🏥 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 💀 🏥 🚑 ♿ ⚠️
2833384 M 03/27/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Genital herpes Genital herpes
Activated genital Herpes; This non-serious case was reported by a consumer and described the occurre... Activated genital Herpes; This non-serious case was reported by a consumer and described the occurrence of genital herpes in a 77-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 28-FEB-2025, the patient received RSV vaccine. On 01-MAR-2025, 1 days after receiving RSV vaccine, the patient experienced genital herpes (Verbatim: Activated genital Herpes). The patient was treated with docosanol (Abreva). On 15-MAR-2025, the outcome of the genital herpes was resolved (duration 14 days). It was unknown if the reporter considered the genital herpes to be related to RSV vaccine. It was unknown if the company considered the genital herpes to be related to RSV vaccine. Additional Information: GSK Receipt Date: 17-MAR-2025 The patient self-reported this case. The patient stated that he applied Abreva twice daily, until the outbreak dried up and started healing. The patient had activated genital herpes and the symptoms were treated. More
2833397 03/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure 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: 20-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2833398 F 03/27/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; Got vaccinated and got it anyway; This serious case was reported by a... Suspected vaccination failure; Got vaccinated and got it anyway; This serious case was reported by a consumer and described the occurrence of vaccination failure in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Got vaccinated and got it anyway). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was unknown. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 21-MAR-2025 This case was reported by a patient via interactive digital media Consumer reported that she got vaccinated and got it anyway. She reported it takes forever to get over it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming RSV were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK RSV vaccine. More
2833399 03/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; They are terrible my Dr said that if I had not had the shot, they wou... Suspected vaccination failure; They are terrible my Dr said that if I had not had the shot, they would have been worse; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: They are terrible my Dr said that if I had not had the shot, they would have been worse). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that they were terrible his/her physician said that if patient had not had the shot, they would have been worse. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2833400 44 M TN 03/27/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Incorrect route of product administration Incorrect route of product administration
patient was administered with a priorix vaccine intramuscularly instead of subcutaneous; This non-se... patient was administered with a priorix vaccine intramuscularly instead of subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a 44-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 15-MAR-2025, the patient received Priorix (intramuscular). On 15-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate route of vaccination (Verbatim: patient was administered with a priorix vaccine intramuscularly instead of subcutaneous). The outcome of the inappropriate route 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: 17-MAR-2025 Pharmacist called to report that a patient was administered with a Priorix vaccine intramuscularly instead of subcutaneous, which led to Inappropriate route of vaccination. More
2833401 F VA 03/27/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
 7E9Y2
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A 1 month 4 days old female patient received a dose of Rotarix (liquid); This non-serious case was r... A 1 month 4 days old female patient received a dose of Rotarix (liquid); 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 1-month-old female patient who received Rota (Rotarix liquid formulation) (batch number 7E9Y2, expiry date 30-MAY-2026) for prophylaxis. On an unknown date, the patient received Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: A 1 month 4 days old female patient received a dose of Rotarix (liquid)). 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: 17-MAR-2025 A medical assistant called to report that they administered a dose of Rotarix (liquid) to a 1 month and 4 days old female patient which led to inappropriate age at vaccine administration. The reporter asked are there any side effects to consider? More
2833402 F TX 03/27/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
over 2 years past for her 3rd one; This non-serious case was reported by a pharmacist via call cente... over 2 years past for her 3rd one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (Patient received first dose on 17-AUG-2022) and Twinrix (Patient received second dose 2 years ago). On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: over 2 years past for her 3rd one). 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: 17-MAR-2025 Reporter stated that a patient that have received 2 of her Twinrix vaccination, and she was over 2 years past for her 3rd one, they were just calling to make sure that she does not have to restart the series. Till the time of reporting the patient did not receive the third dose of Twinrix, which led to invomplete course of vaccination. More
2833403 1.17 M CA 03/27/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 TC3N5
Product preparation issue Product preparation issue
Hiberix only diluent administered; Hiberix only diluent administered; This non-serious case was repo... Hiberix only diluent administered; Hiberix only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 14-month-old male patient who received Hib (Hiberix) (batch number TC3N5, expiry date 17-MAR-2026) for prophylaxis. On 17-MAR-2025, the patient received Hiberix. On 17-MAR-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Hiberix only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Hiberix only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 17-MAR-2025 The nurse reported that on the reporting day only the diluent portion of the Hiberix vaccine was administered to a 14-month-old patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The Vaccine Administration Facility is the same as Primary Reporter. More
2833404 F CA 03/27/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
hasn't received a second dose yet; This non-serious case was reported by a other health profess... hasn't received a second dose yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 47-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose of twinrix on 9th December 2024, batch no D4774 and expiry date 12th September 2026). 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: hasn't received a second dose yet). 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 : 24-MAR-2025 A patient received Twinrix first dose on December 9, 2024 and had not received a second dose yet. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. More
2833436 0.5 TX 03/27/2025 RV5
 MERCK & CO. INC.
