🏥 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 💀 🏥 🚑 ♿ ⚠️
2864796 10/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
The diluent was given only; The diluent was given only; This non-serious case was reported by a nurs... The diluent was given only; The diluent was given only; 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 Herpes zoster (Shingrix) for prophylaxis. On 17-SEP-2025, the patient received Shingrix. On 17-SEP-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: The diluent was given only) and inappropriate dose of vaccine administered (Verbatim: The diluent was given only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 17-SEP-2025 The reporter reported that patient received subsequent dose of Shingrix and the diluent was given only. The reporter wanted to know the waiting period to administer the correct dose. More
2864797 F ID 10/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
improper schedule of vaccine administered; This non-serious case was reported by a consumer via call... improper schedule of vaccine administered; 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 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in APR-2024). In SEP-2025, the patient received the 2nd dose of Shingrix. In SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: improper schedule of vaccine administered). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 25-SEP-2025 The batch number was not provided, and we are unable to contact the reporter. More
2864798 F 10/10/2025 COVID19
 MODERNA
Cellulitis Cellulitis
the pharmacist told her that another female patient had "the same thing".; This spontaneou... the pharmacist told her that another female patient had "the same thing".; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (the pharmacist told her that another female patient had "the same thing".) in a female patient of an unknown age who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (the pharmacist told her that another female patient had "the same thing".). At the time of the report, CELLULITIS (the pharmacist told her that another female patient had "the same thing".) outcome was unknown. No concomitant medication was reported. The pharmacist reported that there was another female patient had the same thing. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789798 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789798:that another female patient had "the same thing" More
2864799 78 F 10/10/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Cellulitis; Cellulitis Cellulitis; Cellulitis
cellulitis; This spontaneous case was reported by a consumer and describes the occurrence of CELLULI... cellulitis; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in a 78-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Previously administered products included for Product used for unknown indication: Pfizer (She also said that her A.fib was diagnosed 3 months ago (after Pfizer vaccines)), COVID-19 VACCINE MRNA OMICRON (KP.2) PFIZER/BIONTECH and COVID-19 VACCINE MRNA OMICRON (KP.2) PFIZER/BIONTECH. Past adverse reactions to the above products included Atrial fibrillation with Pfizer; Pain with COVID-19 VACCINE MRNA OMICRON (KP.2) PFIZER/BIONTECH; and Swelling with COVID-19 VACCINE MRNA OMICRON (KP.2) PFIZER/BIONTECH. Concurrent medical conditions included Atrial fibrillation (She also said that her A.fib was diagnosed 3 months ago (after Pfizer vaccines)) in 2025, Ulcerative colitis and Vaginal infection (she was prone to vaginal infections and because of her ulcerative colitis.). Concomitant products included Apixaban (Eliquis) for an unknown indication. In 2025, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 22-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced CELLULITIS (cellulitis). The patient was treated with Hydrocortisone sodium succinate (Cortison) at an unspecified dose and frequency. At the time of the report, CELLULITIS (cellulitis) was resolving. It was reported that patient received mNEXSPIKE on 22-SEP-2025 and 2 or 3 days later she developed cellulitis. It was painful, itchy, burning and stinging. The cellulitis was spread from above her inner elbow up to her shoulder. She stated that it was not at the site of the injection, she said that the injection was in the left deltoid. She then added that when she informed the pharmacist, the pharmacist told her that another female patient had the same thing. She added that when the cellulitis developed, she went immediately to urgent care where she was prescribed a topical cortisone and an antibiotic 3 times a day for 7 days, she did not want to take the antibiotic at the beginning since she was prone to vaginal infections and because of her ulcerative colitis. She said that the infection was currently almost 50% better. She also said that this was her first time to take Moderna vaccine and that she used to always get Pfizer vaccines, with which she only had pain on the side and swelling. It was unknown if the patient experienced any additional symptoms/events. This case was linked to US-MODERNATX, INC.-MOD-2025-789811 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789811:that another female patient had "the same thing" More
2864800 70 M 10/10/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Vaccination site pain; Vaccination site pain Vaccination site pain; Vaccination site pain
