🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2835503 04/10/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Extra dose administered, Herpes zoster, Pain; Extra dose administered, Herpes zo... Extra dose administered, Herpes zoster, Pain; Extra dose administered, Herpes zoster, Pain More
had the first shingles shot, but got the shingles/second time all over my head, near my eye; patient... had the first shingles shot, but got the shingles/second time all over my head, near my eye; patient received 3 doses of shingles vaccine; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had the first shingles shot, but got the shingles/second time all over my head, near my eye) and extra dose administered (Verbatim: patient received 3 doses of shingles vaccine). The outcome of the shingles was not reported and the outcome of the extra dose administered was not applicable. 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: 03-APR-2025 This case was reported by a patient via interactive digital media. Patient had the first shingles shot, but got the shingles, later the doctor said the first shot was no good. Patient got the shingles second time all over head, near eye. They were very, very painful. Patient then got next two shots, that were suppose to be good ones, thank goodness. Patient had 3 doses of shingles vaccine which led to extra dose administered. The follow-up could not be possible as no contact details were available. More
2835504 AL 04/10/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 9YB4G
Product storage error Product storage error
Boostrix stored at 33.8F for 16hrs 45 mins/ Boostrix used in patients since excursion; This non-seri... Boostrix stored at 33.8F for 16hrs 45 mins/ Boostrix used in patients since excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number 9YB4G, expiry date 20-NOV-2026) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix stored at 33.8F for 16hrs 45 mins/ Boostrix used in patients since 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: 28-MAR-2025 The HCP (health care professional) requested stability data for Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at 33.8F for 16 hours and 45 mins. No prior excursions and Boostrix used in patients since excursion, which led to an incorrect storage of drug. More
2835505 62 M IL 04/10/2025 COVID19
 MODERNA
 031L or 220A
Influenza, Psoriasis Influenza, Psoriasis
skin condition/his hands are very dry and crack/The hands are painful/they're like open sores/,... skin condition/his hands are very dry and crack/The hands are painful/they're like open sores/, they were diagnosing it as some kind of uh. You know, psoriasis; I was sick with the flu; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (skin condition/his hands are very dry and crack/The hands are painful/they're like open sores/, they were diagnosing it as some kind of uh. You know, psoriasis) and INFLUENZA (I was sick with the flu) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L or 220A, 002A21A and 939904) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIASIS (skin condition/his hands are very dry and crack/The hands are painful/they're like open sores/, they were diagnosing it as some kind of uh. You know, psoriasis) and INFLUENZA (I was sick with the flu). The patient was treated with Paraffin (Vaseline) for Psoriasis, at an unspecified dose and frequency. At the time of the report, PSORIASIS (skin condition/his hands are very dry and crack/The hands are painful/they're like open sores/, they were diagnosing it as some kind of uh. You know, psoriasis) and INFLUENZA (I was sick with the flu) had not resolved. No vaccines in the past 4 weeks prior to having the second dose when his side effects had started with which he was diagnosed with Psoriasis. Patient had taken Pfizer vaccine as the 5th dose for product use for unknown indication. Concomitant product use was not provided by the reporter. It's been going on for a few years, patient had Moderna, the booster shot, shortly thereafter patient got a skin condition, and it was continuing and went to dermatologist, gone to the wound care unit. Patient had spent a lot of money and still had this condition. His hands were very dry and crack. The hands were painful. He added it started on his foot, and he still had remnants of dryness of the feet occasionally. But in the hands, when looking at them, they're like dry and cracking and they're like open sores. He went to the dermatologist as he was trying to figure out his condition, they gave different creams and this that and the other thing, they were diagnosing it as some kind of psoriasis or some kind of skin condition, but everything that they tried did not work. Patient tried so many different lotions. Patient put on A lotion and then he put on Vaseline and put gloves on every night because it's just painful and that that helps because it at least takes away the dryness and it, it kind of closes up the wounds a little bit and got some relief. He was then given a lotion which gave him some relief but it's not going away. The only thing that the patient did about every two months was patient got one of those steroids, Z packs or whatever, 6, the first day, 5, the next day 4, whatever it was. Patient found that out by accident because patient took it. Patient was sick with the flu, and they had given that. Patient put it together like when the patient did the steroids on the hands clear up that's the only thing that done anything and was not going back to the wound care unit. There was no X-rays, no blood tests, nothing, just talking and then 2 weeks later he went for a follow up to the wound care unit. There was a different wound care unit and the follow up was closer to his home and same thing and gave him a prescription to for what the patient had before. His side effects started since receiving the first booster. He also added that he visited his dermatologist in 2022 but seems unsure and stated it's his guess. He visited the wound care unit in 2023 or 2024. He confirmed he hadn't spent a lot of time with his primary care physician in reference to his current condition but was prescribed some lotion that didn't work either. The patient did not experience any additional symptoms/events. Reporter causality was not reported. More
2835539 65 M OK 04/10/2025 HPV9
 MERCK & CO. INC.
