🏥 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 💀 🏥 🚑 ♿ ⚠️
2832615 F 03/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Patient did not recived 2nd dose/possible missed dose; This non-serious case was reported by a consu... Patient did not recived 2nd dose/possible missed dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix in Apr 2018), Zostavax (received Zostavax in February of 2013) and Zostavax (Zostavax received on 20 JUN 2018). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient did not recived 2nd dose/possible missed dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 12-MAR-2025 The patient self-reported this case. Consumer stated that she was vaccinated with Zostavax in February of 2013. She received her first dose of Shingrix in April 2018. She was vaccinated 20 JUN 2018 with what she believed to be her second dose of Shingrix. Consumer stated she recently received documentation that the dose of medication she received on 20 JUN 2018 was Zostavax. Consumer was in the process of determining if the wrong vaccine was administered or if the information was documented in correctly (possible missed dose.) Consumer stated she was 71 years old now and she would have been 64 years old at the time of receiving what she thought was the second dose of Shingrix. Consumer declined to provide any demographics or additional information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further information was obtained/provided. More
2832616 52 F NJ 03/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site mass, Injection site oedema, Injection site pain, Injection site ... Injection site mass, Injection site oedema, Injection site pain, Injection site swelling, Pain in extremity More
swollen injection site; injection site lump; injection site edema; arm began hurting/ forearm was pa... swollen injection site; injection site lump; injection site edema; arm began hurting/ forearm was painful; injection site tenderness/injection site became painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In JAN-2025, the patient received the 1st dose of Shingrix (left deltoid). In JAN-2025, immediately after receiving Shingrix, the patient experienced injection site tenderness (Verbatim: injection site tenderness/injection site became painful), injection site swelling (Verbatim: swollen injection site), injection site lump (Verbatim: injection site lump), injection site edema (Verbatim: injection site edema) and pain in arm (Verbatim: arm began hurting/ forearm was painful). In JAN-2025, the outcome of the injection site swelling was resolved. In FEB-2025, the outcome of the injection site lump and injection site edema were resolved. The outcome of the injection site tenderness and pain in arm were not resolved. It was unknown if the reporter considered the injection site tenderness, injection site swelling, injection site lump, injection site edema and pain in arm to be related to Shingrix. It was unknown if the company considered the injection site tenderness, injection site swelling, injection site lump, injection site edema and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 13-MAR-2025 The patient reported that she received her first Shingrix vaccine in January of 2025. The injection was painful, and her arm began hurting immediately, not to resolve for a few weeks. She reported that in the days immediately following the injection the injection site (Left Deltoid) became swollen and painful, with a hard lump. These symptoms persisted for a few weeks and the injection site was still painful to the touch. She also reported that her forearm was painful at the same time, and it was still painful. She stated that she wears a brace at times due to the pain. She denied any medications or conditions that could have contributed to the issue. More
2832617 F 03/21/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure/Shingrix ineffective; Patient got two doses of HZV and developed shing... Suspected vaccination failure/Shingrix ineffective; Patient got two doses of HZV and developed shingles later; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/Shingrix ineffective) (serious criteria GSK medically significant) and shingles (Verbatim: Patient got two doses of HZV and developed shingles later). The outcome of the vaccination failure was not resolved and the outcome of the shingles was not reported. The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date : 14-MAR-2025 Patient got two doses of HZV (herpes zoster vaccine) and developed shingles later. 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 vaccine Shingrix (dose 1) and Shingrix (dose 2). More
2832618 68 F GA 03/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
has not yet received the second dose; This non-serious case was reported by a pharmacist via call ce... has not yet received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (A patient received the first dose of Shingrix 09-JAN-2020). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 14-MAR-2025 The reporter is a pharmacist. A patient received the first dose of Shingrix 9 -JAN -2020, and has not yet received the second dose, which led to incomplete course of vaccination. The pharmacist was unable to provide the lot number and expiration of the first dose as it was not given at their pharmacy. More
2832619 M 03/21/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
we missed the booster; This non-serious case was reported by a consumer via call center representati... we missed the booster; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 5-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received first dose of Bexsero at 19 months ) and Bexsero (received second dose of Bexsero at 21 months old). On an unknown date, the patient did not receive the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: we missed the booster). The outcome of the incomplete course of vaccination 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: 12-MAR-2025 The patient was the son of the reporter. The reporter reported that the patient had the bexero vaccine when he was 19 months and 21 months old. At the time reporting he was 5 and they missed the booster. The reporter asked could he have it at the time of reporting The reporter reported that it was recommened 12 to 23 months after the second dose. Till the time of reporting the patient did not receive the third dose of Bexsero which led to incomplete course of vaccination. More
2832620 F 03/21/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Influenza, Respiratory syncytial virus infection, Vaccination failure Influenza, Respiratory syncytial virus infection, Vaccination failure
catching the flu after taking the vaccine; Suspected vaccination failiure; Had my shot in September ... catching the flu after taking the vaccine; Suspected vaccination failiure; Had my shot in September got RSV in January; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In SEP-2024, the patient received RSV vaccine. In JAN-2025, between 3 and 5 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failiure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Had my shot in September got RSV in January). On an unknown date, the patient experienced influenza (Verbatim: catching the flu after taking the vaccine). The outcome of the vaccination failure and influenza were not reported and the outcome of the respiratory syncytial virus infection was unknown. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and influenza to be related to RSV vaccine. The company considered the vaccination failure, respiratory syncytial virus infection and influenza to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 14-MAR-2025 This case was reported by the patient via interactive digital media. The patient reported that she had shot in September got RSV in January. The patient did not mention a specific product name. However, they mentioned having taken an RSV vaccine and still contracting the flu. Based on this information, it seems the product in question could be the RSV vaccine. The patient did not explicitly mention any other specific side effects, other than still catching the flu after taking the vaccine, which might imply that the vaccine did not provide the expected protection. This case was considered as suspected vaccination failure as details regarding laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Respiratory syncytial virus infection and Influenza are unlisted event which are considered unrelated to GSK RSV vaccine. More
2832621 F IL 03/21/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