tenderness at injection site; This spontaneous case was reported by a consumer and describes the occ... tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at injection site) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (tenderness at injection site). At the time of the report, VACCINATION SITE PAIN (tenderness at injection site) had resolved. No concomitant medications were reported. The patient had COVID vaccinations since they first started coming out, and probably the patient had the most recent one or something within the past year (1 year and a half or something like that). The patient had received last dose last year (2024) or two years ago (2023). The patient did not have any reactions to any of the vaccinations of any kind, particularly in relation to flu vaccines and the COVID vaccines that the patient been getting fairly frequently. Patient had tenderness at the injection site in some cases and for few times, the patient did not have any reaction. Treatment medication was not reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live follow up Significant information received included patient age updated More
2864801 4 F CA 10/10/2025 FLU3
 SANOFI PASTEUR
 U8881AA
Balance disorder, Crying, Irritability, Pallor, Vomiting Balance disorder, Crying, Irritability, Pallor, Vomiting
had turned pale; said that the patient was aggressively vomiting; fussy, crying; little off balance ... had turned pale; said that the patient was aggressively vomiting; fussy, crying; little off balance as she was walking out of the office; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 year old female patient who had had turned pale, little off balance as she was walking out of the office, said that the patient was aggressively vomiting and fussy, crying after receiving Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2025, the patient received a dose of 0.5ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot U8881AA and expiry date-30-Jun-2026) via intramuscular route in unknown administration site for Influenza (Influenza). On an unknown date the patient developed a had turned pale (pallor), and little off balance as she was walking out of the office (balance disorder) and fussy, crying (crying) (unknown latency). Relevant laboratory test results included: Blood pressure measurement - On an unknown date:[99/60 mmhg] Body temperature - On an unknown date: 98 F Pulse pressure - On an unknown date: 82 mmHg Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events. More
2864809 4 F RI 10/10/2025 FLU3
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 2T543
Z011681
Erythema, Local reaction, Skin warm, Swelling; Erythema, Local reaction, Skin wa... Erythema, Local reaction, Skin warm, Swelling; Erythema, Local reaction, Skin warm, Swelling More
local reaction, red slightly warm & swollen. local reaction, red slightly warm & swollen.
2864810 0.25 M MD 10/10/2025 FLU3
 SANOFI PASTEUR
 UJ8544AA
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
This is a vaccine administration error. Patient 3 1/2 month old was given Influenza vaccine instead ... This is a vaccine administration error. Patient 3 1/2 month old was given Influenza vaccine instead of RSV vaccine. No side effects noted. Baby was monitored closely. More
2864811 11 M VT 10/10/2025 FLU3
HPV9
 SEQIRUS, INC.
MERCK & CO. INC.
 406989
Y019459
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
The office was conducting a Flu Clinic. Patient came in for HPV. When we reviewed the records it sh... The office was conducting a Flu Clinic. Patient came in for HPV. When we reviewed the records it showed she also needed a flu. I assumed that is what she was getting but already got at the pharmacy More
2864863 31 M MD 10/10/2025 HPV9
 MERCK & CO. INC.
 Z005469
Acute kidney injury, Psychotic disorder, Toxicity to various agents Acute kidney injury, Psychotic disorder, Toxicity to various agents
Hospitalization for psychosis; HCP states patient was hospitalized for substance use intoxication a... Hospitalization for psychosis; HCP states patient was hospitalized for substance use intoxication and acute kidney injury; HCP states patient was hospitalized for substance use intoxication and acute kidney injury; This spontaneous report was received from a Physician on 01-Oct-2025 and refers to a patient of unknown age and gender. The reporter stated that the patient was a Clinical Study participant enrolled in (withheld) clinical trial (however, no information regarding the study was reported). The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-Aug-2025, the patient was vaccinated with an unspecified dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Z005469, expiration date: 27-Feb-2026) dose: 0.5 mL, route of administration intramuscular for Prophylaxis. On 27-Sep-2025, the patient experienced acute kidney injury and substance use intoxication (Toxicity to various agents). The patient was hospitalized on the same date for 9 days. It was reported that the patient sought unspecified medical attention, and the patient received an unspecified treatment. The patient would be discharged from the hospital on 06-Oct-2025. At the reporting time, the outcome of acute kidney injury and substance use intoxication was unknown. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown. Follow-up information has been received from a physician on 03-OCT-2025. This report concerns a 32-years old male patient. Patient's demographics was added. Vaccine was administered via IM in the left arm. Concomitant medications included Olanzapine, Thamin, Folic Acid. It was reported that patient's Hospitalization for psychosis induced by substance use and acute kidney injury. Hospitalization dates from 27-SEP-2025 to 30-SEP-2025. The patient was recovered from the events. More