 Y014510
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse effects; 65 year-old male received Gardasil 9; This spontaneous report was received from ... No adverse effects; 65 year-old male received Gardasil 9; This spontaneous report was received from a Licensed Nurse and refers to a 65-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-Feb-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y014510, expiration date: 01-Nov-2026) for prophylaxis (product administered to a patient of inappropriate age). No adverse event was reported. More
2835540 F CO 04/10/2025 HIBV
HIBV
 MERCK & CO. INC.
MERCK & CO. INC.
Y005457
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; HCP called to report a 17-year-old patient received a dose of PEDVAX HIB. HCP ver... No additional AE; HCP called to report a 17-year-old patient received a dose of PEDVAX HIB. HCP verified patient was previously vaccinated 11/01/2007; This spontaneous report was received from a Physician Assistant and refers to a 17-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 01-NOV-2001, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (dose, route of administration, vaccination scheme frequency, anatomical site of injection, lot number and expiration date were not reported). On 04-APR-2025, when the patient was 17-years-old, she was vaccinated with a second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Injection 0.5 mL, (lot number Y005457 has been verified to be valid for Haemophilus b Conjugate Vaccine [Meningococcal Protein Conjugate] [LIQUID PEDVAX HIB], expiration date 06-NOV-2026; route of administration, vaccination scheme frequency and anatomical site of injection were not provided); both doses were administered as prophylaxis (Inappropriate schedule of product administration). No additional adverse event was reported for the patient. More
2835541 M TX 04/10/2025 UNK
VARCEL
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
Y002061
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; HCP called to report one patient received VARIVAX after improperly stored. Np side... No Additional AE; HCP called to report one patient received VARIVAX after improperly stored. Np side effects or symptoms reported. No additional information provided. No Additional AE/ No PQC.; This spontaneous report was received from the nurse regarding 22-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-Apr-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lyophilisate and solvent for solution for injection 0.5 mL, lot#Y002061 (expiration date: 09-JAN-2026), along with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not reported) as prophylaxis after being improperly stored (product storage error). Np side effects or symptoms were reported. No additional information was provided. No additional adverse event (AE) was reported. More
2835542 1 F VA 04/10/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Rash, Rash erythematous; Rash, Rash erythematous Rash, Rash erythematous; Rash, Rash erythematous
the rash as "red, raised, not fluid-filled, and maculopapular" which started on the chest ... the rash as "red, raised, not fluid-filled, and maculopapular" which started on the chest and now has spread to the face and groin area; HCP stated that she believes the rash is measles; This spontaneous report was received from a physician and refers to a 12-month-old female patient. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On 25-MAR-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), both vaccines reconstituted with sterile diluent (BAXTER STERILE DILUENT) (strengths, dose descriptions, lot #s and expiration dates were not reported) for Routine vaccination. On 08-APR-2025, the patient experienced red, raised, not fluid-filled, and maculopapular rash which started on the chest and now has spread to the face and groin area, then the patient was taken to the emergency room on 08-APR-2025 and was treated with Vaseline, but was not admitted to the hospital. The patient then had an appointment with the reporting HCP on 09-APR-2025 and HCP stated that she believes the rash is measles. At the reporting time, the patient had not recovered from events. The causal relationship between the events and the suspect vaccines and its constituents was not provided. Lot# would be submitted upon request. More
2835543 39 F PA 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
COVID-19, Herpes zoster, Product administered to patient of inappropriate age COVID-19, Herpes zoster, Product administered to patient of inappropriate age
COVID-19; currently has shingles now, APR 2025; Shingles NOV 2024; Shingles MAR 2024; Shingles Mild ... COVID-19; currently has shingles now, APR 2025; Shingles NOV 2024; Shingles MAR 2024; Shingles Mild case in OCT-2023; 39 year old patient her first dose of Shingrix in June 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 39-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles 11 times with the first time at 19 years old). In JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 year old patient her first dose of Shingrix in June 2023). In OCT-2023, the patient experienced shingles (Verbatim: Shingles Mild case in OCT-2023). In MAR-2024, the patient experienced shingles (Verbatim: Shingles MAR 2024). In NOV-2024, the patient experienced shingles (Verbatim: Shingles NOV 2024) and covid-19 (Verbatim: COVID-19). In APR-2025, the patient experienced shingles (Verbatim: currently has shingles now, APR 2025). The patient was treated with aciclovir sodium (Acyclovir). In NOV-2024, the outcome of the covid-19 was resolved. The outcome of the shingles, shingles and shingles were not reported and the outcome of the shingles was not resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the shingles, shingles, shingles, shingles and covid-19 to be related to Shingrix. It was unknown if the company considered the shingles, shingles, shingles, shingles and covid-19 to be related to Shingrix. Additional Information: GSK Receipt Date: 04-APR-2025 The patient self-reported this case. The patient received her first dose of Shingrix in June 2023 (no specific date provided) and she never received her second dose. The patient had shingles four times since receiving her first dose of Shingrix at the following times in October 2023 (Mild case), March 2024, November 2024 and she currently had shingles now in April 2025. The patient last two times she had shingles in March 2024 and November 2024 were the worst she ever had it. The patient had shingles 11 times in her life, with the first time when she was 19 years old. The patient stated that all four cases of shingles since her first dose of Shingrix presented on the right side of her tailbone or butt area and she took Acyclovir in November 2024 for her shingles outbreak because she also had COVID at that time (no specific dates provided). The patient states the Acyclovir made her nauseous and was so she no longer took antivirals for her shingles outbreaks The patient received 1st dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration. More
