🏥 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 💀 🏥 🚑 ♿ ⚠️
2848106 60 F MS 07/01/2025 HEPAB
MMR
PNC21
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 P2443
4N222
Y019158
EB499
Pruritus, Rash; Pruritus, Rash; Pruritus, Rash; Pruritus, Rash Pruritus, Rash; Pruritus, Rash; Pruritus, Rash; Pruritus, Rash
Patient presented to the pharmacy on 6/26/25 to report a suspected reaction following vaccinations r... Patient presented to the pharmacy on 6/26/25 to report a suspected reaction following vaccinations received on 6/9/25. She stated that on the morning of 6/10/25, she began experiencing symptoms of itching on her shoulders, back and hips. She also noted the appearance of rash on her skin. The patient reported that she has been taking Pregabalin (Lyrica) which appeared to alleviate some of the itchiness. She indicated that the symptoms have significantly improved since onset but have not completely resolved. The patient no longer has visible rash on her skin when she reported to the pharmacy. She denies any new or worsening symptoms. She did report to her primary care doctor as well. More
2848107 63 F CA 07/01/2025 MMR
 MERCK & CO. INC.
 Y004116
Arthralgia, Headache Arthralgia, Headache
c/o Headaches & Joint Pain c/o Headaches & Joint Pain
2847738 MT 06/30/2025 MMRV
 MERCK & CO. INC.
 Y010930
Product storage error Product storage error
HCP reported a lot of PROQUAD was administered on 23MAY2025 after the product experienced a temperat... HCP reported a lot of PROQUAD was administered on 23MAY2025 after the product experienced a temperature excursion on 19MAY2025. No symptoms reported. HCP consented to correspondence. See related AE case 02817288. No additional AEs/No PQC reported; No symptoms reported; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 19-May-2025, doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, underwent a temperature excursion of 10.5F for an hour (no previous excursions had occurred), and was later administered to the patient on 23-May-2025, lot #Y010930, expiration date 14-Dec-2025, reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot #1950636, expiration date: 22-Jan-2026), at a dose of 0.5 mL as prophylaxis by a health professional (route of administration and anatomical location were not reported) (Improper storage of product in use). However, no symptoms were reported. More
2847739 IA 06/30/2025 PNC21
 MERCK & CO. INC.
 Z004301
No adverse event, Product storage error No adverse event, Product storage error
HCP stated that no adverse reactions were experienced after the administered dose; CAPVAXIVE that wa... HCP stated that no adverse reactions were experienced after the administered dose; CAPVAXIVE that was administered after TE on 06/26/2025; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection 168 mcg/ml (lot #Z004301, expiration date: 07-Sep-2026, 0.5 ml, route unknown) for prophylaxis after temperature excursions (product storage error). No adverse reactions were experienced after the administered dose. Administered dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) experienced the temperature excursion below 10.1 degree Celsius for 0 hours, 30 minutes, 0 seconds. No prior excursions. More
2847740 M AZ 06/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Labyrinthitis Labyrinthitis
Labyrinthitis; This non-serious case was reported by a physician via sales rep and described the occ... Labyrinthitis; This non-serious case was reported by a physician via sales rep and described the occurrence of labyrinthitis in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In MAY-2025, the patient received the 2nd dose of Shingrix. In MAY-2025, 2 days after receiving Shingrix, the patient experienced labyrinthitis (Verbatim: Labyrinthitis). The outcome of the labyrinthitis was resolved. The reporter considered the labyrinthitis to be related to Shingrix. The company considered the labyrinthitis to be related to Shingrix. Additional Information: GSK Receipt Date: 24-JUN-2025 The physician reported that the patient got labyrinthitis 2 days after second dose and the symptoms resolved several weeks later and occurred within last month. More
2847741 M 06/30/2025 RVX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Gastroenteritis rotavirus, Vaccination failure; Gastroenteritis rotavirus, Vacci... Gastroenteritis rotavirus, Vaccination failure; Gastroenteritis rotavirus, Vaccination failure More
Suspected vaccination failure; rota virus infections/gastroenteritis; This serious case was reported... Suspected vaccination failure; rota virus infections/gastroenteritis; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 1-year-old male patient who received Rotavirus vaccine for prophylaxis. Co-suspect products included Rotavirus vaccine for prophylaxis. On an unknown date, the patient received the 2nd dose of Rotavirus vaccine and the 1st dose of Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine and Rotavirus vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and rotavirus gastroenteritis (Verbatim: rota virus infections/gastroenteritis) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the rotavirus gastroenteritis was not resolved. The reporter considered the vaccination failure and rotavirus gastroenteritis to be related to Rotavirus vaccine, Rotarix Unspecified Oral Administation Device, Rotavirus vaccine and Rotarix Unspecified Oral Administation Device. The company considered the vaccination failure and rotavirus gastroenteritis to be unrelated to Rotavirus vaccine, Rotarix Unspecified Oral Administation Device, Rotavirus vaccine and Rotarix Unspecified Oral Administation Device. 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: 14-JUN-2025 The case was received from the patient's parent via interactive digital media. The patient gotten Rotarix vaccine, unfortunately he had suffered from two times rota virus infections. The reporter wondered why the patient suffered from rota gastroenteritis although he vaccinated. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming rotavirus infection and gastroenteritis were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Rotarix (Dose 1 and Dose 2) and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE More
2847742 06/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Discomfort, Herpes zoster, Rash, Vaccination failure Discomfort, Herpes zoster, Rash, Vaccination failure
Suspected vaccination failure; the rash during the outbreak to heal or minimize the discomfort/ rash... Suspected vaccination failure; the rash during the outbreak to heal or minimize the discomfort/ rashes still keep coming; Discomfort; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: the rash during the outbreak to heal or minimize the discomfort/ rashes still keep coming) and discomfort (Verbatim: Discomfort). The outcome of the vaccination failure, shingles and discomfort were not reported. It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles and discomfort to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a patient via Interactive digital media. The patient mentioned that he/she had the Herpes Zoster vaccine but the rashes still keep coming. The patient enquired what they could do to the rash during the outbreak to heal or minimize the discomfort. 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 the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Herpes Zoster vaccine. More
2847743 06/30/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza Influenza
