🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2828187 63 F VA 02/25/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7ZM55
Pain, Peripheral swelling, Product preparation issue, Pyrexia; Pain, Peripheral ... Pain, Peripheral swelling, Product preparation issue, Pyrexia; Pain, Peripheral swelling, Product preparation issue, Pyrexia More
body ache; fever; arm swelling; Adjuvant administered alone; gave just the adjuvant component alone... body ache; fever; arm swelling; Adjuvant administered alone; gave just the adjuvant component alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number N77J2, expiry date 23-OCT-2026) and (batch number 7ZM55, expiry date 15-NOV-2026) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 07-FEB-2025, the patient received the 2nd dose of Shingrix. On 06-DEC-2024, the patient received the 1st dose of Shingrix. On 07-FEB-2025, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant administered alone) and inappropriate dose of vaccine administered (Verbatim: gave just the adjuvant component alone). On an unknown date, the patient experienced general body pain (Verbatim: body ache), fever (Verbatim: fever) and swelling arm (Verbatim: arm swelling). The outcome of the general body pain, fever and swelling arm were resolving and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the general body pain, fever and swelling arm to be related to Shingrix. It was unknown if the company considered the general body pain, fever and swelling arm to be related to Shingrix. Additional Information: GSK Receipt Date : 12-FEB-2025 Registered Nurse mentioned that a patient got a first dose of Shingrix on December 6th 2024 and they came to get a second dose on February 7th 2025 but they accidentally gave just the adjuvant component alone which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. So when they realized of the error, they discussed with the patient and decided to give another dose properly mixed on the other arm that same day. Reporter mentioned that after the first dose the patient experienced body aches, fever and arm swelling, and they recommended patient to took Tylenol or Benadryl if needed after the second dose if they feel symptoms, but mentioned that patient was feeling fine so far.; Sender's Comments: US-GSK-US2025018343:same reporter More
2828188 M TX 02/25/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Pruritus Pruritus
whole body itching/Systemic and general itching reaction; This non-serious case was reported by a co... whole body itching/Systemic and general itching reaction; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 59-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced generalized pruritus (Verbatim: whole body itching/Systemic and general itching reaction). The patient was treated with diphenhydramine hydrochloride (Benadryl) and valaciclovir. The outcome of the generalized pruritus was resolved (duration 1 week). It was unknown if the reporter considered the generalized pruritus to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the generalized pruritus to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-FEB-2025 The patient wife reported that a patient had a whole body itching systemic and general itching reaction for one week. The patient had been taking Benadryl and Valaciclovir. The wife wants to know which ingredient had to do with this adverse event. No specific vaccination date given but wife said it was about two weeks ago in Jan 2025, no vaccine detail were obtained in this call. Patient demographics were obtained in this call. No further information was obtained in this call. More
2828189 02/25/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Intercepted product prescribing error Intercepted product prescribing error
Prescription of 1 mL dose to 18 year old patient; This non-serious case was reported by a pharmacist... Prescription of 1 mL dose to 18 year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a 18-year-old patient who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient did not receive Engerix B 1 ml. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug prescribing error (Verbatim: Prescription of 1 mL dose to 18 year old patient). The outcome of the drug prescribing error 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: 18-FEB-2025 The pharmacist called to inform that one of their patients was an 18-year-old that needs the 1 mL dosing of Engerix-B. Reporter mentioned that the doctor had prescribed this 18-year-old patient a 20 year-old dosing which led to Drug prescribing error. No more details were provided by reporter. More
2828190 WI 02/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Incomplete course of vaccination/not received the second dose; This non-serious case was reported by... Incomplete course of vaccination/not received the second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on 03 Oct 2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination/not received the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 19-FEB-2025 The registered nurse mentioned If a person received their first dose of Shingrix on 03 Oct 2023 and had not received the second dose would they just need to complete the second series or would they need to restart. The health care professional reject to provide any other information. Till the time of reporting, the patients did not receive second dose of Shingrix, which led to incomplete course of vaccination. More
2828192 0.67 M OR 02/25/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
 5N2AN
Extra dose administered Extra dose administered
Third dose given; This non-serious case was reported by a other health professional via call center ... Third dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 8-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 5N2AN) for prophylaxis. Previously administered products included Rotarix (received first dose of Rotarix on an unknown date) and Rotarix (received second dose of Rotarix on an unknown date). On 18-FEB-2025, the patient received the 3rd dose of Rotarix lyophilized formulation. On 18-FEB-2025, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: Third dose given). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 20-FEB-2025 The other health professional reported that third vaccines dose in an 8 month old patient which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter. More
2828193 M NJ 02/25/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
