🏥 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 💀 🏥 🚑 ♿ ⚠️
2842528 40 F KS 05/23/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 7NX57
Underdose Underdose
administered a pediatric dose of Engerix-B to an adult patient; administered a pediatric dose of Eng... administered a pediatric dose of Engerix-B to an adult patient; administered a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. On 19-MAY-2025, the patient received Engerix B pediatric. On 19-MAY-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: administered a pediatric dose of Engerix-B to an adult patient ) and adult use of a child product (Verbatim: administered a pediatric dose of Engerix-B to an adult patient ). The outcome of the underdose and adult use of a child product 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: 20-MAY-2025 Healthcare professional explained that they administered a pediatric dose of Engerix-B to an adult patient on May 19th 2025, which led to underdose and adult use of a child product. More
2842529 F 05/23/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 AHBVB767BA
Expired product administered Expired product administered
Engerix-b possible expired dose administration; This non-serious case was reported by a nurse via ca... Engerix-b possible expired dose administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number AHBVB767BA) for prophylaxis. On 31-DEC-2009, the patient received Engerix B. On 31-DEC-2009, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-b possible expired dose administration). 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: 20-MAY-2025 Registered nurse wanted to know the expiration date of an Engerix-B that was administered in 2009 given that their system flagged that the vaccine was expired when it was applied which led to expired vaccine use. The Medical Information agent tried to find it through the lot number provided, but had no luck, thus transferred to the Vaccine Service Center was effectuated. The Medical Information agent could catch in their call while leaving after introducing both parts that the expiration date of the product provided by the Vaccine Service Center agent was in 2010, but still made the adverse event report given that the health care provider mentioned that she was not sure that they had the real date of administration because they don't administer vaccines at the end of the year. More
2842530 NJ 05/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
tech giving a Shingrix vaccine subcutaneously; This non-serious case was reported by a other health ... tech giving a Shingrix vaccine subcutaneously; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: tech giving a Shingrix vaccine subcutaneously). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK Receipt Date: 20-MAY-2025 A pharmacy intern called to inform about a pharmacy tech given a Shingrix vaccine subcutaneously, which led to an intramuscular formulation administered by other route. Reporter did not have information about other details concerned this incident. More
2842531 TX 05/23/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 Y3ME2
Expired product administered Expired product administered
received an expired dose of Havrix.; This non-serious case was reported by a other health profession... received an expired dose of Havrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis. On 20-MAY-2025, the patient received Havrix. On 20-MAY-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Havrix.). 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: 21-MAY-2025 The pharmacy manager reported that a child patient received an expired dose of Havrix vaccine, which led to expired vaccine used. The reporter asked was it a valid dose More
2842532 F 05/23/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Twinrix late 4th dose on the rapid schedule; This non-serious case was reported by a other health pr... Twinrix late 4th dose on the rapid schedule; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 03-JAN-2024, lot no 58160-0815-52), Twinrix (received 2nd dose on 10-JAN-2024, lot no 58160-0815-52) and Twinrix (received 3rd dose on 12-FEB-2024, lot no 58160-0815-52). On an unknown date, the patient did not receive the 4th dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Twinrix late 4th dose on the rapid schedule). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-MAY-2025 The pharmacist student reported that they have a patient who was on the rapid Twinrix dose schedule and she was getting her 4th dose and her Twinrix last dose was on 12th February 2024. Till the time of reporting, the patient did not receive 4th dose (booster) of Shingrix, which led to incomplete course of vaccination. More
2842533 M AZ 05/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center repr... Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix in APR-2018). 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 - Late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 21-MAY-2025 The pharmacist reported that a patient received the first Shingrix dose in April 2018 and never got the second dose. The pharmacist asked if the patient should re start the series or just receive a second dose. Till the time of reporting the patient did not received second doe of Shingrix which led to incomplete course of vaccination. More
2842534 FL 05/23/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMAB043A
Product preparation issue Product preparation issue
