๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2837682 04/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; after i had the vaccine i got shingles; This serious case was reporte... Suspected vaccination failure; after i had the vaccine i got shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: after i had the vaccine i 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 Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 17-APR-2025 The patient had the Shingrix vaccine and got shingles. The reporter asked should have the vaccine again. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2837683 04/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
suspected vaccination failure; most of patients that got the shot, got shingles; This serious case w... suspected vaccination failure; most of patients that got the shot, got shingles; 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: most of patients that got the shot, 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: 17-APR-2025 This case was reported via interactive digital media. The reporter's doctor advised the reporter not to get the shot because most of her patients that got the shot, got shingles. The reporter had the Shingles last year for a month and it was painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2837684 04/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain, Vaccine positive rechallenge Pain, Vaccine positive rechallenge
was more painful; This non-serious case was reported by a consumer via interactive digital media and... was more painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Tetanus vaccine with an associated reaction of pain (received tetanus shot and was painful) and Shingles vaccine with an associated reaction of pain (received 1st dose of Shingles vaccine with event pain for tolerance refer 1st dose case US2025AMR044144.). 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 pain (Verbatim: was more painful). Rechallenge with Shingles vaccine was positive. The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR044144 Additional Information: GSK Receipt Date : 09-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the two shots of shingles and was more painful than a tetanus shot for him/her. The patient suggested that took it on a Friday so you have the weekend to recover.; Sender's Comments: US-GSK-US2025AMR044144:same patient dose 1 More
2837685 04/24/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Headache, Injection site pain, Pain Headache, Injection site pain, Pain
soreness at the injection site; headaches; body aches; This non-serious case was reported by a consu... soreness at the injection site; headaches; body aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: soreness at the injection site), headache (Verbatim: headaches) and general body pain (Verbatim: body aches). The outcome of the injection site pain, headache and general body pain were not reported. It was unknown if the reporter considered the injection site pain, headache and general body pain to be related to RSV vaccine. It was unknown if the company considered the injection site pain, headache and general body pain to be related to RSV vaccine. Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The soreness at the injection site, some headaches and body aches. Actually, some of the mildest problems of all the vaccines. The alternative was horrible sickness or death. Easy decision. More
2837686 04/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected Vaccination failure; got the Shingles vaccine and still got Shingles; This serious case wa... Suspected Vaccination failure; got the Shingles vaccine and still got Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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 Shingles vaccine and still got Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. 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: 17-APR-2025 This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine and still got shingles and was one of the most painful things the patient had ever experienced. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2837687 M 04/24/2025 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 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: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-APR-2025 The patient had taken the vaccines and the doctor had told him he would never get them, but he did and had them now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2837688 66 F NJ 04/24/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
early third dose; Potential late second dose; This non-serious case was reported by a pharmacist via... early third dose; Potential late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Previously administered products included Hepatitis A-B combo vaccine (Received 1st dose of Hepatitis A-B combo vaccine on 26-JUL-2023). On 13-SEP-2024, the patient received the 2nd dose of Twinrix. On 11-OCT-2024, the patient received the 3rd dose of Twinrix. On 13-SEP-2024, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Potential late second dose). On 11-OCT-2024, the patient experienced drug dose administration interval too short (Verbatim: early third dose). The outcome of the drug dose administration interval too long and drug dose administration interval too short were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-APR-2025 Pharmacist stated that a patient got what they thought it was a first dose of Twinrix on 13 September 2024 and second dose on 11 October 2024. But later they discovered that patient forgot that they received a prior dose of a Hepatitis A-B combo vaccine (unknown brand or lot number) on 26JUL2023 which led to drug dose administration interval too long and drug dose administration interval too short. The reporter did not have lot number or expiration date for none of the 2 Twinrix vaccines. Consented to follow up.; Sender's Comments: US-GSK-US2025038452:SAME REPORTER More
2837689 57 M MI 04/24/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 34MF9
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administration of Kinrix to a 57 year old patient; This non-serious case was reported by a other hea... administration of Kinrix to a 57 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. On 10-APR-2025, the patient received Kinrix. On 10-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a 57 year old patient). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-APR-2025 A medical assistant called to report about the administration of Kinrix vaccine to a 57 year old patient which led to inappropriate age at vaccine administration. The medical assistant enquired if the patient should be revaccinated with an appropriate vaccine. More
2837690 PA 04/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Shingrix adjuvant only given; Shingrix adjuvant only given; This non-serious case was reported by a ... Shingrix adjuvant only given; Shingrix adjuvant only given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix adjuvant only given) and inappropriate dose of vaccine administered (Verbatim: Shingrix adjuvant only given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 14-APR-2025 Pharmacy director's assistant called to report the adjuvant portion of the Shingrix vaccine was administered which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. During the call the healthcare professional reported event happened in one of their offsite offices so when details were asked about the patient, lot number or vaccination date, the information was declined because it was not available at that moment. More
2837691 M NY 04/24/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
HCP mentioned that the 1st Twinrix dose was administer on 02-Mar-2025, and who have given the 2nd do... HCP mentioned that the 1st Twinrix dose was administer on 02-Mar-2025, and who have given the 2nd dose of Heplisav instead of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). 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: HCP mentioned that the 1st Twinrix dose was administer on 02-Mar-2025, and who have given the 2nd dose of Heplisav instead of Twinrix). 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: 14-APR-2025 The pharmacist reported that they were giving a patient a dose of Twinrix and they were following the 0,1,6 month vaccine schedule, but apparently they had a floater pharmacist in there who had given the 2nd dose of Heplisav instead of Twinrix. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. More