Reporter was 34 weeks pregnant during time of Arexvy vaccination; Reporter was 34 weeks pregnant dur... Reporter was 34 weeks pregnant during time of Arexvy vaccination; Reporter was 34 weeks pregnant during time of Arexvy vaccination; This non-serious retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included gestational diabetes. Concomitant products included glipizide. On 24-JAN-2024, the patient received Arexvy. On 24-JAN-2024, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Reporter was 34 weeks pregnant during time of Arexvy vaccination). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Reporter was 34 weeks pregnant during time of Arexvy vaccination). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable. Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Details (Neonate 1): Actual Delivery Date: XX-FEB-2024 Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with a congenital anomaly Delivery Notes: gender of the baby was female See case US2025AMR031576 for details regarding the baby case. Additional Information: GSK Receipt Date: 12-MAR-2025 The patient self-reported this case for herself. Reporter received Arexvy vaccine from pharmacy. She was 34 weeks pregnant during time of vaccination, which led to product use in unapproved population. Reporter was also taken a prenatal vitamin started on 24th June 2023 and ended on 26th February 2024 and was also taken Glipizide 2.5milligrams for gestational diabetes started on 18th December 2023 and ended on 26th February 2024. This case was linked with US2025AMR031576, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR031576:baby case More
2832622 03/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
had the first Shingles shot, it had been a few years ago; This non-serious case was reported by a co... had the first Shingles shot, it had been a few years ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix few years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had the first Shingles shot, it had been a few years ago). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 14-MAR-2025 The patient had the first Shingles shot, but it had been a few years ago. The reporter asked if patient should have the second Shingles shot, or should start over with the first. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2832623 F 03/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Don't. I took it n got shingles; This serious case was reported ... Suspected vaccination failure; Don't. I took it n got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Don't. I took it n got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 15-MAR-2025 The reporter reported that took it n got 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 vaccine Shingrix. More
2832624 03/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspeceted vaccination failure; had shingles; This serious case was reported by a consumer via inter... Suspeceted vaccination failure; had 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 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: 14-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that everyone he/she knows who had shingles, his/herself included, took the Shingles shot except one who came down with shingles, in her 40s, shortly after the covid shot. The patient took the Shingles vaccine, and he/she had shingles last year in 2024. The patient mentioned that GlaxoSmithKline was telling him/her it was highly unlikely, that he/she had shingles or that he/she took the Shingles vaccine or that everyone he/she knows that got shingles had the vaccine. Further patient asked what was so highly unlikely. The patient said that what was highly unlikely, apparently, was GSK understanding the and vaccine makers had been lying and had been believing and now could not see truth even when it walks up and shakes their hands. The patient further said that it was much harder to see truth when they had believed a lie for so long. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case had been linked with US2025AMR032397 and US2025AMR032406 reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR032397:same reporter/ created for multiple patient US-GSK-US2025AMR032406:same reporter/ created for dad More
2832625 03/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Everyone I know who has had shingles, myself included, took the shing... Suspected vaccination failure; Everyone I know who has had shingles, myself included, took the shingles shot except 1; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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: Everyone I know who has had shingles, myself included, took the shingles shot except 1). 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: 14-MAR-2025 This case was reported by a reporter via interactive digital media. The reporter reported that everyone he/she knows who had shingles, his/herself included, took the Shingles shot except one who came down with shingles, in her 40s, shortly after the covid shot. The reporter mentioned that GlaxoSmithKline was telling him/her it was highly unlikely, that he/she had shingles or that he/she took the Shingles vaccine or that everyone he/she knows that got shingles had the vaccine. Further reporter asked what was so highly unlikely. The reporter also said his/her two friends also got shingles neither would lie about it and said that what was highly unlikely, apparently, was GSK understanding the and vaccine makers had been lying and had been believing and now could not see truth even when it walks up and shakes their hands. The reporter further said that it was much harder to see truth when they had believed a lie for so long. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case had been linked with US2025AMR032387 and US2025AMR032406 reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR032387:same reporter different patient US-GSK-US2025AMR032406:same reporter different patient More
2832626 M 03/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Shingles so bad he was hospitalized; Suspeceted vaccination failure; This serious case was reported ... Shingles so bad he was hospitalized; Suspeceted vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles so bad he was hospitalized) (serious criteria hospitalization). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 14-MAR-2025 and 15-MAR-2025 This case was reported by a reporter via interactive digital media who was daughter or son of the patient. The reporter reported that everyone he/she knows who had shingles, his/herself included, took the Shingles shot except one who came down with shingles, in her 40s, shortly after the covid shot. The reporter mentioned that GlaxoSmithKline was telling him/her it was highly unlikely, that he/she had shingles or that he/she took the Shingles vaccine or that everyone he/she knows that got shingles had the vaccine. Further reporter said that one was his/her dad (patient). Shingles was so bad he was hospitalized. Neither would lie about it and asked what was so highly unlikely. The reporter also said that what was highly unlikely, apparently, was GSK understanding the and vaccine makers had been lying and had been believing and now could not see truth even when it walks up and shakes their hands. The reporter further said that it was much harder to see truth when they had believed a lie for so long. The reporter just listed everyone he/she knew who got shingles was vaccinate. Further he/she said GSK said it was not credible. That was like saying it was not credible that it rained 3 nights in a row because GSK did not believe it ever rains 3 nights in a row. Yet reporter was there, and they were not. He/she also said that good science examined every side of an issue, did not close its eyes to evidence, and recognized its own bias. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case had been linked with US2025AMR032387 and US2025AMR032397 reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR032387:same reporter different patient US-GSK-US2025AMR032397:same reporter different patient US-GSK-US2025AMR032397:same reporter different patient More
✓
2832627 03/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; got the vaccine and also got shingles; This serious case was reported... Suspected vaccination failure; got the vaccine and also got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the vaccine and also got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure 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 : 16-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she got the vaccine and also got shingles. 15 months later still battled the pain with lidocaine patches. 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 vaccine Shingles vaccine. More