 2088619
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No other AE; The office administered the first ROTATEQ dose to a patient that is 6 months of age. T... No other AE; The office administered the first ROTATEQ dose to a patient that is 6 months of age. This patient has not received any previous doses; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-Feb-2025, the 6-month-old patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot #2088619, expiration date: 09-Mar-2026) (dose, vaccination site and route of administration was not reported) for prophylaxis (product administered to patient of inappropriate age). This patient has not received any previous doses. No symptoms were reported, and no additional details were provided. No other adverse event (AE) pr product quality complaint (PQC) was reported (no adverse event). More
2833437 11 03/27/2025 VARCEL
 MERCK & CO. INC.
 Y015100
Device connection issue, No adverse event Device connection issue, No adverse event
No adverse side effects were reported.; HCP called to report a patient was being administered VARIVA... No adverse side effects were reported.; HCP called to report a patient was being administered VARIVAX and the needle came off during administration, received about half of the dose. Requested information on revaccination see request case 02768484. STERILE DILUENT Lot and Expiration were un; Patient received about half of the dose; anyone was injured; This spontaneous report was received from Other health professional and refers to an 11-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-Mar-2025, the patient was vaccinated with of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (strength, frequency, route of administration, site of administration, and vaccination scheme were not provided; lot # Y015100 which has been verified as a valid number, and expiration date reported and validated as 06-Sep-2026), and was used with a sterile diluent (strength, frequency, route of administration, site of administration, vaccination scheme, lot #, and expiration date were not provided) as a prophylaxis. however, the needle came off during administration since it came detached at the luer lock. Luer lock remained on the syringe, and product leaked out from between the space between luer lock and where neeedle was attached (syringe connection issue), received about half of the dose (accidental underdose), and an injury (unspecified) was performed. Nevertheless, no adverse side effects were reported. At the reporting time, the outcome of the event of injury NOS was not provided. The causal relationship between the event of injury NOS and the suspect vaccine was not provided. More
2833438 UT 03/27/2025 HIBV
 MERCK & CO. INC.
 Y003145
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adverse event; HCP called to state that the patient received a third dose of PEDVAXHIB at 6 month... No adverse event; HCP called to state that the patient received a third dose of PEDVAXHIB at 6 months of age. No symptomatic adverse events were reported. The AE onset date reflects the date of administration. HCP has declined to answer any further questions and has a; This spontaneous report was received from a Nurse and refers to a(n) 6-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 05-Dec-2024, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), lot #Y003145, expiration date: 12-Sep-2026, 0.5 mL (0.5ml/ series) (route of administration and anatomical location were not provided) for prophylaxis (extra dose administered). No additional adverse event reported (no adverse event). More
2833439 CA 03/27/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y011500
Y011500
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No additional AE; shorter than recommended interval between 2nd and 3rd dose; delayed 2nd dose; This... No additional AE; shorter than recommended interval between 2nd and 3rd dose; delayed 2nd dose; This spontaneous report was received from a nurse practitioner and referred to a 25-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 02-OCT-2014, the patient was vaccinated with the first dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (dose, strength, route, anatomical site, lot # and expiration date were not reported) for prophylaxis. On 16-SEP-2024, the patient was vaccinated with the second dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9), and on 18-OCT-2024, the patient was vaccinated with the third dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (for both doses: 0.5 mL, lot # Y011500, expiration date was reported as 18-OCT-2024, but upon internal validation was established as 29-MAY-2026; strength, route and anatomical site were unknown) for prophylaxis. The second dose was delayed and the interval between the second and the third dose was shorter than recommended (inappropriate schedule of product administration, inappropriate schedule of product administration). No additional adverse event (no adverse event). The outcome of the events was unknown. More
2833440 M NY 03/27/2025 SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
SMALLMNK
 BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
BAVARIAN NORDIC
 Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Abscess neck, Biopsy skin abnormal, Blister, Cellulitis, Computerised tomogram n... Abscess neck, Biopsy skin abnormal, Blister, Cellulitis, Computerised tomogram neck abnormal; Epidermal necrosis, Erythema, Fungal test negative, Gomori methenamine silver stain, Gram stain negative; Herpes simplex test negative, Infection, Inflammation, Lymphadenopathy, Monkeypox; Mycobacterium test negative, Next-generation sequencing, Nucleic acid test, Orthopoxvirus test positive, Periodic acid Schiff stain; Polymerase chain reaction, Purulence, Skin burning sensation, Skin erosion, Skin induration; Skin lesion, Skin mass, Skin necrosis, Skin ulcer, Varicella virus test negative More
