🏥 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 💀 🏥 🚑 ♿ ⚠️
2851112 VA 07/25/2025 MMRV
 MERCK & CO. INC.
 Z003309
No adverse event, Product storage error No adverse event, Product storage error
No symptoms or side effects were reported by HCP. No other information reported by HCP. No additiona... No symptoms or side effects were reported by HCP. No other information reported by HCP. No additional AE/No PQC.; HCP reporting that a patient received a dose of improperly stored PROQUAD. HCP reported that she did not know the date the excursion occurred, but knows the PROQUAD was administered on 07/16/2025 following the excursion.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 16-Jul-2025, the patient received a dose of improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot #Z003309 has been verified to be a valid batch lot number, expiration date not reported, but upon internal validation established as 21-Jul-2026) 0.5 mL for prophylaxis by Health Professional, following a temperature excursion of 52.2 Fahrenheit (F), the reporter did not know the date the excursion occurred (Product storage error). No symptoms or side effects were reported (no adverse event) were reported. More
2851113 F CA 07/25/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Acne; Acne Acne; Acne
Pimple like small bump on her head; Patient has not yet received the second dose; This non-serious c... Pimple like small bump on her head; Patient has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of pimple-like rash in an adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In DEC-2024, the patient received the 1st dose of Shingrix. The patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pimple-like rash (Verbatim: Pimple like small bump on her head) and incomplete course of vaccination (Verbatim: Patient has not yet received the second dose). The outcome of the pimple-like rash was resolved and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the pimple-like rash to be related to Shingrix. It was unknown if the company considered the pimple-like rash to be related to Shingrix. Additional Information: GSK Receipt Date: 07-JUL-2025 The reporter was an adult female patient. The patient received the first dose of Shingrix in December 2024. To date, the patient had not yet received the second dose which led to incomplete course of vaccination. The patient experienced a pimple like small bump on her head after receiving the first dose of Shingrix. The patient admitted that it could have been from shampoo or hair color/dye that she was using at the time. More
2851114 12 M IA 07/25/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB064A
Product preparation error Product preparation error
received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that ... received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that is used for the PROQUAD Vaccine instead of reconstituted with the Liquid conjugate for Menveo; received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that is used for the PROQUAD Vaccine instead of reconstituted with the Liquid conjugate for Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 16-JUL-2025, the patient received Menveo (intramuscular, left deltoid). On 16-JUL-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that is used for the PROQUAD Vaccine instead of reconstituted with the Liquid conjugate for Menveo) and inappropriate dose of vaccine administered (Verbatim: received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that is used for the PROQUAD Vaccine instead of reconstituted with the Liquid conjugate for Menveo). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 17-JUL-2025 The reporter was a nurse calling to report that a patient received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that was used for the PROQUAD Vaccine instead of reconstituted with the Liquid conjugate for Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The case had been linked to US2025091800, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2025091800:same reporter, different patient, 2 of 2 More
2851115 F OR 07/25/2025 COVID19
 NOVAVAX
 6024MF012
Illness, Injection site mass, Pain, Pain in extremity Illness, Injection site mass, Pain, Pain in extremity
Made her sick for about 4 or 5 days; It made her feel achy; She had quite a sore arm; She still has ... Made her sick for about 4 or 5 days; It made her feel achy; She had quite a sore arm; She still has a small lump in the area where she received her 20 FEB 2025 vaccine; This case, received on 13-Sep-2024 was assessed as invalid for the following reason: no adverse event. Additional significant information was received on 20-Jun-2025, from a consumer via contact center (Case No. NOV25-00467). This case has been reassessed as valid based on the follow-up information received. Adverse events were added. Updated the patient's DOB, patient's race. Added the following in the patient medical history: FIBROMYALGIA, EHLERS DANLOS SYNDROME (HYPERMOBILITY SUBTYPE), CHRONIC NEUTROPHILLIC LEUKOCYTOSIS, and CHRONIC FATIGUE SYNDROME. Updated therapy site to Arm and Vaccine Anatomical Approach Site to Right Arm for both therapies. Updated vaccination facility details of the vaccine received on 13-Sep-2024. Added the new Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) vaccine received on 25-Feb-2025. Added 2 new events experienced from the mRNA COVID-19 vaccines in the patient past therapy: "She could not tolerate the mRNA COVID-19 vaccines as well" (Adverse event), "Made her feel achy - kind of like when she got an mRNA COVID-19 vaccine" (Pain). Added events experienced with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula): on unspecified dates, the patient reported experiencing "Made her sick for about 4 or 5 days" (Illness), "It made her feel achy" (Pain), "She had quite a sore arm" (Pain in extremity), "She still has a small lump in the area where she received her 20 FEB 2025 vaccine" (Injection site mass) on unspecified dates. At the time of reporting, the outcome of the events was unknown.; Sender's Comments: This Female of an unspecified age experienced Illness, Pain, Pain in extremity and Injection site mass after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Illness was reported as non-serious. The event Pain was reported as non-serious. The event Pain in extremity was reported as non-serious. The event Injection site mass was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Illness, Pain, Pain in extremity and Injection site mass is considered Possible. More
