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
2835792 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Periarthritis Periarthritis
Adhesive capsulitis of shoulder; This non-serious case was reported by a physician via sales rep and... Adhesive capsulitis of shoulder; This non-serious case was reported by a physician via sales rep and described the occurrence of adhesive capsulitis of shoulder in a specified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced adhesive capsulitis of shoulder (Verbatim: Adhesive capsulitis of shoulder). The outcome of the adhesive capsulitis of shoulder was resolved. The reporter considered the adhesive capsulitis of shoulder to be related to Shingrix. The company considered the adhesive capsulitis of shoulder to be related to Shingrix. Additional Information: GSK Receipt Date: 03-APR-2025 Physician discussed two cases of this adhesive capsulitis occurring in separate patients. Both occurring after the first dose of Shingrix was administered and both resolved. More
2835793 71 M PA 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site erythema, Injection site mass, Injection site swelling Injection site erythema, Injection site mass, Injection site swelling
swelling at injection site; red at injection site; hard lump at injection site; This non-serious cas... swelling at injection site; red at injection site; hard lump at injection site; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. On 25-MAR-2025, the patient received the 1st dose of Shingrix (left arm). On 26-MAR-2025, 1 days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at injection site), injection site erythema (Verbatim: red at injection site) and injection site lump (Verbatim: hard lump at injection site). The outcome of the injection site swelling, injection site erythema and injection site lump were resolving. The reporter considered the injection site swelling, injection site erythema and injection site lump to be related to Shingrix. The company considered the injection site swelling, injection site erythema and injection site lump to be related to Shingrix. Additional Information: GSK Receipt Date: 03-APR-2025 The patient received concomitant product wygovey. The reporter reported injection was further down arm than typically done, roughly midway between shoulder and elbow. More
2835794 F 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Influenza, Malaise Influenza, Malaise
flu symptoms; Sick; This non-serious case was reported by a consumer via interactive digital media a... flu symptoms; Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced flu symptoms (Verbatim: flu symptoms) and sickness (Verbatim: Sick). The outcome of the flu symptoms and sickness were not reported. It was unknown if the reporter considered the flu symptoms and sickness to be related to Shingles vaccine. It was unknown if the company considered the flu symptoms and sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date 01-APR-2025 This case was reported by the parent of the patient via interactive digital media. The reporter reported that he/she and her daughter (patient) got first shot and they would have to booster soon. Further reporter stated his/her daughter had side effects like flu symptoms were sick. No other symptoms. Reporter said it was just dependent on the physical situation. The reporter guessed that patient don't want to get Booster, but it was her decision. This case was linked to the US2025AMR039854, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR039854:same reporter More
2835795 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity, Peripheral swelling Pain in extremity, Peripheral swelling
swollen arm; sore arm; This non-serious case was reported by a consumer via interactive digital medi... swollen arm; sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: swollen arm) and pain in arm (Verbatim: sore arm). The outcome of the swelling arm and pain in arm were resolved (duration 3 days). It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine. It was unknown if the company considered the swelling arm and pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-APR-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient had swollen sore arm 3 days and there were no other symptoms. This case is linked with case US2025AMR039848, reported by the same reporter. More
2835796 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
left arm sore; This non-serious case was reported by a consumer via interactive digital media and de... left arm sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: left arm sore). The outcome of the pain in arm was resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK receipt Date: 02-APR-2025 This case was reported by a patient via interactive digital media. The patient had it just like the picture, miserable. Just got second Shingrix shot. The left arm sore for the past week. The doctor said the patient may still get shingles but it would be less than before. More
2835797 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Still in extreme pain; Suspected vaccination failure; have had the shingles since February 16th; Thi... Still in extreme pain; Suspected vaccination failure; have had the shingles since February 16th; 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 16-FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have had the shingles since February 16th). On an unknown date, the patient experienced pain (Verbatim: Still in extreme pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the pain was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-APR-2025 This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine and had the shingles since 16th February and had worst pain ever with still in extreme pain. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination 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 time to onset for shingles, completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. More
2835798 F TN 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Impaired work ability, Malaise Impaired work ability, Malaise
