๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2855685 0.08 M OH 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7392AA
Expired product administered, Injection site pain, Injection site swelling Expired product administered, Injection site pain, Injection site swelling
mild swelling; pain at site of the injection; medication error/an inappropriate use due to administr... mild swelling; pain at site of the injection; medication error/an inappropriate use due to administration of an expired product; This non-serious spontaneous safety report, with reference number 2025SA157135, was received by partner on 30-MAY-2025 and forwarded on 02-JUN-2025 from other heath professional. Due to the nature of the event, the causality between the events 'medication error/an inappropriate use due to administration of an expired product' and Vaxelis was not applicable. Further information is expected. Significant follow-up information was received by the partner on 27-JUN-2025 and forwarded on 27-JUN-2025, from HCP. The case is maintained as non-serious. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events, 'mild swelling' and 'pain at site of the injection'. Due to the nature of the event, the causality between the events 'medication error/an inappropriate use due to administration of an expired product' and Vaxelis was not applicable. Further information is not expected. More
2855686 0.17 VA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7374BA
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse event; Which an expired dose of VAXELIS was administered to a patient; This non-serious s... No adverse event; Which an expired dose of VAXELIS was administered to a patient; This non-serious spontaneous safety report with reference number 02814911 was received by partner on 02-JUN-2025 and forwarded on 02-JUN-2025 from a healthcare professional. This case is non-valid as no patient identifiers were not provided at the time of reporting. Due to the nature of the event, the causality between Vaxelis and the event of "Which an expired dose of VAXELIS was administered to a patient" was not applicable. Further information is expected. SIGNFICANT FOLLOW-UP INFORMATION was received from a nurse on 06-JUN-2025. Patient identifiers were provided, and the case is now valid. Due to the nature of the event, the causality between Vaxelis and the events of "expired dose of VAXELIS was administered to a patient" and "No adverse event" were not applicable. Further information is not expected. More
2855687 F LA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
Product administered to patient of inappropriate age, Product storage error Product administered to patient of inappropriate age, Product storage error
Products that experienced multiple excursions were administered to patients; Age of vaccination (11 ... Products that experienced multiple excursions were administered to patients; Age of vaccination (11 years old); This non-serious, spontaneous, safety report with reference number: 02814773 was received by partner on 02-JUN-2025 and forwarded to agency on 03-JUN-2025 from a nurse. The case is considered non-valid as no patient identifiers were provided in this instance. Due to the nature of the event, the causality between Vaxelis and the event of "Products that experienced multiple excursions were administered to patients" were not applicable. Further information is expected. SIGNFICANT FOLLOW-UP INFORMATION was received from a nurse on 05-JUN-2025. Patient identifiers were provided, and case is now valid. Due to the nature of the event, the causality between Vaxelis and the events of "Products that experienced multiple excursions were administered to patients" and "Age of vaccination (11 years old)" were not applicable. Further information is not expected. More
2855689 1.08 F LA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
No adverse event, Product storage error No adverse event, Product storage error
Products that experienced multiple excursions were administered to patients; No adverse event; This ... Products that experienced multiple excursions were administered to patients; No adverse event; This non-serious, spontaneous, safety report with reference numbers: 02814773/02814717 was received on 05-JUN-2025 from a nurse. Due to the nature of the events, the causality between Vaxelis and the event of "Products that experienced multiple excursions were administered to patients" and "no adverse event" are not applicable. Further information is not expected. More
2855690 M LA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
No adverse event, Product storage error No adverse event, Product storage error
Products that experienced multiple excursions were administered to patients; No adverse event; This ... Products that experienced multiple excursions were administered to patients; No adverse event; This non-serious, spontaneous, safety report with linked reference numbers: 02814773 / 02814717 was received on 05-JUN-2025 from a nurse. Due to the nature of the events, the causality between Vaxelis and the event of "Products that experienced multiple excursions were administered to patients" and "no adverse event" are not applicable. Further information is not expected. More
2855691 F LA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
No adverse event, Product storage error No adverse event, Product storage error
