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
2846480 TX 06/18/2025 RV5
 MERCK & CO. INC.
 2096661
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; Incorrect product storage; This spontaneous report was received from a Other healt... no adverse event; Incorrect product storage; This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-Jun-2025, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2096661, expiration date: 07-Mar-2026) administered by Oral route. On 17-Jun-2025, the patient experienced Incorrect product storage (35.4F for 0 hours 48 minutes 0 seconds. There was no previous temperature excursion. No adverse event was reported.; Reporter's Comments: Keywords : BP More
2846481 MI 06/18/2025 MMRV
MMRV
MMRV
MMRV
 MERCK & CO. INC.
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, Wrong product administered; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
No adverse event; HCP called and reported inadvertent administration of PROQUAD to a 6-month-old pat... No adverse event; HCP called and reported inadvertent administration of PROQUAD to a 6-month-old patient. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a Nurse Practitioner and refers to a(n) 6-month-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 17-Jun-2025, the patient was inadvertently vaccinated with the dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (product administered to patient of inappropriate age). No additional adverse event reported (no adverse event). More
2846482 VA 06/18/2025 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 additional AE; report inadvertent administration of ROTATEQ and VAXELIS after a temperature excur... No additional AE; report inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion; This spontaneous report was received from a nurse practitioner and refers to a 5-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-MAY-2025, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# not reported) underwent a temperature excursion (1.4 degree Celsius, 18 minutes). There was no previous temperature excursions. On 21-MAY-2025, the patient was inadvertently vaccinated with improperly stored diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution administered by oral route (dose, lot # and expiration date were not reported) for prophylaxis (Product storage error). No additional adverse event was reported (No adverse event). Lot# is being requested and will be submitted if received. More
2846483 67 F IN 06/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2M7GR
2M7GR
Eyelid infection, Facial nerve disorder, Facial paralysis, Influenza like illnes... Eyelid infection, Facial nerve disorder, Facial paralysis, Influenza like illness, Pain; Tenderness, Viral infection More
major eye-lid infection/ side of eye affected; spread to face and under cheek close to ear/ Viral in... major eye-lid infection/ side of eye affected; spread to face and under cheek close to ear/ Viral infection in face; facial nerves have been affected; mouth drooping; Flu like symptoms; achy/ feeling achy; This serious case was reported by a consumer via call center representative and described the occurrence of facial droop in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 2M7GR, expiry date 31-JAN-2027) for prophylaxis. On 16-MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular use, left arm). On 16-MAY-2025, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms) and pain (Verbatim: achy/ feeling achy). In JUN-2025, the patient experienced facial droop (Verbatim: mouth drooping) (serious criteria GSK medically significant). On an unknown date, the patient experienced eye infection viral (Verbatim: major eye-lid infection/ side of eye affected), viral infection (Verbatim: spread to face and under cheek close to ear/ Viral infection in face) and facial nerve disorder (Verbatim: facial nerves have been affected). The patient was treated with valaciclovir (Valacyclovir) and prednisone. On 19-MAY-2025, the outcome of the influenza-like symptoms was resolved (duration 3 days). The outcome of the facial droop and facial nerve disorder were not resolved and the outcome of the pain was resolved (duration 3 days) and the outcome of the eye infection viral was resolving and the outcome of the viral infection was resolved. It was unknown if the reporter considered the facial droop, influenza-like symptoms, pain, eye infection viral, viral infection and facial nerve disorder to be related to Shingrix. The company considered the facial droop to be unrelated to Shingrix. It was unknown if the company considered the influenza-like symptoms, pain, eye infection viral, viral infection and facial nerve disorder to be related to Shingrix. Additional Information: GSK Receipt Date: 11-JUN-2025 The patient self-reported this case for herself. She stated that she had received her second dose of Shingrix in her left arm on 16th May 2025. She reported experiencing symptoms that evening, including body aches and flu-like symptoms, which lasted for three days. A few days later, she developed a major infection on her eyelid and the side of her eye. Eight days after that, the infection had spread to her face, beneath her cheek, and near her ear, affecting a wide area. She noted that the condition lasted for a while. She reported that three days ago, her mouth had begun to droop. She had seen three physicians for examination and treatment and had an appointment with a neurologist on 10th June 2025. She stated that she had been prescribed Valacyclovir 1 gram to take every 12 hours for 7 days, and Prednisone 10 milligram, 5 tablets daily for 7 days, with the dosage decreased by one tablet every 7 days until gone (a total of 42 tablets prescribed). The name of the prescribing physician and the date of prescription were not provided. She stated that the achy, flu-like symptoms had resolved, the eyelid area was nearly healed, and although her face remained tender, no infection seem to be present now. She mentioned that the neurologist believed her facial nerves had been affected. She also stated that her husband, an attorney, intended to pursue legal action against GlaxoSmithKline due to the adverse events she experienced following the Shingrix vaccination.; Sender's Comments: Facial paralysis is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2846484 M 06/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash Rash
Rash on torso and arms; This non-serious case was reported by a consumer and described the occurrenc... Rash on torso and arms; This non-serious case was reported by a consumer and described the occurrence of rash in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 06-JUN-2025, the patient received the 1st dose of Shingrix. On 08-JUN-2025, 2 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash on torso and arms). The outcome of the rash was not resolved. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JUN-2025 The patient had rash on torso and arms. It was reported that online review stated that rash is a rare situation with this vaccine, was not rare for the patient. More
2846485 76 F 06/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Rash, Rash erythematous, Vaccination failure; Herpes zoster, Rash... Herpes zoster, Rash, Rash erythematous, Vaccination failure; Herpes zoster, Rash, Rash erythematous, Vaccination failure More
had shingles in June 2025/ red rash in a line on left side of abdomen; Suspected vaccination failure... had shingles in June 2025/ red rash in a line on left side of abdomen; Suspected vaccination failure; in late February 2025 she was diagnosed with shingles/ a red rash on left back torso; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 10-JAN-2019, the patient received the 2nd dose of Shingrix (left arm). On 06-NOV-2018, the patient received the 1st dose of Shingrix (left arm). In FEB-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: in late February 2025 she was diagnosed with shingles/ a red rash on left back torso). In JUN-2025, the patient experienced shingles (Verbatim: had shingles in June 2025/ red rash in a line on left side of abdomen). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 10-JUN-2025 The patient self-reported this case for herself. The patient had other conditions and used other products. The patient reported that she received Shingrix dose 1 and dose 2 both in left arm. She stated in late February 2025 she was diagnosed with shingles. She had a red rash on left back torso. She was given an antiviral for 10 days. At the time of reporting, she was out of town and stated she had red rash in a line on left side of abdomen. She would refer to HCP (health care professional) when she gets back home. This case was considered as suspected vaccination failure as 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, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2846486 16 M NM 06/18/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