Monkeypox; Breakthrough infection; Literature citation. Case reference number US-BN-2025-000359 is ... Monkeypox; Breakthrough infection; Literature citation. Case reference number US-BN-2025-000359 is a spontaneous literature case report, title as stated above, identified on 18-Mar-2025, and concerns a 28-years-old male patient. The aim of the article was to cutaneous small vessel vasculitis following anti-rabies vaccine. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient presented to the emergency department with an asymptomatic neck ulcer, worsening from a dermatology clinic visit two weeks prior, as reported the patient's lesion showed rapid progression in ulceration and induration of the patient's neck lesion with superficial erosion when outpatient. The patient reported increased growth and burning and denied tooth pain or abscesses. On unspecified date, the initial punch biopsy revealed ulceration with focal epidermal and dermal necrosis, nonspecific but suggestive of an infectious process although bacterial, acid-fast bacillus, and fungal cultures were negative. As reported the patient previously saw numerous outpatient providers and received multiple antibiotics without resolution. On unspecified date, focal skin exam showed a large indurated erythematous mass with central purulent ulceration on the left inferior neck. The patient began broad-spectrum vancomycin and piperacillin-tazobactam (brand name: unknown). Computed tomography showed an early abscess with adjacent cellulitis, reactive lymphadenopathy, and patent vasculature. A second punch biopsy demonstrated nonspecific erosion/chronic inflammation with no organisms identified, negative periodic acid schiff, Grocott Methenamine Silver, fite, and gram stains. The patient later endorsed sensation of the neck lesion "expanding upwards," still without drainage. A third deep punch biopsy was obtained with specimen sent for broad range polymerase chain reaction (PCR) sequencing and next generation sequencing analysis at the University. The patient's blood was sent for microbial cell-free DNA detection to expand infectious workup. On an unspecified date, five days after presentation, a new lesion was noted on the patient's left lateral wrist, which he reported began as a blister six days prior and evolved into an ulcerated plaque, similar to initial presentation of the neck lesion, and was thus biopsied. The patient's other laboratory tests included Broad range PCR and next generation sequencing testing returned negative. The deoxy ribonucleic acid (DNA) detection demonstrated 1648 copies of mpox. Dedicated mpox PCR swabs of the neck lesion returned positive. The third neck lesion biopsy showed a superficial and deep dermal/subcutaneous inflammatory infiltrate of lymphocytes, eosinophils, and histiocytes with fibrosis, with intact epidermis and closer magnification revealed a diffuse. Given new DNA and PCR results, retrospective mpox immunostaining was performed, showing focal dot-like positivity at the specimen edge presumably staining follicular epithelium. Wrist biopsy showed an erosion with acute-on-chronic inflammatory dermal infiltrate and positive mpox immunostain with negative Herpes zoster virus 1 (HSV1), Herpes zoster virus 2 (HSV2), and VZV (Varicella zoster virus) immunostains confirming the diagnosis. On unspecified date, the patient was diagnosed with monkeypox breakthrough infection. On unspecified date, the patient stopped treatment with antibiotics and the patient began oral tecovirimat 600 mg twice daily over a five-week period. The patient received a two-injection intralesional cidofovir series over two days as a second agent. The lesion showed improvement one week later. The patient opted to discontinue cidofovir, and the lesion contracted over three months of follow-up. At the time of initial report, the outcome for the events of monkeypox and breakthrough infection was unknown. The reporter did not provide seriousness assessment for the events of monkeypox and breakthrough infection, however the events were assessed as serious due to criteria of medical significance. Causality assessment for the same events was not provided. No further information was provided.; Reporter's Comments: An adult male patient of unspecified age reported as, 50s completed full smallpox vaccination with MVA-BN vaccine for unknown indication. On unspecified date, the patient presented to the emergency department with an asymptomatic neck ulcer. Reportedly, on unspecified date, the patient was diagnosed with the serious event of monkeypox breakthrough infection (medical significance). Monkeypox and breakthrough infection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided, procedure included renal transplantation, and history drug included cyclosporine, mycophenolate mofetil, low-dose prednisone. The outcome was unknown. Considering that MVA-BN vaccine is a non-replicating vaccine which does not contain the monkeypox, causality for both reported events is assessed as not related to MVA-BN vaccine. As with any other vaccine, vaccination with MVA-BN may not result in protection in all cases. The case is serious due to medical significance.; Sender's Comments: An adult male patient of unspecified age reported as, 50s completed full smallpox vaccination with MVA-BN vaccine for unknown indication. On unspecified date, the patient presented to the emergency department with an asymptomatic neck ulcer. Reportedly, on unspecified date, the patient was diagnosed with the serious event of monkeypox breakthrough infection (medical significance). Monkeypox and breakthrough infection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided, procedure included renal transplantation, and history drug included cyclosporine, mycophenolate mofetil, low-dose prednisone. The outcome was unknown. Considering that MVA-BN vaccine is a non-replicating vaccine which does not contain the monkeypox, causality for both reported events is assessed as not related to MVA-BN vaccine. As with any other vaccine, vaccination with MVA-BN may not result in protection in all cases. The case is serious due to medical significance. More
2833441 69 M NV 03/27/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Aggression, Amnesia, Blood sodium decreased, Bradykinesia, Encephalitis; Feeling... Aggression, Amnesia, Blood sodium decreased, Bradykinesia, Encephalitis; Feeling of relaxation, Gait inability, Hallucination, Laboratory test, Speech disorder More