underage; wrong dose in schedule; This non-serious case was reported by a physician via call center ... underage; wrong dose in schedule; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis. On 20-FEB-2025, the patient received the 3rd dose of Kinrix. On 20-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: underage) and wrong vaccine administered (Verbatim: wrong dose in schedule). The outcome of the inappropriate age at vaccine administration and wrong 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: 21-FEB-2025 The physician reported that a 9 month old patient received Kinrix in error, which led to inappropriate age at vaccine administration. Patient was due for DTaP and IPV, which led to wrong vaccine administered. Kinrix was the patient's 3rd dose of each. The patient received their 2nd dose of a DTaP and an IPV on 19-NOV-2024(no mention of brand). More
2828194 CA 02/25/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
PFIZER\WYETH

Interchange of vaccine products; Interchange of vaccine products Interchange of vaccine products; Interchange of vaccine products
Patient had received a dose of Trumenba and one dose of Bexsero; This non-serious case was reported ... Patient had received a dose of Trumenba and one dose of Bexsero; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis. On an unknown date, the patient received Bexsero and Trumenba. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Patient had received a dose of Trumenba and one dose of Bexsero). The outcome of the interchange of vaccine products 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-FEB-2025 The reporter mentioned that a patient had received a dose of Trumenba and one dose of Bexsero , which led to interchange of vaccine products. They wanted to know if the patient still need another Bexsero dose in order to complete the series. The reporter did not provide further details. More
2828195 02/25/2025 COVID19
 JANSSEN
 Unknown
Chest pain Chest pain
chest pains; This spontaneous report received from a patient concerned a patient of unspecified age ... chest pains; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose and frequency not reported, administered on Jun-2021, additional dosage information included: Dose series 1, for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On Jun-2021, the patient experienced chest pains. (Dose series: 1). The patient had chest pains immediately after the Covid vaccine in June 2021 for 12weeks. The action taken with janssen covid-19 vaccine was not applicable. The outcome of chest pains was not reported. This report was non-serious. More
2828197 76 F RI 02/25/2025 COVID19
 MODERNA
Eczema Eczema
I developed eczema; This spontaneous case was reported by a patient and describes the occurrence of ... I developed eczema; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (I developed eczema) in a 76-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ECZEMA (I developed eczema). At the time of the report, ECZEMA (I developed eczema) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. More
2828198 IA 02/25/2025 DTAPIPVHIB
DTPPVHBHPB
MMR
VARCEL
 SANOFI PASTEUR
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
 UK167AA

Y007615
Y011020
Product preparation issue; Product preparation issue; Product preparation issue;... Product preparation issue; Product preparation issue; Product preparation issue; Product preparation issue More
inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of... inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. The patient received both vaccines on the same day on 01/27/2025.; Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. Pentacel vaccine administered the same day; inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. The patient received both vaccines on the same day on 01/27/2025.; This non-serious, spontaneous, safety report was received by partner on 30-JAN-2025 and forwarded to agency on 30-JAN-2025 from a healthcare professional. Due to the nature of the event, the causality between the event "inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. The patient received both vaccines on the same day on 01/27/2025" and Vaxelis was not applicable. Further information is expected Significant follow-up information was received by the partner on 13-FEB-2025 and forwarded to agency on 13-FEB-2025, from other health professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the event "inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT. The patient received both vaccines on the same day on 01/27/2025" and Vaxelis was not applicable. Further information is not expected. More
2828199 MI 02/25/2025 COVID19
 PFIZER\BIONTECH
 LP1776
Device breakage Device breakage
One of the vials was damaged/one of the vials was broken/They have not administered it; This is a sp... One of the vials was damaged/one of the vials was broken/They have not administered it; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), (Lot number: LP1776, Expiration Date: 26Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "One of the vials was damaged/one of the vials was broken/They have not administered it". The action taken for BNT162b2 omicron (kp.2) was unknown. Additional information: One of their vaccines that they received from Pfizer, she realized that one of the vials was damaged. They have not administered it or utilized it. She just realized that one of the vials was broken when she unboxed that. The vaccine was not administered to any patient. They are looking to either return it or get it replaced or get credit. Causality for "one of the vials was damaged/one of the vials was broken/they have not administered it" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction). Product Quality Group provided investigational results on 17Feb2025 for bnt162b2 omicron (kp.2) (device constituent): The complaint for "one of the vials was broken when she unboxed that" of Comirnaty PFS was investigated. The investigation included reviewing the involved batch records, deviation investigation, a picture of the complaint sample, evaluation of retain sample and an analysis of the complaint history for the involved scope and Annual Product Review. Quantity of returned complaint sample: picture. The reported defect was present on the returned complaint sample picture. The complaint is confirmed. No root cause or CAPA were identified as all reviewed records in scope of this investigation met the established requirements at time of release. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The final scope was determined to be the associated lots of the reported lot LP1776. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. Device Investigation: This investigation is based on the information captured in the Complaint Description and Argus Report. The Complaint Issue "Luer Lock Detached During Prep/Use" was reported. The complaint issue is selected as per the sample. The Risk Management File was reviewed to confirm that the Hazard(s) and Hazardous Situation(s) associated with the Complaint Issue are documented in the Hazard Analysis. All complaint investigations are trended. There no current trend alert documented. More
2828200 1.25 M MD 02/25/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 LM7786
LM7786
LM7786