Products that experienced multiple excursions were administered to patients; No adverse event; This ... Products that experienced multiple excursions were administered to patients; No adverse event; This non-serious, spontaneous, safety report with linked reference numbers: 02814773/02814717 was received on 05-JUN-2025 from a nurse. Due to the nature of the events, the causality between Vaxelis and the event of "Products that experienced multiple excursions were administered to patients" and "no adverse event" are not applicable. Further information is not expected. More
2855692 M LA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
No adverse event, Product storage error No adverse event, Product storage error
Products that experienced multiple excursions were administered to patients; No adverse event; This ... Products that experienced multiple excursions were administered to patients; No adverse event; This non-serious, spontaneous, safety report with linked reference numbers: 02814773/02814717 was received on 05-JUN-2025 from a nurse. Due to the nature of the events, the causality between Vaxelis and the event of "Products that experienced multiple excursions were administered to patients" and "no adverse event" are not applicable. Further information is not expected. More
2855693 F LA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7947AA
No adverse event, Product storage error No adverse event, Product storage error
Products that experienced multiple excursions were administered to patients; No adverse event; This ... Products that experienced multiple excursions were administered to patients; No adverse event; This non-serious, spontaneous, safety report with linked reference numbers: 02814773/02814717 was received on 05-JUN-2025 from a nurse. Due to the nature of the events, the causality between Vaxelis and the event of "Products that experienced multiple excursions were administered to patients" and "no adverse event" are not applicable. Further information is not expected. More
2855694 0.5 M MO 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7536AA
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse event experienced; Patient received an expired dose of VAXELIS/ No side effects or sympto... No adverse event experienced; Patient received an expired dose of VAXELIS/ No side effects or symptoms reported.; This non-serious, spontaneous, safety report with reference number: 02818204/ 02818200 was received by partner on 06-JUN-2025 and forwarded to agency on 09-JUN-2025 from a medical assistant. Due to the nature of the event, the causality between Vaxelis and the event of " Patient received an expired dose of VAXELIS/ No side effects or symptoms reported." were not applicable. Further information is expected. FOLLOW-UP INFORMAWTION was received on 24-JUN-2025 from a medical assistant. Due to the nature of the event, the causality between Vaxelis and the event of "Patient received an expired dose of VAXELIS/ No side effects or symptoms reported, and no adverse event" were not applicable. Further information is not expected. More
2855695 M AZ 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 u7899aa
Underdose Underdose
HCP called to report that on 05/22/2025 the patient received a partial dose of Vaxelis; This non-ser... HCP called to report that on 05/22/2025 the patient received a partial dose of Vaxelis; This non-serious spontaneous safety report, with reference number 02819736 (Interaction Number 02819717), was received by partner on 10-JUN-2025 and forwarded to agency on 10-JUN-2025 from a medical assistant. Due to the nature of the event, the causality between the event ๏ฟฝHCP called to report that on 05/22/2025 the patient received a partial dose of Vaxelis' and Vaxelis was not applicable. Further information is expected. More
2855696 M IL 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7392AA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Administration of VAXELIS to a patient more than 5 years of age; This non-serious spontaneous, safet... Administration of VAXELIS to a patient more than 5 years of age; This non-serious spontaneous, safety report with reference numbers 2025SA165307 and 02550786 was received by partner on 09-JUN-2025 and forwarded to agency on 10-JUN-2025 from a heathcare professional. Due to the nature of the event, the causality between Vaxelis and the reported event of "Administration of VAXELIS to a patient more than 5 years of age" was not applicable. This case is considered an instance of off-label use, due to Vaxelis being administered to patient of inappropriate age. Further information is expected. More
2855697 0.58 M PA 08/26/2025 DTPPVHBHPB
PNC20
 MSP VACCINE COMPANY
PFIZER\WYETH
 U7899AA
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
