🏥 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 💀 🏥 🚑 ♿ ⚠️
2818783 57 F OH 12/31/2024 COVID19
FLU3
COVID19
FLU3
 MODERNA
SANOFI PASTEUR
MODERNA
SANOFI PASTEUR
 3042573
tfaa2406
Arthralgia; Arthralgia; Muscular weakness, Pain, Pain in extremity, Tenderness; ... Arthralgia; Arthralgia; Muscular weakness, Pain, Pain in extremity, Tenderness; Muscular weakness, Pain, Pain in extremity, Tenderness More
Severe shoulder pain and the patient has been in physical therapy since Severe shoulder pain and the patient has been in physical therapy since
2815014 37 F NJ 12/09/2024 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9R397
UNK
Product use issue, Wrong product administered; Product administered to patient o... Product use issue, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered More
On 12/3/2024, I went to Pharmacy to receive the FLU vaccine. I was told, and it was documented, that... On 12/3/2024, I went to Pharmacy to receive the FLU vaccine. I was told, and it was documented, that I was given the FLU vaccine: Flucelvax Trival 2024-2025 SYR Manufacturer SEQIRUS, LOT #391416. After returning home, I received a phone call that I was not given the FLU vaccine and that the pharmacist made an error and administered the SHINGRIX vaccine for shingles in error. I am postpartum and breastfeeding a 2-month-old infant. While this vaccine is FDA-approved for those 18 and older, I do not represent the intended population for this vaccine, and there is no research available on receipt of this vaccine and breastfeeding. More
2819191 75 M GA 01/02/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 Ff2589, ff2590
Ff2589, ff2590
Blood test, Computerised tomogram, Dyspnoea, Heart rate increased, Interstitial ... Blood test, Computerised tomogram, Dyspnoea, Heart rate increased, Interstitial lung disease; Magnetic resonance imaging, Oxygen saturation decreased, X-ray More
Shortness of breath, inability to move without blood oxygen saturation dropping drastically & ca... Shortness of breath, inability to move without blood oxygen saturation dropping drastically & causing heart rate to spike More
✓ ✓ ✓
2819192 54 M NJ 01/02/2025 COVID19
 PFIZER\BIONTECH
Benign fasciculation syndrome Benign fasciculation syndrome
Benign Fasciculation Syndrome Benign Fasciculation Syndrome
2819193 8 M WA 01/02/2025 IPV
MMR
TDAP
VARCEL
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 X1C891M
Y000224
CX4HL
Y013348
Pain in extremity; Pain in extremity; Pain in extremity; Pain in extremity Pain in extremity; Pain in extremity; Pain in extremity; Pain in extremity
Report pulled from State Profile did not show a hx of vaccination. Patient received an additional do... Report pulled from State Profile did not show a hx of vaccination. Patient received an additional dose of Varicella, MMR, IPV and TDAP. No adverse reaction found after waiting 15 min post vaccination. Parented reported complaints leg pain to Provider during follow up phone call on 1/02/2025. No other symptoms reported, red flag and return precautions provided. More
2819194 47 F PA 01/02/2025 COVID19
 PFIZER\BIONTECH
Tinnitus Tinnitus
Tinnitus?I?ve gone to clinic to see if they can help and they gave me hearing aids. But it does noth... Tinnitus?I?ve gone to clinic to see if they can help and they gave me hearing aids. But it does nothing to stop the constant ringing in both ears. More
2819195 43 M TX 01/02/2025 COVID19
 MODERNA
Death Death
Death Death
✓
2819203 70 M PA 01/02/2025 FLU3
 SANOFI PASTEUR
 U8429BA
Guillain-Barre syndrome, Muscular weakness Guillain-Barre syndrome, Muscular weakness
pt developed BLE weakness approximately 6 days after receiving flu vaccine. Diagnosed w/ Guillain B... pt developed BLE weakness approximately 6 days after receiving flu vaccine. Diagnosed w/ Guillain Barre Syndrome 10/30/24. No other abnormal findings during hospital admission (acute). Received electronic disease notification report of Guillain Barre, reported by Dr. Neurologist. More
✓
2818864 1 U OK 01/01/2025 MMRV
MMRV
MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y002099
Y002099
Y002099
Y002099
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
No additional AE; HCP called and reported administration of PROQUAD to multiple patients after a pos... No additional AE; HCP called and reported administration of PROQUAD to multiple patients after a possible temperature excursion. HCP did not have complete excursion information and patient demographics were unknown. No additional information was known by reporter. No; This spontaneous report has been received from a health care professional, referring a 12-month-old patient of unknown gender. The patient's medical history, previous adverse drug reactions, drug allergy, concurrent conditions, and concomitant medication were not provided. On 17-OCT-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (strength, dose, frequency, route of administration, site of administration, and vaccination scheme were not provided; lot # Y002099 which has been verified to be a valid number, expiration date reported and validated as 09-JUL-2025) as a prophylaxis; which experienced a temperature excursion before administration (product storage error). However, no signs or symptoms were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2412USA006214: US-009507513-2412USA006402: US-009507513-2412USA006216: US-009507513-2412USA006311: US-009507513-2412USA006100: US-009507513-2412USA005703: More
2818865 0.5 F CO 01/01/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK041AA
Product preparation issue Product preparation issue
one of them only received the DTaP-IPV part and not the whole component; Initial information receive... one of them only received the DTaP-IPV part and not the whole component; Initial information received on 23-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional. This case involves, a 6 months old female patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB (Prp/T) Vaccine [Pentacel (Vero)] and one of them only received the DTAP-IPV part and not the whole component. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine; Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) and Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Immunisation. On 22-Nov-2024, the patient received 0.5 ml (Standard) (1 X-once) dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB (Prp/T) Vaccine Suspension for injection (lot UK041AA, 31-Aug-2025) via intramuscular route in the right thigh and one of them only received the DTAP-IPV part and not the whole component (single component of a two-component product administered) (latency- same day). Reportedly, HCP said that in Nov-2024, they had 2 patients that were given PENTACEL. They don't know which child only received the liquid component so they are asking if they need to revaccinate the 2 children. Infant is currently 7 months old but was 6 months old when she received PENTACEL 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
2818871 2 F VA 01/01/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 TF27T
Product storage error Product storage error