have symptoms flu; This non-serious case was reported by a consumer via interactive digital media an... have symptoms flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a 74-year-old 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 flu symptoms (Verbatim: have symptoms flu). The outcome of the flu symptoms was not reported. It was unknown if the reporter considered the flu symptoms to be related to Arexvy. It was unknown if the company considered the flu symptoms to be related to Arexvy. Additional Information: GSK Receipt Date: 17-JUN-2025 The patient self-reported that case. The patient had symptoms of flu, but patient had flu shot pneumonia shot More
2847744 M GA 06/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 39H2S
Product preparation issue Product preparation issue
administered only the adjuvant portion of Shingrix; administered only the adjuvant portion of Shingr... administered only the adjuvant portion of Shingrix; administered only the adjuvant portion of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 31-MAR-2027) 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 inappropriate preparation of medication (Verbatim: administered only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: administered only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 18-JUN-2025 Nurse called to report that they accidentally could have administered only the adjuvant portion of Shingrix to patient. Also stated that this would be the first dose of Shingrix for the patient and asked is there any immunity screening or any titers test for Shingrix. Asked if they have to revaccinate the patient involved in this possible administration of the adjuvant only. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is one of the seven linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient US-GSK-US2025076594:Same reporter/Diffrent patient US-GSK-US2025076598:Same reporter/Diffrent patient More
2847745 06/30/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product preparation error Product preparation error
got a dose of Menveo reconstituted with normal saline; got a dose of Menveo reconstituted with norma... got a dose of Menveo reconstituted with normal saline; got a dose of Menveo reconstituted with normal saline; 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 patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 18-JUN-2025, the patient received Menveo. On 18-JUN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: got a dose of Menveo reconstituted with normal saline) and inappropriate dose of vaccine administered (Verbatim: got a dose of Menveo reconstituted with normal saline). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 18-JUN-2025 The healthcare professional had called to request data regarding the validity and need for revaccination of a patient who had received a dose of Menveo reconstituted with normal saline which led to, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. They declined to provide information about the vaccine, patient, and event, and did not consent to follow-up. The vaccine administration facility was the same as the primary reporter. More
2847746 0.25 M WI 06/30/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 AC21B163BC
Expired product administered Expired product administered
patient received an expired dose of Pediarix in 2008; This non-serious case was reported by a other ... patient received an expired dose of Pediarix in 2008; 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 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number AC21B163BC, expiry date 06-OCT-2008) for prophylaxis. On 28-OCT-2008, the patient received Pediarix. On 28-OCT-2008, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Pediarix in 2008). 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: 18-JUN-2025 A medical assistant reported that the patient received an expired dose of Pediarix in 2008 which led to expired vaccine used. The expiration date was 6th October 2008, and the vaccine was given on 28th October 2008. The medical assistant asked if this dose was considered valid. This case is linked with US2025076597, reported by same reporter for different (twin) patient.; Sender's Comments: US-GSK-US2025076597:Same reporter/Diffrent patient More
2847747 CA 06/30/2025 DTAP
DTAPHEPBIP
DTAPIPV
HEP
HEPA
MENB
MNQ
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS







Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
Administration after temperature excursion; This non-serious case was reported by a other health pro... Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis. On an unknown date, the patients received Infanrix, Pediarix, Kinrix, Havrix, Engerix B, Bexsero, Menveo and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B, Bexsero, Menveo and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). 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: 18-JUN-2025 The reporter called and reported a temperature excursion for Infanrix, Pediarix, Kinrix, Havrix, Engerix-B, Bexsero, Menveo (1 vial) and Rotarix (liquid) vaccines. Medical assistant mentioned that the excursion happened on 16th May 2025, and since then, they had been using the vaccines. Due to the conditions of the excursion, they explained to the healthcare professional that the products (except Rotarix liquid version) should not be use and they should be discarded. At the end of the call, healthcare professional mentioned that she already reported this excursion in a prior call and mentioned that former agent informed that the vaccines were stable, Healthcare professional informed to be confused due to the below recommended temperature that they just provided. Due to the information from healthcare professional, it seemed that they had been using these vaccines after a temperature excursion which led to incorrect storage of drug. More
2847748 0.17 F AR 06/30/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Administration of Kinrix to a 2 month patient; Administration of Kinrix to a 2 month patient and the... Administration of Kinrix to a 2 month patient; Administration of Kinrix to a 2 month patient and the intended vaccine was Infanrix; 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 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. On 19-JUN-2025, the patient received the 1st dose of Kinrix. On an unknown date, the patient did not receive Infanrix. On 19-JUN-2025, an unknown time after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Kinrix to a 2 month patient) and wrong vaccine administered (Verbatim: Administration of Kinrix to a 2 month patient and the intended vaccine was Infanrix). The outcome of the inappropriate age at vaccine administration and wrong 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: 23-JUN-2025 The patient's age was 2 months and 23 days old. The nurse reported that last week, they had a child patient, and they got Kinrix, which was not recommended until 4 to 6 years old and HCP mentioned that the intended vaccine was Infanrix, it was given by mistake, which led to inappropriate age at vaccine administration and wrong vaccine administered The Vaccine Administration Facility is the same as Primary Reporter. More
2847749 51 F NJ 06/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93N4J
Product preparation issue Product preparation issue
