πŸ₯ VAERS Vaccine Data Browser

πŸ”’ 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.

πŸ“– Help & Search Guide

Column Icons Legend

πŸ’€ Death
πŸ₯ Hospitalized
πŸš‘ Emergency Room
β™Ώ Disability
⚠️ Life Threatening

How to Search

πŸ’‘ 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 "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ 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:

  • βœ… Early warning system for potential safety signals
  • βœ… Open and transparent - publicly accessible
  • βœ… Accepts all reports regardless of likelihood of causation
  • βœ… 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
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2821545 66 F WA 01/17/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Cellulitis Cellulitis
Celluitus Celluitus
2821547 70 M IA 01/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PC57B/7J5MP
Extra dose administered, Injection site pain Extra dose administered, Injection site pain
Prescriber sent prescription to the pharmacy for Shingrix vaccine to receive 1 dose, with a 2nd dose... Prescriber sent prescription to the pharmacy for Shingrix vaccine to receive 1 dose, with a 2nd dose in 2-6 months. (state vaccine registry) was not verified prior to administration. Following vaccine administration upon logging in state vaccine registry it was discovered that patient had already completed the vaccine series in 2020. Patient did not experience any adverse outcomes besides pain at the injection site. Patient and prescriber were notified of the unnecessary administration of the vaccine. More
2821548 75 F CA 01/17/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Neck pain, Pain, Pain in extremity, Pain of skin Arthralgia, Neck pain, Pain, Pain in extremity, Pain of skin
pt says after getting the vaccine that every place on her body that she has scar tissue became sore.... pt says after getting the vaccine that every place on her body that she has scar tissue became sore. The pain was underneath the skin. It was painful to walk. Her left hip, knee, and shoulder became sore. Her right neck and hand became sore. The pain lasted about 2 to 3 days. More
2821549 55 M VA 01/17/2025 FLU3
 SANOFI PASTEUR
Guillain-Barre syndrome Guillain-Barre syndrome
Patient developed Gullian-Barre'. Patient developed Gullian-Barre'.
2821550 0.75 M IL 01/17/2025 COVID19
 PFIZER\BIONTECH
 LN6739
No adverse event, Product preparation error No adverse event, Product preparation error
Undiluted dose given. Pt's mother does not report any symptoms. Manufacturer called. No treatme... Undiluted dose given. Pt's mother does not report any symptoms. Manufacturer called. No treatment provided. More
2821551 0.5 M NE 01/17/2025 DTAPHEPBIP
DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Aphasia, Blood immunoglobulin E normal, Dyskinesia, Mobility decreased, Neurolog... Aphasia, Blood immunoglobulin E normal, Dyskinesia, Mobility decreased, Neurological symptom; Urticaria More
Developed neurologic symptoms (without altered mental status)- 2 days after immunization- stopped ba... Developed neurologic symptoms (without altered mental status)- 2 days after immunization- stopped babbling, less mobile (decreased in rolling over), developed 12 involuntary extremities movements episodes (without loss of consciousness, lethargy or altered mental status; usually lasting up to 1 minute). Symptoms resolved after 1 month. Also developed hives - 2 days after immunization - which lasted for a couple of weeks. More
2821552 65 M MT 01/17/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 B9279
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Pt was given Twinrix 12 days before Pt was due for second dose. No adverse reactions. Just given vac... Pt was given Twinrix 12 days before Pt was due for second dose. No adverse reactions. Just given vaccination too early. More
2821553 43 F 01/17/2025 COVID19
 MODERNA
 3043333
No adverse event, Product storage error No adverse event, Product storage error
No adverse event know. But, vaccine was given after use by date (1/13/25) No adverse event know. But, vaccine was given after use by date (1/13/25)
2821554 60 F MI 01/17/2025 FLU3
 SANOFI PASTEUR
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
High dose IMM ordered. Pt not 65 High dose IMM ordered. Pt not 65
2821556 52 M 01/17/2025 COVID19
 MODERNA
 3043333
No adverse event, Product storage error No adverse event, Product storage error
no adverse event known, dose given after use by date (01/13/25) no adverse event known, dose given after use by date (01/13/25)
2821557 0.75 M OK 01/17/2025 FLU3
 SANOFI PASTEUR
 TFAA2448
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient given Flublok for 18 yrs and older but there was no adverse event. Patient given Flublok for 18 yrs and older but there was no adverse event.
2821558 6 M GA 01/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 22GP3CP
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Patient received first dose of Hep A 10/06/2024 and mistakenly received second dose today (01/17/202... Patient received first dose of Hep A 10/06/2024 and mistakenly received second dose today (01/17/2025) which is due on the 04/06/2025, along side with polio, VZV, and Hep B. Parents and supervisor received notification of the error, Patient monitored for 45 minutes. No reaction noted and patient was stable and encouraged to stay hydrated. Parents encouraged to continue to monitor. More
2821559 0.67 F IN 01/17/2025 COVID19
 MODERNA
Blood glucose increased, Protein urine present, Pyrexia, Seizure Blood glucose increased, Protein urine present, Pyrexia, Seizure
At 2:22am on 1/17, she had a seizure and was febrile. Was taken to the hospital in an ambulance. At... At 2:22am on 1/17, she had a seizure and was febrile. Was taken to the hospital in an ambulance. At around 12:20pm, she had another set of seizures and was febrile (temperature of 101.9). She has had 5 seizures in the 24 hours since receiving the vaccine. More
2821560 40 F VA 01/17/2025 FLU3
 SANOFI PASTEUR
 TFAA2438
Syncope Syncope
Syncope episode. Patient was treated with Ice packs to the back of the neck and face, gave patient c... Syncope episode. Patient was treated with Ice packs to the back of the neck and face, gave patient cold water to drink, and called patients husband to come pick her up. Patient had recovered upon leaving the pharmacy. More
2821562 11 M GA 01/17/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 X026926
LN75D
X449Y
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling More
Developed redness, itching of the site, painful and swollen Developed redness, itching of the site, painful and swollen
2821563 11 M 01/17/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8271AB
U8232AA
Rash, Rash erythematous; Rash, Rash erythematous Rash, Rash erythematous; Rash, Rash erythematous
erythematous rash all over body, Benadryl given at home with no improvement noted. erythematous rash all over body, Benadryl given at home with no improvement noted.