Sick; Not feeling well; This non-serious case was reported by a nurse via sales rep and described th... Sick; Not feeling well; This non-serious case was reported by a nurse via sales rep and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: Sick) and feeling unwell (Verbatim: Not feeling well). The outcome of the sickness and feeling unwell were not reported. It was unknown if the reporter considered the sickness and feeling unwell to be related to Shingrix. It was unknown if the company considered the sickness and feeling unwell to be related to Shingrix. Additional Information: GSK Receipt Date: 01-APR-2025 The reporter reported a patient had been vaccinated with Shingrix but unknown if this was the first or second dose of Shingrix and if the patient completed the two dose series. The patient was sick and missed work for a day or 2 due to not feeling well after Shingrix. More
2835799 F TN 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise, Pain Malaise, Pain
experienced soreness; did not feel well after the first dose; This non-serious case was reported by ... experienced soreness; did not feel well after the first dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included breast cancer (now also recovered from her cancer treatment). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: experienced soreness) and feeling unwell (Verbatim: did not feel well after the first dose). The outcome of the pain and feeling unwell were not reported. It was unknown if the reporter considered the pain and feeling unwell to be related to Shingrix. It was unknown if the company considered the pain and feeling unwell to be related to Shingrix. Additional Information: GSK Receipt Date: 03-APR-2025 The nurse reported that the patient experienced soreness and did not felt well after the first dose of Shingrix vaccine. It was unknow if the symptoms occurred after the second dose. The patient had breast cancer and her physician was treating the cancer suggested she get vaccinated with Shingrix (the cancer was pre-existing before the vaccination). She did completed the 2 dose Shingrix series and the patient was now also recovered from her cancer treatment. More
2835800 M NM 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Extra dose administered, Herpes zoster, Product prescribing issue, Vaccination f... Extra dose administered, Herpes zoster, Product prescribing issue, Vaccination failure More
Suspected vaccination failure; Patient having an active case of shingles; The patient recived Shingr... Suspected vaccination failure; Patient having an active case of shingles; The patient recived Shingrix vaccine 3 to 4 time per year; Prescribed Shingrix now while patient had active with shingles; This serious case was reported by a other health professional via other manufacturer and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Patient having an active case of shingles), extra dose administered (Verbatim: The patient recived Shingrix vaccine 3 to 4 time per year) and drug prescribing error (Verbatim: Prescribed Shingrix now while patient had active with shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the extra dose administered and drug prescribing error were not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 03-APR-2025 The patient received Shingrix vaccine 3 to 4 times per year and states that he was being prescribed this now while having an active case of shingles. The physician was unable to provide any further information and no other adverse events and product quality complaints. The patient received Shingrix vaccine 3 to 4 times per year which led to extra dose administered and prescribed Shingrix now while patient had active with shingles which led to drug prescribing error. 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 vaccine Shingrix. More
2835801 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
Had one shot, got shingles about a month ago; This non-serious case was reported by a consumer via i... Had one shot, got shingles about a month ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Had one shot, got shingles about a month ago). The outcome of the shingles was resolving. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient had one shot, got shingles about a month ago. The patient expressed that wow, think that he/she was getting through the worst. The follow-up could not be possible as no contact details were available. More
2835802 F 04/11/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Neuralgia, Rash, Vaccination failure; Herpes zoster, Neuralgia, R... Herpes zoster, Neuralgia, Rash, Vaccination failure; Herpes zoster, Neuralgia, Rash, Vaccination failure More
Suspected vaccination failure; Shingles; shingles and had It took 2.5 months of agonizing nerve pain... Suspected vaccination failure; Shingles; shingles and had It took 2.5 months of agonizing nerve pain; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: shingles and had It took 2.5 months of agonizing nerve pain). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and post herpetic neuralgia were not reported and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 04-APR-2025 This case was reported by a patient via interactive digital media. The reporter wife had both vaccines and two years later caught the Shingles. She had the shingles for 2.5 months before a doctor finally made a diagnosis. It took 2.5 months of agonizing nerve pain before a minor rash appeared. She has had the Shingles for almost 7 months, and it was just starting to get tolerable. She had been on Valtrex for 4.5 months and will probably have to take it for several more months. So, she paid 160.00 out of pocket for snake oil.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2). More
2835803 04/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Eye discharge Eye discharge
problems with both eyes including a lot of goop in one eye; This non-serious case was reported by a ... problems with both eyes including a lot of goop in one eye; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of eye discharge in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced eye discharge (Verbatim: problems with both eyes including a lot of goop in one eye). The outcome of the eye discharge was not resolved. The reporter considered the eye discharge to be related to Arexvy. The company considered the eye discharge to be related to Arexvy. Additional Information: GSK Receipt Date: 02-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that GlaxoSmithKline was about money. The reporter was shocked how much they changed medicare part, then the reporter problems with both eyes including a lot of goop in one eye. The reporter stated that it turned a mistake getting RSV. More