2851116 07/25/2025 COVID19
UNK
 NOVAVAX
UNKNOWN MANUFACTURER

Intranasal paraesthesia, Mucosal disorder; Intranasal paraesthesia, Mucosal diso... Intranasal paraesthesia, Mucosal disorder; Intranasal paraesthesia, Mucosal disorder More
I've noticed a mucosal response having had every combo; Nose tingles during any exposure; My no... I've noticed a mucosal response having had every combo; Nose tingles during any exposure; My nose tingles during any exposure; This non serious initial spontaneous report was reported by a Consumer via social media monitoring and concerns an individual of unspecified age and sex who experienced I'VE NOTICED A MUCOSAL RESPONSE HAVING HAD EVERY COMBO on an unknown day after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on an unknown date. At the time of the report, the outcome of the Mucosal disorder was Unknown. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. On 08-May-2025, significant information was received from the consumer via Resolver compliance (Resolver number 00345634). On an unspecified date after vaccination, the consumer experienced "nose tingles during any exposure" (PT: Intranasal paraesthesia). The reporter further informed that it started after the second Novavax shot; a second therapy dose was captured with unknown dates. At the time of the report, on 08-May-2025, the outcome of Intranasal paraesthesia was unknown.; Sender's Comments: This individual of an unspecified age and sex experienced Mucosal disorder and Intranasal paraesthesia after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Mucosal disorder and Intranasal paraesthesia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Mucosal disorder and Intranasal paraesthesia is considered Possible. More
2851117 F PA 07/25/2025 COVID19
 NOVAVAX
 6024MF01A
Hyposmia, Influenza virus test, Parosmia, SARS-CoV-2 test, Viral test Hyposmia, Influenza virus test, Parosmia, SARS-CoV-2 test, Viral test
I can't smell flowers strongly, like my food, I can taste it but I can't really smell it; ... I can't smell flowers strongly, like my food, I can taste it but I can't really smell it; I started to developed smell, like cigarette smell and I don't smoke/ Lingering smell of smoke, cigarette smoke; I started to developed smell, like cigarette smell and I don't smoke; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via Novavax Medical Information (AE Number: NOV25-00106) and concerns a 60 year-old female who experienced "I STARTED TO DEVELOPED SMELL, LIKE CIGARETTE SMELL AND I DON'T SMOKE" and "I CAN'T SMELL FLOWERS STRONGLY, LIKE MY FOOD, I CAN TASTE IT BUT I CAN'T REALLY SMELL IT" on an unknown date, after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) at unknown latency. At the time of the report, the outcome of the Parosmia, Hyposmia was Not Recovered/Not Resolved/Ongoing. On 25-Mar-2025, non-significant information was received from a consumer via a query response - No new information was received. Gitelman's was spelled correctly in the previous version. On 19-Apr-2025, non-significant information was received from a consumer via a query response - Consent for follow-up was withdrawn. No new information was received. On 07-May-2025 and 14-May-2025, significant information was received from a consumer via query response and via the Novavax Medical Information (MI No. NOV25-00314) - Lot/Batch number of Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) was reported as 6024MF01A with expiry date of 30-Nov-2024. Updated the event reported term to "I started to developed smell, like cigarette smell and I don't smoke/ Lingering smell of smoke, cigarette smoke". The consumer confirmed that vaccine was administered intramuscularly on her left deltoid. The event of Parosmia started about two weeks after Novavax vaccine.; Sender's Comments: This 60-year-old female experienced Parosmia and Hyposmia after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Parosmia and Hyposmia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Parosmia and Hyposmia is considered Possible. More
2851118 F LA 07/25/2025 COVID19
 UNKNOWN MANUFACTURER
Adverse event, Incomplete course of vaccination, Somnolence Adverse event, Incomplete course of vaccination, Somnolence
Just some sleepiness; Had very little side effects in the aftermath of my first dose; She had her fi... Just some sleepiness; Had very little side effects in the aftermath of my first dose; She had her first dose, but needs to find a place to get her second dose...Hasn't had any previous COVID-19 vaccines before her Novavax vaccine; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00196) and concerns a 23-year-old Female who experienced "JUST SOME SLEEPINESS" on an unknown date and "SHE HAD HER FIRST DOSE, BUT NEEDS TO FIND A PLACE TO GET HER SECOND DOSE...HASN'T HAD ANY PREVIOUS COVID-19 VACCINES BEFORE HER NOVAVAX VACCINE" on 28-Oct-2023 after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on 28-Oct-2023. At the time of the report, the outcome of the Somnolence was Unknown and Incomplete course of vaccination was Recovered/Resolved. On 25-May-2025, significant information was received from a consumer via query response - on an unknown date the patient "had very little side effects in the aftermath of my first dose" after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on 28-Oct-2023. At the time of the report, the outcome of the Adverse event was Unknown.; Sender's Comments: This 23-year-old Female experienced Somnolence, Incomplete course of vaccination, and Adverse event after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The events Somnolence, Incomplete course of vaccination, and Adverse event were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Incomplete course of vaccination, Somnolence, and Adverse event is considered Possible. More