Shingrix adjuvant only administration; Shingrix adjuvant only administration; This non-serious case ... Shingrix adjuvant only administration; Shingrix adjuvant 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 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 93N4J, expiry date 25-APR-2027) for prophylaxis. On 24-JUN-2025, the patient received Shingrix. On 24-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix adjuvant only administration) and inappropriate dose of vaccine administered (Verbatim: Shingrix adjuvant only administration). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 24-JUN-2025 The healthcare professional wanted to know how to proceed after a patient received only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The Vaccine Administration Facility is the same as Primary Reporter. More
2847750 1 M TX 06/30/2025 MEN
MMR
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 U8375AB
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
accidentally given MENQUADFI to a 12-month-old patient instead of an MMR vaccine with no reported ad... accidentally given MENQUADFI to a 12-month-old patient instead of an MMR vaccine with no reported adverse event; Initial information received on 25-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 month old male patient who accidentally received Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] to a 12-month-old patient instead of an Measles vaccine, Mumps vaccine, Rubella vaccine (MMR) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Jun-2025, the patient received a 0.5ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection, frequency-once (lot U8375AB and expiry date- 30-Apr-2028) via intramuscular route in the right arm for Immunization instead of Measles vaccine, Mumps vaccine, Rubella vaccine with no reported adverse event (latency-same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2847752 36 M NY 06/30/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0150
ER8730
Brain fog, Heart rate increased, Heart rate irregular, Nervous system disorder; ... Brain fog, Heart rate increased, Heart rate irregular, Nervous system disorder; Brain fog, Heart rate increased, Heart rate irregular, Nervous system disorder More
brain fog, increase average heart rate & heart rate variability, deregulation of autonomic nervo... brain fog, increase average heart rate & heart rate variability, deregulation of autonomic nervous system More
2847755 75 M OH 06/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain, Pyrexia Pain, Pyrexia
he had a fever; ache/pain; This non-serious case was reported by a consumer via call center represen... he had a fever; ache/pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 23-JUN-2025, the patient received the 2nd dose of Shingrix (left arm). On 24-JUN-2025, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: he had a fever) and pain (Verbatim: ache/pain). The outcome of the fever and pain were not resolved. It was unknown if the reporter considered the fever and pain to be related to Shingrix. It was unknown if the company considered the fever and pain to be related to Shingrix. Additional Information: GSK receipt date: 24-JUN-2025 The patient reported that he had received Shingrix vaccine and had a fever (grade/temp not disclosed,) pain and aches. The reporter mentioned that at the time of the call to GlaxoSmithKline, the adverse events had not resolved. No further information was obtained/provided. More
2847756 F CT 06/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Hiccups, Muscle spasms Hiccups, Muscle spasms
Persistent hiccup condition that started 3 days after the last dose of Shingrix; spasm in her thorac... Persistent hiccup condition that started 3 days after the last dose of Shingrix; spasm in her thoracic region; This non-serious case was reported by a nurse via call center representative and described the occurrence of hiccups in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced hiccups (Verbatim: Persistent hiccup condition that started 3 days after the last dose of Shingrix) and spasms (Verbatim: spasm in her thoracic region). The outcome of the hiccups and spasms were not resolved. It was unknown if the reporter considered the hiccups and spasms to be related to Shingrix. It was unknown if the company considered the hiccups and spasms to be related to Shingrix. Additional Information: GSK receipt Date: 23-JUN-2025 The nurse reported that there was a female patient (over 50 years) that was experiencing some type of spasm in her thoracic region, causing a certain type of hiccup condition. It was persistent and started 3 days after the last dose of Shingrix. At the moment of the call patient's details and dates were not available. The health care professional requested to be contact buck in order to provide all information missing please. The vaccine administration facility was the same as primary reporter. More
2847757 66 F KY 06/30/2025 COVID19
 PFIZER\BIONTECH
Bradycardia, Cardiac arrest, Death, Depression Bradycardia, Cardiac arrest, Death, Depression
I was speaking to my mother on the phone Sunday evening 3/7/21. I always did when I got home from w... I was speaking to my mother on the phone Sunday evening 3/7/21. I always did when I got home from work I called her to check in on her. It was idk exactly but prob around 5pm. She had been very depressed as she couldn't get healed from one broken bone b4 her ex-husband gave her another one. That's the reason she had been in the hospital then and for what seemed like so long prior to the Covid outbreak. We were talking when she got pretty upset and actually yelled at the nurses as they came in. I was shocked because she is always nice and had been so pleasant and happy 2 speak w me on then. But when I said now mom take it easy on them, assuming she maybe in pain she explained. She was angry telling them she didn't want another one of those darned shots as the last one had made her feel awful. Saying she already had covid twice so she didn't see why she needed it. They said they were required to give it to her and thats when she started objecting further saying it was there fault she had gotten covid to begin with as she was under their care and supposed to have been u Der quarantine and she's right. Thats why she was so depressed. We could only talk on the phone, I would drive over put our hands on the glass. The following day they where calling us to come say our final goodbyes, just like they had a couple weeks prior which I now believe was after they gave her the first shot. More
✓
2847758 5 M OH 06/30/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 5G23D
Y015990
Decreased appetite, Impetigo, Pyrexia, Rash; Decreased appetite, Impetigo, Pyrex... Decreased appetite, Impetigo, Pyrexia, Rash; Decreased appetite, Impetigo, Pyrexia, Rash More
(1) Rash - see 12/24/2024 office visit and 12/25/24 phone call report (2) also see 12/27 24 office v... (1) Rash - see 12/24/2024 office visit and 12/25/24 phone call report (2) also see 12/27 24 office visit for Impetigo, fever, loss of appetite More
2847759 61 F ME 06/30/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 MF0425
MF0425
Erythema, Feeling hot, Headache, Mobility decreased, Pain; Pyrexia, Tenderness Erythema, Feeling hot, Headache, Mobility decreased, Pain; Pyrexia, Tenderness
The pt tolerated the injection well and felt fine until she was going to bed a noticed she had a har... The pt tolerated the injection well and felt fine until she was going to bed a noticed she had a hard time lifting her arm. The next day she had body aches, felt feverish, body felt warm the touch. Pt took Tylenol with little help for the headache. Wed night she noted redness on her left arm (not the area of the shot) areas were tender to the touch. More
2847797 F MT 06/30/2025 MMR
 MERCK & CO. INC.
