🏥 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 💀 🏥 🚑 ♿ ⚠️
2828984 NY 03/03/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 395JH
Device connection issue, Underdose Device connection issue, Underdose
The needle and Luer Lok Adaptor broke off during administration but unknown how much vaccine adminis... The needle and Luer Lok Adaptor broke off during administration but unknown how much vaccine administered; The needle and Luer Lok Adaptor broke off during administration; Product Complaint; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete dose administered in a patient who received Hib (Hiberix) (batch number 395JH, expiry date 11-DEC-2028) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: The needle and Luer Lok Adaptor broke off during administration but unknown how much vaccine administered), device connection issue (Verbatim: The needle and Luer Lok Adaptor broke off during administration) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, device connection issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the device connection issue to be related to Hiberix and Haemophilus Influenzae Type B Vaccine And Diluent. It was unknown if the company considered the device connection issue to be related to Hiberix and Haemophilus Influenzae Type B Vaccine And Diluent. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-FEB-2025 The reporter reported that Hiberix prefilled syringe luer lok adaptor broke off 3 to 5 times. The reporter believed up to five prefilled syringes were involved but one prefilled syringe discarded, so he was not sure of the total quantity affected. The box discarded so the batch number was not available. The batch number with expiry date from the prefilled syringe picture of the defect has emailed. The reporter asked to confirm that all operations performed appropriately as defect discovered during administration in one instance, the needle and luer lok adaptor broke off during administration and was unknown how much vaccine the patient received. The reporter does not know if the product not administered or partially administered with the other 2 to 4 suspect prefilled syringes. During injection detaching of the luer lok adaptor but previously discarded needles were not available for return to GlaxoSmithKline. One of the suspect prefilled syringes was available for return to GlaxoSmithKline and box, up to four additional suspect prefilled syringes and the needles discarded. The vaccine administration facility was the same as primary reporter. More
2828985 M IL 03/03/2025 FLUX
FLUX
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Biopsy skin normal, Blepharitis, Glomerular filtration rate decreased, Lymphocyt... Biopsy skin normal, Blepharitis, Glomerular filtration rate decreased, Lymphocyte count, Rash; Rash pruritic, Renal impairment, Tooth extraction; Biopsy skin normal, Blepharitis, Glomerular filtration rate decreased, Lymphocyte count, Rash; Rash pruritic, Renal impairment, Tooth extraction More
kidney function was not normal/kidney problem; tooth pulled; Blepharitis; very itchy rash all over h... kidney function was not normal/kidney problem; tooth pulled; Blepharitis; very itchy rash all over his body; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Influenza vaccine (Flu vaccine VII) for prophylaxis. Previously administered products included Shingrix (Patient received first dose in JAN-2024), Tetanus (Patient received shot in DEC-2023) and zostavax. In APR-2024, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received Flu vaccine VII. In OCT-2024, between 6 and 7 months after receiving Shingrix, the patient experienced itchy rash (Verbatim: very itchy rash all over his body). On an unknown date, the patient experienced renal disorder (Verbatim: kidney function was not normal/kidney problem), tooth extraction (Verbatim: tooth pulled) and blepharitis (Verbatim: Blepharitis). The patient was treated with prednisone, ketotifen fumarate (Zyrtec Itchy), menthol;zinc oxide (Gold Bond), amoxicillin (Amoxicilina) and neomycin hydrochloride;polymyxin B sulfate (Neomycin Polymixin). The outcome of the itchy rash was not resolved and the outcome of the renal disorder, tooth extraction and blepharitis were unknown. It was unknown if the reporter considered the itchy rash, renal disorder, tooth extraction and blepharitis to be related to Shingrix. It was unknown if the company considered the itchy rash, renal disorder, tooth extraction and blepharitis to be related to Shingrix. Additional Information: GSK Receipt Date: 12-FEB-2025 The patient received the first dose of Shingrix in January, 2024, and the second dose in April, 2024. The reporter received a Flu vaccine (manufacturer not known by the reporter) in September, 2024 and a Tetanus shot (manufacturer not known by the reporter) in December 2023. In October 2024, the patient began to develop a very itchy rash all over his body. The patient was treated with Prednisone, which benefits, but once he tapers down, the rash comes back. He was just completing the second course of a Prednisone taper and the rash was coming back, to treat the rash the patient was also taking Zyrtec 2 tablets in the am and 2 tablets in the pm, Gold Bond (formulation not specified), moisturizing creams, and topical Clobetasol (topical clobetasol was not effective). The patient had his house checked for bed bugs, but bed bugs were not found, the patient had 2 different skin Biopsies done which did not show anything. The patient had blood work done in which he states his kidney function was not normal, his eGFR was 55 (it had never been that low before), and a repeat of the blood work indicated an eGFR of 70. The patient's Lymphocyte count was very high, and the leucocytes were a little high. The patient had a tooth pulled (reason for the tooth pull was not provided) about 6 weeks ago, and he was prescribed Amoxicillin status post tooth pull. The Dermatologist was considering putting the patient on Dupixent for treatment for the rash. The patient also had Blepharitis, which started around the same time as the rash and He treated the Blepharitis with a Neomycin / Polymyxin eye ointment. The patient stated that he had not ever had Shingles and has been vaccinated with Zostavax. More
2828986 F 03/03/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Exposure during pregnancy, Inappropriate schedule of product administration; Exp... Exposure during pregnancy, Inappropriate schedule of product administration; Exposure during pregnancy, Inappropriate schedule of product administration More
administered boostrix during pregnancy; Boostrix second dose 2weeks apart form; This non-serious pro... administered boostrix during pregnancy; Boostrix second dose 2weeks apart form; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Boostrix and the 1st dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix and Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: administered boostrix during pregnancy) and drug dose administration interval too short (Verbatim: Boostrix second dose 2weeks apart form). The outcome of the vaccine exposure during pregnancy and drug dose administration interval too short were not applicable. Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 13-FEB-2025 Reporter stated that a 30 week pregnant women received Boostrix second dose 2 weeks apart from Boostrix first dose. Boostrix first dose was approximately at 28 weeks pregnancy. There was no patient information available at the moment of the call. Patient received Boostrix during pregnancy, which led to vaccine exposure during pregnancy. The patient received 2nd dose of Boostrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. More
2828987 47 M IN 03/03/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9R2D7
Underdose, Wrong product administered Underdose, Wrong product administered