Menveo 2 vial inadvertent liquid portion only administration; Menveo 2 vial inadvertent liquid porti... Menveo 2 vial inadvertent liquid portion only administration; Menveo 2 vial inadvertent liquid portion only administration; 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 Men ACWY-CRM NVS (Menveo) (batch number AMAB043A, expiry date 31-JUL-2025) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo 2 vial inadvertent liquid portion only administration) and inappropriate dose of vaccine administered (Verbatim: Menveo 2 vial inadvertent liquid portion only administration). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 21-MAY-2025 The Clinic Supervisor wanted to know the recommendations and the required waiting period if revaccination was necessary after only the liquid portion of Menveo (2-vial) had been administered, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The health care provider had been unaware of which patient may have received this until they realized, days later, that a few patients had received Menveo. Only the lot number, expiration date, and a possible range of administration dates had been shared. The Vaccine Administration Facility was the same as the Primary Reporter. The suspected vaccine start date was possibly between 12th March 2025, and 29th April 2025. More
2842535 M TX 05/23/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 L4EA4
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A 1 month old male patient received a dose of Havrix.; This non-serious case was reported by a other... A 1 month old male patient received a dose of Havrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old male patient who received HAV (Havrix) (batch number L4EA4, expiry date 22-JAN-2027) for prophylaxis. On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 1 month old male patient received a dose of Havrix.). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-MAY-2025 The reporter reported that a pediatrician called to report the administration of Havrix to a 1 month old male patient, which led to inappropriate age at vaccine administration. More
2842536 65 F 05/23/2025 COVID19
 MODERNA
Blood test, COVID-19, Illness, SARS-CoV-2 test Blood test, COVID-19, Illness, SARS-CoV-2 test
got COVID four times; sick; This spontaneous case was reported by a patient and describes the occurr... got COVID four times; sick; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got COVID four times) and ILLNESS (sick) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Cancer (Cancer) in 2018, Liver tumour (Liver Cancer), Hepatitis C (I had Hep C for 40 years), Sickness (With the first round of COVID in 2019, because I was sick for like 4 months), COVID-19 (cause it was late December of 2019, early 2020 and it lasted for 4 months almost) and Surgery (Cause I had surgery on my knee, and I got so sick right after that). Concurrent medical conditions included NASH (NASH), Diabetes (Diabetes), Hashimoto's disease (Hashimoto's), Cardiac disorder (heart disease) and Liver cirrhosis (Liver Cirrhosis). Concomitant products included Empagliflozin (Jardiance) for Diabetes, Levothyroxine sodium (Synthroid), Nifedipine (Nifedipine xl) and Diazepam (Valium) for an unknown indication. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID four times) and ILLNESS (sick). At the time of the report, COVID-19 (got COVID four times) had resolved and ILLNESS (sick) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood work is normal and I have the antibodies for rheumatoid arthritis, I have the antibodies for Hashimoto's. On an unknown date, SARS-CoV-2 test: Positive. It was reported that the patient had Covid four times and but was unable to take Paxlovid due to liver cirrhosis. She had received five covid-19 vaccinations, three Moderna and two Pfizer vaccines. Patient had the fourth dose of Pfizer Comirnaty on 19-May-2022 (batch number FM7553) and the fifth dose of Pfizer BioNTech on 06-Nov-2022 (batch number GJ6739) administered intramuscularly in the right arm. Despite having over 100 inflammatory conditions, her blood work appeared normal except for the presence of antibodies related to rheumatoid arthritis and Hashimoto's disease. At the time of reporting, she had reduced her medications from 15 to 4. She took careful precautions before receiving her vaccines, ensuring she was in the best possible health, as she was fearful of any adverse effects. Although she had not initially planned on getting vaccinated, workplace requirements forced her to do so. As an alternative treatment, she tried a herbal formula combined with vitamin D and zinc, which she believed had helped her recover from COVID within three days. She reported that the same remedy had also helped three other COVID-positive individuals recover within three to four days. While she kept the herbal treatment on hand as a backup, she could not find its expiration date, as her medical records only contained details related to the manufacturer, lot, and location. More
2842537 52 F TN 05/23/2025 COVID19
 MODERNA
Infection, Insomnia, Pain, Pruritus Infection, Insomnia, Pain, Pruritus
Itchy and painful infection site; Itchy and painful infection site; Itchy and painful infection site... Itchy and painful infection site; Itchy and painful infection site; Itchy and painful infection site; insomnia; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Itchy and painful infection site), PRURITUS (Itchy and painful infection site), INFECTION (Itchy and painful infection site) and INSOMNIA (insomnia) in a 52-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 09-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (Itchy and painful infection site), PRURITUS (Itchy and painful infection site), INFECTION (Itchy and painful infection site) and INSOMNIA (insomnia). At the time of the report, PAIN (Itchy and painful infection site), PRURITUS (Itchy and painful infection site), INFECTION (Itchy and painful infection site) and INSOMNIA (insomnia) was resolving. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. More
2842538 60 05/23/2025 COVID19
 MODERNA
COVID-19 COVID-19
I now have covid again; This spontaneous case was reported by a patient and describes the occurrence... I now have covid again; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I now have covid again) in a 60-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (2 years ago) in 2023. Concurrent medical conditions included Immune disorder (NOS). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I now have covid again). At the time of the report, COVID-19 (I now have covid again) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. The patient could not even afford to go to the physician for it due to the company's insurance. No treatment information was provided. More