2821564 64 F DE 01/17/2025 FLU3
 SEQIRUS, INC.
 388519
Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria More
Patient had localized swelling, hives, itching and redness in a approximately 6 inch diameter at th... Patient had localized swelling, hives, itching and redness in a approximately 6 inch diameter at the injection site. Symptoms are subsiding slightly by still present 9 days after the injection. More
2821565 2 M WA 01/17/2025 COVID19
 PFIZER\BIONTECH
 8272
No adverse event, Product preparation error No adverse event, Product preparation error
Patient was given Undiluted 0.3ml. Multidose vial with 3 doses, needs to be diluted. Patient recei... Patient was given Undiluted 0.3ml. Multidose vial with 3 doses, needs to be diluted. Patient received whole vial. Patient parents called by MD. No adverse reaction noted. Parents aware of s/s and plan of care. Parents declined office visit. More
2821566 80 F PA 01/17/2025 FLU3
 SANOFI PASTEUR
 u8519ca
Injection site pain, Loss of personal independence in daily activities, Pain Injection site pain, Loss of personal independence in daily activities, Pain
Patient reported on 1/2/2025 that pain persisted two weeks after vaccination. She has talked to her ... Patient reported on 1/2/2025 that pain persisted two weeks after vaccination. She has talked to her doctor's office and md suggested that she takes over-the-counter pain medication and see if it gets better in a few weeks. Her physical therapist suggested a couple exercises to see if they might help. She described it as a dull ache at the site of injection. She reported that she has difficulty dressing and brushing hair since she can't move her arm much without it causing pain. More
2821567 67 M TN 01/17/2025 FLU3
 SEQIRUS, INC.
Influenza virus test negative, Respiratory tract congestion, SARS-CoV-2 test neg... Influenza virus test negative, Respiratory tract congestion, SARS-CoV-2 test negative More
Chest congestion, prednisone, once every 12 hours for 5 days, feeling bettrr Chest congestion, prednisone, once every 12 hours for 5 days, feeling bettrr
2821568 0.33 M TX 01/17/2025 DTAPIPVHIB
PNC20
RV1
 SANOFI PASTEUR
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 UJ984AA
LC5483
Y4NG3
Erythema multiforme, Viral rash; Erythema multiforme, Viral rash; Erythema multi... Erythema multiforme, Viral rash; Erythema multiforme, Viral rash; Erythema multiforme, Viral rash More
1. Erythema multiforme (Primary) (Rash x2 days) - DDX is reaction for vaccine vs viral exanthem. No ... 1. Erythema multiforme (Primary) (Rash x2 days) - DDX is reaction for vaccine vs viral exanthem. No evidence of anaphylaxis. - Given it was after vaccination, it is possible that the reaction was secondary to Beyfortus. There are some cases of similar rash with Beyfortus. - Also possible that it is a viral exanthem - Not unsafe to given next vaccines but would appreciate recommendations from A&I. Plan: - Supportive care with motrin, moisturizer. - Pediatric Allergy and Immunology. Stat referral for recommendations about 6 mo vaccines. - Counseled on return precautions. More
2821569 1 M CA 01/17/2025 FLU3
MMR
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 U8435BA
X026328
Y013350
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Patient received Fluzone multi dose vial instead of preservative free Flu Patient received Fluzone multi dose vial instead of preservative free Flu
2821570 5 M TX 01/17/2025 FLU3
 SANOFI PASTEUR
 UT8434LA
Injection site erythema, Vaccination site swelling Injection site erythema, Vaccination site swelling
Redness and swelling at vaccine site Redness and swelling at vaccine site
2821589 U PA 01/17/2025 MMRV
 MERCK & CO. INC.
 X018729
Expired product administered, No adverse event Expired product administered, No adverse event
no AE; Caller reported expired PROQUAD administered to a patient. No other information provided. N... no AE; Caller reported expired PROQUAD administered to a patient. No other information provided. No additional AEs/PQC reported.; This spontaneous report was received from an Other Health Professional and referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-JAN-2025, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin(rHA) (PROQUAD) injection, 0.5 milliliter, lot #X018729, expiration date: 06-JAN-2025, administered intramuscularly for prophylaxis (strength was not provided) (Expired product administered). No additional adverse event was reported. More
2821590 18 F CT 01/17/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
GARDASIL 9 at 18 years old in 2018, and is now returning to gynecology's office today, 8JAN2025... GARDASIL 9 at 18 years old in 2018, and is now returning to gynecology's office today, 8JAN2025 at 25 years of age inquiring about third dose.; No symptoms or side effects reported; This spontaneous report was received from a nurse regarding a currently 25-year-old female patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On an unknown date in 2018 (also reported as when the patient was 18 years old), the patient was vaccinated with the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strengths, volume of injections, lot numbers, expiry dates, anatomical locations, and routes of administration were not provided). However, on 08-JAN-2025, she returned to gynecology's office at 25 years of age inquiring about the third dose, hence, the reported inquired about the interrupted dosing schedule and how to proceed (Inappropriate schedule of product administration). No symptoms or side effects reported. Lot # is being requested and will be submitted if received. More
2821591 16 U OR 01/17/2025 MMRV
 MERCK & CO. INC.
 Y010930
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No symptoms reported. No additional details provided. No other AE/PQC reported; Nurse calling to rep... No symptoms reported. No additional details provided. No other AE/PQC reported; Nurse calling to report the inadvertent administration of PROQUAD to a 16 year old on 11/13/2024.; This spontaneous report was received from a nurse referring to a 16-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-NOV-2024, the patient inadvertently received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, lot #Y010930, expiration date: 14-DEC-2025, administered for prophylaxis (strength, dose and route of administration were not provided) (Product administered to patient of inappropriate age). Operator of device was health professional. No symptoms reported. No other adverse event (AE) reported (No adverse event). More
2821592 U GA 01/17/2025 MMR
 MERCK & CO. INC.