2851119 F WI 07/25/2025 COVID19
 NOVAVAX
Asthenia, Feeling abnormal, Injection site pain Asthenia, Feeling abnormal, Injection site pain
After both Novavax vaccines, she had a sore arm at the injection site; For 24h felt less than optima... After both Novavax vaccines, she had a sore arm at the injection site; For 24h felt less than optimal; Felt less energetic; This non-serious initial spontaneous safety report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00232 and NOV25-00224) and concerns a 67-year-old Female who experienced "AFTER BOTH NOVAVAX VACCINES, SHE HAD A SORE ARM AT THE INJECTION SITE", "FOR 24H FELT LESS THAN OPTIMAL" and "FELT LESS ENERGETIC" on an unspecified dates in 2024 and 2025, after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) first time on unspecified date in October/early November 2024 and second time on 11-Feb-2025. At the time of the report, the outcome of the Injection site pain, Feeling abnormal, Asthenia was Recovered/Resolved. A discrepancy was identified in the source document. The events reported were for both doses of the Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) received by the consumer, however, the events are only captured once in this case with the earliest onset date. On 29-Apr-2025, non-significant information was received from a consumer - No new information received. On 27-May-2025, significant information was received from a consumer via contact center (MI No. NOV25-00377) - added "She would experience a fever for a week and a half" event experienced with the mRNA vaccines in the patient past therapy.; Sender's Comments: This 67-year-old Female experienced Injection site pain, Feeling abnormal and Asthenia after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Injection site pain, Feeling abnormal and Asthenia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Injection site pain, Feeling abnormal and Asthenia is considered Possible. More
2851120 F NY 07/25/2025 COVID19
 NOVAVAX
Incomplete course of vaccination, Off label use Incomplete course of vaccination, Off label use
Daughter received the 2024-2025 Novavax vaccine but just one dose; Daughter received the 2024-2025 N... Daughter received the 2024-2025 Novavax vaccine but just one dose; Daughter received the 2024-2025 Novavax vaccine but just one dose; This non-serious initial spontaneous report was reported by a consumer or other non health professional and concerns a female of unspecified age who experienced DAUGHTER RECEIVED THE 2024-2025 NOVAVAX VACCINE BUT JUST ONE DOSE (PT: Incomplete course of vaccination) and DAUGHTER RECEIVED THE 2024-2025 NOVAVAX VACCINE BUT JUST ONE DOSE (PT: Off label use) after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). At the time of the report, the outcome of the Incomplete course of vaccination, Off label use was Recovered/Resolved.; Sender's Comments: This Female of unspecified age experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Incomplete course of vaccination and Off label use were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Incomplete course of vaccination and Off label use is considered Possible. More
2851121 F 07/25/2025 COVID19
 NOVAVAX
Incomplete course of vaccination, Off label use Incomplete course of vaccination, Off label use
I got the one in the last batch in April, but it was only my one shot; I got the one in the last bat... I got the one in the last batch in April, but it was only my one shot; I got the one in the last batch in April, but it was only my one shot; This non-serious initial spontaneous safety report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00415) and concerns a female patient of unspecified age who experienced "I got the one in the last batch in April, but it was only my one shot" and "I got the one in the last batch in April, but it was only my one shot" on an unspecified date in Apr-2025 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on the same day. At the time of the report, the outcome of the Incomplete course of vaccination and Off label use was Recovered/Resolved.; Sender's Comments: This female patient of unspecified age experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Incomplete course of vaccination was reported as non-serious. The event Off label use was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Incomplete course of vaccination and Off label use is considered Possible. More
2851122 F NY 07/25/2025 COVID19
 NOVAVAX
Incomplete course of vaccination, Off label use Incomplete course of vaccination, Off label use
I got my last year only got the one dose, didn't get the second; I got my last year only got th... I got my last year only got the one dose, didn't get the second; I got my last year only got the one dose, didn't get the second; This non-serious initial spontaneous safety report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00427) and concerns an individual of unspecified age and sex who reported experiencing "I GOT MY LAST YEAR ONLY GOT THE ONE DOSE, DIDN'T GET THE SECOND" (Incomplete course of vaccination) and "I GOT MY LAST YEAR ONLY GOT THE ONE DOSE, DIDN'T GET THE SECOND" (off label use) on an unspecified date in 2024 after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) in 2024. At the time of the report, the outcome of the Incomplete course of vaccination, Off label use was Recovered/Resolved. A discrepancy was identified in the source document: For the event of Incomplete course of vaccination and Off label use, event onset year was captured as the year of vaccine administration and event cessation was captured to match the event start date with an outcome of recovered/resolved as it is a special situation event.; Sender's Comments: This Female of an unspecified age experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Incomplete course of vaccination and Off label use were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Incomplete course of vaccination and Off label use is considered Possible. More