HCP reports no adverse events reaction to extra dose/no long term effects noted; Inadvertently admin... HCP reports no adverse events reaction to extra dose/no long term effects noted; Inadvertently administered extra dose of VAXELIS 3 weeks later, after third dose/vaxelis given too soon for schedule; Inadvertently administered extra dose of VAXELIS 3 weeks later, after third dose; This non-serious spontaneous, safety report with reference numbers: 02821253 and 02821250 was received by partner on 12-JUN-2025 and forwarded to RA on 12-JUN-2025 from a physician. The causal relationship between Vaxelis and the reported events; "Inadvertently administered extra dose of VAXELIS 3 weeks later, after third dose", and "HCP reports no adverse events reaction to extra dose" was assessed as not applicable due to the nature of the events. This case was considered off-label use due to patient receiving an extra dose (4th dose) of Vaxelis. Further information is expected. FOLLOW-UP INFORMATION with reference numbers: 02821253 was received by partner, on 05-Aug-2025 and forwarded to RA on 05-Aug-2025 from a physician. The case is maintained as non-serious and off-label. The causal relationship between Vaxelis and the reported events; "Inadvertently administered extra dose of VAXELIS 3 weeks later, after third dose", and "HCP reports no adverse events reaction to extra dose" was assessed as not applicable due to the nature of the events. No further information is expected More
2855698 F VA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion th... no adverse event; inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025; This non-serious spontaneous, safety report with reference numbers 02823415 and 02822913 was received by partner, on 17-JUN-2025 and forwarded to agency on 17-JUN-2025 from a healthcare professional. Additional information was received on 20-JUN-2025. Due to the nature of the event, the causality between Vaxelis and the events of "inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025" and "no adverse event" were not applicable. For reference purposes this case is linked to: MCM-008162, MCM-008164, MCM-008161, MCM-008163, MCM-008169 (same temperature excursion event) No further information is expected. More
2855699 M VA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; Inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion th... No adverse event; Inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025; This non-serious spontaneous, safety report with reference numbers 02823418 and 02822913 was received by partner, on 17-JUN-2025 and forwarded to agency on 17-JUN-2025 from a healthcare professional. Additional information was received on 20-JUN-2025. Due to the nature of the event, the causality between Vaxelis and the events of "Inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025" and "No adverse event" were not applicable. For reference purposes this case is linked to: MCM-008160, MCM-008162, MCM-008163, MCM-008164, and MCM-008169. (same temperature excursion event) No further information is expected. More
2855700 M VA 08/26/2025 DTPPVHBHPB
RV5
 MSP VACCINE COMPANY
MERCK & CO. INC.

No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No adverse event; Inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion th... No adverse event; Inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025; This non-serious spontaneous, safety report with reference numbers 02823416 and 02822913 was received by partner, on 17-JUN-2025 and forwarded to RA on 17-JUN-2025 from a healthcare professional. Additional information was received on 20-JUN-2025. Due to the nature of the event, the causality between Vaxelis and the events of "inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025" and "no adverse event" were not applicable. For reference purposes this case is linked to: MCM-008160, MCM-008161, MCM-008163, MCM-008164, and MCM-008169 (same temperature excursion event) No further information is expected. More
2855701 F VA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion th... no adverse event; inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025; This non-serious spontaneous, safety report with reference numbers 02823417 and 02822913 was received by partner, on 17-JUN-2025 and forwarded to agency on 17-JUN-2025 from a healthcare professional. Additional information was received on 20-JUN-2025. Due to the nature of the event, the causality between Vaxelis and the events of "inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025" and "no adverse event" were not applicable. For reference purposes this case is linked to: MCM-008160, MCM-008161, MCM-008162, MCM-008164, and MCM-008169 (same temperature excursion event). No further information is expected. More
2855702 F VA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; Inadvertent administration of VAXELIS after a temperature excursion that occurred ... No adverse event; Inadvertent administration of VAXELIS after a temperature excursion that occurred on 07MAY2025; This non-serious spontaneous safety report, with reference number 02823419 (Interaction Number 02822913), was received by partner on 17-JUN-2025 and forwarded to agency on 17-JUN-2025 from a nurse. Due to the nature of the event, the causality between the event ๏ฟฝinadvertent administration of VAXELIS after a temperature excursion that occurred on 07MAY2025' and Vaxelis was not applicable. Further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION, was received by agency on 20-JUN-2025 from a nurse. Due to the nature of the event, the causality between the event; "Inadvertent administration of VAXELIS after a temperature excursion that occurred on 07MAY2025" and "No adverse event" and Vaxelis was not applicable. For reference purposes this case is linked to: MCM-008160, MCM-008161, MCM-008162, MCM-008163, and MCM-008169 (same temperature excursion event) No further information is expected. More
2855703 F OR 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7788AA
No adverse event, Product storage error No adverse event, Product storage error
