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
2830576 8 M ND 03/11/2025 HEP
UNK
UNK
UNK
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 95BJ9
946595

Y008284
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, Product storage error; No adverse event, Product storage error More
No additional AE; patients may have received improperly stored PROQUAD; This spontaneous report was ... No additional AE; patients may have received improperly stored PROQUAD; This spontaneous report was received from a Nurse and refers to an 8-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. On 01-Oct-2024 FCPH received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. A document was found on the FDA website. It was assumed that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) could be stored in both the freezer and refrigerator and both State and Private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. On 05-Dec-2024, the patient was vaccinated with the improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y008284, expiration date: 21-Oct-2025) administered by Subcutaneous route in Left Arm for prophylaxis with sterile diluent (MERCK STERILE DILUENT) (Product storage error). On the same day, the patient also received Engerix b (Hepatitis b vaccine rHBsAg (yeast)) (lot #95BJ9) (Left arm), administered by Intramuscular route and Flucelvax quadrivalent (Influenza vaccine inact sAg 4v) (lot #946595) (Right Arm), administered by Intramuscular route. No additional AE. This is one of the several reports received from the same reporter. More
2830577 F KY 03/11/2025 MMR
 MERCK & CO. INC.
No adverse event, Product dose omission issue No adverse event, Product dose omission issue
"The HCP sttated she did not experienced any other adverse issues ir side effects form the admi... "The HCP sttated she did not experienced any other adverse issues ir side effects form the administered or missed dose"; No adverse event; Information has been received from Business Partner/CRO on 28-Feb-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) 51-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On Sep-1978, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported). On an unknown date, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), for the treatment of Prophylaxis. On an unknown date, the patient experienced No adverse event. On an unknown date, the patient experienced "The HCP sttated she did not experienced any other adverse issues ir side effects form the administered or missed dose". At the reporting time, the outcome of No adverse event and "The HCP sttated she did not experienced any other adverse issues ir side effects form the administered or missed dose" was unknown. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable. More
2830578 M LA 03/11/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 797F9
UNK
Rash; Rash Rash; Rash
broke up with rash a month later up the torso like ringworms; has not received a second dose yet; Th... broke up with rash a month later up the torso like ringworms; has not received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 49-year-old male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis. On an unknown date, the patient received the 2nd dose of Twinrix. On 19-NOV-2024, the patient received the 1st dose of Twinrix. On an unknown date, not applicable after receiving Twinrix and 1 month after receiving Twinrix, the patient experienced rash (Verbatim: broke up with rash a month later up the torso like ringworms) and incomplete course of vaccination (Verbatim: has not received a second dose yet). The outcome of the rash was unknown and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the rash to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the rash to be related to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date : 26-FEB-2025 Pharmacist called on February 26, 2025 to report a patient received the first dose for Twinrix on November 19, 2024 and broke up with rash a month later up the torso like ringworms and and had not received a second dose yet. Till the time of reporting, the patient did not receive 2nd dose of twinrix, which led to incomplete course of vaccination. More
2830579 TX 03/11/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Priorix was administered intramuscularly instead of subcutaneously.; This non-serious case was repor... Priorix was administered intramuscularly instead of subcutaneously.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was administered intramuscularly instead of subcutaneously.). The outcome of the subcutaneous injection formulation administered by other route 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:06-MAR-2025 Pharmacist reports Priorix was administered intramuscularly instead of subcutaneously, which led to subcutaneous injection formulation administered by other route The reporter consented to follow up. No details at time of call were available. More
2830580 03/11/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Inappropriate Dose Administered (adult dose maladministered on a pediatric patient); Inappropriate D... Inappropriate Dose Administered (adult dose maladministered on a pediatric patient); Inappropriate Dose Administered (adult dose maladministered on a pediatric patient); This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a patient who received HAV (Havrix 1440 adult) for prophylaxis. On an unknown date, the patient received Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced accidental overdose (Verbatim: Inappropriate Dose Administered (adult dose maladministered on a pediatric patient)) and adult product administered to child (Verbatim: Inappropriate Dose Administered (adult dose maladministered on a pediatric patient)). The outcome of the accidental overdose and adult product administered to child were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-MAR-2025 The reporter called to ask any medical concerns about the maladministration of an adult dose in a pediatric patient on one of their clinics, which led to accidental overdose and adult product administered to child. No vaccination date, nor vaccine detail or patient๏ฟฝs demographics were obtained (Anonymous Healthcare provider did not consent follow-up from Safety Department). No further information was obtained in this call. Did not consent to follow-up. More
2830581 63 M 03/11/2025 COVID19
 MODERNA
 3043159
Night sweats, Sleep disorder Night sweats, Sleep disorder
awoke 3 times at night completely drenched in sweat; awoke 3 times at night completely drenched in s... awoke 3 times at night completely drenched in sweat; awoke 3 times at night completely drenched in sweat; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (awoke 3 times at night completely drenched in sweat) and SLEEP DISORDER (awoke 3 times at night completely drenched in sweat) in a 63-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043159) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Feb-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 26-Feb-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced NIGHT SWEATS (awoke 3 times at night completely drenched in sweat). On an unknown date, the patient experienced SLEEP DISORDER (awoke 3 times at night completely drenched in sweat). At the time of the report, NIGHT SWEATS (awoke 3 times at night completely drenched in sweat) and SLEEP DISORDER (awoke 3 times at night completely drenched in sweat) outcome was unknown. No concomitant medications were reported. It was reported that he has awoken 3 times at night completely drenched in sweat and never experienced this before. No treatment medications were reported. More
2830582 1.25 M LA 03/11/2025 DTAPIPVHIB
MNQ
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
 UK107AA
U8124AB
Y011015
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Menquadfi vaccine administered instead of Prevnar vaccine no adverse reaction Menquadfi vaccine administered instead of Prevnar vaccine no adverse reaction
2830589 PA 03/11/2025 HEPA
 MERCK & CO. INC.
