🏥 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 💀 🏥 🚑 ♿ ⚠️
2842111 53 M WA 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 E754F
Product preparation error Product preparation error
Shingrix vaccine had been incorrectly reconstituted, using saline solution; Shingrix vaccine had bee... Shingrix vaccine had been incorrectly reconstituted, using saline solution; Shingrix vaccine had been incorrectly reconstituted, using saline solution; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number E754F, expiry date 31-MAR-2027) for prophylaxis. On 16-MAY-2025, the patient received Shingrix. On 16-MAY-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix vaccine had been incorrectly reconstituted, using saline solution) and inappropriate dose of vaccine administered (Verbatim: Shingrix vaccine had been incorrectly reconstituted, using saline solution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 16-MAY-2025 On 16th May 2025, a registered nurse had called to report that a Shingrix vaccine had been incorrectly reconstituted using saline solution and had been administered to a patient on the same day, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. More
2842112 F AZ 05/21/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 553J7
Expired product administered Expired product administered
administered an expired dose of Engerix B; This non-serious case was reported by a nurse via call ce... administered an expired dose of Engerix B; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-day-old female patient who received HBV (Engerix B) (batch number 553J7, expiry date 28-MAR-2025) for prophylaxis. On 16-MAY-2025, the patient received the 1st dose of Engerix B. On 16-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Engerix B). 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: 16-MAY-2025 The Vaccine Administration Facility was the same as Primary Reporter On 16 May 2025, a nurse administered an expired dose of Engerix B vaccine to a 2 day old patient which led to expired vaccine used. The nurse wanted to know how to proceed in this case. More
2842113 61 M 05/21/2025 COVID19
 MODERNA
COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (... covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19) in a 61-year-old male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) from 15-Apr-2025 to 20-Apr-2025 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2025, SARS-CoV-2 test: Positive. No concomitant medications provided by the reporter. It was reported that patient was received Moderna- Covid-19 Vaccine and he thought that vaccine would be good. And he thought that he would not get COVID for life because he took the vaccine. But patient had COVID-19 infection three times. Patient had COVID-19 infection multiple times. Also, it was reported that after received the vaccine (Moderna- Covid-19 Vaccine) the three time he had the infection. After second time COVID-19 infection the patient was sick, and patient thought that he would die, and patient was received treatment medication. It was reported that when first time patient had COVID, he took treatment medication, and it worked great, but he took it within 24 hours of the onset of the illness. It was reported that patient had latest covid-19 infection diagnosis on 15-Apr-2025 and patient was received treatment medication. This case was linked to US-MODERNATX, INC.-MOD-2025-786089 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live significant information was received in which reporter detail was updated, patient demographic was updated (DOB, height, weight), lab data was added, and new reference number was added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786089:same reporter different patient More
2842115 M MA 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA; U7907A
Product storage error Product storage error
Unknown number of administrations of VAQTA and VAXELIS SYRINGES following a temperature excursion. T... Unknown number of administrations of VAQTA and VAXELIS SYRINGES following a temperature excursion. Temperature 0.44 C; This non-serious spontaneous safety report, with reference number 02760646 (interaction number: 02760638), was received by partner on 26-FEB-2025 and forwarded on 27-FEB-2025 from a health professional. This case was considered non-valid due to no patient identifiers being provided. Due to the nature of the event, the causality between the event 'Unknown number of administrations of VAQTA and VAXELIS SYRINGES following a temperature excursion. Temperature 0.44 C' and Vaxelis was not applicable. Further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION was received from a health professional on 17-MAR-2025. Patient identifiers were provided; therefore, the case has become valid. Due to the nature of the event, the causality between the event 'Unknown number of administrations of VAQTA and VAXELIS SYRINGES following a temperature excursion. Temperature 0.44 C' and Vaxelis was not applicable. No further information is expected. More
2842116 F CA 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7296AA
Expired product administered Expired product administered