2842539 18 M KY 05/23/2025 COVID19
 PFIZER\BIONTECH
Cardiac disorder, Heart rate, Heart rate irregular, Myocarditis, Palpitations Cardiac disorder, Heart rate, Heart rate irregular, Myocarditis, Palpitations
ALL the symptoms of myocarditis.; heart palpitations; heart problem; irregular heart beat; This is a... ALL the symptoms of myocarditis.; heart palpitations; heart problem; irregular heart beat; This is a spontaneous report received from a Consumer or other non HCP. An 18-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 18 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant) with onset Jul2021, outcome "not recovered", described as "ALL the symptoms of myocarditis."; PALPITATIONS (non-serious) with onset Jul2021, outcome "not recovered", described as "heart palpitations"; CARDIAC DISORDER (non-serious) with onset Jul2021, outcome "not recovered", described as "heart problem"; HEART RATE IRREGULAR (non-serious) with onset Jul2021, outcome "not recovered", described as "irregular heart beat". The patient underwent the following laboratory tests and procedures: Heart rate: irregular. Therapeutic measures were not taken as a result of myocarditis, palpitations, cardiac disorder, heart rate irregular. Clinical course: The patient was forced to take the Pfizer vaccine when he was in basic training for the military around Jun2021, he was 19 at the time. He had heart problems ever since, heart palpitations, irregular heartbeat, as-well as all the symptoms of myocarditis. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2842540 MI 05/23/2025 COVID19
 PFIZER\BIONTECH
Gait inability Gait inability
I woke up unable to walk. I now live with a lifelong disability; This is a spontaneous report receiv... I woke up unable to walk. I now live with a lifelong disability; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (hospitalization, disability), 10 days after the suspect product(s) administration, outcome "unknown", described as "I woke up unable to walk. I now live with a lifelong disability". The patient now live with a lifelong disability, patient had 2 surgeries, got hospitalized multiple times a year and this has been going on for a few years now. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
✓ ✓
2842541 1.33 F IN 05/23/2025 DTAPIPVHIB
 SANOFI PASTEUR
No adverse event, Product preparation issue No adverse event, Product preparation issue
nurse only gave her 1 component and not the other. he thinks that the patient only received the hib ... nurse only gave her 1 component and not the other. he thinks that the patient only received the hib component, but he is not sure with no reported ae; Initial information received on 21-May-2025 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional. This case involves a 16 months old female patient and reporter reported that nurse only gave patient 1 component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and not the other. Reporter thought that the patient only received the HIB component, but he was not sure with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in May 2025, the patient received an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with standard strength (expiry date and lot number not reported) once via unknown route in the leg for Immunization and nurse only gave her 1 component and not the other. Reporter thought that the patient only received the HIB component, but he was not sure 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
2842542 12 M NY 05/23/2025 MEN
 UNKNOWN MANUFACTURER
 U8369BA
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
menquadfi was given twice to a patient 19 days apart with no reported adverse event; Initial informa... menquadfi was given twice to a patient 19 days apart with no reported adverse event; Initial information received on 21-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 12 years old male patient who has been administered Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] twice, 19 days apart 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 HPV Vaccine for prophylactic vaccination. On 01-May-2025, the patient received a 0.5 ml 1x (once) (dose:1) of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (batch number: U8369BA, expiry date: 31-Mar-2028) via intramuscular route in the left arm and on 20-May-2025 the patient had received a 0.5 ml 1x (dose:2) of same vaccine (batch number and expiry date) via intramuscular route in the left arm for immunization. On 20-MAY-2025 Meningococcal A-C-Y-W135 (T CONJ) Vaccine was given twice to a patient 19 days apart with no reported adverse event (Inappropriate schedule of product administration) (latency: 19 days). 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
2842543 TX 05/23/2025 DTAP
 SANOFI PASTEUR
 2CA54C3
Expired product administered, No adverse event Expired product administered, No adverse event
one of the nurses administered daptacel that "went out of date" to a patient with no repor... one of the nurses administered daptacel that "went out of date" to a patient with no reported ae; Initial information received on 21-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient to whom one of the nurses administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] that "went out of date" 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 in 2025, one of the nurses administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection (dose, strength unknown) lot 2CA54C3 expiry date-07-Apr-2025 via unknown route in unknown administration site for Immunization that "went out of date" to a patient with no reported ae (expired product administered) (same day latency). 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
2842545 32 F CA 05/23/2025 FLU3
HEP
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UT8496LA
2ME34
EB499
Unevaluable event; Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event; Unevaluable event
None None
