🏥 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 💀 🏥 🚑 ♿ ⚠️
2854794 F WA 08/19/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
All my shots are through Pfizer/got it (COVID) this weekend/prescribed Paxlovid; All my shots are th... All my shots are through Pfizer/got it (COVID) this weekend/prescribed Paxlovid; All my shots are through Pfizer/got it (COVID) this weekend/prescribed Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "auto immune issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE (All my shots are through Pfizer)), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "All my shots are through Pfizer/got it (COVID) this weekend/prescribed Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient was just prescribed Paxlovid. Maybe she got crazy symptoms and she not thinking. 5 1/2 years, she has not had COVID and suddenly she was at a wedding, and she thought that's how she got it this weekend. She hasn't had anything for 5 1/2 years thanks to Pfizer. But you know being at a wedding with 5 million people around me and no masks she guess she can see how it happened. All my shots are through Pfizer, every one of them. It's just she was super high risk she have auto immune issues. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2854795 74 F MA 08/19/2025 COVID19
 PFIZER\BIONTECH
 EN6208
Fatigue, Pyrexia, Vaccination site pain Fatigue, Pyrexia, Vaccination site pain
pain at injection site; fever; tiredness; This is a spontaneous report received from a Consumer or o... pain at injection site; fever; tiredness; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), in arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis", start date: Feb2017 (ongoing); "Interstitial lung disease", start date: Feb2017 (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown", described as "tiredness". More
2854796 16 F OH 08/19/2025 IPV
 SANOFI PASTEUR
 Y1A212M
Incorrect route of product administration, No adverse event, Wrong product admin... Incorrect route of product administration, No adverse event, Wrong product administered More
inappropriate use due to the administration of ipol instead of the intended ppd with no adverse even... inappropriate use due to the administration of ipol instead of the intended ppd with no adverse event; ipol administered intradermally with no reported adverse event; Initial information received on 18-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old female patient who was inappropriately administered to IPV (Vero) [IPOL] instead of the intended ppd and was administered intradermally with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Aug-2025, the patient received 0.1mL (frequency once) of suspect IPV (Vero) (lot Y1A212M, expiry date 31-Jan-2027, strength standard) via intradermal route in unknown administration site for Immunization and inappropriately administered to Ipol instead of the intended ppd with no adverse event (wrong product administered) and also administered intradermally with no reported adverse event (incorrect route of product administration) (latency same day). Reportedly, the administration had taken place within 30 minutes of the call and requested information on any adverse reactions to look for in the patient after this administration. 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
2854797 17 M GA 08/19/2025 HEPA
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 7PK53
KH2BD
Y000202
Blood pressure decreased, Syncope; Blood pressure decreased, Syncope; Blood pres... Blood pressure decreased, Syncope; Blood pressure decreased, Syncope; Blood pressure decreased, Syncope More
Client had 2 episodes of syncope, B/P were low 70's/50's. Asked parent if he wanted stude... Client had 2 episodes of syncope, B/P were low 70's/50's. Asked parent if he wanted student to be evaluated at the ER. Parent agreed. Pt went to ER via ambulance . Pt eval at ER and sent home, per father. Checked with parent at 3pm client home resting and tired. More
2854798 39 M UT 08/19/2025 HEP
IPV
MMRV
VARCEL
 DYNAVAX TECHNOLOGIES CORPORATION
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 946062
Y1A201M
Z007212
Y015100
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered More
The patient was accidentally given Proquad, MMRV instead of just MMR. The patient was notified of t... The patient was accidentally given Proquad, MMRV instead of just MMR. The patient was notified of the mistake, the manufacturer was contacted for any possible reactions. Noted that there may be an adverse reaction due to the higher varicella dose. Patient as of now has not reaction. Will contact us if he does have an adverse reaction. More
2854799 68 F MN 08/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93n4j
Paraesthesia Paraesthesia
Patient reports arm tingling since vaccination approximately 1 month ago. She reports that she also ... Patient reports arm tingling since vaccination approximately 1 month ago. She reports that she also asked her doctor about the arm tingling. More
2854812 88 F SD 08/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
No adverse event, Product preparation issue No adverse event, Product preparation issue
Shingrix vaccine administered by charge nurse. Vaccine not reconstituted prior to administration, Ad... Shingrix vaccine administered by charge nurse. Vaccine not reconstituted prior to administration, Adjuvant only administered. No adverse effects noted. Resident stayed at facility. PCP and Pharmacy updated. More