Incorrect storage of drug/received Havrix vaccine after temperature excursion; This non-serious case... Incorrect storage of drug/received Havrix vaccine after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 2-year-old female patient who received HAV (Havrix) (batch number TF27T, expiry date FEB-2026) for prophylaxis. On 20-AUG-2024, the patient received the 1st dose of Havrix (intramuscular, right thigh). On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug/received Havrix vaccine after temperature excursion). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK receipt date: 02-DEC-2024 The patient received Havrix vaccine after temperature excursion, which led to incorrect storage of drug. This was 1 of 17 linked report, reported by same reporter; Sender's Comments: US-GSK-US2024123266:Same reporter US-GSK-US2024AMR153927:same reporter More
2818872 M GA 01/01/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Colonoscopy, Herpes zoster, Vaccination failure; Colonoscopy, Herpes zoster, Vac... Colonoscopy, Herpes zoster, Vaccination failure; Colonoscopy, Herpes zoster, Vaccination failure More
suspected vaccination failure; Shingles; Colonoscopy; This serious case was reported by a consumer v... suspected vaccination failure; Shingles; Colonoscopy; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). In DEC-2020, the patient received the 1st dose of Shingrix (unknown arm). 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), shingles (Verbatim: Shingles) and colonoscopy (Verbatim: Colonoscopy). The outcome of the vaccination failure and colonoscopy were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and colonoscopy to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and colonoscopy to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 16-DEC-2024 The patient did not report the location where the vaccine was provided. It was unknown in which arm the vaccines were administered. The patient reported that he got the first dose of Shingrix and received the second dose in April or May of 2021 and had an episode of Shingles after receiving these two doses. The patient did not provide the date of the episodes. The patient reported that recently he got a colonoscopy, and about a week after he had the second episode of shingles and the liquid was provided for the colonoscopy process was a clear cranberry liquid with high concentrations of sugar. The patient reported that he searched and found that high amounts of sugar can trigger shingles. The patient reported that in his case, the shingles have been triggered by the anesthesia and the high concentrations of sugar given during the colonoscopy procedure. The patient reported that he still has shingles, and it has not resolved. The patient inquired that it was recommended to get another series of the vaccine. Not all information was available. Adverse event would be filed with limited information. The patient declined to provide additional information. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2). More
2818873 44 F 01/01/2025 COVID19
FLU3
 UNKNOWN MANUFACTURER
SANOFI PASTEUR
 6024MF012
UT8408LA
Blister, Rash; Blister, Rash Blister, Rash; Blister, Rash
rash; blister; Initial information received on 26-Dec-2024 regarding an unsolicited valid courtesy n... rash; blister; Initial information received on 26-Dec-2024 regarding an unsolicited valid courtesy non-serious case received from a consumer/non-healthcare professional. This case involves a 44 years old female patient who experienced rash and blister after receiving Novavax COVID-19 Vaccine and Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants used. On 04-Oct-2024, the patient received a dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (lot UT8408LA, with unknown strength, dose and expiry) via intramuscular route in unknown administration site as prophylactic vaccination. On 04-Oct-2024, the patient received a 0.5 ml dose of suspect Novavax COVID-19 Vaccine not produced by Sanofi Pasteur injection (lot 6024MF012, with unknown strength and expiry) via intramuscular route in unknown administration site as Covid-19 immunization. On 05-OCT-2024 the patient developed large rash (rash) on back of right thigh. Raised vesicles approximately 3mm in diameter (blister). Started behind and above the knee (Latency: 1 day) following the administration of Influenza Usp Trival A-B Subvirion No Preservative Vaccine and Novavax COVID-19 Vaccine. Action taken: not applicable. Treatment: Applied topical hydrocortisone was used with no effect. Continues to spread up leg wrapping towards the groin. Only stopped and reversed by using Benadryl 2-3 times/day for next 5 days. At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2024 for the events. More
2818892 56 M CA 01/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administration error Product administration error
Patient received the vaccine about 19 hours after reconstitution; This non-serious case was reported... Patient received the vaccine about 19 hours after reconstitution; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of drug administration error in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 02-DEC-2024, the patient received Shingrix. On 02-DEC-2024, an unknown time after receiving Shingrix, the patient experienced drug administration error (Verbatim: Patient received the vaccine about 19 hours after reconstitution). The outcome of the drug administration error was unknown. Additional Information: GSK Receipt Date: 03-DEC-2024 The pharmacist reported that the patient received the vaccine about 19 hours after reconstitution of subsequent dose of Shingrix vaccine, which led to drug administration error. More
2818893 F 01/01/2025 COVID19
RSV
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Pain in extremity; Pain in extremity Pain in extremity; Pain in extremity
sore arm; This non-serious case was reported by a consumer via interactive digital media and describ... sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. On an unknown date, the patient received Arexvy and COVID-19 vaccine. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not resolved. The reporter considered the pain in arm to be related to Arexvy. The company considered the pain in arm to be related to Arexvy. Additional Information: GSK receipt date: 02-DEC-2024 This case was reported by a patient via interactive digital media. Reporter reported that, she went right away and received her RSV and new Covid vaccine on same day. The RSV packed quite a punch with a sore arm but she was good as new and protected. The reporter considered the pain in arm to be related to COVID-19 vaccine. The follow-up could not be possible as no contact details were available. More
2818895 5 F VA 01/01/2025 DTAPHEPBIP
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 E9Y29
BM4R5
Product storage error; Product storage error Product storage error; Product storage error