2837692 F NC 04/24/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Product preparation issue Product preparation issue
Only diluent administered; Only diluent administered; This non-serious case was reported by a pharma... Only diluent administered; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 10-APR-2025, the patient received Priorix. On 10-APR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-APR-2025 On 14th April 2025, a pharmacist called to inform that on 10th April 2025, a patient had received only the diluent component of Priorix, meaning it had not been reconstituted, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. More
2837693 SC 04/24/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; diagnosed today as having an active shingles outbreak; This serious c... Suspected vaccination failure; diagnosed today as having an active shingles outbreak; This serious case was reported by a physician via call center representative 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 and the 1st dose of Shingrix. On 16-APR-2025, 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: diagnosed today as having an active shingles outbreak). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 16-APR-2025 The doctor reported that a patient who was diagnosed today having an active shingles outbreak. The doctor reported that the patient had already received two doses of Shingrix vaccine It was unknown when the patient finished the first two doses. The Health Care Professional (doctor) enquired about getting another series 5 years post first series. The doctor stated that the patient was diagnosed with shingles today and found information online advising a 2nd dose of Shingrix series was needed 5 years after receiving initial 2 dose vaccine. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2837694 2 F AR 04/24/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Administration of Kinrix under age; This non-serious case was reported by a other health professiona... Administration of Kinrix under age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis. On 16-APR-2025, the patient received Kinrix. On 16-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Kinrix under age). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-APR-2025 The reporter reported that a 2-year-old patient received by error Kinrix to continue Dtap and IPV series, which led to inappropriate age at vaccine administration. This was the second dose in the series. The Vaccine Administration Facility is the same as Primary Reporter. More
2837695 M FL 04/24/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 PG3RP
Product storage error Product storage error
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was... Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number PG3RP, expiry date 11-JUL-2027) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-APR-2025 The nurse called to report a temperature excursion and to determine the next steps regarding the vaccines. The vaccine in question was Boostrix, the only one affected. The highest temperature it reached was 11.2 degrees Celsius, and it had been out of temperature range for 55 days. These dose had already been administered to patient. This case is linked with US2025048454, reported by same reporter.; Sender's Comments: US-GSK-US2025048454:same reporter More
2837696 F 04/24/2025 COVID19
 MODERNA
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
got Covid for the second time; COVID-19; COVID-19; This spontaneous case was reported by a patient a... got Covid for the second time; COVID-19; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of DRUG INEFFECTIVE (COVID-19), COVID-19 (COVID-19) and COVID-19 (got Covid for the second time) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 immunisation. Previously administered products included for COVID-19 immunisation: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: Unknown. Location of injection: Arm Right) on 25-Mar-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: Unknown. Location of injection: Arm Right) on 16-Apr-2021, Moderna (Dose Number: 3; booster (single); Batch/Lot No: Unknown. Location of injection: Arm Right) on 08-Nov-2021 and Moderna (Dose Number: 4; booster (single); Batch/Lot No: Unknown. Location of injection: Arm Right) on 18-Sep-2022. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Ehlers-Danlos syndrome and Allergy. On 31-Oct-2023 at 1:00 PM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Jan-2024, the patient experienced DRUG INEFFECTIVE (COVID-19) (seriousness criterion medically significant) and COVID-19 (COVID-19) (seriousness criterion medically significant). On 07-Apr-2025, the patient experienced COVID-19 (got Covid for the second time) (seriousness criterion medically significant). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) from 20-Jan-2024 to 25-Jan-2024 at an unspecified dose and frequency. At the time of the report, DRUG INEFFECTIVE (COVID-19), COVID-19 (COVID-19) and COVID-19 (got Covid for the second time) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2024, SARS-CoV-2 test: Positive. In 2024, SARS-CoV-2 test: Positive. On 07-Apr-2025, SARS-CoV-2 test: Positive. Concomitant medication use information was not provided by reporter. The patient was not taking any other medications/ products within 2 weeks of starting COVID-19 treatment. Patient had nothing major and was not too troubled. Patient finished Paxlovid 5-day course on Thursday morning 25-Jan-2024. Patient had completely cleared symptoms for a few days but started to feel sick again on Saturday 27-Jan-2024 and tested positive again for COVID on Saturday evening. For the past three days, patient had an extremely stuffy runny nose, sore throat and glassy eyes. No fever though. Patient was on day 11 from testing positive the first time and still sick with active symptoms and positive COVID at home antigen test. Patient had yet to return to work. On 08-Apr-2025, the patient stated before she paid for a telehealth visit and before she paid for a blood draw that was going to cost her to make sure her kidney and liver things were in order. She got COVID for the second time, her first time was in Jan-2024, and it went through her insurance. She did not want to take again because she had an underlying health risk and she was 53 and it would be smart for her to take it, her doctor would want her to take it, but she did not have the money to pay. The patient stated they had not even okayed that she can get Paxlovid yet because of they want to check her hepatic function. Therapeutic reasons were taken as a result of COVID-19. The device date was reported as 30-Jan-2024. Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2025: Significant follow-up received: Case was upgraded to serious valid case from non-serious tracking only. Patient details (gender, age group, pregnancy status and race) was updated, medical history was updated, added lab data, suspect was updated to SPIKEVAX 2023-2024, Paxlovid was updated to treatment drug, event COVID-19 rebound was updated to COVID-19, additional event of COVID-19 (second episode) and drug ineffective was added, and narrative was updated.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report. More
2837697 F 04/24/2025 COVID19
 MODERNA
Myocarditis Myocarditis
myocarditis; This spontaneous case was reported by a patient family member or friend and describes t... myocarditis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDITIS (myocarditis) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. It was reported that, one of the reporter's nieces had myocarditis. No treatment information was provided. Company comment: Reportedly, it was stated that the patient developed myocarditis after vaccination, however, no additional details regarding medical history of the patient, clinical course of the event, treatment details, as well as temporal relationship between vaccination and the event of myocarditis were provided at the time of this report. The benefit-risk relationship of the product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2021-307118 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2025: Live non-significant follow up received included reference number added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-307118:master case More