2851140 07/25/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Loss of consciousness, Malaise, Oral herpes zoster, Stress, Vaccination failure;... Loss of consciousness, Malaise, Oral herpes zoster, Stress, Vaccination failure; Vertigo More
Suspected vaccination failure; vertigo so bad I passed out; Oral shingles; Vertigo; I get sick or st... Suspected vaccination failure; vertigo so bad I passed out; Oral shingles; Vertigo; I get sick or stressed I break out again; I get sick or stressed I break out again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), passed out (Verbatim: vertigo so bad I passed out) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: Oral shingles), vertigo (Verbatim: Vertigo), sickness (Verbatim: I get sick or stressed I break out again) and stress (Verbatim: I get sick or stressed I break out again). The outcome of the vaccination failure, passed out, oral herpes zoster, sickness and stress were not reported and the outcome of the vertigo was not resolved. It was unknown if the reporter considered the vaccination failure, passed out, oral herpes zoster, vertigo, sickness and stress to be related to Shingles vaccine. The company considered the vaccination failure and passed out to be unrelated to Shingles vaccine. It was unknown if the company considered the oral herpes zoster, vertigo, sickness and stress to be related to Shingles vaccine. Additional Information: GSK receipt date: 21-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the shingle shot, it gave patient oral shingles and vertigo so bad that he/she passed out. 2 years later, the patient still had vertigo issues and when they get sick or stressed it break out again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding oral shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Loss of consciousness is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2851141 07/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; 2 of my friends never had shingles until they got the shot; This seri... Suspected vaccination failure; 2 of my friends never had shingles until they got the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 2 of my friends never had shingles until they got the shot). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 18-JUL-2025 This case was reported by a consumer for his/her friends via interactive digital media. The reporter reported that 2 of his/her friends (patients) never had shingles until they got the shot. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2851142 33 M FL 07/25/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Engerix-B pediatric dose administered to an adult; Underdose; This non-serious case was reported by ... Engerix-B pediatric dose administered to an adult; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 33-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis. On 01-JUL-2025, the patient received Engerix B pediatric. On 01-JUL-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose administered to an adult) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 Pharmacist who covered several health facilities, reported that in another a 33 year-old patient received Engerix-B pediatric dose which led to underdose and adult use of a child product. Lot number or expiration date unavailable at the moment of the call. More
2851143 6 F PA 07/25/2025 HIBV
 SANOFI PASTEUR
 UK093AC
No adverse event, Product preparation error No adverse event, Product preparation error
acthib that was reconstituted with 0.7 merck sterile water solution with no reported adverse event; ... acthib that was reconstituted with 0.7 merck sterile water solution with no reported adverse event; Initial information received on 21-Jul-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 6 years old female patient who received HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with 0.7 merck sterile water solution 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 (hepatitis A vaccine) and pneumococcal vaccine, both for Immunisation. On 17-Jul-2025, the patient received Dose 2 of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength, frequency once with lot UK093AC and expiry date 30-Sep-2025 via intramuscular route in the left deltoid for Immunization that was reconstituted with 0.7 merck sterile water solution with no reported adverse event (product preparation error) (Latency same day) Reportedly, vaccine was mixed incorrectly, that it was not reconstituted with the correct diluent. Product was administered. But there was no adverse event. 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
2851195 42 F NY 07/25/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Borrelia test negative, Impaired work ability, Laboratory test, Malaise, Pain; S... Borrelia test negative, Impaired work ability, Laboratory test, Malaise, Pain; Systemic lupus erythematosus More
A few months after being vaccinated I became ill and thought it was Lyme disease. After several test... A few months after being vaccinated I became ill and thought it was Lyme disease. After several tests, came back not Lyme or any tick borne illnesses. Was finally referred to Rheumatology and 3 yrs later was diagnosed with an auto immune disease. lupus. I cannot work any longer, and I am in pain and don?t feel good most days. My life has been ruined by this. More
✓
2851196 4 F MI 07/25/2025 MMRV
 MERCK & CO. INC.