the administration of Infanrix instead of Tdap to a 47 year old patient; This non-serious case was r... the administration of Infanrix instead of Tdap to a 47 year old patient; 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 47-year-old male patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis. On 19-FEB-2025, the patient received Infanrix. On 19-FEB-2025, an unknown time after receiving Infanrix, the patient experienced adult use of a child product (Verbatim: the administration of Infanrix instead of Tdap to a 47 year old patient). 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: 20-FEB-2025 A nurse called to report the administration of Infanrix instead of Tdap to a 47 year old patient which led to Adult use of a child product. The health care professional was concerned about expected adverse reactions. More
2828988 NC 03/03/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Off label use, Underdose Off label use, Underdose
adult patients but receiving all their pediatric vaccines; Pediatric vaccine to an adult patient/ us... adult patients but receiving all their pediatric vaccines; Pediatric vaccine to an adult patient/ using vaccine off label; Pediatric vaccine to an adult patient/ using vaccine off label; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis. The patient's past medical history included stem cell transplant. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced underdose (Verbatim: adult patients but receiving all their pediatric vaccines), adult use of a child product (Verbatim: Pediatric vaccine to an adult patient/ using vaccine off label) and off label use (Verbatim: Pediatric vaccine to an adult patient/ using vaccine off label). The outcome of the underdose, adult use of a child product and off label use were not applicable. Additional Information: GSK Receipt Date: 20-FEB-2025 The reporter reported the post stem cell transplant patients receive all their childhood vaccines again after transplant. They were vaccinated like a pediatric patient. And were unsure if they require the 2 vial presentation or 1 vial presentation. These were adult patients but receiving all their pediatric vaccines which led to underdose, adult use of a child product and off label use. All of adult patients were receiving the 2 vial presentation. Health care professional did not mentioned how many patients nor any patient information. Even that health care professional mentioned that they administer the Menveo 2 vial. More
2828989 M IN 03/03/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 3RT93
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Kinrix + after recommended age; This non-serious case was reported by a other health professional vi... Kinrix + after recommended age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis. On 20-FEB-2025, the patient received Kinrix. On 20-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix + after recommended age). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:25-FEB-2025 Medical assistant called to report that the Kinrix was administered to a 7-years and 3-months old patient, which led to inappropriate age at vaccine administration. Patient had previously 4 Dtap doses and 3 IPV doses. The reporter consented to follow up via email. More
2828990 18 M MN 03/03/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 EM9E4
Expired product administered Expired product administered
Expired dose administered; This non-serious case was reported by a nurse via call center representat... Expired dose administered; 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 male patient who received HBV (Engerix B) (batch number EM9E4, expiry date 17-FEB-2025) for prophylaxis. On 25-FEB-2025, the patient received Engerix B. On 25-FEB-2025, an unknown time after receiving Engerix B, 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: 25-FEB-2025 Other HCP reported that they had a Hep B vaccine with a case of, that they had arrived at clinic on December 15th, 2024 and they did had a vaccine, a Hep B vaccine that was given but expired on February 17th, 2025. Reporter did gave it on the day of reporting and so, Nurse Manager wanted us to report to see if it was like definitely expired, reporter did not knew if there was a window past the expiration date if it might still be good? and also they just wanted to clarify too, because they did receive this vaccine like just over two months ago, reporter stated that it was kind of unusual that expired that soon, and that was another thing that they wanted to check because they had another vaccines that expires on August of 2026, they usually get them with the same time. Patient received the expired vaccine which led to expired vaccine used. More
2828991 27 F FL 03/03/2025 RAB
 SANOFI PASTEUR
Off label use Off label use
Intentional Off Label Prescription by HCP with no reported AE; Initial information received on 24-Fe... Intentional Off Label Prescription by HCP with no reported AE; Initial information received on 24-Feb-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 27 years old female patient who received intentional off label prescription of rabies (HDC) vaccine [Imovax Rabies] by Healthcare professional with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received intentional off label prescription by HCP of 1 ml of rabies (HDC) vaccine Powder and solvent for suspension for injection (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for Open bite, right thigh, initial encounter (Bite) with no reported adverse event (off label use). Information on the batch number cannot be requested corresponding to the one at time of event occurrence. Action taken was not applicable. More
2828992 MI 03/03/2025 DTAP
FLU3
FLU3
HIBV
MEN
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
UNKNOWN MANUFACTURER




No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
vaccines were administered post excursion with no reported adverse event; Initial information receiv... vaccines were administered post excursion with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age/gender patient who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK], INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] vaccines post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, solution for injection, DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection, lHIB (PRP/T) VACCINE, Powder and solvent for solution for injection, INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED, Suspension for injection and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation: unknown) post excursion with no adverse event (poor quality product administered) (latency same day) (dose, formulation, strength, route, lot and expiry: unknown) in unknown administration site for prophylactic vaccination. Reportedly, there were no previous excursion, human error not involved. not covered by extended stability This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA054065: US-SA-2025SA054013: US-SA-2025SA054381: US-SA-2025SA054097: US-SA-2025SA054040: US-SA-2025SA053939: More
2828993 67 M MI 03/03/2025 FLU3
 SANOFI PASTEUR
 U8515CA
No adverse event, Product storage error No adverse event, Product storage error
FLUZONE HD given post temperature excursion not covered by extended stability with no reported adver... FLUZONE HD given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case linked to other case US-SA-2025SA053939 This case involves 67 years old male patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] post temperature excursion not covered by extended stability with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 14-Feb-2025, the patient received 0.5 ml of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of standard strength once with lot U8515CA and expiry date 30-JUN-2025 via intramuscular route in right Arm for immunization post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (Latency same day) Reportedly, there were no previous excursion, human error not involved. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA053939:FLUZONE HD Patient #1: US-SA-2025SA054381: US-SA-2025SA054097:Fluzone More