2854813 20 F LA 08/19/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 2553X
Extra dose administered, No adverse event, Wrong product administered Extra dose administered, No adverse event, Wrong product administered
PATIENT REQUESTED HEPATITIS B VACCINE BUT WAS GIVEN HEPATITIS A AND B COMBINATION (TWINRIX). PATIEN... PATIENT REQUESTED HEPATITIS B VACCINE BUT WAS GIVEN HEPATITIS A AND B COMBINATION (TWINRIX). PATIENT HAD NO ADVERSE EVENT, BUT ERROR WAS NOTICED ON PATIENT'S 3RD DOSE. THERE WAS A FLAG ON THE IMMUNIZATION SYSTEM DUE TO PATIENT RECEIVING 2 PREVIOUS DOSES OF HEPATITIS A WHICH MADE 4 TOTAL HEPATITIS A DOSES AND RAISED THE RED FLAG. More
2854814 18 M CA 08/19/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB072A
Rash, Skin warm Rash, Skin warm
Patient's mother called stating patient starting getting a rash all over his body specifically ... Patient's mother called stating patient starting getting a rash all over his body specifically on both his arms, trunk, and peck. Patient's mother also states that his right arm is hot as well. Was recommended that the patient should take Benadryl and go to Urgent care in case symptoms become worse. Mother said she will take his to urgent care. More
2854815 68 M SC 08/19/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was given a dose when he had one in june of 2024. No adverse effects. Patient was given a dose when he had one in june of 2024. No adverse effects.
2854816 53 M 08/19/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 37R35
37R35
Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood thyroi... Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood thyroid stimulating hormone normal, Full blood count normal, Metabolic function test normal; Presyncope, Vertigo More
near syncope, followed by vertigo near syncope, followed by vertigo
2854817 59 F CO 08/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 NR4T5
Dizziness, Extra dose administered, Myalgia Dizziness, Extra dose administered, Myalgia
Patient mistakenly received a 3rd dose of Shingrix (prior doses in (withheld state) on 10/28/22 and ... Patient mistakenly received a 3rd dose of Shingrix (prior doses in (withheld state) on 10/28/22 and 6/6/23) patient had called to verify vaccine status with provider in (withheld state) and they only saw teh 06/06/23 dose, informing patinet to get second dose. patient has experienced severe light headedness, muscle aches through out body but so far nothing recommending hospitalization or beyond what might be expected with a strong reaction to a "2nd" dose More
2854818 54 F VA 08/19/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH

Arthralgia, Blood test normal, Injected limb mobility decreased, Muscle spasms, ... Arthralgia, Blood test normal, Injected limb mobility decreased, Muscle spasms, Pain; Pain in extremity, Tendonitis, X-ray limb abnormal More
7/31/2025 - received Prevanar 20 vaccination as part of routine visit to PCP 8/1/2025 - arm became i... 7/31/2025 - received Prevanar 20 vaccination as part of routine visit to PCP 8/1/2025 - arm became increasingly sore throughout the day 8/2/2025 - pain increased to the point I was unable to lift my right arm above my head 8/3/2025 - sever pain continued; unable to move right arm without pain 8/4/2025 - contacted doctor's office 8/5/2025 - doctor visit; Dr. prescribed methylprednisolon (MEDROL, PAK) 4mg tablet for acute pain in the right shoulder 8/6/2025-8/7/2025 - improvement noted, although still did not regain range of motion 8/8/2025-8/9/2025 - pain increased; started having intense burst of pain in upeer arm (muscle spasms) 8/9/2025 - treated at health clinic and later that evening treated at Hospital. Patient First physician prescribed Methocarbamol 500mg tablets and Tramadol 50mg tablets. ER physician administered morphine intravenously to relieve pain. Lab (blood tests) run with no significant findings noted. ER advised to stop taking Tramadol and instead prescribed Hyrocodone-Acetamin in addition to the Methcarbamol. 8/10/2025 - 8/12/25 - Pain was managed, but range of motion was still very limited. 8/13/2025 - Follow-up visit to PCP. Dr. referred me to orthopedic specialist. 8/14/2025 - Was seen by orthodpedic specialist. She performed an X-ray and then proceeded to give me a bethasone acetate-betamethasone sodium phosphate (CELESTONE) injection 6mg 8/14-2025 - 8/19/2025 - significant improvement noted in pain level and range of motion; can still feel light spasms at times but can move my arm as needed More
2854404 51 F VA 08/18/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH

Back pain, Fatigue, Pain, Product administered to patient of inappropriate age, ... Back pain, Fatigue, Pain, Product administered to patient of inappropriate age, Pyrexia; Rhinorrhoea More
Aches, fever, fatigue, runny nose, cough, aching back Aches, fever, fatigue, runny nose, cough, aching back
2854405 16 M 08/18/2025 MNQ
 SANOFI PASTEUR
 U8369BA
Disorientation, Headache, Hypotonia, Pallor Disorientation, Headache, Hypotonia, Pallor