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; HCP called and reported MMRII administered 4/21/2025 that expired 4/19/2025.; This... No additional AE; HCP called and reported MMRII administered 4/21/2025 that expired 4/19/2025.; This spontaneous report has been received from an other health professional, regarding to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 21-APR-2025, the patient was vaccinated with a expired dose ( Expired product administered) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), at a dose of 0.5 milliliter (ml), expiration date 19-APR-2025, as prophylaxis (strength, dosage, route of administration, anatomical site of injection, vaccination scheme frequency, lot number and expiration date were not reported). More
2847798 M 06/30/2025 UNK
 UNKNOWN MANUFACTURER
Chills, Fatigue, Headache, Injection site pain, Pyrexia Chills, Fatigue, Headache, Injection site pain, Pyrexia
throbbing headache; fever; tiredness/fatigue; sore at the site; chills; This spontaneous report was ... throbbing headache; fever; tiredness/fatigue; sore at the site; chills; This spontaneous report was received from a male patient of unknown age referring to himself. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were unknown. The patient had a "wellness exam" with his primary care provider. On 26-JUN-2025, he was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) (route reported as injection; strength, dose, lot # and expiration date were not reported) for prophylaxis (it was reported he received an unspecified pneumococcal vaccine, he stated listed on the sheet was "Pneumococcal 13, 15, and 20." He was unable to determine which vaccine he received). On the same day, the patient had experienced throbbing headache, fever, tiredness, sore at the site (Vaccination site pain), chills and fatigue. He reported a decrease in the severity of the side effects from 26-JUN-2025. The patient requested information on how long he could expect these side effects. It was unknown if any lab/diagnostic tests were performed. The patient had not sought any medical attention or received any treatment. Outcome of all events was reported as not recovered. The causality between Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) and all events was not reported. Lot # is being requested and will be submitted if received. More
2847799 M 06/30/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Facial paralysis; Facial paralysis Facial paralysis; Facial paralysis
Peripheral facial palsy; This serious case was reported by a consumer and described the occurrence o... Peripheral facial palsy; This serious case was reported by a consumer and described the occurrence of facial palsy in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included No prior history, No diabetes. Concomitant products included atorvastatin, ramipril, ezetimibe and omeprazole. On 18-MAY-2025, the patient received the 2nd dose of Shingrix. On 09-MAR-2025, the patient received the 1st dose of Shingrix. On 20-JUN-2025, 33 days after receiving Shingrix and 103 days after receiving Shingrix, the patient experienced facial palsy (Verbatim: Peripheral facial palsy) (serious criteria GSK medically significant). The patient was treated with prednisone. The outcome of the facial palsy was not resolved. It was unknown if the reporter considered the facial palsy to be related to Shingrix and Shingrix. The company considered the facial palsy to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 23-JUN-2025 The patient self-reported this case for himself. The patient was treating with high dose oral prednisone for 6 days plus a 4-day taper. Patient had taken concomitants include atorvastatin for many years, Ramipril, Ezetimibe, Vit D, Omeprazole and Multivitamin. Peripheral facial palsy symptoms were treated.; Sender's Comments: Facial paralysis is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). More
2847801 06/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Four patients had intervals of up to 2 years; This non-serious case was reported by a other health p... Four patients had intervals of up to 2 years; This non-serious case was reported by a other health professional and described the occurrence of drug dose administration interval too long in a specified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose up to 2 years ago). On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Four patients had intervals of up to 2 years). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 20-JUN-2025 Health care professional noted approximately 4 patients had longer than recommended interval between dose 1 and dose 2 of Shingrix. Reporter stated that four patients had intervals of up to 2 years. No specific patient details given and there were no other adverse effects noted. The patients received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2847802 85 F 06/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash vesicular Rash vesicular
A rash looking like chicken pox; This non-serious case was reported by a consumer and described the ... A rash looking like chicken pox; This non-serious case was reported by a consumer and described the occurrence of varicella-like rash in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). Concomitant products included atorvastatin calcium (Atorvastatin). On 12-JUN-2025, the patient received the 2nd dose of Shingrix (left arm). On 13-JUN-2025, 1 days after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: A rash looking like chicken pox). The outcome of the varicella-like rash was resolving. It was unknown if the reporter considered the varicella-like rash to be related to Shingrix. It was unknown if the company considered the varicella-like rash to be related to Shingrix. Additional Information: GSK Receipt Date: 20-JUN-2025 The patient had taken subsequent dose of Shingrix on 12 Jun 2025. The reporter called patient received Shingrix vaccine on 12 Jun 2025 and had a rash on 13 Jun 2025. There was nothing that reporter would like to share about the primary disease. There was nothing that reporter would like to share about a complicating disease. There was nothing that reporter would like to provide any additional information about this report. More
2847803 71 M NC 06/30/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Extra dose administered, Inappropriate schedule of product administration; Extra... Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration More
Extra dose administered; Inappropriate schedule of vaccine administered; This non-serious case was r... Extra dose administered; Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix) and methotrexate sodium (Methotrexate). On 30-AUG-2018, the patient received the 3rd dose of Shingrix (right arm). On 19-JUL-2018, the patient received the 2nd dose of Shingrix (right arm). On 19-JUL-2018, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine administered). On 30-AUG-2018, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered and drug dose administration interval too short were not applicable. Additional Information: GSK receipt date: 20-JUN-2025 The patient did not have any Lot number of expiry information for any of the three doses received The reporter was a male patient that reported that he was looking at his vaccination records, and it showed that he received three doses of Shingrix. The patient received a third dose of Shingrix on 30th August 2018 which led to extra dose administration. The patient received the first dose of Shingrix on 30th May 20218, and the second dose on 19th July 2018, not two months apart which led to drug dose administration interval too short. The patient stated that there was a good chance that he received all three doses in his right arm, but he did not have this information in his records. The patient stated that neither his local pharmacy nor his physician showed any record of having provided any Shingrix vaccines to him. The patient had no Healthcare Provider information available to provide The patient mentioned that he was on Methotrexate (unknown product information) pre-existing receiving any Shingrix vaccines and is still on Methotrexate today at the time of reporting. More
2847804 2 F OK 06/30/2025 DTAPHEPBIP
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9D25P