She states today he was given bexsero at the pharmacy; This non-serious case was reported by a consu... She states today he was given bexsero at the pharmacy; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received 1st dose of vaccine at age of 11 of batch number MCB4P). On 11-JUN-2025, the patient received the 2nd dose of Bexsero. On 11-JUN-2025, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: She states today he was given bexsero at the pharmacy). The outcome of the drug dose administration interval too long 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: 11-JUN-2025 The reporter was the mother of the patient. She stated his healthcare professional ordered a meningitis vaccine to be given. She stated that on the day of reporting he was given Bexsero at the pharmacy. The registered pharmacist who gave it stated he would need to come back for a Bexsero booster in 3 years only if he was in college. The patient received 2nd dose of Bexsero, later than the recommended interval, which led to lengthening of vaccination schedule. More
2846487 62 F TX 06/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Antibody test positive, Herpes zoster, Vaccination failure; Antibody test positi... Antibody test positive, Herpes zoster, Vaccination failure; Antibody test positive, Herpes zoster, Vaccination failure More
Shingles; Suspected vaccination failure; Shingles; This serious case was reported by a physician via... Shingles; Suspected vaccination failure; Shingles; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 14-JAN-2021, the patient received the 2nd dose of Shingrix (left deltoid). On 06-NOV-2020, the patient received the 1st dose of Shingrix (left deltoid). In NOV-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). In MAY-2025, the patient experienced shingles (Verbatim: Shingles). The outcome of the vaccination failure, shingles and shingles were unknown. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 12-JUN-2025 The reporter was the patient who was also a Dentist. The patient received the first dose of Shingrix on 6th November 2020, and the second dose on 14th January 2021. Both doses were received in the left deltoid. In November 2024 the patient developed Shingles and developed Shingles again in May 2025. The patient stated that the patient did not think that the Shingrix vaccine was effective. The patient had a Varicella Zoster IgG and IgM antibody tests obtained. The IgG was reactive, but a titer was not done. The IgM was negative. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was 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, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2846488 M IL 06/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
he was vaccinated with his first dose of Shingrix in July 2024; This non-serious case was reported b... he was vaccinated with his first dose of Shingrix in July 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in July 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: he was vaccinated with his first dose of Shingrix in July 2024). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 12-JUN-2025 The consumer (patient) was the reporter. The consumer mentioned that he was vaccinated with his first dose of Shingrix in July 2024. The consumer does plan to have his second dose administered as soon as possible. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2846489 F AZ 06/18/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Abdominal pain lower, Back pain, Blister, Herpes zoster, Pain; Rash, Secretion d... Abdominal pain lower, Back pain, Blister, Herpes zoster, Pain; Rash, Secretion discharge, Sensitive skin, Skin lesion, Vaccination failure; Abdominal pain lower, Back pain, Blister, Herpes zoster, Pain; Rash, Secretion discharge, Sensitive skin, Skin lesion, Vaccination failure More
suspected vaccination failure; shingles/pain/skin was sensitive to touch/shingles lesion/blisters or... suspected vaccination failure; shingles/pain/skin was sensitive to touch/shingles lesion/blisters or bumps; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included psoriatic arthritis, gastroesophageal reflux disease, depression and hyperlipidemia. Concomitant products included upadacitinib (Rinvoq), omeprazole, vortioxetine hydrobromide (Trintellix), evolocumab (Repatha) and tirzepatide (Mounjaro). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 30-MAY-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/pain/skin was sensitive to touch/shingles lesion/blisters or bumps). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 12-JUN-2025 The patient received both doses of her Shingrix vaccine beginning in April 2023. Also stated that received both doses in appropriate time frame. She began experiencing pain in her back on 29-May 2025 and she described the pain as like being punched in the kidney her skin was sensitive to touch and the pain radiated from her low back spine around the right side of abdomen to her navel. This is where the shingles lesions erupted as well. Some of the lesions started to open and drain, but the majority of the lesion remain as intact blisters or bumps. This case was considered as suspected vaccination failure as details regarding 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2846490 72 F PA 06/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Extra dose administered, Fatigue, Pain in extremity, Product use in unapproved i... Extra dose administered, Fatigue, Pain in extremity, Product use in unapproved indication More
tiredness; arm soreness; The patient received a 3rd dose; a new vaccine that protects against herpes... tiredness; arm soreness; The patient received a 3rd dose; a new vaccine that protects against herpes simplex 2; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of fatigue (received first dose in 2018, refer case US2025AMR076267), Shingrix with an associated reaction of fatigue (received second dose in 2018, refer case US2025AMR076294) and Valtrex (patient had taken Valtrex). Concurrent medical conditions included herpes simplex type ii (about 20 years ago contracted genital herpes (herpes simplex 2)). Concomitant products included acyclovir. On 19-MAY-2025, the patient received the 3rd dose of Shingrix. On 19-MAY-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: The patient received a 3rd dose) and drug use for unapproved indication (Verbatim: a new vaccine that protects against herpes simplex 2). On an unknown date, the patient experienced tiredness (Verbatim: tiredness) and pain in arm (Verbatim: arm soreness). Rechallenge with Shingrix was positive. The outcome of the tiredness and pain in arm were unknown and the outcome of the extra dose administered and drug use for unapproved indication were not applicable. It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingrix. It was unknown if the company considered the tiredness and pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR076267, US2025AMR076294 Additional Information: GSK Receipt Date: 07-JUN-2025 and 09-JUN-2025 The reporter was the patient and lives part of the year in another country The doctor (gynecologist) that told the patient that there was a new vaccine that protects against herpes simplex 2, and she would no longer need to continue taking Acyclovir. The patient was thrilled and went ahead and got the first dose a few weeks ago. Upon checking out and seeing the name Shingrix, the patient realized they had previously received both doses but did not remember