles have been swelling since I got the bivalent vaccine dose ( the 4th Covid Vaccine dose)). The patient was treated with Apixaban (Eliquis) in March 2023 at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (loss of consiousness), ATRIAL FIBRILLATION (A-fib), MITRAL VALVE INCOMPETENCE (mitral valve leaking), FALL (Fell in bathroom), CONFUSIONAL STATE (confusion), DEPRESSION (depression), APHASIA (unable to remember names and common vocabulary), MEMORY IMPAIRMENT (unable to remember names and common vocabulary), INSOMNIA (inability to sleep), DYSPNOEA (shortness of breath), LYMPHOEDEMA (My lymph nodes in my throat and ankles have been swelling since I got the bivalent vaccine dose ( the 4th Covid Vaccine dose)), VISUAL IMPAIRMENT (vision worsened), DIZZINESS (dizzy), PYREXIA (fever) and HEADACHE (Headaches) outcome was unknown and DECREASED APPETITE (loss of appetite) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 1996, Investigation: Positive. In 2007, Investigation: Positive. In June 2020, Antibody test: Negative and Negative. In June 2020, Blood pressure measurement: Extremely low. In June 2020, Heart rate: 43. In 2021, Computerised tomogram: Afib, HBP, Arrhythmia valve leak. In 2021, Electrocardiogram: Afib, HBP, Arrhythmia valve leak. In 2021, Magnetic resonance imaging: Afib, HBP, Arrhythmia valve leak. In 2021, X-ray: Afib, HBP, Arrhythmia valve leak. In February 2022, SARS-CoV-2 test: Positive. In 2022, Investigation: Negative. On 28-Dec-2022, Computerised tomogram: no stroke. On 28-Dec-2022, SARS-CoV-2 test: Negative. On 28-Dec-2022, Weight: Rapid loss. Patient was tested for lates in 1996 (positive), 2007 (positive), 2022 (positive). In 2018 and 2021, patient had Dexa scan (bone densitometry), results were unknown. On 03-Feb-2022, exposure to Covid at resident facility not monitored by board of health. On 06-Feb-2022, positive COVID diagnosis. On 17-Feb-2022, COVID presented, and she contacted the cubic RN (no physician available). No treatment was recommended except 5 to 7 days of rest. After 2 vaccines, she recovered in 7 days, but cough and ear infection lingered on months. She was referred to an ENT, physician and cardiologist. On Mar-2022, extreme fatigue and no appetite. The cardiologist was not certain of effects on heart by COVID infection. On Nov-2022, she was re-prescribed with heart meds, but no new tests were ordered. The extreme fatigue continued. On 28-Dec-2022, she had fever, confusion, depression, dizzy, losses of consciousness and causing fall in bathroom. The COVID test results were negative. ER was used for damage to knees, ankles, back elevation and blood pressure due to lack of medication (on floor over 5 hours w/o assistance). She was unable to remember names and common vocabulary very suddenly. Single loss of 20. On Mar-2023, she experienced A-fib, mitral valve leaking, inability to sleep, loss of appetite and very rapid weight loss. She reported stopping aspirin regimen and beginning Eliquis which caused intense headaches. On Apr-2023, her vision worsened, depression, shortness of breath and continued lack of appetite. The papers were sent extremely late as COVID was followed by R.S.V and E-coli infection. Booster continued. Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2025: Significant follow-up received: Case was upgraded to serious valid case from non-serious tracking only. Patient's age was added, medical history was updated, added lab data, suspect was updated to SPIKEVAX NOS, co-suspect details updated, additional concomitant medications were added, additional treatment medication was added, event COVID-19 was removed, additional events were added, and narrative was updated. On 15-Apr-2025: Live follow-up received contains non-significant information (reference number was added).; Reporter's Comments: Patients underlying condition in addition with infections with COVID-19 are confounders for Atrial fibrillation and Mitral valve incompetence. Headache is assessed as not related due to long latency and better explained secondary to Eliquis. The benefit-risk relationship of product is not affected by this report. More
2838377 74 M WV 04/28/2025 COVID19
 MODERNA
 8081260
Chills, Pain, Pain in extremity, Vaccination site pain Chills, Pain, Pain in extremity, Vaccination site pain