 X017083
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse event; HCP called to report a child was administered an expired VAQTA vaccine. Lot/Expira... No adverse event; HCP called to report a child was administered an expired VAQTA vaccine. Lot/Expiration X017083 12/13/2024, administered 2/19/2025. Consent to contact is yes. No adverse side effects were reported. No additional information available at this time. N; This spontaneous report was received from a physician and refers to a 3-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-FEB-2025, the patient was vaccinated with an expired dose of with Hepatitis A Vaccine, Inactivated (VAQTA) (lot #X017083, who had been verified to be a valid lot number, expiration date reported and assessed as 13-DEC-2024) administered for prophylaxis (strength, exact dose, anatomical route of administration were not provided) (expired product administered). No adverse event. More
2830590 43 M IL 03/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 4ZN3H
Underdose Underdose
pediatric immunizaton was given to an adult; pediatric immunizaton was given to an adult; This non-s... pediatric immunizaton was given to an adult; pediatric immunizaton was given to an adult; This non-serious case was reported by a other health professional and described the occurrence of underdose in a 43-year-old male patient who received HBV (Engerix B pediatric) (batch number 4ZN3H, expiry date 01-DEC-2026) for prophylaxis. On 02-OCT-2024, the patient received Engerix B pediatric (intramuscular) 1 ml. On 02-OCT-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: pediatric immunizaton was given to an adult) and adult use of a child product (Verbatim: pediatric immunizaton was given to an adult). The outcome of the underdose and adult use of a child product were unknown. Additional Information: GSK Receipt Date: 13-NOV-2024 The other health professional reported that the pediatric immunization was given to an adult which led to underdose and adult use of a child product. More
2830591 03/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Myalgia Fatigue, Myalgia
Fatigue; experienced myalgia; This non-serious case was reported by a physician via sales rep and de... Fatigue; experienced myalgia; This non-serious case was reported by a physician via sales rep and described the occurrence of fatigue in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue) and myalgia (Verbatim: experienced myalgia). The outcome of the fatigue was resolved and the outcome of the myalgia was not reported. The reporter considered the fatigue to be related to Arexvy. It was unknown if the reporter considered the myalgia to be related to Arexvy. The company considered the fatigue to be related to Arexvy. It was unknown if the company considered the myalgia to be related to Arexvy. Additional Information: GSK Receipt Date: 05-MAR-2025 Physician reported that patient took Arexvy vaccine and experienced fatigue and myalgia. More
2830592 F 03/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal Feeling abnormal
I was down for 2 days and it was rough; This non-serious case was reported by a consumer via interac... I was down for 2 days and it was rough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling miserable (Verbatim: I was down for 2 days and it was rough). The outcome of the feeling miserable was resolved (duration 2 days). The reporter considered the feeling miserable to be related to Shingrix. The company considered the feeling miserable to be related to Shingrix. Additional Information: GSK receipt date: 02-MAR-2025 This case was reported by a patient via interactive digital media. Patient reported that he/she was down for 2 days. Patient stated it was rough, but would rather than face shingles. More
2830593 03/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site pain Injection site pain
shots so painful; This non-serious case was reported by a consumer via interactive digital media and... shots so painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shots so painful). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 03-MAR-2025 This case was reported by a patient via interactive digital media. Patient reported that he/she found those shots so painful, but was glad got protected from shingles, too. The follow-up could not be possible as no contact details were available. More
2830594 03/11/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
COVID-19, Herpes zoster, Pruritus, Vaccination failure; COVID-19, Herpes zoster,... COVID-19, Herpes zoster, Pruritus, Vaccination failure; COVID-19, Herpes zoster, Pruritus, Vaccination failure More
Suspected Vaccination failure; still got shingles /but it was very mild, just a little itchiness; af... Suspected Vaccination failure; still got shingles /but it was very mild, just a little itchiness; after my 1st bout of covid; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles /but it was very mild, just a little itchiness) and covid-19 (Verbatim: after my 1st bout of covid). The outcome of the vaccination failure, shingles and covid-19 were not reported. It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and covid-19 to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 04-MAR-2025 This case was reported by a patient via interactive digital media. The patient had two shingles shot and still got shingles, it was after 1st bout of covid. The patient reported shingles was very mild with just a little itchiness. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2. More
2830595 18 M TX 03/11/2025 HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
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 had a non-reactive Hepatitis B surface antigen, non-reactive Hepatitis B surface antibody, a... patient had a non-reactive Hepatitis B surface antigen, non-reactive Hepatitis B surface antibody, and non-reactive Hepatitis B the total antibody; recive 2nd dose of Engerix B on 08-JAN-2013 and 3rd dose recive on 01-OCT-2013; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 19-year-old male patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis. The patient's past medical history included herpes simplex, hiv infection and hypertriglyceridemia. Concurrent medical conditions included tobacco abuse. On 01-OCT-2013, the patient received the 3rd dose of Engerix B. On 08-JAN-2013, the patient received the 2nd dose of Engerix B. On 04-DEC-2012, the patient received the 1st dose of Engerix B. On 01-OCT-2013, an unknown time after receiving Engerix B, not applicable after receiving Engerix B and Engerix B and not applicable after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too long (Verbatim: recive 2nd dose of Engerix B on 08-JAN-2013 and 3rd dose recive on 01-OCT-2013). On 08-MAY-2024, the patient experienced therapy non-responder (Verbatim: patient had a non-reactive Hepatitis B surface antigen, non-reactive Hepatitis B surface antibody, and non-reactive Hepatitis B the total antibody). The outcome of the therapy non-responder was not reported and the outcome of the drug dose administration interval too long was unknown. 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: 24-SEP-2024 The reporter reported that the patient had received four dose doses of Engerix b. The reporter mentioned that the 4th dose of Hep B vaccine was administered at clinic. The reporter reported that this patient had a non-reactive Hepatitis B surface antigen, non-reactive Hepatitis B surface antibody, and non-reactive Hepatitis B the total antibody on 08th May 2024, which led to therapy non responder. The patient received 3rd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. More