2835544 84 F CO 04/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Erythema, Rash, Skin warm, Tenderness Erythema, Rash, Skin warm, Tenderness
Tenderness/ her arm was tender to the touch; Redness; Skin warm/ her arm was warm to the touch; had ... Tenderness/ her arm was tender to the touch; Redness; Skin warm/ her arm was warm to the touch; had a rash around the area; her temperature increased by 1 degree; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 05-APR-2025, the patient received Arexvy. On 06-APR-2025, 1 days after receiving Arexvy, the patient experienced pain in arm (Verbatim: Tenderness/ her arm was tender to the touch), erythema (Verbatim: Redness), skin warm (Verbatim: Skin warm/ her arm was warm to the touch) and rash (Verbatim: had a rash around the area). In APR-2025, the patient experienced body temperature increased (Verbatim: her temperature increased by 1 degree). The outcome of the pain in arm, erythema and skin warm were not resolved and the outcome of the rash and body temperature increased were not reported. It was unknown if the reporter considered the pain in arm, erythema, skin warm, rash and body temperature increased to be related to Arexvy. It was unknown if the company considered the pain in arm, erythema, skin warm, rash and body temperature increased to be related to Arexvy. Additional Information: GSK Receipt Date: 07-APR-2025 The patient self reported this case for herself. The patient had taken the Arexvy vaccine on Saturday, 5th April 2025, at the pharmacy. She had noticed the following day, on Sunday, 6th April 2025, that her arm was tender to the touch, warm to the touch, and had developed a rash around the area. She had been planning to follow up with her doctor and had wanted to report the events. She had mentioned that her temperature had increased by 1 degree. More
2835545 04/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Fatigue, Headache Fatigue, Headache
headache; fatigue; This non-serious case was reported by a consumer via interactive digital media an... headache; fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache 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 headache (Verbatim: headache) and fatigue (Verbatim: fatigue). The outcome of the headache and fatigue were resolved (duration 3 days). It was unknown if the reporter considered the headache and fatigue to be related to Shingles vaccine. It was unknown if the company considered the headache and fatigue 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 patient said vaccine knocked him/her for a loop twice: headache and fatigue for three days. But compared to the infection patient felt worth it. More
2835546 73 NH 04/10/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Product preparation issue Product preparation issue
Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient; Aplisol ... Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient; Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of wrong solution used in drug reconstitution in a 73-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included tuberculin ppd (Aplisol) for product used for unknown indication. On 06-MAR-2025 11:30, the patient received Menveo (intramuscular, unknown deltoid) and Aplisol (intramuscular) .1 ml. On 06-MAR-2025 11:30, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient) and inappropriate dose of vaccine administered (Verbatim: Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 01-APR-2025 A spontaneous report was received from a nurse practitioner, concerning a 73 year old patient of an unknown gender, who experienced product preparation error, product administration error and incorrect route of product administration while using Aplisol for an unknown indication. Medical history and concomitant medications were not reported. On 06th March 2025 at 11:30 hour, the patient started Aplisol single dose via an intramuscular (IM) route in the deltoid (unknown dose). Co suspect medication included Menveo (meningococcal vaccine) via the IM route in the deltoid at an unknown dose and frequency, which was initiated on 06th March 2025 at 11:30 hour. It was reported that Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient. At the time of this report, the action taken with Aplisol and Menveo was not applicable. The outcome of the events of product preparation error, product administration error and incorrect route of product administration was recovered. More
2835547 04/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Stress, Vaccination failure Herpes zoster, Stress, 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. Family history included shingles (patient's father had it for 4 years), emotional distress (too much), neuropathy (destroyed for 30 years after recovery, meditation, relaxation was ticket out of the cycle) and death (patient's mother died). 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 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 and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 03-APR-2025 The patient had discovered he/she get shingles very mild if he/she put his/her body in stress mode such as too much exercise or emotional stress. The patient had the Shingles vaccine in 2019. It would be a lot worse if patient did not have the Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary 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 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
2835548 F 04/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Immediate post-injection reaction Herpes zoster, Immediate post-injection reaction
took the shot and shortly afterwards got shingles; This non-serious case was reported by a consumer ... took the shot and shortly afterwards got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: took the shot and shortly afterwards got shingles). The outcome of the shingles was not reported. 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: 03-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that his/her sister took the shot and shortly afterwards got shingles. More
2835549 04/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise, Nausea, Pain Malaise, Nausea, Pain
Bodyaches; Nausea; This non-serious case was reported by a consumer via interactive digital media an... Bodyaches; Nausea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Bodyaches) and nausea (Verbatim: Nausea). The outcome of the general body pain and nausea were not reported. It was unknown if the reporter considered the general body pain and nausea to be related to Shingles vaccine. It was unknown if the company considered the general body pain and nausea 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 second dose made the patient so sick with body aches and nausea but still worth it. More
2835550 04/10/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Inappropriate schedule of product administration, Vaccination fai... Herpes zoster, Inappropriate schedule of product administration, Vaccination failure; Herpes zoster, Inappropriate schedule of product administration, Vaccination failure More