Customer calling to report temperature excursion. Multiple products were administered to multiple pa... Customer calling to report temperature excursion. Multiple products were administered to multiple patients.; No adverse event; This non-serious spontaneous safety report with reference number 02826008 was received by partner on 23-JUN-2025 and forwarded to agency on 24-JUN-2025 from a pharmacist. Additional information was received from a pharmacist on 30-JUN-2025. Due to the nature of the event, the causality between Vaxelis and the events of "Customer calling to report temperature excursion. Multiple products were administered to multiple patients", and "No adverse event" were not applicable. For reference purposes the case is linked to: MCM-008285 (same event, same reporter) Further information is expected. More
2855704 F OR 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7788AA
Product storage error Product storage error
Customer calling to report temperature excursion. Multiple products were administered to multiple pa... Customer calling to report temperature excursion. Multiple products were administered to multiple patients.; This non-serious spontaneous safety report, with no identified reference number, was received by partner on 30-JUN-2025 and forwarded to agency on 30-JUN-2025 from pharmacist. Due to the nature of the event, the causality between the event 'Customer calling to report temperature excursion. Multiple products were administered to multiple patients' and Vaxelis was not applicable. Further information is not expected. More
2855705 M VA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7788AA
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Nurse reported that they have given a VAXELIS dose to a 5 year old patient; This non-serious spontan... Nurse reported that they have given a VAXELIS dose to a 5 year old patient; This non-serious spontaneous, safety report with reference numbers 2025SA186558 and 02574248 was received by partner on 30-JUN-2025 and forwarded to agency on 01-JUL-202 from a nurse practitioner. Due to the nature of the event, the causality between Vaxelis and the reported event of "Nurse reported that they have given a VAXELIS dose to a 5 year old patient" was not applicable. This case is considered an instance of off-label use, due to Vaxelis being administered to patient of inappropriate age. Further information is expected. More
2855706 M CA 08/26/2025 DTPPVHBHPB
IPV
PNC20
RV1
 MSP VACCINE COMPANY
SANOFI PASTEUR
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 U7947AA
Y1A201M
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No adverse event; received a dose of VAXELIS, which has the Polio, and the patient also received an ... No adverse event; received a dose of VAXELIS, which has the Polio, and the patient also received an extra Ipol; received a dose of VAXELIS, which has the Polio, and the patient also received an extra Ipol; Patient receiving his first dose of VAXELIS past the recommended schedule; This non-serious, spontaneous safety report with reference number: 2025SA193061, 02583395, and 02583320 was received by a partner on 08-JUL-2025 and forwarded to agency on 09-JUL-2025 from a nurse. Due to the nature of the event, the causality between the event "received a dose of VAXELIS, which has the Polio, and the patient also received an extra Ipol", and "patient receiving his first dose of VAXELIS past the recommended schedule." and Vaxelis are not applicable. Further information is expected. FOLLOW-UP INFORMATION was received by partner, on 07-AUG-2025 and forwarded to agency on 08-AUG-2025 from a health professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the events "received a dose of VAXELIS, which has the Polio, and the patient also received an extra Ipol", and "patient receiving his first dose of VAXELIS past the recommended schedule." and "no adverse event" and Vaxelis are not applicable. No further information is expected. CASE CORRECTION performed on 22-AUG-2025. Patient age at vaccination, date of birth, height and weight was corrected. More
2855707 CA 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Urticaria Urticaria
2 months old baby was vaccinated with VAXELIS and experienced hives the next day.; This non-serious ... 2 months old baby was vaccinated with VAXELIS and experienced hives the next day.; This non-serious spontaneous safety report with reference 02836633/02836632 was received by a partner on 10-JUL-2025 and forwarded to agency on 11-JUL-2025 from a health care professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "2 months old baby was vaccinated with VAXELIS and experienced hives the next day". Further information is expected. More
2855708 TX 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions... HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions; This non-serious spontaneous Safety Report was received by MSD, on 15-JUL-2025 and forwarded to RA on 15-JUL-2025 from a medical assistant. Due to the nature of the event, the causality between the event " administration of VAXELIS prefilled syringe that experienced two temperature excursions" was not applicable. Further information is expected. For reference purposed this case is linked to the following cases: MCM-008333, MCM-008332, MCM-008328, MCM-008329, MCM-008331. More
