๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2831285 41 F 03/13/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Twinrix late second dose; This non-serious case was reported by a consumer via call center represent... Twinrix late second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 41-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose of vaccine on an unknown date). On 10-MAR-2025, the patient received the 2nd dose of Twinrix. On 10-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). 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 : 10-MAR-2025 The patient self-reported this case for himself/herself A patient reported that she had Twinrix later than she was supposed to because she did not get a notification from her facility at the time that it should be administered, which led to drug dose administration interval too long. More
2831286 16 M MN 03/13/2025 COVID19
 MODERNA
 8080748
Type 1 diabetes mellitus Type 1 diabetes mellitus
Trigger type 1 diabetes; This spontaneous case was reported by a non-health professional and describ... Trigger type 1 diabetes; This spontaneous case was reported by a non-health professional and describes the occurrence of TYPE 1 DIABETES MELLITUS (Trigger type 1 diabetes) in a 16-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080748) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 50 microgram. On 07-Jan-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced TYPE 1 DIABETES MELLITUS (Trigger type 1 diabetes) (seriousness criterion medically significant). At the time of the report, TYPE 1 DIABETES MELLITUS (Trigger type 1 diabetes) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report. More
2831287 F 03/13/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Vaccination site pain; Vaccination site pain Vaccination site pain; Vaccination site pain
has been experiencing injection site soreness for 7 months; This spontaneous case was reported by a ... has been experiencing injection site soreness for 7 months; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (has been experiencing injection site soreness for 7 months) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. On 18-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 18-Sep-2024, the patient experienced VACCINATION SITE PAIN (has been experiencing injection site soreness for 7 months). At the time of the report, VACCINATION SITE PAIN (has been experiencing injection site soreness for 7 months) had not resolved. No concomitant medication was reported. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-783153 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783153:Invalid case multiple patients having similar events More
2831288 M 03/13/2025 FLUX
PNC20
 UNKNOWN MANUFACTURER
PFIZER\WYETH

Myalgia; Myalgia Myalgia; Myalgia
Muscle back pain; This is a spontaneous report received from a Consumer or other non HCP from medica... Muscle back pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 63-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single). The patient's relevant medical history included: "Pneumonia" (unspecified if ongoing), notes: 2 or 3 weeks before getting Prevnar 20. The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Muscle back pain". Therapeutic measures were taken as a result of back pain. Additional information: The caller mentioned he received Prevnar 20 and got the vaccine two or might be three weeks after he had pneumonia. Stated that after two days he had muscle back pain and mentioned he had also received a flu shot. He thought that the influenza vaccine was not related to his symptoms because he had the same vaccine last year without adverse event. The back pain goes up and down has taken advil and Tylenol for 3 weeks. Caller would like to know if this pain was normal. The caller wants to know how long the back pain would last. The speaker would like to know what medications to take to relieve back pain. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2831289 M OH 03/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID again; COVID again; This is a spontaneous report received from a Consumer or other non HCP, Pr... COVID again; COVID again; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 71-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "medical conditions" (ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Paxlovid for COVID-19 treatment. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunization; Comirnaty (DOSE 2), for COVID-19 immunization; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID again". The clinical course was reported as follows: An elder patient with medical conditions mentioned, had been getting the Pfizer COVID vaccinations every year since they were released. The patient had COVID previously, despite the vaccine. The patient reported had COVID again and was prescribed nirmatrelvir/ritonavir. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2831290 82 M WI 03/13/2025 RSV
 PFIZER\WYETH
Fatigue, Rash Fatigue, Rash
broken out in such a rash on stomach, back and arms; tired; looked like a picture of shingles; This ... broken out in such a rash on stomach, back and arms; tired; looked like a picture of shingles; This is a spontaneous report received from a Consumer or other non HCP. An 82-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 14Jan2025 as dose number unknown, single at the age of 82 years for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 20Jan2025 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 18Jan2025, outcome "not recovered", described as "broken out in such a rash on stomach, back and arms"; HERPES ZOSTER (non-serious) with onset 2025, outcome "unknown", described as "looked like a picture of shingles"; FATIGUE (non-serious) with onset 2025, outcome "unknown", described as "tired". The events "broken out in such a rash on stomach, back and arms" required physician office visit. Therapeutic measures were taken as a result of rash. Additional information: rash was just getting worse. It had been a long time and couldn't figure out. It was really bad. The patient went to the doctor and was given 2 pills and some triamcinolone acetonide ointment, nothing helped. Couldn't figure out what was different and this was the only thing and someone said maybe it was the shot and he was tired, so tired and he was sleeping. It looked like a picture of shingles but it was all over his body like that and clarified it was his back and his stomach and his arms. More