22GP3
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
administered PEDIARIX and HAVRIX to a patient who was already up to date with vaccinations; This non... administered PEDIARIX and HAVRIX to a patient who was already up to date with vaccinations; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9D25P, expiry date 25-OCT-2025) for prophylaxis. Co-suspect products included HAV (Havrix 720) (batch number 22GP3, expiry date 11-SEP-2026) for prophylaxis. On 20-JUN-2025, the patient received Pediarix and Havrix 720. On 20-JUN-2025, an unknown time after receiving Pediarix and Havrix 720, the patient experienced extra dose administered (Verbatim: administered PEDIARIX and HAVRIX to a patient who was already up to date with vaccinations). The outcome of the extra dose administered 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-JUN-2025 The medical assistant reports that she administered Pediarix and Havrix to a patient who was already up to date with vaccinations which led to extra dose administered. The patient did not need the vaccinations. More
2847805 F 06/30/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Impaired work ability, Incomplete course of vaccination, Influenza like illness;... Impaired work ability, Incomplete course of vaccination, Influenza like illness; Impaired work ability, Incomplete course of vaccination, Influenza like illness More
Flu-like symptoms; did not received 2nd dose yet; This non-serious case was reported by a consumer v... Flu-like symptoms; did not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JUL-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In JUL-2024, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu-like symptoms). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: did not received 2nd dose yet). In JUL-2024, the outcome of the influenza-like symptoms was resolved. The outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms to be related to Shingrix. Additional Information: GSK receipt date: 25-JUN-2025 The patient received her first Shingrix dose and one day after vaccination she developed unspecified flu-like symptoms and missed one day of work (AE, recovered). She has not yet received the second dose but plans to (adverse event: inappropriate schedule of vaccine). Nothing else was reported. This report was filed with limited detail as the patient declined to provide her mailing address or answer questions regarding the adverse event report. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. More
2847806 06/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Rash Rash
it was a rash; This non-serious case was reported by a consumer via interactive digital media and de... it was a rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a 57-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis (I have rheumatoid arthritis) and fibromyalgia (I have Fibromyalgia, so with pain that those 2 things give me in a daily basis). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: it was a rash). The outcome of the rash was not reported. It was unknown if the reporter considered the rash to be related to Shingles vaccine. It was unknown if the company considered the rash to be related to Shingles vaccine. Additional Information: GSK receipt date: 16-JUN-2025 This case was reported by a patient via interactive digital media. Patient got the shot; patient was 57 and thought he/she got bit then patient turned around and looked in the mirror and saw it was a rash. Patient had rheumatoid arthritis and fibromyalgia, so with pain that those 2 things give me in a daily basis, patient asked that they could handle Shingles better. More
2847807 06/30/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incorrect dose administered Incorrect dose administered
A nineteen year old patient received a one milliliter dose; This non-serious case was reported by a ... A nineteen year old patient received a one milliliter dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old patient who received HBV (Engerix B) for prophylaxis. In MAY-2025, the patient received the 1st dose of Engerix B. In MAY-2025, an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: A nineteen year old patient received a one milliliter dose). The outcome of the overdose 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: 18-JUN-2025 Registered Nurse called to ask what to do in this case regarding a patient's Engerix B schedule. A nineteen-year-old patient received a one milliliter dose last May 2025, which led to overdose. On the day before reporting on 17-JUN-2025, patient received a zero point five milliliter dose. The reporter asked for advise. Vaccination date was obtained in the call (no specific day of administration mentioned by the Registered Nurse's end for first dose). No vaccine detail and no patient demographics were obtained in the call. No further information was obtained in the call. More
2847808 06/30/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Rash, Skin discolouration Rash, Skin discolouration
I had the vaccine but developed a small patch on my waste area; discoloration; This non-serious case... I had the vaccine but developed a small patch on my waste area; discoloration; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of patchy rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced patchy rash (Verbatim: I had the vaccine but developed a small patch on my waste area) and skin discoloration (Verbatim: discoloration). The outcome of the patchy rash and skin discoloration were resolving. It was unknown if the reporter considered the patchy rash and skin discoloration to be related to Shingles vaccine. It was unknown if the company considered the patchy rash and skin discoloration to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-JUN-2025 This case was reported by the patient via interactive digital media. The patient had the vaccine but developed a small patch on his/her waste area. The patient used a prescription from the Dermatologist that had really reduced all but the discoloration. The patient also said that the Vitamins from Zosterex had taken him/her closer to recovery. The patient asked to give them a try which was available. More
2847809 06/30/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Skin fissures, Vaccination failure; Herpes zoster, Skin fissures,... Herpes zoster, Skin fissures, Vaccination failure; Herpes zoster, Skin fissures, Vaccination failure More
suspected vaccination failure; after getting both doses of shin cracks and keep getting breakouts of... suspected vaccination failure; after getting both doses of shin cracks and keep getting breakouts of the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: after getting both doses of shin cracks and keep getting breakouts of the shingles). 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 22-JUN-2025 Patient asked what they should do after getting both doses of shin cracks if they keep getting breakouts of the shingles. This case was considered as suspected vaccination failure as details regarding 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 regarding completion of primary schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2). More
2847810 1 M MI 06/30/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Incorrect Vaccine; Received at 16 months of age; This non-serious case was reported by a nurse via c... Incorrect Vaccine; Received at 16 months of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis. Co-suspect products included DTPa (DTaP vaccine) for prophylaxis. On 16-JUN-2025, the patient received Kinrix. On an unknown date, the patient did not receive DTaP vaccine. On 16-JUN-2025, an unknown time after receiving Kinrix and not applicable after receiving DTaP vaccine, the patient experienced wrong vaccine administered (Verbatim: Incorrect Vaccine) and inappropriate age at vaccine administration (Verbatim: Received at 16 months of age). The outcome of the wrong vaccine administered 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: 17-JUN-2025 The nurse reported that they had a medication error and calling to see about any actions or anything that they should take as a result. Essentially, they had a 16-months old child who received a Kinrix vaccine that was not indicated until the age of four, which led to inappropriate age at vaccine administration. The patient was going to receive a DTAP vaccine and instead he received a DTAP/IPV vaccine, which led to wrong vaccine administered. More