took booster dose and stil got shingles/ suspected vaccination failure; had the original and several... took booster dose and stil got shingles/ suspected vaccination failure; had the original and several decades later a booster; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: took booster dose and stil got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and drug dose administration interval too long (Verbatim: had the original and several decades later a booster). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 3 days) and the outcome of the drug dose administration interval too long was not applicable. 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: 02-APR-2025 This case was reported by a patient via interactive digital media. Patient had the original and several decades later a booster shingles vaccine and still got shingles, but it was less severe and cleared in about 3 days. The patient received 2nd dose of Shingles vaccine later than the recommended schedule, which led to lengthening of vaccination schedule. This case was considered as suspected vaccination failure as details regarding completion 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 time to onset for shingles, completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1& 2). More
2835551 04/10/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Vision blurred; He... Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Vision blurred; Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Vision blurred More
my vision is blurry in my right eye; Suspected vaccination failure; shingles including my eye; On th... my vision is blurry in my right eye; Suspected vaccination failure; shingles including my eye; On the right side of my head had 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. 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. In DEC-2024, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles including my eye) (serious criteria GSK medically significant) and shingles (Verbatim: On the right side of my head had shingles). On an unknown date, the patient experienced blurred vision (Verbatim: my vision is blurry in my right eye). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported and the outcome of the blurred vision was not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and blurred vision to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and blurred vision to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 03-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Patient had received the two shot vaccine four years earlier and developed shingles in December 2024. The shingles affected the right side of his/her head, including his/her eye. By April 2025, his/her vision in the right eye remained blurry, and he/she were still on medication. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and ophthalmic herpes zoster and laboratory confirmation regarding shingles and ophthalmic herpes zoster 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2835552 F TN 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
was sick and after dose 1 of Shingrix; did not feel well; This non-serious case was reported by a n... was sick and after dose 1 of Shingrix; did not feel 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 the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: was sick and after dose 1 of Shingrix) and feeling unwell (Verbatim: did not feel 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 patient had been vaccinated with Shingrix. The patient was sick and did not feel well after dose 1 of Shingrix. She did get the 2nd dose of Shingrix vaccine. It is unknown if that dose also made her feel bad. More
2835553 04/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
deathly sick; This non-serious case was reported by a consumer via interactive digital media and des... deathly sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles). On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: deathly sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness 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 was deathly sick from the first dose of Shingles vaccine, did not get the second . The patient had shingles when was 20 and it was awful. The second time was very mild. More
2835554 04/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Nerve injury, Vaccination failure Herpes zoster, Nerve injury, Vaccination failure
Suspected vaccination failure; Shingles; 2nd outbreak has left residual nerve damage; This serious c... Suspected vaccination failure; Shingles; 2nd outbreak has left residual nerve damage; 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 shingles (1st time). 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: Shingles) and nerve damage (Verbatim: 2nd outbreak has left residual nerve damage). The outcome of the vaccination failure, shingles and nerve damage were not reported. It was unknown if the reporter considered the vaccination failure, shingles and nerve damage 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 nerve damage 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. Believed every bad and shocking thing had heard about shingles. Some people were more susceptible and harder hit than others, but shingles did not play. It could affect skin and organs even your eyes. Affliction during and after could both be mild his/her 1st time or nightmare his/her second time Yes he/she got the new Shingles shot. The 2nd outbreak has left residual nerve damage . He/she will not took the Covid shots never got Covid by the way but gladly took the shingles shot. It lessened the second episode and he/she believed had prevented a third eruption. If they were over 50 do yourself a big favour and check out the preventative vaccine. 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
2835555 04/10/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Axillary pain, Breast pain, Herpes zoster, Pruritus, Vaccination failure; Axilla... Axillary pain, Breast pain, Herpes zoster, Pruritus, Vaccination failure; Axillary pain, Breast pain, Herpes zoster, Pruritus, Vaccination failure More
Suspected vaccination failure; had 2 shingles vaccines and shingles 2 times also /Under right arm st... Suspected vaccination failure; had 2 shingles vaccines and shingles 2 times also /Under right arm still hurts and under right breast/ back still itches; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 2 shingles vaccines and shingles 2 times also /Under right arm still hurts and under right breast/ back still itches). The patient was treated with pregabalin (Lyrica). 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 and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 03-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had two Shingles vaccines and shingles 2 times also. The patient reported it to be under his/her right arm still hurts and under right breast. The patient reported that his/her back still itches like crazy. The patient took Lyrica for pain. 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, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2835556 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Chills, Pain in extremity Chills, Pain in extremity