2830596 F NC 03/11/2025 VARZOS
 UNKNOWN MANUFACTURER
Flank pain, Laboratory test normal, Vaccination failure, Zoster sine herpete Flank pain, Laboratory test normal, Vaccination failure, Zoster sine herpete
Suspected vaccination failure; suspected zoster sine herpete (ZSH); flank pain/ the patient had this... Suspected vaccination failure; suspected zoster sine herpete (ZSH); flank pain/ the patient had this severe pain; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included diabetes (female patient with diabetes). In FEB-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: suspected zoster sine herpete (ZSH)) and flank pain (Verbatim: flank pain/ the patient had this severe pain). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete and flank pain were unknown. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and flank pain to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the zoster sine herpete and flank pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAR-2025 The reporter called to speak with someone regarding Shingrix and zoster sine herpete (ZSH) and was asking whether there was an increased reaction of zoster sine herpete (ZSH) in patient who were vaccinated (not acutely/recently) with Shingrix. The reporter stated two weeks ago a female patient with diabetes probably 50ish in age who was vaccinated with a shingles vaccine (unknown if it was Shingrix) presented with flank pain as an initial complaint. She had no proof of zoster sine herpete (ZSH), just a clinical suspicion because all the workup was negative but the patient had this severe pain that she could not account for. Now, in retrospect she thought it was zoster sine herpete (ZSH). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for zoster sine herpete (shingles) and laboratory confirmation regarding zoster sine herpete (shingles) were unknown at the time of reporting. This case was one of the three case reported by the same reporter for different patients.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GSK-US2025026210:2 of 3 patient US-GSK-US2025026208:Same reporter/Different patient More
2830597 CT 03/11/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
they are now giving it to many adults; This non-serious case was reported by a pharmacist via call c... they are now giving it to many adults; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in unspecified number of patients who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: they are now giving it to many adults). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date : 05-MAR-2025 This case is for unspecified number of adult patients. A pharmacist contacted us via chat and mentioned that the Priorix insert said subcutaneous, but referred to children only. As they were giving it to many adults, many regulatory bodies were saying intramuscular or subcutaneous, which led to Inappropriate age at vaccine administration. More
2830598 80 F 03/11/2025 COVID19
 JANSSEN
Death Death
Died; This spontaneous report received from a health care professional concerned an 82 year old fema... Died; This spontaneous report received from a health care professional concerned an 82 year old female patient. The patient's height and weight were not reported. Age at time of vaccination 9 old. The patient's concurrent conditions included: carpal tunnel, pain on toes, diabetes, heart condition, and pain on chest. Initial information was processed with additional information received on 11-Feb-2025. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. Dose number in series 2. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced died. (Dose number in series 2). It was reported that the patient got 2 Covid shots and she died after a month of getting the shots. The action taken with janssen covid-19 vaccine was not applicable. It was unknown if an autopsy was performed. Reported cause of death was unknown cause of death. The patient died of died on an unspecified date. This report was associated with a product quality complaint: Product Complaint 90000353966. Investigation Results: 90000353966 - (Void:Y). This record reports patient death with no allegation of a product quality issue. This report of patient death was not referred by Safety partners for investigation. No quality investigation is required at this time. Approval to void due to no PQC identified. This report was serious (death).; Sender's Comments: V0-Death. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: Unknown cause of death More
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2830599 72 F 03/11/2025 COVID19
 PFIZER\BIONTECH
Lymph node pain Lymph node pain
the lymph nodes under the receiving arm (left) were killing her. Pain lasted for 2 days.; This is a ... the lymph nodes under the receiving arm (left) were killing her. Pain lasted for 2 days.; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. A 72-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Feb2025 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 24Feb2025, outcome "recovered" (27Feb2025), described as "the lymph nodes under the receiving arm (left) were killing her. Pain lasted for 2 days.". Therapeutic measures were not taken as a result of lymph node pain. Additional information: Patient reports that the day after receiving her covid booster, the lymph nodes under the receiving arm (left) were killing her. Pain lasted for 2 days. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2830600 F AZ 03/11/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A female pati... covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A female patient 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. Vaccination history included: Bnt162b2 (Primary immunization series complete), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". Patient got covid and wasn't nearly as sick as husband. She did not break out. More
2830601 F 03/11/2025 COVID19
 PFIZER\BIONTECH
Eczema Eczema
severe eczema flare ups all over my neck face back and arms; This is a spontaneous report received f... severe eczema flare ups all over my neck face back and arms; This is a spontaneous report received from a Consumer or other non HCP. A 33-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1 (toppac); single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Kiwi Allergy" (unspecified if ongoing); "eczema" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. Past drug history included: Methylisothiazolinone, reaction(s): "Allergy". Vaccination history included: Covid-19 (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization; Covid-19 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: ECZEMA (non-serious) with onset 2023, outcome "not recovered", described as "severe eczema flare ups all over my neck face back and arms". Therapeutic measures were taken as a result of eczema (Topical steroids). Additional information: Since a few weeks after the Covid booster (my 5th booster) I have had severe eczema flare ups all over my neck face back and arms. This has gone on for 1.5 years now and I can't seem to calm my immune system down. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2830603 65 F WA 03/11/2025 PNC20
 PFIZER\WYETH
 LC5485
Injection site erythema, Injection site pruritus Injection site erythema, Injection site pruritus
Delayed reaction to pneumococcal - developed erythematous injection site reaction on 12/25/24, then ... Delayed reaction to pneumococcal - developed erythematous injection site reaction on 12/25/24, then redness spread to full circumference of arm (itchy, red), resolved after 4 days More
2830638 F LA 03/11/2025 HPV9
 MERCK & CO. INC.