2847811 54 F FL 06/30/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9D52
9D52
Extra dose administered, Product preparation error; Extra dose administered, Pro... Extra dose administered, Product preparation error; Extra dose administered, Product preparation error More
supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally; she w... supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally; she was supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 9D52, expiry date 25-MAR-2027) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number 9D52, expiry date 25-MAR-2027) for prophylaxis and Hepatitis B vaccine for prophylaxis. On 18-JUN-2025, the patient received Shingrix and Shingrix. On an unknown date, the patient did not receive Hepatitis B vaccine. On 18-JUN-2025, an unknown time after receiving Shingrix and Shingrix and not applicable after receiving Hepatitis B vaccine, the patient experienced accidental overdose (Verbatim: supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally) and wrong vaccine administered (Verbatim: she was supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally). The outcome of the accidental overdose and wrong vaccine administered were not applicable. Additional Information: GSK receipt date: 20-JUN-2025 The pharmacist reported that a patient received two Shingrix doses at the same time. She was supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally which led to, accidental overdose and wrong vaccine administered. More
2847812 21 M CA 06/30/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 57H54
Interchange of vaccine products, Wrong product administered Interchange of vaccine products, Wrong product administered
accidentally administer a Menveo to a patient on June 17th 2025 instead of the Bexsero vaccine; inte... accidentally administer a Menveo to a patient on June 17th 2025 instead of the Bexsero vaccine; interchange of vaccine products; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 21-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 57H54, expiry date 31-JAN-2026) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis. Concomitant products included Meningococcal vaccine A/C/Y/W conj (dip tox) (Menactra) and Meningococcal vaccine A/C/Y/W conj (dip tox) (Menactra). On 17-JUN-2025, the patient received Menveo. On an unknown date, the patient did not receive Bexsero. On 17-JUN-2025, an unknown time after receiving Menveo and not applicable after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: accidentally administer a Menveo to a patient on June 17th 2025 instead of the Bexsero vaccine) and interchange of vaccine products (Verbatim: interchange of vaccine products). The outcome of the wrong vaccine administered and interchange of vaccine products 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-JUN-2025 The medical assistant explained that they accidentally administered a Menveo to a patient instead of the Bexsero vaccine that was originally prescribed, which led to wrong vaccine administered. The patient received 2 prior doses of Menactra back and the reporter asked to the treating physician about it and they mentioned that nothing can happen from this mistake and the Menveo dose can be considered as a booster, which led to interchange of vaccine products More
2847813 F MD 06/30/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
received 1st dose on 31-MAY-2025 and 2nd dose on 01-JUN-2025; This non-serious case was reported by ... received 1st dose on 31-MAY-2025 and 2nd dose on 01-JUN-2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 31-year-old female patient who received HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 01-JUN-2025, the patient received the 2nd dose of Twinrix. On 01-JUN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: received 1st dose on 31-MAY-2025 and 2nd dose on 01-JUN-2025). The outcome of the drug dose administration interval too short 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: 23-JUN-2025 The pharmacist reported that the patient received their first dose of Twinrix in May 2025 and the second dose in June 2025 and wanted to know when the third dose should be given. They did not want to provide more data and declined to receive follow-up. The reporter was conflictive and rude during the call, stating that they did not see why providing more data for the case would help them get an answer. The patient received 2nd dose of Twinrix vaccine earlier than the recommended interval, which led to shortening of the vaccination. More
2847814 06/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
received a shot October 22nd, 2023, and then the next shot was not until January 12th 2025; This non... received a shot October 22nd, 2023, and then the next shot was not until January 12th 2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 22-OCT-2023). On 12-JAN-2025, the patient received the 2nd dose of Shingrix. On 12-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received a shot October 22nd, 2023, and then the next shot was not until January 12th 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 01-APR-2025 The patient who received a shot in OCT 2023 and then the next shot was not until 12th JAN 2025 and because of the gap there was a recommendation by a pharmacist to get a 3rd dose. However her insurance was blocking that, so they were calling to see if it was medically necessary for her to receive that other one. The vaccine administration facility was the same as primary reporter. No other information was provided. The patient received 2nd dose of Shingrix later than recommendation, which led to lengthening of vaccine schedule. More
2847815 M 06/30/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Dyskinesia, Facial nerve disorder, Feeding disorder, Feeling abnormal, Headache;... Dyskinesia, Facial nerve disorder, Feeding disorder, Feeling abnormal, Headache; Hypersomnia, Mental impairment, Speech disorder, Swelling, Tremor; Weight, Weight decreased More
not bad but it hurts from thinking properly; hands is constantly shaking/ cannot control body; didn&... not bad but it hurts from thinking properly; hands is constantly shaking/ cannot control body; didn't want to eat and couldn't eat, so lost 70 pounds in a few months; find it very difficult to speak; bump; didn't want to eat and couldn't eat; And the nerves that control lips so can speak properly, have been compromised; sleeps more than 12 hours a day; they don't always go where want them to go; feeling worse everyday; constant headache/pressure headache; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (not bad but it hurts from thinking properly) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (not bad but it hurts from thinking properly) (seriousness criterion medically significant), TREMOR (hands is constantly shaking/ cannot control body), WEIGHT DECREASED (didn't want to eat and couldn't eat, so lost 70 pounds in a few months), SPEECH DISORDER (find it very difficult to speak), SWELLING (bump), FEEDING DISORDER (didn't want to eat and couldn't eat), FACIAL NERVE DISORDER (And the nerves that control lips so can speak properly, have been compromised), HYPERSOMNIA (sleeps more than 12 hours a day), DYSKINESIA (they don't always go where want them to go), FEELING ABNORMAL (feeling worse everyday) and HEADACHE (constant headache/pressure headache). At the time of the report, MENTAL IMPAIRMENT (not bad but it hurts from thinking properly), TREMOR (hands is constantly shaking/ cannot control body), WEIGHT DECREASED (didn't want to eat and couldn't eat, so lost 70 pounds in a few months), SPEECH DISORDER (find it very difficult to speak), SWELLING (bump), FEEDING DISORDER (didn't want to eat and couldn't eat), FACIAL NERVE DISORDER (And the nerves that control lips so can speak properly, have been compromised), HYPERSOMNIA (sleeps more than 12 hours a day), DYSKINESIA (they don't always go where want them to go), FEELING ABNORMAL (feeling worse everyday) and HEADACHE (constant headache/pressure headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: lost 70 pounds in a few