Patient received MCV4 to his left arm. After vaccination, his parent asked him if he was okay, he c... Patient received MCV4 to his left arm. After vaccination, his parent asked him if he was okay, he could respond for a while and leaned on the chair. Eyes are closed and his face was pale. Patient is breathing and alert, but not oriented. Elevated his legs, provided water and wet towel. He wiped his face with wet towel and drank two cups of water. After 4 vital taken, he became more oriented. He complained of a little headache. Instructed patient to remain in the waiting area for 15 more minutes. He could stand up and walk to the waiting area without any problem. More
2854410 TX 08/18/2025 MMRV
 MERCK & CO. INC.
 Z009075
No adverse event, Product storage error No adverse event, Product storage error
Nurse called and reported PROQUAD was administered to a patient after being involved in a temperatur... Nurse called and reported PROQUAD was administered to a patient after being involved in a temperature excursion. Caller stated PROQUAD and VARIVAX were also administered to multiple other patients. See AE cases 02856250, 02856303, 02856305, 02856306,; Caller stated no patient symptoms have been reported; This spontaneous report was received from a licensed vocational nurse (L.V.N) and refers to a patient of unknown age and gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 11-Aug-2025, the patient started was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), solution for injection (lot #Z009075, expiration date: 15-Nov-2026), reconstituted with sterile diluent (MERCK STERILE DILUENT), solution for injection (lot# and expiration date was not reported), 1 dose, as prophylaxis (route of administration and anatomical location were not reported); that was involved in a temperature excursion of -8C, during 15 minutes (a previous excursion had not occurred). The reporter stated no patient symptoms have been reported. This was one of 7 reports received by the same reporter. More
2854411 TX 08/18/2025 MMRV
 MERCK & CO. INC.
 Y019463
No adverse event, Product storage error No adverse event, Product storage error
Nurse called and reported PROQUAD was administered to a patient after being involved in a temperatur... Nurse called and reported PROQUAD was administered to a patient after being involved in a temperature excursion. Caller stated PROQUAD and VARIVAX were also administered to multiple other patients. See AE cases 02856250, 02856303, 02856304, 02856306,; Caller stated no patient symptoms have been reported; This spontaneous report was received from a licensed vocational nurse (L.V.N) and refers to a patient of unknown age and gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 11-Aug-2025, the patient started was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), solution for injection (lot #Y019463, expiration date: 24-May-2026), reconstituted with sterile diluent (MERCK STERILE DILUENT), solution for injection (lot# and expiration date was not reported), 1 dose, as prophylaxis (route of administration and anatomical location were not reported); that was involved in a temperature excursion of -8C, during 15 minutes (a previous excursion had not occurred). The reporter stated no patient symptoms have been reported. This was one of 7 reports received by the same reporter. More
2854412 F NY 08/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
she has not received a second dose; This non-serious case was reported by a consumer via call center... she has not received a second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2021). Concomitant products included rituximab. The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: she has not received a second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date:29-JUL-2025 The reporter was the patient who received her first dose of Shingrix in 2021. She had not received a second dose. She also stated that her doctor has prescribed Valtrex prophylactically to prevent shingles. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2854413 0.17 M AR 08/18/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administered not in recommended age; This non-serious case was reported by a pharmacist via call cen... administered not in recommended age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis. On 23-JUL-2025, the patient received the 1st dose of Kinrix. On 23-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered not in 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: 07-AUG-2025 Pharmacist reported a vaccine was inadvertently administered not in the recommended age group. The physician wanted to know what the next step were. The 2 months old patient received Kinrix, which led to an inappropriate age at vaccine administration. More
2854414 20 M CA 08/18/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB064A
Product preparation issue Product preparation issue
Menveo only liquid portion given; Menveo only liquid portion given; This non-serious case was report... Menveo only liquid portion given; Menveo only liquid portion given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 07-AUG-2025, the patient received Menveo. On 07-AUG-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo only liquid portion given) and inappropriate dose of vaccine administered (Verbatim: Menveo only liquid portion given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date:07-AUG-2025 The pharmacist called to report only the liquid portion of the Menveo vaccine was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered More
2854415 M IN 08/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 332L4
Product preparation issue Product preparation issue