2835804 60 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Neuropathic pruritus, Vaccination failure Herpes zoster, Neuropathic pruritus, Vaccination failure
Suspected vaccination failure; have a very light case of it on a section of my thigh, with only 2 sp... Suspected vaccination failure; have a very light case of it on a section of my thigh, with only 2 spots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In MAR-2025, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have a very light case of it on a section of my thigh, with only 2 spots). 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: 05-APR-2025 This case was reported by a patient via interactive digital media. Patient reported about the Shingle shot. Patient stated that it would save a painful case of it down the road if ever got shingles. Patient got it at 60 and was 68 at the time of reporting and just the past 2 weeks from reporting patient had a very light case of it on a section of his/her thigh, with only 2 spots. Patient got on the anti-viral medications and the next day had nerve itching. Reporter stated if caught soon that helps a lot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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, and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2835805 04/11/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
got both shots about a year ago and still two days ago I have the virus/ suspected vaccination failu... got both shots about a year ago and still two days ago I have the virus/ suspected vaccination failure; Got the mild case of shingles virus 3 days ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got both shots about a year ago and still two days ago I have the virus/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the mild case of shingles virus 3 days ago). 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 Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient got both shots about a year ago and that started three days ago had a mild case(so far) of the virus. The patient was on an antibiotic and so far it was a milder case. Patient did not had any one small patch and hopped that this was a minor case. 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 completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2). More
2835806 55 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Scab, Vaccination failure Herpes zoster, Pain, Scab, Vaccination failure
Suspected vaccination failure; Shingles/on my back, right side and stomach so much pain; This seriou... Suspected vaccination failure; Shingles/on my back, right side and stomach so much pain; 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. The patient's past medical history included chickenpox (had chix pox twice as a kid) and shingles (shingles at 25). On an unknown date, the patient received Shingles vaccine. In MAR-2025, 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/on my back, right side and stomach so much pain). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 06-APR-2025 This case was reported by a patient via interactive digital media. Patient had chicken pox twice as a kid, shingles at 25. Patient got the vaccine at 55. Patient was 57 at the time of reporting and got shingles about 2 weeks ago, on back, right side and stomach. Patient stated that so much pain was there. Gabapentin was the only thing that takes the edge of pain off. Reporter stated that Shingles was no joke. The spots were started to scab but still so much pain. Patient was not sure how much the vaccine helped. Maybe it would have been worse without the vaccine, can't even imagine. 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 details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine." More
2835807 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Rash, Vaccination failure Herpes zoster, Pain, Rash, Vaccination failure
vaccinated for years and now have shingles/ suspected vaccination failure; Shingles/ big rash but so... vaccinated for years and now have shingles/ suspected vaccination failure; Shingles/ big rash but so far not as painful as it could be; 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: vaccinated for years and now have shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/ big rash but so far not as painful as it could be). 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 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: 04-APR-2025 and 05-APR-2025 This case was reported by a patient via interactive digital media. The patient have been vaccinated for years and now the patient had shingles. The patient got the vaccine in 2023 and had shingles and now a big rash but so far not as painful as it could be. 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
2835808 04/11/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Hypoaesthesia, Neuropathy peripheral, Rash, Vaccination failure; ... Herpes zoster, Hypoaesthesia, Neuropathy peripheral, Rash, Vaccination failure; Walking aid user More
Suspected vaccination failure; neuropathy; still got shingles; use a walker; This serious case was r... Suspected vaccination failure; neuropathy; still got shingles; use a walker; 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), neuropathy (Verbatim: neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and walker user (Verbatim: use a walker). The outcome of the vaccination failure, neuropathy, shingles and walker user were not reported. It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and walker user to be related to Shingles vaccine. The company considered the vaccination failure and neuropathy to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and walker user to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-APR-2025 This case was reported by a patient via interactive digital media. The patient had the shots a number of years ago. Thought he/she was covered. Still got the shingles. The patient was expecting the rash but did not know neuropathy could also be a problem. Six months later having to use a walker because there was no feeling on right side from the waist down. Was told that the vaccine was gotten years ago has been replaced by a better product. Planning to get it when doctor says it was time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 time to onset for shingles, completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. Neuropathy peripheral is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. More