2842546 79 M CO 05/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 E754F
Pruritus Pruritus
starting the following day, pt experienced full body itching. Then again the following Sat, and one... starting the following day, pt experienced full body itching. Then again the following Sat, and one more day. symptoms came and went. More
2842547 58 F CO 05/23/2025 HEP
HEPA
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 47XP4
2345B
U8389AA
No adverse event, Underdose, Walking aid user; No adverse event, Underdose, Walk... No adverse event, Underdose, Walking aid user; No adverse event, Underdose, Walking aid user; No adverse event, Underdose, Walking aid user More
Adult patient was given pediatric dose of Hep B. No reaction or treatment required. Patient left c... Adult patient was given pediatric dose of Hep B. No reaction or treatment required. Patient left clinic in stable ambulatory (on crutches) condition. Error discovered after patient left. PCP notified via direct verbal the day of error. Patient notified. Managers notified the next day. Contacted Clinic Nurse Consultant via email. Reply stated that patient will need an adult dose administered. PCP and patient notified. Patient states she will have the vaccine on 06/09/2025 when she comes in for a visit. NUrse visit appointment made for patient. More
2842558 37 M PA 05/23/2025 COVID19
 PFIZER\BIONTECH
Myocarditis, Pericarditis, Troponin increased Myocarditis, Pericarditis, Troponin increased
Acute myocarditis and pericarditis, inpatient for 3 days Acute myocarditis and pericarditis, inpatient for 3 days
✓ ✓
2842559 83 F NV 05/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 MG5S9
Erythema, Lip swelling, Swelling Erythema, Lip swelling, Swelling
got a call on 5/22/25 patient got her 1st shingrix dose on 5/19/25 then on 5/21/25 she experience sw... got a call on 5/22/25 patient got her 1st shingrix dose on 5/19/25 then on 5/21/25 she experience swollen lips and extending to her left neck where she had a previous shingle outbreak. I follow-up on 5/22/25 around 645pm and redness had spread to her face and she was advised by NP to take 2 tablets of benadryl to help her situation. More
2842560 81 M MO 05/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 94se2
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received 3rd dose of shingrix, previous 2 doses were 01/20/2021 and 7/1/2024. no adverse rea... Patient received 3rd dose of shingrix, previous 2 doses were 01/20/2021 and 7/1/2024. no adverse reaction reported. More
2842561 1.25 M MN 05/23/2025 DTAPIPVHIB
DTAPIPVHIB
PNC20
PNC20
 SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
 UK199AA
UK199AA
LX4484
LX4484
Contusion, Ear infection, Immune thrombocytopenia, Petechiae, Platelet count dec... Contusion, Ear infection, Immune thrombocytopenia, Petechiae, Platelet count decreased; Pyrexia, Synovitis, White blood cell count increased, X-ray; Contusion, Ear infection, Immune thrombocytopenia, Petechiae, Platelet count decreased; Pyrexia, Synovitis, White blood cell count increased, X-ray More
Patient developed petechiae on entire body 10 days following vaccine. Guardian took patient to the ... Patient developed petechiae on entire body 10 days following vaccine. Guardian took patient to the emergency department where blood was drawn for lab work. Patient's platelets were only 6. Petechiae and bruising continued to worsen, and patient was admitted to the hospital to be seen by hematology. Patient was diagnosed with ITP (Immune Thrombocytopenia Purpura) as a direct cause of immune response to vaccines given. Patient also had fevers as high as 104 and subsequently developed a double ear infection, and synovitis in legs. Required 5 days of prednisone for ITP and IM Rocephin in conjunction with oral amoxicillin for severe ear infection. More
✓
2842562 29 F CA 05/23/2025 IPV
IPV
 SANOFI PASTEUR
SANOFI PASTEUR
 y1a212m
y1a212m
Blood pressure decreased, Dizziness, Loss of consciousness, Malaise, Nausea; Pre... Blood pressure decreased, Dizziness, Loss of consciousness, Malaise, Nausea; Presyncope, Vomiting More
Patient came to the pharmacy today to receive a Polio vaccine per recommendation. Pt responded "... Patient came to the pharmacy today to receive a Polio vaccine per recommendation. Pt responded "no" to all vaccine precautions and contraindications on the immunization consent form. Pt reported receiving a Covid vaccine a few days before and preferred the polio vaccine on the same arm, so only the left arm would be sore. Pt did not report any other adverse effects from the recent Covid vaccine. Within minutes of administering the Polio vaccine, pt reported not feeling too well. Rph advised pt to stay seated in the the consultation room to be closely monitored. Pt requested some water and while waiting pt's condition started to get worse and pt reported feeling very light headed and about to pass out. Rph held pt to prevent any falls and pt slowly lost consciousness for a few seconds. Rph requested pharmacy staff to call for help, and while on the phone with 911 pt became responsive and requested that EMS is not needed. Pt was still not feeling well and felt like she is going to pass out. She felt nauseous and vomited. Rph stayed close by to prevent her from falling from the chair. Pt's blood pressure was measured and it was very low in 60s/30s and heart rate in 40s. After raising her feet up and drinking some electrolyte solution, pt's blood pressure gradually went up in the 70s/40s and heart rate in 50s, and pt reported feeling better. Pt's boyfriend was accompanying her and they were advised to go to a doctor's office or urgent care to monitor pt until her blood pressure/heart rate is back in a normal range. Pharmacy provided pt with an electric scooter to be transported to her car. Pt reported having a similar reaction to blood draw before but not to vaccines or as extreme as today. Rph reported the event to Dr, who evaluated the event as a vasovagal reaction and believes that pt received the proper care at the pharmacy. More
2842563 64 F NM 05/23/2025 PNC21
 MERCK & CO. INC.