Cough, Diarrhoea, Fatigue, Irritability, Nasal congestion; Otitis media acute, O... Cough, Diarrhoea, Fatigue, Irritability, Nasal congestion; Otitis media acute, Overdose, Product administered to patient of inappropriate age, Pyrexia, Respiratory syncytial virus bronchiolitis; Sneezing More
bilateral acute otitis media; cough; congestion; diarrhea; sneezing; rsv bronchiolitis; more tired; ... bilateral acute otitis media; cough; congestion; diarrhea; sneezing; rsv bronchiolitis; more tired; febrile; fussied; a 12 and plus was given to a 15 month old/Given Covid-19 vaccine for ages 12 and older; a 12 and plus was given to a 15 month old/Given Covid-19 vaccine for ages 12 and older; This is a spontaneous report received from an Other HCP and Physicians from medical information team. A 15-month-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Dec2024 at 09:52 as dose 1, 0.3 ml single (Lot number: LM7786, Expiration Date: 07Apr2025) at the age of 15 months intramuscular, in thigh for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 18Dec2024 at 09:52, outcome "unknown" and all described as "a 12 and plus was given to a 15 month old/Given Covid-19 vaccine for ages 12 and older"; PYREXIA (non-serious) with onset 19Dec2024, outcome "unknown", described as "febrile"; IRRITABILITY (non-serious) with onset 19Dec2024, outcome "unknown", described as "fussied"; FATIGUE (non-serious) with onset 19Dec2024, outcome "unknown", described as "more tired"; RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS (medically significant), outcome "recovering", described as "rsv bronchiolitis"; OTITIS MEDIA ACUTE (non-serious), outcome "recovering", described as "bilateral acute otitis media"; COUGH (non-serious), outcome "unknown"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; SNEEZING (non-serious), outcome "unknown". The events "cough", "congestion", "diarrhea" and "sneezing" required physician office visit. Therapeutic measures were taken as a result of respiratory syncytial virus bronchiolitis, otitis media acute. Clinical course: No prior vaccinations since Aug2024. Difficult to say as patient got dose 18Dec2024. Became febrile 19Dec2024 and was more tired and fussied. Seen in office 20Dec2024 for cough, congestion, sneezing and diarrhea. No Acute findings. Start again 23Dec2024 for similar symptoms, diagnosed with RSV bronchiolitis and bilateral acute otitis media, started an amoxicillin. Defervesced and improved by 24Dec2024. The medication error occurred when the product was dispensed. The medication error occurred when the product was administered to / taken by the patient. Misunderstanding of instructions by the individual administering the medication Checked. Follow-up (18Dec2024): This is a spontaneous follow-up report received from an Other HCP from medical information team. Updated information: dosing information, event (added vaccine overdose), and narrative. Follow-up (26Jan2025): Follow-up attempts are completed. Follow-up (19Feb2025): This is a spontaneous follow-up report received from the Physician. This Physician reported for a patient in response to HCP letter sent which included that: Updated information: Classification removed. Reporter details(New true reporter added), product details(Best Doctor / Health Care Professional Information added. product indication removed from device subtab), event details(new events added, Physician Office Visit checked. Event onset date added. Event outcome added).; Sender's Comments: Based on known disease pathophysiology, the event respiratory syncytial virus bronchiolitis is assessed as not related to BNT162B2 OMICRON (KP.2), and more likely an intercurrent medical condition of respiratory syncytial virus infection. More
2828201 M 02/25/2025 COVID19
 PFIZER\BIONTECH
Feeling abnormal Feeling abnormal
first 3 they made me feel bad; This is a spontaneous report received from a Consumer or other non HC... first 3 they made me feel bad; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 61-year-old male patient received BNT162b2 (BNT162B2), 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: FEELING ABNORMAL (non-serious), outcome "recovered", described as "first 3 they made me feel bad". Additional information: The first three vaccines made the patient feel bad, but in 2 to 3 days, the patient went back to normal. 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-202500040306 same reporter/patient, different dose/event; More
2828202 M 02/25/2025 COVID19
 PFIZER\BIONTECH
Feeling abnormal Feeling abnormal
first 3 they made me feel bad; This is a spontaneous report received from a Consumer or other non HC... first 3 they made me feel bad; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "made me feel bad". The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "first 3 they made me feel bad". Additional information: The first three vaccines made the patient feel bad, but in 2 to 3 days, the patient went back to normal. 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-202500040306 same reporter/patient, different dose/event; More
2828203 M 02/25/2025 COVID19
 PFIZER\BIONTECH
Feeling abnormal Feeling abnormal
feel bad; This is a spontaneous report received from a Consumer or other non HCP from medical inform... feel bad; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An adult male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation, reaction(s): "feel bad"; Bnt162b2 (dose 2), for COVID-19 immunisation, reaction(s): "feel bad". The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "feel bad". Additional information: The first 3 they made the patient feel bad but in 2 to 3 days, the patient was back to normal. 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-202500040306 same reporter/patient, different dose/event;US-PFIZER INC-202500040789 same reporter/patient, different dose/event;US-PFIZER INC-202500040790 same reporter/patient, different dose/event; More
2828204 48 F WI 02/25/2025 COVID19
 PFIZER\BIONTECH
Escherichia sepsis, IgA nephropathy, Urinary tract infection Escherichia sepsis, IgA nephropathy, Urinary tract infection
sepsis (E Coli); IGA Nephropathy; had 3 UTI's; This is a spontaneous report received from a Con... sepsis (E Coli); IGA Nephropathy; had 3 UTI's; This is a spontaneous report received from a Consumer or other non HCP. A 51-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy to tree nuts" (unspecified if ongoing). There were no concomitant medications. No other vaccine on the same date. Vaccination history included: Covid-19 (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 immunization. The following information was reported: IGA NEPHROPATHY (medically significant) with onset 04Dec2023, outcome "recovered with sequelae"; URINARY TRACT INFECTION (medically significant) with onset 04Dec2023, outcome "recovered with sequelae", described as "had 3 UTI's"; ESCHERICHIA SEPSIS (hospitalization) with onset 04Dec2023, outcome "recovered with sequelae", described as "sepsis (E Coli)". The patient was hospitalized for escherichia sepsis (hospitalization duration: 4 day(s)). Clinical course: Prior to this vaccine patient never had an kidney issues or UTI's in her life. Now in 2023 she had 3 UTI's. 2 that she been hospitalized for sepsis (e Coli). And also have been diagnosed with IGA nephropathy. Patient truly believed all this issues were from the vaccine, now she had to live with this the rest of her life. Therapeutic measures were not taken as a result of escherichia sepsis, iga nephropathy, urinary tract infection. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