 X018884
Eye swelling, Swelling face Eye swelling, Swelling face
swelling eye, face; swelling eye, face; Patient had rash toneck/face; This case has been migrated fr... swelling eye, face; swelling eye, face; Patient had rash toneck/face; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2227735. The previous case ID: 2501USA009410, and 2501USA009410. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report. This spontaneous report was received from a nurse via company representative and refers to a patient (age and gender were unknown). The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided). On an unknown date, the patient developed a rash on their face immediately after the vaccination. No additional details to report. At the time of reporting, the outcome of the event was not known. The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. Lot # is being requested and will be submitted if received. This report is considered to be non-valid due to lack of patient's identifiers. Follow up information has been received from an unspecified health care professional on 19-FEB-2025, which reported that and refers to a(n) 14-year-old female patient with no illness at the time of vaccination. The patient's medical history was not reported. The patient's concurrent conditions included obesity. Historical drugs included Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid), and Menquadfi (Meningococcal vaccine A/C/Y/W conj (tet tox)). Concomitant medications included Lisdexamfetamine Mesilate(VYVANSE), Amfetamine aspartate;Amfetamine sulfate;Dexamfetamine saccharate;Dexamfetamine sulfate (ADDERALL), Clonidine hydrochloride (CLONIDINE). On 05-APR-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) Injection, prefilled syringe, (lot #X018884, expiration date: 23-APR-2025) for the treatment of Prophylaxis. On 05-APR-2024, reported as 3-4 hours after vaccination, the patient experienced rash in face and neck (rash) and swelling eye, face. No anaphylaxis was reported. No new medications, products, foods ingested this day. No treatment or medical care sought. The outcome of the events was reported as recovered on 06-APR-2024, reported as duration 1 day. The reporter considered the events to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02741444-02741430 , CLIC number : , ESTAR number : , IRMS number : 500UW00000S4bVWYAZ|19022025230027|1681 , Central date : 2025-02-20 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2501USA009410 , MNSC case number : 02741444 , MNSC interaction number : 02741430 , Integration log UniqueID : 500UW00000S4bVWYAZ|19022025230027|1681 , Service cloud CaseID : 500UW00000S4bVWYAZ More
2830639 CO 03/11/2025 MMR
MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
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; Extra dose administered, No adverse event More
No additional AE; Customer called and reported that an additional dose of MMR-II was administered to... No additional AE; Customer called and reported that an additional dose of MMR-II was administered to a 5-year-old consumer after the series was completed. The final dose of the series was administered on 2/15/2024. The additional dose was administered on 2/13/2025; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, lot #, and expiration date were not reported) for prophylaxis, diluted in sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). On 15-Feb-2024, the patient received the final dose of the series of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), dose number 2, (lot # and expiration date were not reported), diluted in sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). On 13-Feb-2025 (after the series were completed), the patient received a third dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II),, dose number 3, (lot # and expiration date were not reported) diluted in sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) (Extra dose administered). No additional adverse event was reported. More
2830640 PA 03/11/2025 HPV9
 MERCK & CO. INC.
 W031448
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AEs; expired dose of GARDASIL 9 was administered.; This spontaneous report was receive... No additional AEs; expired dose of GARDASIL 9 was administered.; This spontaneous report was received from a medical assistant concerning to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 25-FEB-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) pre-filled syringe, lot #W031448, expiration date: 12-FEB-2025, 0.5 mL administered by intramuscular route (IM) as prophylaxis (expired product administered.) No additional adverse events were reported (no adverse event.) More
2830644 8 F ND 03/11/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y013579
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 reported; multiple patients may have received improperly stored PROQUAD since it &q... No adverse event reported; multiple patients may have received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freezer; This spontaneous report has been received from a nurse regarding an 8-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Polio vaccine inact 3v (Vero) (IPOL), Hepatitis b vaccine rHBsAg (yeast) (ENGERIX-B), and Diphtheria vaccine toxoid (+) Pertussis vaccine acellular 3-component (+) Tetanus vaccine toxoid (BOOSTRIX). On 29-JAN-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Solution for injection, administered subcutaneously in the left arm as the first dose with sterile diluent (BAXTER STERILE DILUENT), for prophylaxis (lot number reported as Y013579, which has been verified as valid, expiration date not reported but validated as 03-FEB-2026). It was reported that when another vaccine's shipment arrived, there was no room in the freezer to accommodate it. It was assumed that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) could be refrigerated, therefore, they were moved to refrigerators where they remained between 36 to 36 degrees Fahrenheit from 13-NOV-2024 until administration (Product storage error). No adverse events were reported. This is one of several reports from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 07/31/2016 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2830645 0.92 NY 03/11/2025 MMR
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
innapropriate age of vaccine administered; HCP states she could not confirm if there were any sympto... innapropriate age of vaccine administered; HCP states she could not confirm if there were any symptomatic events that occurred; This spontaneous report has been received from a health care proffesional regarding a 11-months-old patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On an unspecified date (reported as one day before their first birthday), the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) lyophilisate and solvent for solution for injection (VARIVAX) for prophylaxis, 0.5 milliliters and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live lyophilisate and solvent for solution for injection (MMR-II) for prophylaxis, 0.5 milliliters concomitantly (strengths, lot numbers, expiration dates, anatomical locations, schemes and routes of administration not provided). (innapropriate age of vaccine administered). The health care professional could not confirm if any symptomatic events occurred (no adverse event). More
2830646 M 03/11/2025 MMRV
UNK
 MERCK & CO. INC.