sore arms at injection site and a bit chilly/achiness/had some chills and the arm was achy/Arm pain/... sore arms at injection site and a bit chilly/achiness/had some chills and the arm was achy/Arm pain/Sore arm; We felt a little chilly, no, no fever, but, and then a little achy, you know, the body a little bit/little body ache; sore arms at injection site and a bit chilly/achiness; sore arms at injection site and a bit chilly/achiness chills/had some chills and the arm was achy/Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arms at injection site and a bit chilly/achiness/had some chills and the arm was achy/Arm pain/Sore arm), PAIN (We felt a little chilly, no, no fever, but, and then a little achy, you know, the body a little bit/little body ache), VACCINATION SITE PAIN (sore arms at injection site and a bit chilly/achiness) and CHILLS (sore arms at injection site and a bit chilly/achiness chills/had some chills and the arm was achy/Chills) in a 74-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8081260) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2024-2025 PFS (First booster dose) in September 2024. Past adverse reactions to the above products included No adverse effect with SPIKEVAX 2024-2025 PFS. On 28-Mar-2025, the patient received second dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 28-Mar-2025, the patient experienced PAIN IN EXTREMITY (sore arms at injection site and a bit chilly/achiness/had some chills and the arm was achy/Arm pain/Sore arm), PAIN (We felt a little chilly, no, no fever, but, and then a little achy, you know, the body a little bit/little body ache), VACCINATION SITE PAIN (sore arms at injection site and a bit chilly/achiness) and CHILLS (sore arms at injection site and a bit chilly/achiness chills/had some chills and the arm was achy/Chills). On 30-Mar-2025, PAIN IN EXTREMITY (sore arms at injection site and a bit chilly/achiness/had some chills and the arm was achy/Arm pain/Sore arm), PAIN (We felt a little chilly, no, no fever, but, and then a little achy, you know, the body a little bit/little body ache), VACCINATION SITE PAIN (sore arms at injection site and a bit chilly/achiness) and CHILLS (sore arms at injection site and a bit chilly/achiness chills/had some chills and the arm was achy/Chills) had resolved. Concomitant product use was not provided by the reporter. Patient had received second Booster shot from Moderna. Patient and his wife had received all the Moderna Covid-19 vaccines included another jab this spring. Only reaction patient had this spring were sore arms at injection site and a bit chilly/achiness. Patient and his wife had some chills and the arm was achy and that they were a little, achy. Patient had the sore arm for two days. They felt a little chilly, no, no fever, but, and then a little achy, the body a little bit, but that was it. It resolved. The symptoms started in 28-MAR-2025 in the morning stating after 12 hours exactly for the wife and the patient got it probably 4 hours later than that. So within the 24 hours, but the 1st 12 hours, they generally didn't felt anything and then the arm got sore and sore and then the next day it was really sore. But that didn't bother them. 2 days later, on 30-Mar-2025, basically it was mostly gone, 48 hours later. The patient had experienced sore arm but not much achy and subsided eventually. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-785213 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2025: Live significant information follow-up received: Reporter details added. Lot number along with dosing details were added. Patient details added. Event verbatim updated and new event General body pain added. Event Ache NOS was updated to Pain in arm. Outcome of the events were updated. Reference Id added. On 22-Apr-2025: Live Significant follow up received: Patient initials updated. Event verbatim updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785213:Patient 2 of 2 More
2838378 75 F WV 04/28/2025 COVID19
 MODERNA
 8081260
Chills, Myalgia, Pain, Pain in extremity Chills, Myalgia, Pain, Pain in extremity
the arm was achy/Arm pain; little body ache; had some chills; Muscle ache; This spontaneous case was... the arm was achy/Arm pain; little body ache; had some chills; Muscle ache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (the arm was achy/Arm pain), PAIN (little body ache), CHILLS (had some chills) and MYALGIA (Muscle ache) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8081260) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2024-2025 PFS (First Booster dose) in September 2024. Past adverse reactions to the above products included No adverse effect with SPIKEVAX 2024-2025 PFS. On 28-Mar-2025, the patient received second dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 28-Mar-2025, the patient experienced PAIN IN EXTREMITY (the arm was achy/Arm pain), PAIN (little body ache), CHILLS (had some chills) and MYALGIA (Muscle ache). On 30-Mar-2025, PAIN IN EXTREMITY (the arm was achy/Arm pain) and MYALGIA (Muscle ache) had resolved. At the time of the report, PAIN (little