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2828205 40 F MD 02/25/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
49281072410
Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vag... Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaginal haemorrhage; Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaginal haemorrhage More
Abnormal vaginal bleeding (2.5 weeks too early for a period - have never had mid cycle bleeding); La... Abnormal vaginal bleeding (2.5 weeks too early for a period - have never had mid cycle bleeding); Large itchy red rash at injection site; Large itchy red rash at injection site; Large itchy red rash at injection site; This is a spontaneous report received from a Consumer or other non HCP. A 40-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Feb2025 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 18Feb2025 as dose 1, single (Lot number: 49281072410), in left arm for immunisation. The patient's relevant medical history included: "Ehlers-Danlos Syndrome" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: 01Aug2021, stop date: 21Feb2025; PRAZOSIN, start date: 01May2023, stop date: 21Feb2025. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset 19Feb2025, outcome "not recovered" and all described as "Large itchy red rash at injection site"; VAGINAL HAEMORRHAGE (non-serious) with onset 21Feb2025, outcome "not recovered", described as "Abnormal vaginal bleeding (2.5 weeks too early for a period - have never had mid cycle bleeding)". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site rash, vaginal haemorrhage. Additional information: The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). Large itchy red rash at injection site starting 19Feb2025. Abnormal vaginal bleeding starting 21Feb2025 (2.5 weeks too early for a period - have never had mid cycle bleeding) The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2828206 M RI 02/25/2025 FLUX
 UNKNOWN MANUFACTURER
 No batch number
Eczema Eczema
Eczema after 5-7 days after taking a flu vaccine; This spontaneous case, initially received on 14-Fe... Eczema after 5-7 days after taking a flu vaccine; This spontaneous case, initially received on 14-Feb-2025, was reported by a non health professional and concerns a male patient with unknown age. Drug history included morphine (Reaction: Allergy). At the time of the event the patient had allergic to cats. No concomitant medications were reported. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for unknown indication, dose, route of administration and anatomical location: not reported. Lot number: No batch number available but will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Eczema after 5-7 days after taking a flu vaccine (outcome: Recovered / Resolved). Consumer inquired about adverse reaction after taking one of vaccines. He stated that after 5 to 7 days after taking the vaccine he experienced eczema, he went to his dermatologist, which gave him a shot of steroid. He mentioned that he's going to a allergologist to be tested for several allergens. He also mentioned that he's allergic to cat and morphine, but not allergic to egg. He was not sure about what vaccine he took. He wanted to check what probably caused him the eczema. INN Flu Vaccine Seasonal action taken: Not Applicable Treatment medication: Unspecified Steroids Reporter assessment: The reporter considered the event as non serious and did not provide a causality assessment.; Reporter's Comments: The event is related to the vaccine More
2828211 02/25/2025 COVID19
 MODERNA
Thrombosis Thrombosis
I have suffered blood clots since getting the Moderna vaccines; This spontaneous case was reported b... I have suffered blood clots since getting the Moderna vaccines; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (I have suffered blood clots since getting the Moderna vaccines) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (I have suffered blood clots since getting the Moderna vaccines) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (I have suffered blood clots since getting the Moderna vaccines) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient was on blood thinners for the rest of life. No specified treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of mRNA-1273 (Spikevax) vaccine is not affected by this report. More
2828212 18 M MN 02/25/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
An expired dose of hep B was given to a patient. It was not realized until after the vaccine was giv... An expired dose of hep B was given to a patient. It was not realized until after the vaccine was given that it was expired as our computer inventory said it expired 12/17/2025 and the vaccine expiration date on the package and the vaccine itself said 2/17/25. Call placed to GSK to inquire if vaccine is potentially still good since close to expiration date. GSK said they do in-house testing which shows the potency of the vaccine remains satisfactory for up to 30 days after expiration however they have to recommend per CDC & immunize.gov that the dose be considered invalid and be repeated ASAP. Attempted to reach patient and was not able to get a hold of them. Will continue to try and reach patient. Updated MD who was present, as well as clinic manager and clinical director. More
2828223 0.42 M WI 02/25/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Urticaria Urticaria
Hives Hives
2828224 50 F FL 02/25/2025 FLU3
PNC21
VARZOS
 SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 ut8514ka
y013009
354m3
Fatigue, Influenza like illness, Peripheral swelling, Pyrexia; Fatigue, Influenz... Fatigue, Influenza like illness, Peripheral swelling, Pyrexia; Fatigue, Influenza like illness, Peripheral swelling, Pyrexia; Fatigue, Influenza like illness, Peripheral swelling, Pyrexia More
Pt got vaccines on 2/21, started to have fever on 2/22. She called pharmacy on 2/25 to report her fe... Pt got vaccines on 2/21, started to have fever on 2/22. She called pharmacy on 2/25 to report her fever is getting better, but still feel tire with flu like symptoms and right arm swelling. More
2828225 81 M TN 02/25/2025 UNK
 UNKNOWN MANUFACTURER
No adverse event No adverse event
NO ADVERSE REACTIONS NOTED TO. NO ADVERSE REACTIONS NOTED TO.