 X000178
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AEs; Pharmacist reported that an expired MMR II (Lot X000178 exp 1/2/2025) was adminis... No additional AEs; Pharmacist reported that an expired MMR II (Lot X000178 exp 1/2/2025) was administered on 1/11/2025. No additional AEs were reported. No further information provided. No PQC.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported. On 11-JAN-2025, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot # X000178, expiration date 02-JAN-2025 (dose and route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported. More
2821593 U FL 01/17/2025 HIBV
PNC15
RV5
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 X028615
X026480
Y003753
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No additional AE; ROTATEQ, VAXNEUVANCE (PFS), PEDVAX HIB were administered during the T/E to 1 patie... No additional AE; ROTATEQ, VAXNEUVANCE (PFS), PEDVAX HIB were administered during the T/E to 1 patient. T/E occurred on 1/11/2025; This spontaneous report was received from a Nurse and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-JAN-2025, the patient received the dose with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection lot #X028615, expiration date: 09-JUL-2026, administered for prophylaxis (strength, dose and route of administration were not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid lot #Y003753, expiration date: 18-OCT-2025, administered orally for prophylaxis (strength, dose was not provided); and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection lot #X026480, expiration date: 12-JAN-2026, administered for prophylaxis (strength, dose and route of administration were not provided) after a temperature excursion to 30.2 degree F for 17 hours (Product storage error). There was no previous temperature excursion. No adverse event was reported. More
2821594 0.17 U 01/17/2025 VARCEL
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE; Merck employee called on behalf of an office staff that reported that VARIVAX was ... No additional AE; Merck employee called on behalf of an office staff that reported that VARIVAX was inadvertently administered to a two-month-old patient on 14JAN2025. No additional information was known by reporter. Limited reporter demographics were known. No additi; This spontaneous report was received from an office staff referring to a 2-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported. On 14-JAN-2025, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported. Lot # is being requested and will be submitted if received. More
2821595 37 M MA 01/17/2025 HPV9
 MERCK & CO. INC.
 1965045
Inappropriate schedule of product administration, No adverse event, Product comm... Inappropriate schedule of product administration, No adverse event, Product communication issue More
A HCP called to inquire about how to administer a second dose of GARDASIL 9 to a 38-year-old patient... A HCP called to inquire about how to administer a second dose of GARDASIL 9 to a 38-year-old patient who's schedule was interrupted. The HCP stated the patient received the first dose of GARDASIL 9 in July 2024 (exact date unknown) and came in toda; Patient's confusion on when second dose should have been administered was identified; The patient did not report any additional adverse event issue or reaction; This spontaneous report was received from a pharmacist and refers to a 38 year old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unspecified date in July 2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL (lot # 1965045, expiration date: 19-JAN-2026) (route of administration, anatomical location not provided) as prophylaxis. On 14-JAN-2025 (also reported as today), the patient went to the pharmacy to receive the second dose of the vaccine; therefore, he missed the second dose according to the recommended product information (PI) timeframe/schedule (inappropriate schedule of product administration). It was identified that the patient was confused on when the second dose should had been administered (product communication issue). The patient did not report any additional adverse issue or reaction. More
2821596 U TX 01/17/2025 VARCEL
 MERCK & CO. INC.
 X001000
Expired product administered, No adverse event Expired product administered, No adverse event
No Additional AE. No PQC.; HCP calling to report patient inadvertently received expired dose of VARI... No Additional AE. No PQC.; HCP calling to report patient inadvertently received expired dose of VARIVAX on 1/15/2025 after its labeled expiry date of 1/9/2025.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age an gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 15-JAN-2025, the patient inadvertently was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose (valid lot number X001000, expiration date: 09-JAN-2025), administered for prophylaxis (dose, dose number, and route of administration were not provided) (expired product administered). No additional adverse event (AE ). More
2821597 U 01/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Guillain-Barre syndrome, Neuropathy peripheral Guillain-Barre syndrome, Neuropathy peripheral
it gave me Gillian Bree syndrome; This serious case was reported by a consumer via interactive digit... it gave me Gillian Bree syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received 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 guillain barre syndrome (Verbatim: it gave me Gillian Bree syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. The company considered the guillain barre syndrome to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 03-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient was given the shot and it gave him/her Guillain Barre syndrome. He/she would never took it but doctor told him/her to had it. It would help him/her but instead, it caused a side effect called Guillain Barre syndrome which caused neuropathy.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK Shingles vaccine. More
2821598 0.33 M 01/17/2025 DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
HIBV
MMR
MMR
MMR
MMR
MMR
MMR
MMR
MMR
MMR
PNC13
PNC13
PNC13
PNC13
PNC13
PNC13
PNC13
PNC13
PNC13
RV1
RV1
RV1
RV1
RV1
RV1
RV1
RV1
RV1
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VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