potentially administered with the adjuvant alone without the Lyophilized Antigen component; potentia... potentially administered with the adjuvant alone without the Lyophilized Antigen component; potentially administered with the adjuvant alone without the Lyophilized Antigen component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 332L4, expiry date 04-APR-2027) for prophylaxis. On 31-JUL-2025, the patient received Shingrix. On 31-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: potentially administered with the adjuvant alone without the Lyophilized Antigen component) and inappropriate dose of vaccine administered (Verbatim: potentially administered with the adjuvant alone without the Lyophilized Antigen component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 08-AUG-2025 The vaccine administration facility was the same as primary reporter. Clinical supervisor called to ask about the specific timeframe or additional vaccine administration for a valid dose of Shingrix, since five patients were potentially administered (they were not sure) with the adjuvant alone without the Lyophilized Antigen component, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025103162:same reporter US-GSK-US2025103160:same reporter US-GSK-US2025103644:Same reporter More
2854416 32 M AZ 08/18/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 AHBVD184AC
Inappropriate schedule of product administration Inappropriate schedule of product administration
administration of a late second dose; This non-serious case was reported by a pharmacist via call ce... administration of a late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 32-year-old male patient who received HBV (Engerix B) (batch number AHBVD184AC) for prophylaxis. Previously administered products included Engerix b (received first dose in DEC-2024). On 08-AUG-2025, the patient received the 2nd dose of Engerix B. On 08-AUG-2025, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: administration of a late second dose). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-AUG-2025 The pharmacist called to report the administration of a late second dose of the Engerix-B vaccine to a male patient who received the first dose back in December 2024 and she wanted to know what the schedule for the third shot is. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2854417 13 F TX 08/18/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 4T93R
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
received the Havrix, the adult dose instead of the pediatric dose; Unapproved age; This non-serious ... received the Havrix, the adult dose instead of the pediatric dose; Unapproved age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old female patient who received HAV (Havrix 1440 adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis. Previously administered products included Havrix (1st dose received on 18-SEP-2024). On 11-AUG-2025, the patient received the 2nd dose of Havrix 1440 adult. On 11-AUG-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: received the Havrix, the adult dose instead of the pediatric dose) and adult product administered to child (Verbatim: Unapproved age). The outcome of the 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: 11-AUG-2025 The medical assistant reported they had a patient who received the Havrix, the adult dose instead of the pediatric dose today on the day of reporting, which led to an overdose and adult product administered to child. The reporter wanted to know if GlaxoSmithKline have any recommendations. More
2854418 32 F 08/18/2025 TDAP
 SANOFI PASTEUR
 48420AA
No adverse event, Product storage error No adverse event, Product storage error
vaccine administered post excursion with no reported adverse event; Initial information received on ... vaccine administered post excursion with no reported adverse event; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 32 years old female patient (170.18 cm and 122.73 kg) who was administered with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] 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 an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot 48420AA,expiry date:31-Aug-2027, via unknown route in unknown administration site for prophylactic vaccination (immunisation) post excursion with no reported adverse event (poor quality product administered) (latency: same day). Reportedly,Vaccine fridge out of range temperature. 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
2854419 1 M UT 08/18/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK342AA
No adverse event, Product preparation error No adverse event, Product preparation error
medication error/an inappropriate use due to the reconstituting the ACTHIB component PENTACEL with s... medication error/an inappropriate use due to the reconstituting the ACTHIB component PENTACEL with sterile water with no reported adverse event; Initial information received on 12-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient and there was inappropriate use due to the reconstituting the acthib component Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Caller reported that 0.5mL of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK342AA, expiry date 31-Aug-2026) via intramuscular route in the left thigh for Immunisation and on 11-Aug-2025, an inappropriate use due to the reconstituting the acthib component pentacel with sterile water with no reported adverse event (product preparation error). 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