2828226 76 F TN 02/25/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 52752
7zm55
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient received a RSV shot on 8/28/23 and then another on 2/24/2025. She hasn't reported any i... Patient received a RSV shot on 8/28/23 and then another on 2/24/2025. She hasn't reported any issues other than maybe some headache/lightheadedness. We told the patient to call us if any issue came up. More
2828227 65 TX 02/25/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 4ds4n
Pain in extremity Pain in extremity
pt called today stating her arm has been hurting after she got last vaccine in november. which was t... pt called today stating her arm has been hurting after she got last vaccine in november. which was twinrix. More
2828228 16 F NJ 02/25/2025 MNQ
 SANOFI PASTEUR
 U8369BA
Extra dose administered, No adverse event Extra dose administered, No adverse event
none thus far none thus far
2828229 30 F TX 02/25/2025 TDAP
TDAP
TDAP
TDAP
TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 XN575
XN575
XN575
xn575
xn575
xn575
Arthralgia, Bone pain, Impaired work ability, Injected limb mobility decreased, ... Arthralgia, Bone pain, Impaired work ability, Injected limb mobility decreased, Product administered at inappropriate site; Sleep disorder, X-ray limb; Limb injury; Arthralgia, Bone pain, Impaired work ability, Injected limb mobility decreased, Product administered at inappropriate site; Sleep disorder, X-ray limb; Limb injury More
On 2/23/2025 a pharmacist or technician (I?m not exactly sure what their title is) gave me a tetanus... On 2/23/2025 a pharmacist or technician (I?m not exactly sure what their title is) gave me a tetanus shot, right on top of my left shoulder causing me excruciating pain on my shoulder, collar bone and immobility on my left arm. Because of that, I was told by my occupational health department at my work that I can?t go back to work if I?m under restrictions because my job is unable to accommodate me. So I?m out a week at least. I work a very hands on job. I went to see a doctor the next day (02/24/2025) because I was unable to sleep at night due to the pain getting worse. My doctor looked very appalled after I explained how the vaccine was injected; I was told Vaccines like tetanus shots are supposed to be administered in the deltoid muscle, not on top of the shoulder which is considered improper technique, violating the standard of care. More
2828230 63 F FL 02/25/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LG5579
9429J
Injection site erythema, Injection site pruritus; Injection site erythema, Injec... Injection site erythema, Injection site pruritus; Injection site erythema, Injection site pruritus More
On 02/17/25, patient received Prevnar 20 IM left deltoid and Boostrix IM right deltoid. On 02/23/25,... On 02/17/25, patient received Prevnar 20 IM left deltoid and Boostrix IM right deltoid. On 02/23/25, she began experiencing itchiness and redness below the injection site of left arm (Prevnar 20) and redness below injection site of right arm (Boostrix). She states both have improved since, but still has some redness on both arms. She purchased hydrocortisone cream 02/25/25 as recommended by a family member who is a physician. More
2828232 11 F CA 02/25/2025 HEPA
MNQ
 MERCK & CO. INC.
SANOFI PASTEUR
 Y012054
U83698A
Erythema, Peripheral swelling, Pyrexia, Skin warm; Erythema, Peripheral swelling... Erythema, Peripheral swelling, Pyrexia, Skin warm; Erythema, Peripheral swelling, Pyrexia, Skin warm More
The next day after getting the vaccine, got fever of 102 and extreme right arm swelling, redness an... The next day after getting the vaccine, got fever of 102 and extreme right arm swelling, redness and warm. More
2828233 61 M TX 02/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 52F7M
Rash Rash
Patient started having rash on the same arm that was vaccinated a few days later after receiving vac... Patient started having rash on the same arm that was vaccinated a few days later after receiving vaccine -the left arm--Rash continued traveling down arm. Patient is now expiring rash on other arm. More
2828234 74 M TX 02/25/2025 PNC20
 PFIZER\WYETH
Injection site erythema, Injection site pruritus Injection site erythema, Injection site pruritus
REDNESS PRESENT AT THE INJECTION SITE A DAY AFTER THE INJECTION. PATIENT REPORT THAT BEGIN ITCHING ... REDNESS PRESENT AT THE INJECTION SITE A DAY AFTER THE INJECTION. PATIENT REPORT THAT BEGIN ITCHING 9 DAYS AFTER INJECTION More
2828235 32 M MI 02/25/2025 COVID19
COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
JANSSEN
 1955191
1955191
1955191
1955191
Chest pain, Computerised tomogram, Coordination abnormal, Dizziness, Dyspnoea; E... Chest pain, Computerised tomogram, Coordination abnormal, Dizziness, Dyspnoea; Echocardiogram, Electrocardiogram abnormal, Electrocardiogram ambulatory, Fine motor skill dysfunction, Heart rate decreased; Heart rate increased, Hypoaesthesia, Laboratory test, Memory impairment, Pallor; Palpitations, Sinus tachycardia, Supraventricular tachycardia, Syncope, Visual impairment More
Sinus tachycardia ( diagnosed svt), therapist accelerating and deceleration if heart rate, shortness... Sinus tachycardia ( diagnosed svt), therapist accelerating and deceleration if heart rate, shortness of breath, Dizziness, fainting, left side of body, legs and face numbness, vision changes, severe chest pain, palputations, complete color in skin loss, motorskills and coordination loss, memory issues. More
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2828243 3 M FL 02/25/2025 DTAP
FLU3
HEPA
PNC20
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
 3CA58C1
UT8485NA
Y012054
LG5578
Injection site erythema, Injection site oedema, Injection site swelling; Injecti... Injection site erythema, Injection site oedema, Injection site swelling; Injection site erythema, Injection site oedema, Injection site swelling; Injection site erythema, Injection site oedema, Injection site swelling; Injection site erythema, Injection site oedema, Injection site swelling More
Large amount of swelling & redness to the left thigh on 2/23/25. Parent took pt to ER and was pr... Large amount of swelling & redness to the left thigh on 2/23/25. Parent took pt to ER and was prescribed steroid cream. Patient seen 2/25/25 by PCP who noted a tennis ball size area of redness w/ small ecchymosis, minimal edema. More
2828244 81 M SC 02/25/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT8473CA
UT8473CA
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No adverse event reported, office practice manager requested report be made No adverse event reported, office practice manager requested report be made
2566332 42 F OK 02/24/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 FK9894
FK9894
Arterial occlusive disease, Brain injury, Cerebrovascular accident, Thrombosis; ... Arterial occlusive disease, Brain injury, Cerebrovascular accident, Thrombosis; Bedridden, Cerebrovascular accident More