2855709 TX 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions... HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions.; This non-serious spontaneous safety report, with reference number 02838566 (Interaction Number 02838525), was received by partner on 15-JUL-2025 and forwarded to agency on 15-JUL-2025 from an other health professional. Due to the nature of the event, the causality between the event ๏ฟฝHCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions.' and Vaxelis was not applicable. Further information is expected. More
2855710 TX 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions... HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions; This non-serious spontaneous safety report was received by partner with reference number: 02838564 on 15-JUL-2025 and forwarded to agency on 15-JUL-2025 from a healthcare professional and concerned a patient from unknown ethnic origin. Due to the nature of the event, the causality between Vaxelis and the events of "HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions" were not applicable. For reference purposes this case is linked to: MCM-008327, MCM-008328, MCM-008331, MCM-008332, and MCM-008333. Further information is expected. More
2855711 TX 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions... HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions.; This non-serious spontaneous Safety Report was received by partner on 15-JUL-2025 and forwarded to agency on 15-JUL-2025 from a health care professional. Due to the nature of the event, the causality between the event " administration of VAXELIS prefilled syringe that experienced two temperature excursions" was not applicable. Further information is expected. For reference purposed this case is linked to the following cases: MCM-008333, MCM-008332, MCM-008328, MCM-008329, MCM-008327. More
2855712 TX 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions... HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions; This non-serious spontaneous safety report was received by partner with reference number: 02838568 on 15-JUL-2025 and forwarded to agency on 15-JUL-2025 from a healthcare professional and concerned a patient from unknown ethnic origin. Due to the nature of the event, the causality between Vaxelis and the events of "HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions" were not applicable. For reference purposes this case is linked to: MCM-008327, MCM-008329, MCM-008328, MCM-008331, and MCM-008333. Further information is expected. More
2855713 TX 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8265AA
Product storage error Product storage error
HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions... HCP reported administration of VAXELIS Prefilled Syringe that experienced two temperature excursions.; This non-serious spontaneous Safety Report was received by partner on 15-JUL-2025 and forwarded to agency on 15-JUL-2025 from a health care professional. Due to the nature of the event, the causality between the event " administration of VAXELIS prefilled syringe that experienced two temperature excursions" was not applicable. Further information is expected. For reference purposed this case is linked to the following cases: MCM-008327, MCM-008332, MCM-008328, MCM-008329, MCM-008331. More
2855714 F OH 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7374BA
Expired product administered Expired product administered
An inappropriate use due to administering an expired VAXELIS/human error; No adverse event; This non... An inappropriate use due to administering an expired VAXELIS/human error; No adverse event; This non-serious spontaneous safety report, with reference number 2025SA221292 (Inquiry Number: 02604791), was received by partner on 28-JUL-2025 and forwarded to agency on 29-JUL-2025 from a healthcare professional. Due to the nature of the event, the causality between the event 'An inappropriate use due to administering an expired VAXELIS' and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION was received on 12-AUG-2025 from a healthcare professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the event 'An inappropriate use due to administering an expired VAXELIS' and "No adverse event" and Vaxelis was not applicable. Further information is not expected More
2855715 NY 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U8313AA
Product storage error Product storage error
Customer called to report TE for VAXELIS PFS. VAXELIS was administered to 14 patients.; This non-ser... Customer called to report TE for VAXELIS PFS. VAXELIS was administered to 14 patients.; This non-serious spontaneous safety report with reference number: 02848528 was received by partner on 31-JUL- 2025 and forwarded on 31-JUL-2025 from a healthcare professional and concerned a patient of unknown ethnic origin. Due to the nature of the event, the causality between Vaxelis and the events of "Customer called to report TE for VAXELIS PFS. VAXELIS was administered to 14 patients" were not applicable. Further information is expected. More
2855716 F NC 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Vomiting Vomiting
vomiting (self-limiting) for about 8 hours. HCP states "no side effects from 1st shot, but vomi... vomiting (self-limiting) for about 8 hours. HCP states "no side effects from 1st shot, but vomiting occurred within hours of her second shot; This non-serious spontaneous safety report was received by partner on 31-JUL-2025 and forwarded to agency on 01-AUG-2025 from a health car professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event. Further information is expected. More
2855717 F MD 08/26/2025 DTPPVHBHPB
PNC15
 MSP VACCINE COMPANY
MERCK & CO. INC.