2835809 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Burning sensation, Herpes zoster, Vaccination failure Burning sensation, Herpes zoster, Vaccination failure
suspected vaccination failure; had shingles 3 times; This serious case was reported by a consumer vi... suspected vaccination failure; had shingles 3 times; 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 3 times). 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: 06-APR-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine shot 5 years ago from reporting date. The patient had shingles 3 times in the last 2 years. The reporter has discovered a gel that takes all the burning out. I just had them down the side of nose down to jaw. The reporter put this gel on them several times a day the burning was gone. It was truly amazing. This case was considered as suspected vaccination failure as details regarding completion of primary schedule 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 regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2835810 F 04/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspeceted vaccination failure; She still got shingles when she was in the hospital; This serious ca... Suspeceted vaccination failure; She still got shingles when she was in the hospital; 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included immune system disorder. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: She still got shingles when she was in the hospital). 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 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: 08-APR-2025 This case was reported by a Consumer via interactive digital media. The reporter reported that his/her mother got the Shingrix vaccine 2 doses. The patient still got shingles when she was in the hospital. The vaccines were never a guarantee. Also her immune system was low and she was getting medications, steroids, antibiotics ,so it might had triggered it. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).. More
2835811 VT 04/11/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 3L339
Inappropriate schedule of product administration Inappropriate schedule of product administration
wrong vaccine schedule/ approximately 20 patients, about 50/50 male and female, were affected by thi... wrong vaccine schedule/ approximately 20 patients, about 50/50 male and female, were affected by this; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received Men B NVS (Bexsero) (batch number 3L339) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate schedule of vaccine administered (Verbatim: wrong vaccine schedule/ approximately 20 patients, about 50/50 male and female, were affected by this). The outcome of the inappropriate schedule of vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-MAR-2025 A registered nurse contacted GlaxoSmithKline to report that they were having issues interpreting the information that was presented in the prescribing information for Bexsero, as it stated that two doses of Bexsero could be given at least one month apart but in the (CDC) Centers for Disease Control and Prevention it stated that the interval had to be a zero- and six-month schedule. The prescribing information was revised, using the most up-to-date version which included the zero- and six-month vaccination schedule or the 0, 1 to 2- and six-month vaccination schedule. The health care professional stated that the reason for which they used the incorrect vaccination schedule was due to the fact that the package insert that had been included in their vaccine container was the prescribing information before the 2024 revision, which led to an inappropriate schedule of vaccine administered They mentioned that approximately 20 patients, about 50 by 50 male and female, were affected by this. The vaccine administration facility was the same as primary reporter.; Sender's Comments: US-GSK-US2025038577:same reporter different patient More
2835812 04/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Pruritus, Vaccination failure Herpes zoster, Pain, Pruritus, Vaccination failure
Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via ... Suspected vaccination failure; still got 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: still got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 3 months). 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: 05-APR-2025 This case was reported by a patient via interactive digital media. The patient had Shingles vaccine and still got shingles. They hurt and itched for 3 months. Probably would had killed if had not received vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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
2835813 FL 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
patients were getting Shingrix (2nd dose) a year later; This non-serious case was reported by a phar... patients were getting Shingrix (2nd dose) a year later; 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 an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient had first dose a year ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patients were getting Shingrix (2nd dose) a year later). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 31-MAR-2025 Pharmacist reported that during COVID, patients were getting Shingrix (2nd dose) a year later. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2835814 M GA 04/11/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