Encephalitis NOS; aggressive; loss of memory; cant walk; Hallucinations; body was slow; inability to... Encephalitis NOS; aggressive; loss of memory; cant walk; Hallucinations; body was slow; inability to talk/ not talking much; Sodium low; calm; This serious case was reported by a consumer via call center representative and described the occurrence of encephalitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes, hypertension and hypercholesterolemia. In NOV-2024, the patient received the 1st dose of Shingrix (right arm). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced encephalitis (Verbatim: Encephalitis NOS) (serious criteria hospitalization and GSK medically significant), aggression (Verbatim: aggressive) (serious criteria hospitalization), memory loss (Verbatim: loss of memory) (serious criteria hospitalization), unable to walk (Verbatim: cant walk) (serious criteria hospitalization), hallucination (Verbatim: Hallucinations) (serious criteria GSK medically significant), movements reduced (Verbatim: body was slow), aphasia (Verbatim: inability to talk/ not talking much), sodium decreased (Verbatim: Sodium low) and relaxed (Verbatim: calm). The outcome of the encephalitis, aggression, memory loss, unable to walk and aphasia were not resolved and the outcome of the hallucination, movements reduced, sodium decreased and relaxed were unknown. It was unknown if the reporter considered the encephalitis, aggression, memory loss, unable to walk, hallucination, movements reduced, aphasia, sodium decreased and relaxed to be related to Shingrix. The company considered the encephalitis, aggression, memory loss, unable to walk, hallucination, movements reduced, aphasia, sodium decreased and relaxed to be unrelated to Shingrix. Additional Information: GSK Receipt Date : 18-MAR-2025 and 19-MAR-2025 Reporter reported that her husband was vaccinated with Shingrix in November 2024 (exact date unknown). Received first dose of Shingrix in his right arm. The consumer received the vaccination at approximately two weeks after vaccination with Shingrix the consumer started hallucinated. The reporter stated the consumer's body was slow, he was calm and not talked much which was abnormal for the consumer. The consumer was taken to the emergency department for evaluation. The consumer was diagnosed as having low sodium and released to home with instructions for high sodium diet. Approximately one month later the consumer became aggressive and he was admitted to the hospital. Date of hospital admission 29 DEC 2024. The reporter stated many tests were performed by the hospital. The consumer remained in the hospital and on 11 February 2025 the consumer was given a diagnosis of Encephalitis. The consumer was released from the hospital on 23rd January 2025 and due to aggression the consumer was readmitted to the hospital on 25 January 2025. The consumer remained hospitalized at the time of the call from the reporter. The reporter stated she was unsure if consumer received any other vaccinations/medication at the time of vaccination with Shingrix.; Sender's Comments: Encephalitis, Aggression, Amnesia, Gait inability, Hallucination , Hypokinesia, Aphasia, Blood sodium decreased and Feeling of relaxation are unlisted events which are considered unrelated to GSK vaccine Shingrix. More
✓
2833442 OH 03/27/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 3D72S
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient was administered diluent for Priorix; patient was administered diluent for Priorix; This non... patient was administered diluent for Priorix; patient was administered diluent for Priorix; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered diluent for Priorix) and inappropriate dose of vaccine administered (Verbatim: patient was administered diluent for Priorix). 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: 10-MAR-2025 The reporter did not know this was which dose of the Priorix vaccine. The patient was administered diluent for Priorix which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The healthcare professional submitted claim and stated diluent for Priorix was broken and then later confirmed only diluent was administered to a patient. This was not related to an existing case. More
2833443 CA 03/27/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation error Product preparation error
patient was given saline diluent only; only received the saline diluent; This non-serious case was r... patient was given saline diluent only; only received the saline diluent; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: patient was given saline diluent only) and inappropriate dose of vaccine administered (Verbatim: only received the saline diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 17-MAR-2025 The reporter reported that patient received only received the saline diluent. The patient received only adjuvant of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2833444 M 03/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspeceted vaccination failure; Shingles; This serious case was reported by a consumer via interacti... Suspeceted 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. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that the reporter husband had shingles, got the vaccine and got them again, terrible pain. 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 (h/o shingles and 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
2833445 03/27/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Malaise, Vaccination failure; Herpes zoster, Malaise, Vaccination... Herpes zoster, Malaise, Vaccination failure; Herpes zoster, Malaise, Vaccination failure More