2831291 F MD 03/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Disease recurrence, Influenza virus test, SARS-CoV-2 test, Vaccination... COVID-19, Disease recurrence, Influenza virus test, SARS-CoV-2 test, Vaccination failure More
came back positive for COVID/started with the symptoms; Last year (2024) the patient had COVID/came ... came back positive for COVID/started with the symptoms; Last year (2024) the patient had COVID/came back positive for COVID; Last year (2024) the patient had COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 77-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 was not reported. Concomitant medication(s) included: ROSUVASTATIN (ongoing); FOSAMAX (ongoing). Vaccination history included: Bnt162b2 (PRIMARY IMMUNIZATION SERIES COMPLETED), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, BOOSTER, SINGLE), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 2024, outcome "unknown", described as "Last year (2024) the patient had COVID"; VACCINATION FAILURE (medically significant) with onset 2024, outcome "not recovered", described as "Last year (2024) the patient had COVID/came back positive for COVID"; DISEASE RECURRENCE (medically significant) with onset 10Mar2025, outcome "not recovered", described as "came back positive for COVID/started with the symptoms". The events "last year (2024) the patient had covid/came back positive for covid", "last year (2024) the patient had covid" and "came back positive for covid/started with the symptoms" required physician office visit. The patient underwent the following laboratory tests and procedures: Influenza virus test: Unknown results; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (last year) with Paxlovid. Clinical course: Last year (2024) the patient had COVID, they prescribed Paxlovid. The patient went to doctor today (11Mar2025) for a pre-op because she has another surgery on the 27th of this month, and patient was not feeling well, the patient took flu test and COVID test, came back positive for COVID. The patient's doctor called the pharmacy immediately and sent the prescription. The patient said this was the second time having been taking Paxlovid (not started yet). The patient started with the symptoms yesterday (10Mar2025). The patient had all vaccines through Pfizer. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2831292 03/13/2025 PNC20
 PFIZER\WYETH
Asthma, Drug ineffective, Hypersensitivity, Pneumonia Asthma, Drug ineffective, Hypersensitivity, Pneumonia
was hospitalized with Pneumonia; was hospitalized with Pneumonia; bad asthma; allergies; This is a s... was hospitalized with Pneumonia; was hospitalized with Pneumonia; bad asthma; allergies; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2020 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Pneumonia", start date: 2020 (unspecified if ongoing); "a virus", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), PNEUMONIA (hospitalization, medically significant) all with onset May2024, outcome "unknown" and all described as "was hospitalized with Pneumonia"; ASTHMA (non-serious), outcome "not recovered", described as "bad asthma"; HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "allergies". The patient was hospitalized for drug ineffective, pneumonia (start date: May2024). Therapeutic measures were taken as a result of asthma. Clinical course: Patient received Prevnar 20 in 2020 and second part 2021 and was hospitalized with pneumonia in 2024. Doctor recommended patient to get Capvaxive but it was not covered by medical insurance (withheld). It was confirmed that patient has not yet received Capvaxive and "it's thousands of dollars". Patient has bad asthma and takes Advair, patient has allergies. Patient has a need, they were in the hospital last May2024 with pneumonia. Patient tried to get the vaccine last year but once you get Prevnar 20, don't get it again. 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-202500054706 same patient and product, different dose and event; More
โœ“
2831293 MI 03/13/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

COVID-19, Drug ineffective; COVID-19, Drug ineffective COVID-19, Drug ineffective; COVID-19, Drug ineffective
got COVID/ I had three of your vaccinations, Pfizer's vaccinations; got COVID/ I had three of y... got COVID/ I had three of your vaccinations, Pfizer's vaccinations; got COVID/ I had three of your vaccinations, Pfizer's vaccinations; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 66-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pain management" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID/ I had three of your vaccinations, Pfizer's vaccinations". The patient had three Pfizer's vaccinations. When they were asked to confirm that they had received Pfizer vaccinations, the patient stated, "Yep, long time ago, when COVID was [inaudible]." After providing their provider information, the caller stated, ". He's my primary doctor, and then I have a pain management doctor; he's the one that prescribed the medication for me." More
2831294 M 03/13/2025 MEN
 UNKNOWN MANUFACTURER
Loss of consciousness, Seizure Loss of consciousness, Seizure
Passed out 3 separate times; 3 separate seizures 2 years ago after receiving meningococcal booster; ... Passed out 3 separate times; 3 separate seizures 2 years ago after receiving meningococcal booster; Initial information received on 09-Mar-2025 regarding an unsolicited valid serious case received from an unknown reporter. This case involves Child male patient who passed out 3 separate times and 3 separate seizures 2 years ago after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). On an unknown date the patient passed out 3 separate times (loss of consciousness) and 3 separate seizures (seizure) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine. Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events. Seriousness criteria: Both the events were assessed as medically significant.; Sender's Comments: Sanofi company comment dated 12-mar-2025: This case involves Child male patient who passed out 3 separate times and 3 separate seizures 2 years ago after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed More