 Z002987
Injection site erythema Injection site erythema
Patient developed large area of erythema surrounding injection site Patient developed large area of erythema surrounding injection site
2851197 16 F PA 07/25/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 343DD
Extra dose administered Extra dose administered
Patient was given an additional dose of Menveo Patient was given an additional dose of Menveo
2851198 60 F OH 07/25/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EWO158
EWO158
Amyotrophic lateral sclerosis, Asthenia, Depressed level of consciousness, Dyspn... Amyotrophic lateral sclerosis, Asthenia, Depressed level of consciousness, Dyspnoea, Intensive care; Lethargy, Mechanical ventilation, Mobility decreased, Motor neurone disease, Tracheostomy; Amyotrophic lateral sclerosis, Asthenia, Depressed level of consciousness, Dyspnoea, Intensive care; Lethargy, Mechanical ventilation, Mobility decreased, Motor neurone disease, Tracheostomy More
My friend had covid 19 before her 1st vaccine April 7 2021. She was refused to get but due to her wo... My friend had covid 19 before her 1st vaccine April 7 2021. She was refused to get but due to her work policy she must to have. Ten days later after the first vaccine, she started having weakness and lethargy symptoms. She went to see doctors with no diagnosis. When the second vaccine coming , she was very afraid and do not want get the second one. But all the policy ,she had to get it . Two days later ( 8/15/2022 ) after the second vaccine 08/13/2022, She went to ICU due to difficult breath and coma symptoms. At that time she been diagnosed ALS. She has motor neuron damaged, her whole body can not move. She had her trachea cut off and on a ventilator to keep her alive. More
✓ ✓ ✓
2851199 64 F FL 07/25/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 F4AC3
Fatigue, Injection site erythema, Injection site pruritus, Injection site swelli... Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Rash macular More
Patient came in a week after vaccination reporting that they were extremely tired after the vaccine ... Patient came in a week after vaccination reporting that they were extremely tired after the vaccine and then that the site of vaccination had been red, splotchy, swollen, and very itchy. Patient's arm was still red and somewhat swollen at the site of vaccination when they presented back to the pharmacy a week after vaccination. Patient is improving and swelling is going down each day. More
2851200 82 F OH 07/25/2025 COVID19
 MODERNA
 3043409
Death Death
Patient passed away 12/25/2024 with immediate cause listed as Alzheimer's disease. No other inf... Patient passed away 12/25/2024 with immediate cause listed as Alzheimer's disease. No other information known. More
✓
2851201 20 F NC 07/25/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 ZK9P4
Musculoskeletal stiffness Musculoskeletal stiffness
pain and stiffness in right arm reported by Grandfather via phone later in the day. pain and stiffness in right arm reported by Grandfather via phone later in the day.
2851202 18 M KS 07/25/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4ZC23
Incorrect route of product administration Incorrect route of product administration
Inadvertent administration in IM route instead of SC route Inadvertent administration in IM route instead of SC route
2851203 16 F AR 07/25/2025 MNQ
 SANOFI PASTEUR
 U8256A8
Headache, Malaise, Pain, Urticaria Headache, Malaise, Pain, Urticaria
Approx. 24 hours after receiving her vaccination, the patient broke out in hives on the shoulder she... Approx. 24 hours after receiving her vaccination, the patient broke out in hives on the shoulder she got the vaccine in. She was given benadryl, pepcid, and zyrtec, which relieved symptoms, but they returned the next morning. They also spread to the right side of her face. In the week since that, they have continued to appear on her face, neck, back, left arm, abdomen, and legs. She reports experiencing body aches, headaches, malaise. More
2851204 68 M TN 07/25/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 793PT
Fatigue, Inappropriate schedule of product administration Fatigue, Inappropriate schedule of product administration
As of 7/25/25, patient has not experienced any side effects besides some fatigue. He also received a... As of 7/25/25, patient has not experienced any side effects besides some fatigue. He also received a Comirnaty vaccination that day as well. We were notified that the patient has previously received a TDAP in 9/2024 so he has received this vaccination out of the recommended vaccine schedule. This vaccination was not reported to the state database that we had checked so we were unable to see that he received this. More
2851205 11 M TX 07/25/2025 HPV9
 MERCK & CO. INC.
Blindness transient Blindness transient
He lost vision for 30 seconds as he received shot He lost vision for 30 seconds as he received shot
2851206 55 M CA 07/25/2025 HEP
HEPA
IPV
MMR
MNQ
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
 4BX39
22GP3
W1B511M
KH2BD
X4T99
Y007955
No adverse event, Underdose; No adverse event, Underdose; No adverse event, Unde... No adverse event, Underdose; No adverse event, Underdose; No adverse event, Underdose; No adverse event, Underdose; No adverse event, Underdose; No adverse event, Underdose More
Pt received a pediatric dose of Hep A. Pt had no adverse reactions related to this event. Pt tolera... Pt received a pediatric dose of Hep A. Pt had no adverse reactions related to this event. Pt tolerated all vaccines well. Pt was informed and will be coming back in 1 month to receive his adult dose of HEP A. More
2851207 1 M NY 07/25/2025 VARCEL
 MERCK & CO. INC.
 y007955
Skin lesion, Varicella post vaccine, Varicella virus test positive Skin lesion, Varicella post vaccine, Varicella virus test positive
Developed full body lesions 2 weeks post vaccination with lab confirmed varicella from lesion. Developed full body lesions 2 weeks post vaccination with lab confirmed varicella from lesion.