expired VAXELIS was administered; This non-serious spontaneous safety report, with reference number ... expired VAXELIS was administered; This non-serious spontaneous safety report, with reference number 02763945 (interaction number: 02763936), was received by partner on 04-MAR-2025 and forwarded on 04-MAR-2025 from other health professional. This case was considered non-valid due to no patient identifiers provided. Due to the nature of the event, the causality between the event 'expired VAXELIS was administered' and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION was received on 25-MAR-2025 from a healthcare professional. The case becomes valid. Due to the nature of the event, the causality between the event 'expired VAXELIS was administered' and Vaxelis was not applicable. Further information is not expected More
2842117 M KY 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7296AA
Expired product administered Expired product administered
administration of an expired VAXELIS to three patients; This spontaneous safety report, with referen... administration of an expired VAXELIS to three patients; This spontaneous safety report, with reference number 2025SA067138, was received by the partner on 05-MAR-2025 and forwarded on 06-MAR-2025, from the physician. Due to the nature of the event, the causality between the event "administration of an expired VAXELIS to three patients" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007666. Further information is expected. More
2842118 M KY 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7296AA
Expired product administered Expired product administered
administration of an expired VAXELIS to three patients.; This spontaneous safety report, with refere... administration of an expired VAXELIS to three patients.; This spontaneous safety report, with reference number 2025SA067169, was received by the partner on 05-MAR-2025 and forwarded on 06-MAR-2025, from the physician. Due to the nature of the event, the causality between the event "administration of an expired VAXELIS to three patients" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007665. Further information is expected. More
2842119 M KY 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7296AA
Expired product administered Expired product administered
administration of an expired VAXELIS to three patients.; This spontaneous safety report, with refere... administration of an expired VAXELIS to three patients.; This spontaneous safety report, with reference number 2025SA067179, was received by the partner on 05-MAR-2025 and forwarded on 06-MAR-2025, from other health professional. Due to the nature of the event, the causality between the event "administration of an expired VAXELIS to three patients" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007665. Further information is expected. More
2842120 F MI 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7296AA
Expired product administered Expired product administered
medication error/inappropriate use caused by the administration of expired VAXELIS to a patient; Thi... medication error/inappropriate use caused by the administration of expired VAXELIS to a patient; This non-serious spontaneous safety report, with reference number 2025SA067192, was received by partner on 05-MAR-2025 and forwarded on 06-MAR-2025 from other health professional. Due to the nature of the event, the causality between the events medication error/inappropriate use caused by the administration of expired VAXELIS to a patient' and Vaxelis were not applicable. Further information is expected. More
2842121 CA 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7296AA
Expired product administered Expired product administered
VAXELIS vaccine that expired 2/26/2025 and was administered to a patient; This non-serious spontaneo... VAXELIS vaccine that expired 2/26/2025 and was administered to a patient; This non-serious spontaneous safety report, with reference number 02766549 (interaction number: 02766543), was received by partner on 07-MAR-2025 and forwarded on 07-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'VAXELIS vaccine that expired 2/26/2025 and was administered to a patient' and Vaxelis was not applicable. Further information is expected. More
2842122 M TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7392AA
Off label use, Product administered to patient of inappropriate age Off label use, Product administered to patient of inappropriate age
VAXELIS to a patient aged 5 years and 6 months. They wanted to know if it is okay if the patient rec... VAXELIS to a patient aged 5 years and 6 months. They wanted to know if it is okay if the patient received the vaccine; This non-serious, spontaneous, safety report was received by partner, on 11-MAR-2025 and forwarded on 12-MAR-2025 from a healthcare professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events; "VAXELIS to a patient aged 5 years and 6 months. They wanted to know if it is okay if the patient received the vaccine". This case is considered an off-label use, due to product administered to patient of inappropriate age. Further information is expected. More
2842123 M SD 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Product storage error Product storage error