few chills later in day; arm being sore; This non-serious case was reported by a consumer via intera... few chills later in day; arm being 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. 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 in arm (Verbatim: arm being sore) and chills (Verbatim: few chills later in day). The outcome of the pain in arm was resolved (duration 1 day) and the outcome of the chills was resolved. It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix. It was unknown if the company considered the pain in arm and chills to be related to Shingrix. Additional Information: GSK Receipt Date: 03-APR-2025 The patient just got first dose of shingrix and would go for the 2nd dose in May. The patient had heard that the shingles are awful so he/she got the vaccine. The patient have had no problem with vaccine other than arm being sore and had a few chills later in day. But chills didn't last long and soreness in arm gone after a day. More
2835557 04/10/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Blindness unilateral, Blister, Deafness unilateral, Diarrhoea, Discoloured vomit... Blindness unilateral, Blister, Deafness unilateral, Diarrhoea, Discoloured vomit; Herpes zoster, Loss of personal independence in daily activities, Vaccination failure More
suspected vaccination failure; lost sight in my right eye; throwup yellowstuff and had runs now I ha... suspected vaccination failure; lost sight in my right eye; throwup yellowstuff and had runs now I had them; lost sight in my right eye and right ear; it has took my life away from me; 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), loss of vision (Verbatim: lost sight in my right eye) (serious criteria GSK medically significant), shingles (Verbatim: throwup yellowstuff and had runs now I had them), ear disorder (Verbatim: lost sight in my right eye and right ear) and activities of daily living impaired (Verbatim: it has took my life away from me). The outcome of the vaccination failure and activities of daily living impaired were not reported and the outcome of the loss of vision and ear disorder were not resolved and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure, loss of vision, shingles, ear disorder and activities of daily living impaired to be related to Shingles vaccine. The company considered the vaccination failure and loss of vision to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, ear disorder and activities of daily living impaired to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-APR-2025 The case was received from the patient via interactive digital media. The patient was been told he/she need to get Shingles shots so he/she did and was so sick he/she did not know if make it home. The patient was throw up yellow stuff and had runs now, had them (shingles) for 5 years they had destroyed body as they never came out. He/she lost sight in my right eye and right ear plus spent a lot of money on physician, the patient stated he/she on medication for them. A few blisters would come out and go away for two years. The patient cannot go anywhere because mess herself/himself and did not know when it happened it just running yellow stuff it has took life away from he/she. This case was considered as suspected vaccination failure as details regarding completion of primary 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. Blindness is an unlisted event which is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR041581:Same reporter/ Diferent patient More
2835558 04/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
sore arm; This non-serious case was reported by a consumer via interactive digital media and describ... sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included varicella zoster vaccine with an associated reaction of pain in extremity. Family history included shingles (sister had shingles) and depression (sister had depression). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR037979 Additional Information: GSK Receipt Date: 27-MAR-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 a sore arm from the shot, also stated that shingles can last for years for some people. For tolerance of first dose refer case US2025AMR037979.; Sender's Comments: US-GSK-US2025AMR037979: More
2835559 04/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
I got the first vaccine and got shingles back within a couple days; This non-serious case was report... I got the first vaccine and got shingles back within a couple days; 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. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got the first vaccine and got shingles back within a couple days). The outcome of the shingles was not reported. 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: 05-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that doctor would not allow to get the vaccine as they have never fully gone away the reporter got the first vaccine and got shingles back within a couple days. More
2835560 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I received one shot three years ago. Is it too late for the second dose; This non-serious case was r... I received one shot three years ago. Is it too late for 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 shot three 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 received one shot three years ago. Is it too late for the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 05-APR-2025 The patient self-reported this case. The patient received one shot three years ago and asked was it too late for the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination More
2835561 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal Feeling abnormal
made me feel horrible for 2-3; This non-serious case was reported by a consumer via interactive digi... made me feel horrible for 2-3; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included post herpetic neuralgia (had it in my sciatic nerve when patient was 23, the post heretic neuralgia lasted about 6 months). 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 feeling bad (Verbatim: made me feel horrible for 2-3). The outcome of the feeling bad was resolved (duration 3 days). It was unknown if the reporter considered the feeling bad to be related to Shingrix. It was unknown if the company considered the feeling bad to be related to Shingrix. Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had it in my sciatic nerve when he/she was 23. The post heretic neuralgia lasted about 6 months. It was awful. As soon as I could get the vaccine I did and even though it made me feel horrible for 2-3, I did not hesitate to get the 2nd dose. I did not ever want to have shingles again. More