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Band neutrophil percentage decreased, Basophil percentage, Blood albumin normal,... Band neutrophil percentage decreased, Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood culture negative, Blood glucose increased; Blood potassium normal, Blood sodium decreased, Blood urea normal, Carbon dioxide normal, Culture stool positive; Culture urine negative, Diarrhoea, Eosinophil percentage, Febrile convulsion, Gastroenteritis; Gaze palsy, Generalised tonic-clonic seizure, Haematocrit normal, Haemoglobin normal, Influenza virus test negative; Lethargy, Loss of consciousness, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased; Mean cell volume decreased, Mean platelet volume normal, Monocyte percentage increased, Musculoskeletal stiffness, Postictal state; Protein total normal, Pyrexia, Red blood cell count normal, Vomiting, White blood cell count normal; pH urine normal; Band neutrophil percentage decreased, Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood culture negative, Blood glucose increased; Blood potassium normal, Blood sodium decreased, Blood urea normal, Carbon dioxide normal, Culture stool positive; Culture urine negative, Diarrhoea, Eosinophil percentage, Febrile convulsion, Gastroenteritis; Gaze palsy, Generalised tonic-clonic seizure, Haematocrit normal, Haemoglobin normal, Influenza virus test negative; Lethargy, Loss of consciousness, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased; Mean cell volume decreased, Mean platelet volume normal, Monocyte percentage increased, Musculoskeletal stiffness, Postictal state; Protein total normal, Pyrexia, Red blood cell count normal, Vomiting, White blood cell count normal; pH urine normal; Band neutrophil percentage decreased, Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood culture negative, Blood glucose increased; Blood potassium normal, Blood sodium decreased, Blood urea normal, Carbon dioxide normal, Culture stool positive; Culture urine negative, Diarrhoea, Eosinophil percentage, Febrile convulsion, Gastroenteritis; Gaze palsy, Generalised tonic-clonic seizure, Haematocrit normal, Haemoglobin normal, Influenza virus test negative; Lethargy, Loss of consciousness, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased; Mean cell volume decreased, Mean platelet volume normal, Monocyte percentage increased, Musculoskeletal stiffness, Postictal state; Protein total normal, Pyrexia, Red blood cell count normal, Vomiting, White blood cell count normal; pH urine normal; Band neutrophil percentage decreased, Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood culture negative, Blood glucose increased; Blood potassium normal, Blood sodium decreased, Blood urea normal, Carbon dioxide normal, Culture stool positive; Culture urine negative, Diarrhoea, Eosinophil percentage, Febrile convulsion, Gastroenteritis; Gaze palsy, Generalised tonic-clonic seizure, Haematocrit normal, Haemoglobin normal, Influenza virus test negative; Lethargy, Loss of consciousness, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased; Mean cell volume decreased, Mean platelet volume normal, Monocyte percentage increased, Musculoskeletal stiffness, Postictal state; Protein total normal, Pyrexia, Red blood cell count normal, Vomiting, White blood cell count normal; pH urine normal; Band neutrophil percentage decreased, Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood culture negative, Blood glucose increased; Blood potassium normal, Blood sodium decreased, Blood urea normal, Carbon dioxide normal, Culture stool positive; Culture urine negative, Diarrhoea, Eosinophil percentage, Febrile convulsion, Gastroenteritis; Gaze palsy, Generalised tonic-clonic seizure, Haematocrit normal, Haemoglobin normal, Influenza virus test negative; Lethargy, Loss of consciousness, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased; Mean cell volume decreased, Mean platelet volume normal, Monocyte percentage increased, Musculoskeletal stiffness, Postictal state; Protein total normal, Pyrexia, Red blood cell count normal, Vomiting, White blood cell count normal; pH urine normal; Band neutrophil percentage decreased, Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood culture negative, Blood glucose increased; Blood potassium normal, Blood sodium decreased, Blood urea normal, Carbon dioxide normal, Culture stool positive; Culture urine negative, Diarrhoea, Eosinophil percentage, Febrile convulsion, Gastroenteritis; Gaze palsy, Generalised tonic-clonic seizure, Haematocrit normal, Haemoglobin normal, Influenza virus test negative; Lethargy, Loss of consciousness, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased; Mean cell volume decreased, Mean platelet volume normal, Monocyte percentage increased, Musculoskeletal stiffness, Postictal state; Protein total normal, Pyrexia, Red blood cell count normal, Vomiting, White blood cell count normal; pH urine normal; Band neutrophil percentage decreased, Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal; Blood calcium normal, Blood chloride normal, Blood creatine normal, Blood culture negative, Blood glucose increased; Blood potassium normal, Blood sodium decreased, Blood urea normal, Carbon dioxide normal, Culture stool positive; Culture urine negative, Diarrhoea, Eosinophil percentage, Febrile convulsion, Gastroenteritis; Gaze palsy, Generalised tonic-clonic seizure, Haematocrit normal, Haemoglobin normal, Influenza virus test negative; Lethargy, Loss of consciousness, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased; Mean cell volume decreased, Mean platelet volume normal, Monocyte percentage increased, Musculoskeletal stiffness, Postictal state; Protein total normal, Pyrexia, Red blood cell count normal, Vomiting, White blood cell count normal; pH urine normal More
gastroenteritis; febrile seizure; This 17-month-old male subject was enrolled in a study. The subjec... gastroenteritis; febrile seizure; This 17-month-old male subject was enrolled in a study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 12-SEP-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 27-DEC-2018, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 12-MAR-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 12-MAR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 12-SEP-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 12-SEP-2019, for prophylaxis. The subject received the 4th dose of Prevnar 13 (intramuscular, left thigh) on 12-SEP-2019, for prophylaxis. On 01-FEB-2020 03:34, 142 days after receiving Bexsero vs Placebo, M-M-R II, Varivax and Prevnar 13, 401 days after receiving Rotarix lyophilized formulation and 326 days after receiving DTPa-HBV-IPV and Hiberix, the subject developed mild - grade 1 febrile seizure (Non-serious, Verbatim: febrile seizure). Additional event(s) included mild - grade 1 gastroenteritis (Verbatim: gastroenteritis) on 01-FEB-2020 03:36 with serious criteria of hospitalization. The subject was treated with ibuprofen, paracetamol (Acetaminophen), salbutamol (Albuterol) and ondansetron (Zofran). The outcome of febrile seizure was resolved on 02-FEB-2020 14:51. The outcome(s) of the additional event(s) included gastroenteritis (resolved on 02-FEB-2020 14:51). Relevant Tests: On 01 Feb 2020 Subject had influenza test done on earlier in the ER (emergency room) with negative result. Urine culture had no growth. Blood culture had no growth. Stool culture had moderate growth if normal stool flora. Diagnostic results (reference ranges are provided in parenthesis if available): Band neutrophil count- 01-FEB-2020 18 percent, (0.00-8.00). Basophil count- 01-FEB-2020 1 percent, (0.00-2.00). Blood albumin- 01-FEB-2020 3.7 οΏ½G/DL, (3.40-4.80). Blood alkaline phosphatase- 01-FEB-2020 205 unit/litre, (32.00-350.00). Blood bilirubin- 01-FEB-2020 0.9 mg/dL, (0.00-1.00). Blood calcium- 01-FEB-2020 9.3 mg/dL, (8.90-10.30). Blood chloride- 01-FEB-2020 102 mEq/L, (101.00-111.00). Blood creatine- 01-FEB-2020 0.3 mg/dL, (0.70-1.20). Blood glucose- 