months. Went from 220 pounds what he weighed now, which was 150 pounds. No concomitant medication was reported. Patient did not want to eat and could not eat, so patient lost 70 pounds in a few months. And the nerves that control lips so he can speak properly, had been compromised. Patient found it very difficult to speak, so normally he did not speak. Patient's hands were constantly shaking, and they did not always go where he want them to go. He also had some bump in the side, he felt it. Patient had most of the side effects with the exception of being blind and having a migraine headache. The patient cannot control his body. He also had constant headache describing it as "not bad but it hurts him from thinking properly." It was reported that it was a pressure headache and that there was no pain associated with it. His headache was like a pressure headache, and it was always there. In regard to him having a difficulty in speaking, he had to speak very slowly so that he can be understood. He received the vaccine 2 years ago in 2022, he thinks. It was the original vaccine and was able to receive it twice, the 2nd time being the booster shot. Patient also had more of the symptoms than most people. He was feeling worse every day. He slept more than 12 hours a day and when he gets up from sleeping, he falls asleep while watching television. No treatment medication was reported.; Reporter's Comments: The advanced age is a contributor for the events. The benefit -risk relationship of product is not affected by this report. More
2847816 65 F SC 06/30/2025 COVID19
 MODERNA
Balance disorder, Dizziness, Gait disturbance, Nausea Balance disorder, Dizziness, Gait disturbance, Nausea
I'm still off balance; My body just started feeling like a little fluid acting like" and &... I'm still off balance; My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy; My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy; Body stuff was going on and I couldn't, when I thought I could get up to go to the bathroom, my legs was/I thought I could have walked but I still couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy), DIZZINESS (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy), GAIT DISTURBANCE (Body stuff was going on and I couldn't, when I thought I could get up to go to the bathroom, my legs was/I thought I could have walked but I still couldn't walk) and BALANCE DISORDER (I'm still off balance) in a 65-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu (Patient had past history of receiving COVID shots and flu shots) and COVID-19 Vaccine (Patient had past history of receiving COVID shots and flu shots). Past adverse reactions to the above products included No adverse effect with COVID-19 Vaccine and Flu. In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In October 2024, the patient experienced NAUSEA (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy) (seriousness criterion hospitalization), DIZZINESS (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Body stuff was going on and I couldn't, when I thought I could get up to go to the bathroom, my legs was/I thought I could have walked but I still couldn't walk) (seriousness criterion hospitalization). On an unknown date, the patient experienced BALANCE DISORDER (I'm still off balance) (seriousness criterion hospitalization). The patient was treated with Physical therapy for Balance disorder. At the time of the report, NAUSEA (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy), DIZZINESS (My body just started feeling like a little fluid acting like" and "this is a little different, ordinary/I had like kind of throw up and I was feeling a little dizzy), GAIT DISTURBANCE (Body stuff was going on and I couldn't, when I thought I could get up to go to the bathroom, my legs was/I thought I could have walked but I still couldn't walk) and BALANCE DISORDER (I'm still off balance) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided. Patient took no vaccines in past four weeks. Patient had a COVID shot which was for age 65 and over which left her with a bad side effect. It was not the first COVID vaccine she had. Patient was not sure about administration date, and thinks it was on 22-oct-2024 which was on Thursday. The patient was not sure if it was Moderna COVID vaccine as she had to get the information from hospital where she works at and there it was like mandatory thing to take vaccine. Patient received a shot every year, regular COVID shot and did not affect her but the shot for age 65 and older got affected her. On Friday she started feeling like a little fluid acting and Saturday morning she was feeling a little dizzy. The patient could not walk and had to crawl on the floor so taken to hospital and stayed for 2 almost 3 days. She had therapy to come by the house because she thinks it was that when she went back to work. Patient don't know if it had interfered with her regular medicine, and she had a reaction which was like allergic reaction after eating something which happened right after the shot. Patient was still experiencing the symptoms and cannot drive the car herself and had to depend on other people to come back from work for over a month. Patient had to use a walker when she goes outside as she was off balance. Patient went to doctor and doctor said it was a pre and must be her medical condition, but she always had known the condition that she had, and she took regular COVID shot but this time it was so different and that was when everything came down on her. Patient had to take the shot every year and at first, she used to get the flu shot and when COVID came out she got COVID shot which she had to get it. It was unknown if patient experienced any additional symptoms or events. Patient was still a little off balance so getting a therapy sometimes once a week and twice a week and had physical therapy.; Reporter's Comments: Company comment: The benefit-risk relationship of the product is not affected by this report. More
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2847817 97 F 06/30/2025 COVID19
 MODERNA
COVID-19 COVID-19
almost died from Covid last may; This spontaneous case was reported by a consumer and describes the ... almost died from Covid last may; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (almost died from Covid last may) in a 97-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. 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 (almost died from Covid last may) (seriousness criterion life threatening). At the time of the report, COVID-19 (almost died from Covid last may) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that patient almost died from Covid last May. Ever since then they made sure to keep up with all boosters. But they were worried about availability although they would be making it available for everyone 65 and older. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Age is a contributor for the event. The benefit-risk relationship of the product is not affected by this report. More
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2847818 30 F CA 06/30/2025 COVID19
COVID19
 MODERNA
MODERNA
 3046734
3046734
Back pain, Chest pain, Chills, Headache, Nausea; Pain Back pain, Chest pain, Chills, Headache, Nausea; Pain
chest pain; upper back pain; sore body; headache; chills; nausea; This spontaneous case was reported... chest pain; upper back pain; sore body; headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), BACK PAIN (upper back pain), PAIN (sore body), HEADACHE (headache) and CHILLS (chills) in a 30-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 25-Jun-2025, the patient experienced CHEST PAIN (chest pain), BACK PAIN (upper back pain), PAIN (sore body), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea). At the time of the report, CHEST PAIN (chest pain), BACK PAIN (upper back pain), PAIN (sore body), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. More
2847819 M 06/30/2025 COVID19
 MODERNA
Cardiac disorder Cardiac disorder