can you still administer the second dose as part of the series; This non-serious case was reported b... can you still administer the second dose as part of the series; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received 1st dose on 14-AUG-2024). 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: can you still administer the second dose as part of the series). 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: 02-APR-2025 The nurse reported that a patient had a dose 7 months prior, could still administer the second dose as part of the series. Health care professional states that patient was there today to receive 2nd dose of Bexsero. The reporter disconnected chat prior to data being provided. Unknown if patient received 2nd dose on 02-APR-2025. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination. More
2835815 CA 04/11/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
Extra dose (Potential); This non-serious case was reported by a other health professional via sales ... Extra dose (Potential); This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a patient who received Rota (Rotarix) for prophylaxis. Previously administered products included rotarix (received the 1st dose of Rotarix vaccine on unknown date) and rotarix (received the 2nd dose of Rotarix on unknown date). On an unknown date, the patient received the 3rd dose of Rotarix. On an unknown date, an unknown time after receiving Rotarix, the patient experienced extra dose administered (Verbatim: Extra dose (Potential)). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-APR-2025 The reporter reported that we accidentally gave a baby a third dose of Rotarix, which led to extra dose administered. More
2835816 F LA 04/11/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Intercepted product prescribing error Intercepted product prescribing error
48 years of age has a prescription to receive a Bexsero; This non-serious case was reported by a pha... 48 years of age has a prescription to receive a Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 48-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. The patient's past medical history included splenectomy. On an unknown date, the patient did not receive Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: 48 years of age has a prescription to receive a Bexsero). The outcome of the intercepted drug prescribing 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: 03-APR-2025 The pharmacist reported patient 48 years of age has a prescription to receive a Bexsero vaccine after splenectomy. The vaccines was not administered at the moment of the reporting which led to intercepted drug prescribing error. The Vaccine Administration Facility was the same as Primary Reporter. More
2835817 NC 04/11/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Incorrect route of product administration Incorrect route of product administration
it said that administer subcutaneously, we did one intramuscularly; This non-serious case was report... it said that administer subcutaneously, we did one intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: it said that administer subcutaneously, we did one intramuscularly). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 03-APR-2025 It was reported for the MMR, Priorix vaccine, it said to administer subcutaneously, they did one intramuscularly which led to subcutaneous injection formulation administered by other route. The reporter wanted to know about the side effects or what happens, and asked If it is not effective. More
2835818 GA 04/11/2025 DTAP
DTAPIPV
FLU3
HEP
MENB
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS





Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
Possible administration of vaccines after temperature excursion; This non-serious case was reported ... Possible administration of vaccines after temperature excursion; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Flu Seasonal TIV Quebec (Flulaval) for prophylaxis, DTPa (Infanrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis. On an unknown date, the patient received Bexsero, Boostrix, Engerix B, Flulaval, Infanrix and Kinrix. On an unknown date, an unknown time after receiving Bexsero, Boostrix, Engerix B, Flulaval, Infanrix and Kinrix, the patient experienced incorrect storage of drug (Verbatim: Possible administration of vaccines after temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-APR-2025 The doctor called to report Bexsero, Boostrix, Engerix-B, Flulaval, Infanrix, Kinrix experienced a temperature excursion at 24.2๏ฟฝF for 14 hours and after that was possible some of the vaccines were administered but did not had any more information, which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter. More
2835819 69 M NY 04/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 f95ys
Inappropriate schedule of product administration Inappropriate schedule of product administration
patient had first dose one year ago/late second dose; This non-serious case was reported by a pharma... patient had first dose one year ago/late second dose; 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 69-year-old male patient who received Herpes zoster (Shingrix) (batch number f95ys, expiry date 31-MAR-2027) for prophylaxis. Previously administered products included Shingrix (Patient had first dose one year ago). On 04-APR-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient had first dose one year ago/late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 04-APR-2025 Patient had 1 dose Shingrix 1 year ago and second dose on the day of reporting. Also asked how many doses does patient need of Shingrix if 2 dose given 1 year after 1st. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2835820 0.5 F MD 04/11/2025 HIBV
 SANOFI PASTEUR
Paralysis Paralysis
palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS; Initial information... palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS; Initial information received on 08-Apr-2025 regarding an unsolicited valid serious case received from a other health professional. This case involves a 6 months old female patient who had palsy-like" reaction at 6 months of age after receiving HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Jul-2024, the patient received a 0.5ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength, frequency-once, (lot number, expiry date-unknown) via unknown route in unknown administration site for Immunization. On an unknown date the patient developed a serious palsy-like" reaction at 6 months of age after receiving acthib and vaxelis (paralysis) (latency-6 months). Reportedly- The patient continues to see a neurologist since the adverse reaction. Caller didn't have any further information about current symptoms/treatment other than the patient sees a neurologist for ongoing problems. The patient received the products at another pediatrician's office, so the details of administration are limited. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. Seriousness Criteria- This event is assessed as medically significant.; Sender's Comments: Sanofi company comment dated 11-Apr-2025: This case involves a 6 months old female patient who had palsy-like" reaction at 6 months of age after receiving HIB (PRP/T) vaccine [ACT-HIB].Further information regarding regarding allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
2835821 NY 04/11/2025 IPV
 SANOFI PASTEUR
 W1C831M
No adverse event, Product storage error No adverse event, Product storage error
IPOL that was no longer viable was given to a patient after temperature excursion (with no reported ... IPOL that was no longer viable was given to a patient after temperature excursion (with no reported adverse event); Initial information received on 08-Apr-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 received IPV (VERO) [IPOL] which was no longer viable given to a patient after temperature excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect IPV (VERO) lot W1C831M,expiry date :18-Nov-2025 via unknown route in unknown administration site for Immunization which was no longer viable after temperature excursion (with no reported adverse event) (poor quality product administered) (latency: same day) Reportedly, Caller states that one their providers called previously to report a temperature excursion and some of the vaccines were not viable. She is calling to get information if they need to re-vaccinate the patient if the vaccine that was given were not viable. She states they had MENQUADFI, ACT-HIB, IPOL, QUADRACEL, PENTACEL, and TENIVAC but only MENQUADFI, QUADRACEL and IPOL were given to a patient after the excursion. 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.; Sender's Comments: US-SA-2025SA102586: US-SA-2025SA101723: More
2835822 25 F SC 04/11/2025 MEN
MMR
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
 U7852AB
No adverse event, Product preparation error; No adverse event, Product preparati... No adverse event, Product preparation error; No adverse event, Product preparation error More
vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined th... vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined the MENQUADFI with the MMR-II/administered this mixture to patient, with no reported adverse event; vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined the MENQUADFI with the MMR-II/administered this mixture to patient, with no reported adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to US-SA-2025SA105121 (Cluster case). This case involves a 25 years old female patient who experienced a vaccine mix-up" and that the Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] was beside the diluent for mmr-ii/mistakenly combined the menquadfi with the mmr-ii and the patient was administered this mixture, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Apr-2025, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot U7852AB , Expiry: 31-Oct-2025) (Strength: Standard) via intramuscular route in the left arm as immunization which was mistakenly mixed with Mmr ii as diluent, the menquadfi was beside the diluent for mmr-ii with no reported adverse event (product preparation error) (poor quality product administered) (Latency: same day). Reportedly, They said that these patients did not need MENQUADFI. Pharmacist said that patients did not report any adverse events. Action taken: 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.; Sender's Comments: US-SA-2025SA105121: More
2835823 65 F LA 04/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 TS525
TS525
Fatigue, Headache, Injection site erythema, Injection site swelling, Muscular we... Fatigue, Headache, Injection site erythema, Injection site swelling, Muscular weakness; Nausea More
Severe redness and swelling at injection site, nausea, fatigue, muscle weakness , severe HA. Severe redness and swelling at injection site, nausea, fatigue, muscle weakness , severe HA.
2835824 11 M IN 04/11/2025 UNK
 UNKNOWN MANUFACTURER
 7GF79
Injection site erythema, Injection site inflammation, Injection site warmth, Pyr... Injection site erythema, Injection site inflammation, Injection site warmth, Pyrexia More
Left arm vaccination site 8x6 inches - warm to the touch, hard, red and inflammed. Fever experienced... Left arm vaccination site 8x6 inches - warm to the touch, hard, red and inflammed. Fever experienced 4/10/25. More
2835825 40 M ND 04/11/2025 HEPA
 MERCK & CO. INC.
 Y008338
Underdose Underdose
Pediatric dose of Vaqta (0.5 ml IM) administered to an adult patient. Pt will be recalled to receive... Pediatric dose of Vaqta (0.5 ml IM) administered to an adult patient. Pt will be recalled to receive correct dose. More
2835826 0.25 F IN 04/11/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 ln8272
946627
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
dose was given to soon before the right age. Patient made aware of it as soon as it happened and has... dose was given to soon before the right age. Patient made aware of it as soon as it happened and has not reported any adverse physical events. More
2835827 72 F FL 04/11/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LX4482
l5229
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Administered Prevnar 20 dose 4/7/2025 when patient had been vaccinated 11/08/2023, outside of CDC gu... Administered Prevnar 20 dose 4/7/2025 when patient had been vaccinated 11/08/2023, outside of CDC guideline. More
2835828 1.42 M 04/11/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Peripheral swelling Peripheral swelling
Diffuse limb swelling. Entire thigh where vaccine was injected. Diffuse limb swelling. Entire thigh where vaccine was injected.