01-FEB-2020 107 mg/dL, (70.00-100.00). Blood potassium- 01-FEB-2020 4.1 mEq/L, (3.60-5.10). Blood sodium- 01-FEB-2020 135 mEq/L, (136.00-145.00). Blood urea- 01-FEB-2020 9 mg/dL, (6.00-20.00). Carbon dioxide- 01-FEB-2020 23 mEq/L, (22.00-32.00). Eosinophil count- 01-FEB-2020 1 percent, (0.00-5.00). Haematocrit- 01-FEB-2020 32.5 percent, (35.00-45.00). Haemoglobin- 01-FEB-2020 11.3 g/dL, (11.00-15.00). Lymphocyte count- 01-FEB-2020 24 percent, (20.00-50.00). Mean cell haemoglobin- 01-FEB-2020 26.9 pg, (24.00-28.00). Mean cell haemoglobin concentration- 01-FEB-2020 34.8 g/dL, (31.50-35.50). Mean cell volume- 01-FEB-2020 77.4 fL, (75.00-85.00). Mean platelet volume- 01-FEB-2020 8.6 fL. Monocyte count- 01-FEB-2020 10 percent, (0.00-10.00). Protein total- 01-FEB-2020 6.2 οΏ½G/DL, (6.10-8.00). Red blood cell count- 01-FEB-2020 4.20 M /mm3, (4.10-5.30). White blood cell count- 01-FEB-2020 10.7 K/MM3, (5.00-11.00). pH urine- 01-FEB-2020 6.0 (5.00-7.00). The investigator considered that there was no reasonable possibility that the febrile seizure and gastroenteritis may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, DTPa-HBV-IPV, Hiberix, M-M-R II, Varivax and Prevnar 13. The company considered that there was no reasonable possibility that the febrile seizure and gastroenteritis may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, DTPa-HBV-IPV, Hiberix, M-M-R II, Varivax and Prevnar 13. Linked case(s) involving the same subject: US2022081864 GSK Receipt date: 10-MAR-2020 Subject presented to the ER (emergency room) on 01Feb2020 post seizure following a febrile seizure with vomiting and diarrhea. Flu test was done at this visit. With negative results and no further seizure symptoms, subject was released to go home with a script for Zofran for the gastroenteritis. Subject returned to the ER (emergency room)approximately 15 hours later after another febrile seizure. It was deemed he would be admitted for observation and further tests. UA and blood tests were ordered, as well as urine and blood cultures. No further seizures took place through the night. Subject was released the following day with the diagnosis of complex febrile seizure likely secondary to gastroenteritis. Parent had not stated subject had further seizures since discharge. Subject was admitted on 01 Feb 2020, discharged on 02 Feb 2020. The blood culture, urine culture, stool culture and influenza test were all done on 01 Feb 2020. Parent informed subject had a previous seizure 12 Dec 2019. December seizure was not a SAE (serious adverse event), but will discuss with provider about adding as a separate AE (adverse event). Question Responses from Query previously. 1. Did the subject lose consciousness No 2. Was the seizure generalised/localised generalized 3. Were any medical investigations performed? Not that are reported 4. Please update the child's birth and family history. There are no changes. Mother describes similar seizure (01Feb2020) to that of 12 Dec 2019 which was also a febrile seizure. Child had tonic-clonic activity of arms and legs with stiffness and eyes rolled back. Postictal confusion and lethargy for 1 hour. Seizure no. 1 The seizure was witnessed by study parents or relatives. The date of first seizure was 1/Feb/2020 and time of first seizure was 03:34. Fever at the time or immediately before generalized convulsive seizure: 103.0 degrees Fahrenheit. Duration of seizure in minutes (approximately): 5 minutes. Number of generalized convulsive seizures: 1. There was past history of similar events - Type of Seizure was generalized seizure, arms & legs stiff, eyes rolled back, fever. Familial history of similar events: No Diagnostic certainty level: Level 1; Witnessed sudden loss of consciousness and generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations. No Familial history of similar events. This case contains an event assessed by the investigator as a non-serious adverse event of special interest (AESI). On 03Mar2021 investigator reported event discription as generalized seizure, arms & legs stiff, eyes rolled back. Seizure no.2: The date of generalized seizure was 12/Dec/2019. Fever at the time or immediately before generalized convulsive seizure was 105.0 Fahrenheit. Duration of seizure was approximately 5 minutes. Number of generalized convulsive seizures -1. There were no past history of similar events, no familial history of similar events. Diagnostic certainty level was Level 1; Witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations. Follow up information received on 04-AUG-2022. This follow up was considered significant. Summary of changes: The investigator text were updated. Follow up information received on 10-JAN-2025 Summary of changes: General narrative comment updated. Upon internal review the case was updated on: 13-JAN-2025 : suspect product Bexsero / Placebo vaccination date updated 12/Mar/2019 to 12/Sep/2019, TTO updated, suspect product Pediarix updated. Follow up information received on 13-JAN-2025 Reported medications name ibuprofen 100mg/5mL, acetaminophen 160mg/5ml suspension and albuterol 0.63mg/3ml nebulizer Summary of changes: General narrative comment updated. Upon internal review the case was updated on 16-Jan-2025 Suspect vaccine coding updated.; Sender's Comments: A case of gastroenteritis and febrile convulsion, 142 days after receiving Bexsero vs Placebo (4th dose) , M-M-R II (1st dose) Prevnar (4th dose) and Varivax (1st dose), 326 days after receiving DTPa-HBV-IPV (3rd dose) and Hiberix (3rd dose) and 401 days after receiving Rotarix (2nd dose) in a 17-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternate etiology (gastroenteritis) for the event febrile convulsion. US-GLAXOSMITHKLINE-US2022081864: More
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2821599 M MA 01/17/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Confusional state, Product administered to patient of inappropriate age Confusional state, Product administered to patient of inappropriate age
Mental confusion; Drug administered to patient of inappropriate age; This non-serious case was repor... Mental confusion; Drug administered to patient of inappropriate age; This non-serious case was reported by a non-health professional and described the occurrence of mental confusion in a 62-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included apixaban (Eliquis). On 10-DEC-2024, the patient received Bexsero. On 10-DEC-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Drug administered to patient of inappropriate age). On 11-DEC-2024, the patient experienced mental confusion (Verbatim: Mental confusion). The outcome of the mental confusion was not resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the mental confusion to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the mental confusion to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-DEC-2024 The reporter reported that the patient received 1st dose of Bexsero and experienced mental confusion. The patient was 62 years old when received the vaccine which led to inappropriate age at vaccine administration. More
2821600 73 F 01/17/2025 COVID19
COVID19
FLU3
FLU3
RSV
RSV
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 6024MF016