Incorrect storage of drug; This non-serious case was reported by a other health professional and des... Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 5-year-old female patient who received HAV (Havrix) (batch number BM4R5, expiry date APR-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date OCT-2024) for prophylaxis. On 10-SEP-2024, the patient received Havrix (intramuscular, right thigh) and Pediarix (intramuscular, right thigh). On an unknown date, an unknown time after receiving Havrix and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 02-DEC-2024 The patient received Pediarix and Havrix vaccines after temperature excursion, which led to an incorrect storage of drug. No adverse event were reported. This was 1 of 17 linked cases, reported by same reporter.; Sender's Comments: US2024AMR153742:Original Case : US2024AMR153742 US-GSK-US2024AMR153917:Original Case : US2024AMR153742 US-GSK-US2024AMR153918:Original Case : US2024AMR153742 US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024AMR153920:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153924:Original Case : US2024AMR153742 US-GSK-US2024AMR153925:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter More
2818896 10 F VA 01/01/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 LB93L
TD2FD
Product storage error; Product storage error Product storage error; Product storage error
received Menveo and Boostrix vaccines after temperature excursion; This non-serious case was reporte... received Menveo and Boostrix vaccines after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number LB93L, expiry date JUN-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number TD2FD, expiry date MAY-2026) for prophylaxis. On 27-AUG-2024, the patient received the 1st dose of Menveo (intramuscular, left deltoid) and the 1st dose of Boostrix (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Menveo and Boostrix, the patient experienced incorrect storage of drug (Verbatim: received Menveo and Boostrix vaccines after temperature excursion). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received Menveo and Boostrix vaccines after temperature excursion, which led to an incorrect storage of drug. No adverse event were reported. This was 1 of 17 linked cases, reported by same reporter.; Sender's Comments: US-GSK-US2024AMR153916:Original Case : US2024AMR153742 US-GSK-US2024AMR153742:Original Case : US2024AMR153742 US-GSK-US2024AMR153918:Original Case : US2024AMR153742 US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024AMR153920:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153924:Original Case : US2024AMR153742 US-GSK-US2024AMR153925:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024123268:Same reporter US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024123266:Same reporter More
2818897 13 F VA 01/01/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 NR394
Product storage error Product storage error
Incorrect storage of drug; This non-serious case was reported by a other health professional and des... Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number NR394, expiry date JUL-2025) for prophylaxis. On 20-AUG-2024, the patient received the 1st dose of Menveo (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received menveo vaccine. The other health professional reported that she does not know which vaccines were administered after the temperature excursion to which patients which led to incorrect storage of drug. This was 1 of 15 cases reported by same reporter.; Sender's Comments: US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter More
2818898 5 M VA 01/01/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 E9Y29
Product storage error Product storage error
vaccines were administered after the temperature excursion; This non-serious case was reported by a ... vaccines were administered after the temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date OCT-2025) for prophylaxis. On 11-SEP-2024, the patient received the 5th dose of Pediarix (intramuscular, left thigh). On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: vaccines were administered after the temperature excursion). The outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received Pediarix vaccine. The other health professional reported that she does not know which vaccines were administered after the temperature excursion to which patients which led to incorrect storage of drug. This was 1 of 15 cases reported by same reporter.; Sender's Comments: US-GSK-US2024123266:Same reporter US-GSK-US2024123268:Same reporter More
2818899 3 U VA 01/01/2025 HEPA
HIBV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 TF27T
7AC3C
Product storage error; Product storage error Product storage error; Product storage error
Incorrect storage of drug; This non-serious case was reported by a other health professional and des... Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 3-year-old patient who received Hib (Hiberix) (batch number 7AC3C, expiry date SEP-2025) for prophylaxis. Co-suspect products included HAV (Havrix) (batch number TF27T, expiry date FEB-2026) for prophylaxis. Previously administered products included Hiberix (Received first dose on unknown date), Hiberix (Received second dose on unknown date) and Hiberix (Received third dose on unknown date). Additional patient notes included Ethnicity. On 19-AUG-2024, the patient received the 4th dose of Hiberix (intramuscular, left thigh) and the 1st dose of Havrix (intramuscular, right thigh). On an unknown date, an unknown time after receiving Hiberix and Havrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK receipt date: 02-DEC-2024 The patient received Hiberixand Havrix vaccine after temperature excursion, which led to incorrect storage of drug. This was 1 of 17 linked report, reported by same reporter.; Sender's Comments: US-GSK-US2024AMR153916:Original Case : US2024AMR153742 US-GSK-US2024AMR153917:Original Case : US2024AMR153742 US-GSK-US2024AMR153918:Original Case : US2024AMR153742 US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024AMR153920:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153742:Original Case : US2024AMR153742 US-GSK-US2024AMR153925:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter More
2818900 5 U VA 01/01/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 BM4R5
Product storage error Product storage error
received Havrix vaccine after temperature excursion; This non-serious case was reported by a other h... received Havrix vaccine after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 5-year-old patient who received HAV (Havrix) (batch number BM4R5, expiry date APR-2026) for prophylaxis. Additional patient notes included: (redacted) On 21-AUG-2024, the patient received the 1st dose of Havrix (intramuscular, left thigh). On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: received Havrix vaccine after temperature excursion). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received Havrix vaccine after temperature excursion, which led to an incorrect storage of drug. No adverse event were reported. This was 1 of 17 linked cases, reported by same reporter.; Sender's Comments: US-GSK-US2024AMR153916:Original Case : US2024AMR153742 US-GSK-US2024AMR153917:Original Case : US2024AMR153742 US-GSK-US2024AMR153918:Original Case : US2024AMR153742 US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024AMR153920:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153924:Original Case : US2024AMR153742 US-GSK-US2024AMR153742:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter More