 U7829AA
Z003633
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Inadvertent administration of a VAXNEUVANCE and VAXELIS dose to a 6-day old patient; patient did not... Inadvertent administration of a VAXNEUVANCE and VAXELIS dose to a 6-day old patient; patient did not experience ay adverse reaction to the administration of Vaxelis and Vaxneuvance after.; This non-serious spontaneous safety report, with reference number 02851064 (interaction number: 02851062), was received by partner on 05-AUG-2025 and forwarded to agency on 05-AUG-2025 from a health professional. Off-label classification was added due to Vaxelis being administered to a 6-day-old patient. Due to the nature of the event, the causality between the event 'Inadvertent administration of a VAXNEUVANCE and VAXELIS dose to a 6-day old patient' and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION was received by agency, on 11-AUG-2025 and forwarded to agency on 11-AUG-2025 from a Health professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the event 'Inadvertent administration of a VAXNEUVANCE and VAXELIS dose to a 6-day old patient/patient did not experience ay adverse reaction to the administration of Vaxelis' and Vaxelis was not applicable Further information is not expected. More
2855718 MD 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Erroneously by mistake, administered to a 6-day-old infant; VAXELIS and VAXNUEVANCE were ad, erroneo... Erroneously by mistake, administered to a 6-day-old infant; VAXELIS and VAXNUEVANCE were ad, erroneously by mistake, administered to a 6-day-old infant.; This non-serious spontaneous safety report with case ID reference number: 02851000 (Interaction number: 02850957) was received by partner on 05-AUG-2025 and forwarded to agency on 05-AUG-2025 from a physician. Due to the nature of the event, the causality between the events "VAXELIS and VAXNUEVANCE were ad, erroneously by mistake, administered to a 6-day-old infant." and Vaxelis was assessed as not applicable. The case was considered off-label use due to Vaxelis being administered to a 6-year-old infant. Further information is expected. More
2855719 SC 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Extra dose administered Extra dose administered
Vaccination error; Two doses of Vaxelis were administered to a 2-month old instead of one dose of Va... Vaccination error; Two doses of Vaxelis were administered to a 2-month old instead of one dose of Vaxelis and one dose of PCV; This spontaneous safety report, with reference number 2025SA244489 (Inquiry # 02623323), was received by the partner on 14-AUG-2025 and forwarded to RA on 16-AUG-2025, from a health care professional. Due to the nature of the event, the causality between the events "Two doses of Vaxelis were administered to a 2-month old instead of one dose of Vaxelis and one dose of PCV (Overdose)" and vaccination error and Vaxelis was not applicable. Further information is expected. More
2855720 M CA 08/26/2025 COVID19
 NOVAVAX
Arthritis Arthritis
Mild inflammation on his knee after having the Novavax vaccine; This non-serious initial spontaneous... Mild inflammation on his knee after having the Novavax vaccine; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00632) and concerns an elderly Male who experienced "MILD INFLAMMATION ON HIS KNEE AFTER HAVING THE NOVAVAX VACCINE" after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 02-Oct-2024. At the time of the report, the outcome of the Arthritis was Recovered/Resolved. A few discrepancies were identified in the source document. Patient's age group was reported as "Adult" but was captured as "Elderly" according to the reported date of birth. The Novavax vaccination information reported for the 'Body Site Location' of the product administration was provided as "Left". Left arm was conservatively selected and will be confirmed with the query sent to the consumer.; Sender's Comments: This Male of an unspecified age experienced Arthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Arthritis was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Arthritis is considered Possible. More
2855723 1 F OH 08/26/2025 HEPA
MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Z005852
Z002520
Z006737
Hand-foot-and-mouth disease; Hand-foot-and-mouth disease; Hand-foot-and-mouth di... Hand-foot-and-mouth disease; Hand-foot-and-mouth disease; Hand-foot-and-mouth disease More
Received vaccines on 8/14/25 + started Amoxicillin. Went to hospital for rash on 8/24/25 Dx hand foo... Received vaccines on 8/14/25 + started Amoxicillin. Went to hospital for rash on 8/24/25 Dx hand foot and mouth. Changed Amoxicillin to Cefdinir rash improving. More
2855724 11 F CA 08/26/2025 HEP
HPV9
IPV
MNQ
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Z004729
Z002903
X1C891M
U8494AA
PG3RP
Blister rupture, Rash, Rash papular, Skin exfoliation; Blister rupture, Rash, Ra... Blister rupture, Rash, Rash papular, Skin exfoliation; Blister rupture, Rash, Rash papular, Skin exfoliation; Blister rupture, Rash, Rash papular, Skin exfoliation; Blister rupture, Rash, Rash papular, Skin exfoliation; Blister rupture, Rash, Rash papular, Skin exfoliation More
11 yo F; rash breaking out after Tdap, IVP, hep B, MCV and HPV given on 8/14/25. She has some slough... 11 yo F; rash breaking out after Tdap, IVP, hep B, MCV and HPV given on 8/14/25. She has some sloughed skin on the nose and popped vesicles around the mouth. It started out with papular rash diffusely just on her face. Bacitracin given. More