 z003579
Cellulitis, Infection, Swelling Cellulitis, Infection, Swelling
swelling, cellulitis, infection. patient went to see the doctor and got a Clindamycin prescription, ... swelling, cellulitis, infection. patient went to see the doctor and got a Clindamycin prescription, the antibiotic from the doctor. More
2842564 49 M AZ 05/23/2025 COVID19
COVID19
 MODERNA
MODERNA

Antinuclear antibody positive, Headache, Hyperacusis, Movement disorder, Photoph... Antinuclear antibody positive, Headache, Hyperacusis, Movement disorder, Photophobia; Temperature intolerance More
Intense headache and sensitivity to light/sound/temperature/movement which has continued to today. N... Intense headache and sensitivity to light/sound/temperature/movement which has continued to today. No treatment has yet helped much. More
2842719 72 F MI 05/23/2025 FLU3
 SEQIRUS, INC.
 388489
Blood test normal, Gait inability, Mobility decreased, Pain, Urine analysis norm... Blood test normal, Gait inability, Mobility decreased, Pain, Urine analysis normal More
Woke up in the early morning with terrible amount of pain from my neck to my feet. I could not walk ... Woke up in the early morning with terrible amount of pain from my neck to my feet. I could not walk move my hands, and lift my arm. I could not sit up, could only lay down. Took Motrin, pain eased very little, went right to my Dr. Ran blood for and precriped predisone. Saw my heart Dr. Saw my Oncologist, then saw my Rheumatologist was precribed moloxicam for pain. Also took NARCO. I was in pain for 3 months. More
2842181 VA 05/22/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 Unknown
Unknown
Cough, Influenza virus test negative, Laboratory test, Measles, Polymerase chain... Cough, Influenza virus test negative, Laboratory test, Measles, Polymerase chain reaction positive; Pyrexia, Rash, Rash maculo-papular, Rhinorrhoea, SARS-CoV-2 test negative More
measles-like symptoms following vaccination; This spontaneous report was received from a consumer re... measles-like symptoms following vaccination; This spontaneous report was received from a consumer regarding a child patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 23-APR-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 mL administered intramuscularly as prophylaxis (lot number reported as 4015995, which is an invalid lot number for this product, expiration date reported as 24-SEP-2026) (vaccination scheme and anatomical site of injection were not reported). The vaccine was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot # and expiration date were not reported). On 01-MAY-2025, the patient started to experience unusually severe measles-like symptoms (Measles) following the vaccination, such as runny nose and cough. On 04-MAY-2025, the patient experienced maculopapular rash covering most of the body. On 05-MAY-2025, the patient experienced 102 Fahrenheit degree (F) fever. On an unknown date in 2025, the patient tested negative for COVID and flu, and polymerase chain reaction (PCR) showed +. MeVa test result was pending. The outcome of measles-like symptoms was unknown. The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported. More
2842182 13 M 05/22/2025 HPV9
MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Dyspnoea, Urticaria; Dyspnoea, Urticaria; Dyspnoea, Urticaria Dyspnoea, Urticaria; Dyspnoea, Urticaria; Dyspnoea, Urticaria
shortness of breath; hives; This spontaneous report was received from a consumer via Company represe... shortness of breath; hives; This spontaneous report was received from a consumer via Company representative, concerning their child as a currently 15-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On approximately 2023 (reported as "at age 13"), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) dose number 1, 0.5 mL administered by intramuscular (IM) route (lot #, expiration date and anatomical location were not reported); and on the same date with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 mL (dosage regimen, lot #, expiration date, anatomical location and route of administration were not reported) which was diluted with sterile diluent, 0.5 mL (expiration date, and lot # were not reported). Both vaccines were administered as prophylaxis. On an unknown date, after receiving his first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), shortness of breath (dyspnoea) and hives (urticaria.) The patient recovered from the events on an unspecified date. The causal relationship between dyspnoea, urticaria and the suspect vaccines/sterile diluent was not provided. Lot # is being requested and will be submitted if received. More
2842184 TX 05/22/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
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; Inappropriate schedule of product administration, No adverse event More
No additional AE; stated patient is scheduled to receive third dose on 5/16/2025; patient received t... No additional AE; stated patient is scheduled to receive third dose on 5/16/2025; patient received the 2 dose of GARDASIL 9 doses outside of the schedule regimen within the Prescribing Information on 17-JAN-2025; This spontaneous report was received from a pharmacist on 16-MAY-2025 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-MAR-2024, the patient was vaccinated with a first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (lot #, expiration date, dose, anatomical location and route of administration were not mentioned) for prophylaxis. On 17-JAN-2025, the patient received the second dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) outside of schedule regimen within the Prescribing Information (lot #, expiration date, dose, anatomical location and route of administration were not mentioned) for prophylaxis (Inappropriate schedule of product administration). Reporter stated patient was scheduled to receive third dose on 16-MAY-2025 (Inappropriate schedule of product administration). No additional adverse event reported. Lot # is being requested and will be submitted if received. More
