🏥 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 💀 🏥 🚑 ♿ ⚠️
2844609 06/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; have them and its been weeks; This serious case was reported by a con... Suspected vaccination failure; have them and its been weeks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 86-year-old 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: have them and its been weeks). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-JUN-2025 This case was reported by a patient via interactive digital media. A patient reported that he/she has them (shingles) and its been weeks. The patient thought he/she had got shots but going to check to make sure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles ) is considered unrelated to GSK vaccine Shingles vaccine. More
2844610 M NC 06/11/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 P2443
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late second dose /first shot of Twinrix in November 2024 and today the second dose was given; This n... Late second dose /first shot of Twinrix in November 2024 and today the second dose was given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis. Previously administered products included Twinrix (received first dose in November 2024.). On 02-JUN-2025, the patient received the 2nd dose of Twinrix. On 02-JUN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose /first shot of Twinrix in November 2024 and today the second dose was given ). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-JUN-2025 The pharmacist called regarding a patient who had received the first shot of Twinrix in November 2024 and today the second dose was given which led to drug dose administration interval too long. The pharmacist asked information about the recommended interval between the delayed second dose and the third dose. More
2844611 11 F CA 06/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB064A
Product administered to patient of inappropriate age, Product preparation error Product administered to patient of inappropriate age, Product preparation error
Use of a Non-approved diluent; Use of a Non-approved diluent; This non-serious case was reported by ... Use of a Non-approved diluent; Use of a Non-approved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 28-MAY-2025, the patient received Menveo. On 28-MAY-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Use of a Non-approved diluent) and inappropriate dose of vaccine administered (Verbatim: Use of a Non-approved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 03-JUN-2025 A Medical assistant called and reported that the Menveo vaccine was administered, and he/she used a different sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked if the patient needs to retake the vaccine. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. More
2844612 CA 06/11/2025 FLU3
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Product storage error; Product storage error Product storage error; Product storage error
Vaccine stored outside recommended conditions and administered to patient.; Repeated dose of Shingri... Vaccine stored outside recommended conditions and administered to patient.; Repeated dose of Shingrix was administered in less time than recommended.; Incorrect storage of drug; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. On 08-OCT-2021, the patient received the 3rd dose of Shingrix. On 21-SEP-2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, not applicable after receiving Shingrix and FluLaval 2024-2025 season and an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient.), extra dose administered (Verbatim: Repeated dose of Shingrix was administered in less time than recommended.) and incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug, extra dose administered and incorrect storage of drug were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-JUN-2025 and 05-JUN-2025 Registered Nurse called to report that she just have a general question. When a vaccine goes out of range. When a vaccine was stored and it was out of range in the refrigerator and if patient had to revaccinate the patient, how soon can we re-vaccinate them? What should be the time interval if it should be immediately or if patient have wait a certain period of time? The reporter asked these questions specifically for the Flu vaccine and the Shingrix. The reporter consented to follow up. The HCP did not specify the conditions of the temperature excursion since she said it happened a couple of years ago. The repeated dose of Shingrix vaccine was administered in less than 28 days. She did not know which number of dose was administered. Less than 20 patients were affected but she stated that they made the report. Patient stated that the flu vaccine was Flulaval however she stated that she did not have the information in front of her. The reporter mentioned that a patient received the second dose of Shingrix, however this dose was involved in a temperature excursion, which led to incorrect storage of drug. Therefore, they revaccinate the patient, which led to extra dose administered. The reporter wanted to confirm if the dose given on 08-OCT-2021 was considered valid since the the CDC recommended a 28-day interval from the invalid dose to reduce the risk for interference from interferon on the subsequent doses. More
2844613 F PA 06/11/2025 MENB
MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS


Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