UNKNOWN MANUFACTURER
Y017208
Product storage error; Product storage error Product storage error; Product storage error
Improper storage of product in use; This spontaneous report was received from a nurse referring to a... Improper storage of product in use; This spontaneous report was received from a nurse referring to a 6-year-old male patient. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided. On 23-Jan-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for prophylaxis, lot number Y017208, which has been verified to be valid, expiration date reported and validated as 13-Apr-2026, second dose, subcutaneously, in left thigh. (strength not provided) The administered dose of the vaccine was stored at multiple temperatures with a range from 15 degree Fahrenheit to 46 degree Fahrenheit during an 432 (unit not provided).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 08/05/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2830647 KY 03/11/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y009348
Y017205
Inappropriate schedule of product administration, No adverse event, Product admi... Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age More
No additional AE/; Patient received a dose of PROQUAD in September and another dose in February. No ... No additional AE/; Patient received a dose of PROQUAD in September and another dose in February. No reported signs or symptoms of adverse effects. Permission to contact HCP was given. No additional AE/no PQC; Patient received a dose of PROQUAD in September and another dose in February. No reported signs or symptoms of adverse effects. Permission to contact HCP was given. No additional AE/no PQC; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On an unknown date in September 2024, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot#: y009348, expiration date: 11-NOV-2025; strength, dose, and route of administration were not reported) for prophylaxis. On 25-FEB-2025, the patient was vaccinated with the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot#: y017205, expiration date: 13-APR-2026; strength, dose, and route of administration were not reported) for prophylaxis (inappropriate age at vaccine administration and inappropriate schedule of vaccine administered). . No reported signs or symptoms of adverse effects. More
2830648 1 M WA 03/11/2025 FLUX
HIBV
MMR
UNK
UNK
VARCEL
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.

X011441
X025482
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, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No additional AE reported; products that experienced temperature excursion were administered to pati... No additional AE reported; products that experienced temperature excursion were administered to patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 10-DEC-2024, the patient was vaccinated with improperly stored doses of the following vaccines: dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #, expiration date, exact dose route and site of administration was not reported) reconstituted with sterile diluent (lot # and expiration date were not reported); first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R II) lot # X011441 was confirmed to be valid, expiration date 19-APR-2025, subcutaneously at right thigh (exact dose was not reported) reconstituted with sterile diluent (lot # and expiration date were not reported); first dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot # X025482 was confirmed to be valid, expiration date 12-APR-2025, intramuscularly at right thigh (exact dose was not reported) fourth dose of Pneumococcal vaccine conj 20v lot # reported as HN2630, expiration date reported as 31-AUG-2025, intramuscularly at left thigh (exact dose was not reported) second dose of influenza vaccine lot # reported as U8518DA, expiration date reported as 30-JUN-2025, intramuscularly at right thigh (exact dose was not reported) first doe of Haemophilus influenzae type b vaccine lot # reported as M94PZ, expiration date reported as 14-MAR-2026, intramuscularly at left thigh (exact dose was not reported) all vaccines administered for prophylaxis. The temperature excursion was a result of a reading from a digital data logger, however no details were provided. No additional adverse event was reported. Lot # is being requested and will be submitted if received. More
2830649 1 M WA 03/11/2025 HIBV
MMR
UNK
UNK
UNK
UNK
VARCEL
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.
X011441
X025482
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, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No additional AE reported; products that experienced temperature excursion were administered to pati... No additional AE reported; products that experienced temperature excursion were administered to patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 08-JAN-2025 (conflicting information: also reported as 08-JAN-2024), the patient was vaccinated with improperly stored doses of the following vaccines: first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #, expiration date, exact dose route and site of administration was not reported) reconstituted with sterile diluent (lot # and expiration date were not reported); first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R II) lot # X011441 was confirmed to be valid, expiration date 19-APR-2025, subcutaneously at right thigh (exact dose was not reported) reconstituted with sterile diluent (lot # and expiration date were not reported); first dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot # X025482 was confirmed to be valid, expiration date 12-APR-2025, intramuscularly at right thigh (exact dose was not reported) fourth dose of Pneumococcal vaccine conj 20v lot # reported as HN2630, expiration date reported as 30-AUG-2025, intramuscularly at right thigh (exact dose was not reported) first doe of Haemophilus influenzae type b vaccine lot # reported as M94PZ, expiration date reported as 14-JUN-2026, intramuscularly at left thigh (exact dose was not reported) all vaccines administered for prophylaxis. The temperature excursion was a result of a reading from a digital data logger, however no details were provided. No additional adverse event was reported. Lot # is being requested and will be submitted if received. More
2830650 M FL 03/11/2025 MMR
MMR
MMR
MMR
VARCEL
VARCEL
VARCEL
VARCEL
MMR
MMR
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.