✓
2864865 CA 10/10/2025 FLUX
MMR
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
Z004961
No adverse event, Product preparation issue; No adverse event, Product preparati... No adverse event, Product preparation issue; No adverse event, Product preparation issue More
No additional AE/PQC.; a patient who was administered a dose of MMR-II that was inadvertently recons... No additional AE/PQC.; a patient who was administered a dose of MMR-II that was inadvertently reconstituted with a prefilled syringe containing a flu vaccine (unspecified) instead of sterile diluent; Caller reported AE on behalf of a patient who was administered a dose of MMR-II that was inadvertently reconstituted with a prefilled syringe containing a flu vaccine (unspecified) instead of sterile diluent on 10/03/2025. No symptoms reported. Obtai; This spontaneous report was received from a Nurse and refers to a 32-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 03-Oct-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #Z004961. The lot number has been verified as valid, with an expiration date of 24-Feb-2027. The vaccine was administered at a dose of 0.5 mL for prophylaxis (route of administration and anatomical site of injection were not provided). The vaccine was inadvertently reconstituted with a prefilled syringe containing an influenza vaccine (reported as "flu vaccine," trade name unspecified) instead of the sterile diluent (dose description, indication, lot # and expiration date was not provided) (Wrong vaccine administered, vaccine incorrect diluent used). No symptoms were reported (no adverse event).; Reporter's Comments: Keywords: OCL More
2864866 1 M 10/10/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Febrile convulsion, Pyrexia, Rash Febrile convulsion, Pyrexia, Rash
My son had a febrile seizure; Rash; This serious case was reported by a consumer via interactive di... My son had a febrile seizure; Rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of febrile seizure in a 1-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced febrile seizure (Verbatim: My son had a febrile seizure) (serious criteria GSK medically significant and other: Serious as per reporter) and rash (Verbatim: Rash) (serious criteria other: Serious as per reporter). The patient was treated with paracetamol (Tylenol) and ibuprofen (Motrin). The outcome of the febrile seizure was resolved and the outcome of the rash was not reported. The reporter considered the febrile seizure and rash to be related to Bexsero. It was unknown if the reporter considered the febrile seizure and rash to be related to Bexsero Pre-Filled Syringe Device. The company considered the febrile seizure and rash to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2025AMR129552 Additional Information: GSK Receipt Date: 27-SEP-2025 This case was reported by a patient via interactive digital media. The reporter's son had a febrile seizure after his 1-year-old shots. He had developed a fever and rash and they said it was normal. His fever went higher so they gave baby Tylenol and alternated with baby Motrin as instructed by doctor. Fever didn't go down, he had a seizure, and they rushed to emergency room (ER). He had no more seizures until after they forced him to take the Meningococcal B shot for school when he was 19 years old. The batch number was not provided, and we are unable to contact the reporter. The case had been linked to US2025AMR129552 and US2025AMR129737, reported by the same reporter, for a different patient.; Sender's Comments: A case of Febrile convulsion and Rash, an unknown time after receiving Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE, in 1-year-old male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR129552:Same patient another dose US-GSK-US2025AMR129737:Original Case Number : US2025AMR124514 More
2864867 FL 10/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Underdose Underdose
Wrong vaccine administered; received the pediatric formulation of Engerix B instead of the adult for... Wrong vaccine administered; received the pediatric formulation of Engerix B instead of the adult formulation; 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 an unspecified number of patients who received HBV (Engerix B pediatric) for prophylaxis. On an unknown date, the patients received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patients experienced adult use of a child product (Verbatim: Wrong vaccine administered) and underdose (Verbatim: received the pediatric formulation of Engerix B instead of the adult formulation). The outcome of the adult use of a child product and 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: 23-SEP-2025 The reporter reported that an unknown number of patients received the pediatric formulation of Engerix B instead of the adult formulation. The patient does not have any demographic information at this time and will call back with additional information. The batch number was not provided and a request for this information has been made. More