9-month-old son received VAXELIS that was improperly stored; This spontaneous safety report, with re... 9-month-old son received VAXELIS that was improperly stored; This spontaneous safety report, with reference numbers 2025SA075227/ 02445318), was received by the partner on 12-MAR-2025 and forwarded on 13-MAR-2025, from a health care professional. Additional safety information with reference number 0244949, was received by partner on 14-MAR-20225 and forwarded on 17-MAR-2025. Due to the nature of the event, the causality between the event "9-month-old son received VAXELIS" that was improperly stored and Vaxelis was not applicable. Further information is expected. More
2842124 F NY 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7296AA
Expired product administered Expired product administered
accidentally given an expired VAXELIS vaccine to a 6-month-old/arrangement of the day and year in &q... accidentally given an expired VAXELIS vaccine to a 6-month-old/arrangement of the day and year in "26/02/25", the expiration date...confused her; This non-serious spontaneous safety report, with reference number 2025SA080015, was received by partner on 17-MAR-2025 and forwarded on 18-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'accidentally given an expired VAXELIS vaccine to a 6-month-old' and Vaxelis were not applicable. Further information is expected. Significant follow-up information was received by the partner on 17-MAR-2025 and forwarded on 20-MAR-2025, from other health professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the event 'accidentally given an expired VAXELIS vaccine to a 6-month-old' and Vaxelis were not applicable. Further information is expected. More
2842125 F NC 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7295AA
Expired product administered Expired product administered
Expired VAXELIS administered to a patient; This non-serious spontaneous safety report, with referenc... Expired VAXELIS administered to a patient; This non-serious spontaneous safety report, with reference numbers (2025SA079521and 02451593), was received by partner on 17-MAR-2025 and forwarded on 18-MAR-2025 from a health professional. Due to the nature of the event, the causality between the event "expired Vaxelis administered to a patient" and Vaxelis was not applicable. Further information is expected. This non-serious spontaneous safety report was forwarded on 30-APR-2025 from a health professional. Due to the nature of the event, the causality between the event "expired Vaxelis administered to a patient" and Vaxelis was not applicable. Further information is expected. More
2842126 F TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7535AA
Pyrexia Pyrexia
Baby has H.influenza (untypable) [NOT a Vaxelis compound]; started a fever, of 104 degrees; This non... Baby has H.influenza (untypable) [NOT a Vaxelis compound]; started a fever, of 104 degrees; This non-serious spontaneous safety report with reference number: 2025SA085952 was received by a partner on 21-MAR-2025 and forwarded on 24-MAR-2025 from other health professional. The reporter did not assess the causal relationship between Vaxelis and 'baby has HIB', 'started a fever, of 104 degrees'. Further information is expected. Significant follow-up information was received on 07-APR-2025 from a healthcare provider. The case is maintained as non-serious. The reporter assessed the causal relationship between Vaxelis and 'baby has HIB/Baby has H. influenza (untypable)', as not related. The reporter did not assess the causal relationship between Vaxelis and the event 'started a fever, of 104 degrees. Further information is expected. More
2842127 F TX 05/21/2025 DTPPVHBHPB
PNC15
RV5
 MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
 u7767aa
y005351
y009786
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration More
patient received ROTATEQ, VAXELIS and VAXNEUVANCE at 41 days instead of the recommended 42 day vacci... patient received ROTATEQ, VAXELIS and VAXNEUVANCE at 41 days instead of the recommended 42 day vaccination schedule; No adverse event; This non-serious spontaneous safety report, with reference number 02775781 (interaction number: 02775778), was received by partner on 24-MAR-2025 and forwarded on 25-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'patient received ROTATEQ, VAXELIS and VAXNEUVANCE at 41 days instead of the recommended 42-day vaccination schedule' and Vaxelis was not applicable. Further information is expected. Significant follow-up information was received on 10-APR-2025 from a health professional. Due to the nature of the event, the causality between the event "patient received ROTATEQ, VAXELIS and VAXNEUVANCE at 41 days instead of the recommended 42-day vaccination schedule" and Vaxelis was not applicable. No further information is expected. More
2842128 M PA 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7296AA
Expired product administered Expired product administered
expired VAXELIS was administered to a patient today; This Spontaneous Safety Report with reference n... expired VAXELIS was administered to a patient today; This Spontaneous Safety Report with reference number: 2025SA090728 was received by a partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'expired VAXELIS was administered to a patient today' and Vaxelis was not applicable. Further information is expected. More