2818901 14 F VA 01/01/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 95D74
Product storage error Product storage error
administered after temperature excursion; This non-serious case was reported by a other health profe... administered after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 14-year-old female patient who received HBV (Engerix B) (batch number 95D74, expiry date MAR-2025) for prophylaxis. On 21-AUG-2024, the patient received the 3rd dose of Engerix B (right deltoid). On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: administered after temperature excursion). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received Engerix B vaccine. As per the reporter it was not sure which vaccines were administered after the temperature excursion which led to incorrect storage of drug. This was 1 of 15 cases reported by same reporter.; Sender's Comments: US-GSK-US2024123266:Same reporter US-GSK-US2024123268:Same reporter More
2818902 14 F VA 01/01/2025 HEP
HEPA
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 95D74
BM4R5
TD2FD
Product storage error; Product storage error; Product storage error Product storage error; Product storage error; Product storage error
Incorrect storage of drug; This non-serious case was reported by a other health professional and des... Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TD2FD, expiry date MAY-2026) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 95D74, expiry date MAR-2025) for prophylaxis and HAV (Havrix) (batch number BM4R5, expiry date APR-2026) for prophylaxis. Additional patient notes included patient weight: 119. On 05-AUG-2024, the patient received the 1st dose of Boostrix (intramuscular, left deltoid), the 1st dose of Engerix B (intramuscular, right deltoid) and the 2nd dose of Havrix (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Boostrix, Engerix B and Havrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received Boostrix, Engerix -B and Havrix vaccine. The other health professional reported that she does not know which vaccines were administered after the temperature excursion to which patients which led to incorrect storage of drug. This was 1 of 15 cases reported by same reporter. More
2818903 U 01/01/2025 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 three times; This serious case was reported by a consumer vi... Suspected vaccination failure; shingles three times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year 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 three times). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine 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: 17-DEC-2024 This case was reported by a patient via interactive digital media. Reporter reported that patient had the shingles shot about a year ago then had the second one a couple months after that. In less than a year patient had the shingles three times. This case was considered as suspected vaccination failure as details regarding completion of time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine shingles dose 1 and shingles dose 2. More
2818904 M NY 01/01/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4T39P
4T39P
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
drug dose interval too short; drug dose interval too long; This non-serious case was reported by a n... drug dose interval too short; drug dose interval too long; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 19-year-old male patient who received HBV (Engerix B adult) (batch number YY37B, expiry date 24-AUG-2026) and (batch number 4T39P, expiry date 09-DEC-2025) for prophylaxis. Co-suspect products included HBV (Engerix B adult) (batch number 4T39P, expiry date 09-DEC-2025) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b adulto). On 02-DEC-2024, the patient received the 3rd dose of Engerix B adult. On 12-JUL-2024, the patient received the 2nd dose of Engerix B adult. On 12-JUL-2024, not applicable after receiving Engerix B adult, not applicable after starting Engerix B adult and an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: drug dose interval too long). On 02-DEC-2024, the patient experienced drug dose administration interval too short (Verbatim: drug dose interval too short). The outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-DEC-2024 Nurse reported that she administered a third dose of Engerix-B to a patient on 02-DEC-2024. She administered an adult dose to the patient. She initially thought the patient had received an adult dose for the first two doses as well when she was looking at the medical record and recorded NDC numbers, and so she asked the doctor if it was ok for the patient to also receive an adult dose, and the doctor said yes. After the nurse had administered the adult dose, she was looking back in the chart and realized they may not have received adult dose for the first two doses, based on billing charges. However, lot number she provided for first two doses does correspond with adult formulation. The patient received second dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received Third dose of Engerix B earlier than recommended interval, which led to shortening of vaccination schedule. More
2818905 F MA 01/01/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 77KA5
Occupational exposure to product Occupational exposure to product
vaccine leak; Product Complaint; While trying to remove bubble in pre-filled syringe, the vaccine le... vaccine leak; Product Complaint; While trying to remove bubble in pre-filled syringe, the vaccine leaked onto the nurse's ungloved hand; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure via skin contact with product in a female patient who received Men B NVS (Bexsero) (batch number 77KA5, expiry date 30-NOV-2027) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Bexsero. On 02-DEC-2024, an unknown time after receiving Bexsero, the patient experienced occupational exposure via skin contact with product (Verbatim: While trying to remove bubble in pre-filled syringe, the vaccine leaked onto the nurse's ungloved hand). On an unknown date, the patient experienced product leakage (Verbatim: vaccine leak) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the occupational exposure via skin contact with product, product leakage and pharmaceutical product complaint were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-DEC-2024 The reporter stated that seven Bexsero pre-filled syringes each contained a large (full width of the syringe, about half the volume of vaccine), clear, air bubble that was observed during preparation for administration and was unable to be remove without wasting vaccine. While trying to remove bubble during this phone call, the vaccine leaked onto the nurse's ungloved hand which led to occupational exposure via skin contact with product. Confirmed that all operations were performed appropriately before the defect was discovered. The product was not administered. There were not any visible damage present on the syringe. There were not any temperature excursions during storage. The product was at room temperature when particle was observed. Requested return of the suspect pre-filled syringes and all the original packaging without further manipulation/handling. More