2864868 F NJ 10/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via... Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included chickenpox (patient had chickenpox as a child). Previously administered products included Shingrix (received first dose years ago in her left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 23-SEP-2025 The 72-year-old, female patient reported that she received the first dose of Shingrix (she thinks it was Shingrix) years ago (no specific date provided), and she never went back to get the second dose. The patient did not have any information to provide about the first dose like lot, expiry, route and date of administration. The patient stated she probably received the vaccine in her left arm because she was right-handed. The patient stated that her physician and her pharmacist gave her two different answers about receiving the second dose of Shingrix, so now she was confused. The patient stated she had chickenpox as a child and had reported all that was provided about this adverse event. Till the time of reporting, the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The batch number was not provided and a request for this information has been made. More
2864869 M CA 10/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Facial nerve disorder, Headache, Herpes zoster Facial nerve disorder, Headache, Herpes zoster
Patient reported that Shingrix reactivated a previous episode of singles; shingles had affected his ... Patient reported that Shingrix reactivated a previous episode of singles; shingles had affected his temporal nerve, causing a headache that lasted a year. Patient had to see a neurologist; This serious case was reported by a other health professional via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles). On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Patient reported that Shingrix reactivated a previous episode of singles) (serious criteria other: Serious as per reporter) and post herpetic neuralgia (Verbatim: shingles had affected his temporal nerve, causing a headache that lasted a year. Patient had to see a neurologist) (serious criteria other: Serious as per reporter). The outcome of the shingles was unknown and the outcome of the post herpetic neuralgia was resolved (duration 1 year). The reporter considered the shingles and post herpetic neuralgia to be related to Shingles vaccine. The company considered the shingles and post herpetic neuralgia to be unrelated to Shingles vaccine.; Sender's Comments: A case of Herpes zoster and Post herpetic neuralgia, an unknown time after receiving Shingles vaccine, in a male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2864870 M 10/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain, Pyrexia Pain, Pyrexia
Fever; aches; This non-serious case was reported by a consumer via sales rep and described the occur... Fever; aches; This non-serious case was reported by a consumer via sales rep and described the occurrence of fever in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In SEP-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever) and pain (Verbatim: aches). The outcome of the fever and pain were resolved. The reporter considered the fever and pain to be related to Shingrix. The company considered the fever and pain to be related to Shingrix. Additional Information: GSK receipt date: 29-SEP-2025 The batch number was not provided, and we are unable to contact the reporter. More
2864871 1 F IL 10/10/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5H773
Expired product administered Expired product administered
Expired vaccine used/accidentally administered an expired dose of Infanrix; This non-serious case wa... Expired vaccine used/accidentally administered an expired dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis. On 08-OCT-2025, the patient received Infanrix. On 08-OCT-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine used/accidentally administered an expired dose of Infanrix). The outcome of the expired vaccine used 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. Linked case(s) involving the same patient: US2025113898 Additional Information: GSK receipt date: 08-OCT-2025 Registered nurse was calling to report that their office accidentally administered an expired dose of Infanrix via prefilled syringe to a patient on the day of reporting. The case was linked with case US2025113898, reported by the same reporter for different product. More
2864872 F 10/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Hypersensitivity, Intensive care Hypersensitivity, Intensive care
had allergic reaction and I was in ICU; This serious case was reported by a consumer via interactive... had allergic reaction and I was in ICU; This serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergic reaction (Verbatim: had allergic reaction and I was in ICU) (serious criteria hospitalization). The outcome of the allergic reaction was unknown. The reporter considered the allergic reaction to be related to Shingles vaccine. The company considered the allergic reaction to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-OCT-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles shot a few years ago and had an allergic reaction to it. The patient stated that it almost killed her and was in intensive care unit (ICU) for a week. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Hypersensitivity, on an unknown time after receiving Shingles vaccine, in an adult female patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received More
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2864873 M 10/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