when. The patient checked with her Primary Care Professional who said that the patient had gotten the series in 2018 (in the US) and that no boosters are recommended. The patient received a 3rd dose of Shingrix vaccine from a doctor (gynecologist) on 19 May 2025 which led extra dose administered. The doctor proceeded to provide the Shingrix vaccine to the patient, which led to drug use for unapproved indication. The patient reported only side effects she experienced from any dose of Shingrix vaccine were arm soreness and tiredness. About 20 years ago, the patient contacted genital herpes. The patient had taken Valtrex, then went to Acyclovir for suppressive therapy. The patient stopped taking Acyclovir since receiving the 3rd dose of Shingrix vaccine. The patient mentioned that gynecologist did not respond to her questions, so she was reaching out to us. The patient enquired if Shingrix only protects against shingles, not herpes simplex 2 and if they should not get the second vaccine (what would be a 4th dose since patient received 2 doses in 2018). Further patient enquired if there are any positive or negative effects from having a third dose and is there anything else that patient should know.; Sender's Comments: US-GSK-US2025AMR076267:Same patient, 1st dose US-GSK-US2025AMR076294:Same patient, 2 nd dose More
2846491 F 06/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Crying, Herpes zoster, Pain, Screaming, Vaccination failure Crying, Herpes zoster, Pain, Screaming, Vaccination failure
Suspected vaccination failure; I'm just getting over shingles; cried; screamed; This serious ca... Suspected vaccination failure; I'm just getting over shingles; cried; screamed; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (shingles diagnosed on 06-AUG-2012), rash (had a little rash on her hip and she got like a faint rash on her abdomen), burn (got burnt when patient was seven years old), hip replacement (had a hip replacement and then she got infection, and she was in the hospital), clot blood (had two blood clots and then she got infection, and she was in the hospital) and aneurysm (had aneurysm and then she got infection, and she was in the hospital). Concurrent medical conditions included neuralgia (still take medication today for the neuropathy the neuralgia). On an unknown date, 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), shingles (Verbatim: I'm just getting over shingles), crying (Verbatim: cried) and screaming (Verbatim: screamed). The outcome of the vaccination failure, shingles, crying and screaming were not reported. It was unknown if the reporter considered the vaccination failure, shingles, crying and screaming 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 shingles, crying and screaming to be related to Shingles vaccine. Additional Information: GSK receipt date: 11-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that shingles were awful. Shwe would never forget when she was diagnosed on August 6, 2012. It was the worst pain she had ever experienced. She did not even had a bad rash. She reported that had a small rash on her hip and a faint one on her abdomen, but the pain from that disease never went away. She still took medication for the neuropathy and neuralgia she suffered from. It was not as bad as it had been, but it still brought fear to her heart and mind whenever she thought about it. The patient reported that she had gotten the shingles shot it did not stop her from getting shingles again, but it was supposed to make it less severe. Still, shingles felt like a disease from the devil because the pain was awful. She had been through a lot in her life. she was burned when she was seven years old. She was hit by a car when she was a little girl. Even later in life, she had a hip replacement and ended up with two blood clots and an aneurysm. Then she got an infection and was hospitalized. She went into the hospital in June and did not come home until September. But shingles were the worst pain she had ever experienced. After that, she told everyone she met, even strangers, to get the shot. She told them about shingles because she did not want anyone still do not want anyone to suffer like she did. It was horrible, horrible pain. she cried and screamed. She thought she was going to go absolutely crazy. Sometimes it felt like she was being electrocuted the pain was that bad. So, if had ever had chickenpox, she urged to get the shingles shot. She did not care what it cost, because if you did not and you got shingles, you might wish you had. Not everyone who got shingles suffered as badly as she did, but she would never take that chance again. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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. More
2846492 06/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I had first dose if Shingrix 5 years ago but never had the second dose; This non-serious case was re... I had first dose if Shingrix 5 years ago but never had the second dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 5 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I had first dose if Shingrix 5 years ago but never had the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 08-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had first dose if Shingrix 5 years ago but never had the second dose. Did the patient had to get the first dose again. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2846493 06/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Paraesthesia, Swelling, Swelling of eyelid, Vaccination failure Herpes zoster, Paraesthesia, Swelling, Swelling of eyelid, Vaccination failure
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, 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) and shingles (Verbatim: shingles). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine last year in 2024 and a few months ago he/she had a tingly little bump on his/her belly. A couple days later one popped up on his/her eyelid. It was shingles so he/she started a course of Valtrex. 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. More
2846494 F NY 06/18/2025 HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS


Extra dose administered, Inappropriate schedule of product administration; Extra... Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration More
the fourth dose in May 29, 2025.; second dose in January 29, 2025, the third dose in February 25, 20... the fourth dose in May 29, 2025.; second dose in January 29, 2025, the third dose in February 25, 2025; first dose in September 3, 2025, their second dose in January 29, 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 34-year-old female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis. Previously administered products included Engerix b (received 1st dose on 03-SEP-2024). On 29-MAY-2025, the patient received the 4th dose of Engerix B. On 25-FEB-2025, the patient received the 3rd dose of Engerix B. On 29-JAN-2025, the patient received the 2nd dose of Engerix B. On 29-JAN-2025, not applicable after receiving Engerix B and Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: first dose in September 3, 2025, their second dose in January 29, 2025). On 25-FEB-2025, the patient experienced drug dose administration interval too short (Verbatim: second dose in January 29, 2025, the third dose in February 25, 2025). On 29-MAY-2025, the patient experienced extra dose administered (Verbatim: the fourth dose in May 29, 2025.). The outcome of the drug dose administration interval too long, drug dose administration interval too short and extra dose administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-JUN-2025 A registered nurse reported that the patient received their first dose of Engerix B on 3rd September 2024, their second dose on 29th January 2025, the third dose on 25th February 2025 and the fourth dose on 29th May 2025. The nurse initially stated they wanted data about the administration of a vaccine because the intervals were shorter than recommended. They also stated the need to test for titers. The Vaccine Administration Facility was the same as Primary Reporter The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix B earlier than recommended interval, which led to shortening of vaccination schedule. The patient received 4th dose of Engerix B not as per local schedule, which led to extra dose administered.; Sender's Comments: US-GSK-US2025071746:same reporter More