2851208 41 F MI 07/25/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y010656
Y010656
Y010656
Angioedema, Anti-thyroid antibody increased, Antinuclear antibody negative, Biop... Angioedema, Anti-thyroid antibody increased, Antinuclear antibody negative, Biopsy skin, Blood immunoglobulin E; Blood thyroid stimulating hormone normal, C-reactive protein normal, C1 esterase inhibitor test, Complement factor C4, Tryptase; Urticaria, Vitamin D decreased More
Within 24 hours of receiving the injection I developed hives that have not resolved. I have hives ev... Within 24 hours of receiving the injection I developed hives that have not resolved. I have hives every single day, sometimes with migrating facial angiodema. I have taken Benadryl, tried creams, colloidal oatmeal soaks, been biopsied, did a steroid taper, am now taking 4 doses of two different allergy meds (Allegra and Zyrtec), and have received 3 injections of Xolair with no change or relief. There have been no other potential allergens to cause the reaction. More
2851209 14 F NM 07/25/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 XL223
Inappropriate schedule of product administration Inappropriate schedule of product administration
administered vaccine to early not due unti 2027 administered vaccine to early not due unti 2027
2851210 39 F ME 07/25/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 43G92
Expired product administered Expired product administered
Vaccine was unfortunately administered 52 days after Expiration date. Date was missed during workflo... Vaccine was unfortunately administered 52 days after Expiration date. Date was missed during workflow and discovered after administration. Patient was notified and advised to repeat vaccination in one month. Provider office has been notified. Pharmacy Quality Assurance report submitted to improve process to reduce repeat error. More
2851211 1 F IN 07/25/2025 FLU3
FLU3
HEPA
HEPA
MMR
MMR
VARCEL
VARCEL
 SEQIRUS, INC.
SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 946596
946596
L9R92
L9R92
Y014096
Y014096
Y011018
Y011018
Body temperature increased, Gastroenteritis, Influenza A virus test negative, In... Body temperature increased, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative, Irritability; Respiratory syncytial virus test negative, Tachycardia, Urticaria, Vomiting projectile; Body temperature increased, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative, Irritability; Respiratory syncytial virus test negative, Tachycardia, Urticaria, Vomiting projectile; Body temperature increased, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative, Irritability; Respiratory syncytial virus test negative, Tachycardia, Urticaria, Vomiting projectile; Body temperature increased, Gastroenteritis, Influenza A virus test negative, Influenza B virus test negative, Irritability; Respiratory syncytial virus test negative, Tachycardia, Urticaria, Vomiting projectile More
HIVES DEVELOPED LATE EVENING SAME DAY AS VACCINES GIVEN AND WERE WORSE BY NEXT MORNING BUT THEN WE... HIVES DEVELOPED LATE EVENING SAME DAY AS VACCINES GIVEN AND WERE WORSE BY NEXT MORNING BUT THEN WENT AWAY NEXT DAY. TEMP AT HOME 104.7 F RECTAL ON 5-26-25 IN AM AND PROJECTILE VOMITING, FUSSY AND TACHYCARDIA (PULSE 176), MOTHER GAVE IBUPROFEN,. WENT TO ER. ZOFRAN PRESCRIBED DX WAS LIKEY GASTROENTERITIS. HX OF PREMATURE BIRTH 34 WEEKS GESTATION. More
2851212 0.33 F TX 07/25/2025 DTAPIPVHIB
PNC15
RV5
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 UK168AB
Z003633
Y014320
Injection site rash, Injection site warmth, Paraesthesia; Injection site rash, I... Injection site rash, Injection site warmth, Paraesthesia; Injection site rash, Injection site warmth, Paraesthesia; Injection site rash, Injection site warmth, Paraesthesia More
Right thigh prickly skin rash measuring 3in by 1.5in around the injection site and Left thigh prickl... Right thigh prickly skin rash measuring 3in by 1.5in around the injection site and Left thigh prickly skin rash measuring 1in by 1in; felt warm to the touch. Treatment hydrocortisone 1% apply to affected area BID. Patient to follow up Monday 7/28/25. More
2851213 18 F SC 07/25/2025 MNQ
 SANOFI PASTEUR
 u8558ba
Vaccination error Vaccination error
on 07/25/2025 the patient came into the facility for a school physical, she brought a immunization r... on 07/25/2025 the patient came into the facility for a school physical, she brought a immunization record showing that she was due to receive a meningococcal vaccine which i administered to her, but it was later discovered in state system that the patient was not due to have the vaccine. More
2851214 11 F NJ 07/25/2025 MNQ
MNQ
TDAP
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 EK7DG
EK7DG
CX4HL
CX4HL
Diarrhoea, Fatigue, Headache, Injection site pain, Injection site urticaria; Mya... Diarrhoea, Fatigue, Headache, Injection site pain, Injection site urticaria; Myalgia; Diarrhoea, Fatigue, Headache, Injection site pain, Injection site urticaria; Myalgia More
Mother reports that on the evening of 7/16/25, the child began with muscle pain, fatigue, headache,... Mother reports that on the evening of 7/16/25, the child began with muscle pain, fatigue, headache, diarrhea, injection site pain and hives. Mother reports giving the child Tylenol. Denies administering Benadryl or other antihistamines for the hives. Mother states she took the child to urgent care on 7/19/25. No medications or treatments were administered at that time. Mother states the hives resolved on 7/21/25. More
2851215 47 M MO 07/25/2025 TDAP
 SANOFI PASTEUR
 49281-400-20
Arthralgia, Chest X-ray, Chest pain, Electrocardiogram, Neck pain Arthralgia, Chest X-ray, Chest pain, Electrocardiogram, Neck pain
Pain in left shoulder, neck and chest. Ibuprofen Pain in left shoulder, neck and chest. Ibuprofen
2851216 69 F CT 07/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster Herpes zoster
Patient has a case of shingles despite the vaccine Patient has a case of shingles despite the vaccine
2851217 14 M IL 07/25/2025 HPV9
 MERCK & CO. INC.