suspected vaccination failure; months after his first RSV vaccination, he came down with a diagnosed... suspected vaccination failure; months after his first RSV vaccination, he came down with a diagnosed case of RSV; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included multiple myeloma (treatment every 2 weeks). On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, several months after receiving Arexvy, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: months after his first RSV vaccination, he came down with a diagnosed case of RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. It was unknown if the company considered the respiratory syncytial virus infection to be related to Arexvy. Additional Information: GSK Receipt Date: 02-OCT-2025 The patient received a Respiratory syncytial virus (RSV) vaccination 2 years ago. A couple of months after his first RSV vaccination, he came down with a diagnosed case of respiratory syncytial virus infection. His oncologist off. The patient's hematologist had recommended to get a second RSV immunization because of his multiple myeloma. The reporter asking was this considered safe to have another one. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding respiratory syncytial virus were unknown at the time of reporting. Batch number "UNK" and follow-up cannot be performed: The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, several months after receiving Arexvy, in a male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2864874 F 10/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Loss of personal independence in daily activities, Vaccination fa... Herpes zoster, Loss of personal independence in daily activities, Vaccination failure More
Suspected vaccination failure; got shingles; it really disrupted her life; This serious case was re... Suspected vaccination failure; got shingles; it really disrupted her life; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles) and activities of daily living impaired (Verbatim: it really disrupted her life). The outcome of the vaccination failure was not reported and the outcome of the shingles and activities of daily living impaired were not resolved. It was unknown if the reporter considered the vaccination failure, shingles and activities of daily living impaired to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles and activities of daily living impaired to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 02-OCT-2025 This case was reported by a reporter who knew the patient via interactive digital media. The reporter said that patient was still trying to recover. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Herpes Zoster vaccine, in a female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2864875 M 10/10/2025 HPVX
MENB
 UNKNOWN MANUFACTURER
NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
UNK
Epilepsy; Epilepsy Epilepsy; Epilepsy
epilepsy; This serious case was reported by a consumer via interactive digital media and described t... epilepsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of epilepsy in a male patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis. On an unknown date, the patient received Bexsero and HPV vaccine. On an unknown date, an unknown time after receiving Bexsero and HPV vaccine, the patient experienced epilepsy (Verbatim: epilepsy) (serious criteria GSK medically significant and other: Serious as per reporter). The outcome of the epilepsy was not reported. The reporter considered the epilepsy to be related to Bexsero and HPV vaccine. It was unknown if the reporter considered the epilepsy to be related to Bexsero Pre-Filled Syringe Device. The company considered the epilepsy to be unrelated to Bexsero, Bexsero Pre-Filled Syringe Device and HPV vaccine. 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: 27-SEP-2025 This case was reported by a patient via interactive digital media. The reporter's another son who had epilepsy and he was perfectly fine before 14 yrs old then all of a sudden with meningococcal, HPV vaccines. The batch number was not provided, and we are unable to contact the reporter. This case is linked to case US2025AMR129552 and US2025AMR124514, from the same reporter.; Sender's Comments: A case of Epilepsy, unknown time after receiving Bexsero , HPV vaccine and Bexsero Pre-Filled Syringe Device, in a male patient. Report is inconsistent with causal relation to the vaccine product. Causal relation is indeterminate considering multiple vaccines given concomitantly . US-GSK-US2025AMR129552:Other son (dose at 19 year old), same reporter US-GSK-US2025AMR124514:Other son (dose at 1 year old), same reporter More
2864877 M NY 10/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Off label use, Product administered to patient of inappropriate age Off label use, Product administered to patient of inappropriate age
off label use for unapproved indication; This non-serious case was reported by a other health profes... off label use for unapproved indication; This non-serious case was reported by a other health professional via call center representative and described the occurrence of off label use in unapproved age group in a 17-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included lung transplant, stem cell transplant, graft versus host disease in lung and lung disease obstructive (obstructive lung condition). Concurrent medical conditions included leukemia (stage 3) and bronchiolitis obliterans. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced off label use in unapproved age group (Verbatim: off label use for unapproved indication). The outcome of the off label use in unapproved age group was not applicable. Additional Information: GSK Receipt Date: 11-SEP-2025 A physician assistant reported that they had a 17 years old patient and unfortunately a lung transplant candidate, he had stage 3 leukemia and received a stem cell transplant as part of his curative therapy, and developed a very extensive chronic graft vs host disease, and with that something called Bronchiolitis obliterans which was a very developed obstructive lung condition, which unfortunately had not been controlled, and really had to received QA lung transplant, reporter question was if there was any way they could obtain RSV vaccine through your company. Reporter made it clear they were aware the age of the patient was not the indication for Arexvy, but that it was their intention to administer it to the patient as it could be lifesaving, which led to off label use for unapproved age group. More