2846495 F OK 06/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 H97H2
Inappropriate schedule of product administration Inappropriate schedule of product administration
second dose was given April 8, 2025; This non-serious case was reported by a pharmacist via call cen... second dose was given April 8, 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number H97H2, expiry date 29-MAR-2027) for prophylaxis. Previously administered products included Shingrix (a patient received a first dose of Shingrix back in September 21, 2018). On 08-APR-2025, the patient received the 2nd dose of Shingrix. On 08-APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose was given April 8, 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 10-JUN-2025 Pharmacist called on June 10, 2025 to report a patient received a first dose of Shingrix back in September 21, 2018 and then a second dose was given April 8, 2025. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case was linked with US2025072148, reported by same reporter different patient.; Sender's Comments: US-GSK-US2025072148:case created for husband and wife More
2846496 42 M PA 06/18/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
the 1st dose in 08-Nov-2024, will get 2nd dose today; This non-serious case was reported by a pharma... the 1st dose in 08-Nov-2024, will get 2nd dose today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 43-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (1st dose on 08-Nov-2024). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: the 1st dose in 08-Nov-2024, will get 2nd dose today). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-JUN-2025 Pharmacist reported that the following called regarding the Twinrix dosing, if the 1st dose was like 7 months ago on 8-Nov-2024 and they would get the 2nd dose now (on 10-Jun-2025). The reporter asked that when they should get the 3rd dose or not. During the call, the reporter confirmed that they will get the 2nd dose on the day of reporting. Pharmacist reported the 1st dose received it in a different location, they did not mention which one nor the address, they just said that it was different. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. More
2846497 1 M KY 06/18/2025 DTAP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 223Y9
Product storage error; Product storage error Product storage error; Product storage error
Infanrix and Engerix B have been used in patients; This non-serious case was reported by a nurse via... Infanrix and Engerix B have been used in patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of product storage error in a male patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. On 27-MAY-2025, the patient received Infanrix. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Infanrix and Engerix B, the patient experienced product storage error (Verbatim: Infanrix and Engerix B have been used in patients). The outcome of the product storage error 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: Licensed Practical Nurse requested stability data for Havrix, Kinrix, Boostrix, Infanrix, Engerix B stored at 18.8 Celsius for 9 hours 20 minutes on 17 May 2025. The excursion was caught when doing monthly quality check. There were no prior excursions. The Infanrix vaccine and Engerix B vaccine have been used in patients which led to product storage error. More
2846498 MO 06/18/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Unevaluable event Unevaluable event
Administration of Priorix to adult patients; This non-serious case was reported by a pharmacist via ... Administration of Priorix to adult patients; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of adult patients who received MMR (Priorix) for prophylaxis. On an unknown date, the patients received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Priorix to adult patients). 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: 11-JUN-2025 A sales representative called to transfer over a pharmacist, who informed that lately he had been getting a lot of adult patients that requested vaccination with Priorix in his facility which led to inappropriate age at vaccine administration No more details were provided by reporter. More
2846499 TN 06/18/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Late 2nd dose; This non-serious case was reported by a other health professional via sales rep and d... Late 2nd dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a adolescent patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (1st dose received on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 11-JUN-2025 Field Representative asked for information on what to tell an adolescent if it had been longer than 6 months since their first dose of Bexsero which led to incomplete course of vaccination Do they go ahead and give the second dose, or do they re-start the series? More
2846500 F 06/18/2025 COVID19
 MODERNA
Cerebrovascular accident, Swelling face Cerebrovascular accident, Swelling face
After the 2nd, she had a severe stroke; she took 1 shot after that; her face swelled up; This sponta... After the 2nd, she had a severe stroke; she took 1 shot after that; her face swelled up; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (After the 2nd, she had a severe stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (After the 2nd, she had a severe stroke) (seriousness criterion medically significant) and SWELLING FACE (she took 1 shot after that; her face swelled up). At the time of the report, CEREBROVASCULAR ACCIDENT (After the 2nd, she had a severe stroke) and SWELLING FACE (she took 1 shot after that; her face swelled up) outcome was unknown. No concomitant medication was reported. The patient took 1 shot after that her face swelled up. After taking 2nd shot, she had a severe stroke. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787432, US-MODERNATX, INC.-MOD-2025-787430, US-MODERNATX, INC.-MOD-2025-787435, US-MODERNATX, INC.-MOD-2025-787434, US-MODERNATX, INC.-MOD-2025-787439, US-MODERNATX, INC.-MOD-2025-787440, US-MODERNATX, INC.-MOD-2025-787443, US-MODERNATX, INC.-MOD-2025-787447, US-MODERNATX, INC.-MOD-2025-787452, US-MODERNATX, INC.-MOD-2025-787489, US-MODERNATX, INC.-MOD-2025-787491, US-MODERNATX, INC.-MOD-2025-787492, US-MODERNATX, INC.-MOD-2025-787497, US-MODERNATX, INC.-MOD-2025-787502, US-MODERNATX, INC.-MOD-2025-787511, US-MODERNATX, INC.-MOD-2025-787514, US-MODERNATX, INC.-MOD-2025-787472 (E2B Linked Report). Reporter did not allow further contact; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787434:For nephew US-MODERNATX, INC.-MOD-2025-787435:Her neighbor' sister case US-MODERNATX, INC.-MOD-2025-787430:For teacher US-MODERNATX, INC.-MOD-2025-787432:Her dad's friend US-MODERNATX, INC.-MOD-2025-787440:For landlord US-MODERNATX, INC.-MOD-2025-787439:Invalid case for people US-MODERNATX, INC.-MOD-2025-787447:For police officer (Husband) US-MODERNATX, INC.-MOD-2025-787443:For friend US-MODERNATX, INC.-MOD-2025-787452:For elders patient US-MODERNATX, INC.-MOD-2025-787492:For people case (Product Spikevax NOS) US-MODERNATX, INC.-MOD-2025-787489:For people (Invalid Case) US-MODERNATX, INC.-MOD-2025-787491:Huge number of people case US-MODERNATX, INC.-MOD-2025-787497:For doctor US-MODERNATX, INC.-MOD-2025-787502:Many people case US-MODERNATX, INC.-MOD-2025-787514:Reporter's Son's collage friend case US-MODERNATX, INC.-MOD-2025-787511:For people US-MODERNATX, INC.-MOD-2025-787472:Tracking only for 12-year old girl More
2846501 66 M 06/18/2025 COVID19
 MODERNA
 041C21A
Heart rate irregular, Orthostatic hypotension Heart rate irregular, Orthostatic hypotension