2831295 0.5 CO 03/13/2025 FLU3
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
administration of the second dose of FLUZONE NP one week earlier than the minimum interval, with no ... administration of the second dose of FLUZONE NP one week earlier than the minimum interval, with no reported advrse event; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a Other health professional. This case involves, a 6 months old and unknown gender patient who had administration of the second dose of Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] one week earlier than the minimum interval, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jan-2025, the patient received (dose 1) and on 31-Jan-2025, (dose 2) of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine (unknown strength, dosage, expiry date, formulation, batch number and route) via unknown administration site for prophylactic vaccination was administration of the second dose of fluzone np one week earlier than the minimum interval, with no reported adverse event (inappropriate schedule of product administration) (latency-22 days). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly, Medical assistant wanted to know if the patient was going to be okay and if they need an additional dose if the second dose was one week too early. They also asked what to do if the patient was not able to receive the second dose of FLUZONE NP four weeks from the invalid dose.They said that they still have patients to attend to and disconnected from the call. 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
2831296 1 F MS 03/13/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UJ973AA
Expired product administered, No adverse event Expired product administered, No adverse event
expired PENTACEL administered, with no reported adverse event; Initial information received on 12-Ma... expired PENTACEL administered, with no reported adverse event; Initial information received on 12-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 year old female patient who had expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] administered, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine for Immunization. On 11-Mar-2025, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UJ973AA , Frequency : Once, Expiry date : 12-Feb-2025 (Expired product administered) via intramuscular route in the right thigh for Immunization with no reported adverse event (latency : same day) (strength was unknown). 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
2831297 NY 03/13/2025 IPV
 SANOFI PASTEUR
 W1C751M
Expired product administered, No adverse event Expired product administered, No adverse event
Open ipol was administered post excursion with no reported adverse event; Initial information receiv... Open ipol was administered post excursion with no reported adverse event; Initial information received on 12-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who had open IPV (VERO) [IMOVAX POLIO] was administered post excursion 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 an unknown date, the patient received a unknown dose of suspect IPV (VERO) (suspension for injection) lot W1C751M, Expiry date: 18-Nov-2025, strength was unknown via unknown route in unknown administration site for Immunization of open ipol was administered post excursion with no reported adverse event (poor quality product administered) (latency: same day). Reportedly "Reason: power outage Max/low temperature reached: max temp of 63.3๏ฟฝF (17.39๏ฟฝC)Duration: 12 hours and 25 mins. Previous Excursion? NONE. Human error? NO.Does extended stability data cover the excursion? The UNOPEN products are supported by the extended stability information post excursion but the punctured IPOL is not. " 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
2831329 M TN 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Myelitis transverse Myelitis transverse
Transverse Myelitis; This serious case was reported by a physician via sales rep and described the o... Transverse Myelitis; This serious case was reported by a physician via sales rep and described the occurrence of myelitis transverse in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced myelitis transverse (Verbatim: Transverse Myelitis) (serious criteria GSK medically significant). The outcome of the myelitis transverse was resolved. The reporter considered the myelitis transverse to be possibly related to Shingrix. The company considered the myelitis transverse to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 07-MAR-2025 Patient had been vaccinated with Shingrix dose 1. A few days after the vaccination the patient went to the emergency room and had developed Transverse Myelitis. The patient was treated and managed by neurology and with physical therapy the patient recovered. The hospital physicians had no other causes and believed the vaccine might have caused the issue. The patient later refused to get the 2nd dose but has fully recovered.; Sender's Comments: Myelitis transverse is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2831330 F 03/13/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
second dose after a year; This non-serious case was reported by a consumer via interactive digital m... second dose after a year; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a 3-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received first dose of Bexsero at 7 months). On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: second dose after a year). 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: 05-MAR-2025 The case was received from the patient via (Bexsero GSK Chatbot) interactive digital media. The reporter had a patient who received first dose of Bexsero at 7 months and the second dose after a year. At the time of reporting the patient had 3 years and 10 months. The reporter asked was she safe, should she get another dose. The patient received second dose of Bexsero longer than the recommended interval which led to lengthening of vaccination schedule. More
2831331 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