2835562 M 04/10/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspeceted vaccination failure; got the vaccine and he got a small version of shingles; This serious... Suspeceted vaccination failure; got the vaccine and he got a small version of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the vaccine and he got a small version of shingles). 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-APR-2025 This case was reported by a consumer via interactive digital media. The patient wife reported that her husband got the vaccine, and he got a small version of shingles he did not even remember if he ever had chicken pox when he was a kid, or not. 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 vaccine schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2835563 69 F PA 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 74NC9
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late second dose; This non-serious case was reported by a pharmacist via call center representative ... 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 female patient who received Herpes zoster (Shingrix) (batch number 74NC9, expiry date 13-NOV-2026) for prophylaxis. Previously administered products included Shingrix (Patient had first dose in 30-AUG-2023 with batch number 2GG34 and expiry date 21-AUG-2024). On 09-JAN-2025, the patient received the 2nd dose of Shingrix. On 09-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 27-MAR-2025 Patient got their first dose of Shingrix on August 30th 2023 and a late second dose on January 9th 2025, and patient was recommended to restart the series. Patient did not tell her anything about being immunocompromised. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2835564 11 M CO 04/10/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 HR4RB
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
11-year-old patient received an adult dose of Havrix this morning; 11-year-old patient received an a... 11-year-old patient received an adult dose of Havrix this morning; 11-year-old patient received an adult dose of Havrix this morning; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 11-year-old male patient who received HAV (Havrix 1440 adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis. On 31-MAR-2025, the patient received the 1st dose of Havrix 1440 adult. On 31-MAR-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: 11-year-old patient received an adult dose of Havrix this morning) and overdose (Verbatim: 11-year-old patient received an adult dose of Havrix this morning). The outcome of the adult product administered to child and overdose 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: 31-MAR-2025 Other Health Professional stated an 11-year-old patient received an adult dose of Havrix this morning, which led to Adult product administered to child and overdose. It was the first dose for the patient. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. More
2835565 16 M AL 04/10/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product preparation issue Product preparation issue
inappropriate reconstitution technique; received only the diluent portion of Menveo; This non-seriou... inappropriate reconstitution technique; received only the diluent portion of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 30-SEP-2024, the patient received Menveo. On 30-SEP-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: received only the diluent portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 31-MAR-2025 The registered nurse reported that a patient received only the diluent portion of Menveo (two vial), which led to an inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter wanted to know what they need to do. More
2835566 VT 04/10/2025 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. This case was linked with US2025AMR044125, reported by same reporter for a different female patients.; Sender's Comments: US-GSK-US2025AMR044125:same reporter different patient More
2835567 M TX 04/10/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 223Y9
Circumstance or information capable of leading to medication error, Incorrect do... Circumstance or information capable of leading to medication error, Incorrect dose administered More
A 2 years old male patient received Infanrix and when administering the dose the patient pulled away... A 2 years old male patient received Infanrix and when administering the dose the patient pulled away the syringe so he received an incomplete dose of Infanrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 2-year-old male patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis. On an unknown date, the patient received the 1st dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incomplete dose administered (Verbatim: A 2 years old male patient received Infanrix and when administering the dose the patient pulled away the syringe so he received an incomplete dose of Infanrix.). The outcome of the incomplete 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: 31-MAR-2025 On 31/MARCH/2025 a registered nurse called to report that a male patient received Infanrix and when administering the dose, the patient pulled away the syringe so the patient received an incomplete dose of Infanrix, which led to Incomplete dose administered. The series of Dtap vaccine that the patient has: 3 months, 7 months and 16 months. The patient was 2 years old now. Reporter wants to ask about should the patient receive a secondary dose or not Other Health Professional mentioned that she was ready to revaccinate the patient. The reporter consented to follow up. More
2835568 F OH 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
The patient recived first dose of Shingrix in 2021 and not recived second dose; This non-serious cas... The patient recived first dose of Shingrix in 2021 and not recived second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (the patient received first dose of in 2021). 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 incomplete course of vaccination (Verbatim: The patient recived first dose of Shingrix in 2021 and not recived second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 03-APR-2025 No personal information provided and no other information such as lot number, expiration date, patient's initials were provided. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. More
2835569 F MI 04/10/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 9M2R7
Extra dose administered Extra dose administered