Suspected Vaccination failure; I got shingles a year after I had the shingles vaccine; second one ma... Suspected Vaccination failure; I got shingles a year after I had the shingles vaccine; second one made the patient ill for 2 months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got shingles a year after I had the shingles vaccine) and unwell (Verbatim: second one made the patient ill for 2 months). The outcome of the vaccination failure and shingles were not reported and the outcome of the unwell was resolved (duration 2 months). It was unknown if the reporter considered the vaccination failure, shingles and unwell to be related to Shingles vaccine. 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 and Shingles vaccine. It was unknown if the company considered the shingles and unwell to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAR-2025 and 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient got shingles a year after he/she had the Shingles vaccine. The patient said yes he/she did and the second one made the patient ill for 2 months. This case was considered as suspected vaccination failure since the details regarding the 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 details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2833446 03/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; still got the Shingles; This serious case was reported by a consumer ... Suspected vaccination failure; still got the Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got the 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: 20-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she got the shingles vaccines and still got the shingles although it was painful and had a mild case with no nerve pain or scarring . This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2833447 M IL 03/27/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 K45H7
Underdose Underdose
accidentally gave him your hepatitis B vaccine, 0 months to 19 years and he needed the 19 years and ... accidentally gave him your hepatitis B vaccine, 0 months to 19 years and he needed the 19 years and up; accidentally gave him your hepatitis B vaccine; 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 64-year-old male patient who received HBV (Engerix B pediatric) (batch number K45H7) for prophylaxis. On 17-MAR-2025, the patient received the 1st dose of Engerix B pediatric. On 17-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: accidentally gave him your hepatitis B vaccine, 0 months to 19 years and he needed the 19 years and up) and accidental underdose (Verbatim: accidentally gave him your hepatitis B vaccine). The outcome of the adult use of a child product and accidental underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-MAR-2025 The certified Medical assistant reported that patient had a 64 years old, male here in the office at the day of reporting and had accidentally gave him hepatitis B vaccine, 0 months to 19 years and he needed the 19 years and up, which led to adult use of a child product and accidental underdose. He came on Friday for something else and just wondering if it was okay to give him the adult hepatitis B vaccination on Friday or had to wait certain amount of time in between mess up and the correction. More
2833448 81 M TX 03/27/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Arthralgia, Joint swelling, Muscular weakness, Myalgia Arthralgia, Joint swelling, Muscular weakness, Myalgia
Pain in knees; Swelling of knees; Muscle pain; swelling of the ankles; weakness in legs; This non-se... Pain in knees; Swelling of knees; Muscle pain; swelling of the ankles; weakness in legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a 81-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included diabetes. On 24-SEP-2024, the patient received Arexvy (intramuscular). On 24-SEP-2024, less than a day after receiving Arexvy, the patient experienced swelling of knees (Verbatim: Swelling of knees), muscle pain (Verbatim: Muscle pain), ankle swelling (Verbatim: swelling of the ankles) and lower extremities weakness of (Verbatim: weakness in legs). On an unknown date, the patient experienced knee pain (Verbatim: Pain in knees). The outcome of the swelling of knees, muscle pain, ankle swelling and lower extremities weakness of were not resolved and the outcome of the knee pain was unknown. It was unknown if the reporter considered the swelling of knees, muscle pain, ankle swelling, lower extremities weakness of and knee pain to be related to Arexvy. It was unknown if the company considered the swelling of knees, muscle pain, ankle swelling, lower extremities weakness of and knee pain to be related to Arexvy. Additional Information: GSK receipt date: 17-MAR-2025 Consumer stated he received an RSV shot in Sept 2024 from Pharmacy. Reporter was unable to verify if he received Arexvy, just stated it was an RSV vaccine. This vaccine was administered in left arm as he recalled. Consumer asked questions in regards to his symptoms for swelling of the knees and ankles, weakness in knees and muscle pain and how long will it last. Consumer stated that he saw in the advertisement on tv that muscle pain and pains all over are side effects of the vaccine. He stated that he had a lot of muscle pain after 6 months of receiving it. He has had a lot of pain in the knees, weakness in knees, and a lot of swelling in the legs. The pain started about 2 days after the injection. He had to use both hands to get up from the chair because of the weakness in his knees. He went to the emergency room about a week or so after receiving the shot and they could not tell him what the problem could be. The pain and swelling were not as bad as the first few days, he still had some swelling in his legs. His doctor prescribed water pills and they didn't helped him much, it helped a little with the swelling. This case is linked with US2023000765 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021090108:same reporter US-GSK-US2023000765:same reporter More
2833449 2 M LA 03/27/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 3RT93
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
2 and a half year old patient received a Kinrix vaccine; This non-serious case was reported by a nur... 2 and a half year old patient received a Kinrix vaccine; 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 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis. Previously administered products included Pediarix (received a dose on 02-MAY-2023). On 10-MAR-2025, the patient received Kinrix. On 10-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 and a half year old patient received a Kinrix vaccine). 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: 18-MAR-2025 The nurse mentioned that a 2 and a half year old patient received a Kinrix vaccine on 10th March 2025 which led to inappropriate age at vaccine administration. The patient got a Vaxelis vaccine on 20th March 2024 and Pediarix on 2nd May 2023. More
2833450 F 03/27/2025 COVID19
 MODERNA
Influenza Influenza