suspected vaccination failure/ vaccine did not work; shingles 3 times; This serious case was reporte... suspected vaccination failure/ vaccine did not work; shingles 3 times; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/ vaccine did not work) (serious criteria GSK medically significant) and shingles (Verbatim: shingles 3 times). The outcome of the vaccination failure and shingles were resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 29-JAN-2025 The patient had shingles 3 times unfortunately the vaccine did not work. The patient had indescribable pain from shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix . More
2831332 61 F MD 03/13/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 A2J35
Product preparation issue Product preparation issue
administered only the sterile water for injection component of the Priorix vaccine; administered onl... administered only the sterile water for injection component of the Priorix vaccine; administered only the sterile water for injection component of the Priorix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old female patient who received MMR (Priorix) (batch number A2J35, expiry date 01-SEP-2025) for prophylaxis. On 02-MAR-2025, the patient received Priorix. On 02-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: administered only the sterile water for injection component of the Priorix vaccine) and inappropriate dose of vaccine administered (Verbatim: administered only the sterile water for injection component of the Priorix vaccine). 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 : 03-MAR-2025 Pharmacy manager reported that two patients were administered only the sterile water for injection component of the Priorix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2025026207, reported by same reporter different patient.; Sender's Comments: US-GSK-US2025026207:Same reporter/Diffrent patient More
2831333 F NH 03/13/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and... Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 49-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 16th May 2024). On 04-MAR-2025, the patient received the 2nd dose of Twinrix. On 04-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). 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:04-MAR-2025 Pharmacist called to verify when the 3rd dose of Twinrix could be administered. The reporter did not consent to follow-up. No lot number nor expiry date were available. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. More
2831334 FL 03/13/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Antibody test; Antibody test Antibody test; Antibody test
No titers; This non-serious case was reported by a other health professional via call center represe... No titers; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced therapy non-responder (Verbatim: No titers). The outcome of the therapy non-responder was not applicable. Additional Information: GSK Receipt Date: 06-MAR-2025 The Shingrix information for a patient vaccinated with Shingrix, two doses, and showed no titers on a standard lab test 1 year later. The reporter asked was there a specific lab test to show immunity for Shingrix. The Vaccine Administration Facility was the same as Primary Reporter. More
2831335 F CT 03/13/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
Contracted COVID; contracted COVID; This is a spontaneous report and received from Consumer or other... Contracted COVID; contracted COVID; This is a spontaneous report and received from Consumer or other non HCPs, Program ID. An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "trouble hearing" (unspecified if ongoing); "my ears are all sort of plugged up" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Contracted COVID"; COVID-19 (medically significant), outcome "not recovered", described as "contracted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: have COVID, notes: she tested me and discovered I do, in fact, have COVID. The patient just contracted COVID for the first time her life. The patient got all the Pfizer vaccines but had come down with it, shockingly. The patient went to an urgent care office here and the patient was tested and discovered the patient had COVID, and was prescribed then sent the prescription in for the PAXLOVID 5-day regimen. More
2831336 77 M OR 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 33473
Guillain-Barre syndrome, Mobility decreased Guillain-Barre syndrome, Mobility decreased
patient woke up unable to move in hospital for 5 days and diagnosed with guillan-barre syndrome patient woke up unable to move in hospital for 5 days and diagnosed with guillan-barre syndrome
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2831337 16 M TX 03/13/2025 IPV
 SANOFI PASTEUR
No adverse event, Wrong product administered No adverse event, Wrong product administered
vaccine was confused for another vaccine , Pt had no symtems to vaccine give. vaccine was confused for another vaccine , Pt had no symtems to vaccine give.
2831338 80 F GA 03/13/2025 PNC21
 MERCK & CO. INC.
 Y019158
Fatigue, Injection site swelling Fatigue, Injection site swelling
PATIENT SAID HER LEFT ARM WAS SWOLLEN AROUND INJECTION SITE AND PATIENT FELT TIRED/FATIGUE FOR THE N... PATIENT SAID HER LEFT ARM WAS SWOLLEN AROUND INJECTION SITE AND PATIENT FELT TIRED/FATIGUE FOR THE NEXT 2 DAYS. More
2831339 50 F NM 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 H97H2
Fatigue, Injection site erythema, Injection site pain, Nausea, Pyrexia Fatigue, Injection site erythema, Injection site pain, Nausea, Pyrexia
Patient reported redness at the injection site and severe pain, nausea, fever, fatigue. Patient reported redness at the injection site and severe pain, nausea, fever, fatigue.
2831340 55 F 03/13/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 AK334
Dyspnoea, Pain, Pain in extremity, Pyrexia Dyspnoea, Pain, Pain in extremity, Pyrexia
patient came by today and said she was in hospital for shortness of breath, fever, body aches, arm p... patient came by today and said she was in hospital for shortness of breath, fever, body aches, arm pain. says the dr told her not to take the Boostrix vaccine again. he gave her steroid and cetirizine More
2831362 65 F CA 03/13/2025 PNC20
 PFIZER\WYETH
 LC5485
Rash Rash
Localized rash on upper deltoid. Localized rash on upper deltoid.