2832628 03/21/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; got them twice within a matter of months; This serious case was repor... Suspected vaccination failure; got them twice within a matter of months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got them twice within a matter of months). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAR-2025 The reporter reported that he/she had both vaccines, the first one that was not very effective and the second series of two, and he/she developed shingles after getting the shots. He/she got shingles every year on his/her arm for at least the last 6 years, but last year got them twice within a matter of months. He/she sometimes wonder if the shots did not give him/her shingles, because he/she never had an outbreak before getting the shots. 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 vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). More
2832629 F 03/21/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; she got the Shingles; This serious case was reported by a consumer vi... Suspected vaccination failure; she got the 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. 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, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she got the Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 1 month). 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: 15-MAR-2025 The reporter reported that her sister had the vaccine about a year before she got the Shingles. Reporter could not believe that she would ever get the shingles but she did. Not such a bad case of it but she did have it for about a month. Reporter said that she took the shingle shot about 12 years ago, and it was the older shot so she did not know if it was as good as the newer one that she took since she had the 2 shots with months in between. The reporter sated that never know when could get the Shingles it was immune system if it was really low. So be careful out there. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was 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 laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2832630 03/21/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; got the shingles on my upper half of my back up to my neck and mostly... Suspected vaccination failure; got the shingles on my upper half of my back up to my neck and mostly on my left side of back; 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix (left arm) and the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles on my upper half of my back up to my neck and mostly on my left side of back). 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 Shingrix and Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 15-MAR-2025, 16-MAR-2025 and 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the Shingrix shingles vaccine and low and behold got the shingles. The patient stated the same thing happened to a coworker. The patient further said that he/she got shingles after the second dose of Shingrix vaccine, and he/she got it on his/her upper half of his/her back up to his/her neck and mostly on his/her left side of back. The patient thought it was too much viral load. 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. This case was linked with case US2025AMR034444 from the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). US-GSK-US2025AMR034444:different patient/same reporter More
2832631 03/21/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Chills, Fatigue, Feeling abnormal, Feeling hot, Migraine; Nasopharyngitis, Pain Chills, Fatigue, Feeling abnormal, Feeling hot, Migraine; Nasopharyngitis, Pain
Migraine headache; cold; hot; chills; achy; Tired; Feeling so bad; This non-serious case was reporte... Migraine headache; cold; hot; chills; achy; Tired; Feeling so bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of migraine headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (shingles on leg a few years ago) and pain (pain was horrible.). Previously administered products included Varicella zoster vaccine (received first dose of Shingles vaccine on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced migraine headache (Verbatim: Migraine headache), cold (Verbatim: cold), feeling hot (Verbatim: hot), chills (Verbatim: chills), pain (Verbatim: achy), tiredness (Verbatim: Tired) and feeling bad (Verbatim: Feeling so bad). The outcome of the migraine headache, cold, feeling hot, chills, pain, tiredness and feeling bad were not reported. It was unknown if the reporter considered the migraine headache, cold, feeling hot, chills, pain, tiredness and feeling bad to be related to Shingles vaccine. It was unknown if the company considered the migraine headache, cold, feeling hot, chills, pain, tiredness and feeling bad to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient had shingles on leg a few years ago did not know what it was until went to the doctor and was 11 days in, the pain was horrible. The patient just got second shingles shot and it has made feel so bad. Headache (migraine), cold, hot, chills, achy and Tired. But pray it was worth it in the end. More
2832632 03/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Bedridden, Pain Bedridden, Pain
was in bed all day yesterday; The body aches were tremendous; This non-serious case was reported by ... was in bed all day yesterday; The body aches were tremendous; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 14-MAR-2025, the patient received Shingles vaccine. On 15-MAR-2025, 1 days after receiving Shingles vaccine, the patient experienced bedridden (Verbatim: was in bed all day yesterday). In MAR-2025, the patient experienced general body pain (Verbatim: The body aches were tremendous). The outcome of the bedridden was resolved and the outcome of the general body pain was not reported. It was unknown if the reporter considered the bedridden and general body pain to be related to Shingles vaccine. It was unknown if the company considered the bedridden and general body pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient got shingles shot Friday and was in bed all day the day before reporting. The body aches were tremendous. More
2832633 03/21/2025 VARZOS
VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Ear pain, Eye pain, Facial pain, Headache, Herpes zoster; Herpes zoster oticus, ... Ear pain, Eye pain, Facial pain, Headache, Herpes zoster; Herpes zoster oticus, Ophthalmic herpes zoster, Vaccination failure; Ear pain, Eye pain, Facial pain, Headache, Herpes zoster; Herpes zoster oticus, Ophthalmic herpes zoster, Vaccination failure More
Suspected vaccination failure; still got shingles in my ear; still got shingles in my eye; the side ... Suspected vaccination failure; still got shingles in my ear; still got shingles in my eye; the side of my face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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), herpes zoster otitis externa (Verbatim: still got shingles in my ear) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: still got shingles in my eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: the side of my face). The outcome of the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster and facial herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, herpes zoster otitis externa and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date : 16-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had two shingles shots and still got shingles in his/her ear, eye, the side of his/her face. Excruciated pain in his/her eye, ear and side of his/her head and face. 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 vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). Herpes zoster oticus and Ophthalmic herpes zoster are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). More
2832634 03/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, 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: 15-MAR-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 shot, hoping to protect himself/herself, but ended up with full-blown shingles. It was extremely painful and something he/she would not have wished on anyone. 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 vaccine Shingles vaccine. More
2832635 03/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Had 1st Shingles shot a year ago; This non-serious case was reported by a consumer via interactive d... Had 1st Shingles shot a year ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (had 1st Shingles shot a year ago). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Had 1st Shingles shot a year ago). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 15-MAR-2025 The patient had 1st Shingles shot a year ago and asked ok to get his/her 2nd shot now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2832636 03/21/2025 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: 16-MAR-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient got the vaccine and months later got Shingles. Patient stated that should have passed on the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose)and Shingles vaccine( 2nd dose) . More