body ache) and CHILLS (had some chills) had resolved. Patient did not receive any vaccines within the past 4 weeks. The concomitant medication was not reported. Patient had received second Booster shot from Moderna. Patient had sore arm for two days, felt a little chilly, no fever but then a little achy, the little bit body ache, but that was it. The symptoms started on 28-MAR-2025 in the morning, and it was started after 12 hours exactly for patient. Within the 24 hours, the first 12 hours, patient generally didn't feel anything, and then the arm got sore and sore and then the next day it was really sore. But that didn't bother her. 2 days later, that is 30th, basically it was mostly gone. She had said, it was 48 hrs. Patient had Moderna COVID vaccines all the way through since day one. It was unknown if the patient experienced any additional symptoms/events The treatment drug information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-785217 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2025: Live follow up received that contains significant information includes reporter details, initials, historical vaccine, lot number, dose details, event latency and date of birth was added and event verbatim and coding for arm pain was updated. On 22-Apr-2025: Live Significant follow up received includes new event of Muscle ache and reference were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785217:Husband case More
2838382 79 M CA 04/28/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



Brain fog, Computerised tomogram; Brain fog, Computerised tomogram; Brain fog, C... Brain fog, Computerised tomogram; Brain fog, Computerised tomogram; Brain fog, Computerised tomogram; Brain fog, Computerised tomogram More
brain fog; This is a spontaneous report received from a Consumer or other non HCP from medical infor... brain fog; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 80-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "broken leg from parachuting" (unspecified if ongoing); "Hypertension" (ongoing); "general aches and pains and developed neuropathy" (ongoing); "pulls water out of the system" (ongoing); "limited asthma" (ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for hypertension (ongoing); GABAPENTIN taken for neuralgia (ongoing); HYDROCORT [HYDROCORTISONE ACETATE] oral taken for fluid retention (ongoing); ADVAIR taken for asthma (ongoing). The patient also took other concomitant therapy. The following information was reported: BRAIN FOG (non-serious) with onset 01May2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient stated, "I woke up and felt I've felt like I was drugged. It starts to lessen as the day goes on. After I wake up the next day, it starts all over again..." He described the intensity of the brain fog to be the worst in the morning right after waking up and the intensity lessens throughout the day. He also mentioned posting an ad on Craigslist regarding brain fog after getting the vaccine and he got 27 responses from the (Redact) and (Redact) reporting the same thing. He states, "It wasn't necessarily all Pfizer... but they are experiencing things they have never had before like runny nose. Their life has never been the same after the vaccine. It was not safe for me to drive because of the intensity of the brain fog at 8 or 9 (in the morning)." He further complained of this delayed side effect and how this is a "collateral damage" of the vaccine. "It was frustrating. I know the intension is to eliminate death from Covid but the collateral damage is these side effects." He said he already spoke about this with his doctor, and the CDC but they were not helpful. Also reported that, On 21Feb2021 he got the vaccine. Clarifies 1May2021 he had brain fog like he had never experienced in his life. When he was younger and wild and crazy he drove drunk and shouldn't have. This was a type of brain fog that his first reaction was he had been drugged but he hadn't been. He has gotten some strange side effects within that that he discovered. He 1st sought out a doctor and got a CAT scan and the neurologist saw nothing. Has done research and has a ton of information. He has had booster since then and remains the same He has found out he is not alone. outcome - persisting, states it is so predictable NDC, lot and expiry - he has a card with information but doesn't have it with him. States he got it in the arm probably early afternoon. Dose unknown. Concomitant Medication: gabapentin States this helps some. His wife purchased an expensive scale looking thing that vibrates and has an automatic timer you stand for 10 minutes and for some reason at night he will wake up and feel like his feet are