2864878 MA 10/10/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
subcu administration instead of IM/ Incorrect Route of Administration; This non-serious case was rep... subcu administration instead of IM/ Incorrect Route of Administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. On 15-SEP-2025, the patient received the 1st dose of Priorix (intramuscular). On 15-SEP-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: subcu administration instead of IM/ Incorrect Route of Administration). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-SEP-2025 The pharmacist enquired if the intramuscular administration of the medication, instead of the subcutaneous route, constituted a contraindication. He queried if this had any implications for the patient and whether any further actions were required after the situation. HCP confirmed that the patient was administered the Priorix shot intramuscularly. More
2864879 64 M TX 10/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 NR4T5
Product preparation issue Product preparation issue
Administration of diluent alone; Administration of diluent alone; This non-serious case was reporte... Administration of diluent alone; Administration of diluent alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number NR4T5) for prophylaxis. On 08-AUG-2025, the patient received Shingrix. On 08-AUG-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of diluent alone) and inappropriate dose of vaccine administered (Verbatim: Administration of diluent alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 17-SEP-2025 On 17th September 2025, a registered nurse called and reported that they had wanted information regarding the Shingrix vaccine and had only administered the diluent. More
2864880 34 F 10/10/2025 COVID19
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 30527343
9JC49H
Injection site pain, Injection site swelling, Injection site warmth, Pyrexia; In... Injection site pain, Injection site swelling, Injection site warmth, Pyrexia; Injection site pain, Injection site swelling, Injection site warmth, Pyrexia More
Local injection site pain from flu shot started within 2 hours. Over course of 10 hours, pain increa... Local injection site pain from flu shot started within 2 hours. Over course of 10 hours, pain increased considerably, including swelling and feeling of heat at the localized area. Low grade fever started around midnight and still have low grade fever (8 AM this morning). More
2864881 45 F WA 10/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 JB4K2
Underdose Underdose
Engerix-B pediatric dose administration to an adult; Engerix-B pediatric dose administration to an a... Engerix-B pediatric dose administration to an adult; Engerix-B pediatric dose administration to an adult; 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 45-year-old female patient who received HBV (Engerix B pediatric) (batch number JB4K2, expiry date 23-JAN-2027) for prophylaxis. On 11-SEP-2025, the patient received Engerix B pediatric. On 11-SEP-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose administration to an adult) and underdose (Verbatim: Engerix-B pediatric dose administration to an adult). The outcome of the adult use of a child product and 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-SEP-2025 A health care provider had wanted to know how to proceed after having administered a pediatric dose of Engerix-B to an adult. More
2864882 16 M AR 10/10/2025 MNQ
 SANOFI PASTEUR
 U8573AA
Urticaria Urticaria
pt developed hives on 10/6/2025, he was given benadryl and the hives went away, they have been off a... pt developed hives on 10/6/2025, he was given benadryl and the hives went away, they have been off and on since then while treating w/ benadryl. PCP is out of town this week, they will be calling 10/13/25 to make an appointment. More
2864885 43 M MA 10/10/2025 FLU3
 SEQIRUS, INC.
 407254
Incorrect dose administered Incorrect dose administered
I gave the high dose influenza vaccine to someone under the age of 65 I gave the high dose influenza vaccine to someone under the age of 65
2864886 69 F OH 10/10/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT8794BA
UT8794BA
Asthenia, Fatigue, Injection site erythema, Injection site warmth, Malaise; Pain... Asthenia, Fatigue, Injection site erythema, Injection site warmth, Malaise; Pain, Pain in extremity, Pyrexia, Somnolence More
PATIENT WOKE UP MORNING AFTER VACCINE FEELING VERY SICK, FEVER, EXTREME ACHES, FATIGUE, SLEEPINESS, ... PATIENT WOKE UP MORNING AFTER VACCINE FEELING VERY SICK, FEVER, EXTREME ACHES, FATIGUE, SLEEPINESS, WARM AND RED INJECTION SITE, SORE ARM. SYMPTOMS HAVE NOT RESOLVED AFTER 2 DAYS, STILL WEAK AND ACHY More
2864887 13 F MA 10/10/2025 FLU3
 SEQIRUS, INC.