2832637 M 03/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; just had shingles; This serious case was reported by a consumer via i... Suspected vaccination failure; just had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: just had shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-MAR-2025 The patient's wife reported this case via interactive digital media. The reporter and her husband (patient) had the shots 2 years ago (from the date of reporting) in 2023. The hubby (patient) just had shingles. The patient went on medications that day and they started drying up in a week or two. 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 the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2832638 03/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Feeling abnormal Feeling abnormal
Patient did not feel great after 2nd dose of vaccine; This non-serious case was reported by a consum... Patient did not feel great after 2nd dose of vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine (received first dose of Shingles vaccine on an unknown date). On 14-MAR-2025, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, less than a week after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: Patient did not feel great after 2nd dose of vaccine). The outcome of the feeling abnormal was not reported. It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine. It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient got 2nd vaccine yesterday on 14 MAR 2025 and did not feel great but think it was better than getting shingles especially with skin. More
2832639 F 03/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles a few days apart; This serious case was reported by a consum... Suspected vaccination failure; shingles a few days apart; 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 a few days apart). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 15-MAR-2025 This case was reported by a patient via interactive digital media. Reporter and husband got the vaccines and they both got shingles. They got the shots at the same time and shingles a few days apart. They hoped that they never get them again. They told themselves that they got milder cases than if had not gotten the vaccines. But reporter often wonder if they did not get it because of the vaccine. 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. This case is linked with US2025AMR033943 reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR033943:same reporter different patient More
2832640 M 03/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected Vaccination failure; got shingles; This serious case was reported by a consumer via intera... Suspected Vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 15-MAR-2025 This case was reported by a patient's wife via interactive digital media. The patient (husband) and reporter got the vaccines and they both got shingles and they got the shots at the same time and shingles a few days apart. 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. This case is linked with US2025AMR033905 reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR033905:same reporter different patient More
2832641 03/21/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles three times in a year; This serious case was reported by a c... Suspected vaccination failure; shingles three times in a year; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles three times in a year). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Patient got the two shot vaccine but still had shingles three times in a year. 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2832642 0.5 M CO 03/21/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 7D2Y4
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Kinrix administration instead of Pediarix; Kinrix administration to a 6-month-old patient; This non-... Kinrix administration instead of Pediarix; Kinrix administration to a 6-month-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. On 05-MAR-2025, the patient received Kinrix. On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Kinrix and Pediarix, the patient experienced wrong vaccine administered (Verbatim: Kinrix administration instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: Kinrix administration to a 6-month-old patient). 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: 12-MAR-2025 The practitioner nurse called to ask the safety and efficacy of given Kinrix instead of Pediarix to a 6-month-old patient, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter. More
2832643 1 F UT 03/21/2025 HEP
 UNKNOWN MANUFACTURER
 X9LB7
Expired product administered Expired product administered
Potential expired dose administered; This non-serious case was reported by a other health profession... Potential expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Hepatitis B vaccine (batch number X9LB7, expiry date 10-FEB-2012) for prophylaxis. On 29-DEC-2014, the patient received Hepatitis B vaccine. On 29-DEC-2014, an unknown time after receiving Hepatitis B vaccine, the patient experienced expired vaccine used (Verbatim: Potential expired dose administered). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 12-MAR-2025 The patient who received a dose of Hepatitis B vaccine (unknown brand, but manufactured by GlaxoSmithKline according to patient's records) on 29-December-2014 but their records stated expiration date was 10-February-2012, which led expired vaccine used. The reporter did not consent to follow-up. More
2832644 TX 03/21/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received a dose of Twinrix on September 2024; This non-serious case was reported by a pharmacist via... received a dose of Twinrix on September 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received a dose in September 2024). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received a dose of Twinrix on September 2024). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-MAR-2025 The pharmacist reported that a patient received a dose of Twinrix on September 2024 and in October a dose of Havrix Hepatitis A was administered in unknown location. The reporter asked how to continue with the schedule. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. More
2832645 TX 03/21/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation error Product preparation error
reconstituted with a different diluent; inappropriate dose of vaccine administered; This non-serious... reconstituted with a different diluent; inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received MMR (Priorix) for prophylaxis. Co-suspect products included mmr vaccine pre-filled syringe device (Priorix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 12-MAR-2025, the patient received Priorix. On an unknown date, the patient started Priorix Pre-Filled Syringe Device. On an unknown date, an unknown time after receiving Priorix and an unknown time after starting Priorix Pre-Filled Syringe Device, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a different diluent) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-MAR-2025 The pharmacist called to report Priorix was reconstituted with a different diluent than the one supplied and administered to a pediatric patient. Diluent used was sterile water, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter. More
2832646 60 F TX 03/21/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 324BY
Inappropriate schedule of product administration Inappropriate schedule of product administration
early 3rd dose; This non-serious case was reported by a pharmacist via call center representative an... early 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old female patient who received HAB (Twinrix adult) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. Previously administered products included Twinrix (Patient received first dose on 29-NOV-2024) and Twinrix (Patient received second dose on 29-DEC-2024). On 19-FEB-2025, the patient received the 3rd dose of Twinrix adult. On 19-FEB-2025, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too short (Verbatim: early 3rd dose). The outcome of the drug dose administration interval too short was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-MAR-2025 The patient received third dose of Twinrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. More
2832647 F FL 03/21/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 MD9SL
Extra dose administered Extra dose administered