Injection site erythema, Injection site pain; Injection site erythema, Vaccinati... Injection site erythema, Injection site pain; Injection site erythema, Vaccination site bruising, Vaccination site pain; Injection site erythema, Injection site pain; Injection site erythema, Vaccination site bruising, Vaccination site pain; Injection site erythema, Injection site pain; Injection site erythema, Vaccination site bruising, Vaccination site pain; Injection site erythema, Injection site pain; Injection site erythema, Vaccination site bruising, Vaccination site pain; Injection site erythema, Injection site pain; Injection site erythema, Vaccination site bruising, Vaccination site pain; Injection site erythema, Injection site pain; Injection site erythema, Vaccination site bruising, Vaccination site pain More
arm was improved but looked a little bruised; her son began complaining of pain if his left upper ar... arm was improved but looked a little bruised; her son began complaining of pain if his left upper arm and did not want his mother to touch the area; she noticed there was a reddened area; This spontaneous report was received from a consumer or other non health professional and refers to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-Feb-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), in the right arm right arm . On the same date, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), in the left arm (lot # and expiration date were not reported). Both vaccines were administered for prophylaxis (doe, scheme, strength, route of administration, expiration date, and lot number were not reported). Both vaccines were reconstituted with sterile diluent (BAXTER STERILE DILUENT), (indication, expiration date, and lot # were not reported). On the evening of 06-MAR-2025 her son began complaining of pain if his left upper arm and did not want his mother to touch the area and she noticed there was a reddened area like a "giant rosette" in the middle with an extra red ring around the edges that measured about the size of a silver dollar in which she gave her son Tylenol for the pain and he went to bed (vaccination site pain) (vaccination site erythema). On the morning of 07-MAR-2025 the caller stated her son's arm was improved but looked a little bruised and he seemed "fine and did not complain of pain" (vaccination site bruised). At the reporting time, the outcome of the events was unknown. The causal relationship between the events and the suspect vaccines was not provided. More
2830651 60 F NJ 03/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2T92N
Hypoaesthesia, Neurological symptom, Paraesthesia, Polyneuropathy Hypoaesthesia, Neurological symptom, Paraesthesia, Polyneuropathy
Transient ischemic attack; Peripheral polyneuropathy; This serious case was reported by a consumer v... Transient ischemic attack; Peripheral polyneuropathy; This serious case was reported by a consumer via other manufacturer and described the occurrence of transient ischemic attack in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 52F7M, expiry date 15-JUN-2026) and (batch number 2T92N, expiry date 15-JUN-2026) for prophylaxis. The patient's past medical history included alcohol use, cholecystectomy (in 2010) and plastic surgery (in 2001, tummy tuck). Concurrent medical conditions included anxiety (in 2001), arthritis (in 2000), depression (in 2001), thyroid disorder (in 1994), hay fever, hypercholesterolemia, asthma, blood pressure high, penicillin allergy (Anaphylaxis and Hives) and rhinitis. Additional patient notes included patient height was 1.651 m. Concomitant products included atomoxetine hydrochloride (Strattera), buspirone hydrochloride (Buspar), levocetirizine dihydrochloride (Allegra), guanfacine hydrochloride (Guanfacine Hcl), montelukast sodium (Singulair), progesterone (Progesteron), rosuvastatin calcium, thyroid, testosterone, buspirone, rosuvastatin calcium (Crestor), amlodipine, mirabegron (Myrbetriq), macrogol, salbutamol (Albuterol), atorvastatin, estradiol, prazosin, semaglutide, bupropion hydrochloride (Wellbutrin Xl), salbutamol sulfate (Albuterol Sulfate) and guanfacine hydrochloride (Intuniv). Family history included arthritis (mother and father) and diabetes (father). On 12-NOV-2024, the patient received Shingrix. In NOV-2024, less than a week after receiving Shingrix, the patient experienced transient ischemic attack (Verbatim: Transient ischemic attack) (serious criteria hospitalization and GSK medically significant) and polyneuropathy (Verbatim: Peripheral polyneuropathy) (serious criteria hospitalization and GSK medically significant). The patient was treated with acetylsalicylic acid (Aspirin). The outcome of the transient ischemic attack and polyneuropathy were not reported. It was unknown if the reporter considered the transient ischemic attack and polyneuropathy to be related to Shingrix. The company considered the transient ischemic attack and polyneuropathy to be unrelated to Shingrix. Additional Information: GSK receipt date: 24-FEB-2025 The patient recived Shingrix vaccine and experienced transient ischemic attack and peripheral polyneuropathy. The reporter mentioned that the patient developed numbness/tingling left side of face. The phone call completed, or visit completed within 48 hours of Discharge on 18th November 2024. They received discharge summary and hospital records for reviewed. The medication reconciliation was completed. The education provided for disease and illness self-management, independent living and activities of daily living. The patient was in office for routine follow up. Patient would like to discuss hospital admission 22nd November 2024 to 23rd November 2024 for stroke-like symptoms. The suspect patient might had a TIA (transient ischemic attack) as the inpatient team discharged her on ASA and statin. Patient was still having numbness and tingling in her left lower extremity and left face. The possible patient's hormone replacement therapy of estrogen, progesterone and testosterone could had caused occult clotting leading to a TIA. The medication Dispense History from 27th November 2023 to 25th November 2024. The patient reports that she had never smoked. She had never used smokeless tobacco. She reported that she did not currently use alcohol after a past usage of about 1.0 standard drink of alcohol per week. The neurological positive for numbness. The reporter mentioned the problem list the bronchiectasis without complication. The patient had an iron deficiency pulmonary infection due to Mycobacterium avium complex. Allergic shiners and allergic rhinitis with postnasal drip. The drug-induced constipation was anxiety and depression. The urinary incontinence vegetarian acquired hypothyroidism and facial paresthesia. The clock draw test, recall 3 words and mini-cog score was not recorded. The Influenza, Pneumococcal and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination declined by patient. The current long-term use of postmenopausal hormone replacement therapy.; Sender's Comments: Transient ischaemic attack and Polyneuropathy are unlisted events which are considered unrelated to GSK vaccine Shingrix. More