2837698 58 M OH 04/24/2025 COVID19
 MODERNA
Cardiac stress test, Coronary artery occlusion Cardiac stress test, Coronary artery occlusion
My LAD artery has become 70% blocked / it appears the vaccine caused the blockage; This spontaneous ... My LAD artery has become 70% blocked / it appears the vaccine caused the blockage; This spontaneous case was reported by a patient and describes the occurrence of CORONARY ARTERY OCCLUSION (My LAD artery has become 70% blocked / it appears the vaccine caused the blockage) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2020, the patient experienced CORONARY ARTERY OCCLUSION (My LAD artery has become 70% blocked / it appears the vaccine caused the blockage) (seriousness criterion medically significant). At the time of the report, CORONARY ARTERY OCCLUSION (My LAD artery has become 70% blocked / it appears the vaccine caused the blockage) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Cardiac stress test: All arteries were completely clear. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant and treatment medication were reported. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2837699 68 F NY 04/24/2025 COVID19
 MODERNA
Chills, Fatigue, Headache, Pain Chills, Fatigue, Headache, Pain
headache; body aches; chills; fatigue; This spontaneous case was reported by a patient and describes... headache; body aches; chills; fatigue; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache), PAIN (body aches), CHILLS (chills) and FATIGUE (fatigue) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 24-Mar-2025, the patient experienced HEADACHE (headache), PAIN (body aches), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, HEADACHE (headache), PAIN (body aches), CHILLS (chills) and FATIGUE (fatigue) was resolving. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. The patient experienced events 10 hours after vaccine and two days later symptoms persisted but lessened. The patient had no medical history, concomitant disease or risk factor. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. More
2837700 70 F 04/24/2025 COVID19
 MODERNA
 004D21A
Dyspnoea, Fatigue, Gait disturbance, Sleep disorder Dyspnoea, Fatigue, Gait disturbance, Sleep disorder
shortness of breath; sleep issues; gait/problems walking; experiencing fatigue for years; This spont... shortness of breath; sleep issues; gait/problems walking; experiencing fatigue for years; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), SLEEP DISORDER (sleep issues), GAIT DISTURBANCE (gait/problems walking) and FATIGUE (experiencing fatigue for years) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004D21A, 006D21A and 066H21A) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 16-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), SLEEP DISORDER (sleep issues), GAIT DISTURBANCE (gait/problems walking) and FATIGUE (experiencing fatigue for years). At the time of the report, DYSPNOEA (shortness of breath), SLEEP DISORDER (sleep issues), GAIT DISTURBANCE (gait/problems walking) and FATIGUE (experiencing fatigue for years) outcome was unknown. No concomitant medication was reported. Patient was inquired regarding the PVS test. Patient shared experiencing multiple side-effects. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. More
2837701 72 F 04/24/2025 COVID19
 MODERNA
Post-acute COVID-19 syndrome Post-acute COVID-19 syndrome
She has experienced long COVID herself; This spontaneous case was reported by a patient and describe... She has experienced long COVID herself; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (She has experienced long COVID herself) in a 72-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 first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (She has experienced long COVID herself). At the time of the report, POST-ACUTE COVID-19 SYNDROME (She has experienced long COVID herself) outcome was unknown. No concomitant medications were reported. The patient had experienced long COVID herself and noted that there was no test available to diagnose it. She wanted to know if there were any specific studies for a long COVID because nobody seemed to have any idea what to do with long COVID. She had not switched companies at any point. She had consistently received the same Moderna vaccine over the past couple of years. Also, she mentioned it was not anyone's fault. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. Reporter did not allow further contact More
2837702 77 M 04/24/2025 COVID19
 MODERNA
Diabetes mellitus Diabetes mellitus
the diabetes was diagnosed after the covid vaccine; This spontaneous case was reported by a patient ... the diabetes was diagnosed after the covid vaccine; This spontaneous case was reported by a patient and describes the occurrence of DIABETES MELLITUS (the diabetes was diagnosed after the covid vaccine) in a 77-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Ulcerative colitis. 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 DIABETES MELLITUS (the diabetes was diagnosed after the covid vaccine) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (the diabetes was diagnosed after the covid vaccine) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. No treatment medications were reported. Reporter did not allow further contact; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2837703 54 F VA 04/24/2025 COVID19
 MODERNA
 021B21A/048B21A
Impaired work ability, Migraine Impaired work ability, Migraine
I couldn't work so I filled for disability; Chronic Intractable Migraine. Extremely painful mig... I couldn't work so I filled for disability; Chronic Intractable Migraine. Extremely painful migraines that lasted for days; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (I couldn't work so I filled for disability) and MIGRAINE (Chronic Intractable Migraine. Extremely painful migraines that lasted for days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A/048B21A/029H21B) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In May 2021, the patient experienced IMPAIRED WORK ABILITY (I couldn't work so I filled for disability) and MIGRAINE (Chronic Intractable Migraine. Extremely painful migraines that lasted for days). At the time of the report, IMPAIRED WORK ABILITY (I couldn't work so I filled for disability) had not resolved and MIGRAINE (Chronic Intractable Migraine. Extremely painful migraines that lasted for days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported the patient missed children's wedding, graduation, birthdays, holidays, vacations. Patient can't go out because, afraid of something will trigger a migraine. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. No treatment medications were reported. More
2837704 66 F FL 04/24/2025 COVID19
 MODERNA
Anaemia, Food allergy Anaemia, Food allergy
I have acquired anemia; I๏ฟฝm allergic to foods; This spontaneous case was reported by a patient and... I have acquired anemia; I๏ฟฝm allergic to foods; This spontaneous case was reported by a patient and describes the occurrence of ANAEMIA (I have acquired anemia) and FOOD ALLERGY (I๏ฟฝm allergic to foods) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Concurrent medical conditions included Immunocompromised and Soy allergy (Have a soy sensitivity too, and that was great when she took the pneumonia vaccine). On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (I have acquired anemia) and FOOD ALLERGY (I๏ฟฝm allergic to foods). The patient was treated with Cyanocobalamin (B12) for Anemia, at a dose of 1 milliliter. At the time of the report, ANAEMIA (I have acquired anemia) had not resolved and FOOD ALLERGY (I๏ฟฝm allergic to foods) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant product information was not provided by the reporter. Since patient had taken the COVID vaccines and they were all from Moderna, patient had acquired anemia. That was the first thing. But at the time of reporting patient noticed that she was allergic to foods. Foods that she was never been allergic to. It was an additive in the food. It was not the food itself. So, one of them was sodium tripolyphosphate, the other one was sodium phosphate. Regarding management of her anemia, reporter stated, that she takes B12 shots and had left everything else and she had gotten it to just above normal. Patient was never allergic to these foods before, these additives. Now cannot eat, like it was weird. Patient cannot eat half the foods she used to eat because they all contain sodium phosphate. It was all, it was preservative. Sodium tripolyphosphate was a neuro, a neurotoxin, but they put that in fish. This case was linked to MOD-2022-672563 (Patient Link). More