patient got a possible dose of Menveo on 2020; 69 years old female patient vaccinated with two doses... patient got a possible dose of Menveo on 2020; 69 years old female patient vaccinated with two doses of Bexsero; 69 years old female patient vaccinated with two doses of Bexsero; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 69-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis. The patient's past medical history included splenectomy. On 09-NOV-2020, the patient received the 2nd dose of Bexsero. On 20-JUL-2020, the patient received the 1st dose of Bexsero. On an unknown date, the patient received Menveo. On 20-JUL-2020, an unknown time after receiving Bexsero, Bexsero and Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 69 years old female patient vaccinated with two doses of Bexsero). On 09-NOV-2020, the patient experienced inappropriate age at vaccine administration (Verbatim: 69 years old female patient vaccinated with two doses of Bexsero). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: patient got a possible dose of Menveo on 2020). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and inappropriate age at vaccine administration 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: 05-JUN-2025 Reporter called to ask about a 69 years old female patient who had a splenectomy surgery and the patient was vaccinated on 2020 with two doses of Bexsero and now the patient was coming to receive a dose of Menveo, because she got recommended to get a Men B vaccine every 5 years, which led to inappropriate age at vaccine administration. HCP mentioned that the patient got a possible dose of Menveo on 2020 but they were not really sure because the patient got it in another office and they do not have the record. More
2844614 IL 06/11/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 4KF75
Expired product administered Expired product administered
Expired Dose Administered; This non-serious case was reported by a pharmacist via call center repres... Expired Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis. On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). 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. Additional Information: GSK Receipt Date: 05-JUN-2025 The pharmacist reported that a patient was mistakenly administered an expired Twinrix vaccine, which led to expired vaccine used. So wanted to know the lot number of that and see if there is any recommendations. More
2844615 M GA 06/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Shingrix second dose never administered; This non-serious case was reported by a pharmacist via call... Shingrix second dose never administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 15-APR-2019 with batch number 4X733 and expiry date 08 March 2021). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix second dose never administered). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 05-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter On 5 June 2025, a pharmacist called on behalf of a patient for asking how to proceed on a Shingrix second dose never administered. The patient asked his doctor about getting the complete doses again and wanted it to be confirmed by the manufacturer. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2844616 NH 06/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Possible administration only of the adjuvant portion; Possible administration only of the adjuvant p... Possible administration only of the adjuvant portion; Possible administration only of the adjuvant portion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Possible administration only of the adjuvant portion) and inappropriate dose of vaccine administered (Verbatim: Possible administration only of the adjuvant portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 05-JUN-2025 It was asked if its possible to use the Arexvy vaccine with another diluent, different that the one in the vaccine box. They reported that they cannot find the adjuvant portion for the Arexvy vaccine. They are not sure if they missed the diluent, if they drop the vial, if a patient received only the diluent, etc During the call, they mentioned that they did not administer the powder portion plus another diluent to any patient, however, we will report this as a possible AE in case that a patient received only the adjuvant portion. As they did not know what happened with the Arexvy diluent, HCP did not provide any patient nor vaccine details. They mentioned that they did not administer the powder portion plus another diluent to any patient, however, we will report this as a possible AE in case that a patient received only the adjuvant portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2844617 71 M 06/11/2025 COVID19
 MODERNA
 3042646
COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
testing positive for covid; This spontaneous case was reported by a consumer and describes the occur... testing positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (testing positive for covid) in a 71-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042646) for COVID-19 prophylaxis. The patient's past medical history included Clinical trial participant (Participated in Johnson and Johnson Covid Clinical trial) on 02-Dec-2020. Previously administered products included for Product used for unknown indication: Johnson and johnson Covid Clinical trial (Dose 1, intramuscular and Johnson and Johnson Covid Clinical trial) on 02-Dec-2020; for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 2) on 14-Jan-2021, Moderna Vaccine (Dose 3) on 11-Feb-2021, Moderna Vaccine (Dose 4) on 22-Oct-2021, Moderna Vaccine (Dose 5) on 20-Mar-2022, Moderna Vaccine (Dose 6) on 04-Sep-2022, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Dose 7) on 20-Apr-2023, Moderna Vaccine (Dose 8) on 16-Sep-2023 and Spikevax 2023-2024 formula (Dose 9) on 07-Mar-2024. Past adverse reactions to the above products included No adverse effect with Johnson and johnson Covid Clinical trial, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Moderna COVID-19 vaccine, Moderna Vaccine, Moderna Vaccine, Moderna Vaccine, Moderna Vaccine, Moderna Vaccine and Spikevax 2023-2024 formula. Concurrent medical conditions included Increased blood pressure (under control with medications.), Blood cholesterol increased (under control with medications.) and Seasonal allergy (Seasonal allergies). Concomitant products included Rosuvastatin calcium (Rosuvastatin) for Blood cholesterol increased, Lisinopril for Increased blood pressure, Loratadine (Claritin) for Seasonal allergy, Cyanocobalamin (Vitamin b12) for an unknown indication. On 07-Sep-2024 at 3:00 PM, the patient received tenth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 22-Feb-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced COVID-19 (testing positive for covid). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) from 23-Feb-2025 to 28-Feb-2025 at an unspecified dose and frequency. On 26-Feb-2025, COVID-19 (testing positive for covid) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2025, SARS-CoV-2 test: Positive. On 26-Feb-2025, SARS-CoV-2 test: Negative. The patient was not allergic to previous vaccination, medications, food, or other products. The patient did not receive any other vaccines within first 4 weeks prior to the first administration of the suspect vaccine. It was reported that patient had all Covid-19 vaccinations and boosters and even participated in Clinical trial of Johnson and Johnson vaccine. The patient had avoided getting Covid for four plus years even his wife had it twice. It was reported that the patient tested positive for Covid on 22-Feb-2025 and it did not require a visit to the Emergency Room or Physician's Office. Patient took Paxlovid and tested negative for Covid on 26-Feb-2025. The patient again tested positive on 29-Feb-2025 and mild symptoms resolved in few days but had rebound effect. It was reported that cough and headache of patient had resolved and still had allergy symptoms due to seasonal allergies. No predisposing factors were there and no at risk health issue or exposures. No culture was performed. No other relevant tests were reported. No other antipyretic products used around date of vaccination. More
2844618 41 F VA 06/11/2025 COVID19
 MODERNA
 054C21A
Hyperlipidaemia, Inflammation, Weight, Weight increased Hyperlipidaemia, Inflammation, Weight, Weight increased
Hyperlipidemia, continues to increase and not lower; Body inflammation; Weight gain; This spontaneou... Hyperlipidemia, continues to increase and not lower; Body inflammation; Weight gain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERLIPIDAEMIA (Hyperlipidemia, continues to increase and not lower), INFLAMMATION (Body inflammation) and WEIGHT INCREASED (Weight gain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 28-May-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 25-Jun-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient experienced HYPERLIPIDAEMIA (Hyperlipidemia, continues to increase and not lower), INFLAMMATION (Body inflammation) and WEIGHT INCREASED (Weight gain). The patient was treated with Fluvastatin sodium (oral use) at a dose of 20 milligram once a day. At the time of the report, HYPERLIPIDAEMIA (Hyperlipidemia, continues to increase and not lower), INFLAMMATION (Body inflammation) and WEIGHT INCREASED (Weight gain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2022, Weight: Weight gain. Concomitant medication use information was not provided by reporter. More
2844619 80 M MS 06/11/2025 PNC20
 PFIZER\WYETH
Injection site pain, Oropharyngeal pain, Pain in extremity, Respiratory tract co... Injection site pain, Oropharyngeal pain, Pain in extremity, Respiratory tract congestion More
Arm sore; congestion; Sore throat; Cough; pain on the injection site; This is a spontaneous report r... Arm sore; congestion; Sore throat; Cough; pain on the injection site; This is a spontaneous report received from a Physician from medical information team. An 80-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 29May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 80 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2025, outcome "unknown", described as "Arm sore"; COUGH (non-serious) with onset 2025, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 2025, outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 2025, outcome "unknown", described as "congestion"; VACCINATION SITE PAIN (non-serious) with onset 2025, outcome "unknown", described as "pain on the injection site". Additional information: Patient stated, "I am retired OBGYN (Obstetrics and Gynecology), doctor and I had the Prevnar vaccine one week ago (last Thursday 29May2025). and I looked into the website, and I could not find common side effects. So, I am calling to see if you can tell me what may be is fairly common with this vaccine. I am in tip top shape, I am very healthy, I have no comorbidities, no blood pressure, no diabetes, blood sugar, no pulmonary symptoms, urinary, kidney issues, I am very healthy and other than when I got the vaccine. It really made my arm sore. I was expecting that the nurse told me probably that would happen but I have developed a congestion, a sore throat, a cough". The reporter wondered whether that is common with the Prevnar 20 vaccine. He also mentioned that he had pain on the injection site. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2844620 82 M MA 06/11/2025 COVID19
 PFIZER\BIONTECH
 LM2210
Syncope Syncope
I didn't faint until nearly two and a half days; This is a spontaneous report received from a C... I didn't faint until nearly two and a half days; This is a spontaneous report received from a Consumer or other non HCP. An 82-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Sep2024 at 09:00 as dose 1, single (Lot number: LM2210) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing), notes: heart arrhythmia; "syncope" (ongoing); "A-Fib" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 13Sep2024 as dose number unknown, single; METOPROLOL; LOSARTAN taken for atrial fibrillation, start date: Feb2024; ELIQUIS taken for atrial fibrillation, start date: Feb2024; SIMVASTATIN; DOXAZOSIN; VITAMIN D [VITAMIN D NOS]; MIRALAX; MELATONIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, When I received the original two shots, my only reactions were chills and arm soreness.), for COVID-19 immunization, reaction(s): "chills"; Bnt162b2 (DOSE 1, SINGLE, original two shots,only reactions were chills and arm soreness.), for COVID-19 immunization, reaction(s): "arm soreness"; Bnt162b2 (DOSE 2, SINGLE, original two shots,only reactions were chills and arm soreness.), for COVID-19 immunization, reaction(s): "chills", "arm soreness"; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, tired for the first few booster shots. about 3 years ago, started about 12 hours after the shot and ended after about 24 hours.), administration date: 2022, for COVID-19 