2835829 51 M DC 04/11/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00017
Extra dose administered Extra dose administered
Vaccine was given on March 17th, ten days past beyond use date. Vaccine had been stored at frozen, ... Vaccine was given on March 17th, ten days past beyond use date. Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C. Eight weeks of eligible use in the fridge ended on March 7th. Patient did not report any adverse events related this to this vaccine administration. Revaccination was offered to patient and he is considering it. More
2835830 12 F VA 04/11/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Y012865
U8369BA
2B723
Malaise, Pallor; Malaise, Pallor; Malaise, Pallor Malaise, Pallor; Malaise, Pallor; Malaise, Pallor
Approximately 5 min after receiving 3 vaccinations, student appeared pale in the face, leaning forwa... Approximately 5 min after receiving 3 vaccinations, student appeared pale in the face, leaning forward in her chair, stated feeling sick. RN vaccinated stayed with patient and called for assistance. Post-vac RN and another RN assisted student, obtained BP 98/72, oxygen level 99%, 61HR. Student vomited, small amount, while sitting on chair, able to still follow commands, oriented x3. Student rested at the station for about 5 more minutes, wheelchair was brought and student escorted to nurse station for further monitoring. School nurse contacted student's parents to notify them of situation. No known prior reaction to vaccinations or medical conditions on record. Patient denied any chance of pregnancy, confirmed no known allergies. Student denied having any breakfast prior to receiving vaccinations. More
2835831 47 F OH 04/11/2025 MMR
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y011484
3BH5K
Hypoaesthesia; Hypoaesthesia Hypoaesthesia; Hypoaesthesia
patient states that in March of 2025 she began feeling numbness to her feet that then went up to her... patient states that in March of 2025 she began feeling numbness to her feet that then went up to her legs and eventually her waist which prompted her to visit the ER, she states she was in the hospital for some time and now she is following with a neurologist she states she is unsure if it could be the vaccine but her doctors wanted to know what ones she got the day she was here. More
โœ“ โœ“
2835832 33 M DC 04/11/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00017
Expired product administered, No adverse event Expired product administered, No adverse event
Vaccine was given on March 11th, four days past beyond use date. Vaccine had been stored at frozen,... Vaccine was given on March 11th, four days past beyond use date. Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C. Eight weeks of eligible use in the fridge ended on March 7th. Patient did not report any adverse events related this to this vaccine administration. Revaccination was offered to patient and he is considering it. More
2835833 21 F PA 04/11/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00017
Expired product administered, No adverse event Expired product administered, No adverse event
Vaccine was given on March 10th, three days past beyond use date. Vaccine had been stored at frozen... Vaccine was given on March 10th, three days past beyond use date. Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C. Eight weeks of eligible use in the fridge ended on March 7th. Patient did not report any adverse events related this to this vaccine administration. Revaccination was offered to patient and she was revaccinated on 3/26/2025. More
2835834 16 F 04/11/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS

Urticaria; Urticaria Urticaria; Urticaria
hives located on the arm of which patient received the immunizations and spread to face hives located on the arm of which patient received the immunizations and spread to face
2835835 24 F DC 04/11/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00017
Expired product administered, No adverse event Expired product administered, No adverse event
Vaccine was given on March 11th, four days past beyond use date. Vaccine had been stored at frozen,... Vaccine was given on March 11th, four days past beyond use date. Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C. Eight weeks of eligible use in the fridge ended on March 7th. Patient did not report any adverse events related this to this vaccine administration. Revaccination was offered to patient and she declined. More
2835836 72 F WA 04/11/2025 COVID19
 MODERNA
 3044079
Underdose Underdose