received 4 doses of Engerix-B inadvertently; This non-serious case was reported by a pharmacist via ... received 4 doses of Engerix-B inadvertently; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received HBV (Engerix B) (batch number MD9SL, expiry date 08-DEC-2026) for prophylaxis. Previously administered products included Engerix b (received first dose of Engerix b on an unknown date), Engerix b (received second dose of Engerix b on an unknown date) and Engerix b (received third dose of Engerix b on an unknown date). On an unknown date, the patient received the 4th dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: received 4 doses of Engerix-B inadvertently). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 13-MAR-2025 The pharmacist reports a patient received 4 doses of Engerix b inadvertently which led to extra dose administered. More
2832648 M CA 03/21/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 KH2BD
Incorrect route of product administration Incorrect route of product administration
Incorrect Route of Administration; This non-serious case was reported by a pharmacist via call cente... Incorrect Route of Administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a male patient who received MMR (Priorix) (batch number KH2BD, expiry date 01-JAN-2026) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Incorrect Route of Administration). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-MAR-2025 The pharmacist had a question regarding one of GlaxoSmithKline vaccines the Mmr vaccine, the Priorix. So, it was this only subcutaneously only. The pharmacist asked but what happens if it actually had been given intramuscularly which led to subcutaneous injection formulation administered by other route. The pharmacist reported, like was there any side effects for that. More
2832649 48 M VA 03/21/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 X2233
Extra dose administered, Underdose Extra dose administered, Underdose
gave a pediatric dose Hepatitis A to an adult patient; gave a pediatric dose Hepatitis A to an adult... gave a pediatric dose Hepatitis A to an adult patient; gave a pediatric dose Hepatitis A to an adult patient; 3rd dose of havrix was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 48-year-old male patient who received HAV (Havrix pediatric) (batch number X2233, expiry date 14-NOV-2025) for prophylaxis. On 13-MAR-2025, the patient received the 3rd dose of Havrix pediatric. On 13-MAR-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: gave a pediatric dose Hepatitis A to an adult patient), underdose (Verbatim: gave a pediatric dose Hepatitis A to an adult patient) and extra dose administered (Verbatim: 3rd dose of havrix was administered). The outcome of the adult use of a child product, underdose and extra dose administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-MAR-2025 The reporter reported that one of staff members gave a pediatric dose Hepatitis A to an adult patient and just needed to call to see what the next dosing will be for the patient? The adult patient received Havrix pediatric vaccine which led to adult use of child product and underdose. And the received dose was 3rd dose of Havrix which led to extra dose administration. More
2832650 F CA 03/21/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 27NG7
Unevaluable event Unevaluable event
one was sent to the hospital because she's really bad/patient was hospitalized; This serious ca... one was sent to the hospital because she's really bad/patient was hospitalized; This serious case was reported by a consumer via call center representative and described the occurrence of hospitalization in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 27NG7, expiry date 31-OCT-2025) for prophylaxis. On 20-NOV-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hospitalization (Verbatim: one was sent to the hospital because she's really bad/patient was hospitalized) (serious criteria hospitalization). The outcome of the hospitalization was unknown. It was unknown if the reporter considered the hospitalization to be related to Arexvy. The company considered the hospitalization to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 14-MAR-2025 The two patients that received Arexvy one was in the hospital, and one was in the nursing home. Both patients stay in the nursing home, one was sent to the hospital because she's really bad. They did not provide details as to what really bad. The sales representative did not know which patient was hospitalized or what occurred with the other patient. She stated that information was not relayed to her and what was provided was all the information she had. She also stated that the organization wanted to remain anonymous but that she would call back if they had any additional information to provide. The reporter did not consent to follow-up. This case was linked with case US2025031537 reported by the same reporter, for different patient.; Sender's Comments: Hospitalization is an unlisted event which is considered unrelated to GSK vaccine Arexvy. More
✓
2832651 F NY 03/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster Herpes zoster
shingles; This non-serious case was reported by a other health professional via call center represen... shingles; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 22-NOV-2024, the patient received the 1st dose of Shingrix. On 05-MAR-2025, 103 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 16-MAR-2025 The patient received dose of Shingrix vaccine and developed Shingles. The reporter was ask when should receive the second dose of Shingrix vaccine. More
2832652 68 F 03/21/2025 COVID19
 MODERNA
White blood cell count, White blood cell count decreased White blood cell count, White blood cell count decreased
The white blood cell ones decreased a ton since 2023; This spontaneous case was reported by a patien... The white blood cell ones decreased a ton since 2023; This spontaneous case was reported by a patient and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (The white blood cell ones decreased a ton since 2023) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Family history included Cancer (sister just died of cancer when she was 67, and patient's whole side of the mom's family, well, actually both sides, a lot of cancer.) and Leukemia (grandmother had leukemia). In February 2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced WHITE BLOOD CELL COUNT DECREASED (The white blood cell ones decreased a ton since 2023). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (The white blood cell ones decreased a ton since 2023) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, White blood cell count: decreased a ton since 2023. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered WHITE BLOOD CELL COUNT DECREASED (The white blood cell ones decreased a ton since 2023) to be related. Patient had received 11 Moderna vaccines since February 2021. Concomitant product use was not provided by the reporter. The white blood cell ones decreased a ton since 2023 and patient thought that it might be from these vaccines because patient took so many of them and patient took them every 3 to 4 months. Patient never got COVID. Treatment information was not provided. This case was linked to MOD-2025-782473, MOD-2023-716619 (Patient Link). More
2832653 70 M 03/21/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA







Acquired haemophilia, Activated partial thromboplastin time, Anti-cyclic citrull... Acquired haemophilia, Activated partial thromboplastin time, Anti-cyclic citrullinated peptide antibody, Antineutrophil cytoplasmic antibody, Antinuclear antibody; Antiphospholipid antibodies, Blood fibrinogen, Blood thyroid stimulating hormone, C-reactive protein, Coagulation factor IX level; Coagulation factor XI level, Coagulation factor XII level, Coagulation test, Complement factor C3, Complement factor C4; Computerised tomogram abdomen, Computerised tomogram pelvis, Factor VIII activity test, Fibrin D dimer, Haemoglobin; Inflammatory marker test, International normalised ratio, Laboratory test, Liver function test, Normocytic anaemia; Platelet count, Pneumonia, Prostatic specific antigen, Prothrombin time, Red blood cell sedimentation rate; Renal function test, Thyroid function test, Thyroxine free, Tri-iodothyronine, Vital signs measurement; Von Willebrand's factor activity test, Von Willebrand's factor antigen test, Weight, White blood cell count More