2842185 M VA 05/22/2025 MMR
 MERCK & CO. INC.
 4015995
Morbillivirus test positive Morbillivirus test positive
Measles PCR+; This spontaneous report was received from an unspecified health care professional on 1... Measles PCR+; This spontaneous report was received from an unspecified health care professional on 16-MAY-2025 and refers to a Child male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-APR-2025, the patient was vaccinated with a first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (Batch/Lot number 4015995 is an invalid batch/lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live , expiration date reported as 24-SEP-2026), (dose, frequency, anatomical location, and route of administration were not reported) and with a first dose of sterile diluent (MERCK STERILE DILUENT), (dose, frequency, anatomical location, route of administration, lot#, expiration date and indication were not reported) for prophylaxis at Clinic. On 10-MAY-2025, the patient presented to the emergency department with fever, rash, wheezing, and cough, and was confirmed measles Polymerase Chain Reaction (PCR) positive, on 15-MAY-2015 (Measles). They would submit the specimen for Measles Virus Genotype A Realtime -qPCR (MeVA) testing to confirm it is vaccine strain as soon as the specimen arrived at their state lab." At the reporting time, the outcome of Measles was unknown. The reporter considered the event unknown to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and sterile diluent (MERCK STERILE DILUENT). Lot # will be requested and will be submitted if received. This is one of several reports from the same source. More
2842186 F FL 05/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster, Rash Herpes zoster, Rash
Shingles; This non-serious case was reported by a consumer via call center representative and descri... Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood pressure high and blood cholesterol increased. Concomitant products included atenolol, losartan, simvastatin and acetylsalicylic acid (Aspirin). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The patient was treated with aciclovir sodium (Acyclovir) and bentonite, calamine, phenol, zinc oxide (Calamine). The outcome of the shingles was resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 15-MAY-2025 The reporter was the patient who received 2 doses of Shingrix last year. 2 days after each dose, she experienced a rash on her right buttock that was diagnosed as shingles. It was the size of a silver dollar and in both instances, the rash was in the same spot. It did not get bigger or spread. Her doctor prescribed acyclovir 400 mg and the rash went away after 1 or 2 weeks. She also applied calamine lotion to the rash in addition to taking acyclovir. For tolerance of 2nd dose of Shingrix, refer case US2025AMR060778.; Sender's Comments: US-GSK-US2025AMR060778:same patient/Dose 2 More
2842187 0.33 F NY 05/22/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 Y49BZ
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Vaccine inappropriate age administration; of 4 months old instead of the correct age vaccine and thi... Vaccine inappropriate age administration; of 4 months old instead of the correct age vaccine and this was supposed to be the second dose in the DTaP series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On 15-MAY-2025, the patient received the 2nd dose of Kinrix. On 15-MAY-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Vaccine inappropriate age administration) and inappropriate schedule of vaccine administered (Verbatim: of 4 months old instead of the correct age vaccine and this was supposed to be the second dose in the DTaP series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:15-MAY-2025 The reporter called to inform that a Kinrix vaccine dose was administered to a female patient of 4 months old instead of the correct age vaccine and this was supposed to be the second dose in the DTaP series, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reporter wanted to know how to proceed. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. More
2842188 M KY 05/22/2025 DTPPVHBHPB
PNC15
RV5
 MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
 U7767AA
Incorrect route of product administration, Off label use; Incorrect route of pro... Incorrect route of product administration, Off label use; Incorrect route of product administration, Off label use; Incorrect route of product administration, Off label use More
an inappropriate use due to VAXELIS being administered via the incorrect route/VAXELIS to a patient ... an inappropriate use due to VAXELIS being administered via the incorrect route/VAXELIS to a patient subcutaneous instead of intramuscular; This non-serious spontaneous safety report, with reference number 02733835 (interaction number: 02733830), was received by partner on 28-FEB-2025 and forwarded to UBC on 03-MAR-2025 from other health professional. Off-label classification was added due to Vaxelis being administered via incorrect route. Due to the nature of the event, the causality between the event 'an inappropriate use due to VAXELIS being administered via the incorrect route/VAXELIS to a patient subcutaneous instead of intramuscular' and Vaxelis was not applicable. Further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION was received from a health professional on 28-MAR-2025. Due to the nature of the event, the causality between the event 'an inappropriate use due to VAXELIS being administered via the incorrect route/VAXELIS to a patient subcutaneous instead of intramuscular' and Vaxelis was not applicable. No further information is expected. More