2828994 70 M MI 03/03/2025 FLU3
 SANOFI PASTEUR
 U8515CA
No adverse event, Product storage error No adverse event, Product storage error
fluzone hd given post temperature excursion not covered by extended stability with no reported adver... fluzone hd given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case linked to other case US-SA-2025SA053939 This case involves a 70 years old male patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] post temperature excursion not covered by extended stability with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 17-Feb-2025, the patient received influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of standard strength once with lot U8515CA and expiry date 30-JUN-2025 via intramuscular route in right Arm for immunization post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (Latency same day) Reportedly, there were no previous excursion, human error not involved. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA053939:FLUZONE HD Patient 2 More
2828995 34 F MI 03/03/2025 TDAP
 SANOFI PASTEUR
 U8115AA
No adverse event, Product storage error No adverse event, Product storage error
an inappropriate use due to dose of ADACEL given post temperature excursion not covered by extended ... an inappropriate use due to dose of ADACEL given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA054065 (Master case). This case involves a 34 years old female patient to whom had inappropriate use of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] given post temperature excursion not covered by extended stability with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Feb-2025, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 31-Mar-2026 and lot: U8115AA) via intramuscular route in the right arm as immunization and inappropriate use of suspect given post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (latency: same day). Reportedly: "Max/low temperature reached: Negative 0.3 degrees C, Duration: 1 hour, Previous Excursion: no Human error: NO, Administered post-excursion: Yes, 2-Fluzone HD doses, 1-ADACEL dose, and 3-PENTACEL. doses. the extended stability data cover the excursion for BEYFORTUS but no for all other products." Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA054065: More
2828996 0.58 M MI 03/03/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK174AB
No adverse event, Product storage error No adverse event, Product storage error
inappropriate use due to dose of PENTACEL given post temperature excursion not covered by extended s... inappropriate use due to dose of PENTACEL given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA054065 (Master case). This case involves a 7 months old male patient to whom had inappropriate use of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] and given post temperature excursion not covered by extended stability with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine; Rotavirus Vaccine Live Reassort Oral 5v (Rotateq); And Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) for Immunisation. On 17-Feb-2025, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: Mar-2026 and lot UK174AB via intramuscular route in the left leg as immunization and inappropriate use of suspect given post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (latency: same day). Reportedly: "Max/low temperature reached: Negative 0.3 degrees C, Duration: 1 hour, Previous Excursion: no Human error: NO, Administered post-excursion: Yes, 2-Fluzone HD doses, 1-ADACEL dose, and 3-PENTACEL doses. the extended stability data cover the excursion for BEYFORTUS but no for all other products." Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA054065:Fluzone More
2828997 0.42 F MI 03/03/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK112AA
No adverse event, Product storage error No adverse event, Product storage error
an inappropriate use due to dose of pentacel given post temperature excursion not covered by extende... an inappropriate use due to dose of pentacel given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. The case is linked to US-SA-2025SA054097 (Master case). This case involves a 5 months old female patient who had an inappropriate use due to dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] given post temperature excursion not covered by extended stability with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Immunisation; and Pneumococcal Vaccine Conj 20V (CRM197) (PREVNAR 20) for Immunisation. On 14-Feb-2025, the patient received a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UK112AA, Expiry date: 30-Sep-2025, strength was unknown via intramuscular route in the right leg for Immunization and an inappropriate use due to dose of pentacel given post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (latency : same day). Reportedly "Reason: Refrigerator Malfunction Max/low temperature reached: Negative 0.3 degrees c Duration: 1 hour. Previous Excursion? no. Human error? NO. Administered post excursion? YES." Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA053939:PENTACEL Patient 3 US-SA-2025SA054097:Master case More
2828998 CT 03/03/2025 IPV
 SANOFI PASTEUR
No adverse event, Product storage error No adverse event, Product storage error
patient received IPOL after the excursion (with no reported adverse event); Initial information rece... patient received IPOL after the excursion (with no reported adverse event); Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] after the excursion (with no reported adverse event). The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect IPV (VERO) Suspension for injection (Unknown strength, lot and expiry Date) via unknown route in unknown administration site for Immunization after the excursion (with no reported adverse event) (poor quality product administered) (Latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, reporter stated that, Power Outage. Max/low temperature reached: 59.9F for 5 hours product was Opened. Human error not involved. extended stability data did not cover the excursion. Nurse manager also clarified based on the stability calculator that if unpunctured, it's still stable and MIS confirmed. Nurse manager also asked if the vaccine should be repeated since the opened IPOL was given to patient Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2828999 71 F ID 03/03/2025 TDAP
 SANOFI PASTEUR
 U8264A
Injection site bruising, Injection site induration, Injection site warmth, Off l... Injection site bruising, Injection site induration, Injection site warmth, Off label use, Product administered to patient of inappropriate age More
patient looked like they were punched on their left arm because there was bruising and under it; tig... patient looked like they were punched on their left arm because there was bruising and under it; tight spot that seems like a lump; Patient initially felt heat and the bruising got more pronounced; swelling; tight spot that seems like a lump; This situation is pre-assessed as an off-label use as per local labelling due to use in patient older than 65; Initial information received on 20-Feb-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 71 years old female patient who looked like they were punched on their left arm because there was bruising and under it, tight spot that seems like a lump, patient initially felt heat and the bruising got more pronounced, this situation is pre-assessed as an off-label use as per local labelling due to use in patient older than 65 and swelling after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Autoimmune disorder. Concomitant medications included Acetylsalicylic acid (Baby aspirin). On 14-Feb-2025, the patient received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine 1x(once) dose 0.5 ml Suspension for injection (strength-standard) lot U8264A expiry-31-Aug-2026 via intramuscular route in the left deltoid for Immunization, this situation is pre-assessed as an off-label use as per local labelling due to use in patient older than 65 (off label use) (latency same day). On 15-FEB-2025 the patient looked like they were punched on their left arm because there was bruising and under it (contusion), tight spot that seems like a lump (rash) (mass), patient initially felt heat and the bruising got more pronounced (feeling hot) and swelling (latency 1 day). Reportedly, the patient told them about getting ADACEL every 10 years. Pharmacist asked the patient if they were on blood thinners and patient declined but said that they were taking baby aspirin. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the events At time of reporting, the outcome was Not Recovered / Not Resolved for all the events except off label use. More