immunization, reaction(s): "being tired"; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Staring about 3 years ago, at about 12 hours would get chills, and then in the next 12 hours would faint, quickly awake, but be unstable, not aware of what is going on and sleep for x hours.), administration date: 2022, for COVID-19 immunization, reaction(s): "chills"; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Staring about 3 years ago, at about 12 hours would get chills, and then in the next 12 hours would faint, quickly awake, but be unstable, not aware of what is going on and sleep for x hours.), for COVID-19 immunization, reaction(s): "unstable", "faint". The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "I didn't faint until nearly two and a half days". Therapeutic measures were not taken as a result of syncope. Clinical course: The reporter has a history of heart arrhythmia and syncope, and was more recently diagnosed with atrial fibrillation (AFib). Their current medications include Metoprolol, Losartan, Finasteride, Doxazosin, Simvastatin, and Eliquis. When the initial two COVID-19 vaccine doses were administered, the only side effects reported were chills and soreness in the arm. For the first few booster shots, fatigue was also experienced, typically beginning around 12 hours after the injection and resolving within 24 hours. However, starting approximately three years ago, a new pattern began to emerge. Around 12 hours post-vaccination, chills would set in, followed by an episode of fainting within the next 12 hours. Although consciousness was quickly regained, the individual would remain disoriented, unstable, and would then sleep for several hours. Since the diagnosis of AFib and the initiation of treatment with Losartan and Eliquis, a change has occurred: the interval between receiving the booster and experiencing a fainting episode has gradually increased. After the most recent booster, given in the fall, the fainting did not occur until nearly two and a half days later. Now in their eighties, the reporter remains committed to continuing with COVID-19 boosters.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500117114 same patient, different dose/events;US-PFIZER INC-202500117115 same patient, different dose/events;US-PFIZER INC-202500117116 same patient, different dose/events;US-PFIZER INC-202500117641 same patient, different dose/events; More
2844621 80 M MA 06/11/2025 COVID19
 PFIZER\BIONTECH
Atrial fibrillation, Chills, Syncope Atrial fibrillation, Chills, Syncope
faint/quickly awake/be unstable/not aware of what is going on and sleep for x hours; A-Fib; chills; ... faint/quickly awake/be unstable/not aware of what is going on and sleep for x hours; A-Fib; chills; This is a spontaneous report received from a Consumer or other non HCP. An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Heart arrhythmia" (unspecified if ongoing), notes: Heart; "syncope" (ongoing); "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; SIMVASTATIN; DOXAZOSIN; VITAMIN D NOS; MELATONIN; MIRALAX. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Primary immunisation series complete; manufacturer unknown), for COVID-19 immunisation. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "faint/quickly awake/be unstable/not aware of what is going on and sleep for x hours"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "A-Fib"; CHILLS (non-serious), outcome "unknown". Clinical course: The reporter has a history of heart arrhythmia and syncope, and was more recently diagnosed with atrial fibrillation (AFib). Their current medications include Metoprolol, Losartan, Finasteride, Doxazosin, Simvastatin, and Eliquis. When the initial two COVID-19 vaccine doses were administered, the only side effects reported were chills and soreness in the arm. For the first few booster shots, fatigue was also experienced, typically beginning around 12 hours after the injection and resolving within 24 hours. However, starting approximately three years ago, a new pattern began to emerge. Around 12 hours post-vaccination, chills would set in, followed by an episode of fainting within the next 12 hours. Although consciousness was quickly regained, the individual would remain disoriented, unstable, and would then sleep for several hours. Since the diagnosis of AFib and the initiation of treatment with Losartan and Eliquis, a change has occurred: the interval between receiving the booster and experiencing a fainting episode has gradually increased. After the most recent booster, given in the fall, the fainting did not occur until nearly two and a half days later. Now in their eighties, the reporter remains committed to continuing with COVID-19 boosters. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500117105 same patient, different dose/events;US-PFIZER INC-202500117115 same patient and drug, different dose and events;US-PFIZER INC-202500117641 same patient, different dose/events;US-PFIZER INC-202500117116 same patient, different dose/events; More
2844622 70 F 06/11/2025 COVID19
 PFIZER\BIONTECH
Chills, Hypersomnia, Vaccination site erythema, Vaccination site pain Chills, Hypersomnia, Vaccination site erythema, Vaccination site pain
had a reaction after she received the covid vaccine/redness and soreness in arm; had a reaction afte... had a reaction after she received the covid vaccine/redness and soreness in arm; had a reaction after she received the covid vaccine/redness and soreness in arm; chills; slept for 12 hours last night; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019548 (Biotech), 2021SA279542 (SANOFI). Initial information received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from the patient. This case involves a 70 years old female patient who had a reaction after she received the covid vaccine/ redness and soreness in arm, slight chills, and slept for 12 hours last night while being treated with DUPILUMAB [DUPIXENT] delivered via Dupilumab syringe and COVID-19 VACCINE. And forgot to inject her Dupixent and is z week late on it with no reported adverse event directly linked to product dose omission in error. The patient's past medical history included Personal History of other malignant neoplasm of skin, Insomnia, Gastro-Esophageal Reflux Disease without Esophagitis and Bilateral Acute Atopic Conjunctivitis. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Poly osteoarthritis, Chronic Obstructive Asthma, Allergic Rhinitis Due To Pollen and Allergy-Codeine Sulfate, Iodine, Tizanidine HCL (hydrochloride). Concomitant medications included MULTIVITAMIN [VITAMINS NOT OTHERWISE SPECIFIED (NOS)] (MULTIVITAMIN [VITAMINS NOS]); ASCORBIC ACID, BETACAROTENE, COPPER, MANGANESE, NICOTINIC ACID, RIBOFLAVIN, RIBOFLAVIN, SELENIUM, VITAMIN E NOS, XANTOFYL, ZINC (OCUVITE + LUTEIN); CALCIUM CARBONATE (OYSTER SHELL CALCIUM); ELASOMERAN (SPIKEVAX); MONTELUKAST SODIUM (MONTELUKAST SODIUM); AZELASTINE HCL (AZELASTINE HCL); BECLOMETASONE DIPROPIONATE (QVAR REDIHALER); FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE); MOXIFLCXACIN HCL (MOXIFLOXACIN HCL); FLUCONAZOLE (FLUCONAZOLE); AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN CLAVULANIC ACID); ASPIRIN [ACETYLSALICYLIC ACID] (ASPIRIN [ACETYLSALICYLIC ACID]); GUAIFENESIN (MUCINEX); AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE (AZELASTINE/FLUTlCASONPROPIONAAT); and FAMOTIDINE (FAMOTIDINE). On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection of strength 300 mg/2 ml at a dose of 300 mg Q O W via subcutaneous route for Refractory extrinsic Asthma. On 11-AUG-2021, the patient developed a non-serious event "forgot to inject her Dupixent and is a week late on it with no reported adverse event" (product dose omission in error) (unknown latency) following the first dose intake (Batch number: EW2480, expiry date on 31-Oct-2026) of DUPILUMAB. On 22-Apr-2025, the patient took COVID-19 VACCINE (unknown formulation, strength, dose, frequency, route of administration and indication). On 22-APR-2025, the patient developed a non-serious event "reaction after she received the covid vaccine/redness and soreness in arm" (vaccination site erythema) (vaccination site pain) (unknown latency) following the first dose intake (Batch number: EW2480, expiry date on 31-Oct-2026) of DUPILUMAB and COVID-19 Vaccine. On 22-APR-2025, the patient developed a non- serious event "slight chills" (chills) (unknown latency) following the first dose intake and (unknown latency) (unknown latency) following the first dose intake (Batch: EW2480, expiry date on 31-Oct-2026) of DUPILUMAB and COVID-19 VACCINE. On 22-APR-2025 the patient developed a non- serious event "slept for 12 hours last night" (hypersomnia) (unknown latency) following the first dose intake and (unknown latency) (unknown latency) following the first dose intake and (unknown latency) (unknown latency) following the first dose intake (Batch: EW2480, expiry date on 31-Oct-2026) of DUPILUMAB and COVID-19 VACCINE. It was reported "Patient stated that she forgot to inject her Dupixent and is a week late on it. I advised patient to inject her dose today and resume the every other week dosing. Patient expressed verbal understanding. She had a reaction after she received the covid vaccine on 22-Apr-2025. She has redness and soreness in arm, slight chills, and slept for 12 hours last night. Reports she gets that every time she gets a covid vaccine. No other details provided." Action taken: With respect to Dupilumab: No action taken for the events vaccination site erythema, vaccination site pain, chills, hypersomnia and unknown for the event product dose omission in error. With respect to Covid-19 Vaccine: Not applicable for all the events. Corrective treatment: Not reported for the events vaccination site erythema, vaccination site pain, chills, hypersomnia. Outcome: Unknown for the events vaccination site erythema, vaccination site pain, chills, hypersomnia. 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. Additional information was received on 23-Apr-2025 from patient: Based on information received new events vaccination site erythema, vaccination site pain, chills, hypersomnia, concomitant medications, co-suspect, medical history were added and text amended accordingly. More
2844623 F 06/11/2025 FLU3
 SANOFI PASTEUR
Malaise Malaise
was down and out for 2 days; Initial information received on 05-Jun-2025 regarding an unsolicited va... was down and out for 2 days; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a patient. This case is linked to case- US-SA-2025SA163745 This case involves an unknown age female patient who was down and out for 2 days after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received Influenza Quadrivalent Recombinant Vaccine (form, dose, strength, batch and expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On an unknown date the patient was down and out for 2 days (illness) (unknown latency). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event At time of reporting, the outcome was Unknown for the event; Sender's Comments: US-SA-2025SA163745:Pateint 1 More
2844624 15 M WA 06/11/2025 MEN
 UNKNOWN MANUFACTURER
Inappropriate schedule of product administration Inappropriate schedule of product administration
15 year old was given MENQUADFI a month early with no reported AE; Initial information received on 0... 15 year old was given MENQUADFI a month early with no reported AE; Initial information received on 09-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 years old male patient who was given Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] a month early with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient who was given a dose 2 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection Frequency = once (strength standard) (batch, dose, expiry date unknown) via unknown route in the left arm for Immunization a month early with no reported ae (inappropriate schedule of product administration) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Action taken: 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
2844625 1 M MO 06/11/2025 DTAPIPVHIB
 SANOFI PASTEUR
No adverse event, Product preparation issue No adverse event, Product preparation issue