 406989
Injection site erythema Injection site erythema
Local 5 x 4 cm erythematous area left upper arm at site of injection Local 5 x 4 cm erythematous area left upper arm at site of injection
2864888 75 M MI 10/10/2025 FLU3
RSV
 SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
 407269
7HZ93
Mobility decreased; Mobility decreased Mobility decreased; Mobility decreased
Limited range of motion, no treatment given, started shortly after receiving vaccine and still prese... Limited range of motion, no treatment given, started shortly after receiving vaccine and still present two days later More
2864889 35 F WI 10/10/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 ZE423
Erythema, Feeling hot, Swelling Erythema, Feeling hot, Swelling
Redness, swelling, warmth Redness, swelling, warmth
2864890 56 F MA 10/10/2025 FLU3
 SANOFI PASTEUR
 UT8817NA
Injected limb mobility decreased Injected limb mobility decreased
Patient complained of inability to lift her left arm lower than shoulder level and inability to reac... Patient complained of inability to lift her left arm lower than shoulder level and inability to reach her arm backwards. More
2864891 74 F OR 10/10/2025 COVID19
 PFIZER\BIONTECH
Vertigo Vertigo
Woke up with vertigo x 2 days Woke up with vertigo x 2 days
2864892 48 M IL 10/10/2025 UNK
 UNKNOWN MANUFACTURER
 4F2AJ
Injection site erythema, Injection site pruritus, Injection site rash, Injection... Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth More
10/7 developed itching and bumps, 10/8 developed more bumps, redness and warm to touch from elbow to... 10/7 developed itching and bumps, 10/8 developed more bumps, redness and warm to touch from elbow to shoulder in right arm-took Benadryl and will follow up with Occupational health More
2864893 9 F OR 10/10/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 FH4YR
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Mom called for patient. She has red, raised, warm area at the site of injection and moving down the ... Mom called for patient. She has red, raised, warm area at the site of injection and moving down the arm. More
2864894 78 M FL 10/10/2025 FLU3
 SEQIRUS, INC.
 407264
Atrial fibrillation, Chest pain, Dizziness Atrial fibrillation, Chest pain, Dizziness
Acute chest pain, acute light headedness, new onset atrial fibrillation. Patient visited ER on two o... Acute chest pain, acute light headedness, new onset atrial fibrillation. Patient visited ER on two occasions, admitted to hospital on 10/08/25 for further evaluation. More
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2864895 85 F FL 10/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
Patient received this dose that was not indicated for the patient who previously received in 12/2023 Patient received this dose that was not indicated for the patient who previously received in 12/2023
2864896 82 M IL 10/10/2025 PNC21
 MERCK & CO. INC.
 Y011819
Expired product administered, No adverse event Expired product administered, No adverse event
Patient has not reported any adverse event at this time. Patient daughter was contacted and inform... Patient has not reported any adverse event at this time. Patient daughter was contacted and informed that he was given a vaccination that expired on 10/1/2025 on 10/9/2025. Patient will return to office and receive another vaccination as that is the recommendation to repeat. More
2864897 80 M ND 10/10/2025 COVID19
 MODERNA
 3052859
Underdose Underdose
Patient received a child dose of Covid 0.25 mL instead of the adult dose of 0.5 mL Patient received a child dose of Covid 0.25 mL instead of the adult dose of 0.5 mL
2864898 4 F RI 10/10/2025 DTAPIPV
DTAPIPV
FLU3
FLU3
MMR
MMR
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 4L454
4L454
U8854AA
U8854AA
Y019930
Y019930
Discomfort, Productive cough, Rash, Rash pruritic, Respiratory tract congestion;... Discomfort, Productive cough, Rash, Rash pruritic, Respiratory tract congestion; Sleep disorder; Discomfort, Productive cough, Rash, Rash pruritic, Respiratory tract congestion; Sleep disorder; Discomfort, Productive cough, Rash, Rash pruritic, Respiratory tract congestion; Sleep disorder More
Began with rash yesterday, started with tiny cluster on knee. +itchy. Also, had a few spots on flank... Began with rash yesterday, started with tiny cluster on knee. +itchy. Also, had a few spots on flank. Awoke this AM with rash "everywhere." Still uncomfortable - gave Benadryl 4mL this AM. Rash has only gotten worse since she woke up. Denies fever. +cough, was present before vaccines, becoming more wet/croupy. +congestion. Denies v/d. I/O WNL, sleep interrupted over the last 2 nights, decreased activity level.Recommend Cetirizine 5mL today, then switch to 2.5mL BID starting tomorrow. If itching persists, parents to call and we can RX Prednisolone. Will refer allergist for eval of possible DTaP reaction, explained to parents that pt will not receive polio, MMR, or VZV vaccines in the future. Will look for clearance for pt to receive Tdap in future. Discussed signs of anaphylaxis in detail call if they occur. Parents agreeable to plan, no unanswered questions. More
2864899 82 M CA 10/10/2025 COVID19
 MODERNA
 3052581
Pyrexia Pyrexia
Fever 102. Treatment of Tylenol 650mg Q 4hrs PRN, cooling measures. Fever reducing with cooling meas... Fever 102. Treatment of Tylenol 650mg Q 4hrs PRN, cooling measures. Fever reducing with cooling measures. Will monitor x 72 hours More
2864900 70 F NC 10/10/2025 FLU3
 SANOFI PASTEUR
 U8862CA
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
redness, swelling, "warmness" that spread from injection site to elbow and causes excrucia... redness, swelling, "warmness" that spread from injection site to elbow and causes excruciating pain More
2864902 55 F MI 10/10/2025 FLU3
 SANOFI PASTEUR
 U8764AB
Incorrect dose administered Incorrect dose administered
Gave a HD Fluzone vaccine to patient who was <65 years of age. Gave a HD Fluzone vaccine to patient who was <65 years of age.