2818906 U GA 01/01/2025 DTAPHEPBIP
DTAPIPV
MENB
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS



Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error More
Improper Storage Error; This non-serious case was reported by a physician via call center representa... Improper Storage Error; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Kinrix, Boostrix, Pediarix and Bexsero. On an unknown date, an unknown time after receiving Kinrix, Boostrix, Pediarix and Bexsero, the patient experienced incorrect storage of drug (Verbatim: Improper Storage Error). The outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-DEC-2024 The physician reported that the stability data for Bexero, Kinrix, Pedarix and Boostrix which was stored at 8.7 degree Celsius for 45 minutes on 01-MAY-2024, patient involvement and at 8.1 degree Celsius for approximately 18 minutes may be lower, patient involvement. The vaccine was administered to patients after temperature excursion prior to confirming stability of vaccines, which led to incorrect storage of drug. More
2818907 U TN 01/01/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
received an expired dose; This non-serious case was reported by a pharmacist via call center represe... received an expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a child patient who received Hib (Hiberix) (expiry date 23-OCT-2024) for prophylaxis. On 03-DEC-2024, the patient received Hiberix. On 03-DEC-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: received an expired dose). The outcome of the expired vaccine used was unknown. Additional Information: GSK receipt date: 04-DEC-2024 The reporter reported that the patient received an expired dose of Hiberix vaccine which led to, expired vaccine used. The reporter did not had lot number of the vaccine or demographics for the patient. More
2818908 1 F VA 01/01/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
expired dose administered; This non-serious case was reported by a other health professional via cal... expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received Hib (Hiberix) (expiry date 12-NOV-2024) for prophylaxis. On 06-DEC-2024, the patient received Hiberix. On 06-DEC-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown. Additional Information: GSK receipt date: 06-DEC-2024 The clinic supervisor reported that an expired dose of Hiberix was administered to a patient today (on the day of reporting) which led to, expired vaccine used. The reporter did not have lot number at the time of the call. The vaccine administration facility was the same as primary reporter. More
2818909 M LA 01/01/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 ES49H
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
gave a dose of Bexsero to an 8 year old patient/wrong age; This non-serious case was reported by a n... gave a dose of Bexsero to an 8 year old patient/wrong age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received Men B NVS (Bexsero) (batch number ES49H, expiry date 31-MAY-2027) for prophylaxis. On 22-NOV-2024, the patient received the 1st dose of Bexsero. On 22-NOV-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: gave a dose of Bexsero to an 8 year old patient/wrong age). The outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-DEC-2024 Nurse reported that they had an administration error since they gave a dose of Bexsero to an 8 year old patient. It was the first dose of a meningitis b vaccine for the patient. The Vaccine Administration Facility was the same as primary reporter. The patient received Bexsero earlier than the recommended age which led to inappropriate age at vaccine administration. More
2818910 47 F PA 01/01/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2XK44
Device connection issue, Injury associated with device Device connection issue, Injury associated with device
one Flulaval TIV pre-filled syringe, and was stuck by the needle in her right hand due to this detac... one Flulaval TIV pre-filled syringe, and was stuck by the needle in her right hand due to this detachment of the LLA and needle when trying to engage the safety on the needle; Syringe issue; Product Complaint; the practice is no longer engaging the safety on the needle in order to keep using the Flulaval pre-filled syringes; This non-serious case was reported by a other health professional via call center representative and described the occurrence of needle stick/puncture in a 47-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 2XK44, expiry date 13-JUN-2025) for prophylaxis. This case was associated with a product complaint. On 19-NOV-2024, the patient received FluLaval 2024-2025 season. On 19-NOV-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced needle stick/puncture (Verbatim: the practice is no longer engaging the safety on the needle in order to keep using the Flulaval pre-filled syringes). On an unknown date, the patient experienced accidental exposure while administering drug (Verbatim: one Flulaval TIV pre-filled syringe, and was stuck by the needle in her right hand due to this detachment of the LLA and needle when trying to engage the safety on the needle), syringe connection issue (Verbatim: Syringe issue) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the needle stick/puncture, accidental exposure while administering drug and pharmaceutical product complaint were unchanged and the outcome of the syringe connection issue was unknown. It was unknown if the reporter considered the needle stick/puncture and syringe connection issue to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. It was unknown if the company considered the needle stick/puncture and syringe connection issue to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-DEC-2024 The reporter was a medical assistant calling to report that the practice has had 6 Flulaval TIV pre-filled syringes, that all 6 doses, when the healthcare professional finish administering the doses and go to engage the safety on the needle, the entire needle and LLA fall off the end of the pre-filled syringes. The reporter stated that they did administer all 6 of these suspect doses and will administer 7 other doses from this same shipment. The reporter states that her GSK Field Representative asked all practice locations via email, to call GSK and ask to have all remaining doses in the practices for this lot replaced. The reporter stated that the GSK Field Representative states GSK was already taking care of this situation. The reporter stated that this practice has 420 unused Flulaval doses for return for replacement. The 433 quantity affected includes the 6 suspect doses, the 7 unused doses the practice will continue to use, and the 420 unused doses for return