6024MF016
U8515CA
U8515CA
2FP37
2FP37
Headache, Injection site erythema, Injection site induration, Injection site mas... Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling; Injection site warmth, Lymphadenopathy, Mammogram; Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling; Injection site warmth, Lymphadenopathy, Mammogram; Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling; Injection site warmth, Lymphadenopathy, Mammogram More
Lymph nodes on right side are swollen; Headache; Injection site erythema /redness on whole upper rig... Lymph nodes on right side are swollen; Headache; Injection site erythema /redness on whole upper right arm; Injection site induration; Injection site mass; Injection site swelling/swollen, hard bump; Injection site warmth/injection site hot to touch; This non-serious case was reported by a consumer via regulatory authority and described the occurrence of lymphadenopathy in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2FP37) for prophylaxis. Co-suspect products included COVID-19 VACCINE PROT. SUBUNIT (NVX COV 2373) (NOVAVAX COVID-19 VACCINE) (batch number 6024MF016) for covid-19 immunization and INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) (batch number U8515CA) for prophylaxis. On 25-OCT-2024, the patient received Arexvy (intramuscular), NOVAVAX COVID-19 VACCINE (intramuscular) and FLUZONE HIGH DOSE (intramuscular). On 25-OCT-2024, less than a day after receiving Arexvy, the patient experienced lymphadenopathy (Verbatim: Lymph nodes on right side are swollen), headache (Verbatim: Headache), injection site erythema (Verbatim: Injection site erythema /redness on whole upper right arm), injection site induration (Verbatim: Injection site induration), injection site mass (Verbatim: Injection site mass), injection site swelling (Verbatim: Injection site swelling/swollen, hard bump) and injection site warmth (Verbatim: Injection site warmth/injection site hot to touch). On 27-OCT-2024, the outcome of the headache was resolved (duration 2 days). The outcome of the lymphadenopathy, injection site erythema, injection site induration, injection site mass, injection site swelling and injection site warmth were not resolved. It was unknown if the reporter considered the lymphadenopathy, headache, injection site erythema, injection site induration, injection site mass, injection site swelling and injection site warmth to be related to Arexvy. It was unknown if the company considered the lymphadenopathy, headache, injection site erythema, injection site induration, injection site mass, injection site swelling and injection site warmth to be related to Arexvy. Additional Information: GSK Receipt Date: 20-DEC-2024 A 73 year old female patient received Arexvy vaccine, Fluzone high dose vaccine and Novavax Covid-19 Vaccine and experienced headache, injection site erythema, injection site induration, injection site mass, injection site swelling, injection site warmth, lymphadenopathy and mammogram abnormal. The patient reported redness on whole upper right arm, swollen, hard bump, injection site was also hot to touch, and headache for 2 days. The patient stated the symptoms were improving such as injection site was not as red but blotchy, still present bump but not as hard, injection site was not as hot but still warm and no headache. The patient had a routine mammogram and was informed about lymph nodes on right side were swollen. The reporter considered the adverse events to be possibly related to Novavax Covid-19 Vaccine. It was unknown if the reporter considered the adverse events to be related to Fluzone high dose vaccine. No concomitants were used/reported. This report was one of several cases received as part of a line-listing, each containing minimal information. No further information was expected. More
2821601 F NC 01/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; came down with shingles; This serious case was reported by a consumer... Suspected vaccination failure; came down with shingles; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: came down with shingles). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to 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-JAN-2025 The reporter reported that friend of him/her had just come down with shingles. She was in the Shingrix trial - active arm. The reporter want to ask that it might be time to consider the need for a booster shot especially since shingles was worse. She had been given Valtrex and do not know if she was taking other drugs that suppress her immune system, she did not say about it. She was a nurse so medically savvy. 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
2821602 11 M NC 01/17/2025 MNQ
MNQ
TDAP
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Face injury, Fall, Head injury, Loss of consciousness, Somnolence; Suture insert... Face injury, Fall, Head injury, Loss of consciousness, Somnolence; Suture insertion, Syncope; Face injury, Fall, Head injury, Loss of consciousness, Somnolence; Suture insertion, Syncope More
Fainted; Vision went out (said he saw black); really sleepy; fell to the floor; hit head on floor an... Fainted; Vision went out (said he saw black); really sleepy; fell to the floor; hit head on floor and required stitches for face injury; hit head on floor and required stitches for face injury; This serious case was reported by a consumer via sales rep and described the occurrence of fainting in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. Concurrent medical conditions included anxiety. Concomitant products included fluoxetine hydrochloride (Prozac). On 03-JAN-2025, the patient received the 1st dose of Menveo (right arm) and the 1st dose of Boostrix (left arm). On 03-JAN-2025, less than a day after receiving Menveo and Boostrix, the patient experienced fainting (Verbatim: Fainted) (serious criteria hospitalization and GSK medically significant), blackout (Verbatim: Vision went out (said he saw black)) (serious criteria GSK medically significant), sleepiness (Verbatim: really sleepy), fall (Verbatim: fell to the floor), face injury (Verbatim: hit head on floor and required stitches for face injury) and head injury (Verbatim: hit head on floor and required stitches for face injury). The outcome of the fainting was resolving and the outcome of the blackout, sleepiness, fall, face injury and head injury were not reported. It was unknown if the reporter considered the fainting, blackout, sleepiness, fall, face injury and head injury to be related to Menveo and Boostrix. The company considered the fainting and blackout to be unrelated to Menveo and Boostrix. It was unknown if the company considered the sleepiness, fall, face injury and head injury to be related to Menveo and Boostrix. Additional Information: GSK receipt date: 03-JAN-2025 The patient was said he was really sleepy, his vision went out (said he saw black) and then fell to the floor off exam table. The patient fainted after vaccines and hit head on floor and required stitches for injury on face.; Sender's Comments: Syncope is a listed event which, due to the following criteria (concurrent anxiety) is considered unrelated to GSK vaccine Menveo and Boostrix. Loss of consciousness is an unlisted event which is considered unrelated to GSK vaccine Menveo and Boostrix. More