2842129 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administ... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778063 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842130 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administ... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; No adverse event; This non-serious spontaneous safety report, with reference number 02778134 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842131 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administ... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; This non-serious spontaneous safety report, with reference number 02778056 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. FOLLOW-UP INFORMATION was forwarded on 24-APR-2025 from a healthcare professional. The case is maintained as non-serious. : The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event. No further information is expected. More
2842132 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administ... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; This non-serious spontaneous safety report, with reference number 02778084 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842133 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778100 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842134 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778130 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842135 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778151 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842136 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778108 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842137 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administ... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778169 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842138 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778115 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842139 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administ... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778158 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842140 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778172 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842141 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; HCP confirmed that there were no symptomatic events; This non-serious spontaneous safety report, with reference number 02778145 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds', 'HCP confirmed that there were no symptomatic events' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842142 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number: 02778105 (Interaction number 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from a nurse. Due to the nature of the event, the causality between the event "HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007760, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842143 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; HCP confirmed that there were no symptomatic events; This non-serious spontaneous safety report, with reference number 02777952 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds', 'HCP confirmed that there were no symptomatic events' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007769, MCM-007770, MCM-007771. Further information is expected. More
2842144 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778165 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds', 'HCP confirmed that there were no symptomatic events' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007770, MCM-007771. Further information is expected. More
2842145 TX 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
No adverse event, Product storage error No adverse event, Product storage error
HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VA... HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778153 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional. Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds', 'HCP confirmed that there were no symptomatic events' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007771. Further information is expected. More
2842146 F ID 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7899AA
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; VAXELIS was administered after a temperature excursion. (54.19F for 2hours 45 min)... No adverse event; VAXELIS was administered after a temperature excursion. (54.19F for 2hours 45 min); This non-serious spontaneous safety report, with reference number 02779819 (interaction number: 02779738), was received by partner on 31-MAR-2025 and forwarded on 01-APR-2025 from other health professional. Due to the nature of the event, the causality between the event 'VAXELIS was administered after a temperature excursion' and Vaxelis was not applicable. Further information is expected. Follow-up information, with reference number 02779819 (interaction number: 02779738), was forwarded on 01-MAY-2025 from other health professional. Due to the nature of the event, the causality between the event 'VAXELIS was administered after a temperature excursion', 'No adverse event' and Vaxelis was not applicable. No further information is expected. More
2842147 NY 05/21/2025 DTPPVHBHPB
HEP
 MSP VACCINE COMPANY
MERCK & CO. INC.

Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXE... 1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine; 1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine; This non-serious spontaneous safety report, with reference number 02780823 (interaction number: 02780822), was received by partner on 02-APR-2025 and forwarded on 02-APR-2025 from other health professional. Due to the nature of the event, the causality between the event '1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine' and Vaxelis was not applicable. Further information is expected. This non-significant follow-up report, with reference number 02780823 (interaction number: 02780822), was received on 30-APR-2025 from other health professional. Due to the nature of the event, the causality between the event '1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine' and Vaxelis was not applicable. Further information is not expected. More
2842148 F MD 05/21/2025 DTPPVHBHPB
HIBV
 MSP VACCINE COMPANY
SANOFI PASTEUR

Extra dose administered, Paralysis; Extra dose administered, Paralysis Extra dose administered, Paralysis; Extra dose administered, Paralysis
Patient had a "palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS;... Patient had a "palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS; Patient had a "palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS; This non-serious spontaneous, safety report was received by partner on 08-APR-2025 and forwarded on 09-APR-2025 from a healthcare professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events; "Patient had a "palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS", and overdose. Further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION was received on 24-APR-2025 from a healthcare professional (clinical manager). The healthcare professional reported that both Vaxelis and ACTHIB were not administered together at the same time. She further noted that the patient had reaction ("palsy-like" reaction) to Vaxelis, or Prevnar, or Rota according to the patient's mother. The reported was not able to confirm the reaction nor provide any further information as the event occurred while under the care of a previous pediatrician and there was no documentation was received from previous pediatrician. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events; "Patient had a "palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS", and overdose. No further information is expected. More
2842149 MI 05/21/2025 DTPPVHBHPB
HIBV
 MSP VACCINE COMPANY
MERCK & CO. INC.

Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Inbound call from HCP with questions regarding a patient who was co-administered VAXELIS and PEDVAXH... Inbound call from HCP with questions regarding a patient who was co-administered VAXELIS and PEDVAXHIB; HCP reported that there were no symptomatic events from the patient.; This non-serious spontaneous safety report, with reference number 02791973 (Interaction Number 02791970), was received by partner on 21-APR-2025 and forwarded on 22-APR-2025 from other health professional. Due to the nature of the event, the causality between the events �Inbound call from HCP with questions regarding a patient who was co-administered VAXELIS and PEDVAXHIB' and 'HCP reported that there were no symptomatic events from the patient.' and Vaxelis was not applicable. Further information is expected. More
2842150 NM 05/21/2025 DTPPVHBHPB
RV5
 MSP VACCINE COMPANY
MERCK & CO. INC.
 U7947AA
2088619
Product storage error; Product storage error Product storage error; Product storage error
HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion.; This no... HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion.; This non-serious spontaneous safety report, with reference number 02796514 (interaction number: 02796419), was received by the partner on 29-APR-2025 and forwarded on 29-APR-2025, from other health professional. Due to the nature of the event, the causality between the event "HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion" and Vaxelis was not applicable. Further information is expected. More
2842151 NM 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
Product storage error Product storage error
HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion.; This no... HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion.; This non-serious spontaneous safety report, with reference number 02796506 (interaction number: 02796419), was received by the partner on 29-APR-2025 and forwarded on 30-APR-2025, from other health professional Due to the nature of the event, the causality between the event "HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion" and Vaxelis was not applicable. Further information is expected. More
2842152 NM 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
Product storage error Product storage error