patient received an extra dose of Menveo 1 year after her last dose.; This non-serious case was repo... patient received an extra dose of Menveo 1 year after her last dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9M2R7, expiry date 31-DEC-2025) for prophylaxis. On 03-APR-2025, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: patient received an extra dose of Menveo 1 year after her last dose.). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 04-APR-2025 The reporter reported that on 04 APRIL 2025 a Registered Medical Assistant called to report that yesterday on 3 April 2025 they administered an extra dose of Menveo to a 17 years 7 months old female patient, which led to extra dose administered. A year ago, was her last dose of Menveo on 1 April 2024, so the patient received the extra dose yesterday. Were there any side effects that would hurt the patient. More
2835570 18 F 04/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3T5L9
Expired product administered Expired product administered
Engerix-B - Administration of expired vaccine.; This non-serious case was reported by a nurse via ca... Engerix-B - Administration of expired vaccine.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis. On 03-APR-2025, the patient received Engerix B. On 03-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B - Administration of expired vaccine.). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 04-APR-2025 A nurse practitioner mentioned that the patient received an expired dose of Engerix-B, which led expired vaccine used. The reporter consented to follow up; Sender's Comments: US-GSK-US2025040983:same reporter/ Different patient US-GSK-US2025040985:same reporter/ Different patient More
2835571 43 F TX 04/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 9JG23
Expired product administered Expired product administered
Expired Dose Administered; This non-serious case was reported by a other health professional via cal... Expired Dose Administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HBV (Engerix B adult) (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis. On 04-APR-2025, the patient received Engerix B adult. On 04-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 04-APR-2025 Other HCP had a Hepatitis B vaccine that was given to an adult patient on the day of reporting and after it was given it was noticed that the vaccine had expired in February two months ago, so reporter was wondering what the protocol for that was. If there was like a window or anything. Patient received expired Engerix B, which led to expired vaccine used. More
2835572 41 F ND 04/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 H2B22
Underdose Underdose
Engerix-B two pediatric 10 micrograms doses to make one of 20 micrograms given to an adult; This non... Engerix-B two pediatric 10 micrograms doses to make one of 20 micrograms given to an adult; This non-serious case was reported by a physician via call center representative and described the occurrence of adult use of a child product in a 41-year-old female patient who received HBV (Engerix B pediatric) (batch number H2B22, expiry date 07-MAR-2026) for prophylaxis. On 04-APR-2025, the patient received Engerix B pediatric. On 04-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B two pediatric 10 micrograms doses to make one of 20 micrograms given to an adult). The outcome of the adult use of a child product 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: 04-APR-2025 A physician wanted to get information regarding giving two pediatric doses of Engerix-B to an adult, which led adult use of a child product. They first gave one pediatric dose and after realizing this, gave the second one to administer a total of 20 micrograms of Engerix-B. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. More
2835573 55 M TX 04/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 47XT4
Underdose Underdose
received pediatric dose of Engerix-B; received pediatric dose of Engerix-B; This non-serious case wa... received pediatric dose of Engerix-B; received pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 55-year-old male patient who received HBV (Engerix B Junior) (batch number 47XT4, expiry date 16-JUL-2026) for prophylaxis. On 04-APR-2025, the patient received Engerix B Junior. On 04-APR-2025, an unknown time after receiving Engerix B Junior, the patient experienced adult use of a child product (Verbatim: received pediatric dose of Engerix-B) and underdose (Verbatim: received pediatric dose of Engerix-B). The outcome of the adult use of a child product and underdose 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: 04-APR-2025 On 04th April 2025, a pharmacist called to inform that they had a patient, that earlier that day received pediatric dose of Engerix-B which led to adult use of child product and underdose. More
2835574 57 F AZ 04/10/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 4DS4N
Inappropriate schedule of product administration Inappropriate schedule of product administration
Twinrix late second dose; This non-serious case was reported by a pharmacist via call center represe... Twinrix 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 57-year-old female patient who received HAB (Twinrix) (batch number 4DS4N, expiry date 25-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received first dose of Twinrix on 04-OCT-2024). On 03-MAR-2025, the patient received the 2nd dose of Twinrix. On 03-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). 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: 07-APR-2025 The pharmacist reported that the patient received a first dose of Twinrix and then the second dose was given late. The Vaccine Administration Facility was the same as Primary Reporter. The patient received second dose of Twinrix longer than the recommended interval which led to lengthening of vaccination schedule. More
2835575 F TN 04/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
needs restart the series or if the patient just need one more dose; This non-serious case was report... needs restart the series or if the patient just need one more dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 27-JAN-2018 with batch number 1S534 and lot expiry 27-JAN-2019). 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: needs restart the series or if the patient just need one more dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 08-APR-2025 The pharmacist reported that a patient received one dose (Shingrix) in 2018, and requested information about whether the patient needs restart the series or if the patient just need one more dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2835576 63 M OH 04/10/2025 MMR
 MERCK & CO. INC.
 Y015020
Feeling abnormal, Loss of consciousness Feeling abnormal, Loss of consciousness
The patient received the vaccine and then a couple of minutes later said he felt 'funny' a... The patient received the vaccine and then a couple of minutes later said he felt 'funny' and he passed out. An epipen was administered and 911 was called. He was coherent and responding to ems when he was taken away. More
2835577 54 F 04/10/2025 MMR
 MERCK & CO. INC.
Injection site mass, Injection site swelling Injection site mass, Injection site swelling
Bump where vaccine was administered. Upper arm swollen, now resolved. Bump where vaccine was administered. Upper arm swollen, now resolved.