2831363 17 F MI 03/13/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
PFIZER\WYETH
SANOFI PASTEUR
 Y010656
HP9988
U8351CA
Erythema of eyelid, Eyelids pruritus; Erythema of eyelid, Eyelids pruritus; Eryt... Erythema of eyelid, Eyelids pruritus; Erythema of eyelid, Eyelids pruritus; Erythema of eyelid, Eyelids pruritus More
Patient had itching of eyelids and redness of upper eyelids yesterday. She is better today.Mother g... Patient had itching of eyelids and redness of upper eyelids yesterday. She is better today.Mother gave her Motrin yesterday. She does not have any systemic symptoms like cough , wheezing, abdominal discomfort or vomiting More
2831364 71 F IN 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93KK4
Laboratory test normal, Mobility decreased, Pain in extremity Laboratory test normal, Mobility decreased, Pain in extremity
Patient experienced extreme pain in her arm to a point where she could not move it. No redness or st... Patient experienced extreme pain in her arm to a point where she could not move it. No redness or streaks on arm. Patient went to the emergency room because she experienced so much pain. More
2831365 77 F NM 03/13/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Arthralgia, Chills, Diarrhoea, Fatigue, Headache; Myalgia, Pain, Pyrexia, Somnol... Arthralgia, Chills, Diarrhoea, Fatigue, Headache; Myalgia, Pain, Pyrexia, Somnolence More
Feverish, severe chills, moderate headache, severe joint pain, severe muscle and body aches, severe... Feverish, severe chills, moderate headache, severe joint pain, severe muscle and body aches, severe fatigue and tiredness, moderate diarrhea, severe sleepiness. Approx 7 days. More
2831366 67 F AZ 03/13/2025 COVID19
 PFIZER\BIONTECH
 lm7786
Bell's palsy, Discomfort, Eyelid disorder, Facial paralysis Bell's palsy, Discomfort, Eyelid disorder, Facial paralysis
bells palsy. left sided facial paralysis, eye irritation and discomfort due to inability to blink. ... bells palsy. left sided facial paralysis, eye irritation and discomfort due to inability to blink. md prescribed valtrex, erythromycin opthlamic ointment, and medrol dose pack. More
2831367 31 F ME 03/13/2025 COVID19
 MODERNA
Asthenia, Confusional state, Decreased interest, Hypersomnia Asthenia, Confusional state, Decreased interest, Hypersomnia
Sleeping 18 hrs a day for a month, no interest, week, confused Sleeping 18 hrs a day for a month, no interest, week, confused
2831368 55 F 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 KB2YT
Dysgeusia Dysgeusia
Pt got a metallic taste in her mouth. Pt was given a bottle of water. Pt left before resolution of a... Pt got a metallic taste in her mouth. Pt was given a bottle of water. Pt left before resolution of adverse taste More
2831369 65 F TX 03/13/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 g97y
g97y
Myalgia, Pain in extremity; Injection site pain; Myalgia, Pain in extremity; Inj... Myalgia, Pain in extremity; Injection site pain; Myalgia, Pain in extremity; Injection site pain More
sore arm, painful, muscle ache lasting for 2 weeks sore arm, painful, muscle ache lasting for 2 weeks
2831370 47 M CO 03/13/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 XN575
Injected limb mobility decreased, Muscular weakness Injected limb mobility decreased, Muscular weakness
pt presents in march, the 13th, complaining of weakness in his left shoulder. he cant raise his arm... pt presents in march, the 13th, complaining of weakness in his left shoulder. he cant raise his arm above his head. he is not ill, does not have redness, swelling, or pain in the shoulder. about 2-3-5 days after the injection the shoulder started to become weak and is still weak 1 month later. on physical exam, he has paralysis/weakness of supraspinatus and infraspinatus muscles. trapezius, deltoid, and subscapularis muscles all seem to be working fine. he does not remember any "pain" that proceeded this issue. he did not suffer any injury or accident. he is not playing any sports or using any ladders, nothing he can think of, other than the vaccine, that could have caused this. More
2831371 28 M CA 03/13/2025 FLU3
FLU3
FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
 946615
946615
946615
946615
Erythema, Hyperhidrosis, Palpitations; Chest discomfort, Erythema, Hyperhidrosis... Erythema, Hyperhidrosis, Palpitations; Chest discomfort, Erythema, Hyperhidrosis, Palpitations; Erythema, Hyperhidrosis, Palpitations; Chest discomfort, Erythema, Hyperhidrosis, Palpitations More