to GSK. The reporter did confirm there was no damage due to shipping. None of the 6 suspect doses were available for return, as the needles and the pre-filled syringes have all been disposed in Sharps. The healthcare professional administering the 6 suspect doses are all experienced. The Product Instructions for use were reviewed step by step. A picture of the defect cannot be sent, as the 6 suspect needles and syringes have all been disposed in Sharps. Confirmation that all operations were performed appropriately before defect was discovered. The reporter asked at what step was the defect discovered. The defect was discovered after administration for each of the 6 suspect doses, when trying to engage the safety of the needle. It was not known where the 6 suspect pre-filled syringes were located in the multi pack. The 6 suspect doses were all administered. The component involved in all 6 suspect doses was the LLA with the safety needles attached. Luer Lok Adaptor (LLA) was detached or rotating, at what step did the detaching or rotating of the LLA occur. The LLA was detached from the end of the 6 suspect pre-filled syringes when the healthcare professional were trying to activate the safety on the needle. During injection, did any leaking occur during this step and if so, where was the leak location, No. If the needles used were still available, request return of them along with the other components. None of the 6 suspect needles were available for return. The needle stick was on 19th November 2024. If safety needle used, what brand and type of safety needle was it, Terumo Sureguard 3. The reporter was asking for replacement for 420 doses of Flulaval TIV. The healthcare professional would call back with this information. Replacement was pending the account and the case will be escalated to team liaison. The reporter was a Medical Assistant calling to report that an HCP in the practice had a needle stick from one Flulaval TIV pre-filled syringe and was stuck by the needle in her right hand due to this detachment of the LLA and needle when trying to engage the safety on the needle. The reporter also stated that because of this concern, the practice was no longer engaging the safety on the needle in order to keep using the Flulaval pre-filled syringes. The reporter had reported all that was provided about these adverse events. More
2818911 62 M MA 01/01/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Brain fog, Diarrhoea, Headache, Muscle discomfort, Musculoskeletal discomfort; R... Brain fog, Diarrhoea, Headache, Muscle discomfort, Musculoskeletal discomfort; Rhinorrhoea More
brain fog; muscle joints (reports it feels like an "ice pick" and described as a "tea... brain fog; muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps); runny nose; headache; diarrhea; muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps); Initial information received on 19-Dec-2024 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 62 years old male patient who experienced brain fog, muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps), runny nose, headache and diarrhea after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadtt]. 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 1 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot number, dose, strength and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination. There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. On an unknown date the patient developed brain fog, muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps) (muscle strain) (myalgia), runny nose (rhinorrhoea), headache and diarrhea (diarrhoea) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine. Action taken: not applicable. The patient was treated with Iptacopan Hydrochloride Monohydrate (Fabhalta) for Headache, Rhinorrhoea and Diarrhoea. At time of reporting, the outcome was Unknown for the events. More
2818912 11 M TN 01/01/2025 DTAP
 SANOFI PASTEUR
 3CA03C3
No adverse event, Wrong product administered No adverse event, Wrong product administered
given daptacel instead of adacel with no reported adverse event; Initial information received on 30-... given daptacel instead of adacel with no reported adverse event; Initial information received on 30-Dec-2024 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi); and HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) both for Immunisation. On 17-Dec-2024, the patient received 0.5 ml of diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection with standard strength (expiry date- 30-Sep-2025 and lot 3CA03C3) once via intramuscular route in the left arm as Immunization instead of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot number not reported) with no reported adverse event (wrong product administered) (latency- same day). 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
2818913 M MD 01/01/2025 FLU3
FLU3
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 No batch number
No batch number
Chills, Cough, Headache, Oropharyngeal pain, Pain; Pyrexia Chills, Cough, Headache, Oropharyngeal pain, Pain; Pyrexia
Chills; Fever; Sore throat; Cough; felt like he was hit by a truck; Headaches; This spontaneous case... Chills; Fever; Sore throat; Cough; felt like he was hit by a truck; Headaches; This spontaneous case, initially received on 18-Dec-2024, was reported by a non health professional and concerns an adult male patient. Administration of company suspect drug(s): On an unknown date, the patient received Fluvirin for Flu vaccine, Flu vaccine, Flu vaccine., dose, route of administration and anatomical location were not provided. Lot number: No batch number available. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Chills (outcome: Unknown), Fever (outcome: Unknown), Sore throat (outcome: Unknown), Cough (outcome: Unknown), felt like he was hit by a truck (outcome: Unknown), Headaches (outcome: Unknown). Consumer called to inquire about an alternative flu vaccine. He received the flu vaccine three years in a row and had a rection. He explained after an hour or 2 getting vaccine he experienced chills, fever, dore throat, cough. He felt like he was hit by a truck. He had never had a reaction with other vaccines such as covid, pneumonia, tetanus. He mentioned he did not have an egg allergy. Unable to determine what year he received the vaccine. He stopped taking few years ago. Patient called back and stated the medication was Fluvirin. He had it 10 years ago 2015 season. He also reported headaches after receiving the vaccine. Symptoms went away after a couple hours. Fluvirin action taken: Not Applicable Reporter's assessment: The reporter considered the events as non serious and causality was not reported.; Reporter's Comments: All events were considered related. More
2818914 0.25 M CA 01/01/2025 PNC20
RV1
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 HR3650
32PF3
Miliaria, Rash, Urticaria; Miliaria, Rash, Urticaria Miliaria, Rash, Urticaria; Miliaria, Rash, Urticaria
Hives, rashes spreading through out his whole that comes and goes. Hives, rashes spreading through out his whole that comes and goes.