2837705 71 F VA 04/24/2025 COVID19
 MODERNA
 8080803
Erythema, Pain in extremity, Peripheral swelling Erythema, Pain in extremity, Peripheral swelling
When I received the vaccine my arm was red and swollen for over a week; When I received the vaccine ... When I received the vaccine my arm was red and swollen for over a week; When I received the vaccine my arm was red and swollen for over a week; I still have pain; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (When I received the vaccine my arm was red and swollen for over a week), PERIPHERAL SWELLING (When I received the vaccine my arm was red and swollen for over a week) and PAIN IN EXTREMITY (I still have pain) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080803) for COVID-19 prophylaxis. No Medical History information was reported. On 11-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 50 microgram. On an unknown date, the patient experienced ERYTHEMA (When I received the vaccine my arm was red and swollen for over a week), PERIPHERAL SWELLING (When I received the vaccine my arm was red and swollen for over a week) and PAIN IN EXTREMITY (I still have pain). At the time of the report, ERYTHEMA (When I received the vaccine my arm was red and swollen for over a week) and PERIPHERAL SWELLING (When I received the vaccine my arm was red and swollen for over a week) had resolved and PAIN IN EXTREMITY (I still have pain) had not resolved. No concomitant medications were reported. The patient received the vaccine, and her arm was red and swollen for over a week, went away but it had been over a month and still had pain. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported. More
2837706 90 M NV 04/24/2025 RSV
 MODERNA
Asthenia, Malaise Asthenia, Malaise
extreme weakness; Covid like symptoms; This spontaneous case was reported by a consumer and describe... extreme weakness; Covid like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (extreme weakness) and SUSPECTED COVID-19 (Covid like symptoms) in a 90-year-old male patient who received mRNA-1345 (mRESVIA) for Lower respiratory tract infection. The patient's past medical history included Long COVID. Concurrent medical conditions included Respiratory disorder NOS since 2022. On 25-Mar-2025, the patient received dose of mRNA-1345 (mRESVIA) (Intramuscular use) .5 milliliter. On 26-Mar-2025, the patient experienced ASTHENIA (extreme weakness) and SUSPECTED COVID-19 (Covid like symptoms). On 26-Mar-2025, ASTHENIA (extreme weakness) and SUSPECTED COVID-19 (Covid like symptoms) had resolved. No concomitant medications were reported. The patient did not experience any additional symptoms or events. No treatment medications were reported. More
2837707 77 M MN 04/24/2025 COVID19
COVID19
 NOVAVAX
NOVAVAX

Blood test, COVID-19, Incomplete course of vaccination, Renal impairment, SARS-C... Blood test, COVID-19, Incomplete course of vaccination, Renal impairment, SARS-CoV-2 test; Weight decreased More
Started losing weight about 4-5 months later; My kidneys declined; Had Covid again in 2023; I got a ... Started losing weight about 4-5 months later; My kidneys declined; Had Covid again in 2023; I got a Novavax in 2022; This non-serious, initial spontaneous safety was reported by a Consumer or other non-health professional via the Novavax Medical Information (MI no. NOV25-00120) and concerns a 76-year-old Male who "received Novavax in 2021 only" on an unspecified date in 2021, and "had Covid again in 2023" on an unspecified date in 2023 after receiving Novavax COVID-19 Vaccine, Adjuvanted on an unspecified date in 2021. At the time of the report, the outcome of COVID-19 was Unknown and Incomplete course of vaccination was Recovered/Resolved. On 18-Apr-2025, significant information was received from a consumer via contact center (MI No. NOV25-00214) - This case was upgraded from non-serious to serious. Patient and primary reporter details were updated, a third reporter was added, "hernia repair" was added to the patient's medical history, added 04-Apr-2025 dose to patient's past therapy, updated therapy start and end date from --2021 to -Oct-2022, updated the event verbatim "Received Novavax in 2021 only" (Incomplete course of vaccination) to "I got a Novavax in 2022", added two new events: "My kidneys declined" (Renal impairment) (Seriousness criteria: Other medically important condition) and Started losing weight about 4-5 months later (Weight decreased), and added new lab data "I got a blood draw" done on an unknown date in 2023 with the result of "my kidneys declined". The outcome of the events renal impairment and weight decreased were unknown.; Sender's Comments: This 77-year-old Male experienced Renal impairment, Incomplete course of vaccination, COVID-19, and Weight decreased after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (1). The event Renal impairment was reported as serious. The events Incomplete course of vaccination, COVID-19, and Weight decreased were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted and Renal impairment, Incomplete course of vaccination, COVID-19, and Weight decreased is considered Possible. More
2837708 F NY 04/24/2025 PNC20
 PFIZER\WYETH
 LK6655
Injection site pain, Injection site pruritus, Injection site swelling, Sleep dis... Injection site pain, Injection site pruritus, Injection site swelling, Sleep disorder More
Extreme injection site pain and swelling; Extreme injection site pain and swelling; extreme itchines... Extreme injection site pain and swelling; Extreme injection site pain and swelling; extreme itchiness; Unable to sleep at night because of the pain; This is a spontaneous report received from a Nurse from a sales representative. A 64-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 17Mar2025 at 11:45 as dose 1, single (Lot number: LK6655), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 20Mar2025, outcome "recovered" (26Mar2025) and all described as "Extreme injection site pain and swelling"; SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (non-serious) with onset 20Mar2025, outcome "recovered" (26Mar2025), described as "Unable to sleep at night because of the pain"; VACCINATION SITE PRURITUS (non-serious) with onset 20Mar2025, outcome "recovered" (26Mar2025), described as "extreme itchiness". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, vaccination site pruritus, sleep disorder due to general medical condition, insomnia type. Additional information: Extreme injection site pain and swelling. Along with extreme itchiness. Unable to sleep at night because of the pain. The patient did not receive any other vaccines on the same date as the PREVNAR 20. More
2837709 F CA 04/24/2025 COVID19
 PFIZER\BIONTECH
Micturition urgency, Nocturia, Pollakiuria Micturition urgency, Nocturia, Pollakiuria
overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident;... overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident; It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night; Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours; This is a spontaneous report received from a Consumer or other non HCP. A female patient in her 60's (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: Jan2024; LOSARTAN/HYDROCHLOROTHIAZIDE, start date: Jan2022; ATORVASTATIN, start date: Jan2022. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "Urgency urination", "Nocturia", "Increased urinary frequency". The following information was reported: MICTURITION URGENCY (non-serious), outcome "recovered", described as "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident"; NOCTURIA (non-serious), outcome "recovered", described as "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; POLLAKIURIA (non-serious), outcome "recovered", described as "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours". Therapeutic measures were not taken as a result of micturition urgency, nocturia, pollakiuria. Additional information: Patient managed hypertension effectively with medication. Since receiving the initial COVID-19 vaccination in February 2021, she has had seven booster shots. After each Pfizer vaccination, patient experienced an intense and unusual side effect starting about 6-8 hours post-injection. She developed an overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident. Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours. It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night. Despite trying to rest, she found it impossible due to the frequency and urgency of these episodes. Notably, after her first injection, this cycle lasted between 12-14 hours. These symptoms only occur following the vaccine. 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-202500067929 same patient/event, different dose; More
2837710 F CA 04/24/2025 COVID19
 PFIZER\BIONTECH
Micturition urgency, Nocturia, Pollakiuria Micturition urgency, Nocturia, Pollakiuria
intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate... intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate; This cycle occurs approximately every 20 minutes and lasts for about 8 hours; It significantly disrupts sleep, the need to urinate wakes patient repeatedly throughout the night; This is a spontaneous report received from a Consumer or other non HCP. A female patient in her 60's (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: manage effectively with medication. Concomitant medication(s) included: ATENOLOL, start date: Jan2024; HYDROCHLOROTHIAZIDE;LOSARTAN, start date: Jan2022; ATORVASTATIN, start date: Jan2022. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for covid-19 immunisation, reaction(s): "overwhelming urge to urinate", "disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunisation, reaction(s): "urge to urinate", "disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "This cycle occurs approximately every 20 minutes and lasts for about 8 hours".The following information was reported: MICTURITION URGENCY (non-serious), outcome "recovered", described as "intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; POLLAKIURIA (non-serious), outcome "recovered", described as "This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; NOCTURIA (non-serious), outcome "recovered", described as "It significantly disrupts sleep, the need to urinate wakes patient repeatedly throughout the night". Therapeutic measures were not taken as a result of micturition urgency, pollakiuria, nocturia. Additiona information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which reporting. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. Patient had non allergy. Since receiving the initial COVID-19 vaccination in Feb2021, patient have had seven booster shots. After each Pfizer vaccination, patient experience an intense and unusual side effect starting about 6-8 hours post-injection. Patient develop an overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident. Each time, bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours. It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night. Despite trying to rest, patient find it impossible due to the frequency and urgency of these episodes. Notably, after my first injection, this cycle lasted between 12-14 hours. These symptoms only occur following the vaccine. 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-202500067929 same patient/event, different dose; More
2837711 F CA 04/24/2025 COVID19
 PFIZER\BIONTECH
Micturition urgency, Nocturia, Pollakiuria Micturition urgency, Nocturia, Pollakiuria
overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident;... overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident; It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night; Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours; This is a spontaneous report received from a Consumer or other non HCP. A female patient in her 60's (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: Jan2024; HYDROCHLOROTHIAZIDE;LOSARTAN, start date: Jan2022; ATORVASTATIN, start date: Jan2022. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, when the patient was 66 years old, for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes/ lasted between 12-14 hours"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours". The following information was reported: MICTURITION URGENCY (non-serious), outcome "recovered", described as "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident"; NOCTURIA (non-serious), outcome "recovered", described as "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; POLLAKIURIA (non-serious), outcome "recovered", described as "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours". Therapeutic measures were not taken as a result of micturition urgency, nocturia, pollakiuria. Additional information: The patient had no known allergies. Manufacture for Atenolol was UNICHEM PH, manufacture for HYDROCHLOROTHIAZIDE;LOSARTAN was AUROBINDO, manufacture for Atorvastatin was NOVADOZ. The patient was a 70-year-old woman with hypertension, which she managed effectively with medication. Since receiving the initial COVID-19 vaccination in Feb2021, she has had seven booster shots. After each Pfizer vaccination, she experienced an intense and unusual side effect starting about 6-8 hours post-injection. She developed an overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident. Each time, her bladder was completely full, and the urine was expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours. It significantly disrupted her sleep, as the need to urinate woke her repeatedly throughout the night. Despite trying to rest, she found it impossible due to the frequency and urgency of these episodes. These symptoms only occurred following the vaccine. 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-202500067929 same patient/event/product, different dose; More
2837712 F FL 04/24/2025 COVID19
 PFIZER\BIONTECH
Vaccination site warmth Vaccination site warmth
latex-like reaction/ with in 2 days feel hot, prickly "on fire" shot area around right arm... latex-like reaction/ with in 2 days feel hot, prickly "on fire" shot area around right arm; This is a spontaneous report received from a Consumer or other non HCP. A 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 0.3 ml single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, single, manufacturer unknown), for Covid-19 immunization, reaction(s): "no adverse event"; Flu vaccine (Dose number unknown, single), for Immunization, reaction(s): "no adverse event". The following information was reported: VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "latex-like reaction/ with in 2 days feel hot, prickly "on fire" shot area around right arm". Additional information: Patient never had reaction to either the flu or covid shots in the past and these were much like latex reactions. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. More
2837713 04/24/2025 COVID19
 PFIZER\BIONTECH
Death Death
Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; ... Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Seven family members died in the last three years because they have that Covid Vaccine from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500066514 same reporter/events, different patient;; Reported Cause(s) of Death: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer More
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2837714 04/24/2025 COVID19
 PFIZER\BIONTECH
Death Death
Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; ... Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Seven family members died in the last three years because they have that Covid Vaccine from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500066514 same reporter/events, different patient;; Reported Cause(s) of Death: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer More