HBP reported patient was administered VAXELIS during a temperature excursion.; This non-serious spon... HBP reported patient was administered VAXELIS during a temperature excursion.; This non-serious spontaneous safety report, with reference number 02796524 (Interaction Number 02796419), was received by partner on 29-APR-2025 and forwarded on 29-APR-2025 from an other Health Professional. Due to the nature of the event, the causality between the event �HBP reported patient was administered VAXELIS during a temperature excursion.' and Vaxelis was not applicable. Further information is expected. More
2842153 F KY 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Eye swelling, Peripheral swelling, Rash Eye swelling, Peripheral swelling, Rash
swollen lower legs; both legs are swollen; lower legs are swollen "like golf balls".; swol... swollen lower legs; both legs are swollen; lower legs are swollen "like golf balls".; swollen eyes; About 4 hours after receiving the vaccine, the patient developed a fever; rash on her back and belly; This non-serious spontaneous safety report, with reference number 02796482 (interaction number: 02796481), was received by partner on 29-APR-2025 and forwarded on 29-APR-2025 from other non-health professional. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events, 'swollen lower legs; both legs are swollen; lower legs are swollen "like golf balls"', 'swollen eyes', 'About 4 hours after receiving the vaccine, the patient developed a fever' and 'rash on her back and belly'. Further information is expected. CASE CORRECTION performed on 13-MAY-2025 following QPPV review on the same date: Tylenol was coded as treatment under product tab and treatment was added for the event of fever under event tab. Outcome for the event of "Eye swelling" was conservatively updated to "Unknown". More
2842154 F ID 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7921AA
Off label use, Product administered to patient of inappropriate age Off label use, Product administered to patient of inappropriate age
Caller stated that 5-week baby was give the product 4 days early.; This non-serious spontaneous safe... Caller stated that 5-week baby was give the product 4 days early.; This non-serious spontaneous safety report, with reference number 2025SA134302 (Inquiry Number 02514653), was received by partner on 08-MAY-2025 and forwarded on 09-MAY-2025 from an other health professional. Case was considered as off-label use due to the reported event of patient being administered Vaxelis at age of 5 weeks. Due to the nature of the event, the causality between the event �Caller stated that 5-week baby was give the product 4 days early.' and Vaxelis was not applicable. Further information is expected. More
2842155 OK 05/21/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7374BA
Expired product administered Expired product administered
VAXELIS expired on 5/6/2025 and was administered to a patient on 5/12/2025; This Spontaneous Safety ... VAXELIS expired on 5/6/2025 and was administered to a patient on 5/12/2025; This Spontaneous Safety Report with reference number: 02804293/interaction number 02804291 was received by a partner on 13-MAY-2025 and forwarded on 13-MAY-2025 from a health professional. Due to the nature of the event, the causality between the event "VAXELIS expired on 5/6/2025 and was administered to a patient on 5/12/2025" and Vaxelis was not applicable. Further information is expected. More
2842156 M IN 05/21/2025 DTPPVHBHPB
HIBV
 MSP VACCINE COMPANY
SANOFI PASTEUR
 U7947AA
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
patient was given two doses of HIB; Vaccine coordinator said that there were no adverse events repor... patient was given two doses of HIB; Vaccine coordinator said that there were no adverse events reported; This non-serious, spontaneous safety report with reference number: 2025SA130977, 02506717, and 02506678 was received by a partner on 01-MAY-2025 and forwarded on 06-MAY-2025 from a health professional. Due to the nature of the event, the causality between the event "patient was given two doses of HIB" and Vaxelis was not applicable. Further information is expected. More
2842157 33 F FL 05/21/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Condition aggravated, Fear of injection, Heart rate, Investigation, Magnetic res... Condition aggravated, Fear of injection, Heart rate, Investigation, Magnetic resonance imaging heart; Myocarditis, Tachycardia, Ventricular extrasystoles More
Maybe she had myocarditis; fear of the vaccine; tachycardia; increased number of PCVs / PVCs got wor... Maybe she had myocarditis; fear of the vaccine; tachycardia; increased number of PCVs / PVCs got worse; increased number of PCVs / PVCs got worse; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 33-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "PVCs" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: Wasn't hospitalized; "anxiety" (unspecified if ongoing), notes: Regarding covid; "PTSD" (unspecified if ongoing), notes: Regarding covid; "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE oral taken for gastrooesophageal reflux disease, start date: 2021 (ongoing). The following information was reported: VENTRICULAR EXTRASYSTOLES (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "unknown" and all described