2829000 24 F CA 03/03/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR

Arthralgia, Burning sensation, Chest pain, Chills, Hypersomnia; Injection site p... Arthralgia, Burning sensation, Chest pain, Chills, Hypersomnia; Injection site pain, Malaise, Pain, Pain in extremity, Pyrexia More
sick; pain radiates to the chest when sleeping; pain in the joint of the arm; sleeping a lot; pain i... sick; pain radiates to the chest when sleeping; pain in the joint of the arm; sleeping a lot; pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire; fever; chills; Initial information received on 20-Feb-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 24 years old female patient who experienced sick, pain radiates to the chest when sleeping, pain in the joint of the arm, sleeping a lot, pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire, fever and chills after receiving Diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength, lot/batch number and expiration date: not provided) for Prophylactic vaccination (immunization). On an unknown date the patient developed sick (illness), pain radiates to the chest when sleeping (chest pain), pain in the joint of the arm (pain in extremity), sleeping a lot (hypersomnia), pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire (vaccination site pain), fever (pyrexia) and chills (unknown latency). Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Not Recovered / Not Resolved for the event pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire, pain radiates to the chest when sleeping, sleeping a lot, pain in the joint of the arm was Unknown for the event fever, sick, chills. More
2829001 0.42 M TX 03/03/2025 FLU3
 SANOFI PASTEUR
 AE2J7
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
used outside of indicated administration age with no reported adverse event; Initial information rec... used outside of indicated administration age with no reported adverse event; Initial information received on 21-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 months old male patient to whom had received Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] and outside of indicated administration age with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap); HIB vaccine conj (tet tox) (Act hib); Pneumococcal vaccine polysacch 23v (Pneumovax) and Iodinated glycerol (Ipol) for Immunisation. On 17-Feb-2025, the 5 months old male patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved Suspension for injection (strength: standard, frequency: once, expiry date: unknown and lot AE2J7) via intramuscular route in unknown administration site as immunization and outside of indicated administration age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829002 1 M TX 03/03/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UJ981AA
Expired product administered, No adverse event Expired product administered, No adverse event
expired dose of PENTACEL was inadvertently administered with no adverse event; Initial information ... expired dose of PENTACEL was inadvertently administered with no adverse event; Initial information received on 21-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient and expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was inadvertently administered to him with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis b vaccine rHBsAg (yeast) (Engerix); Influenza vaccine (Flu); Pneumococcal vaccine conj 7v (CRM197) (Prevnar); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); and Varicella zoster vaccine live (Oka/Merck) (Varivax) all for Immunisation. On 21-Feb-2025, the patient was inadvertently administered an expired dose once of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Powder and suspension for suspension for injection) (lot: UJ981AA; expiry date: 11-Feb-2025) (strength unknown) via intramuscular route in the right thigh for Immunisation (expired product administered) (latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829003 25 F 03/03/2025 YF
 SANOFI PASTEUR
 UK125AA
No adverse event, Product preparation error No adverse event, Product preparation error
instead of the provided diluent, the vaccine was mixed with sterile water (with no reported adverse ... instead of the provided diluent, the vaccine was mixed with sterile water (with no reported adverse event); instead of the provided diluent, the vaccine was mixed with sterile water (with no reported adverse event); Initial information received on 21-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 25 years old female patient to whom had administered Yellow Fever Vaccine - [YF-VAX] was mixed with sterile water instead of the provided diluent (with no reported adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Feb-2025, the patient received a 0.5 ml dose of suspect Yellow Fever Vaccine - Solution for injection (strength: standard, frequency: once, expiry date: 31-Oct-2025 and lot UK125AA) a via subcutaneous route in the left arm as immunization and instead of the provided diluent, the vaccine was mixed with sterile water (with no reported adverse event) (product preparation error) (poor quality product administered) (latency: same day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829004 22 F OH 03/03/2025 IPV
 SANOFI PASTEUR
 X1C891M
Incorrect route of product administration, No adverse event, Wrong product admin... Incorrect route of product administration, No adverse event, Wrong product administered More
patient was supposed to receive a PPD dose, but received IPOL via subdermal route with no adverse ev... patient was supposed to receive a PPD dose, but received IPOL via subdermal route with no adverse event; patient was supposed to receive a PPD dose, but received IPOL via subdermal route with no adverse event; Initial information received on 24-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 22 years old female patient who was supposed to receive a ppd dose, but received IPV (VERO) [IPOL] via subdermal route with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) for Immunisation. On 24-Feb-2025, the patient received a 0.1 ml dose of suspect IPV (VERO) (lot X1C891M , Expiry: 31-Oct-2026, with unknown strength) via subdermal route in the left forearm as Immunization (incorrect route of product administration) but was supposed to receive PPD with no adverse event (wrong product administered) (Latency: same day). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829005 4 F MN 03/03/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UJ981AA
Expired product administered, No adverse event Expired product administered, No adverse event