2818915 33 F IN 01/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Muscular weakness, Myalgia, Pyrexia Muscular weakness, Myalgia, Pyrexia
fever, muscle pain in legs and thighs, muscle weakness in legs upon standing fever, muscle pain in legs and thighs, muscle weakness in legs upon standing
2818916 32 F SC 01/01/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH

Exposure during pregnancy, Gestational diabetes, Induced labour, Premature baby,... Exposure during pregnancy, Gestational diabetes, Induced labour, Premature baby, Premature labour; Spontaneous rupture of membranes More
Patient was 33-34 weeks pregnant when RSV vaccine was received on 11/15/24. This was the patients 1s... Patient was 33-34 weeks pregnant when RSV vaccine was received on 11/15/24. This was the patients 1st pregnancy. Patient had gestational diabetes (diet controlled) and no other complications noted . Due date was 12/24/24, with a scheduled induction for 12/17/24. Patient experienced spontaneous rupture of membranes on 11/XX/24, was transported to the hospital, induced with oxytocin, then gave birth to preterm baby on 11/XX/24 at 7pm. Birth weight was 5 lbs 10 oz. Newborn was initially admitted to the ICU for monitoring due to low birth weight. Newborn was discharged from hospital on 11/XX/24 with no further complications. Newborn is healthy and well nourished as of 1/1/25. Preterm labor was 9 days after receiving the dose of RSV vaccine (Abrysvo). More
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2818917 58 M OH 01/01/2025 COVID19
FLU3
 NOVAVAX
SEQIRUS, INC.
 6024mf016a
388532
Burning sensation, Injection site bruising, Injection site pain, Needle issue, X... Burning sensation, Injection site bruising, Injection site pain, Needle issue, X-ray normal; Burning sensation, Injection site bruising, Injection site pain, Needle issue, X-ray normal More
Pt received two injections in the left arm on 10/29/24. When Injecting the novavax vaccine it was di... Pt received two injections in the left arm on 10/29/24. When Injecting the novavax vaccine it was discovered that the needle was faulty (needle would not allow injection to occur) and had to be switched out after initial poke to a new needle. Injection had no issue once needle was swapped. Pt states that over the next few days a bruise developed that extended down his entire left bicep and he started to develop a burning sensation about 3 days after injection. The sensation shoots from top of bicep to mid forearm and occasionally moves down to finger tips. Certain movements when he moves from close to body to out of body can aggravate the sensation, lifting weights or letting arm hang do not aggravate. Pt presented to urgent care on 11/3/24. They did an x ray and could not find anything wrong. Patient started OTC ibuprofen 400 mg every 8 hours. He is unsure that it was helping or if it was more of a placebo effect. Pt went to clinic for an annual check up 12/13. Was prescribed to start physical therapy which he will start on 1/6. Clinic hopes to do an MRI to get further imaging results after physical therapy is started. More
2818918 0.33 F CA 01/01/2025 DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 U7907AA
U7907AA
HR3650
HR3650
2032353
2032353
Bone disorder, Bone marrow oedema, Infant irritability, Injected limb mobility d... Bone disorder, Bone marrow oedema, Infant irritability, Injected limb mobility decreased, Magnetic resonance imaging abnormal; Skin oedema, X-ray limb abnormal; Bone disorder, Bone marrow oedema, Infant irritability, Injected limb mobility decreased, Magnetic resonance imaging abnormal; Skin oedema, X-ray limb abnormal; Bone disorder, Bone marrow oedema, Infant irritability, Injected limb mobility decreased, Magnetic resonance imaging abnormal; Skin oedema, X-ray limb abnormal More
Baby reported as fussy starting after the vaccine, admitted to hospital 17 days after vaccine with d... Baby reported as fussy starting after the vaccine, admitted to hospital 17 days after vaccine with decreased left leg movement and increased fussiness, found to have abnormal XR and MRI of left thigh consistent with possible osteomyelitis, treated with IV antibiotics and now home on po antibiotics, still with decreased leg movement at time of this report. More
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2818919 64 M OH 01/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 E7335
Burning sensation, Electromyogram, Laboratory test Burning sensation, Electromyogram, Laboratory test
Patient reports diffuse burning sensation, felt like he was burning from the inside out approximatel... Patient reports diffuse burning sensation, felt like he was burning from the inside out approximately three three weeks after vaccination More
2818920 53 F AZ 01/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Condition aggravated, Herpes simplex, Herpes simplex test positive Condition aggravated, Herpes simplex, Herpes simplex test positive
The injection reactivated a mostly dormant HSV-2 infection. HSV-2 outbreaks have been continuous fo... The injection reactivated a mostly dormant HSV-2 infection. HSV-2 outbreaks have been continuous for two years. Before the vaccine, outbreaks occurred approximately once per year. More
2818921 57 F AZ 01/01/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EL8982
EL8982
EL8982
EL9264
EL9264
EL9264
EW0191
EW0191
EW0191
Acoustic stimulation tests abnormal, Blood test normal, Cerebrovascular accident... Acoustic stimulation tests abnormal, Blood test normal, Cerebrovascular accident, Computerised tomogram heart normal, Echocardiogram normal; Fundoscopy, Headache, Hypoacusis, Magnetic resonance imaging head abnormal, Migraine; Tinnitus, Tremor, Ultrasound Doppler, Visual acuity tests, Visual impairment; Acoustic stimulation tests abnormal, Blood test normal, Cerebrovascular accident, Computerised tomogram heart normal, Echocardiogram normal; Fundoscopy, Headache, Hypoacusis, Magnetic resonance imaging head abnormal, Migraine; Tinnitus, Tremor, Ultrasound Doppler, Visual acuity tests, Visual impairment; Acoustic stimulation tests abnormal, Blood test normal, Cerebrovascular accident, Computerised tomogram heart normal, Echocardiogram normal; Fundoscopy, Headache, Hypoacusis, Magnetic resonance imaging head abnormal, Migraine; Tinnitus, Tremor, Ultrasound Doppler, Visual acuity tests, Visual impairment More