Acquired haemophilia A; multifocal pneumonia; Normocytic anaemia; This literature-non-study case was... Acquired haemophilia A; multifocal pneumonia; Normocytic anaemia; This literature-non-study case was reported in a literature article and describes the occurrence of ACQUIRED HAEMOPHILIA (Acquired haemophilia A) and PNEUMONIA (multifocal pneumonia) in an 8-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: The patient's past medical history included Adenocarcinoma of prostate (high-risk, (treated with prostatectomy, adjuvant radiotherapy and androgen deprivation therapy 4 years ago, now under surveillance with a normal PSA of less than 0.1ng/mL), Coronary artery bypass graft, Renal artery stent placement, Prostatectomy (high-risk prostate adenocarcinoma), Radiotherapy to prostate (high-risk prostate adenocarcinoma), Colonoscopy (removal of 3 subcentimetre tubular adenomas) and Root canal procedure. Previously administered products included for Drug use for unknown indication: lidocaine since an unknown date. Past adverse reactions to the above products included No adverse effect with lidocaine. Concurrent medical conditions included Coronary artery disease, Hyperlipidaemia, Hypertension, Renal artery stenosis and Unintentional weight loss (Unintentional 20-pound weight loss over 4 months). On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACQUIRED HAEMOPHILIA (Acquired haemophilia A) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced PNEUMONIA (multifocal pneumonia) (seriousness criterion medically significant) and NORMOCYTIC ANAEMIA (Normocytic anaemia). The patient was treated with Prednisone (oral use) for Acquired haemophilia, at a dose of 1 milligram/kilogram once a day; Prednisone (oral use) for Acquired haemophilia, at a dose of 5 milligram, every 4 days; Cyclophosphamide for Acquired haemophilia, at a dose of 100 milligram once a day; Cyclophosphamide for Acquired haemophilia, at a dose of 25 milligram every two weeks and Azithromycin for Pneumonia, at an unspecified dose and frequency. At the time of the report, ACQUIRED HAEMOPHILIA (Acquired haemophilia A) and PNEUMONIA (multifocal pneumonia) had resolved and NORMOCYTIC ANAEMIA (Normocytic anaemia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Activated partial thromboplastin time: normalised on day 14 after starting cyclophosphamide, 55 secs, 62 secs Prolonged, 44.8 secs the aPTT was 62.3 and fully corrected on immediate mix to 34.4, then prolonged to 44.8s on incubation. This pattern suggests the presence of an inhibitor. and 35 secs About 10 days after starting prednisone. On an unknown date, Anti-cyclic citrullinated peptide antibody: 3 units. On an unknown date, Antineutrophil cytoplasmic antibody: less than 0.2U/mL, less than 0.2 units, less than 1:20 and less than 1:20. On an unknown date, Antinuclear antibody: SSA/anti-Ro less than 0.2 and SSB/anti-La less than 0.2. On an unknown date, Antiphospholipid antibodies: Normal. On an unknown date, Blood fibrinogen: 296 mg/dl Normal. On an unknown date, Blood thyroid stimulating hormone (0.4-4.7): less than 0.015 uIU/mL. On an unknown date, C-reactive protein: less than 1mg/dL. On an unknown date, Coagulation factor IX level: Normal. On an unknown date, Coagulation factor XI level: Normal. On an unknown date, Coagulation factor XII level: Normal. On an unknown date, Coagulation test: repeat BA showed eradication of the inhibitor and 4.8 Bethesda unit per millilitre Bethesda assay. On an unknown date, Complement factor C3: 87 mg/dl. On an unknown date, Complement factor C4: 21 mg/dl. On an unknown date, Computerised tomogram abdomen: unremarkable. On an unknown date, Computerised tomogram pelvis: unremarkable. On an unknown date, Factor VIII activity test (57-163 %): 1 %, 2 %, 6 %, 22 % About 10 days after starting prednisone, 60 % Seven days after initiating cyclophosphamide and 125 % day 14 after initiating cyclophosphamide. On an unknown date, Fibrin D dimer: 457 ng/mL Normal. On an unknown date, Haemoglobin: 10.4 gram per litre Normocytic anaemia and baseline was15 g/L 2 years prior, 13.3 gram per litre and 12.2 gram per litre at haematology clinic. On an unknown date, Inflammatory marker test: Normal. On an unknown date, International normalised ratio: normal at 1.14 and Normal at 1. On an unknown date, Laboratory test: A 1:1 mixing assay showed aPTT 62.3 that fully corrected on immediate mix to 34.4, then prolonged to 44.8s on incubation, which suggested the presence of clotting factor inhibitors.. On an unknown date, Liver function test: Normal. On an unknown date, Platelet count: 236 10^9/L Normal and 252 10^9/L. On an unknown date, Prostatic specific antigen: less than 0.1ng/mL and less than 0.04ng/mL. On an unknown date, Prothrombin time (9.1-12 secs): 12.7 secs mildly elevated and 11.3 secs Normal. On an unknown date, Red blood cell sedimentation rate: 2 mm/hr. On an unknown date, Renal function test: Normal. On an unknown date, Thyroid function test: Repeat thyroid studies were normal.. On an unknown date, Thyroxine free (0.82-1.77 ng/dL): 1.16 ng/dL normal. On an unknown date, Tri-iodothyronine (71-180 ng/dL): 66 ng/dL mildly low. On an unknown date, Vital signs measurement: vital signs were normal, and he was well appearing.. On an unknown date, Von Willebrand's factor activity test: 147 % Normal. On an unknown date, Von Willebrand's factor antigen test: 150 % Normal. On an unknown date, Weight: unintentional 20 pound weight loss over 4 months. On an unknown date, White blood cell count: 7.3 10^9/L Normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACQUIRED HAEMOPHILIA (Acquired haemophilia A) to be related. No further causality assessments were provided for PNEUMONIA (multifocal pneumonia) and NORMOCYTIC ANAEMIA (Normocytic anaemia). Patient presented to ER with 2days of haematochezia. The bleeding began the night after a colonoscopy and 2days following a root canal procedure. The dental procedure was complicated by local haematoma formation at the lidocaine injection site. Bleeding episodes were preceded 1week prior with receipt of his fifth COVID-19 booster. Patient endorsed fatigue, chest pain and palpitations. He denied any constitutional symptoms, myalgias or arthralgias. He had an unintentional 20-pound weight loss over 4 months and noted bilateral upper extremity bruises within the last few days. The patient was not actively bleeding and so was discharged. Bruising progressed (a large bruise developed over his left cubital fossa). 2weeks later, he developed a large left knee haematoma. Given the stability of the patient and the absence of active bleeding, he started oral prednisone. Bethesda assay (BA) result correlated with a 6% FVIII activity level and a diagnosis of AHA. Received additional immunosuppression, with cyclophosphamide added to a prednisone taper initiated at 1 mg/kg. The plan for the prednisone taper was to decrease by 5 mg every 4 days as long as FVIII activity continued to improve. Once the BA reflected successful eradication of the inhibitor, the cyclophosphamide was decreased by 25 mg every 2 weeks. Appropriate prophylaxis for fungal infections along with proton pump inhibitors was also prescribed and he did not develop significant bleeding to warrant initiation of a bypassing agent. His treatment was complicated by a course of flu-like symptoms, so immunosuppression was held while the prednisone was slowly tapered. He completed a course of Azithromycin for multifocal pneumonia and his symptoms improved along with his blood counts and factor levels. At this time, he has been off treatment for 10 months and remains free of any bleeding symptoms.; Reporter's Comments: Causality for Pneumonia was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report. More
✓
2832654 03/21/2025 COVID19
 MODERNA
Breast cancer stage IV Breast cancer stage IV
finally diagnosed with stage 4 metastatic breast cancer; This spontaneous case was reported by a pat... finally diagnosed with stage 4 metastatic breast cancer; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER STAGE IV (finally diagnosed with stage 4 metastatic breast cancer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST CANCER STAGE IV (finally diagnosed with stage 4 metastatic breast cancer) (seriousness criterion medically significant). The patient was treated with Curcuma longa root (Turmeric) at an unspecified dose and frequency and Zingiber officinale (Ginger) at an unspecified dose and frequency. At the time of the report, BREAST CANCER STAGE IV (finally diagnosed with stage 4 metastatic breast cancer) had not resolved. No Concomitant medications provided by the reporter. It was reported that patient was received two Covid 19 shots in 2021 and post vaccination patient body was reacted horribly. Post vaccination patient lymph nodes were swelled up, included under arms, behind the neck, under breasts. Patient was consulted with three doctors and two years before patient was finally diagnosed with stage 4 metastatic breast cancer. It was reported that patient lymph nodes were still enlarged at the time of reporting. It was reported that patient had ascites also, hence patient used to go for drainage every month for a year. Patient started to drink treatment medication of turmeric and ginger every day which subsided the swelling for patient. It was reported that patient had positive symptom due to covid-vaccination. Patient went to cancer center for treatment at present. Patient was refused to take any boosters Covid 19 vaccine or any other vaccines at this point.; Reporter's Comments: Causality for Breast cancer stage IV was assessed as not related, due to mechanism of action. The benefit-risk relationship of product is not affected by this report. More