2864903 61 F MI 10/10/2025 FLU3
 SANOFI PASTEUR
 U8764AB
Incorrect dose administered Incorrect dose administered
Gave a HD Fluzone vaccine to patient who was <65 years of age. Gave a HD Fluzone vaccine to patient who was <65 years of age.
2864904 69 F NC 10/10/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 u8859ba
z009681
Erythema, Influenza like illness, Pain in extremity, Skin warm; Erythema, Influe... Erythema, Influenza like illness, Pain in extremity, Skin warm; Erythema, Influenza like illness, Pain in extremity, Skin warm More
Patient states that the symptoms started the same evening as receiving the vaccines. Symptoms includ... Patient states that the symptoms started the same evening as receiving the vaccines. Symptoms include sore, swollen arm with redness, and Flu like symptoms. as of 10/10/2025 at 9:30 am symptoms are arm soreness with redness and is hot to the touch. no current flu like symptoms. More
2864905 71 F 10/10/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Cheilitis, Dysphagia, Dyspnoea, Gingival erythema, Hypoaesthesia; Lip erythema, ... Cheilitis, Dysphagia, Dyspnoea, Gingival erythema, Hypoaesthesia; Lip erythema, Mobility decreased, Mouth swelling, Noninfective gingivitis, Slow speech More
My mouth got swollen and my lips and gums got red and had sores, i was short of breath with diffcult... My mouth got swollen and my lips and gums got red and had sores, i was short of breath with diffculty swallowing and later on in the day, I couldnt move and felt numb. I am also speaking really slow More
2864906 TN 10/10/2025 FLU4
HEPA
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS



Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error More
Inadvertent Administration After a vaccine Temperature Excursion; This non-serious case was reported... Inadvertent Administration After a vaccine Temperature Excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included HAV (Havrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis. On an unknown date, the patient received Menveo, Havrix, Boostrix and FluLaval Quadrivalent. On an unknown date, an unknown time after receiving Menveo, Havrix, Boostrix and FluLaval Quadrivalent, the patient experienced incorrect storage of drug (Verbatim: Inadvertent Administration After a vaccine Temperature Excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 22-SEP-2025 Medical assistant reported that the vaccines Infanrix, Pediarix, Kinrix, Havrix, Engerix-B, Flulaval, Menveo, Bexsero, Priorix, Rotarix, Boostrix were experienced a temperature excursion below the normal range on 19th September 2025, having lowest temperature reached at 0.3 degree Celsius.and excursion lasted for:1hr and 33 min. There was not any prior excursions. There were 4 possible 4 vaccines that has been administered to patients including Menveo, Havrix, Boostrix, Flulaval TIV. The batch number was not provided and a request for this information has been made. More
2864907 59 F MI 10/10/2025 UNK
 UNKNOWN MANUFACTURER
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Gave a HD Fluzone vaccine to patient who was <65 years of age. Gave a HD Fluzone vaccine to patient who was <65 years of age.
2864909 75 F MI 10/10/2025 FLU3
 SANOFI PASTEUR
Arthralgia, Eye pain, Headache, Neck pain, Tenderness Arthralgia, Eye pain, Headache, Neck pain, Tenderness
Two hours after receiving the flu vaccine on Sept. 30., I noticed a tenderness on either side of my ... Two hours after receiving the flu vaccine on Sept. 30., I noticed a tenderness on either side of my neck that grew worse. Then, I began to experience pain that started in my left shoulder and traveled to the back of my neck, about my left eye and temple. This pain worsened and became sharp stabbing pains from September 30 and continuing to October 9. Advil provided some relief but had to be discontinued after three days due to its negative effect on my stomach. I saw Dr on October 9 and she prescribed a 6 day treatment of Methylprednisolone which greatly reduced the severity of the pain within one day. (Of note: an elderly friend who received the same vaccine yesterday is experiencing a similar reaction.) More
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