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2821603 U 01/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I had shingles on my face; This serious case was reported by a consum... Suspected vaccination failure; I had shingles on my face; 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 facial herpes zoster (Verbatim: I had shingles on my face). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolved (duration 9 days). It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-JAN-2025 This case was reported by a patient via interactive digital media. The patient had shingles on his/her face. He/she bought a bottle of everclear 190 at the liquor store and used Q tips to put it on his/her face. Dry it up and gone in 9 days. Never had it again. The patient never had shingles before till he/she got the Shingles 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
2821604 U 01/17/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; Bad shingles; This serious case was reported by a consumer via intera... Suspected vaccination failure; Bad 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Bad 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 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: 05-JAN-2025 This case was reported by a patient via interactive digital media. Patient have had 2 shingle shots and still get bad shingles. For some reason, it just did not seem to help the patient. 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. The follow-up could not be possible as no contact details were available.; 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 (Dose 1 and Dose 2). More
2821605 U 01/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The patient was treated with aciclovir (Acyclovir). 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-JAN-2025 This case was reported by a patient via interactive digital media. Patient was the reporter. Patient reported that vaccine was a scam. He/she had the shots and got shingles 2 months later. And while taking acyclovir twice a day too. 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 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
2821606 U 01/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was 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-JAN-2024 This case was reported by a patient via interactive digital media. The patient received the vaccine but still had Shingles. It lasted for about two and a half months and it was very painful. Would not wish it on anyone. Was not mild. Had to go on heavy duty pain medication. 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 Shingles vaccine. More
2821607 U 01/17/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain Herpes zoster, Pain
had shingles that is driving me nuts three years later; This non-serious case was reported by a cons... had shingles that is driving me nuts three years later; 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 Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had shingles that is driving me nuts three years later). The outcome of the shingles was not resolved. 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: 07-JAN-2025 This case was reported by a patient via interactive digital media. The patient stated that his/her shingles vaccine was very painful and two weeks later he/she had shingles that was driving him/her nuts three years later. More
2821608 F WV 01/17/2025 DTAPHEPBIP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 77J49
42B22
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Double hep B dose; This non-serious case was reported by a nurse via call center representative and ... Double hep B dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 10-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 77J49) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 42B22) for prophylaxis. On 16-DEC-2024, the patient received the 1st dose of Pediarix and the 1st dose of Engerix B. On 16-DEC-2024, an unknown time after receiving Pediarix and Engerix B, the patient experienced overdose (Verbatim: Double hep B dose). The outcome of the overdose was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-DEC-2024. The reporter reported that the following incident that happened on 16-Dec-2024, reporter had a patient come in for her immunization and she received a Pediarix but also received a separated hep B vaccination (Engerix-B) on the same day, which led to overdose. . More
2821609 47 M 01/17/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Twinrix 2nd dose on Sep 5th 2023 and 3rd dose on Dec 20th 2023; Twinrix 1st dose taken on Aug 30th 2... Twinrix 2nd dose on Sep 5th 2023 and 3rd dose on Dec 20th 2023; Twinrix 1st dose taken on Aug 30th 2023 and 2nd dose on Sep 5th 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug administration duration too short in a 47-year-old male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On 20-DEC-2023, the patient received the 3rd dose of Twinrix. On 05-SEP-2023, the patient received the 2nd dose of Twinrix. On 05-SEP-2023, not applicable after receiving Twinrix, an unknown time after receiving Twinrix and an unknown time after receiving TWINRIX, the patient experienced drug administration duration too short (Verbatim: Twinrix 1st dose taken on Aug 30th 2023 and 2nd dose on Sep 5th 2023). On 20-DEC-2023, the patient experienced drug administration duration too short (Verbatim: Twinrix 2nd dose on Sep 5th 2023 and 3rd dose on Dec 20th 2023). The outcome of the drug administration duration too short and drug administration duration too short were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-DEC-2024 A pharmacist mentioned she had a patient that received three doses of Twinrix at different intervals. 1st dose received on 30 Aug 2023. The patient received 2nd and 3rd dose early which led to shortening of vaccinations schedule. The pharmacist asked for recommendations on this situation. More
2821610 F MN 01/17/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
only received one dose; This non-serious case was reported by a nurse via call center representative... only received one dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received first dose of Bexsero on 26th July 2023). 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: only received one dose). The outcome of the incomplete course of vaccination was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-DEC-2024 The nurse reported that the patient that would come into their facility on the day of reporting who had only received one dose of Bexsero and asked information to make clinical decision about administering a second dose during patientοΏ½s visit. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting the patient did not receive the second dose of Bexsero which led to incomplete course of vaccination. More
2821611 17 F GA 01/17/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Injection site pain, Nausea, Pain, Pyrexia Injection site pain, Nausea, Pain, Pyrexia