Blood clots which simultaneously clogged both arteries; brain blowout; 14 strokes within a 6 month p... Blood clots which simultaneously clogged both arteries; brain blowout; 14 strokes within a 6 month period.; Blood clots which simultaneously clogged both arteries; This is a spontaneous report received from a Consumer or other non HCP. A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27May2022 at 15:00 as dose 1, single (Lot number: FK9894) at the age of 42 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CEREBROVASCULAR ACCIDENT (death, caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27May2022 at 15:00, outcome "fatal", described as "14 strokes within a 6 month period."; THROMBOSIS (death, caused and prolonged hospitalization, disability, medically significant, life threatening), ARTERIAL OCCLUSIVE DISEASE (death, caused and prolonged hospitalization, disability, medically significant, life threatening) all with onset 27May2022 at 15:00, outcome "fatal" and all described as "Blood clots which simultaneously clogged both arteries"; BRAIN INJURY (death, caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27May2022 at 15:00, outcome "fatal", described as "brain blowout". The patient was hospitalized and prolonged hospitalization for thrombosis, brain injury, cerebrovascular accident, arterial occlusive disease (hospitalization duration: 200 day(s)). Therapeutic measures were taken as a result of thrombosis, brain injury, cerebrovascular accident, arterial occlusive disease. The patient date of death was 11Feb2025. Reported cause of death: "Final stroke from blood clots". It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Final stroke from blood clots; Final stroke from blood clots More
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2827687 M 02/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Ophthalmic herpes zoster Herpes zoster, Ophthalmic herpes zoster
It got into his eye too; two weeks later he had shingles; This serious case was reported by a consum... It got into his eye too; two weeks later he had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster 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 ophthalmic herpes zoster (Verbatim: It got into his eye too) (serious criteria GSK medically significant) and shingles (Verbatim: two weeks later he had shingles). The outcome of the ophthalmic herpes zoster and shingles were not reported. It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine. The company considered the ophthalmic herpes zoster and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 14-FEB-2025 This case was reported by the daughter/son of the patient via interactive digital media. Th reporter stated that his/her father (patient) went and got his Shingles vaccine and about two weeks later he had shingles. Reporter stated that it got into his eye too.; Sender's Comments: Ophthalmic herpes zoster and Herpes zoster are unlisted events which are considered unrelated to GSK Shingles vaccine. More
2827688 17 M MI 02/24/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 9M2R7
Extra dose administered, No adverse event, Product preparation error Extra dose administered, No adverse event, Product preparation error
The sterile water diluent from a Merck MMR-Varicella vaccine was used to reconstitute the MENVEO Vac... The sterile water diluent from a Merck MMR-Varicella vaccine was used to reconstitute the MENVEO Vaccine on 13 February 2025; The sterile water diluent from a Merck MMR-Varicella vaccine was used to reconstitute the MENVEO Vaccine on 13 February 2025; Extra dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 9M2R7) for prophylaxis. On 13-FEB-2025, the patient received the 2nd dose of Menveo. On 13-FEB-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: The sterile water diluent from a Merck MMR-Varicella vaccine was used to reconstitute the MENVEO Vaccine on 13 February 2025), inappropriate dose of vaccine administered (Verbatim: The sterile water diluent from a Merck MMR-Varicella vaccine was used to reconstitute the MENVEO Vaccine on 13 February 2025) and extra dose administered (Verbatim: Extra dose administered). The outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and extra dose administered were unknown. Additional Information: GSK Receipt Date: 18-FEB-2025 The reporter was a medical assistant for a medical office. The sterile water diluent from a Merck MMR Varicella vaccine was used to reconstitute the Menveo vaccine on 13th February 2025 which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The MMR Varicella antigen was not involved. The diluent was baxter sterile water. This was the second Menveo dose for the patient no other adverse event reported which led to extra dose administered. More
2827689 NY 02/24/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 XX33P
Incorrect dose administered, Injection site pain, Product quality issue Incorrect dose administered, Injection site pain, Product quality issue
Pain at injection site; several Bexsero syringes having too much air and administered one dose which... Pain at injection site; several Bexsero syringes having too much air and administered one dose which included the air bubble; administer one dose which included the air bubble in the syringe; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: Pain at injection site), syringe issue (Verbatim: several Bexsero syringes having too much air and administered one dose which included the air bubble), incomplete dose administered (Verbatim: administer one dose which included the air bubble in the syringe) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain was resolved and the outcome of the syringe issue, incomplete dose administered and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site pain and syringe issue to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain and syringe issue to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JAN-2025 The healthcare professional reported that they did inject one dose of Bexsero with the air bubble in the syringe and the patient complained of pain upon injection and for several hours after, which led to syringe issue and incomplete dose administered They have experienced problems with several Bexsero syringes having too much air and had tried to expel the air with and without the syringe attached and the suspect syringes had been discarded. The HCP now knew to save the suspect syringes if it happens again. They stated that this had been happening intermittently with all batches since the new syringe presentation. They are aware of the documentation stating they may administer the vaccine with the air. The defect was discovered during preparation for administration and only one dose was administered. The vaccine syringe is included in the product complaint. This case is linked with US2025008843, reported by same reporter.; Sender's Comments: US-GSK-US2025008843:same reporter More
2827690 32 F TX 02/24/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 XN575
Exposure during pregnancy, Extra dose administered Exposure during pregnancy, Extra dose administered