2854420 19 F TX 08/18/2025 MEN
 UNKNOWN MANUFACTURER
 U8361AA
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
menquadfi was administered but was given did intradermally instead of intramuscularly with no report... menquadfi was administered but was given did intradermally instead of intramuscularly with no reported adverse event; about 0.2 ml of menquadfi was given in the error/after the error was discovered a proper dose of menquadfi was administered intramuscularly with no reported adverse event; When the tb test was placed by a medical assistant (MA), the patient complained that it was hurting; Initial information received on 12-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 years old female patient who was administered to Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] but was given did intradermally instead of intramuscularly with no reported adverse event, about 0.2 ml of menquadfi was given in the error/after the error was discovered a proper dose of menquadfi was administered intramuscularly and when the Tuberculin Test [Tubersol] was placed by a medical assistant (ma), the patient complained that it was hurting. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) for Product used for unknown indication. On 11-Aug-2025, the patient received 0.2mL of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (lot U8361AA, expiry date 31-Mar-2028) via intradermal route in the left forearm, also received an unknown dose of vaccine (lot U8361AA, expiry date 31-Mar-2028) via intramuscular route in unknown administration site and Tubersol (Tuberculin Test) Solution for injection, (lot 4CA02C1 and expiry date on 31-Jan-2028) dosage unknown for prophylactic vaccination (Immunisation). On 11-Aug-2025, the patient was administered to menquadfi but was given intradermally instead of intramuscularly with no reported adverse event (incorrect route of product administration), 0.2 ml of menquadfi was given in the error/after the error was discovered a proper dose of menquadfi was administered intramuscularly with no reported adverse event (extra dose administered) and when the tb test was placed by a medical assistant (ma), the patient complained that it was hurting (vaccination site pain) following Tuberculin Test and Meningococcal A-C-Y-W135 (T Conj) Vaccine. Reportedly, After the the mistake, the patient was fine. The caller planned to continue to check with the patient about her status. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (vaccination site pain). At time of reporting, the outcome was Unknown for the event (vaccination site pain). 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
2854421 F 08/18/2025 FLU3
 SANOFI PASTEUR
 U8764BB
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
warm just below the injection site; had a red reaction just below the injection site; small, puffy, ... warm just below the injection site; had a red reaction just below the injection site; small, puffy, swollen just below the injection site; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves an unknown age female patient who had a red reaction, small, puffy, swollen and warm just below the injection site after receiving influenza usp trival a-b high dose subvirion vaccine [Fluzone hd]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Aug-2025, the patient received an unknown dose of suspect influenza usp trival a-b high dose subvirion vaccine, Suspension for injection in pre-filled syringe (lot U8764BB and expiry date: 30-Jun-2026) (strength not reported) via unknown route in unknown administration sit for influenza. On an unknown date in Aug-2025, the patient had a red reaction, small, puffy, swollen, warm just belowthe injection site (vaccination site erythema) (vaccination site swelling) (vaccination site warmth) (latency: Few days approximately). Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events. More
2854424 08/18/2025 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 on my right hand, wrist, and arm; This serious case was repo... suspected vaccination failure; shingles on my right hand, wrist, and arm; 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 on my right hand, wrist, and arm). 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: 03-AUG-2025 and 06-AUG-2025 This case was reported by a patient via interactive digital media. Patient had 2 shots within the last few years (from the date of reporting) and now (at the time of reporting) have shingles on his/her right hand, wrist, and arm. This case was considered as suspected vaccination failure as details regarding time to onset 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 & 2). More
2854425 MD 08/18/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product preparation issue Product preparation issue
A patient received only the liquid portion of Menveo; A patient received only the liquid portion of ... A patient received only the liquid portion of Menveo; A patient received only the liquid portion of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: A patient received only the liquid portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: A patient received only the liquid portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 05-AUG-2025 A pharmacy manager called to report that a patient received only the liquid portion of Menveo, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional asked what they should do next. More