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2830652 50 F TX 03/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 KB2YT
Injection site rash Injection site rash
Skin Rash at injection site; This non-serious case was reported by a other health professional via s... Skin Rash at injection site; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number KB2YT) for prophylaxis. On 04-DEC-2024, the patient received the 1st dose of Shingrix (left deltoid). On 04-DEC-2024, less than a day after receiving Shingrix, the patient experienced injection site rash (Verbatim: Skin Rash at injection site). On 11-DEC-2024, the outcome of the injection site rash was resolved (duration 7 days). The reporter considered the injection site rash to be related to Shingrix. The company considered the injection site rash to be related to Shingrix. Additional Information: GSK Receipt Date: 04-MAR-2025 The healthcare professional reported that the patient received the 1st dose of Shingrix and experienced skin rash at injection site. The patient was not on other products. This was not related to an existing case. The healthcare professional did not have consent to contact. More
2830653 F 03/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Balance disorder, Gait disturbance, Hypoaesthesia, Paraesthesia Balance disorder, Gait disturbance, Hypoaesthesia, Paraesthesia
balance affected; walking affected; Sudden tingling in left foot and lower leg; Tingling and numbnes... balance affected; walking affected; Sudden tingling in left foot and lower leg; Tingling and numbness in left foot; This non-serious case was reported by a consumer and described the occurrence of tingling of extremity in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood pressure high. Concomitant products included lisinopril. On 06-SEP-2024, the patient received Shingrix. On 07-SEP-2024, 1 days after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: Sudden tingling in left foot and lower leg) and numbness in feet (Verbatim: Tingling and numbness in left foot). On an unknown date, the patient experienced balance difficulty (Verbatim: balance affected) and walking difficulty (Verbatim: walking affected). The outcome of the tingling of extremity and numbness in feet were not resolved and the outcome of the balance difficulty and walking difficulty were not reported. It was unknown if the reporter considered the tingling of extremity, numbness in feet, balance difficulty and walking difficulty to be related to Shingrix. It was unknown if the company considered the tingling of extremity, numbness in feet, balance difficulty and walking difficulty to be related to Shingrix. Additional Information: GSK Receipt Date: 05-MAR-2025. The patient after taking the Shingrix vaccine and he experienced sudden tingling and numbness in left foot and lower leg. The reporter wanted to know what could do about this or it had not gone away. Patient's walking was affected and balance was affected. Pharmacist said to the patient the Shingrix vaccine could cause this and she read this on line as well. More
2830654 M 03/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza like illness Influenza like illness
Flu like symptoms; This non-serious case was reported by a consumer via sales rep and described the ... Flu like symptoms; This non-serious case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 08-JAN-2025, the patient received the 1st dose of Shingrix. On 09-JAN-2025, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). The outcome of the influenza-like symptoms was resolved. The reporter considered the influenza-like symptoms to be related to Shingrix. The company considered the influenza-like symptoms to be related to Shingrix. Additional Information: GSK Receipt Date: 04-MAR-2025 The patient experienced flu like symptoms, joint pain and headache after the first dose of Shingrix. More
2830655 03/11/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Neutropenia Neutropenia
my child was diagnosed with neutropenia 66 days after Pediarix3 (Hep b 4); This serious case was rep... my child was diagnosed with neutropenia 66 days after Pediarix3 (Hep b 4); This serious case was reported by a consumer via interactive digital media and described the occurrence of neutropenia in a child patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. On an unknown date, the patient received the 3rd dose of Pediarix. On an unknown date, 66 days after receiving Pediarix, the patient experienced neutropenia (Verbatim: my child was diagnosed with neutropenia 66 days after Pediarix3 (Hep b 4)) (serious criteria GSK medically significant and other: Serious as per reporter). The outcome of the neutropenia was unknown. The reporter considered the neutropenia to be related to Pediarix and Pediarix Pre-Filled Syringe Device. The company considered the neutropenia to be unrelated to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 04-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that his/her child was diagnosed with neutropenia 66 days after Pediarix. The reporter mentioned that the burden of proof was to show product did not cause , had neutropenia.; Sender's Comments: Neutropenia is an unlisted event which is considered unrelated to GSK vaccine Pediarix and Pediarix PRE-FILLED SYRINGE DEVICE. More
2830656 03/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination, Pain in extremity Incomplete course of vaccination, Pain in extremity
arm hurt; This non-serious case was reported by a consumer via interactive digital media and describ... arm hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm hurt). The outcome of the pain in arm was resolved (duration 1 week). It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-MAR-2025 This case was reported by a patient via interactive digital media. The patient took the first vaccine and arm hurt for a week. He/she passed on the second one. He/she already had shingles and stated would rather risk getting them again than getting that second shot. More
2830657 03/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
did not hurt as much as the pharmacist said it would; This non-serious case was reported by a consum... did not hurt as much as the pharmacist said it would; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: did not hurt as much as the pharmacist said it would). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. The patient just got first shot of shingles vaccine and it did not hurt as much as the pharmacist said it would. The patient will go back in about 3 months or so for second dose. More
2830658 M 03/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza Influenza
flu symptoms for two days; This non-serious case was reported by a consumer via interactive digital ... flu symptoms for two days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had the shingles last summer, it last about 30 day) and pain. In MAR-2025, the patient received Shingrix. In MAR-2025, an unknown time after receiving Shingrix, the patient experienced flu symptoms (Verbatim: flu symptoms for two days). The outcome of the flu symptoms was not resolved. The reporter considered the flu symptoms to be related to Shingrix. The company considered the flu symptoms to be related to Shingrix. Additional Information: GSK receipt date: 07-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the shingles last summer, it was last about 30 days, very painful, trying to sleep at night was uncomfortable. The patient reporter that he just got the first shot four days ago (Day before reporting) and had flu symptoms for two days but it beats the shingles by far. More