2842189 F GA 05/22/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7921AA
Needle issue, Underdose Needle issue, Underdose
Received less than the desired dose/needle came off of the syringe tip and some of the product was n... Received less than the desired dose/needle came off of the syringe tip and some of the product was not administered; Received less than the desired dose/needle came off of the syringe tip and some of the product was not administered; Received less than the desired dose/needle came off of the syringe tip and some of the product was not administered; This non-serious spontaneous safety report, with reference number 02763066 (interaction number: 02763063), was received by partner on 03-MAR-2025 and forwarded on 04-MAR-2025 from other health professional. Additional information was received on 04-MAR-2025 by the partner and forwarded on 05-MAR-2025 from the other health professional. Combination product classification was added as the event concerned the device part. Due to the nature of the event, the causality between the event "6 month old female received less than the desired dose of VAXELIS. HCP states that during administration of the vaccine, the needle came off of the syringe tip and some of the product was not administered to the patient", and Vaxelis was not applicable. Further information is expected. Non-significant follow-up information was received by the partner on 04-MAR-2025 and forwarded on 10-MAR-2025, from other health professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the event "6 month old female received less than the desired dose of VAXELIS. HCP states that during administration of the vaccine, the needle came off of the syringe tip and some of the product was not administered to the patient", and Vaxelis was not applicable. Further information is expected. More
2842190 F NJ 05/22/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Contusion, Erythema, Skin mass, Skin warm Contusion, Erythema, Skin mass, Skin warm
lump under the skin; warm to the touch; lump under the skin and appears bruised.; The area became re... lump under the skin; warm to the touch; lump under the skin and appears bruised.; The area became red; This non-serious spontaneous, Safety Report was received by partner, on 12-MAR-2025 and forwarded on 12-MAR-2025 from a consumer. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events; "lump under the skin" "warm to the touch"", lump under the skin and appears bruised"; and "The area became red". Further information is expected. More
2842191 TX 05/22/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administ... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; This non-serious spontaneous safety report, with reference number 02778163 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842192 TX 05/22/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; HCP confirmed that there were no symptomatic events; This non-serious spontaneous safety report, with reference number 02778139 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds', 'HCP confirmed that there were no symptomatic events' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770. Further information is expected. More
2842193 F 05/22/2025 COVID19
 PFIZER\BIONTECH
 MD3414
COVID-19, Vaccination failure COVID-19, Vaccination failure
COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from medi... COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Apr2025 as dose 1, single (Lot number: MD3414) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN (All of her COVID vaccines prior to Comirnaty were manufactured by Moderna)), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2025, outcome "unknown" and all described as "COVID-19". It was reported on 20May2025 that the patient contracted COVID-19 the week prior. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included nirmatrelvir, ritonavir (PAXLOVID). No follow-up attempts are possible. More
2842202 GA 05/22/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
Product preparation error Product preparation error
Bexsero syringe is not shaken immediately before use; This non-serious case was reported by a other... Bexsero syringe is not shaken immediately before use; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong technique in product usage process (Verbatim: Bexsero syringe is not shaken immediately before use). The outcome of the wrong technique in product usage process was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 15-MAY-2025 The medical assistant did not provided the details of the healthcare providers that prepare and administer the product. The Bexsero syringe was not shaken immediately before use which led to wrong technique in product usage. More
2842203 05/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Blood pressure increased Blood pressure increased