inappropriate use due to only the DTaP/IPV portion of the product being administered/ The patient on... inappropriate use due to only the DTaP/IPV portion of the product being administered/ The patient only received the liquid part of the vaccine, it was not mixed with no reported adverse event; Initial information received on 10-Jun-2025 (with live follow up process together with CSD: 10-Jun-2025) regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old male patient for whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] inappropriate use due to only the DTaP/IPV portion of the product being administered/ The patient only received the liquid part of the vaccine, it was not mixed with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-May-2025, the patient received an unknown dose (0.5ml) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine; Suspension for injection (lot number, strength and expiry date not reported) via intramuscular route in the left thigh for Immunization; inappropriate use due to only the DTaP/IPV portion of the product being administered/ The patient only received the liquid part of the vaccine, it was not mixed with no reported adverse event (single component of a two-component product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. 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
2844626 30 F GA 06/11/2025 RAB
 SANOFI PASTEUR
Loss of personal independence in daily activities, Muscle spasms Loss of personal independence in daily activities, Muscle spasms
Since a few hours after receiving the shot, I?ve had continuous both painless and painful CONSTANT m... Since a few hours after receiving the shot, I?ve had continuous both painless and painful CONSTANT muscle spasms. I?ve been the the hospital multiple times and they keep saying, ?it?s anxiety? when I know for a fact it is not. It?s been well over a month I?ve been dealing with this and the hospital pushes it off like this is a joke. It?s effecting my daily life and SICK OF NOT BEING LISTENED TOO. They literally tell me it?s ?in my head? yet I?ve NEVER had this issue before. More
2844627 11 M MI 06/11/2025 IPV
 SANOFI PASTEUR
 W1C831M
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received a dose of IPOL when he was not eligible for the dose. Patient has not had any sympt... Patient received a dose of IPOL when he was not eligible for the dose. Patient has not had any symptoms, but did receive an extra dose. More
2844628 56 F NH 06/11/2025 COVID19
 MODERNA
 unknown
Brain fog, Headache, Immediate post-injection reaction, Tinnitus Brain fog, Headache, Immediate post-injection reaction, Tinnitus
Immediate 6/10 headache for one week, brain fog for one week. Approx one month later - tinnitus Immediate 6/10 headache for one week, brain fog for one week. Approx one month later - tinnitus
2844629 0.83 F MI 06/11/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 C24B9
Inappropriate schedule of product administration Inappropriate schedule of product administration
10 month old patient delayed immunizations 10 month old patient delayed immunizations
2844630 72 M NC 06/11/2025 COVID19
 PFIZER\BIONTECH
 ln0591
Colitis ulcerative, Condition aggravated, Faecal calprotectin abnormal Colitis ulcerative, Condition aggravated, Faecal calprotectin abnormal
Reporting suspect effect of covid 19 vaccine and its causal relationship to autoimmune ulcerative co... Reporting suspect effect of covid 19 vaccine and its causal relationship to autoimmune ulcerative colitis condition . this should be further investigated. Patient was first diagnosed with pancolitis in 8/2024 by colonoscopy (he has had numerous previous covid vaccines, He remains asymptomatic, however inflammation due to autoimmune response is increasing. Note my intent on reporting is to report a suspect relationship. I have no actual causal proof. More
✓
2844631 0.42 M NC 06/11/2025 DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
PNC20
PNC20
RV5
RV5
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 K25M5
K25M5
Y005366
Y005366
LN4929
LN4929
2096656
2096656
Condition aggravated, Dermatitis diaper, Electroencephalogram, Full blood count,... Condition aggravated, Dermatitis diaper, Electroencephalogram, Full blood count, Metabolic function test; Rash, Seizure, Viral rash; Condition aggravated, Dermatitis diaper, Electroencephalogram, Full blood count, Metabolic function test; Rash, Seizure, Viral rash; Condition aggravated, Dermatitis diaper, Electroencephalogram, Full blood count, Metabolic function test; Rash, Seizure, Viral rash; Condition aggravated, Dermatitis diaper, Electroencephalogram, Full blood count, Metabolic function test; Rash, Seizure, Viral rash More
Pt taken to ER, 3 seizures 6-5-25. Pt taking Kepra BID. At office visit 6-4-25, pt also had a ras... Pt taken to ER, 3 seizures 6-5-25. Pt taking Kepra BID. At office visit 6-4-25, pt also had a rash to trunk, diaper area, no fever. Diagnosed as viral exanthem. Pt reported to have 1-2 minute seizures a few times a week. Seizure on 6-5-25 lasted 8-10 minutes. Hospitalized overnight and given fosphenytoin loading dose and contiued on Kepra. Pt will habe follow up appointments with Peds neuro and pediatrician More
✓
2844632 63 F OH 06/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
No adverse event, Product preparation issue No adverse event, Product preparation issue
This RN did not reconstitute this vaccine, this RN only gave the adjuvant. No symptoms or issues aft... This RN did not reconstitute this vaccine, this RN only gave the adjuvant. No symptoms or issues after vaccine. More
2844633 11 M MT 06/11/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 Y015180
292L4
DY3K7
Pruritus, Rash, Urticaria; Pruritus, Rash, Urticaria; Pruritus, Rash, Urticaria Pruritus, Rash, Urticaria; Pruritus, Rash, Urticaria; Pruritus, Rash, Urticaria
received call from mom at 4:15pm that child had a rash from head to toe and his palms and feet were ... received call from mom at 4:15pm that child had a rash from head to toe and his palms and feet were itchy. No problems with breathing or swelling in the throat or face. She gave him a Benadryl and the hives resolved several hours later. The next morning I called and the hives are gone and he has no other problems. More
2844634 0.08 F VA 06/11/2025 RV5
 MERCK & CO. INC.