2830659 03/11/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
Priorix was given IM instead of SQ; This non-serious case was reported by a other health professiona... Priorix was given IM instead of SQ; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was given IM instead of SQ). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-MAR-2025 The reporter reported that they had an incident where Priorix was given intramuscular instead of subcutaneous which led to subcutaneous injection formulation administered by other route. The reporter asked do they need to re-vaccinate. More
2830660 GA 03/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Pediatric dose given; Pediatric dose given; This non-serious case was reported by a pharmacist via c... Pediatric dose given; Pediatric dose given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis. Previously administered products included Engerix b (received 1st dose of Engerix b in an unknown date). On an unknown date, the patient received the 2nd dose of Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose given) and adult use of a child product (Verbatim: Pediatric dose given). The outcome of the underdose and adult use of a child product were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-MAR-2025 The pharmacist that an adult patient received their second Engerix-B dose as a Pediatric dose which led to underdose and adult use of a child product. They had no information about the event, dose or patient, The Vaccine Administration Facility is the same as Primary Reporter. More
2830661 53 F SD 03/11/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 XN575
XN575
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
accidental administartion of Two Boostrix doses given at one instance; This non-serious case was rep... accidental administartion of Two Boostrix doses given at one instance; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 53-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XN575, expiry date 22-MAR-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number XN575, expiry date 22-MAR-2027) for prophylaxis. On 05-MAR-2025, the patient received the 2nd dose of Boostrix and the 1st dose of Boostrix. On 05-MAR-2025, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced accidental overdose (Verbatim: accidental administartion of Two Boostrix doses given at one instance). The outcome of the accidental overdose was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-MAR-2025 The pharmacist called in to request data about the recommendations following the accidental administration of 2 doses of Boostrix at one which led to Accidental overdose and asked if Shingrix can be given in such scenario. The vaccine administration facility was the same as primary reporter. More
2830662 80 F IA 03/11/2025 COVID19
 MODERNA
 066H22A
Death Death
Death Death
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2830663 1.25 M MI 03/11/2025 HEPA
MMR
PNC20
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.



Injection site pain, Injection site reaction, Injection site swelling, Pyrexia; ... Injection site pain, Injection site reaction, Injection site swelling, Pyrexia; Injection site pain, Injection site reaction, Injection site swelling, Pyrexia; Injection site pain, Injection site reaction, Injection site swelling, Pyrexia; Injection site pain, Injection site reaction, Injection site swelling, Pyrexia More
fever, red, painful, raised area on the right thigh Proximal. Patient was placed on cephalexin for ... fever, red, painful, raised area on the right thigh Proximal. Patient was placed on cephalexin for skin infection and is to return in 2 weeks for recheck of area More
2830664 1 F 03/11/2025 HEPA
HIBV
MMRV
PNC20
 MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
 Y012054
UK010AA
Y012077
LG5578
Expired product administered; Expired product administered; Expired product admi... Expired product administered; Expired product administered; Expired product administered; Expired product administered More
The ActHIB expired on 2-28-25. this was an expired vaccine that was given to patient The ActHIB expired on 2-28-25. this was an expired vaccine that was given to patient
2830665 9 F OR 03/11/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9KB9G
Epilepsy Epilepsy
Patient had a status epileptucs seizure lasting 25 minutes and requiring use of seizure medication Patient had a status epileptucs seizure lasting 25 minutes and requiring use of seizure medication
2830666 0.17 M KS 03/11/2025 DTAPHEPBIP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 D252F
Y011267
LK6650
Infant irritability, Injection site pain, Product administered at inappropriate ... Infant irritability, Injection site pain, Product administered at inappropriate site; Infant irritability, Injection site pain, Product administered at inappropriate site; Infant irritability, Injection site pain, Product administered at inappropriate site More
Patients mother also sent in a photo that showed the injection sites were not appropriately spaced. ... Patients mother also sent in a photo that showed the injection sites were not appropriately spaced. This resulted in increased fussiness and tenderness to the area in patient. More
2830667 23 F FL 03/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 9429J
Epistaxis, Pain in extremity, Pyrexia, Rash Epistaxis, Pain in extremity, Pyrexia, Rash
Rash from head to toe. Bloody nose. Fever. Arm soreness. Rash from head to toe. Bloody nose. Fever. Arm soreness.
2830668 7 M MI 03/11/2025 DTAP
HIBV
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 223y9
UK169AC
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
no adverse reactions no adverse reactions
2830669 5 M TX 03/11/2025 FLU3
MMR
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 UT8514NA
Y013132
Y006524
Dysphagia, Injection site reaction, Paraesthesia oral, Pharyngeal swelling, Urti... Dysphagia, Injection site reaction, Paraesthesia oral, Pharyngeal swelling, Urticaria; Dysphagia, Injection site reaction, Paraesthesia oral, Pharyngeal swelling, Urticaria; Dysphagia, Injection site reaction, Paraesthesia oral, Pharyngeal swelling, Urticaria More
MMR and Varicella were administered separately due to history of epilepsy. However, about 10 minutes... MMR and Varicella were administered separately due to history of epilepsy. However, about 10 minutes after vaccines were given, he developed a welt on the L leg where varicella and flu were administered. Benadryl was ordered but before it could be given, he started complaining of throat swelling, lips tingling and inability to swallow. Epi pen dose ordered, verified and administered. Patient walked down to ED. More
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