Patient started experiencing heart palpitations, redness of face, sweating and rash after being giv... Patient started experiencing heart palpitations, redness of face, sweating and rash after being given the flu vaccination. The adverse reaction lasted over 45 minute and had to call emergency service. He later said he always have a reaction when he receives vaccinations. More
2831372 85 M SC 03/13/2025 PNC20
 PFIZER\WYETH
 LJ5280
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adverse events noted. Patient received a Prevnar 20 dose in 2022 that was not reported to facilit... No adverse events noted. Patient received a Prevnar 20 dose in 2022 that was not reported to facility. This is the patient's second dose of Prevnar 20 More
2831373 71 F GA 03/13/2025 PNC20
 PFIZER\WYETH
 lj5281
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received Prevnar 20 on 06/30/2023 so did not need to receive the dose on 03/12/2025. The st... Patient received Prevnar 20 on 06/30/2023 so did not need to receive the dose on 03/12/2025. The state registry did not pick it up because patient had the vaccine given in another state. The advisor tool PneumoRecs Vax Advisor recommended the vaccine because the patient stated she had never had Prevnar 20. The patient did not remember receiving vaccine in 2023. She stated today 3/13/2025 that she feels fine and has not had any reactions. More
2831374 16 M NV 03/13/2025 MENB
MENB
MNQ
MNQ
 PFIZER\WYETH
PFIZER\WYETH
SANOFI PASTEUR
SANOFI PASTEUR
 LF5303
LF5303
U8194AA
U8194AA
Anxiety, Dizziness, Loss of consciousness, Mydriasis, Pallor; Seizure, Somnolenc... Anxiety, Dizziness, Loss of consciousness, Mydriasis, Pallor; Seizure, Somnolence, Unresponsive to stimuli, Vision blurred; Anxiety, Dizziness, Loss of consciousness, Mydriasis, Pallor; Seizure, Somnolence, Unresponsive to stimuli, Vision blurred More
Patient left the office in stable and normal state. After the vaccination, he walked out of the offi... Patient left the office in stable and normal state. After the vaccination, he walked out of the office with Mom. Few seconds later, Mom comes back to the front desk, saying, "something happened to my son". MA rushed to the parking lot with Mom. I also followed quickly. We found him in their car, sitting down. Mom said, as soon as he sat down in the car, he just suddenly started with mild convulsive movements for few seconds then passed out. He awoke after few seconds. When I arrived at the scene, he was awake, but slightly closing his eyes, sleepy, but responsive. He was looking pale and diaphoretic. He was responsive to my questions. He looked very anxious. His pulse was low at 55. He said he felt dizzy. I reclined the seat. After 45-60 seconds , we brought the O2 tank out into the car and started him on 3 LPM of 100% O2, because of persistent paleness and sleepiness. Despite the O2, he was still looking pale and complained that his vision was blurry and couldn't see a thing. His pupils were dilated. The car was exposed to the sun and his face was in the sun, so I asked the Mom to move the car closer to the office door. The distance was about 200 feet. O2 was continued for another minute. He was still looking pale and still sleepy, but awake. 911 was dialed by Mom approximately about 4-5 minutes from the time of his syncope. His vision returned and started to look pinkish. By the time EMS arrived , his vision was back and his color and alertness have improved. EMS took over and I left the scene. He was checked and was sent home in their car. He was not brought to ER. He seemed to have a vaso-vagal syncope and a slightly prolonged post-syncopal state. The triggering factor was vaccination. More
2831375 55 F 03/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7zm55
Blister, Rash, Rash erythematous Blister, Rash, Rash erythematous
Pt reported severe red bumps and blisters around entire neck. Pt reported severe red bumps and blisters around entire neck.
2831376 55 M 03/13/2025 PNC20
 PFIZER\WYETH
 LK6650
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received an additional Prevnar 20 vaccine - he received the first one on 9/12/24 and second ... Patient received an additional Prevnar 20 vaccine - he received the first one on 9/12/24 and second 3/11/25 - patient reports no adverse reactions at this time More
2831377 0.33 F MD 03/13/2025 HIBV
 MERCK & CO. INC.