2854426 M IA 08/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Second dose of Shingrix has not yet been administered; This non-serious case was reported by a pharm... Second dose of Shingrix has not yet been administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (received a dose in 2007) and Shingrix (1 dose received on 10-DEC-2019). The patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Second dose of Shingrix has not yet been administered). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 05-AUG-2025 Pharmacist reported, till the time of reporting, the patient did not receive second dose of Shingrix, which led to an incomplete course of vaccination. More
2854471 MO 08/18/2025 MMR
MMR
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered
No additional AE; HCP called and reported a patient who received a dose of inactivated polio vaccine... No additional AE; HCP called and reported a patient who received a dose of inactivated polio vaccine (IPV) and a dose of PROQUAD on 24JUL2025. Patient also received two total doses of MMR-II in 2023. No additional information was provided. No additional AE/PQC.; HCP called and reported a patient who received a dose of inactivated polio vaccine (IPV) and a dose of PROQUAD on 24JUL2025. Patient also received two total doses of MMR-II in 2023. No additional information was provided. No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a 7-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Polio vaccine inactivated (IPV). On an unspecified dates in 2023, the patient received two total doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered by unknown route (lot # and expiration date were not reported) as prophylaxis (Inappropriate schedule of product administration). On 24-Jul-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 1 dosage form, administered by unknown route (lot # and expiration date were not reported) as prophylaxis (Extra dose administered). The suspect vaccines were reconstituted with sterile diluent (no details reported). No additional information was provided. No additional adverse events. At the reporting time, the outcome of the events was unknown. The action taken with the suspect products was not reported, but established as not applicable. More
2854472 MS 08/18/2025 HPV9
 MERCK & CO. INC.
 Y013407
No adverse event, Product storage error No adverse event, Product storage error
No symptoms reported.; Customer called to report TE. GARDASIL 9 was administered to one patient.; Th... No symptoms reported.; Customer called to report TE. GARDASIL 9 was administered to one patient.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 04-AUG-2025, the patient was vaccinated with an improper stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (lot #Y013407, which had been verified to be a valid lot number, expiration date reported and confirmed as 01-FEB-2027) as prophylaxis. Temperature excursion was reported as 35.89 F with a time frame of 30 minutes. No previous temperature excursion. No symptoms reported (no adverse event). More
2854473 M 08/18/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Cerebrovascular accident Cerebrovascular accident
Stroke; This serious case was reported by a consumer via interactive digital media and described the... Stroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced stroke (Verbatim: Stroke) (serious criteria GSK medically significant). The outcome of the stroke was not reported. It was unknown if the reporter considered the stroke to be related to RSV vaccine. The company considered the stroke to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a consumer via interactive digital media. The reporter stated that more poison they were trying to get to take, husband was in very good health passed heart test with flying colors then got the RSV vaccine and had a stroke. So did not tell vaccines were safe keep believing that nonsense sooner or later they will catch up. The reporter stated all brainwashed if believe that information about vaccines were good let your own body heal you. And if keep getting those vaccines body could not fight.; Sender's Comments: A case of Cerebrovascular accident, an unknown time after receiving RSV vaccine, in a male patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2854474 12 M 08/18/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 U6952AA
Extra dose administered Extra dose administered
maladministration/2nd dose received; This non-serious case was reported by a other health profession... maladministration/2nd dose received; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number U6952AA) for prophylaxis. Previously administered products included Menveo (first dose given on 7 Feb 2020 in (lot number AMVA199A, expiry date 03 Sep 2020). On 13-AUG-2021, the patient received the 2nd dose of Menveo. On 13-AUG-2021, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: maladministration/2nd dose received). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 23-JUL-2025 The patient received a dose of Menveo at healthcare professional office at age 11. Dose given on 07 Feb 2020. According to state immunization registry, a dose of Menveo was given when patient was 12 and half years. The dose was not given in the healthcare professional office and was only noted on the registry as having been administered 13 Aug 2021 which led to extra dose administered. According to the healthcare professional, patient did not report any event at the time of the 2nd dose administration. They inquire if the patient should still get Menveo booster dose at 16 if he received 2 doses already. More