2835578 53 F GA 04/10/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Erythema, Migraine, Oropharyngeal discomfort, Pain of skin, Pyrexia; Vertigo Erythema, Migraine, Oropharyngeal discomfort, Pain of skin, Pyrexia; Vertigo
throat scratchy like closing, skin became red and sore to touch all over body, fever, vertigo, migra... throat scratchy like closing, skin became red and sore to touch all over body, fever, vertigo, migraine More
2835579 20 F CT 04/10/2025 HEP
HEP
 DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
 945660
945660
Cough, Influenza virus test negative, Lymphadenopathy, Mononucleosis heterophile... Cough, Influenza virus test negative, Lymphadenopathy, Mononucleosis heterophile test negative, SARS-CoV-2 test negative; Streptococcus test negative More
Patient woke up the next day following the vaccine administration with a swollen posterior cervical ... Patient woke up the next day following the vaccine administration with a swollen posterior cervical lymph node and a cough. Saw her PCP, tested for strep, covid, mono, and influenza which were all negative. Patient treated for URI and sinusitis with a course of abx. More
2835580 10 F NY 04/10/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 AE2J7
AE2J7
Blood test, Cyanosis, Fall, Hypoaesthesia, Loss of consciousness; Pallor Blood test, Cyanosis, Fall, Hypoaesthesia, Loss of consciousness; Pallor
Patient received flu immunization and then had blood work done in room. When patient was getting rea... Patient received flu immunization and then had blood work done in room. When patient was getting ready to leave the patient's room in health center patient stood up and told her mother" I don't feel my legs" and then started to fall. At this time the patient's mother called out for the doctor. Dr., LPN and MA went to patient's room and assisted with patient at 8:50 am. First 911 call was made at 8:50 am. Patient was on the floor, extremely pale skin, blue lips, and not conscious. BP within normal range, pulse within normal range, Oxygen was placed on patient. Patient was being spoke to which made her aware of her surroundings. alert and orientated to time and location. More
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2835581 82 F OH 04/10/2025 RSV
RSV
RSV
RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 255T2
255T2
255T2
255T2
255T2
Asthenia, Blood culture, Blood glucose, Blood lactic acid, Brain natriuretic pep... Asthenia, Blood culture, Blood glucose, Blood lactic acid, Brain natriuretic peptide; Chest X-ray, Computerised tomogram thorax, Cough, Culture urine, Decreased appetite; Differential white blood cell count, Dyspnoea, Electrocardiogram, Full blood count, Legionella test; Liver function test, Metabolic function test, Nasal congestion, Pneumonia, Prothrombin time; Scan with contrast, Troponin, Urine analysis More
was seen in Dr's office on 3/20/25 for acute visit. c/o cough, nasal congestion. respiratory PC... was seen in Dr's office on 3/20/25 for acute visit. c/o cough, nasal congestion. respiratory PCR testing done. was positive for "Human Metapneumonvirus". called our office on 3/27/25. c/o symptoms getting worse and being very short of breath, weak and not eating. Dr. advised her to go to ER. She did go to ER, and was placed under observation. She was discharged on 3/29/25. Clinical Impressions were; "unspecified Dyspnea: and "unspecified community acquired pneumonia". More
2835582 11 M ME 04/10/2025 DTAPIPV
HPV9
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
 Y49BZ
Y012508
U8493AA
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Provider ordered DTap to be given, I didn't catch it should have been TDap given pts age. thoug... Provider ordered DTap to be given, I didn't catch it should have been TDap given pts age. thought I gave what was ordered, but gave Kinrix instead. More
2835584 27 F CA 04/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 M2RH3
Underdose Underdose
27-year-old patient received a pediatric dose of Engerix-B; Underdose; This non-serious case was rep... 27-year-old patient received a pediatric dose of Engerix-B; Underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number M2RH3) for prophylaxis. On 04-APR-2025, the patient received the 1st dose of Engerix B pediatric. On 04-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 27-year-old patient received a pediatric dose of Engerix-B) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose 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: 08-APR-2025 The registered nurse stated that a 27-year-old patient received a pediatric dose of Engerix-B, first dose, which led to adult use of a child product and underdose. No side effects or adverse reactions noted. The Vaccine Administration Facility is the same as Primary Reporter. More
2835585 60 M IA 04/10/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 K9XL5
Death Death
Resident passes away while on hospice. Resident passes away while on hospice.
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2835586 60 F FL 04/10/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 ER2613
EW0153
33036BD
Biopsy skin abnormal, Lymph node pain, Scleroderma, Skin disorder; Biopsy skin a... Biopsy skin abnormal, Lymph node pain, Scleroderma, Skin disorder; Biopsy skin abnormal, Lymph node pain, Scleroderma, Skin disorder; Biopsy skin abnormal, Lymph node pain, Scleroderma, Skin disorder More
COVID Vaccine #1: 03/26/21 at (redacted) COVID Vaccine #2: 04/16/21 at (redacted), COVID Vaccine #3... COVID Vaccine #1: 03/26/21 at (redacted) COVID Vaccine #2: 04/16/21 at (redacted), COVID Vaccine #3 at (redacted) Pharmacy. I had a pretty bad reaction to Vaccine #1. Fatigue, muscle pain, and difficulty breathing for a few days afterwards. Vaccine #2 went OK. A few days after Vaccine #3 I developed pain in my lymph nodes under both of my arms which lasted about 3 to 5 months. A couple of months later I started noticing changes in my skin. I went to several dermatologists for diagnosis but no one could figure out what it was. When I moved to (redacted) from (redacted) I went to a new Primary Care Physician in 2024 who said she thought it looked like Scleroderma. I went to see another Dermatologist in (redacted) in 2025 who took a biopsy and confirmed Scleroderma Morphia. More
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