 Y006392
Injection site discolouration, Injection site induration, Injection site swellin... Injection site discolouration, Injection site induration, Injection site swelling, Injection site warmth More
On the evening of the vaccine pt developed significant swelling in rt thigh, spoke to doctor at our ... On the evening of the vaccine pt developed significant swelling in rt thigh, spoke to doctor at our after hours location who recommended cool compresses and tylenol "if bad", they used compresses but no tylenol given. 10 days later there is still significant induration of 5cm in length by 2 cm at distal end and 2.5 cm at superior part, sl warmth, no fluctuant areas, overlying area of induration looks bruised, family thought it was tender but baby did not seem bothered with my palpation of area. FROM in bilat LE. More
2831378 50 F MN 03/13/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FA7485
FA7485
FA7485
FA7485
FA7485
EY0584
EY0584
EY0584
EY0584
EY0584
Biopsy bone marrow, Biopsy skin abnormal, Blood test, Chromosomal analysis, Comp... Biopsy bone marrow, Biopsy skin abnormal, Blood test, Chromosomal analysis, Computerised tomogram; Cutaneous T-cell lymphoma, Differential white blood cell count, Flow cytometry, Fluorescent in situ hybridisation, Full blood count; Inflammation, Laboratory test abnormal, Metabolic function test, Metastatic lymphoma, Pathology test; Pruritus, Rash, Rash erythematous, Reticulocyte count, Skin warm; T-cell receptor gene rearrangement test, Treatment failure; Biopsy bone marrow, Biopsy skin abnormal, Blood test, Chromosomal analysis, Computerised tomogram; Cutaneous T-cell lymphoma, Differential white blood cell count, Flow cytometry, Fluorescent in situ hybridisation, Full blood count; Inflammation, Laboratory test abnormal, Metabolic function test, Metastatic lymphoma, Pathology test; Pruritus, Rash, Rash erythematous, Reticulocyte count, Skin warm; T-cell receptor gene rearrangement test, Treatment failure More
Shortly after receiving the vaccine I became very itchy, mostly on my back at first, then all over. ... Shortly after receiving the vaccine I became very itchy, mostly on my back at first, then all over. I developed a rash between my shoulder blades by the spring of 2022. The rash spread to my whole torso and became red, hot and inflamed. The doctors thought it was an allergic reaction or contact dermatitis. Eventually I got a biopsy in March of 2023. It came back positive for Cutaneous T-Cell Lymphoma. I later had more testing done and I also have blood and bone marrow involvement at low levels. I see a Dermapathologist and an oncologist regularly and have currently failed all non-systemic treatments. I have recently started Methotrexate. It is helping but hasn?t cleared yet, they are going to up my dose in a few weeks. More
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2830730 7 F 03/12/2025 UNK
 UNKNOWN MANUFACTURER
 Y013579
No adverse event, Product storage error No adverse event, Product storage error
No additional adverse event; HCP reports multiple patients may have received improperly stored PROQU... No additional adverse event; HCP reports multiple patients may have received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freeze; This spontaneous report has been received from a nurse, regarding a 7-year-old female patient. The patient's concomitant therapies included polio vaccine inact 3v (vero) (IPOL) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid) (BOOSTRIX). The patient's pertinent medical history, concurrent conditions, and previous drug reactions or allergies were not reported. On 08-JAN-2025, the patient was vaccinated with an improperly stored second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (rHA [recombinant human albumin]) (PROQUAD) administered subcutaneously on the left arm as prophylaxis (Lot No. Y013579 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection], expiration date was not reported but upon internal validation established as 03-FEB-2026) (strength and vaccination scheme frequency were not reported) (product storage error) after a temperature excursion with a range of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) (-9 degree Celsius to 8 degree Celsius during a time frame of 1344 (time units not provided). No previous temperature excursion was reported. No additional information or adverse events were provided (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 04/12/2017 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2830731 F CA 03/12/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
A HCP (pharmacist) called to inquire about whether the GARDASIL 9 vaccine was indicated for use in w... A HCP (pharmacist) called to inquire about whether the GARDASIL 9 vaccine was indicated for use in women greater than 45 years of age. The HCP stated she had a 62 or 63 year old consumer/patient presently at the pharmacy who requested to receive her; No additional AE.; This spontaneous report was received from a Pharmacist and refers to an Adult (62 or 63 year old) female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-SEP-2024, the patient was vaccinated with the first dose of human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route, lot #, expiration date and anatomical location were not provided), then on 04-NOV-2024, the patient received the second dose of human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route, lot #, expiration date and anatomical location were not provided) for prophylaxis (Inappropriate age at vaccine administration). The patient presented at the pharmacy who requested to receive her third dose of human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) vaccine on 07-MAR-2025. No adverse event reported. It was also mentioned that the patient had an article with her that recommended healthcare workers who had been exposed to "fumes" should get the human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) vaccine to prevent throat cancer (captured in case#: 2263369) More
2830732 F TX 03/12/2025 TD
TD
TD
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 U8021BA
U8021BA
U8021BA
Anxiety, Chest discomfort, Condition aggravated, Hypermetabolism, Hypoglycaemia;... Anxiety, Chest discomfort, Condition aggravated, Hypermetabolism, Hypoglycaemia; Insomnia, Phonophobia, Presyncope, Syncope, Tachycardia; Weight decreased More