vaccine was given to a today that had expired with no reported ae; Initial information received on 2... vaccine was given to a today that had expired with no reported ae; Initial information received on 24-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old female patient who had received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] was given to a today that had expired with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for Immunisation; and Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for Immunisation. On 24-Feb-2025, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UJ981AA, Expiry date : 11-Feb-2025, strength was unknown via intramuscular route in unknown administration site for Immunization of vaccine was given to a today that had expired with no reported ae (expired product administered) (latency : same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829006 58 F MI 03/03/2025 TD
 SANOFI PASTEUR
 U8303BA
Product storage error Product storage error
Max/low temperature reached Negative 1.5 F (NEGATIVE 18.6 C) for 48 hours and 45 minutes for and ten... Max/low temperature reached Negative 1.5 F (NEGATIVE 18.6 C) for 48 hours and 45 minutes for and tenivac was administered after excursion occurred with no reported ae; Initial information received on 24-Feb-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 58 years old female patient where max/low temperature reached negative 1.5 F (negative 18.6 c) for 48 hours and 45 minutes for Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] and was administered after excursion occurred with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Feb-2025, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U8303BA and expiration date- 30-SEP-2026) via intramuscular route in the left deltoid (strength: not provided) for Immunization and max/low temperature reached negative 1.5 f (negative 18.6 c) for 48 hours and 45 minutes for and tenivac was administered after excursion occurred with no reported ae (poor quality product administered) (latency- same day). Reportedly, Previous Excursion, Yes; Does extended stability data cover the excursion, No. Action taken- not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829007 CA 03/03/2025 HIBV
 SANOFI PASTEUR
Expired product administered, No adverse event Expired product administered, No adverse event
expired ACTHIB given to a patient, with no reported adverse event; Initial information received on 2... expired ACTHIB given to a patient, with no reported adverse event; Initial information received on 24-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of an unknown age and gender who was given expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2025, the patient was given expired HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (expiry date: 31-Dec-2024) (strength unknown) with no reported adverse event (expired product administered) (latency: same day) via unknown route in unknown administration site for Immunisation. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829008 0.17 F DE 03/03/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UKD43AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
only the DTap-IPV solution was given and the Hib component was not reconstituted with no reported ad... only the DTap-IPV solution was given and the Hib component was not reconstituted with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 weeks old female patient who experienced only the DTAP-IPV solution was given and the HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was not reconstituted with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Feb-2025, the patient received only the DTAP-IPV solution with an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength- unknown, expiry date- 3-Aug-2025 and lot UKD43AA) via intramuscular route in unknown administration site for Immunization and the HIB component was not reconstituted with no reported adverse event (single component of a two-component product administered) (latency- same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829009 47 F MD 03/03/2025 IPV
 SANOFI PASTEUR
 WIC741M
Incorrect route of product administration, No adverse event, Wrong product admin... Incorrect route of product administration, No adverse event, Wrong product administered More
ipol was administered instead of tubersol with no reported adverse event; patient received 0.1cc of ... ipol was administered instead of tubersol with no reported adverse event; patient received 0.1cc of IPOL intradermally with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 47 years old female patient who received IPV (VERO) [IPOL] instead of tuberculin test [Tubersol] and received intradermally with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking dosage unknown route unknown for Tuberculin test. On 25-Feb-2025, the patient received 0.1 cc of IPV (VERO) Suspension for injection with standard strength (expiry date- 17-NOV-2025 and lot WIC741M) once via intradermal route in the left forearm (incorrect route of product administration) for Immunization instead of Tuberculin test Solution for injection with strength- 5-TU (Tuberculin unit) (lot and expiry date- unknown) (wrong product administered) with no reported adverse event (latency- same day). Reportedly, patient visited the ER (Emergency room) right after receiving IPOL and no adverse event was reported. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829010 0.08 NY 03/03/2025 FLU3
 SANOFI PASTEUR
 UT8514NA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
FLUZONE PFS NP if it was given to a 1-month-old with no reported adverse event; Initial information ... FLUZONE PFS NP if it was given to a 1-month-old with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 1-month-old of unknown gender patient whom influenza USP trival A-B subvirion no preservative vaccine [Fluzone] was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Feb-2025, the 1-month-old patient received a 0.5 ml dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection strength: standard of lot UT8514NA and expiry date: 30-Jun-2025 via intramuscular route in the right thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day). Action taken was not applicable. Reportedly, Nurse clarified that no adverse event has been reported This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829011 52 F TX 03/03/2025 IPV
 SANOFI PASTEUR
 W1A102M
Expired product administered, No adverse event Expired product administered, No adverse event
inappropriate use due to the administration of an expired dose of IPOL to a patient with no reported... inappropriate use due to the administration of an expired dose of IPOL to a patient with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 52 years old female patient as inappropriate use due to the administration of an expired dose of IPV (VERO) [IPOL] to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix); Yellow fever vaccine (Yellow fever vaccine); and Typhoid vaccine (Typhoid) for Immunisation. On 24-Feb-2025, the patient received IPV (VERO) Suspension for injection dose 0.5 ml 1x(once) (strength-standard) lot W1A102M expiry-10-Feb-2025 via intramuscular route in the left deltoid for immunization, inappropriate use due to the administration of an expired dose of ipol to a patient with no reported adverse event (expired product administered) (latency same day). Action take: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829012 0.83 M PA 03/03/2025 IPV
 SANOFI PASTEUR
 W1A191M
Expired product administered, No adverse event Expired product administered, No adverse event
inappropriate use due to the administration of an expired dose of ipol to a patient with no reported... inappropriate use due to the administration of an expired dose of ipol to a patient with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 10 months old male patient where patient had inappropriate use of IPV (Vero) [IPOL] due to the administration of an expired dose of ipol to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix); HIB vaccine conj (tet tox) (ACTHIB) and pneumococcal vaccine conj 20V (CRM197) for Immunisation. On 25-Feb-2025, inappropriate use due to the administration of 0.5 ml (once) dose of suspect IPV (VERO) Suspension for injection (Strength- standard) (lot- W1A191M and expiry date- 16-FEB-2025) via intramuscular route in the left thigh for immunization and expired dose of vaccine to a patient with no reported adverse event (expired product administered) (latency- same day). Action taken- not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829017 0.33 M CA 03/03/2025 DTAPHEPBIP