now have heart issues/heart condition; This spontaneous case was reported by a consumer and describe... now have heart issues/heart condition; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (now have heart issues/heart condition) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (now have heart issues/heart condition). At the time of the report, CARDIAC DISORDER (now have heart issues/heart condition) had not resolved. No concomitant medications were reported. The patient had both doses of vaccine for Covid and now had heart issues. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2025: Follow-up received contains non-significant information included reference number added. On 27-Jun-2025: Follow-up received contains non-significant information included reference numbers were added. More
2847820 43 F MA 06/30/2025 COVID19
COVID19
 MODERNA
UNKNOWN MANUFACTURER

Illness, Influenza like illness, Malaise, Pyrexia; Illness, Influenza like illne... Illness, Influenza like illness, Malaise, Pyrexia; Illness, Influenza like illness, Malaise, Pyrexia More
flu like symptoms; malaise; illness; high fever; This spontaneous case was reported by a consumer an... flu like symptoms; malaise; illness; high fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), ILLNESS (illness) and PYREXIA (high fever) in a 43-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Co-suspect product included non-company product COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), ILLNESS (illness) and PYREXIA (high fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), ILLNESS (illness) and PYREXIA (high fever) had resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown. No concomitant medications were reported. The patient experienced flu-like symptoms and fever following every COVID-19 vaccine received (both Moderna and Novavax). Reported fever after second Novavax dose. Reactions including high fever, malaise, and illness lasting 24-48 hours. Despite the side effects, the patient continued vaccination due to immunocompromised status. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. More
2847821 M NY 06/30/2025 COVID19
 PFIZER\BIONTECH
Myocardial infarction Myocardial infarction
myocardial infarction; This is a spontaneous report received from an Other HCP from a sales represen... myocardial infarction; This is a spontaneous report received from an Other HCP from a sales representative. A 45-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening), 24 hrs after the suspect product(s) administration, outcome "recovered". Therapeutic measures were taken as a result of myocardial infarction. Clinical course: It was unknown if the patient had any other vaccine on the same date or in four weeks. It was also unknown if the patient took other medications in 2 weeks. The providers husband experience a myocardial infarction within 24 hours after the 2nd dose of the original Pfizer BioNTech COVID-19 vaccine.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. More
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2847822 06/30/2025 PNC20
 PFIZER\WYETH
 LJ5284
Erythema, Injection site swelling, Rash, Skin warm, Swelling Erythema, Injection site swelling, Rash, Skin warm, Swelling
Swelling; Redness; Rash/rash with warmth; Rash/rash with warmth; swelling at the injection site; Thi... Swelling; Redness; Rash/rash with warmth; Rash/rash with warmth; swelling at the injection site; This is a spontaneous report and received from Consumer or other non HCPs. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Lot number: LJ5284) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown"; ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; RASH (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "Rash/rash with warmth"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling at the injection site". More
2847823 M 06/30/2025 RSV
 UNKNOWN MANUFACTURER
Rash Rash
My immune system reacts to the RSV Pfizer with a large rash; This is a spontaneous report received f... My immune system reacts to the RSV Pfizer with a large rash; This is a spontaneous report received from a Consumer or other non HCP. An elderly male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "My immune system reacts to the RSV Pfizer with a large rash". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2847824 M IL 06/30/2025 COVID19
 PFIZER\BIONTECH
Biopsy, Investigation, Rash Biopsy, Investigation, Rash
3 weeks later he started a rash; This is a spontaneous report received from a Consumer or other non ... 3 weeks later he started a rash; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: RASH (non-serious) with onset Nov2021, 3 weeks after the suspect product(s) administration, outcome "not recovered", described as "3 weeks later he started a rash". The event "3 weeks later he started a rash" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. Additional information: The reporter's husband received his 1st covid booster 22Oct2021. 3 weeks later he started a rash. 4 doctors, numerous ointments, light box treatments and then medication orally, the rash was not only still there, but was spreading. Doctors had taken various tests and punch biopsies, and no one knew what the rash was. Ruled out various common skin disorders, all negative. Reporter stated that need your help to see if this was a bad reaction to a chemical in the booster shot he received. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received More
2847825 16 F CA 06/30/2025 MEN
 UNKNOWN MANUFACTURER
Dizziness, Dyspnoea, Haemophilus infection, Nausea Dizziness, Dyspnoea, Haemophilus infection, Nausea
Haemophilus influenza; trouble breathing; felt dizziness; nausea; Initial information received on 24... Haemophilus influenza; trouble breathing; felt dizziness; nausea; Initial information received on 24-Jun-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 16 year old female patient who had haemophilus influenza, patient is still experiencing felt dizziness, nausea and trouble breathing after receiving vaccine Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Jun-2025, at 11:00 hours the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection standard strength frequency-once (lot number and expiry date-unknown) via unknown route in unknown administration site for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On 22-Jun-2025 the patient developed haemophilus influenza (haemophilus infection) (latency-2 days) On 20-Jun-2025 at 02:00 hours the patient developed felt dizziness (dizziness), nausea, trouble breathing (dyspnoea) (latency- 11 hours). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events of (dizziness), nausea, trouble breathing (dyspnoea) and haemophilus infection). At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness Criteria-The patient was hospitalized for the event of haemophilus infection.; Sender's Comments: Sanofi company comment dated 26-JUN-2024: This case involves a 16 year old female patient who had haemophilus influenza, patient is still experiencing felt dizziness, nausea and trouble breathing after receiving vaccine Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Further information regarding regarding allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
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2847826 5 TX 06/30/2025 DTP
TDAP
 UNKNOWN MANUFACTURER
SANOFI PASTEUR

No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
5-year old twins received ADACEL instead of DTaP with no reported AE; Initial information received o... 5-year old twins received ADACEL instead of DTaP with no reported AE; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 years old and unknown gender patient who experienced 5-year old twins received adacel instead of dtap with no reported ae (adverse event) while receiving vaccines diphtheria, tetanus and nos pertussis vaccine and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the 5-year old twins received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine; Suspension for injection for Immunization and received an unknown dose of suspect diphtheria, tetanus and nos pertussis vaccine produced by unknown manufacturer with unknown formulation for Prophylactic vaccination (Immunisation) and both (lot number, strength and expiry date not reported) via unknown route in unknown administration site with no reported ae (wrong product administered) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. No follow-up is possible as Reporter cannot be contacted by Sanofi. 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
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