 Y012865
Cold sweat, Fall, Pallor Cold sweat, Fall, Pallor
Patient received his 2nd dose of Gardasil around 1030 after normal WCC/school physical. He was talki... Patient received his 2nd dose of Gardasil around 1030 after normal WCC/school physical. He was talking and interactive during appointment. He was feeling fine immediately after vaccine and walked out of exam room to check out with guardian. At front desk he went down - unwitnessed by staff but guardian said "fell slowly and did not hit his head" I responded just after fall - no seizure like activity noted, patient was pale and clammy but eyes were opened and with assistance x 2 we were able to stand and walk 15 feet to chair. Re-evaluated multiple times over 45 minutes, and nursing sat with patient. Color returned but he never spoke and could only follow short and simple commands. Guardian did agree to ER evaluation for possible seizure after vaccine. and ER notified. - guardian did report he has had syncopal episode after blood draw in past but never takes more than 30 minutes to come out of it. no known seizures More
2851218 21 F WI 07/25/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 CD44A
Erythema, Induration, Pain in extremity, Peripheral swelling Erythema, Induration, Pain in extremity, Peripheral swelling
Calling 4 days later stating that her left arm is extremely painful, swollen and red. Red area is a... Calling 4 days later stating that her left arm is extremely painful, swollen and red. Red area is about the size of a golf ball and there is a hard area inside of red area about the size of a quarter. Provider on call messaged to address and will give further recommendations. More
2851219 69 F IL 07/25/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9JT4S
9JT4S
Abdominal pain, Diarrhoea, Dizziness, Headache, Nausea; Vomiting Abdominal pain, Diarrhoea, Dizziness, Headache, Nausea; Vomiting
Headache, nausea, diarrhea for 3 days, abdomenal cramps, dizziness and vomiting, in bed for 2 1/2 da... Headache, nausea, diarrhea for 3 days, abdomenal cramps, dizziness and vomiting, in bed for 2 1/2 days. More
2851220 16 F AZ 07/25/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
PFIZER\WYETH
SANOFI PASTEUR
 Y013565
LF5302
U8493AA
Extra dose administered, Nausea, Pain; Extra dose administered, Nausea, Pain; Ex... Extra dose administered, Nausea, Pain; Extra dose administered, Nausea, Pain; Extra dose administered, Nausea, Pain More
Patient was given an extra dose of HPV-9 in error as patient was up to date on this vaccine .Patient... Patient was given an extra dose of HPV-9 in error as patient was up to date on this vaccine .Patients'smom called in to ask what vaccines were recieved as she was not present at the appointment and she was told MCV and MenB. When reviewing patients chart we discovered the HPV-9 was also given to patient . A phone call was placed to mom to notify of the incident and she reported that the patient was having nausea and body aches. More
2851221 1.08 M CA 07/25/2025 HEPA
HEPA
MMR
MMR
PNC20
PNC20
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 A3X2K
A3X2K
Y004116
Y004116
MF0416
MF0416
Y015108
Y015108
Cyanosis, Gaze palsy, Generalised tonic-clonic seizure, Hypotonia, Musculoskelet... Cyanosis, Gaze palsy, Generalised tonic-clonic seizure, Hypotonia, Musculoskeletal stiffness; Tardive dyskinesia, Unresponsive to stimuli; Cyanosis, Gaze palsy, Generalised tonic-clonic seizure, Hypotonia, Musculoskeletal stiffness; Tardive dyskinesia, Unresponsive to stimuli; Cyanosis, Gaze palsy, Generalised tonic-clonic seizure, Hypotonia, Musculoskeletal stiffness; Tardive dyskinesia, Unresponsive to stimuli; Cyanosis, Gaze palsy, Generalised tonic-clonic seizure, Hypotonia, Musculoskeletal stiffness; Tardive dyskinesia, Unresponsive to stimuli More
Patient received MMR, VRZ, Peumo20, and Hep A vaccines for 12 Months WCC visit with Pediatrician on ... Patient received MMR, VRZ, Peumo20, and Hep A vaccines for 12 Months WCC visit with Pediatrician on 07/17/2025 around 08:30am. Patient had no fevers or other symptoms during visit and was discharged. Per mother, around 07:50pm same day, patient started going limp followed by eyes rolling with lip smacking, cyanosis, being unresponsive, and his body stiffened. Patient had his first-time tonic-clonic seizure lasting around 5 minutes. EMS called and transported to ED. During ED visit, patient had 39.4 Celsius fever, Tylenol given, kept under observation, and discharge home with acetaminophen and ibuprofen. ED F/U w/ Dr. the following day. More
2851222 6 F PA 07/25/2025 COVID19
 PFIZER\BIONTECH
 LN7302
Expired product administered Expired product administered
Pt was administered the Covid vaccine 3 days past the Beyond Use date. Pt was administered the Covid vaccine 3 days past the Beyond Use date.