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2837715 04/24/2025 COVID19
 PFIZER\BIONTECH
Death Death
Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; ... Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Seven family members died in the last three years because they have that Covid Vaccine from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500066514 same reporter/events, different patient;; Reported Cause(s) of Death: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer More
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2837716 04/24/2025 COVID19
 PFIZER\BIONTECH
Death Death
Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; ... Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Seven family members died in the last three years because they have that Covid Vaccine from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500066514 same reporter/events, different patient;; Reported Cause(s) of Death: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer More
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2837717 50 F NJ 04/24/2025 COVID19
 PFIZER\BIONTECH
Hypoaesthesia Hypoaesthesia
Numbness in her forehead; forehead numb; This is a spontaneous report received from a consumer from ... Numbness in her forehead; forehead numb; This is a spontaneous report received from a consumer from medical information team, Program ID. A 50-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Little bit fat" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Joint pain"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Joint pain". The following information was reported: HYPOAESTHESIA (non-serious) with onset Apr2024, 20 min after the suspect product(s) administration, outcome "recovered" (Apr2024), described as "Numbness in her forehead; forehead numb". Therapeutic measures were not taken as a result of hypoaesthesia. Additional Information: The patient had no other conditions, other products, or investigations. The patient has no significant health conditions other than being a little bit fat. When the patient received her last booster in Apr2024 (to stay current and was going to a group setting), she experienced numbness in her forehead about 20 minutes after she received the vaccine (made her forehead numb), but it went away (recovered completely). It only lasted for less than 5 minutes and went away. No treatment was received for the event. The patient wanted to know if she should be concerned about getting another vaccine booster and if the forehead numbness could be a buildup of too much of the spike proteins. Her pharmacist said not to worry about the forehead numbness as they had heard about this before. The patient doesn't understand how the vaccine works and why there is a new one seemingly every year that patients need to get. The patient would like to know if she can get booster again with her children with the 2024 formulation in Oct2025. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500069247 Same patient and product; different dose and event; More
2837718 65 F DE 04/24/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH

Injection site bruising, Injection site erythema, Injection site haemorrhage, In... Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site rash; Injection site swelling, Rash pruritic More
bruising at the site; rash at the site/is like a rash, but a rash is itchy, and this is just a red s... bruising at the site; rash at the site/is like a rash, but a rash is itchy, and this is just a red swollen area, a rectangle, going across caller's arm; redness at the site/is like a rash, but a rash is itchy, and this is just a red swollen area, a rectangle, going across caller's arm; sore/the site got bigger on my arm and sore probably because I was working the muscle and injured it/rectangle going across caller's arm; sore/the site got bigger on my arm and sore probably because I was working the muscle and injured it; there was line of blood going down caller's elbow when given the shot, started purple; red swollen area/is like a rash, but a rash is itchy, and this is just a red swollen area, a rectangle, going across caller's arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Mar2025 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) at the age of 65 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 25Mar2025, outcome "not recovered", described as "bruising at the site"; VACCINATION SITE RASH (non-serious) with onset 25Mar2025, outcome "not recovered", described as "rash at the site/is like a rash, but a rash is itchy, and this is just a red swollen area, a rectangle, going across caller's arm"; VACCINATION SITE SWELLING (non-serious) with onset 25Mar2025, outcome "unknown", described as "red swollen area/is like a rash, but a rash is itchy, and this is just a red swollen area, a rectangle, going across caller's arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 25Mar2025, outcome "not recovered", described as "redness at the site/is like a rash, but a rash is itchy, and this is just a red swollen area, a rectangle, going across caller's arm"; VACCINATION SITE MASS (non-serious) with onset 25Mar2025, outcome "unknown", described as "sore/the site got bigger on my arm and sore probably because I was working the muscle and injured it"; MYALGIA (non-serious) with onset 25Mar2025, outcome "unknown", described as "sore/the site got bigger on my arm and sore probably because I was working the muscle and injured it/rectangle going across caller's arm"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 25Mar2025, outcome "recovering", described as "there was line of blood going down caller's elbow when given the shot, started purple". Therapeutic measures were taken as a result of myalgia, vaccination site mass. Additional information: Patient is putting ice on it, and has a steroid cream because has a skin condition which may or may not be part of this. When gets bit by a mosquito gets swelling in the area, it takes a week to two weeks for it to go away so has a steroid cream (a tube of triamcinolone acetonide ointment 0.5) that stops that and makes go down. Patient is also icing it and taking NSAID. 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. More
2837719 F CA 04/24/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Chills, Decreased appetite, Fatigue, Irritability, Malaise; Nausea, Oral candidi... Chills, Decreased appetite, Fatigue, Irritability, Malaise; Nausea, Oral candidiasis More
white thrush in the mouth worsened; irritability; tiredness; chills; nausea; feeling unwell; decreas... white thrush in the mouth worsened; irritability; tiredness; chills; nausea; feeling unwell; decreased appetite; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 83-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 26Mar2025 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; fluticasone propionate (FLUTICASONE PROPIONATE HFA) at 1x/day (unk, 1x/day). The patient's relevant medical history included: "cast" (unspecified if ongoing); "sprained hand" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset Mar2025, outcome "unknown"; DECREASED APPETITE (non-serious) with onset Mar2025, outcome "unknown"; MALAISE (non-serious) with onset Mar2025, outcome "unknown", described as "feeling unwell"; IRRITABILITY (non-serious) with onset Mar2025, outcome "unknown"; NAUSEA (non-serious) with onset Mar2025, outcome "unknown"; FATIGUE (non-serious) with onset Mar2025, outcome "unknown", described as "tiredness"; ORAL CANDIDIASIS (non-serious) with onset 29Mar2025, outcome "not recovered", described as "white thrush in the mouth worsened". The action taken for fluticasone propionate was unknown. Additional information: Patient regarding the Pfizer COVID vaccine. After receiving a booster dose, Patient developed a white thrush in the mouth. Patient wanted to know if this was a reported side effect from the vaccine. Patient also mentioned to have experienced chills and tiredness after the injection. A review of the Prescribing Information for Comirnaty did not find information regarding white thrush. As the Prescribing Information