pain at the injection site; fever; nausea; severe body aches; This non-serious case was reported by ... pain at the injection site; fever; nausea; severe body aches; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. On 23-DEC-2024, the patient received Bexsero. On 23-DEC-2024, 4 hrs after receiving Bexsero, the patient experienced injection site pain (Verbatim: pain at the injection site), fever (Verbatim: fever), nausea (Verbatim: nausea) and general body pain (Verbatim: severe body aches). On 24-DEC-2024, the outcome of the injection site pain, fever, nausea and general body pain were resolved (duration 1 day). It was unknown if the reporter considered the injection site pain, fever, nausea and general body pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, fever, nausea and general body pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-DEC-2024 The physician reported that the patient received the Bexsero vaccine. Four hours after the vaccination the patient began to experience severe body aches, nausea, fever of 101.6 Fahrenheit and pain at the injection site. The physician reported all the symptoms resolved the following day. The Vaccine Administration Facility was the same as Primary Reporter. More
2821612 M UT 01/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
hasn't received a second dose yet; This non-serious case was reported by a pharmacist via call ... hasn't received a second dose yet; 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 male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 31-OCT-2019 with batch number 54A2T and lot expiry 11-DEC-2021). 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: hasn't received a second dose yet). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 The pharmacist reported that a patient received a first dose and had not received a second dose yet. The patient was asking for a second dose today and pharmacist calls to request information to make clinical decision. Health care professional stated the first dose given to the patient happened at a different facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2821613 58 F SC 01/17/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Herpes zoster, Pain, Rash, Vaccination failure; Herpes zoster, Pain, Rash, Vacci... Herpes zoster, Pain, Rash, Vaccination failure; Herpes zoster, Pain, Rash, Vaccination failure More
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call cente... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 15-JAN-2021, the patient received the 2nd dose of Shingrix. On 18-SEP-2020, the patient received the 1st dose of Shingrix. On 23-DEC-2024, 1438 days after receiving Shingrix and 1557 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. 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: 02-JAN-2025 The reporter was the patient. The patient developed Shingles even though she received the full vaccination with Shingrix. The patient received the first dose of Shingrix on 18th September 2020, and the second dose on 15th January 2021. The lot number provided for the first dose was 35943 and expiration was 26th January 2022 and the lot number for the second dose was EV4TD and expiration was 4th January 2022. Both the lot numbers provided do not correspond Shingrix. The patient began experiencing pain on 23rd December 2024, and developed a rash (no blisters) on 26th December 2024. The pain had started on the left flank, then her back, lower abdomen, groin area and thigh. The rash was developed on the out aspect of the left thigh. The patient stated she has never had Shingles (disease) before, and that she did not receive Zostavax prior to receiving Shingrix. The patient was also a nurse and self-diagnosed the Shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2) More
2821614 77 M CO 01/17/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Death, Incomplete course of vaccination, Malaise; Death, Incomplete course of va... Death, Incomplete course of vaccination, Malaise; Death, Incomplete course of vaccination, Malaise More
Got ill; the patient never went back to receive the second dose; Death; This serious case was report... Got ill; the patient never went back to receive the second dose; Death; This serious case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In APR-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 29-OCT-2024, between 5 and 7 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced unknown cause of death (Verbatim: Death) (serious criteria death and GSK medically significant). On an unknown date, the patient experienced illness (Verbatim: Got ill) and incomplete course of vaccination (Verbatim: the patient never went back to receive the second dose). The outcome of the illness and incomplete course of vaccination were unknown. The patient died on 29-OCT-2024. The reported cause of death was unknown. The reporter considered the unknown cause of death to be unrelated to Shingrix. It was unknown if the reporter considered the illness to be related to Shingrix. The company considered the unknown cause of death and illness to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 10-JAN-2025 The reporter reported that patient received his first dose of Shingirx, she thinks, in April 2024 and the patient never went back to receive the second dose which leads to incomplete course of vaccination, patient got ill after receiving the Shingrix vaccine, and died. The reporter also reports that the patient did receive another vaccine that same day in the opposite arm, but cannot remember what the name of the other vaccine was. The reporter states that the death had nothing to do with the Shingrix Vaccine. This case is linked with US2025003275, reported by same reporter.; Sender's Comments: Death and Illness are unlisted events which are considered unrelated to GSK vaccine Shingrix. US-GSK-US2025003275:Same reporter/Different patient; Reported Cause(s) of Death: Unknown cause of death More
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2821615 U 01/17/2025 COVID19
 PFIZER\BIONTECH
Overdose, Product administered to patient of inappropriate age, Pyrexia Overdose, Product administered to patient of inappropriate age, Pyrexia
fever; 3 year old received the Pfizer vaccine 12 and plus; 3 year old received the Pfizer vaccine 12... fever; 3 year old received the Pfizer vaccine 12 and plus; 3 year old received the Pfizer vaccine 12 and plus; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:. A 3-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "3 year old received the Pfizer vaccine 12 and plus". Additional information: Two children (3 year old and 1 year old) received the Pfizer vaccine 12 and plus and they are having a fever. The reporter is the children's parent. They went to the doctor to get the vaccine, and they received a call that the vaccine that was administered to both patients is the Pfizer vaccine for age 12 and older. The patients have fevers at the time of the report. The reporter was asking if the children should be taken to the ER/hospital. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500008909 same reporter/suspect vaccine/event, different patients; More
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