so hot he is going to set the sheets on fire. He will stand on that for 10 minutes if he hadn't done it earlier and it's done, gone. This he would say 90% of the time reduces the fire sensation in his feet. Sometimes it did not but most times it did. States the limited asthma seems to be slowly waning. doctor said it might do that. Medical History: shot in war 4 times, broken leg from parachuting, states all external stuff. Investigations: not that can think of pretty healthy until later years and old wearing down. States he would do anything cut off my leg to end this brain fog it's so annoying and interferes with his life. Physically he is fine. He can't drive a car in the morning. The fog isn't constant and is worse in the morning. By midnight it is completely gone, when he wakes up he has started the cycle all over again. 2 weeks ago his wife woke up around 4am thinking she was having heart attack. They jumped in the car and he had about 4 hours of sleep he realized going to be a real problem concentrating. He has been driving that area for 51 years and he knew he would have to pay super careful attention and she couldn't talk to him so he could focus. Driving in pitch black and concentrate with no external noise so could make the turn right. It was magnified by 20. He knew it was coming. If he wants to go camping and leave at 8 or 9 she would have to drive, he couldn't. The fog is so intense he can't take his eyes off the road for a split second. He is not alone with this symptom. If he glances and snaps back he can't because he did not know how much time elapsed since glanced away. Around noon or 1 it gets much easier. Around 4-5 it's not near that and driving after dark is not a problem because the day has gone by. It's how long he has been awake. While researching and getting don't know what to tell you from doctors so he gave up on that route. Has been reading online and found article a doctor makes a quick reference to vax fog. He made an appointment with her and explained the symptoms. It was like she almost said tell me something new. This was 2021 later in the year. When he shuts his eyes the brain fog disappears. The provider said shut one eye and it dissipated. If he pushes on his temples hard enough that it starts to hurt and lets go, the fog disappears. That was in 2021. He went on social media and made a paragraph about his symptoms and started by picking 9 cities. He posted from (redact) and in (Redact) and got 27 responses back telling him they experienced the same thing. It's a 2-month delayed reaction. Declines to report. He had a 22-year-old female from (Redact)reported brain fog with constantly runny nose. Relays a couple of other people reported this also. Declines to report He has contacted the CDC 3 times and told the story, and they said oh that is interesting like they had never heard of it before. The immunologist in (Redact) said don't talk to them. What he has gathered is the vaccine was a quick rush to prevent the death happening by the thousands. At the time it was the thing to do. He was asked if he could go back would he take it again and he thinks he probably wouldn't have taken it but then he might have gotten Covid. Late last year the (Rredact)Times did an article about vax fog. They said what he knew in 2021 and 2022 that there is this reaction. He read on the internet a woman when she was little girl her parents owned a lot of horses. They had a stable with horses and goes out and boards them and horses are her life. Today she can't stand the smell of barn or horse accompanied with it or the smell of a warm lake in summertime accompanied with brain fog. It's a type of person that the common reaction happens to. How does pushing on his temples stop it? He doesn't know. Dates for Concomitant Products Ventolin HEA AER GLAX: (Start: Unknown Stop: Ongoing). started taking maybe 6 years ago, once a day maybe if that for limited asthma. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2838383 M FL 04/28/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
we've always gotten the Pfizer vaccine, you know Covid vaccine; we've always gotten the Pf... we've always gotten the Pfizer vaccine, you know Covid vaccine; we've always gotten the Pfizer vaccine, you know Covid vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 67-year-old 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. Vaccination history included: Bnt162b2 (Previous Pfizer Covid vaccine), for COVID-19 IMMUNIZATION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we've always gotten the Pfizer vaccine, you know Covid vaccine". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500087820 same reporter drug AE different patient; More