 2003147
Expired product administered, No adverse event Expired product administered, No adverse event
Patient given vaccine that had expired (two days) prior, expired 6/7/2025 and administered 6/9/2025.... Patient given vaccine that had expired (two days) prior, expired 6/7/2025 and administered 6/9/2025. No noted effects or follow-up required at this time. More
2844635 1.25 M NE 06/11/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK216AB
Product preparation issue Product preparation issue
15 month old patient was in for WCC and was suppose to receive Pentacel. However, we discovered toda... 15 month old patient was in for WCC and was suppose to receive Pentacel. However, we discovered today that we had 1 "extra" vial of Hib powder and no vial of Dtap/Polio. I ran an audit and found that this patient is the only one that received that lot number. I came to the conclusion that he only received Dtap & Polio (no Hib). More
2844636 1 M OH 06/11/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Cough Cough
cough , croup like cough , croup like
2844637 0.67 F MD 06/11/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
 YL9YN
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Vaccine given off schedule-reporting Vaccine given off schedule-reporting
2844638 82 M 06/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ME424
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Patient given first dose in series on 07/31/24 and second dose on 9/6/24- less than the 2 month mini... Patient given first dose in series on 07/31/24 and second dose on 9/6/24- less than the 2 month minimum. No side effects noted. More
2844639 31 M 06/11/2025 VARCEL
 MERCK & CO. INC.
Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event More
Provider reconstituted the diluent and the vaccine powder administered right vaccine reconstituted b... Provider reconstituted the diluent and the vaccine powder administered right vaccine reconstituted but clicked the wrong button on a vaccine sheet where it asks if provider is aware that the vaccine needs to be reconstituted. Patient informed of that there is possibility he might have received partial component of Varicella vaccine . Recommendation for revaccination to ensure maximum protection benefits can be reached. Patient declined revaccination. No adverse effects to the patient More
2844640 68 F IN 06/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 L17N34
L17N34
Blister, Burning sensation, Dyspnoea, Nausea, Pruritus; Pyrexia Blister, Burning sensation, Dyspnoea, Nausea, Pruritus; Pyrexia
Fever, Nausea, Skin Broke out into Blisters in Multiple Locations, Burning Sensations, Itchiness, Tr... Fever, Nausea, Skin Broke out into Blisters in Multiple Locations, Burning Sensations, Itchiness, Trouble Breathing for 6 Days More
2844641 79 M WI 06/11/2025 COVID19
 MODERNA
 3046732
Death Death
Expired Expired
✓
2844642 43 M NJ 06/11/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Dizziness, Fatigue, Vomiting Dizziness, Fatigue, Vomiting
Extreme Dizziness and vomiting and fatique Extreme Dizziness and vomiting and fatique
2844643 4 M WV 06/11/2025 IPV
MMRV
TDAP
 SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
 W1C83M
Y019465
U8232AA
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Tdap was given to patient rather than dTap. No adverse reaction or unusual symptoms occurred. Tdap was given to patient rather than dTap. No adverse reaction or unusual symptoms occurred.
2844644 69 M CA 06/11/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Laryngitis Laryngitis
non-febrile laryngitis lasting 3 days. non-febrile laryngitis lasting 3 days.
2844645 62 F CA 06/11/2025 MMR
MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Bursitis, Fatigue, Headache, Lymphadenopathy, Musculoskeletal stiffness; Periphe... Bursitis, Fatigue, Headache, Lymphadenopathy, Musculoskeletal stiffness; Peripheral swelling, Pyrexia, Rash, Rash morbilliform, Swelling face; Tonsillar hypertrophy, Upper-airway cough syndrome More
Summary: Headache, post nasal drip, puffy cheeks, excessive tiredness, measles-like rash on face, to... Summary: Headache, post nasal drip, puffy cheeks, excessive tiredness, measles-like rash on face, torso and upper limbs (not itchy), fever 100.9, swollen tonsils and neck glands. Swollen bursae all over the body in all the major joints and hands, staggered timing over a period of 15 days. Still some residual stiffness and swelling in hands remaining. More
✓
2844646 28 M NY 06/11/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
2 Live vaccines administered on 2 separate days outside the recommendation. MMR vaccine on 06/09/25 ... 2 Live vaccines administered on 2 separate days outside the recommendation. MMR vaccine on 06/09/25 and Varicella vaccine on 06/10/25. Patient has not currently reported experiencing any side effects. More
2844647 77 M MI 06/11/2025 PNC21
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 z002626
Y3Z9P
Pain; Pain Pain; Pain
Pt came in day after vaccine administration, said he could not move his arm without severe pain. No ... Pt came in day after vaccine administration, said he could not move his arm without severe pain. No swelling or redness at injection site when checked More
2844648 0.5 M NV 06/11/2025 HPV9
 MERCK & CO. INC.