I was a little fluish; This spontaneous case was reported by a patient and describes the occurrence ... I was a little fluish; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (I was a little fluish) in an elderly 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, the patient experienced INFLUENZA (I was a little fluish). At the time of the report, INFLUENZA (I was a little fluish) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient did not experience any reactions, except for the very first dose, she was little fluish. No treatment medications were reported. Reporter did not allow further contact More
2833453 70 F KS 03/27/2025 COVID19
 PFIZER\BIONTECH
 30155BA
Body temperature, COVID-19, Drug ineffective Body temperature, COVID-19, Drug ineffective
got covid; got covid; This is a spontaneous report received from a Consumer or other non HCP. A fem... got covid; got covid; This is a spontaneous report received from a Consumer or other non HCP. A female patient in her 70's received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in right arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 15Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Arth." (ongoing), notes: Onset date: Child, bad in hands, hurts to write. The patient took concomitant medication within 2 weeks prior to the event onset. The patient didn't received other vaccines on the same date as the Pfizer vaccine. Vaccination history included: Flu shot, for immunization, reaction(s): "allergic", "sick/flu". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "got covid".Clinical details: Every covid shot patient received, she got covid. Extremely tired- fever 102 degree - body aches, can't breath properly - headache. The patient refused to get the flu shot & covid -vacs because she got so sick from them. So sick for 3 to 4 days each time. No culture performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500017839 Same patient/Vaccine, different event, different vaccine dose; More
2833454 71 F KS 03/27/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FN19992
FN19992
FN19992
FN19992
Body temperature, COVID-19, Drug ineffective; Cardiomegaly; Body temperature, CO... Body temperature, COVID-19, Drug ineffective; Cardiomegaly; Body temperature, COVID-19, Drug ineffective; Cardiomegaly More
Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick fo... Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time; Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in right arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 15Oct2021 as dose 3, (booster) single (Lot number: 30155BA) and on 26May2022 as dose 4 (booster), single (Lot number: FN19992) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Arth" (ongoing), notes: Onset date: Child; So bad in hands, hurts to write. The patient took concomitant medications. The patient didn't receive any other vaccines on the same date as the Pfizer vaccine. Vaccination history included: Flu shot, for Immunization, reaction(s): "allergic", "Flu/ sick". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Covid/ Extremely tired- fever 102 degree - body aches, can't breath properly - headache/sick for 3 to 4 days each time". The patient underwent the following laboratory tests and procedures: Body temperature: 102, notes: fever 102 degree centigrade. Clinical course: she has had Covid-19 for 4x's, every covid shot she received, she got Covid. Extremely tired, fever 102 degree centigrade, body aches, can't breath properly, headache. She refused to get the flu shot & covid -vaccines because she get so sick from them, she was so sick for 3 to 4 days each time.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500017839 Same patient/Vaccine, different event, different vaccine dose; More
2833455 F KS 03/27/2025 RSV
 UNKNOWN MANUFACTURER
Fatigue Fatigue
got really tired; Is the patient allergic: RSV vac. Got really tired; This is a spontaneous report r... got really tired; Is the patient allergic: RSV vac. Got really tired; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Illness: Arth (arthritis)" (unspecified if ongoing), notes: Onset date: Child. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (I get the flu), for immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "got really tired"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Is the patient allergic: RSV vac. Got really tired". Additional information: The patient got really tired d slept for 2 days. But did not get sick. The information on the batch/lot number for RSV VACCINE PROT.SUBUNIT PREF 2V will be requested and submitted if and when received. More
2833456 F TX 03/27/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective; COVID-1... COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective; COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective More
COVID positive; COVID positive; This is a spontaneous report received from a Consumer or other non H... COVID positive; COVID positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 70-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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2025, outcome "unknown" and all described as "COVID positive". Clinical course: The patient has been having fever then cough for the past 3,4 days Uh, today (24Mar2025), no past 2 days. And today (24Mar2025), patient got tested, and was COVID positive. Last time when patient had COVID, had to admit to the ICU because it went really serious. This time, even though she was fully vaccinated, she was still having a lot of symptoms. Her doctor prescribed Paxlovid. That was the time when COVID first came, and she had only the first shot. So, when the COVID came, right. The first time, so it was two shots, she only got one shot. And before she got her second shot, she got infected. And she had to be in ICU for like a week. And so, she reacted very badly with COVID. Even though she was fully vaccinated, so that's why she wanted to get the medication. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2833457 IL 03/27/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, Vaccination failure COVID-19, SARS-CoV-2 test, Vaccination failure