Stroke (TIA) occurred 11/21/2023. Partial loss eye sight, hand tremor, partial hearing loss with sev... Stroke (TIA) occurred 11/21/2023. Partial loss eye sight, hand tremor, partial hearing loss with severe tinnitus and moderate headaches that developed into debilitating migraines requiring ER attention and abortive medication. More
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2818922 51 F TX 01/01/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 YZ27N
YZ27N
YZ27N
Bickerstaff's encephalitis, Diplopia, Fatigue, Gait disturbance, Guillain-B... Bickerstaff's encephalitis, Diplopia, Fatigue, Gait disturbance, Guillain-Barre syndrome; Headache, Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal; Nausea, Neuralgia More
Received vaccine on 7/1/2023 and was hospitalized with a diagnosis of Guillain-Barre on 7/13/2023. ... Received vaccine on 7/1/2023 and was hospitalized with a diagnosis of Guillain-Barre on 7/13/2023. Woke up on 7/13/2023 with double vision, headache, gait instability. No fever no diarrhea, no vomiting, did have some nausea. By about 5 to 6 pm needed assistance walking and was admitted. Received IVIG after a week to 10 days was sent to inpatient rehab. Was seen on f/u at Neurology clinic in 9/2023 and diagnosed with a variant of Guillain-Barre called Bickerstaff Brainstem Encephalitis. Most problematic and persistent symptoms is neuropathic pain to legs and easily fatigue. More
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2818924 61 M MN 01/01/2025 COVID19
 MODERNA
 8080748
Bell's palsy, Borrelia test negative, Facial paralysis Bell's palsy, Borrelia test negative, Facial paralysis
Left sided 7th nerve palsy (Bell's Palsy) Left sided 7th nerve palsy (Bell's Palsy)
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2818925 59 M WI 01/01/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Asthenia, Chills, Musculoskeletal discomfort, Pruritus, Rash; Sensitive skin, Te... Asthenia, Chills, Musculoskeletal discomfort, Pruritus, Rash; Sensitive skin, Tenderness More
Dec 3 - patient began feeling chills, low energy, generally poor as might be typical per the listed ... Dec 3 - patient began feeling chills, low energy, generally poor as might be typical per the listed side effects of this vaccine. These symptoms continued through Dec 4 & 5. On Dec 6 (+3 days) discomfort was felt on right hip, tender to the touch. Patient had a right total hip arthroplasty on August 6, four months prior. Dec 7 - hip tenderness increased and a rash covering buttocks on right side was noticed. Patient has never had a rash from any cause previously. Rash lasted until December 11, 4-5 days, after which the skin was sensitive and itchy. Symptoms dissipated from that date forward. More
2818927 51 M CT 01/01/2025 COVID19
 MODERNA
 3043837
Chills, Dyspnoea, Vomiting Chills, Dyspnoea, Vomiting
chills, vomit and shortness of breath chills, vomit and shortness of breath
2818928 39 F CA 01/01/2025 COVID19
 MODERNA
 046A21A
Herpes zoster, Malaise Herpes zoster, Malaise
Severe shingles started after one day, went to urgent care 3 days later and twice more. Took 3 month... Severe shingles started after one day, went to urgent care 3 days later and twice more. Took 3 months to recover. 3 years later still have lingering long covid symptoms More
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2818929 34 F MN 01/01/2025 TDAP
TDAP
VARCEL
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.



Blister, Discomfort, Oral disorder, Pruritus, Throat lesion; Varicella virus tes... Blister, Discomfort, Oral disorder, Pruritus, Throat lesion; Varicella virus test positive; Blister, Discomfort, Oral disorder, Pruritus, Throat lesion; Varicella virus test positive More
Developed vesicular lesions on head, neck, torso, arms and legs on 11/19/24. Within a week there we... Developed vesicular lesions on head, neck, torso, arms and legs on 11/19/24. Within a week there were approximately 500+ lesions. At day 8 there were no new lesions and over the next 10 days the lesions scabbed and healed. Lesions were uncomfortable and itchy. A few lesions were present in the mouth/throat. More
2818930 4 M CA 01/01/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Gait disturbance, Injection site erythema, Injection site hypersensitivity, Inje... Gait disturbance, Injection site erythema, Injection site hypersensitivity, Injection site swelling, Irritability More
Swelling of thigh for about 4 days, mild fever (Tylenol), sensitivity to injection site, limping for... Swelling of thigh for about 4 days, mild fever (Tylenol), sensitivity to injection site, limping for about 4 days, increased irritability, redness over whole thigh where injection site was. More
2818931 42 M WA 01/01/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 007C21A
007C21A
007C21A
007C21A
007C21A
Blood cholesterol, Blood test, Chest X-ray, Dizziness, Dyspnoea; Electrocardiogr... Blood cholesterol, Blood test, Chest X-ray, Dizziness, Dyspnoea; Electrocardiogram, Facial pain, Fatigue, Fibromyalgia, Hypoaesthesia; Impaired work ability, Insomnia, Limb discomfort, Mobility decreased, Oral pain; Orthostatic hypotension, Pain in jaw, Scan myocardial perfusion, Stool analysis, Urine analysis; Vertigo positional More
Pain in face/jaw/mouth, severe insomnia for two months (treatment at two months: trazodone 50 mg), f... Pain in face/jaw/mouth, severe insomnia for two months (treatment at two months: trazodone 50 mg), fatigue/exhaustion, dizziness, light headedness, shortness of breath, heavy limbs, numb fingers, positional vertigo, orthostatic hypotension. This developed into a chronic condition without recovery which progressed in severity. Exertion caused extreme exhaustion the next day and for several days after, some exertion caused worsening illness which did not improve with rest. I had to stop working altogether and live in bed for the last year. this illness has been for over 3.5 years so far (jan 1 2025). Still working with specialists on exact diagnosis. Rheumatologist diagnosed fibromyalgia and suspected ME/CFS as well. More
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