2838384 19 F MA 04/28/2025 COVID19
 PFIZER\BIONTECH
Vaccination site erythema, Vaccination site swelling, Vaccination site warmth Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
redness at injection site, slight swelling and warm to the touch; redness at injection site, slight ... redness at injection site, slight swelling and warm to the touch; redness at injection site, slight swelling and warm to the touch; redness at injection site, slight swelling and warm to the touch; This is a spontaneous report received from a Consumer or other non HCP. A 19-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 26Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 19 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "dysautonomia" (unspecified if ongoing); "nut allergy" (unspecified if ongoing); "crohn" (unspecified if ongoing); "EOE" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 27Apr2025 at 10:00, outcome "unknown" and all described as "redness at injection site, slight swelling and warm to the touch". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site warmth. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2838398 31 F TX 04/28/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 Y015551
Y015551
Blood glucose increased, Blood thyroid stimulating hormone increased, Erythema, ... Blood glucose increased, Blood thyroid stimulating hormone increased, Erythema, Injection site erythema, Joint swelling; Lymphadenopathy, Pruritus More
increase in glucose (measured by CGM), increase in TSH (from previous level of 3 to about 7), swelli... increase in glucose (measured by CGM), increase in TSH (from previous level of 3 to about 7), swelling in joints, swollen knee, redness at injection site and neck, itchiness all over body, swollen lymph nodes More
2838399 50 F CA 04/28/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Ataxia, Blood test normal, Burning sensation, Cognitive disorder, Computerised t... Ataxia, Blood test normal, Burning sensation, Cognitive disorder, Computerised tomogram normal; Confusional state, Disorientation, Dystonia, Fear, Impaired work ability; Loss of personal independence in daily activities, Paranoia, Seizure More
Total body dystonia. Seizures. Extreme confusion and disorientation. Ataxia. Paranoia. Terror. Whole... Total body dystonia. Seizures. Extreme confusion and disorientation. Ataxia. Paranoia. Terror. Whole body and brain on fire. Loss of cognitive abilities. Lost ability to function or take care of myself. Still not able to work or leave house for long periods of time. More
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2838400 11 M CO 04/28/2025 TYP
 SANOFI PASTEUR
 X1A271M
Lip pruritus, Throat irritation, Urticaria Lip pruritus, Throat irritation, Urticaria
Client's mother came back into office with client. Client has hives to trunk, bilateral shoulde... Client's mother came back into office with client. Client has hives to trunk, bilateral shoulders, neck, bilateral legs. Mother notes allergy to peanuts, no allergy to latex, gelatin or eggs. Mother gave 25mg diphenhydramine PO in office. O2 98% room air, 78 BPM. At approximately 1256, client states lips are itchy, and mild itchiness in throat. This RN proceeded with administering 0.3mL diphenhydramine IM at 1258. Client was monitored for an additional ten minutes. Client remained stable and no complaints of itching or tingling in airway. Client's color within normal limits, patent airway. Informed mother we can call 911, however, mother felt comfortable driving client to urgent care five min away. Mother is going to take client to urgent care. Client also has epi pen and rescue inhaler on person. More
2838411 1 M PA 04/28/2025 HEPA
HEPA
HEPA
HEPA
HEPA
MMR
MMR
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PNC15
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VARCEL
VARCEL
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VARCEL
VARCEL
VARCEL
HEPA
HEPA
HEPA
HEPA
HEPA
MMR
MMR
MMR
MMR
MMR
PNC15
PNC15
PNC15
PNC15
PNC15
UNK
UNK
UNK
UNK
UNK
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y015910
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Y015910
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Y015995
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Y015558
Y015558
Y015558
Y015558
Y015558
Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin disc... Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin discolouration, Urine output decreased; Irritability, Rash vesicular; Cough, Food refusal, Irritability, Laboratory test, Oral pain; Rash maculo-papular, Rhinorrhoea; Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin discolouration, Urine output decreased; Irritability, Rash vesicular; Cough, Food refusal, Irritability, Laboratory test, Oral pain; Rash maculo-papular, Rhinorrhoea; Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin discolouration, Urine output decreased; Irritability, Rash vesicular; Cough, Food refusal, Irritability, Laboratory test, Oral pain; Rash maculo-papular, Rhinorrhoea; Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin discolouration, Urine output decreased; Irritability, Rash vesicular; Cough, Food refusal, Irritability, Laboratory test, Oral pain; Rash maculo-papular, Rhinorrhoea; Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin discolouration, Urine output decreased; Irritability, Rash vesicular; Cough, Food refusal, Irritability, Laboratory test, Oral pain; Rash maculo-papular, Rhinorrhoea; Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin discolouration, Urine output decreased; Irritability, Rash vesicular; Cough, Food refusal, Irritability, Laboratory test, Oral pain; Rash maculo-papular, Rhinorrhoea; Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin discolouration, Urine output decreased; Irritability, Rash vesicular; Cough, Food refusal, Irritability, Laboratory test, Oral pain; Rash maculo-papular, Rhinorrhoea; Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin discolouration, Urine output decreased; Irritability, Rash vesicular; Cough, Food refusal, Irritability, Laboratory test, Oral pain; Rash maculo-papular, Rhinorrhoea; Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin discolouration, Urine output decreased; Irritability, Rash vesicular; Cough, Food refusal, Irritability, Laboratory test, Oral pain; Rash maculo-papular, Rhinorrhoea; Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea; Scab, Skin discolouration, Urine output decreased; Irritability, Rash vesicular; Cough, Food refusal, Irritability, Laboratory test, Oral pain; Rash maculo-papular, Rhinorrhoea More
Approximately a week after receiving the above vaccines, patient showed increased irritability and r... Approximately a week after receiving the above vaccines, patient showed increased irritability and refusal to eat foods that required chewing, presumably due to mouth pain. Patient also showed a runny nose. On 4/25/2025, patient developed spots on body, which started at the hairline and progressed downward across the face and onto the trunk and limbs over the next few days. Spots were raised and crusty and looked like chicken pox. Patient was estimated to have >200 spots on body. Patient also developed spots in the mouth. Patient showed increasing irritability/fussiness, decreased appetite, fewer wet diapers, refusal to eat foods that required chewing, and developed a cough. More
2838412 0.17 M 04/28/2025 FLU3
 SANOFI PASTEUR
 UT8423MA
Wrong product administered Wrong product administered
Patient was to get dose of Vaxelis. When reviewing chart after finding discrepancy in weekly vaccina... Patient was to get dose of Vaxelis. When reviewing chart after finding discrepancy in weekly vaccination counts, it was found that the lot number and expiration date did not match up to a Vaxelis dose but did match an influenza dose. Patient appears to have been given a flu shot and not his scheduled Vaxelis. Notified Clinical Services for direction. Incident report filed. Provider notified. Clinical Services reached out to CDC for guidance. Will be having discussion of incident with staff involved tomorrow 4/29/25 and will instruct them to call family to notify of the incident and to schedule patient to come in to get the scheduled Vaxelis dose. Working with Clinical Services on immunization administration process and will be creating new workflow to prevent further incidents. More
2838413 61 M 04/28/2025 HEPAB
PNC21
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS


Aphasia, Hypoaesthesia oral; Aphasia, Hypoaesthesia oral; Aphasia, Hypoaesthesia... Aphasia, Hypoaesthesia oral; Aphasia, Hypoaesthesia oral; Aphasia, Hypoaesthesia oral More
The day after vaccine , patient went in hot tub for 15-20 minutes and after he came out his tongue w... The day after vaccine , patient went in hot tub for 15-20 minutes and after he came out his tongue was numb and he could not speak - patient's wife called ER and upon their arrival his vitals were normal. More
2838414 70 F FL 04/28/2025 PNC20
 PFIZER\WYETH
 lx4482
Extra dose administered, No adverse event Extra dose administered, No adverse event
Pt got Prevnar 20 3/21/2023 and another Prevnar 20 4/25/25 (duplication of vaccine). No side effects... Pt got Prevnar 20 3/21/2023 and another Prevnar 20 4/25/25 (duplication of vaccine). No side effects per pt. More
2838415 62 M CA 04/28/2025 CHIK
CHOL
JEV1
TYP
 VALNEVA USA, INC.