 Y009051
No adverse event, Product administered to patient of inappropriate age, Wrong pa... No adverse event, Product administered to patient of inappropriate age, Wrong patient More
Vaccine error - medical assistant gave the HPV vaccine ( that was meant for a different patient) in... Vaccine error - medical assistant gave the HPV vaccine ( that was meant for a different patient) in error to this patient who is 6 months old. No adverse reactions were noted during time in clinic for 30 minutes after vaccine was given. Phone call being made to parent to followup More
2844649 53 F 06/11/2025 YF
 SANOFI PASTEUR
No adverse event, Product preparation error No adverse event, Product preparation error
Vaccine was reconstituted with sterile water instead of normal saline. Patient not exhibiting any ad... Vaccine was reconstituted with sterile water instead of normal saline. Patient not exhibiting any adverse events. More
2844650 54 F MI 06/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 JB4kz
Underdose Underdose
Pediatric Hep B was given instead of Adult. Doctor was notified and she contacted patient and expla... Pediatric Hep B was given instead of Adult. Doctor was notified and she contacted patient and explained what happened and we will administer adult vaccine at next visit. More
2844651 61 F FL 06/11/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9sb34
ast73
Vaccination site infection; Vaccination site infection Vaccination site infection; Vaccination site infection
Patient came in on Thursday 5th of June and said the site of vaccination was infected. RPH advised p... Patient came in on Thursday 5th of June and said the site of vaccination was infected. RPH advised patient to use triple antibiotic cream, patient came back on Sunday the 8th and reported that it was getting better. More
2844652 4 F GA 06/11/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 U8383AB
Injection site erythema, Injection site reaction, Injection site swelling, Skin ... Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion More
erythematous raised lesion at site of injection, non tender, no fevers erythematous raised lesion at site of injection, non tender, no fevers
2844653 1.08 F CT 06/11/2025 VARCEL
 MERCK & CO. INC.
 y015559
Wrong product administered Wrong product administered
child was in office for MMR and Varicella vaccines. Nurse drew up an MMRV and Varicella. Administere... child was in office for MMR and Varicella vaccines. Nurse drew up an MMRV and Varicella. Administered one vaccine before realizing the mistake and excused herself from the room when she realized she wasn't sure which vaccine was given. child was given a varicella but unaware if was given MMRV or Varivax More
2844654 1.75 M MA 06/11/2025 DTAPIPV
 SANOFI PASTEUR
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Pt is 1 year 9 months and received DTAP-IPV combination vax . Pt is 1 year 9 months and received DTAP-IPV combination vax .
2844655 63 F FL 06/11/2025 TDAP
 SANOFI PASTEUR
 2CA55C1
Expired product administered Expired product administered
OUTDATED VACCINE OUTDATED VACCINE
2844656 29 M 06/11/2025 HPV9
 MERCK & CO. INC.
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
I accidentally used a 5/8 inch needle to administer an IM vaccine to a pt over 130 lb instead of the... I accidentally used a 5/8 inch needle to administer an IM vaccine to a pt over 130 lb instead of the recommended 1 inch needle. Pt will have an additional clinic visit to have the vaccine administered with the correct needle length. More
2844657 39 M AZ 06/11/2025 COVID19
 MODERNA
 3046732
Extra dose administered, No adverse event Extra dose administered, No adverse event
No known adverse reaction. Pt received two doses of COVID vaccine. Dose 1: 12/11/2024. Dose 2: 06/11... No known adverse reaction. Pt received two doses of COVID vaccine. Dose 1: 12/11/2024. Dose 2: 06/11/2024 More
2844658 90 F VA 06/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5Y4TL
Rash Rash
patient had shingles vaccine on 03/26/2025 and states she noticed a rash on her ankles on Easter Su... patient had shingles vaccine on 03/26/2025 and states she noticed a rash on her ankles on Easter Sunday (4/20/2025). She stated that she has seen her pcp and he doesn't not believe it is related to shingles vaccine, he believed it could be "flea or something" but patient thinks it might be vaccine. She states she also "may have a rash on some of her body". She has taken prednisone and another medication she didn't not know the name of but took one every 7 days and stated she only saw small improvement. Advised patient to follow up with PCP More
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