as "increased number of PCVs / PVCs got worse"; TACHYCARDIA (non-serious) with onset 2021, outcome "recovered" (2021); MYOCARDITIS (medically significant), outcome "unknown", described as "Maybe she had myocarditis"; FEAR OF INJECTION (non-serious), outcome "not recovered", described as "fear of the vaccine". The events "tachycardia", "increased number of pcvs / pvcs got worse" and "fear of the vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: 130, notes: Without doing anything, just sitting there; 138; full cardiac workup: Unknown results, notes: Prior to getting the covid 19 vaccine; Magnetic resonance imaging heart: slight weakness within one of the ventricles, notes: After the covid 19 vaccine. Therapeutic measures were not taken as a result of tachycardia. Clinical course: Patient got the Pfizer covid-19 vaccine in June or July 2021 and she believed that within 3 hours after getting the vaccine, the patient experienced tachycardia and increased number of premature ventricular contractions (PCVs). The patient was under the care of cardiologist due to having PVCs occurring and then got the vaccine. By tachycardia, she meant her heart rate was 130 without her doing anything, she was just sitting there, and the patient could not get it to go down for 9 hours. Patient's heart went up to 130 for no reason, except for the vaccine she wasn't doing anything, that would warrant a heart rate of 130. The patient called the cardiologist office to tell them what was happening to her after the vaccine, she was told that if it did not go away after 24 hours to give them a call. It went away, so she never really saw a doctor about that. During the tachycardia episode with the vaccine her PVCs got worse and her heart start racing like she was going on the brisk walk or run. She felt them more frequently, she couldn't say for certain that PVCs were from the vaccine, she was having them before, her cardiologist did not really explain it to her. Patient's physician wanted her to move forward with the vaccine and get it because she was in the high-risk group. Her asthma was flaring up so bad that was why the physician really think that she should get the vaccine. As a result, she was nervous to move forward, she didn't want that to happen again, she didn't want to feel like that again and she was scared to get the vaccine, without being in like a medical setting and being monitored afterwards, to make sure that was not happening to her. The patient had all her vaccines, it was just this one that made her pause of and she didn't know if she should get it. She never had any reaction to any vaccine before. The patient had a history of anxiety and this episode had never happened before. She just went home from getting the vaccine. She was at home for about 2 hours and she went to get a shower and as soon as she started going down the stairs her heart started racing, and then in the entire duration of the shower her heart was racing and just continued from that point until like 03:00. She got the vaccine like at 17:00 in the afternoon, it was going on for like 6 hours. Physician recommended the vaccine for her because the risk of covid severe illness was more than risk of the side effect of the vaccine. The patient got her tetanus shot, flu shot this year and pneumonia shot. She was just literally nervous about this shot, based on her personal experience. The patient stated that she never experienced myocarditis herself, if she got it she would not know. Maybe she had myocarditis when she was experiencing tachycardia but she did not go to the emergency room and they did not evaluate that. The patient quit her job due to having severe anxiety regarding covid and she had been dealing with post-traumatic stress disorder since then. The patient had been in this situation for 5 years now, 3 and a half years from the vaccine period and haven't been cured for her fear of the vaccine by any physician. About three hours after the vaccination, she reported tachycardia with increased number of PVCs. She contacted her doctor's after-hours line since her heart rate was 138. She was nervous about getting a vaccine again. Her primary doctor advised her to do so but she was calling Pfizer to check to see if she should get another vaccine. She was nervous and anxious due to her previous experience with the vaccine. She spoke to cardiologist when it happened but did not seek treatment, she was advised to wait 24 hours. She only got one dose of the Pfizer covid-19 vaccine. The tachycardia was no longer ongoing and recovered about 6 or 7 hours after it started. She had a full cardiac workup due to PVCs she was having prior to getting the covid 19 vaccine. The lot number for BNT162b2, was not provided and will be requested during follow up. More
2842158 65 F AZ 05/21/2025 PNC20
 PFIZER\WYETH
 GT6700
Cold type haemolytic anaemia, Laboratory test Cold type haemolytic anaemia, Laboratory test