2832655 3 M VA 03/21/2025 COVID19
 MODERNA
 3044210
Blood test, Colitis ulcerative, Colonoscopy, Endoscopy, Parasite stool test Blood test, Colitis ulcerative, Colonoscopy, Endoscopy, Parasite stool test
was diagnosed with Very Early Onset Ulcerative Colitis; This spontaneous case was reported by a cons... was diagnosed with Very Early Onset Ulcerative Colitis; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (was diagnosed with Very Early Onset Ulcerative Colitis) in a 3-year-old male patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (batch no. 3044210) for COVID-19 prophylaxis. No Medical History information was reported. On 18-Oct-2024, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 19-Oct-2024, after starting mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS), the patient experienced COLITIS ULCERATIVE (was diagnosed with Very Early Onset Ulcerative Colitis) (seriousness criterion medically significant). The patient was treated with Mesalazine (Mesalamine) for Ulcerative colitis, at an unspecified dose and frequency and Prednisone for Ulcerative colitis, at an unspecified dose and frequency. At the time of the report, COLITIS ULCERATIVE (was diagnosed with Very Early Onset Ulcerative Colitis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Positive) very elevated levels of calprotectin indicating inflammation. On an unknown date, Colonoscopy: Test Result (Qualifier):- EQ, Colonoscopy showed ulcers throughout large intestine and was diagnosed with Very Early Onset Ulcerative Colitis. On an unknown date, Endoscopy: Endoscopy and colonoscopy showed ulcers throughout large instestine and was diagnosed with Very Early Onset Ulcerative Colitis. On an unknown date, Parasite stool test: Negative. The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported. Next day patient had loose stool, and within 3 days had mucous and blood with stool. It was resolved in 20 days but came back a few weeks later even worse. The patient did not experience any additional symptoms or events. Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report. More
2832656 67 F 03/21/2025 COVID19
 MODERNA
Psoriasis Psoriasis
itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis; Thi... itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis) in a 67-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis). At the time of the report, PSORIASIS (itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that patient noticed itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis which patient never had before. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. Reporter causality was not reported. More
2832657 50 F NJ 03/21/2025 COVID19
 PFIZER\BIONTECH
Body height, Pain, Thyroid mass, Weight Body height, Pain, Thyroid mass, Weight
she had nodules in her thyroid so she had half of her thyroid removed a couple of few weeks ago; ter... she had nodules in her thyroid so she had half of her thyroid removed a couple of few weeks ago; terrible body pains over all body pains; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 50-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: Jun2021, for COVID-19 treatment; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), administration date: Jul2021, for COVID-19 treatment. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "terrible body pains over all body pains"; THYROID MASS (medically significant), outcome "unknown", described as "she had nodules in her thyroid so she had half of her thyroid removed a couple of few weeks ago". The event "terrible body pains over all body pains" required physician office visit. The patient underwent the following laboratory tests and procedures: Body height: 5 8, notes: She is about 5 8; Weight: 120, notes: her weight 120 something like that. Therapeutic measures were taken as a result of thyroid mass, pain. Clinical course: The caller was reporting on behalf of her daughter who was the patient. The patient complained of terrible body pain for the last 3 years. She got her first Pfizer Covid vaccine shot on Jun2021, second shot on Jul2021, and Pfizer Covid booster on Jan2022. She wanted to know any possibility that the terrible body pain was due to the shots. They have expanded all their options and had consulted 9 different specialists, and no one seems to know what was causing the pain. When the patient first experienced the pain, the caller remembered that it was like right shortly after she got the booster. She had no other vaccines except these three shots of Covid vaccine. The patient had this pain for three years and she finally about a month ago had half of her thyroid removed but it had nothing to do with this pain according to the caller. The patient had Hashimoto's disease, and the caller was thinking that it can be the cause of pain too. She had been seen by a lot of different doctors, but no one had been able to help her. She tried massage, physical therapy and acupuncture but nothing had helped her with the pain. She just had her thyroid removed but the caller thinks that was not related to the pain. She had nodules in her thyroid, and she had half of her thyroid removed a couple of few weeks ago. They were trying to narrow down what could be causing this pain that she had, if it was vaccine or the Hashimoto's disease, no one seems to know. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2832658 75 F FL 03/21/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Asthenia, Blood pressure measurement, Brain fog, Dizziness, Headache; Nervousnes... Asthenia, Blood pressure measurement, Brain fog, Dizziness, Headache; Nervousness, Post-acute COVID-19 syndrome More
long COVID; brain fog, where can't remember; very dizzy; bad headaches; nervous; no strength, v... long COVID; brain fog, where can't remember; very dizzy; bad headaches; nervous; no strength, very weak; This is a spontaneous report and received from Consumer or other non HCPs from medical information team. A 75-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: 2021, for COVID-19 immunization. The following information was reported: NERVOUSNESS (non-serious) with onset 2023, outcome "not recovered", described as "nervous"; ASTHENIA (non-serious) with onset 2023, outcome "not recovered", described as "no strength, very weak"; HEADACHE (non-serious) with onset 2024, outcome "recovering", described as "bad headaches"; BRAIN FOG (non-serious) with onset Jun2024, outcome "not recovered", described as "brain fog, where can't remember"; DIZZINESS (non-serious) with onset 2024, outcome "not recovered", described as "very dizzy"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long COVID". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of post-acute covid-19 syndrome, dizziness, asthenia, nervousness, brain fog. Therapeutic measures were taken as a result of headache. Additional information: The patient took two shots the same year 2021, both were Pfizer. The vaccine was not administered at a (redacted) facility. The patient did not receive any other vaccines on the same date nor within 4 weeks prior as the Pfizer vaccine. The patient was calling in regards to a Pfizer COVID vaccines for 2021 and she thinks that she has long COVID and wondering if there's anything she can do about it. The patient has been sick since she got the shot in 2021. Now they think she has long covid. The patient asked if there was anything she can do for that because she was really sick. The patient clarified the term has been sick as very dizzy, has no strength, very weak, has bad headaches. The patient was nervous. She was uneasy of bad headaches, especially in morning when gets up. It was getting worse in the last 2 years. She has brain fog, where can't remember. The very dizzy started within the last year and ongoing; no strength, very weak started 2 years ago and ongoing; bad headaches started about a year ago and ongoing, has them every morning until takes Excedrin or something like that then it started to go away. The nervous started probably a couple years ago and ongoing. She confirmed, started after the covid 19 shot. The brain fog, hard to remember things started probably about 9 months ago and still ongoing. The patient has had no interventions, except for using Tylenol and Excedrin. The adverse events did not require a visit to the Emergency Room nor require a visit to a Physician's Office. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2832659 F CT 03/21/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Eating disorder, Heavy menstrual bleeding, Oligomenorrhoea, Peripheral swelling,... Eating disorder, Heavy menstrual bleeding, Oligomenorrhoea, Peripheral swelling, Swelling; Weight, Weight increased More