PAXVAX
INTERCELL AG
SANOFI PASTEUR
 24B011
4344103
JEV23K07E
X1A271M
Bell's palsy; Bell's palsy; Bell's palsy; Bell's palsy Bell's palsy; Bell's palsy; Bell's palsy; Bell's palsy
4/7/25 Received: Ixchiq, Cholera, JE, Typhoid Vi. 4/22/25 in ER. 4/28/25 Per patient, he is ho... 4/7/25 Received: Ixchiq, Cholera, JE, Typhoid Vi. 4/22/25 in ER. 4/28/25 Per patient, he is home, dx with Bell's Palsy, currently being treated with steroids, his doctors aware of vaccine hx. More
2838416 31 M WI 04/28/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



Arteriogram carotid, Balance disorder, Brain oedema, Carotid artery occlusion, C... Arteriogram carotid, Balance disorder, Brain oedema, Carotid artery occlusion, Cognitive disorder; Computerised tomogram head abnormal, Dizziness, Echocardiogram, Echocardiogram normal, Electrocardiogram normal; Hemiparesis, Ischaemic stroke, Loss of personal independence in daily activities, Memory impairment, Middle cerebral artery stroke; Mobility decreased, Scan with contrast, Thrombectomy More
Patient was admitted to the hospital 10/08/21 because after playing soccer he developed dizziness an... Patient was admitted to the hospital 10/08/21 because after playing soccer he developed dizziness and left-sided weakness . On admission head CT showed large right MCA and small right ACA ischemic CVA with cytotoxic right basal ganglia edema . Head and neck CTA showed occlusion of right ICA at the level of ophthalmic artery. The patient was transferred to another hospital where he had thrombectomy. Additional study was done TEE with did not reveal any shunt, did not reveal any valvular abnormalities. Patient was consulted by neurologist with recommendation treat patient with aspirin, Plavix and statin Because of patient weakness, left-sided neglect, impaired mobility, ADLs he was consulted by PM&R service and decided he will benefit from comprehensive inpatient rehab program and on 10/24/2021 transfer to rehab hospital to start comprehensive inpatient rehab program. Hospital Course: Principal Problem: Ischemic stroke (HCC) -recommended continue aspirin and Plavix Ischemic CVA-EKG showed sinus rhythm but does not explain patient's stroke and cardiology recommended loop recorder after patient will be discharged what could be placed as outpatient Cognitive deficit-patient still require minimal assistance for memory, moderate assistance for problem solving and recommended continue speech therapy as outpatient Impaired balance with left hemiparesis-recommend continue AFO and standard cane for ambulation. This is permanent left hemiparesis as of 2025. More
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2838417 0.25 F MO 04/28/2025 HIBV
 MERCK & CO. INC.
 X009000
Screaming Screaming
Inconsolable screaming for 3 hours straight. Starting about 3. 5 hours after vaccine given. Inconsolable screaming for 3 hours straight. Starting about 3. 5 hours after vaccine given.
2838418 0.17 F MO 04/28/2025 PNC20
 PFIZER\WYETH
 HN5978
Infant irritability, Pyrexia Infant irritability, Pyrexia
3 hours after vaccine, became fussy, clingy, febrile x 2 days. 3 hours after vaccine, became fussy, clingy, febrile x 2 days.
2838159 4 F IN 04/27/2025 HEPA
HEPA
HEPA
HEPA
MMRV
MMRV
PNC15
PNC15
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.







Cough, Eye discharge, Irritability, Morbillivirus test positive, Rash; Rash eryt... Cough, Eye discharge, Irritability, Morbillivirus test positive, Rash; Rash erythematous, Rash papular, Rash pruritic, Rhinorrhoea; Cough, Eye discharge, Irritability, Morbillivirus test positive, Rash; Rash erythematous, Rash papular, Rash pruritic, Rhinorrhoea; Cough, Eye discharge, Irritability, Morbillivirus test positive, Rash; Rash erythematous, Rash papular, Rash pruritic, Rhinorrhoea; Cough, Eye discharge, Irritability, Morbillivirus test positive, Rash; Rash erythematous, Rash papular, Rash pruritic, Rhinorrhoea More
patient is a 4 y.o. female who presents for evaluation of a skin concern involving the face and tors... patient is a 4 y.o. female who presents for evaluation of a skin concern involving the face and torso that the patient's father describes as a rash. Historian : Father. This concern started within the last hour prior to arrival. She has also had a cough and runny nose for the last 48 hours. Appearance is raised, red, and round and is pruritic (minimally). Appearance has become more wide spread over time. Associated symptoms: cough and irritability. Patient has not had contacts with similar concern. Patient has recently received the MMRV vaccine as well as DTap, IPV, Hib, HepB, HepA, and PCV15 vaccines 4/2/25. Patient has tried nothing for treatment. Father states he has to clean out mucous from patient's eyes. Temp is 99.1F, HR 133, R 18, SpO2 98% on room air, wt 16.9 kg. Symptomatic management was recommended. More
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