Cold agglutinin disease; This is a spontaneous report received from a Consumer or other non HCP. A ... Cold agglutinin disease; This is a spontaneous report received from a Consumer or other non HCP. A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2023 as dose number unknown, 0.5 ml single (Lot number: GT6700, Expiration Date: 31Oct2024) at the age of 65 years intramuscular, in right deltoid for immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN taken for hypertension. The following information was reported: COLD TYPE HAEMOLYTIC ANAEMIA (medically significant) with onset Feb2024, outcome "unknown", described as "Cold agglutinin disease". The event "cold agglutinin disease" required physician office visit. The patient underwent the following laboratory tests and procedures: lab test: (2023) unknown results. 5 days after she was given Prevnar 20 (NDC number 0005200010), she was donating blood and they would not accept her blood. In Feb2024 she was given a letter that stated the diagnosis. She was seeing a hematologist. More
2842159 M 05/21/2025 COVID19
 PFIZER\BIONTECH
Electromyogram, Guillain-Barre syndrome, Magnetic resonance imaging neck, Nerve ... Electromyogram, Guillain-Barre syndrome, Magnetic resonance imaging neck, Nerve conduction studies More
Guillain-Barre syndrome; This is a literature report for the following literature source(s). A 59-y... Guillain-Barre syndrome; This is a literature report for the following literature source(s). A 59-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), 60 days after the suspect product(s) administration, outcome "recovering" (reported as partial recovery). The clinical course was reported as follows: the patient experienced lower back pain, numbness and tingling of the bilateral lower extremities, urinary retention and constipation. The patient underwent the following investigations: a magnetic resonance imaging (MRI) of the spine, which demonstrated signs of osteoarthritis with the spinal cord intact and nerve conduction and electromyography studies, which revealed demyelination and dysfunctions in the engagement of distal muscles below the knee. Therapeutic measures were taken as a result of guillain-barre syndrome, which included intravenous immunoglobulin (IV IG).; Sender's Comments: Given the compatible time association, the reasonable possibility that the event Guillain-Barre syndrome is related to BNT162b2 administration cannot be completely excluded. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. This case will be reassessed should additional information become available. 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
2842160 05/21/2025 COVID19
 PFIZER\BIONTECH
Limb injury Limb injury
recently scraped her leg; This is a spontaneous report received from a Consumer or other non HCP, Pr... recently scraped her leg; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB INJURY (non-serious) with onset May2025, outcome "unknown", described as "recently scraped her leg". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2842161 WA 05/21/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Bone pain, Chills, Fatigue, Hypersomnia, Pain in extremity; Pyrexia, Retching Bone pain, Chills, Fatigue, Hypersomnia, Pain in extremity; Pyrexia, Retching
have my bones hurt so much that I felt nearly unable to walk; tired; sore arm; dry heaves; not be ab... have my bones hurt so much that I felt nearly unable to walk; tired; sore arm; dry heaves; not be able to stay awake to eat for over 30 hours; have blood in my urine; fever; chills; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in May2025 as dose 1, 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, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 2, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 3, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 4, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 5, single, manufacturer unknown), for Immunisation. The following information was reported: CHILLS (non-serious) with onset May2025, outcome "unknown"; RETCHING (non-serious) with onset May2025, outcome "unknown", described as "dry heaves"; PYREXIA (non-serious) with onset May2025, outcome "unknown", described as "fever"; BLOOD URINE PRESENT (non-serious) with onset May2025, outcome "unknown", described as "have blood in my urine"; BONE PAIN (medically significant) with onset May2025, outcome "unknown", described as "have my bones hurt so much that I felt nearly unable to walk"; HYPERSOMNIA (non-serious) with onset May2025, outcome "unknown", described as "not be able to stay awake to eat for over 30 hours"; PAIN IN EXTREMITY (non-serious) with onset May2025, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset May2025, outcome "unknown", described as "tired". The patient specified that he/she recently had 6th COVID vaccine. The patient had a mix of Pfizer and Moderna. This past Friday the patient had the Pfizer shot. The patient expected to be tired and had a sore arm. He/she did not expect to have dry heaves; the patient had bones hurt so much that he/she felt nearly unable to walk, not be able to stay awake to eat for over 30 hours, had blood in urine and of course had fever and chills. More
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