2855725 63 F WA 08/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 NR4T5
Hypoaesthesia, Paraesthesia Hypoaesthesia, Paraesthesia
Patient sates experienced numbness and tingling from arm to fingers Patient sates experienced numbness and tingling from arm to fingers
2855726 65 F FL 08/26/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 U8764BB
LN4927
Dizziness, Headache, Nausea, Vomiting; Dizziness, Headache, Nausea, Vomiting Dizziness, Headache, Nausea, Vomiting; Dizziness, Headache, Nausea, Vomiting
Patient received vaccines at around 7:30 pm on 8-20-25, on 8-21-25 at 2 am and 4 am was vomiting, th... Patient received vaccines at around 7:30 pm on 8-20-25, on 8-21-25 at 2 am and 4 am was vomiting, then later that day was dizzy, had severe headache that tylenol didn't help, and was nauseous. By 8-22-25 she had felt better with no symptoms. More
2855727 71 F TX 08/26/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8764DB
U8764DB
Diarrhoea, Injection site erythema, Nausea, Pain, Pain in extremity; Peripheral ... Diarrhoea, Injection site erythema, Nausea, Pain, Pain in extremity; Peripheral swelling More
After receiving the vaccine patient expired a swollen, achy arm, erythema/redness all around the inj... After receiving the vaccine patient expired a swollen, achy arm, erythema/redness all around the inject site as well as her entire bicep muscle. The following day she had body aches, nausea, diarrhea, severe arm soreness. However, no swollen throat or tongue, no itching or burning. More
2855742 7 F NM 08/26/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient was supposed to have recived Boostrix for her age, but received infarix. no adverse reactio... Patient was supposed to have recived Boostrix for her age, but received infarix. no adverse reaction observed or reported. More
2855743 37 M CA 08/26/2025 FLU3
HEP
IPV
 SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
SANOFI PASTEUR
 U8832DA
946063
Y1D03P1
Dizziness, Hyperhidrosis, Hypopnoea, Syncope, Tachycardia; Dizziness, Hyperhidro... Dizziness, Hyperhidrosis, Hypopnoea, Syncope, Tachycardia; Dizziness, Hyperhidrosis, Hypopnoea, Syncope, Tachycardia; Dizziness, Hyperhidrosis, Hypopnoea, Syncope, Tachycardia More
After the last of the 3 shots was administered, patient began to show signs of syncope/dizziness wit... After the last of the 3 shots was administered, patient began to show signs of syncope/dizziness within 1 minute. As he was trying to reorient himself, he began to perspire and started to feel hot. His partner was with him and gave him some water at this point. I advised patient to lean back. When that did not improve, I advised patient to lie down and called another pharmacist to assist with moving him. As patient began to slump (this was about 3 minutes after he initially began to show symptoms), his partner was trying to help him stay upright. Patient did not want to lie down but I and another pharmacist were standing by ready to move him. Pulse and breathing was checked. Breathing was shallow but present and patient was slightly tachycardic (about 100bpm). No epinephrine was administered. His sweating began to subside but still felt hot. He did not want ice pack at first but I eventually just offered it to him. After about 4-5 minutes, patient recovered fully without lying down. More
2855744 18 F MD 08/26/2025 MENB
 PFIZER\WYETH
 LP6524
Wrong product administered Wrong product administered
Patient asked for Meningococcal vaccine. She received Meningococcal B (Truenba) Later the parent ca... Patient asked for Meningococcal vaccine. She received Meningococcal B (Truenba) Later the parent called to say her school required ACY not B. She received it the next day at another facility as we did not have in stock. More
2855745 89 M NC 08/26/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 934FZ
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient with no adverse events, 2 days post administration. Received 2 shots of RSV arexvy even thou... Patient with no adverse events, 2 days post administration. Received 2 shots of RSV arexvy even though not recommended by the CDC due to reporting errors. Received a dose in 2023 and 2025 More
2855746 4 M CA 08/26/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 Z003401
Z003401
Cognitive disorder, Diarrhoea, Lethargy, Personality change, Pyrexia; Tremor Cognitive disorder, Diarrhoea, Lethargy, Personality change, Pyrexia; Tremor
Reported by father to me on 8/26/25: diarrhea, lethargy, fever, decrease cognitive function, dulled ... Reported by father to me on 8/26/25: diarrhea, lethargy, fever, decrease cognitive function, dulled personality and shaking episode at night More
2855747 72 M 08/26/2025 COVID19
 MODERNA
 3046734
Decreased appetite, Fatigue, Headache, Pain Decreased appetite, Fatigue, Headache, Pain
Patient stopped by the pharmacy on 08/26/2025 and asked to me to report his side effects of Spikevax... Patient stopped by the pharmacy on 08/26/2025 and asked to me to report his side effects of Spikevax vaccine given on 08/17/2025. Patient states he had sever exhaustion, headache, body aches, and loss of appetite. Side affects subsited without medical intervention. More
2855748 70 F 08/26/2025 COVID19
 MODERNA
 3046734