PATIENT WAS GIVEN THE PEDIATRIC FORMULATION OF THE COVID VACCINE. PATIENT WAS CONTACTED TO OFFER THE... PATIENT WAS GIVEN THE PEDIATRIC FORMULATION OF THE COVID VACCINE. PATIENT WAS CONTACTED TO OFFER THE CORRECT FORMULATION BUT PATIENT DENIED THE CORRECT VACCINE AT THIS TIME AND STATES THEY WILL RECEIVE IT NEXT YEAR. More
2835837 39 M MD 04/11/2025 SMALLMNK
 BAVARIAN NORDIC
 FDP00017
Expired product administered, No adverse event Expired product administered, No adverse event
Vaccine was given on March 10th, three days past beyond use date. Vaccine had been stored at frozen... Vaccine was given on March 10th, three days past beyond use date. Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C. Eight weeks of eligible use in the fridge ended on March 7th. Patient did not report any adverse events related this to this vaccine administration. Revaccination was offered to patient and he is considering it. More
2835838 1 M MD 04/11/2025 HEPA
HEPA
MMR
MMR
PNC20
PNC20
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 Y015027
Y015027
Y008592
Y008592
LK6651
LK6651
Y007176
Y007176
Culture throat negative, Influenza virus test negative, Pyrexia, Rash, Respirato... Culture throat negative, Influenza virus test negative, Pyrexia, Rash, Respiratory tract congestion; SARS-CoV-2 test negative, Streptococcus test negative; Culture throat negative, Influenza virus test negative, Pyrexia, Rash, Respiratory tract congestion; SARS-CoV-2 test negative, Streptococcus test negative; Culture throat negative, Influenza virus test negative, Pyrexia, Rash, Respiratory tract congestion; SARS-CoV-2 test negative, Streptococcus test negative; Culture throat negative, Influenza virus test negative, Pyrexia, Rash, Respiratory tract congestion; SARS-CoV-2 test negative, Streptococcus test negative More
Fever and congestion started 3/23/25 100.5F. He had PET placed monday 3/24/25. That evening he spike... Fever and congestion started 3/23/25 100.5F. He had PET placed monday 3/24/25. That evening he spiked fever 102.8F, up to 104.1F Tuesday 3/25/25. He was seen in office Wednesday 3/26/25 after having a fever 102.6. He had a rapid strep that was negative, throat culture ended up resulting negative as well. Rash developed as small red dots on back of neck/upper back on Wednesday. Thursday 3/27/25 the rash spread to his face - small red dots. Persistent fever 103.5F that day. The rash spread down over chest, back, torso and he developed red watery eyes. He was very fatigued, not eating well with decreased urine output. Then on Friday 3/28/25 he had a fever 102F and returned to office. In office rapid covid-19 and flu swabs were negative. Due to concerning timeline of rash, Measles oropharyngeal PCR and serum IgM were sent. The rash reached its peak on Saturday 3/29/25 which was his last day of fever 101F. On Monday 3/31/25 his measles PCR resulted positive, which was sent to the state health department who ran genotype testing and determined that it was vaccine type (not wild type measles virus) and the IgM resulted negative. His rash began to improve after 3/31/25. More
2835839 50 F NC 04/11/2025 PNC20
UNK
 PFIZER\WYETH
UNKNOWN MANUFACTURER

Cellulitis, Injection site pain, Injection site swelling, Injection site warmth,... Cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia; Cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia More
Cellulitis-like reaction in the left arm near the bicep appearing approximately 24 hours post-vaccin... Cellulitis-like reaction in the left arm near the bicep appearing approximately 24 hours post-vaccination measuring approximately 8 inches by 4 inches in size, raised, hot to the touch, sore to the touch. Still present 48 hours after vaccination (when this report was submitted); mild fever ~12 hours post-vaccination resolving after 8 hours. More
2835840 64 M ND 04/11/2025 MMR
PNC20
 MERCK & CO. INC.
PFIZER\WYETH
 X019107
LX2497
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient came into facility for MMR vaccine. Review of his forecast done with a fellow staff, reviewe... Patient came into facility for MMR vaccine. Review of his forecast done with a fellow staff, reviewed that he could receive Zoster and was up to date on PCV. Misinterpreted the communication and thought she had said that he needed the PCV vaccine. Patient last received the PCV vaccine in December 2024. Patient was notified. Medical director notified as well. More
2835841 63 F 04/11/2025 PPV
 MERCK & CO. INC.
Injection site rash, Lymphadenopathy, Nausea Injection site rash, Lymphadenopathy, Nausea
Rash from injection site to the elbow, Axillary lymph node enlargement, Nausea Rash from injection site to the elbow, Axillary lymph node enlargement, Nausea
๐Ÿ“‹ Privacy Policy & Data Disclaimer