syncope; constellation of atypical symptoms after the reaction chest vibrations; tachycardia; hyperm... syncope; constellation of atypical symptoms after the reaction chest vibrations; tachycardia; hypermetabolism; phonophobia; insomnia; severe anxiety; weight loss; hypoglycemic symptoms; Initial information received on 06-Mar-2025 regarding an unsolicited valid serious case received from Health Care Professional. This case involves Adult female patient who experienced syncope, constellation of atypical symptoms after the reaction chest vibrations, tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety, weight loss and hypoglycemic symptoms after receiving Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. The patient's past medical history included Post-traumatic stress disorder as she describes as PTSD and general anxiety at one point history consistent with agoraphobia, (Anxiety and Agoraphobia). The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 07-Jul-2024, the patient received unknown dose of suspect Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (lot U8021BA; strength and expiry date not reported) via unknown route in unknown administration site for vaccination. On 07-Jul-2024 (15 mins after vaccination) the patient developed a serious syncope. This event was assessed as medically significant. She went to ED and emergency room physician felt she had vasovagal reaction. She had on 07-Jul-2024 constellation of atypical symptoms after the reaction chest vibrations (chest discomfort), tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety (anxiety), weight loss (weight decreased) and hypoglycemic symptoms (hypoglycaemia) on same day. Action taken: Not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events. These symptoms slowly resolved over 2 months. She feels she is better now. No other information was able to be gathered from the HCP.; Sender's Comments: Sanofi Company Comment dated 11-MAR-2025: This case involves Adult female patient who experienced syncope, constellation of atypical symptoms after the reaction chest vibrations, tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety, weight loss and hypoglycemic symptoms after receiving Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. Post-traumatic stress disorder and general anxiety at one point history consistent with agoraphobia could also paly confounding role Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. More
2830733 4 F AL 03/12/2025 TDAP
 SANOFI PASTEUR
 U8115AA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administration of adacel to a patient less than 10 years of age with no reported adverse event; Init... administration of adacel to a patient less than 10 years of age with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves 4 years old female patient less than 10 years of age who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio vaccine inact (IPV), measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (varicella vaccine) for prophylactic vaccination (Immunisation). On 05-Mar-2025, a less than 10 years of age patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection (lot U8115AA and expiry date 31-Mar-2026) (frequency: once, strength: standard) via intramuscular route in the right thigh for Immunization 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
2830734 11 M OH 03/12/2025 IPV
 SANOFI PASTEUR
 W1A191M
Expired product administered, No adverse event Expired product administered, No adverse event
administration of an expired vaccine with no reported adverse event; Initial information received on... administration of an expired vaccine with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old male patient who had received an expired IPV (VERO) [IPOL] with no reported adverse event. This case is linked to US-SA-2025SA070267 The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine; mumps vaccine; rubella vaccine; varicella zoster vaccine, Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), and Hepatitis B vaccine (hepatitis B vaccine) all for Immunisation. On 06-Mar-2025 at 11:00 am, the patient received an expired 0.5ml dose of suspect IPV (VERO) Suspension for injection (strength-standard, frequency-once, lot W1A191M, expiry date-16-Feb-2025) via intramuscular route in the left deltoid for Immunization, with no reported adverse event (expired product administered) (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.; Sender's Comments: US-SA-2025SA070267:2nd patient More
2830735 10 M OH 03/12/2025 IPV
 SANOFI PASTEUR
 W1A191M
Expired product administered, No adverse event Expired product administered, No adverse event
inappropriate use due to administration of an expired vaccine with no reported adverse event; Initia... inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 10 years old male patient who had inappropriate use due to administration of an expired vaccine IPV (VERO) [IPOL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B vaccine (Hepatitis B vaccine) and Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for prophylactic vaccination (Immunisation). On 06-Mar-2025 at 11:00 hours, the patient received a dose of 0.5 ml of suspect IPV (VERO), Suspension for injection (lot W1A191M and expiry date 16-Feb-2025) (frequency: once and strength: standard) via intramuscular route in the left deltoid for immunisation with no reported adverse event (expired product administered) (Latency: same day). Reportedly, Medical Assistant called to ask the validity of the administered expired IPOL to 2 patients. 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.; Sender's Comments: US-SA-2025SA070402:2nd patient More
2830736 SC 03/12/2025 TD
 SANOFI PASTEUR
No adverse event, Wrong product administered No adverse event, Wrong product administered
they were supposed to administer Boostrix but administered TENIVAC instead with no reported AE; Init... they were supposed to administer Boostrix but administered TENIVAC instead with no reported AE; Initial information received on 07-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient with unknown age and gender who was supposed to get Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid [Boostrix] but Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered instead with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, patient was supposed to get Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid [Boostrix] but Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection (lot number, expiry date not reported) for immunisation was administered instead with no reported adverse event (wrong product administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence Action taken was not applicable. Reportedly, the nurse was confirmed with the brand names of the vaccines afterwards and informed that Boostrix is not a Sanofi product and advised them to call the manufacturer of Boostrix directly regarding their inquiry. 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
2830748 30 F DC 03/12/2025 DTAP
 SANOFI PASTEUR
Headache, Nausea, Pyrexia Headache, Nausea, Pyrexia
Fever 103 degrees, headache, nausea. Fever 103 degrees, headache, nausea.
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