DTAPHEPBIP
PNC20
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
PFIZER\WYETH
 TC47K
TC47K
HR3650
HR3650
Haematochezia, Immunisation reaction, Immunoglobulin therapy, Mouth haemorrhage,... Haematochezia, Immunisation reaction, Immunoglobulin therapy, Mouth haemorrhage, Petechiae; Platelet count decreased; Haematochezia, Immunisation reaction, Immunoglobulin therapy, Mouth haemorrhage, Petechiae; Platelet count decreased More
Patient vaccinated at 4mos appointment on 11/01/2024. Symptoms occurred on n 11/06/2024. Symptoms in... Patient vaccinated at 4mos appointment on 11/01/2024. Symptoms occurred on n 11/06/2024. Symptoms included: blood in stool in diaper, petechiae all over body/inside mouth. Upon advice nurse recommendations-made appt for next day. On arrival at appointment on 11/07/2024 the doctor knew something was wrong and ordered blood stay and had us wait in office for results. Patients blood results came back at 6,000 platelets?normal range is about 130,000-400,00. Patient immediately sent to hospital and admitted upon arrival. IVIG treatment given next day. Platelets increased. Treatment worked to increase platelets for a month and then platelets dropped again to 100,000 in beginning of Jan 2025, then 50,000 in beginning Feb. Still unresolved and unstable condition. Advised by many doctors that this event was a direct result and reaction of the vaccines. Now advised to stop vaccine use until patient shows stability with platelets. More
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2829019 03/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Late 2nd dose.; This non-serious case was reported by a other health professional via call center re... Late 2nd dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (on 23-JUN-2021 received 1st dose). 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: Late 2nd dose.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 24-FEB-2025 The patient got the first dose of Shingrix and had not gotten the 2nd one yet. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. More
2829020 0.92 M MD 03/03/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UJ983AA
Expired product administered, No adverse event Expired product administered, No adverse event
administration of an expired vaccine to a patient with no reported adverse event; Initial informatio... administration of an expired vaccine to a patient with no reported adverse event; Initial information received on 26-Feb-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11-month-old male patient who had administration of an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Feb-2025, the patient received a 0.5 ml dose of expired suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection of lot UJ983AA and expiry date: 12-Feb-2025 via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (latency: on same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2829068 0.25 F IN 03/03/2025 UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Extra dose administered, Inappropriate schedule of product administration; Extra... Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration More
HiB 1/19/1995; HiB 12/16/1993; This spontaneous report has been received from a lawyer, via an immun... HiB 1/19/1995; HiB 12/16/1993; This spontaneous report has been received from a lawyer, via an immunization record from a case in litigation for Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (case # 2249323), concerning a 5-month-old female patient. Concurrent condition and medical history were not reported. Concomitant vaccine included diphtheria vaccine toxoid (+) pertussis vaccine (+) tetanus vaccine toxoid (DTP). On 21-OCT-1993, the patient was vaccinated with the 1st dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) suspension for injection, administered for prophylaxis at a hospital (strength, dose, route, lot#, and expiration date were not reported). On 16-DEC-1993, the patient was vaccinated with the 2nd dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (Inappropriate schedule of product administration). On 18-JUL-1994, the patient was vaccinated with the 3rd dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown). On 19-JAN-1995, the patient was vaccinated with the 4th dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (Extra dose administered). This is one of several reports for the same patient. More
2829069 F IL 03/03/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination Incomplete course of vaccination
Received First Dose on June 4th 2024, and Here for the Second Dose Now; Initial report received on 0... Received First Dose on June 4th 2024, and Here for the Second Dose Now; Initial report received on 07-Feb-2025. A pharmacist reported that a 50-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second dose yet. No medical history or concomitant medications were reported. On 04-Jun-2024, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). On 07-Feb-2025, 248 days after having been vaccinated with HEPLISAV-B, the patient presented to a pharmacy to receive the second dose of HEPLISAV-B. The pharmacist inquired if the patient needed to restart the vaccine series as the first dose was received more than one month prior. The patient has not received the second dose of HEPLISAV-B yet but was in the pharmacy to receive the second dose. No adverse reactions were reported. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2829070 F MA 03/03/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945660
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
16 Year Old Received Dose 1 of HEPLISAV-B; Initial report received on 11-Feb-2025. A nurse reported... 16 Year Old Received Dose 1 of HEPLISAV-B; Initial report received on 11-Feb-2025. A nurse reported that a 16-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history was reported. No concomitant medications were reported. On 10-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 945660, expiration date 31-Jan-2027, NDC# 43528-0003-05)] intramuscularly in the arm. The patient was 16 years old at the time she received HEPLISAV-B. The patient had no adverse effects. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2829071 M CT 03/03/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
Received First Dose in Dec 2023, But Has Not Had the Second Dose; Initial report received on 11-Feb-... Received First Dose in Dec 2023, But Has Not Had the Second Dose; Initial report received on 11-Feb-2025. A nurse reported that a male (age, race, and ethnicity not reported) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Dec-2023 but has not had the second dose yet. No medical history or concomitant medications were reported. In Dec-2023, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). In Feb-2025, at the time of reporting the patient had not received the second dose yet. No adverse reactions were reported. The reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2829072 60 F 03/03/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Ankle fracture, Cardiac failure congestive, Immediate post-injection reaction, I... Ankle fracture, Cardiac failure congestive, Immediate post-injection reaction, Incomplete course of vaccination, Myocardial infarction; Ankle fracture, Cardiac failure congestive, Immediate post-injection reaction, Incomplete course of vaccination, Myocardial infarction More