Orthostatic hypotension; orthostatic hypotension/knock down vertigo, it was a mild slow spinning ver... Orthostatic hypotension; orthostatic hypotension/knock down vertigo, it was a mild slow spinning vertigo/sense of vertigo you get with orthostatic hypotension/a slower form of dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ORTHOSTATIC HYPOTENSION (orthostatic hypotension/knock down vertigo, it was a mild slow spinning vertigo/sense of vertigo you get with orthostatic hypotension/a slower form of dizziness) and ORTHOSTATIC HYPOTENSION (Orthostatic hypotension) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 011D214) for COVID-19 prophylaxis. No Medical History information was reported. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In May 2021, the patient experienced ORTHOSTATIC HYPOTENSION (orthostatic hypotension/knock down vertigo, it was a mild slow spinning vertigo/sense of vertigo you get with orthostatic hypotension/a slower form of dizziness). On 26-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ORTHOSTATIC HYPOTENSION (Orthostatic hypotension). At the time of the report, ORTHOSTATIC HYPOTENSION (orthostatic hypotension/knock down vertigo, it was a mild slow spinning vertigo/sense of vertigo you get with orthostatic hypotension/a slower form of dizziness) and ORTHOSTATIC HYPOTENSION (Orthostatic hypotension) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Heart rate irregular: Due to orthostatic hypotension when patient used to stand up that time patient experienced heart missed the signal. No concomitant medications provided by the reporter. It was reported that patient received his first Moderna vaccine on 25-May-2021 and 3-4 days later patient experienced symptom of orthostatic hypotension. It was reported that symptom was totally unexpected for patient. Patient had a slower kinetic symptom, and it was almost like, not hypoxia, but there was, the same sense of vertigo patient experienced with orthostatic hypotension when patient used to stand up that time patient experienced heart missed the signal. It was reported that symptom was slow and lasted for a minute and almost to the point where he would have to hold onto something not to fall over. Patient symptom was lasted for 3 weeks. Patient was in a reasonably good state of health and had no problems with ladders. Patient sometimes for fun he used to walk on the single railroad line to practice his balance. Patient had several physical exams after the first dose but there were no underlying conditions. Patient had his second vaccination on 25-Jun-2021 and patient symptom returned the next morning, and they were in force with more severe and symptom was lasted for months. Patient had most similar symptom to orthostatic hypotension where had dizziness on standing but a slower form of dizziness. As a result, patient felt like drugged, and things just move slower. Patient did not fall but he was knock down due to vertigo. Because it was a mild slow spinning vertigo. It was reported that patient experienced it at a small degree. It was reported that patient symptom was different now than what he was before the second dose. Patient did not have the same reflexes because if there was a slowdown in his neuromuscular system and neurovascular. Further it was reported that patient thought that things were little bit slower. It was also reported that for the main symptom went away after a few months of the second dose. No treatment medications provided by the reporter. More
2846502 20 F TX 06/18/2025 MNP
 PFIZER\WYETH
Condition aggravated, Peripheral swelling Condition aggravated, Peripheral swelling
hand swelled up again was reported as worsened; hand swelled up again was reported as worsened; This... hand swelled up again was reported as worsened; hand swelled up again was reported as worsened; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 20-year-old female patient received meningococcal group abcwy vaccine (MENINGOCOCCAL GROUP ABCWY VACCINE), on 10Jun2025 as dose 1, single (Batch/Lot number: unknown) at the age of 20 years for immunisation. The patient's relevant medical history included: "eczema on hands", start date: 2010 (not ongoing); "hand swelling" (unspecified if ongoing); "bees stung" (unspecified if ongoing); "red hand" (unspecified if ongoing); "Allergic to sulfate" (unspecified if ongoing). Concomitant medication(s) included: OMEGA 3 [FISH OIL] oral, start date: 07Jun2025. The patient also took other concomitant therapy. The following information was reported: PERIPHERAL SWELLING (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 11Jun2025, outcome "not recovered" and all described as "hand swelled up again was reported as worsened". Therapeutic measures were taken as a result of peripheral swelling, condition aggravated. Additional information: The reporter would like to inquire about the shot for meningococcal disease. She can't identify the name of the product but she said it was from Pfizer. She mentioned that her child recently had the vaccine but just wants to know if there could be any correlation between getting the shot and having hand swelling. Her child had a bee sting 4 days prior to getting the shot. Patient got the shot in arm, and she got stung by bees in left hand. Today is Wednesday, so about 4 days prior to getting the shot. the patient's left hand was stung by 5 bees removing bees from the backyard. Before patient got the shot, patient's hand swelling went down, the red had gone down, could still see where the bee stings were. Patient went to get the shot, and hand swelled up again. Caller asked patient, what did patient use on hand, patient said all patient did was do dishes and has been doing dishes every single day. Confirmed patient was stung by bees prior to getting the shot, about 4 days before getting the shot. Was a good 4 days before the shot. Patient was fine when got the shot, was not sick. Reporter wanted to ask, looked at hand again, said was cured, perfect, so may be the shot. reporter stated sometimes she could be feeling fine, and then reporter could get a flu shot and then all of sudden nose starts running because of the antibodies or something, whatever gets in that shot, because body is fighting whatever is fighting. Patient was also fighting hand bee sting, so wondering if there is any correlation with getting the shot after the bee sting. Dates, outcome: Thinks patient got the shot on 10Jun2025 in the evening or afternoon, and then on 11Jun2025 mentioned her hand. Confirmed hand swelling up again started 11Jun2025. Was fine before went. Saw patient's hand this morning before going to work and had gotten worse, confirmed worsened. Treatment or medical interventions: Gave patient Benadryl last night, one little Benadryl, patient slept good. Patient received 1 dose in right arm, that was it, dosage amount unknown, was a small little thing put in arm was quick. Bee sting was left hand, was left hand that had that swelling right where the 5 bites are. Indication: College, has to go to college can't go without it. Has a meeting with college counselor this week or next, wanted to make sure has transcripts and shot. patient did not receive any other vaccines on the same date as the Pfizer vaccine. Patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. AE did not require a visit to a Physician's Office and visit to the Emergency Room. Did the patient previously receive the Pfizer suspect vaccine? Thinks last dose was when patient was a little kid, but caller has no idea. Patient had all immunizations that the federal government requires to go to public school, presented to college but college said was too old, patient had to get another one. Caller has no additional information to provide such as lot numbers or expirations. Would be on patient's shot record from when was a baby. Any adverse events following this vaccination? If yes, please specify: No. Patient had history of eczema on hands From: 2010, patient was just a little kid To: Patient knows how to take care of it now, had it on fingers, knows what to do. Not ongoing, is all cleared up since knows what to do. Patient had Other medicines Multivitamin: Start: About a month ago Stop: Stopped before bees, stopped taking multivitamin, 07Jun2025, Saturday and Omega 3: Not sure of brand. Start: About a month ago Indication: Really good for brain and immune system, need good brains for college. This report is not related to a study or programme. The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received. More
2846503 M FL 06/18/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Investigation COVID-19, Drug ineffective, Investigation
COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID. A 65-year-ol... COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID. A 65-year-old male 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 included: "Low immunity" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The event "covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: Test: Unknown results. During an inbound call for financial assistance, the patient's wife calling on behalf of his behalf. The patient's wife just took nirmatrelvir/ritonavir (PAXLOVID) and is in the middle of it, because she had COVID-19 since the other day. The patient has a prescription, and he went to a pharmacy. After he got, took the test, got the prescription from the doctor. The patient's wife just paid the other day. The patient has a low immunity so it's more important for him to have the PAXLOVID than it was his wife. The patient was still working but he's going to have to miss a whole week of work next week and his wife was not allowed to go in until Tuesday because of the 5-day period that will be up on Tuesday. The patient's wife did take PAXLOVID, had been taking it herself. So, it was easy for patient's wife but not so much for the patient. The patient and his wife did get Pfizer COVID-19 shots. They both have COVID-19 after receiving Pfizer COVID-19 shots. The patient also had a pharmacy wherein he gets his albuterol. The information on the batch/lot number for BNT162b2 Omicron (KP.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500071903 Same reporter, product, and event; different patient; More
2846504 M 06/18/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 IMM309
IMM309
Dizziness, Nausea, Pain, Pain in extremity, Sciatica; Sensory disturbance, Visio... Dizziness, Nausea, Pain, Pain in extremity, Sciatica; Sensory disturbance, Vision blurred, Vomiting More
persistent body pain; blurry vision; I had an exacerbation of existing sciatica-related pain in my l... persistent body pain; blurry vision; I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes.; I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes.; I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes.; vomiting; nausea; dizziness; This is a spontaneous report received from a Consumer or other non HCP. An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01May2025 at 15:30 as dose number 1, single (Lot number: IMM309) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SCIATICA (non-serious), SENSORY DISTURBANCE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01May2025 at 18:00, outcome "not recovered" and all described as "I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes."; VISION BLURRED (non-serious) with onset 01May2025 at 18:00, outcome "not recovered", described as "blurry vision"; DIZZINESS (non-serious) with onset 01May2025 at 18:00, outcome "not recovered"; NAUSEA (non-serious) with onset 01May2025 at 18:00, outcome "not recovered"; PAIN (non-serious) with onset 01May2025 at 18:00, outcome "not recovered", described as "persistent body pain"; VOMITING (non-serious) with onset 01May2025 at 18:00, outcome "not recovered". Therapeutic measures were not taken as a result of pain, vision blurred, sciatica, sensory disturbance, pain in extremity, vomiting, nausea, dizziness. Additional information: Vaccine was administered at Doctor's office/urgent care. The patient didn't receive any other vaccines on the same date or within 4 weeks prior to Comirnaty vaccine. Device Date: 16Jun2025. More
2846505 F FL 06/18/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
both had Covid after receiving Pfizer Covid Shots/had COVID-19; both had Covid after receiving Pfize... both had Covid after receiving Pfizer Covid Shots/had COVID-19; both had Covid after receiving Pfizer Covid Shots/had COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "both had Covid after receiving Pfizer Covid Shots/had COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was calling on behalf of her husband, but she just took Paxlovid, she's in the middle of it because she had COVID-19. They both had Covid after receiving Pfizer Covid Shots. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122715 Same reporter/drug/event; different patients; More
2846506 06/18/2025 COVID19
 PFIZER\BIONTECH
Autoimmune disorder Autoimmune disorder
Pfizr Covid vaccines 2021 created in me autoimmune disorder; This is a spontaneous report received f... Pfizr Covid vaccines 2021 created in me autoimmune disorder; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Pfizr Covid vaccines 2021 created in me autoimmune disorder". Pfizr Covid vaccines 2021 created in patient autoimmune disorder so rhmaologist doctor won't let patient do more rna types. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2846507 WA 06/18/2025 MEN
 UNKNOWN MANUFACTURER
 U8494AA
No adverse event, Product preparation error No adverse event, Product preparation error
one of their providers mistakenly mixed sterile water diluent with MENQUADFI and a patient received ... one of their providers mistakenly mixed sterile water diluent with MENQUADFI and a patient received it with no reported AE; Initial information received on 16-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who had received Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] which was mistakenly mixed with sterile water diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Jun-2025, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection, lot U8494AA,expiry date: 30-Jun-2028, Frequency = once, Strength = standard via unknown route in unknown administration site for immunization which was mistakenly mixed with sterile water diluent with no reported adverse event (product preparation error) (latency: same day). Reportedly, Vaccine program coordinator called saying that one of their providers mistakenly mixed sterile water diluent with MENQUADFI and a patient received it. They wanted to confirm if the patient should be revaccinated Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2846508 1.25 M OH 06/18/2025 HIBV
 SANOFI PASTEUR
 UK201AC
No adverse event, Product preparation error No adverse event, Product preparation error
inappropriate use due to a nurse accidentally administering ACT-HIB reconstituted with only sterile ... inappropriate use due to a nurse accidentally administering ACT-HIB reconstituted with only sterile water as diluent to a patient with no reported adverse event; Initial information received on 17-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old male patient who had inappropriate use due to a nurse accidentally administering HIB (PRP/T) vaccine [ACT-HIB] reconstituted with only sterile water as diluent to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation. On 11-Jun-2025, the patient accidentally administering an unknown dose (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection with strength: standard (lot UK201AC with expiry date 20-APR-2026) via intramuscular route in the right thigh for Immunization; act-hib reconstituted with only sterile water as diluent to a patient with no reported adverse event (product preparation error) (latency: same day) Reportedly: patient was Not pregnant. Patient age was less then 1 year. their nurses accidentally administered ACT-HIB reconstituted using only sterile water as diluent to a patient. She called to check if this was considered as a valid dose. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2846509 9 F MI 06/18/2025 COVID19
 PFIZER\BIONTECH
 LT7425
No adverse event, Product storage error No adverse event, Product storage error
Expired vaccine only due to the fact that it was out of the freezer longer and in the refrigerator l... Expired vaccine only due to the fact that it was out of the freezer longer and in the refrigerator longer than manufacturer recommendation. No side effects or symptoms during occurrence More
2846510 17 F CO 06/18/2025 HPV9
 MERCK & CO. INC.
 X014788
Expired product administered, No adverse event Expired product administered, No adverse event
Pt reported no adverse reaction. Pt was just given expired vaccine . Pt reported no adverse reaction. Pt was just given expired vaccine .