did not include all adverse reactions that had been reported or that may occur, asked to consult with healthcare provider about what patient was experiencing. Patient was in a cast, had a sprained hand so phone was on speaker. Patient had the Pfizer booster, patient then clarified the booster was the COVID-19 vaccine mRNA, Pf, Pfizer, 30mcg/0.3mL, IM 91320 CPT(R). Patient received the vaccine on Wednesday, 26Mar2025. Had call handler heard from anyone else if they have gotten thrush in their mouth after getting the booster. Patient had experienced that, later confirmed patient had experienced thrush in mouth, and was asking if that had been a side effect for anyone else other than patient. Another possibility was that patient did take an inhaler, initially provided as Flovent, which could cause thrush, but patient rinses mouth every time takes, every day. Could be possible the COVID vaccine lowered patient immune system and that inhaler caused the thrush. Patient had a bit of a reaction to the COVID vaccine. Inhaler information: Patient clarified the inhaler was a new one, rather than Flonase, patient then corrected and confirmed rather than Flovent, it was fluticasone propionate HFA inhalation aerosol, manufacturer was Prasco. Patient used to have Flovent, may be the generic instead of Flovent. This was the one patient had been taking now for a couple of years, confirmed the fluticasone propionate HFA inhalation aerosol, patient just noticed did not say Flovent on it anymore, there was a label across things, confirmed a pharmacy label, but the fluticasone propionate HFA inhalation aerosol had been for the last four refills. No longer had Flovent to provide any information, but was also was fluticasone. Had thrush in mouth this weekend on 29Mar2025. Indication: On medical records was time for 6th booster. Concomitant products: Just regular medications patient had been taking for years, nothing new that would have caused anything different. Declined to provide additional information, saying there was nothing pertinent. Medical conditions: Patient stated the other side effects patient had from the most recent dose of the COVID vaccine were nausea, feeling unwell, decreased appetite, and irritability. Clarified and confirmed patient was diagnosed with sprained hand the same day as getting the COVID vaccine, was right arm, so got vaccine on left arm. Patient stated had two more symptoms patient remembered after being on hold, after most recent COVID vaccine injection patient also had chills and tiredness. No Investigations reported. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2837720 F 04/24/2025 COVID19
 PFIZER\BIONTECH
Acute kidney injury, Renal function test Acute kidney injury, Renal function test
she was diagnosed with acute kidney injury; This is a spontaneous report received from a Consumer or... she was diagnosed with acute kidney injury; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACUTE KIDNEY INJURY (medically significant), outcome "unknown", described as "she was diagnosed with acute kidney injury". The patient underwent the following laboratory tests and procedures: Renal function test: (Feb2024) 71 %. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2837721 M 04/24/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Vaccine does not work; Have had COVID three times; Vaccine does not work; Have had COVID three times... Vaccine does not work; Have had COVID three times; Vaccine does not work; Have had COVID three times; Vaccine does not work; Have had COVID three times; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), administration date: Jan2021, for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE (BOOSTER)), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE (BOOSTER)), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5, SINGLE (BOOSTER)), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Vaccine does not work; Have had COVID three times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: have had COVID three times. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical course: The patient had all the boosters, and they all are Pfizer COVID-19 vaccines (1, 2, 3, 4, 5, and 6 vaccines), and got COVID three times. Vaccine does not work. Prescribed Paxlovid after getting COVID at the beginning; He has been prescribed Paxlovid to treat COVID again. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2837722 56 F GA 04/24/2025 COVID19
 PFIZER\BIONTECH
 EW0198
Asthenia, Dyspnoea Asthenia, Dyspnoea
shortness of breath; reduced energy; This is a spontaneous report received from a Consumer or other ... shortness of breath; reduced energy; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jul2021 as dose 1, single (Lot number: EW0198) at the age of 56 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: May2017; HYDROCHLOROTHIAZIDE, start date: Jan2020; LOSARTAN, start date: Sep2020. Past drug history included: Lisinopril, reaction(s): "allergy". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; ASTHENIA (non-serious), outcome "unknown", described as "reduced energy". Additional information: Not long after taking the vaccines, the patient had shortness of breath and reduced energy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500084622 Same patient/drug; different dose/events; More
2837723 F FL 04/24/2025 COVID19
 UNKNOWN MANUFACTURER
Parkinson's disease Parkinson's disease
After taking the Pfizer booster shot, I was diagnosed with Parkinson's; This is a spontaneous r... After taking the Pfizer booster shot, I was diagnosed with Parkinson's; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Vascular Disease" (unspecified if ongoing); "Dementia" (unspecified if ongoing); "Alzheimer's" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LANTUS; ATORVASTATIN; LISINOPRIL. Vaccination history included: Covid-19 vaccine (Primary immunisaton completed; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: PARKINSON'S DISEASE (disability, medically significant), outcome "not recovered", described as "After taking the Pfizer booster shot, I was diagnosed with Parkinson's". Therapeutic measures were taken as a result of parkinson's disease. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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2837724 F 04/24/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Our daughter got the Pfizer ones and wound up getting Covid 5 times; Our daughter got the Pfizer one... Our daughter got the Pfizer ones and wound up getting Covid 5 times; Our daughter got the Pfizer ones and wound up getting Covid 5 times; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A child female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Our daughter got the Pfizer ones and wound up getting Covid 5 times". Clinical course: The consumer's child received the Comirnaty COVID-19 Vaccine; they wrote: ''Our daughter got the Pfizer ones and wound up getting Covid 5 times. No other details are known. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2837725 28 M TX 04/24/2025 COVID19
 PFIZER\BIONTECH
Blood glucose, COVID-19, Drug ineffective, SARS-CoV-2 antibody test Blood glucose, COVID-19, Drug ineffective, SARS-CoV-2 antibody test
patient's 3rd time having Covid; patient's 3rd time having Covid; This is a spontaneous re... patient's 3rd time having Covid; patient's 3rd time having Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 28-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Dec2024 as dose 1, single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: The last time he had COVID, he was hospitalized for 3 days/he's had COVID twice; "sick" (unspecified if ongoing), notes: It was awful he was so sick; "hospitalized" (not ongoing), notes: The last time he had COVID, he was hospitalized for 3 days. The patient's concomitant medications were not reported. Past drug history included: Monoclonal antibodies, notes: he had to get the monoclonal antibodies that was before the meds were out; a year half ago. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient's 3rd time having Covid". Clinical details: The patient had COVID twice. The first time, way back in the day, he had to get the monoclonal antibodies that was before the meds were out; a year half ago, he was- his glucose shot up, his stats were in the low 80s. He had to hospitalized for 3 days. It was just a nightmare. It was awful he was so sick, so that's how much it means to his family. The last time he had COVID, he was hospitalized for 3 days, he tested positive for COVID. He has a prescription with the pharmacy. This was the patient's 3rd time having Covid. He has had his shot preventative and it was Pfizer, he got the recent one back in December. That was the most recent vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2837726 F PA 04/24/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Blood pressure measurement, Brain fog, COVID-19, Cardiac disorder, Drug ineffect... Blood pressure measurement, Brain fog, COVID-19, Cardiac disorder, Drug ineffective; Fatigue, Hypotension, Post-acute COVID-19 syndrome, Tremor More