Heart attack; Congestive heart failure; Broken ankle; Inappropriate schedule of vaccine administered... Heart attack; Congestive heart failure; Broken ankle; Inappropriate schedule of vaccine administered; This serious case was reported by a consumer via call center representative and described the occurrence of heart attack in a 60-year-old female 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 (intramuscular). On an unknown date, the patient did not receive the 2nd dose of Shingrix. In APR-2024, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced heart attack (Verbatim: Heart attack) (serious criteria hospitalization and GSK medically significant), congestive heart failure (Verbatim: Congestive heart failure) (serious criteria hospitalization and GSK medically significant) and ankle fracture (Verbatim: Broken ankle) (serious criteria hospitalization). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the heart attack, congestive heart failure and ankle fracture were resolved with sequelae and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the heart attack, congestive heart failure and ankle fracture to be related to Shingrix. The company considered the heart attack, congestive heart failure and ankle fracture to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter stated she received first dose of Shingrix vaccine in April 2024. She stated that shortly thereafter she had broken her ankle and was in the hospital with a heart attack and congestive heart failure. She was now recovered and ambulatory and wanted to get dose 2 of vaccine Till the time of reporting, the patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination.; Sender's Comments: Myocardial infarction, Cardiac failure congestive and Ankle fracture are unlisted events which are considered unrelated to GSK vaccine Shingrix. More
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2829074 67 F CO 03/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
second Shingrix dose was 1 week late; This non-serious case was reported by a consumer via call cent... second Shingrix dose was 1 week late; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in AUG-2024). On 24-FEB-2025, the patient received the 2nd dose of Shingrix. On 24-FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second Shingrix dose was 1 week late). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter was the patient and reported the second Shingrix dose was 1 week late. The reporter said her pharmacy did not call her that she needed the second dose until 21st February 2025. The reporter received the second Shingrix dose on 25th February 2025 which led to lengthening of vaccination schedule. The reporter did not had the date of the first dose of Shingrix other than it was in August 2024. The pharmacist told her since she was a week late that this would be considered her first dose and she would have to return to get another dose. More
2829075 03/03/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
I got the first shot almost 5 years ago and I got the shingles from the vaccine/I am having another ... I got the first shot almost 5 years ago and I got the shingles from the vaccine/I am having another horrible episode right now; 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 shot almost 5 years ago and I got the shingles from the vaccine/I am having another horrible episode right now). 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: 06-FEB-2025 This case was reported by a patient via interactive digital media. The patient got the first shot almost 5 years ago and got the shingles from the vaccine. It was reported as many people have got shingles from the new vaccines and knows about it. The patient was having another horrible episode right now. The patient thought that he/she was preventing shingles but got it from the 1st Shot and said they could not have the 2nd shot. The follow-up could not be possible as no contact details were available. More
2829076 03/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal Feeling abnormal
feel bad after the Shingrix vaccine/certianly did; This non-serious case was reported by a consumer ... feel bad after the Shingrix vaccine/certianly did; This non-serious case was reported by a consumer and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: feel bad after the Shingrix vaccine/certianly did ). The outcome of the feeling bad was resolved. 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: 17-FEB-2025 The patient posted stating that, some people could feel pretty bad after the Shingrix vaccine, including themselves after receiving it. The patient certainly did. The patient commented that, they did not have any outbreak or a blistering rash.; Sender's Comments: US-GSK-US2025AMR020275:same reporter different patient More
2829077 03/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pruritus, Pustule, Rash vesicular Pruritus, Pustule, Rash vesicular
chicken-pox like violently itchy pustules; This non-serious case was reported by a consumer and desc... chicken-pox like violently itchy pustules; This non-serious case was reported by a consumer and described the occurrence of varicella-like rash in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: chicken-pox like violently itchy pustules). The outcome of the varicella-like rash was not resolved. It was unknown if the reporter considered the varicella-like rash to be related to Shingrix. It was unknown if the company considered the varicella-like rash to be related to Shingrix. Additional Information: GSK Receipt Date: 21-FEB-2025 One week after vaccination developed chickenpox like violently itchy pustules. This case was linked with case US2025AMR023133 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025AMR023133: More
2829078 03/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pruritus, Pustule, Rash vesicular Pruritus, Pustule, Rash vesicular
chickenpox-like itchy pustules; This non-serious case was reported by a consumer and described the o... chickenpox-like itchy pustules; This non-serious case was reported by a consumer and described the occurrence of varicella-like rash in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: chickenpox-like itchy pustules). The outcome of the varicella-like rash was not resolved. It was unknown if the reporter considered the varicella-like rash to be related to Shingrix. It was unknown if the company considered the varicella-like rash to be related to Shingrix. Additional Information: GSK Receipt Date: 21-FEB-2025 One week after vaccination developed chicken-pox like violently itchy pustules.; Sender's Comments: US-GSK-US2025AMR023131: More
2829079 03/03/2025 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; 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. 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: Shingles). The patient was treated with aciclovir (Aclovir). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 22-FEB-2025 This case was reported by a patient via interactive digital media. The patient had both vaccines and have shingles. The patient tried aclovir pills and topical cream and that still has not gotten rid of them. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2. More
2829080 M 03/03/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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 male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: 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 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: 22-FEB-2025 This case was reported by a patient via interactive digital media. The reporter stated that Shingles was a pain, but Shingrix was a disaster. The patient had shingles and took the 2 doses of Shingrix and it came back. The reporter stated that worst yet and his wife and he often breakfast at a small local diner and some of the guys at our group table have taken the double dose 4 times and in the 21 men. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). More
2829081 03/03/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Myalgia Myalgia