2851223 1.58 M TN 07/25/2025 DTAPIPVHIB
HEPA
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 UK225AB
Y014585
Injection site erythema, Injection site nodule; Injection site erythema, Injecti... Injection site erythema, Injection site nodule; Injection site erythema, Injection site nodule More
Right Thigh has redness that runs into the inner thigh and half dollar size knot. It started late ... Right Thigh has redness that runs into the inner thigh and half dollar size knot. It started late in the afternooon on 07/23/2025. Patient contacted our office. PAC told her to give him Zyrtec and Motrin, try to do a cool compress. Patient's mother brought patient by office 07/25/2025, the redness is going away and the knot has gone down. More
2851224 0.75 M MI 07/25/2025 COVID19
 PFIZER\BIONTECH
 ln7305
No adverse event, Product preparation issue No adverse event, Product preparation issue
There were no adverse reactions. The vaccine was diluted twice. Patient was under dosed. There were no adverse reactions. The vaccine was diluted twice. Patient was under dosed.
2851225 1 F ID 07/25/2025 MMRV
 MERCK & CO. INC.
 X018732
Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered
Patient was given a MMRV vaccine at her 12 month check-up instead of MMR. She was given the varicell... Patient was given a MMRV vaccine at her 12 month check-up instead of MMR. She was given the varicella vaccine as well that day. More
2851226 18 F TX 07/25/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 343DD
Fall, Head injury, Seizure Fall, Head injury, Seizure
Systemic: Seizure-Mild, Additional Details: On 7/15/2025 pt received 2 vaccines - Comirnaty and Menv... Systemic: Seizure-Mild, Additional Details: On 7/15/2025 pt received 2 vaccines - Comirnaty and Menveo in order - on the left deltiod muscle. After aprox one min of receiving the vaccines pt started having a seizure. Pt ws standing up, she bumped her head against the wall and fell. Pt was put in recovery position on the floor. seizure lasted around 30-40 seconds, pt became aware and concious soon after being put in recovery position. 911 and parents contacted. BP 115/75 mmHg , pulse 50 bts/min. Pt refused to go to ER after recovery., Other Vaccines: VaccineTypeBrand: Comirnaty 2024-25; Manufacturer: Pfizer; LotNumber: ME7062; Route: IM; BodySite: LEFT DELTOID; Dose: ; VaxDate: UNKNOWN More
2851227 60 M CA 07/25/2025 COVID19
 PFIZER\BIONTECH
 me6072
Syncope, Unresponsive to stimuli Syncope, Unresponsive to stimuli
Systemic: Fainting / Unresponsive-Medium, Other Vaccines: Vaccine Type Brand: priorix; Manufacturer... Systemic: Fainting / Unresponsive-Medium, Other Vaccines: Vaccine Type Brand: priorix; Manufacturer: gsk; LotNumber: 2N795; Route: Sq; BodySite: right arm; Dose: 1; VaxDate: 07/15/2025 More
2851228 54 F CA 07/25/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 ec2r9
Injection site bruising, Injection site erythema, Rash Injection site bruising, Injection site erythema, Rash
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic:... Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild More
2851229 56 F CA 07/25/2025 PNC21
 MERCK & CO. INC.
 Y019158
Injected limb mobility decreased, Injection site erythema, Injection site pain, ... Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Pain in extremity More
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject... Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient complained of pain in arm and could not lift arm for day after vaccine. Also noted that vaccine site was itchy and red rash formed. She took allergy medications and said arm seemed to be getting better. She did not seek medical help, counseled to monitor and seek help if symptoms get worse but she says they are improving. More
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