2846511 56 F VA 06/18/2025 HEP
HEPA
PNC20
TDAP
VARZOS
 DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 946060
ey57a
lx4484
793pt
93n4j
Pain in extremity, Peripheral swelling; Pain in extremity, Peripheral swelling; ... Pain in extremity, Peripheral swelling; Pain in extremity, Peripheral swelling; Pain in extremity, Peripheral swelling; Pain in extremity, Peripheral swelling; Pain in extremity, Peripheral swelling More
Patient called to report soreness and swelling in the arms following vaccines given the prior day wi... Patient called to report soreness and swelling in the arms following vaccines given the prior day with one arm (left) being more swollen More
2846512 75 F IA 06/18/2025 RSV
 PFIZER\WYETH
 LN5486
Extra dose administered, No adverse event Extra dose administered, No adverse event
no adverse events, it was a wrong dose because two doses got administered instead of 1. first in feb... no adverse events, it was a wrong dose because two doses got administered instead of 1. first in february 2025 and second in june 2025 More
2846516 0.25 F AZ 06/18/2025 DTPPVHBHPB
PNC20
 MSP VACCINE COMPANY
PFIZER\WYETH
 U7776AA
HL3888
Injection site discolouration; Injection site discolouration Injection site discolouration; Injection site discolouration
Parents report a small brown spot on child's right thigh which they first noticed about a day a... Parents report a small brown spot on child's right thigh which they first noticed about a day after vaccines were given. Parents deny any other symptoms at this time. When examining child's leg, small brown spot was noted on right thigh, similar to a mole. Spot is not raised to the touch and child does not seem to have any discomfort when pressing down on the spot. Advised parents to keep an eye on the right thigh and report any changes in size, any swelling or raising of small spot, or any other changes to the leg that they can observe as soon as possible. Advised parents that vaccines given today would both be given on left thigh to avoid aggravating skin, muscle, or any other tissue irritation the previous vaccine could have caused. Advised parents to report any changes to child's left thigh after today's vaccines although combination vaccine is different. Parent voiced understanding. More
2846517 65 F CA 06/18/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019157
Y019157
Chills, Hypoaesthesia, Injection site erythema, Injection site induration, Injec... Chills, Hypoaesthesia, Injection site erythema, Injection site induration, Injection site swelling; Muscle fatigue, Pain More
Pt received capvaxive on 6/11. Starting that night pt c/o chills and body aches. Then on 6/14, pt c/... Pt received capvaxive on 6/11. Starting that night pt c/o chills and body aches. Then on 6/14, pt c/o L arm numbness so pt took gabapentin and it made her even more fatigued. On 6/15, pt c/o L arm swelling and redness where pt received the vaccine. Pt states the area is very hard to the touch. Today, her symptoms improved, so she no longer has chills and body aches but still has some swelling and redness near injection site plus L arm numbness. Med taken: tylenol 500 mg 2po bid Patient was seen at office on 06/16/25 for eval. Exam: mild erythema and swelling 10 x 8 cm. no fluctuance Treatment: Rx cetirizine 10 mg prn, tylenol 500mg qid prn More
2846518 77 F CA 06/18/2025 COVID19
 MODERNA
 3044069
Bell's palsy, Computerised tomogram head normal Bell's palsy, Computerised tomogram head normal
6/18/25 - Patient said after obtaining Spikevax (5/5/25), she developed Bells Palsys about a week af... 6/18/25 - Patient said after obtaining Spikevax (5/5/25), she developed Bells Palsys about a week after. She had nerve sensation on the left side of her face, so she went to the emergency room to rule out stroke. The CAT scan ruled out stroke. She is currently obtaining PT and it is getting better. Pt also noted that she have past medical history of Bells Palsy many decades ago, that have been resolved. More
2846632 0.5 F OH 06/18/2025 DTPPVHBHPB
PNC20
RV5
 MSP VACCINE COMPANY
PFIZER\WYETH
MERCK & CO. INC.
 U8313AA
LN4928
2096656
Death; Death; Death Death; Death; Death
Patient Died 5 days after Patient Died 5 days after
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2845234 50 F GA 06/17/2025 HEPA
 MERCK & CO. INC.
 X024966
Expired product administered Expired product administered
Confirmed no symptomatic adverse events reported; that an expired dose of VAQTA was inadvertently ad... Confirmed no symptomatic adverse events reported; that an expired dose of VAQTA was inadvertently administered to a patient; This spontaneous report was received from a medical Assistant who is a Clinical supervisor and refers to a 50-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-Jun-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), (lot #X024966, expiration date: 23-Mar-2025) administered by Unknown route for prophylaxis (Expired product administered). Caller also added that the patient was receiving Hepatitis A Vaccine, Inactivated (VAQTA) because she was going to be traveling out of country. Confirmed no symptomatic adverse events reported. No additional AE. No PQC. More
2845235 M CO 06/17/2025 HEPA
HEPA
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No additional AE; the patient's initial dose was administered on 11/29/2006 and his second was ... No additional AE; the patient's initial dose was administered on 11/29/2006 and his second was administered earlier than 6-months after the initial dose on 05/18/2007; This spontaneous report was received from a nurse and refers to a 19-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-NOV-2006, the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) and on 18-MAY-2007, the patient was vaccinated with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, anatomical location, route of administration, lot number and expiration date were not reported for both vaccines) for prophylaxis. The healthcare provider (HCP) wanted to know if it was safe or recommended to administer 2 doses of the pediatric formulation of Hepatitis A Vaccine, Inactivated (VAQTA) in lieu of the one adult dose formulation of Hepatitis A Vaccine, inactivated (VAQTA) because the office did not have an adult dose on hand. The HCP stated the patient needed a booster dose of Hepatitis A Vaccine, Inactivated (VAQTA) for pilot school because the patient's initial dose was administered on 29-NOV-2006 and his second was administered earlier than 6-months after the initial dose on 18-MAY-2007 (inappropriate schedule of product administration). It was unknown by the HCP if the patient had a titer drawn initiating the need of a third "booster" dose of Hepatitis A Vaccine, Inactivated (VAQTA) and the nurse was under the impression the booster was required as a standard protocol for the patient to go to pilot school, but the nurse stated the patient had not experienced any other adverse issues or side effects related to the prior administered doses. No additional adverse event (AE). More
2845236 PA 06/17/2025 DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
RV5
RV5
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.







Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
the patient inadvertently received a 4th dose of the ROTATEQ vaccine/ received an extra dose of VAXE... the patient inadvertently received a 4th dose of the ROTATEQ vaccine/ received an extra dose of VAXELIS; no adverse reaction to extra dose; This spontaneous report was received from a physician and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20). On 04-JUN-2024, 05-AUG-2024, 16-SEP-2024, the patient was vaccinated with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS), dose number 1-2 and 3, (doses descriptions, lot #s and expiration date were not reported), then on 08-OCT-2024, at their 6 month well check, the patient had inadvertently received an extra dose (dose number 4) of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS) (dose description, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) dose number 1-2 and 3 (doses description, route of administrations, lot #s and expiration dates were not reported), then, 3 weeks after completing the 3-dose series for the vaccine, on an unknown date, the patient inadvertently received a 4th dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dose description, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient experienced no adverse reaction to extra dose. More
2845237 WI 06/17/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y014059
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
no adverse event; 1st dose of GARDASIL 9 on 1/8/2025 and 2nd dose on 3/1/2025; This spontaneous repo... no adverse event; 1st dose of GARDASIL 9 on 1/8/2025 and 2nd dose on 3/1/2025; This spontaneous report was received from a pharmacist and refers to a 26-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-Jan-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (dose, formulation, route of administration, injection site, lot # and expiration date were not reported). On 01-Mar-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) at 0.5 mL (lot #Y014059 was verified to be a valid number, expiration date: 01-Nov-2026) (scheme, formulation, route of administration and injection site were not reported); both doses for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported. More
2845238 M PA 06/17/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945662
Headache, Injection site pain, Nausea, Pyrexia Headache, Injection site pain, Nausea, Pyrexia
Pain at the Site; Low Grade Fever; Nausea; Headache; 15 year old Patient Was Given Heplisav-B; Initi... Pain at the Site; Low Grade Fever; Nausea; Headache; 15 year old Patient Was Given Heplisav-B; Initial report received on 07-May-2025. Additional information received on 05-Jun-2025 included confirmation that HEPLISAV-B was given in error, information on the second dose of a hepatitis B vaccine received, and the patient's date of birth. A physician reported that a 15-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and reported pain at the site, a low-grade fever, nausea, and a headache the day following the injection. No medical history or concomitant medications were reported. On 09-Apr-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 945662, expiration date 31-Jan-2027, and NDC number 4352800301) intramuscularly in the left upper deltoid. This dose was ordered and given to the patient unintentionally. The patient was 15 years old when he received the HEPLISAV-B dose. On 10-Apr-2025, the day after having been vaccinated with HEPLISAV-B, the patient reported pain at the injection site, a low-grade fever, nausea, and a headache. On 07-May-2025, 29 days after receiving HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine, ENGERIX-B (lot number and expiration date not provided). The patient received a pediatric dose to complete his hepatitis B series. No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2845244 49 F MA 06/17/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 013L20A
013L20A
010M20A
010M20A
Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia, Intensive care,... Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Lumbar puncture abnormal; Mobility decreased, Paraesthesia; Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Lumbar puncture abnormal; Mobility decreased, Paraesthesia More
Diagnosed with GBS (Gullaine-Barre Syndrome) after experiencing numbness and tingling to both hands/... Diagnosed with GBS (Gullaine-Barre Syndrome) after experiencing numbness and tingling to both hands/feet. The diagnosis was confirmed after a spinal tap was performed. I was intubated and in the ICU for several weeks. I was sent to a rehab to help regain my mobility, but my symptoms returned and subsequently, I was sent back to the hospital for a higher level of treatment a total of three times while in rehab. I was between the hospital and rehab for a total of three months before returning home. More
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2845245 M 06/17/2025 COVID19
 MODERNA
COVID-19 COVID-19
getting Covid; This spontaneous case was reported by a non-health professional and describes the occ... getting Covid; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (getting Covid) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (getting Covid). At the time of the report, COVID-19 (getting Covid) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The patient took the shots, and he kept getting Covid. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:For landlord More
2845246 0.33 F MI 06/17/2025 HIBV
PNC20
RV5
VARCEL
 MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 Y013471
LJ5282
2095065
Y017914
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; No adverse event, Wrong product administered More
VAR inadvertently given - was ordered as IPV Mother notified on 6/16/2025; mom denies any neg side e... VAR inadvertently given - was ordered as IPV Mother notified on 6/16/2025; mom denies any neg side effects. More
2845247 0.83 F MN 06/17/2025 MMR
 MERCK & CO. INC.
 Y015552
Abdominal pain upper, Pyrexia, Rash, Rash erythematous Abdominal pain upper, Pyrexia, Rash, Rash erythematous
At 8-10 days after the immunization, she had a fever for 36-48 hours. On day 10, she developed a ras... At 8-10 days after the immunization, she had a fever for 36-48 hours. On day 10, she developed a rash of small pink dots that spread across the whole body. On days 11-12, she has suspected stomach pains. More
2845275 26 M SC 06/17/2025 MMR
 MERCK & CO. INC.
 49M2F
Rash Rash
Client states he woke up with a rash covering his body two days after receiving the vaccines - clien... Client states he woke up with a rash covering his body two days after receiving the vaccines - client then followed up at urgent care the same day and received prednisone for treatment More
2845276 36 M 06/17/2025 PNC20
 PFIZER\WYETH
Wrong product administered Wrong product administered
Patient was administered the wrong vaccine, patient was given the Prevnar20 vaccine instead of the M... Patient was administered the wrong vaccine, patient was given the Prevnar20 vaccine instead of the Menveo vaccine, which was ordered. Pt was made aware of the mistake and asked to come back to receive the correct vaccine. More
2845277 44 F NC 06/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 F95YS
Feeling abnormal, Hyperhidrosis, Pyrexia Feeling abnormal, Hyperhidrosis, Pyrexia
PT RECEIVED SHINGRIX 6/7/25 AROUND 12:47 PM...SAID ABOUT 4 HRS LATER, SHE DEVELOPED FEVER & COVI... PT RECEIVED SHINGRIX 6/7/25 AROUND 12:47 PM...SAID ABOUT 4 HRS LATER, SHE DEVELOPED FEVER & COVID LIKE SYMPTOMS...HAS HAD HIGH FEVER AND SWEATS PRETTY MUCH EVER SINCE THEN. SAID SHE IS CURRENTLY STARTING TO FEEL BETTER. SHE IS A LUPUS PT AND GETS SAPHNELO INFUSION AND HAD ONE 6/3/25. THIS WAS HER 2ND SHINGLES VACCINE WHICH HER PROVIDER WANTED HER TO GET IN ORDER TO START THE INFUSIONS FOR LUPUS. SHE WENT TO ER ON 6/8/25 BECAUSE SHE FELT SO BAD...THEY JUST GAVE HER FLUIDS AT ER AND FEEL LIKE SYMPTOMS WERE A RESULT OF THE 2ND SHINGLES VACCINE. (SHE DID FINE WITH HER 1ST SHINGLES VACCINE WHICH SHE RECEIVED ON 2/3/25) More
2845278 0.5 F MO 06/17/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
 Y4NG3
Diarrhoea, Irritability Diarrhoea, Irritability
pt was having 10 or more looser stools a day, not really soaking into the diaper not overly watery, ... pt was having 10 or more looser stools a day, not really soaking into the diaper not overly watery, she seems fussy more at night and not as much during the day. She is BF well and taking her baby/table foods as usual. Mom has rice cereal that she has been using at times. Recommended using rice cereal to all baby foods to help bulk up stool. BRAT diet reviewed for her age. Unfortunately it will take time for the diarrhea to improve. Informed mom there is nothing we can give her to stop the diarrhea. Monitor and keep her hydrated. Sounds like mom is keeping her hydrated, she is wetting 3-4 or more diapers a day. No fevers. Mom will touch base in 2 days or sooner with an update or bring her into clinic for revaluation. More
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