Can i take Tylenol for the muscle pain. I just have a shingles vaccine yesterday; This non-serious c... Can i take Tylenol for the muscle pain. I just have a shingles vaccine yesterday; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 20-FEB-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced muscle pain (Verbatim: Can i take Tylenol for the muscle pain. I just have a shingles vaccine yesterday). The outcome of the muscle pain was not reported. It was unknown if the reporter considered the muscle pain to be related to Shingles vaccine. It was unknown if the company considered the muscle pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-FEB-2025 The case was received from the patient via interactive digital media. The reporter asked could he/she took Tylenol for the muscle pain. The patient just had a shingles vaccine a day before day of reporting. More
2829082 03/03/2025 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; got both shots just like they said and got Shingles anyway; This seri... Suspected Vaccination failure; got both shots just like they said and got Shingles anyway; 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: got both shots just like they said and got Shingles anyway). 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: 24-FEB-2025 This case was reported by a patient via interactive digital media. The patient got both shots just like they said and got them anyway, both shots made sick. The patient guess it was a damned. 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 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
2829083 03/03/2025 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; shingles again; Shingles; This serious case was reported by a consume... Suspected vaccination failure; shingles again; 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 Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles again) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved 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 and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. The company considered the vaccination failure, shingles and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 24-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the first vaccine as soon as he/she was old enough and got shingles. The moment they were cleared received the newer 2 dose vaccine and currently have shingles again. 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 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. US-GSK-US2025AMR024379:same patient Case created in error, Deleted More
2829084 0.17 F WI 03/03/2025 HEP
HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 5JX2E
UNK
UNK
UNK
Extra dose administered, Inappropriate schedule of product administration; Extra... Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration More
accidentally administered an adult dose of Engerix-B to a 19 year old patient; accidentally administ... accidentally administered an adult dose of Engerix-B to a 19 year old patient; accidentally administered an adult dose of Engerix-B to a 19 year old patient; 1st on August 18th 2005 and 4th on Feb 6 2006; 1st on August 18th 2005 and 3rd on December 5th 2005; 1st on August 18th 2005 and 2nd on October 13th 2005; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 9-week-old female patient who received HBV (Engerix B adult) (batch number 5JX2E, expiry date 15-DEC-2026) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis. Concomitant products included HEPATITIS B VACCINE (HEPATITIS B). On 17-FEB-2025, the patient received the 5th dose of Engerix B adult. On 06-FEB-2006, the patient received the 4th dose of Hepatitis B vaccine. On 05-DEC-2005, the patient received the 3rd dose of Hepatitis B vaccine. On 13-OCT-2005, the patient received the 2nd dose of Hepatitis B vaccine. On 13-OCT-2005, an unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: 1st on August 18th 2005 and 2nd on October 13th 2005). On 05-DEC-2005, the patient experienced drug dose administration interval too short (Verbatim: 1st on August 18th 2005 and 3rd on December 5th 2005). On 06-FEB-2006, the patient experienced extra dose administered (Verbatim: 1st on August 18th 2005 and 4th on Feb 6 2006). On 17-FEB-2025, the patient experienced adult product administered to child (Verbatim: accidentally administered an adult dose of Engerix-B to a 19 year old patient) and accidental overdose (Verbatim: accidentally administered an adult dose of Engerix-B to a 19 year old patient). The outcome of the adult product administered to child, accidental overdose, extra dose administered, drug dose administration interval too short and drug dose administration interval too long 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: 17-FEB-2025 The patient received 2nd dose, which was later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose, which was earlier than the recommended interval, leading to shortening of vaccination schedule. The patient received 4th dose of Hepatitis B, which was an extra dose administered. The reporter stated that they accidentally administered an adult dose of Engerix-B to a 19 year old patient, which led to adult product administered to child and accidental overdose. The reporter did not have lot number or expiration date for any of the 4 prior doses, brand name not provided. More
2829086 1 M TX 03/03/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 BE9G7
Needle issue Needle issue
needle broke in the patient's leg during Hiberix administration; This non-serious case was repo... needle broke in the patient's leg during Hiberix administration; This non-serious case was reported by a physician via call center representative and described the occurrence of needle stick/puncture in a 1-year-old male patient who received Hib (Hiberix) (batch number BE9G7, expiry date 15-JUL-2026) for prophylaxis. On 19-FEB-2025, the patient received Hiberix. On 19-FEB-2025, less than a day after receiving Hiberix, the patient experienced needle stick/puncture (Verbatim: needle broke in the patient's leg during Hiberix administration). The outcome of the needle stick/puncture was not applicable. It was unknown if the reporter considered the needle stick/puncture to be related to Hiberix. It was unknown if the company considered the needle stick/puncture to be related to Hiberix. Additional Information: GSK Receipt Date: 20-FEB-2025 The physician asked how to proceed after the needle broke in the patient's leg during Hiberix administration. The vaccine administration facility was the same as primary reporter. More
2829087 1 F MN 03/03/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 T9TL9
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
accidentally administered an adult presentation of Havrix to a 12 month old patient on February 21st... accidentally administered an adult presentation of Havrix to a 12 month old patient on February 21st 2025; accidentally administered an adult presentation of Havrix to a 12 month old patient on February 21st 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 12-month-old female patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis. On 21-FEB-2025, the patient received the 1st dose of Havrix adult. On 21-FEB-2025, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: accidentally administered an adult presentation of Havrix to a 12 month old patient on February 21st 2025) and adult product administered to child (Verbatim: accidentally administered an adult presentation of Havrix to a 12 month old patient on February 21st 2025). The outcome of the accidental overdose and adult product administered to child were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 21-FEB-2025 Licensed practical nurse stated that they accidentally administered an adult presentation of Havrix to a 12 month old patient, which led to accidental overdose, adult product administered to child. The reporter refused to provide initials and date of birth of the patient. The vaccine administration facility was the same as primary reporter. More
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