Covid; Covid; The initial case was missing the following minimum criteria: No adverse effect. Upon r... Covid; Covid; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 01May2024, this case now contains all required information to be considered valid. This is a spontaneous report and received from Consumer or other non HCPs, Program ID. An 89-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immobile" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: During an inbound call for financial assistance, the caller states, "I have COVID and I am supposed to be on this new medication. I'm in assisted living." When advised that the processing information can be provided to the pharmacy over the phone or in person, the caller responds "Well I'm immobile. " At the end of the call, the caller states" Covid has really thrown me for a loop because this is the second time I've had it, and I've had three shots, all Pfizer and it's just that, I don't know I never have any symptoms all I know is that test procedure's great". Patient was treated with Paxlovid. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2833458 NC 03/27/2025 COVID19
 PFIZER\BIONTECH
Pruritus Pruritus
was itching like crazy / Legs, arms, back, feet, hands, etc.; This is a spontaneous report received ... was itching like crazy / Legs, arms, back, feet, hands, etc.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) 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: PRURITUS (non-serious), outcome "unknown", described as "was itching like crazy / Legs, arms, back, feet, hands, etc.". Therapeutic measures were taken as a result of pruritus. Additional information: When patient got the covid shot, patient was itching like crazy and the people came and checked on the patient because the patient couldn't stop itching and they wanted to call the rescue squad. The patient thought it would pass but months later, patient was told that some anti itching cream would be sent to the patient but never sent anything. Patient had to buy 4% lidocaine spray and cream and put it on when the patient wake up and during and at night before going to bed. It was horrible. Legs, arms, back, feet, hands, etc. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2833459 18 F NY 03/27/2025 FLUX
 UNKNOWN MANUFACTURER
No adverse event, Wrong product administered No adverse event, Wrong product administered
use of Tubersol instead of the intended flu vaccine with no reported adverse event; Initial informat... use of Tubersol instead of the intended flu vaccine with no reported adverse event; Initial information received on 24-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old female patient who experienced inappropriate use of Tubersol [Tuberculin test] instead of the intended flu vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Mar-2025, the patient received an 0.5 ml dose of tuberculin test [tubersol], Solution for injection 0.5 for Immunisation was exposed to tubersol instead of the intended flu vaccine via intramuscular route in the left deltoid for tuberculin skin test (tuberculin test) (wrong product administered) (latency: same day) (lot number:3CA48C1, unknown strength, expiry date:31-OCT-2031) List concomitant or no other vaccines no other vaccines. Reportedly, Nurse at a walk-in clinic at college called regarding TUBERSOL that was incorrectly administered. Should have administered 0.1 ml intradermal and instead was delivered at 0.5 intramuscular. 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
2833460 11 M MI 03/27/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 L5229
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling More
Patient was given a tdap and covid vaccine in the left arm on 3/21/2025. Mom called 3/22/2025 and sp... Patient was given a tdap and covid vaccine in the left arm on 3/21/2025. Mom called 3/22/2025 and spoke to a nurse on our triage team. She reported patient had swelling in his left with redness the size of a softball and bruising size of popcorn. She stated he was complaining of area being itchy, there was no fever and no other signs of illness. Nurse routed this to provider on call and mom was notified of providers advise " if this is concerning to family, they can go to ER tonight or doctor in the morning. If they have not tried ice and NSAIDS I would advise they try this" Mom was notified of this and verbalized understanding, stated they will try ice and NSAIDS and if no improvement by next day they would go in and be seen. More
2833461 8 F IN 03/27/2025 HPV9
IPV
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Y012865
X1D141M
9YB4G
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
During a subsequent vaccine appointment the mother pointed out that the child's date of birth w... During a subsequent vaccine appointment the mother pointed out that the child's date of birth was incorrect, thereby deeming the child eight years old not nine. There were not reported adverse effects reported by mother at this time from the dose of HPV the child received on 2/24/2025. More
2833462 50 F MN 03/27/2025 HEP
VARZOS
 DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
EK255
Chills, Pain, Pyrexia; Chills, Pain, Pyrexia Chills, Pain, Pyrexia; Chills, Pain, Pyrexia
Fever, chills, body aches 24 hours after administration. Patient took over the counter pain medicat... Fever, chills, body aches 24 hours after administration. Patient took over the counter pain medications to help with symptoms and got some rest. After 48 hours after administration, the symptoms were greatly improved More
2833463 33 M IN 03/27/2025 COVID19
FLU3
HEP
HEPA
HPV9
IPV
TDAP
UNK
VARCEL
 MODERNA
SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
MERCK & CO. INC.
 8081260
u8524ca
944920
4t93r
y010466
x1c891m
333sk
x027903
y011018
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
High-Dose Flu administered to an out of age range patient High-Dose Flu administered to an out of age range patient
2833464 64 F GA 03/27/2025 FLU3
 SEQIRUS, INC.
Extra dose administered Extra dose administered
Patient received 2 flu vaccines in (2024-2025) flu season Patient received 2 flu vaccines in (2024-2025) flu season
2833465 30 M IN 03/27/2025 COVID19
FLU3
HEP
HEPA
HPV9
IPV
MMR
TDAP
VARCEL
 MODERNA
SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 8081260
u8524CA
944920
t93r
y010466
x1c891m
x027903
333sk
y011018
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
High Dose Flu Vaccine administered to an out of age range patient. High Dose Flu Vaccine administered to an out of age range patient.
2833466 12 F WY 03/27/2025 DTAP
HPV9
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.