Drug Exposure During Pregnancy; Extra dose to pregnant patient; This non-serious case was reported b... Drug Exposure During Pregnancy; Extra dose to pregnant patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XN575, expiry date 22-MAR-2027) for prophylaxis. Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (BOOSTRIX). On 28-JAN-2025, the patient received the 2nd dose of Boostrix. On 28-JAN-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Extra dose to pregnant patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the extra dose administered and vaccine exposure during pregnancy were unknown. Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Estimated Delivery/Due date: 10-MAR-2025 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: 28-JAN-2025 The medical assistant explained that they accidentally administered a second dose of Boostrix to a pregnant patient on 28th January 2025 which led to extra dose administered and vaccine exposure during pregnancy. First dose of Boostrix vaccine was administered on 19th December 2024. More
2827691 55 M NC 02/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9C5T4
Product preparation issue Product preparation issue
somebody administer a Shingrix vaccine without reconstitute it, they just use the liquid, and not th... somebody administer a Shingrix vaccine without reconstitute it, they just use the liquid, and not the lyophilized gE antigen component; somebody administer a Shingrix vaccine without reconstitute it, they just use the liquid, and not the lyophilized gE antigen component; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 9C5T4, expiry date 26-OCT-2026) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on 14th November 2024). On 17-JAN-2025, the patient received the 2nd dose of Shingrix. On 17-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: somebody administer a Shingrix vaccine without reconstitute it, they just use the liquid, and not the lyophilized gE antigen component) and inappropriate dose of vaccine administered (Verbatim: somebody administer a Shingrix vaccine without reconstitute it, they just use the liquid, and not the lyophilized gE antigen component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 30-JAN-2025 Reporter called from a clinic, and they provided a vaccine for a patient. He/she was doing the inventory management for the month for vaccines, and it looked like someone administered a Shingrix vaccine without reconstituting it. They just used the liquid and not the lyophilized gE antigen component, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. He/she was told by his/her manager that he/she needed to call and find out from what they needed to do. Healthcare professional reported that the 1st complete Shingrix dose was administered on 14th November 2024, then this 2nd dose (only the liquid portion) was on 17th January 2025. More
2827692 1 F MO 02/24/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
a twelve month old female patient was administered a Kinrix vaccine by mistake; a twelve month old f... a twelve month old female patient was administered a Kinrix vaccine by mistake; a twelve month old female patient was administered a Kinrix vaccine by mistake; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis. Previously administered products included Dtp ipv vaccine (Received 2 doses on an unknown date). On 26-SEP-2024, the patient received Kinrix. On 26-SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a twelve month old female patient was administered a Kinrix vaccine by mistake) and inappropriate schedule of vaccine administered (Verbatim: a twelve month old female patient was administered a Kinrix vaccine by mistake). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. 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: 30-JAN-2025 The reporter reported that a twelve month old female patient was administered a Kinrix vaccine by mistake which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. Reporter confirms this was the third dose of Dtap/IPV vaccination. No further information was obtained in this call. More
2827693 FL 02/24/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Menveo one vial presentation administered to patients under 10 year of age; This non-serious case wa... Menveo one vial presentation administered to patients under 10 year of age; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo one vial presentation administered to patients under 10 year of age). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 10-FEB-2025 The doctor stated that several patients under 10 year old received Menveo one vial presentation which led to inappropriate age at vaccine administration. The doctor wanted to know if these children under 10 year old who had been administered with Menveo one vial presentation will be protected from MCV4 compared with Menveo 2 vials presentation. The vaccine administration facility is the same as primary reporter. Consented to follow up. More
2827694 F TX 02/24/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
a patient received Twinrix -1st dose in May 2024 and 2nd dose October 2024; This non-serious case wa... a patient received Twinrix -1st dose in May 2024 and 2nd dose October 2024; 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 57-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (1st dose received in May 2024). In OCT-2024, the patient received the 2nd dose of Twinrix. In OCT-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received Twinrix -1st dose in May 2024 and 2nd dose October 2024). The outcome of the drug dose administration interval too long 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: 11-FEB-2025 The reporter reported a patient received Twinrix 1st dose in May 2024 and 2nd dose October 2024. The reporter declined to provide patient demographics, Lot and Expiration dates of vaccines were not available at time of call. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2827695 65 M CO 02/24/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Lip swelling, Lymphadenopathy, Oropharyngeal pain, Skin irritation, Throat irrit... Lip swelling, Lymphadenopathy, Oropharyngeal pain, Skin irritation, Throat irritation More
swollen lymph nodes; throat itchy; jaw irritation; having swollen lips; throat itchy and painful,; T... swollen lymph nodes; throat itchy; jaw irritation; having swollen lips; throat itchy and painful,; This non-serious case was reported by a consumer via call center representative and described the occurrence of swollen lymph nodes in a 65-year-old male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included Typhoid vaccine for prophylaxis. On 07-FEB-2025, the patient received Twinrix (intramuscular, right arm). On 05-FEB-2025, the patient received Typhoid vaccine (left arm). On 10-FEB-2025, 3 days after receiving Twinrix, the patient experienced swollen lymph nodes (Verbatim: swollen lymph nodes), itchy throat (Verbatim: throat itchy), mouth irritation (Verbatim: jaw irritation), lip swelling (Verbatim: having swollen lips) and sore throat (Verbatim: throat itchy and painful,). The outcome of the swollen lymph nodes, itchy throat, mouth irritation, lip swelling and sore throat were not resolved. It was unknown if the reporter considered the swollen lymph nodes, itchy throat, mouth irritation, lip swelling and sore throat to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the swollen lymph nodes, itchy throat, mouth irritation, lip swelling and sore throat to be related to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt Date: 12-FEB-2025 The patient was the reporter who received the Twinrix vaccine on and started having symptoms. The reporter stated he also received the Typhoid vaccine. The reporter stated that after the Twinrix vaccine, he noticed within 48 hours that he had swollen lips, swollen lymph nodes, jaw irritation, and his throat was itchy and painful. All these symptoms were ongoing. The reporter stated he was going to see his health case professional on the day of reporting. The reporter consented to follow-up. The Vaccine Administration Facility was the same as the Primary Reporter. More