Increased menstrual cycle bleeding like a lot of bleeding constantly; Increased menstrual cycle blee... Increased menstrual cycle bleeding like a lot of bleeding constantly; Increased menstrual cycle bleeding like a lot of bleeding constantly; body swelling/ body felt bigger; gained weight; hands and fingers were puffier; wasn't eating more; This is a spontaneous report received from a Physician from medical information team. A 44-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 2, 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 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious) all with onset Jan2022, outcome "unknown" and all described as "Increased menstrual cycle bleeding like a lot of bleeding constantly"; SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "body swelling/ body felt bigger"; WEIGHT INCREASED (non-serious) with onset Jan2022, outcome "unknown", described as "gained weight"; PERIPHERAL SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "hands and fingers were puffier"; EATING DISORDER (non-serious) with onset Jan2022, outcome "unknown", described as "wasn't eating more". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was calling to report side effects from the Pfizer Covid-19 vaccine and to see if the side effects she experienced are known with the covid vaccine. Caller stated that she received the 2nd dose series of the Pfizer BioNTech Covid-19 vaccine, 12 years and up in Nov2021. Caller stated "2 months after receiving the vaccine, she experienced a lot of vaginal bleeding and had normal menstrual cycles, but she was bleeding for 4-5 months." Caller stated that she "gained weight, her hands and fingers were puffier and her body felt bigger, however she wasn't eating more." Caller stated in Jan2022, she got covid and received the Pfizer Covid-19 booster vaccine in Sep2022. Caller stated that she consulted with another doctor in which they were unsure what her side effects were from. Caller stated that she is a physician working and she got sick in the ER. Caller stated that she read the labeling information and noted that if a person had bleeding or a bleeding disorder, it was advised for them not to take the vaccine. Caller asked if that would be considered a contraindication. Caller stated she tried to apply for temporary medical exemption, as she wasn't sure if her reactions were related to the vaccine and needed to do a workup. Caller stated that she is a physician herself who is going against another physician for a medical exemption and she believes she should be able to provide a medical exemption for personal reasons, her own concerns and uncertainties. Caller stated their facility is forcing providers to get vaccinated and some are getting 3-4 boosters back to back. Caller stated, "I wish you had a protocol, you put out the product and the medical exemption needs to be coming from you. You should be able to file medical exemptions for things other than the listed contraindications of anaphylaxis." Caller asked if Pfizer had any resource that she could get guidance on for medical exemptions. Caller stated that her medical exemption is being denied under oath based on an opinion. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500060744 Same patient, Different vaccine dose number and event;US-PFIZER INC-202500061347 Same patient, Different vaccine dose number and event; More
2832660 F CT 03/21/2025 COVID19
 PFIZER\BIONTECH
Illness Illness
got sick in the ER; This is a spontaneous report received from a Physician from medical information ... got sick in the ER; This is a spontaneous report received from a Physician from medical information team. A 44-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "got covid", start date: Jan2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunization; Bnt162b2 (dose 2), administration date: Nov2021, for COVID-19 Immunization, reaction(s): "hands puffier", "fingers puffier", "body felt bigger", "lot of vaginal bleeding", "gained weight". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick in the ER". The event "got sick in the er" required physician office visit. Additional information: The patient was calling to report side effects from the Pfizer Covid-19 vaccine and to see if the side effects she experienced were known with the covid vaccine. She consulted with another doctor in which they were unsure what her side effects were from. She was a physician working and she got sick in the ER. She tried to apply for temporary medical exemption, as she wasn't sure if her reactions were related to the vaccine and needed to do a workup. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500061109 same patient, different dose/events; More
2832661 F 03/21/2025 COVID19
 PFIZER\BIONTECH
Magnetic resonance imaging, Tremor Magnetic resonance imaging, Tremor
internal tremor; This is a spontaneous report received from a Consumer or other non HCP from medical... internal tremor; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 (BNT162B2), as dose 1, single and as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "internal tremor". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller states that she received the COVID vaccines when COVID first came out. Caller confirms that she got the Pfizer COVID vaccines twice. Caller adds that she has a problem with the MRI for her back where she was told that she lost bones in her lumbar and she is losing bones because she is getting older. Caller mentions that she has internal tremor which the vaccine caused. Caller mentions that there was a borderline with the vaccine thing. More
2832662 F NY 03/21/2025 PNC20
 PFIZER\WYETH
Drug ineffective, Pneumonia Drug ineffective, Pneumonia
a severe case of pneumonia; a severe case of pneumonia; This is a spontaneous report received from a... a severe case of pneumonia; a severe case of pneumonia; This is a spontaneous report received from an Other HCP from a sales representative. A 67-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Feb2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant) all with onset Feb2025, outcome "unknown" and all described as "a severe case of pneumonia". The patient was hospitalized for pneumonia, drug ineffective (start date: Feb2025). The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (pneumonia) with the suspect product PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be fully excluded. More
✓
2832663 M NY 03/21/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
got Covid; it didn't work, it didn't protect at all; got Covid; it didn't work, it di... got Covid; it didn't work, it didn't protect at all; got Covid; it didn't work, it didn't protect at all; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 66-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 (dose 1), for COVID-19 immunization, reaction(s): "it didn't work, it didn't protect at all"; Bnt162b2 (dose 2), for COVID-19 immunization, reaction(s): "it didn't work, it didn't protect at all"; Bnt162b2 (dose 3, formulation NOS), for COVID-19 immunization, reaction(s): "it didn't work, it didn't protect at all". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 6 months after the suspect product(s) administration, outcome "unknown" and all described as "got Covid; it didn't work, it didn't protect at all". Clinical course: The reporter was calling for husband and yesterday (unspecified) he got Covid and the doctor prescribed the medication. The patient took the four times vaccines, in six months and he still got it. The reporter informed that they didn't get sick very often. The reporter informed that every time they took all the vaccine, seemed it didn't work, it didn't protect them at all. The last ones they did last Nov (unspecified). The reporter stated "You can tell your company our concerns." More
2832664 MA 03/21/2025 COVID19
 PFIZER\BIONTECH
Blood test, Ocular myasthenia Blood test, Ocular myasthenia
right eye closed shut / Ocular Myasthenia Gravis; This is a spontaneous report received from a Consu... right eye closed shut / Ocular Myasthenia Gravis; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), on 18Dec2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. On 22Dec2024, patient's right eye closed shut and a blood test showed that patient had developed Ocular Myasthenia Gravis. Outcome of the event was unknown. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
📋 Privacy Policy & Data Disclaimer