I experienced a rise with blood pressure with the first Shingles; This non-serious case was reported... I experienced a rise with blood pressure with the first Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of increased blood pressure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced increased blood pressure (Verbatim: I experienced a rise with blood pressure with the first Shingles). The outcome of the increased blood pressure was not reported. It was unknown if the reporter considered the increased blood pressure to be related to Shingrix. It was unknown if the company considered the increased blood pressure to be related to Shingrix. Additional Information: GSK receipt date: 16-MAY-2025 Patient stated that they experienced a rise with blood pressure with the first Shingrix vaccine. Patient was hesitate to take the second shot. More
2842204 05/22/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site erythema Injection site erythema
severely red about the size of a baseball injection site; This non-serious case was reported by a co... severely red about the size of a baseball injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In MAY-2025, the patient received Shingles vaccine. In MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced injection site erythema (Verbatim: severely red about the size of a baseball injection site). The outcome of the injection site erythema was not reported. It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine. It was unknown if the company considered the injection site erythema to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAY-2025 The case was received from the patient via (Shringrix GSK Chatbot) interactive digital media. The reporter got a shingle shot 3 days before reporting and it was red severely red about the size of a baseball injection site. More
2842205 M MO 05/22/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 39LB7
Product storage error Product storage error
Administration after a below temperature excursion of 29.9�F as the minimum reached; This non-seri... Administration after a below temperature excursion of 29.9�F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9�F as the minimum reached). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Boostrix. The Vaccine Administration Facility was the same as Primary Reporter; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient More
2842206 F MO 05/22/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 39LB7
Incorrect dose administered Incorrect dose administered
Administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non... Administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 15-MAY-2025 Other HCP reported that after giving several vaccines that were exposed to a below temperature excursion of 29.9 degree F as the lowest reached for Boostrix, which led to incorrect storage of drug. This case is 1 of 3 cases reported by same reporter.; Sender's Comments: US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient More
2842207 F MO 05/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 M7G39
Product storage error Product storage error
Administration after a below temperature excursion of 29.9�F as the minimum reached; This non-seri... Administration after a below temperature excursion of 29.9�F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9�F as the minimum reached). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Shingrix. The Vaccine Administration Facility was the same as Primary Reporter; Sender's Comments: US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient More
2842208 F MO 05/22/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 LB93L
Product storage error Product storage error
Administration after a below temperature excursion of 29.9�F as the minimum reached; This non-seri... Administration after a below temperature excursion of 29.9�F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number LB93L) and (batch number AMVBO44A) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9�F as the minimum reached). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Menveo. The Vaccine Administration Facility was the same as Primary Reporter; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061573:SAME PATIENT SAME REPORTER, DIFFERENT SUSPECT More
2842276 31 F MI 05/22/2025 RSV
 PFIZER\WYETH
Exposure during pregnancy, Pathology test, Premature delivery, Premature separat... Exposure during pregnancy, Pathology test, Premature delivery, Premature separation of placenta, Stillbirth More
Had a stillbirth at 34 weeks gestation secondary to placental abruption. Baby was born with a weight... Had a stillbirth at 34 weeks gestation secondary to placental abruption. Baby was born with a weight of 4lb 4oz. Acute onset with minimal to no risk factors. Autopsy results were normal. Placental path just showed placental abruption More
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2842277 38 F MI 05/22/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 PE9G5
Expired product administered Expired product administered
vaccine expired on 5/19/2025 vaccine expired on 5/19/2025
2842278 11 F MI 05/22/2025 HPV9
MENB
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 Y003462
TH9NR
3CA17C1
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Individual given three vaccines, two in the left deltoid and the other in the right deltoid. After ... Individual given three vaccines, two in the left deltoid and the other in the right deltoid. After administration client and mother left with information on all the vaccines given. Soon after individual left this writer noticed that MenB was given instead of MenQuadfi. Called the mother of the client to notify her that an error was made but that it wouldn't cause any injury at 4:17 pm. Emailed direct supervisor with the error and outcome. More
2842279 82 M IA 05/22/2025 COVID19
 MODERNA
Death Death
Passed away while receiving hospice care. Passed away while receiving hospice care.
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