Injection site erythema, Injection site pain, Injection site swelling; Injection... Injection site erythema, Injection site pain, Injection site swelling; Injection site erythema, Injection site pain, Injection site swelling More
L thigh has an area of redness and slight swelling about 2" diameter surrounding injection site... L thigh has an area of redness and slight swelling about 2" diameter surrounding injection site - seen by myself, the school nurse, on 3/24/25. Tells me that it is painful. I call Mom and encourage her to call the doctor's office who administered the vaccine. On 3/26/25, Mom tells me via phone that she thinks the redness and swelling are abating. More
2833467 2 M TX 03/27/2025 COVID19
 PFIZER\BIONTECH
 LN6739
Expired product administered Expired product administered
expired NS 0.9% diluent given with vaccine expired NS 0.9% diluent given with vaccine
2833468 4 F TN 03/27/2025 PNC15
 MERCK & CO. INC.
 y010035
Injection site erythema, Injection site inflammation, Injection site pruritus, I... Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth More
PT MOTHER STATES "REDNESS/ INFLAMMATION/ WARM AND ITCHING AT THE SITE OF INJECTION" PT MOTHER STATES "REDNESS/ INFLAMMATION/ WARM AND ITCHING AT THE SITE OF INJECTION"
2833469 5 F PA 03/27/2025 ADEN_4_7
 TEVA PHARMACEUTICALS
 U8209CB
Erythema, Peripheral swelling, Skin warm, Tenderness Erythema, Peripheral swelling, Skin warm, Tenderness
Parent called- patient received vaccine on 3/25/25. Arm swollen, red, hot to touch, tender to touch,... Parent called- patient received vaccine on 3/25/25. Arm swollen, red, hot to touch, tender to touch, started with symptoms on 3/26/25. Follow up visit scheduled for 3/27/25. More
2833470 23 F NY 03/27/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 L5229
Dizziness, Dyskinesia, Loss of consciousness, Seizure like phenomena Dizziness, Dyskinesia, Loss of consciousness, Seizure like phenomena
2 minutes after administering the vaccine, patient said she was feeling dizzy and passed out. Had lo... 2 minutes after administering the vaccine, patient said she was feeling dizzy and passed out. Had loss of consciousness with bilateral upper and lower extremity jerky/seizure like movements lasted for 20 seconds and recovered without any intervention. More
2833471 4 M PA 03/27/2025 DTAPIPV
 SANOFI PASTEUR
 U8209CB
Erythema, Pain, Peripheral swelling Erythema, Pain, Peripheral swelling
Parent calling- patient seen in ER due to reaction from Quadracel vaccine administered on 3/24/25. R... Parent calling- patient seen in ER due to reaction from Quadracel vaccine administered on 3/24/25. Right upper arm swelling, redness and pain. Follow up guidelines provided. More
2833472 44 F MO 03/27/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 LN0591
946623
Arthralgia; Arthralgia Arthralgia; Arthralgia
Patient reported experiencing a shoulder pain after receiving the vaccines Patient reported experiencing a shoulder pain after receiving the vaccines
2833473 17 F PA 03/27/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945658
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Heplisav-B accidently given to 17year old patient. Manufacturer indications list vaccine recommended... Heplisav-B accidently given to 17year old patient. Manufacturer indications list vaccine recommended to patients 18 years and older More
2833474 21 M IN 03/27/2025 TDAP
 SANOFI PASTEUR
 U8264AA
Erythema, Induration, Injection site erythema, Skin warm Erythema, Induration, Injection site erythema, Skin warm
Erythema noted on rt deltoid, rt axillary region and rt side of neck. Area on arm warm to touch and ... Erythema noted on rt deltoid, rt axillary region and rt side of neck. Area on arm warm to touch and firm. Pt states he noticed redness the day after his injection. More
2833475 47 F KY 03/27/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 42b22
Underdose Underdose
ADULT PATIENT WAS GIVEN PEDIATRIC DOSE OF 0.5. Patient notified to return to clinic to recevie adddi... ADULT PATIENT WAS GIVEN PEDIATRIC DOSE OF 0.5. Patient notified to return to clinic to recevie addditional 0.5ml today or 1 ml dose if after 3.27.25 More
2833476 50 F OH 03/27/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 Ln4927
Kj3n3
Product preparation issue; Product preparation issue Product preparation issue; Product preparation issue
RN accidentally gave only diluent with no vaccine. Pt will need to be given the vaccine. RN accidentally gave only diluent with no vaccine. Pt will need to be given the vaccine.
2833477 17 F SC 03/27/2025 HIBV
 MERCK & CO. INC.
 X017448
Wrong product administered Wrong product administered
There was not an adverse event. This is reported as a vaccine administration error. The patient was ... There was not an adverse event. This is reported as a vaccine administration error. The patient was due to receive her Men-B vaccine but was administered the Hib vaccine in error. More
2833478 1.25 F TX 03/27/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 LN6739
LN8272
Expired product administered; Expired product administered Expired product administered; Expired product administered
expired 0.9% NS diluent used for admin expired 0.9% NS diluent used for admin
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