Covid; Covid; Long Covid; cardiac issues; blood pressure when she lay down went really low like 60/4... Covid; Covid; Long Covid; cardiac issues; blood pressure when she lay down went really low like 60/40; internal vibrations and tremors; fatigue; brain fog; This is a spontaneous report received from a Nurse, Program ID. A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing); "pancreatic tumor" (unspecified if ongoing); "whipple operation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Covid"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "cardiac issues"; HYPOTENSION (non-serious), outcome "unknown", described as "blood pressure when she lay down went really low like 60/40 "; TREMOR (non-serious), outcome "unknown", described as "internal vibrations and tremors"; FATIGUE (non-serious), outcome "unknown"; BRAIN FOG (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 60/40, notes: go really low. The clinical course was reported as follows: Patient's husband was going to be 84 and they both have had cancer, he had cancer now, he had menthenmathoma. Patient also had Long Covid and she was no longer allowed to take the vaccines, which she had been taking for Covid. Her husband took nirmatrelvir, ritonavir and he did very well on it. The patient and her husband had a prescription for nirmatrelvir, ritonavir, but did not have Covid at this time. They were so ill before, her husband had cancer and they were going to take a trip, so they would like to have nirmatrelvir, ritonavir with him, if they should get it. Patient was in really bad shape with the Covid, with all sorts of all sorts of issues, and was in bed for long long time and had cardiac issues. Her blood pressure when she lay down went really low like 60/40 and then she had internal vibrations and tremors and incredible fatigue for so so long. Patient still was not where she was, but she was a whole lot better. She also had brain fog. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with Comirnaty (2024-2025 Formula) can not be fully excluded. More
2837727 F 04/24/2025 COVID19
 PFIZER\BIONTECH
Ageusia, Anosmia, Balance disorder Ageusia, Anosmia, Balance disorder
She said that she had no smell, no taste, and no balance after taking them; She said that she had no... She said that she had no smell, no taste, and no balance after taking them; She said that she had no smell, no taste, and no balance after taking them; She said that she had no smell, no taste, and no balance after taking them; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (unspecified if ongoing); "cholesterol abnormal" (unspecified if ongoing). Concomitant medication(s) included: COLESTID taken for blood cholesterol abnormal. The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "She said that she had no smell, no taste, and no balance after taking them". Additional information: She was taking Colestid which was a medication for cholesterol. She took 2 packets of it every day then she was made to take these huge pills that she really has trouble swallowing. She also wanted to know if Pfizer had a program for Eliquis and Gemtesa where she could get them at a cheaper price. She further stated that she has multiple sclerosis, and she had to take three shots of the Pfizer COVID vaccine because she was in the (PRIVACY) and she could not get them to check her blood thinner without taking the shots. She said that she had no smell, no taste, and no balance after taking the Pfizer COVID vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2837728 F 04/24/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
the patient had COVID; the patient had COVID; This is a spontaneous report received from a Consumer ... the patient had COVID; the patient had COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the patient had COVID". Clinical course: This is the second time patient got Covid. Last time, when she was prescribed Paxlovid, she didn't have any issue getting the medication, but right now, when she went to the pharmacy, and the pharmacist told her that she needs the billing information, so she kind of worried because she didn't have this experience before and she's is sick. She need assistance on how to taken care of it, like, you know, getting the medication for the Paxlovid". The reason for the call was because the patient had Covid for a second time, took Paxlovid previously, and needed assistance. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2837729 KY 04/24/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Balance disorder, Brain fog, Deafness unilateral, Dizziness, Memory impairment; ... Balance disorder, Brain fog, Deafness unilateral, Dizziness, Memory impairment; Nystagmus, Tinnitus, Vertigo More
left ear deafness; tinnitus 24/7; Balance Problems; vertifo; nystagmus; dizziness; memory problems; ... left ear deafness; tinnitus 24/7; Balance Problems; vertifo; nystagmus; dizziness; memory problems; brain fog; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS UNILATERAL (medically significant), outcome "not recovered", described as "left ear deafness"; TINNITUS (non-serious), outcome "not recovered", described as "tinnitus 24/7"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "Balance Problems"; VERTIGO (non-serious), outcome "not recovered", described as "vertifo"; NYSTAGMUS (non-serious), outcome "not recovered"; DIZZINESS (non-serious), outcome "not recovered"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "memory problems"; BRAIN FOG (non-serious), outcome "not recovered". Clinical course: The patient was reporting side effects and health problems from the COVID vaccinations and boosters. Patient was required to get them for work as a health professional. Has left ear deafness, tinnitus, nystagmus, balance problems, memory loss, brain fog, vertigo and dizziness. Has never ever called in sick for work and can now barely function. Patient states that" It is easy to say that you all are too busy, but my life is awful now. I will never get my life back.". Received 5 vaccinations/boosters More
2837730 TX 04/24/2025 COVID19
 PFIZER\BIONTECH
Alopecia areata Alopecia areata
lost all of my hair Alopecia areata totals; This is a spontaneous report received from a Consumer or... lost all of my hair Alopecia areata totals; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA AREATA (non-serious), outcome "unknown", described as "lost all of my hair Alopecia areata totals". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2837731 CO 04/24/2025 DTAPIPV
 SANOFI PASTEUR
No adverse event, Underdose No adverse event, Underdose
Needle slipped and incomplete dose given with no reported adverse event; Initial information receive... Needle slipped and incomplete dose given with no reported adverse event; Initial information received on 31-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) [Quadracel] whose needle slipped, and incomplete dose given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2025, the patient received a 0.5ml dose of suspect Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine Suspension for injection (lot number, expiry date-unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) and needle slipped and incomplete dose given with no reported adverse event (incorrect dose administered) (latency- 1 day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
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