2827696 67 F FL 02/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Innapropiate Schedule for vaccine (2 previous doses 2 years apart); This non-serious case was report... Innapropiate Schedule for vaccine (2 previous doses 2 years apart); 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 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient got a first dose of the Shingrix vaccine on 31st October, 2022). On 25-SEP-2024, the patient received the 2nd dose of Shingrix. On 25-SEP-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Innapropiate Schedule for vaccine (2 previous doses 2 years apart)). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK receipt date: 12-FEB-2025 Other HCP reported that a female patient got a first dose of the Shingrix vaccine on October 31st, 2022 and also did get a second dose on September 25th, 2024. Physician advised to administer a third dose. HCP wanted to know which guidance GSK has on this topic. The patient received 2nd dose of Shingrix,?later than the recommended interval, which led to lengthening of vaccinations schedule (Drug dose administration interval too long). More
2827697 M IN 02/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 G97Y2
Inappropriate schedule of product administration Inappropriate schedule of product administration
second dose was given 01/14/2025; This non-serious case was reported by a other health professional ... second dose was given 01/14/2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number G97Y2, expiry date 19-MAY-2031) for prophylaxis. Previously administered products included Shingrix (The first dose was given 07-SEP-2019). On 14-JAN-2025, the patient received the 2nd dose of Shingrix. On 14-JAN-2025, 1956 days after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose was given 01/14/2025). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 18-FEB-2025 A pharmacy student contacted to request information about the validity of a second dose of Shingrix that was administered years after the initial dose. The first dose was given 07-SEP-2019, no other information was given and second dose was given 14-JAN-2025 which led to drug dose administration interval too long. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. More
2827698 37 M TN 02/24/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 47XE4
Underdose Underdose
administration of Pediatric dose of Engerix B to adult patient.; administering a pediatric dose of E... administration of Pediatric dose of Engerix B to adult patient.; administering a pediatric dose of Engerix B to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 37-year-old male patient who received HBV (Engerix B pediatric) (batch number 47XE4, expiry date 16-JUL-2026) for prophylaxis. On 19-FEB-2025, the patient received Engerix B pediatric. On 19-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: administration of Pediatric dose of Engerix B to adult patient.) and underdose (Verbatim: administering a pediatric dose of Engerix B to an adult patient). The outcome of the adult use of a child product and underdose were unknown. 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 :19-FEB-2025 Medical assistant called to request information on how to proceed after administering a pediatric dose of Engerix B to an adult patient that is still in the office. Then reporter reported administered to a pediatric dose of Engerix B to an adult patient, which led to underdose and adult use of a child product. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. More
2827699 F MS 02/24/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
The patient recived first dose but not recived second dose of Twinrix; This non-serious case was rep... The patient recived first dose but not recived second dose 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 55-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 05 January 2024 with lot number 797F9 and expiry date 30th December 2025). 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: The patient recived first dose but not recived second dose of Twinrix). The outcome of the incomplete course of vaccination was unknown. 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: 19-FEB-2025 The reporter was aware that patient should receive the second dose of Twinrix as soon as possible and asked when this patient should receive the third dose. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. More
2827700 F 02/24/2025 FLUX
 UNKNOWN MANUFACTURER
Influenza Influenza
Type A flu only; Initial information received on 12-Feb-2025 regarding an unsolicited valid non-seri... Type A flu only; Initial information received on 12-Feb-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves Adult female patient who experienced type a flu only after receiving Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza vaccine solution for injection produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (strength and expiration date: not provided) for Immunisation. Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. On an unknown date the patient developed type a flu only (influenza) (unknown latency). Action taken- not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. More
2827701 0.33 GA 02/24/2025 FLU3
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
fluzone mistaken for a 4 month vaccination with no reported adverse event; Initial information recei... fluzone mistaken for a 4 month vaccination with no reported adverse event; Initial information received on 12-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old and unknown gender patient who had received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] mistaken for a 4 month vaccination with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided. On 12-Feb-2025, the patient received a dose of 1 mg of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (Suspension for injection) strength, expiry date, lot number not reported via intramuscular route in unknown administration site for Prophylactic vaccination (Immunization) and fluzone mistaken for a 4 month vaccination with no reported adverse event (product administered to patient of inappropriate age)(latency : same day). 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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