Cognitive disorder, Diarrhoea, Hallucination, Nausea, Vomiting Cognitive disorder, Diarrhoea, Hallucination, Nausea, Vomiting
Patient husband stopped by the pharmacy and expressed that both him and his wife experienced side af... Patient husband stopped by the pharmacy and expressed that both him and his wife experienced side affects post receiving Spikevax vaccine on 08/14/2025. Per husband patient experienced diarrhea, and nausea accompanied by throwing up. In addition, patient had some cognitive side effects, per husband, patient had "loss of time and reality". Patient was hilucinating and talking about their daughter as if she was still 3 years old. Patient states that the side affects subsited without any medical intervention. More
2855361 08/25/2025 RVX
RVX
RVX
RVX
RVX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
UNK
UNK
Dysphagia, Gastrointestinal tube insertion, Guillain-Barre syndrome, Movement di... Dysphagia, Gastrointestinal tube insertion, Guillain-Barre syndrome, Movement disorder, Neurological symptom; Quadriplegia; Gait inability, Gastrointestinal tube insertion, Guillain-Barre syndrome, Paralysis; Dysphagia, Gastrointestinal tube insertion, Guillain-Barre syndrome, Movement disorder, Neurological symptom; Quadriplegia; Gait inability, Gastrointestinal tube insertion, Guillain-Barre syndrome, Paralysis More
Guillain-Barre syndrome; total body paralysis from feet to eyes/ could not move or swallow; Severe n... Guillain-Barre syndrome; total body paralysis from feet to eyes/ could not move or swallow; Severe nerve reaction; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant), quadraplegic (Verbatim: total body paralysis from feet to eyes/ could not move or swallow) (serious criteria GSK medically significant) and neurologic reaction (Verbatim: Severe nerve reaction). The outcome of the guillain barre syndrome, quadraplegic and neurologic reaction were not reported. It was unknown if the reporter considered the guillain barre syndrome, quadraplegic and neurologic reaction to be related to RSV vaccine. The company considered the guillain barre syndrome, quadraplegic and neurologic reaction to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and had a severe nerve reaction. By the end of the week the patient was in the emergency room with Guillain-Barre syndrome. One of the first questions that was asked was if patient had gotten the RSV vaccine. The patient eventually had total body paralysis from his/her feet to his/her eyes. The patient could not move or swallow. The patient used feeding tube and months in rehab to learn how to walk again. The patient advised to not get this vaccine.; Sender's Comments: A case of Guillain-Barre syndrome and Quadriplegia, on an unknown date after receiving RSV vaccine in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2855363 73 F MI 08/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ353
Product preparation issue Product preparation issue
Inappropriate reconstitution technique; Inappropriate dose of vaccine administered; This non-serious... Inappropriate reconstitution technique; Inappropriate dose of vaccine administered; 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 73-year-old female patient who received Herpes zoster (Shingrix) (batch number PJ353) for prophylaxis. On 13-AUG-2025, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 13-AUG-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 19-AUG-2025 The reporter stated that the antigen was mixed with sterile water and not with the adjuvant component of the vaccine Shingrix which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This was the first dose of Shingrix. More
2855364 08/25/2025 MMR
 UNKNOWN MANUFACTURER
 UNK
Swelling, Swelling face Swelling, Swelling face
woke up with swollen face and turkey neck; woke up with swollen face and turkey neck; This non-serio... woke up with swollen face and turkey neck; woke up with swollen face and turkey neck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of facial swelling in a patient who received MMR (MMR vaccine) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of influenza. On an unknown date, the patient received MMR vaccine. On an unknown date, an unknown time after receiving MMR vaccine, the patient experienced facial swelling (Verbatim: woke up with swollen face and turkey neck) and neck swelling (Verbatim: woke up with swollen face and turkey neck). The outcome of the facial swelling and neck swelling were not reported. It was unknown if the reporter considered the facial swelling and neck swelling to be related to MMR vaccine. It was unknown if the company considered the facial swelling and neck swelling to be related to MMR vaccine. Additional Information: GSK receipt date: 28-JUL-2025 This case was reported by a patient via interactive digital media. The patient stated that he/she do not get the vaccines or shots because when they get it, catch whatever it was that the vaccine are trying to cure from or keep from catching. For example, patient got the mumps, measles and rubella vaccine and woke up with a turkey neck and swollen face. Patient took the flu shot and caught the flu and learned lesson that none of the vaccines or shots are for them. Patent body will fight off whatever it was and vaccine are No for patient as Everybody bodies react different to vaccinations and patient was one of them. More
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