2854475 1 M 08/18/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Kinrix vaccine was given to a 23-month-old patient; This non-serious case was reported by a physicia... Kinrix vaccine was given to a 23-month-old patient; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis. On 07-AUG-2025, the patient received the 1st dose of Kinrix. On 07-AUG-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix vaccine was given to a 23-month-old patient). 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: 07-AUG-2025 The medical clinic supervisor reported that a Kinrix vaccine was given to a 23-month-old patient, which led to inappropriate age at vaccine administration. The reporter asked does it count and was it a valid dose. The Vaccine Administration Facility is the same as Primary Reporter More
2854476 08/18/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Erythema, Swelling Erythema, Swelling
redness; swelling; This non-serious case was reported by a pharmacist via sales rep and described th... redness; swelling; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of erythema in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 05-AUG-2025, the patient received Menveo. In AUG-2025, less than a week after receiving Menveo, the patient experienced erythema (Verbatim: redness) and swelling (Verbatim: swelling). The outcome of the erythema and swelling were unknown. It was unknown if the reporter considered the erythema and swelling to be related to Menveo. It was unknown if the company considered the erythema and swelling to be related to Menveo. Additional Information: GSK Receipt Date: 08-AUG-2025 The pharmacy buyer reported about a potential reaction to Menveo and the patient had the readiness and swelling. No more information at this time and said will fill out additional report once more information is obtained This case is linked with US2025102720, by the same reporter; Sender's Comments: US-GSK-US2025102720:Diffrent patient More
2854477 F 08/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
ended up with shingles; This non-serious case was reported by a consumer and described the occurren... ended up with shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 28-JUL-2025, the patient received the 2nd dose of Shingles vaccine. On 29-JUL-2025, 1 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: ended up with shingles). The patient was treated with valaciclovir (Valacyclovir). 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: 10-AUG-2025 The patient received shingles vaccine on 28-Jul-2025 and ended up with shingles from 29-Jul-2025. Reporter seriousness for ended up with shingles was reported as intervention required. More
2854478 08/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Skin ulcer, Stress, Vaccination failure Herpes zoster, Skin ulcer, Stress, Vaccination failure
Suspected vaccination failure; got shingles on my surgery leg; Stress; This serious case was report... Suspected vaccination failure; got shingles on my surgery leg; Stress; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included surgery. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles on my surgery leg) and stress (Verbatim: Stress). The outcome of the vaccination failure, shingles and stress were not reported. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and stress to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-AUG-2025 This case was reported by a patient via interactive digital media. The patient had shingles shot before EAD perfected. The patient was under a lot of stress last year, got shingles on the surgery leg. It was reported as the patient caught one soar and right away went to doctor. The patient had only got 3 soars. The patient took medication and was fortunate. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2854479 08/18/2025 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; had 3 attacks of shingles in an unmentionable area; This serious case... suspected vaccination failure; had 3 attacks of shingles in an unmentionable area; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 3 attacks of shingles in an unmentionable area). 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: 07-AUG-2025 This case was reported by a patient via interactive digital media. The patient had it now in an unmentionable area and he/she had both of the vaccines. This was the patient's 3rd attack of shingles and by far the worst. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2854480 F WI 08/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Back pain, Fatigue, Nausea, Pain Back pain, Fatigue, Nausea, Pain
Low back pain (without radiation); Nausea; Fatigue; Ache; This non-serious case was reported by a c... Low back pain (without radiation); Nausea; Fatigue; Ache; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of nausea (Received 1st dose of Shingrix vaccine on 12-APR-2025). On 22-JUL-2025, the patient received the 2nd dose of Shingrix (intramuscular). On 22-JUL-2025, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: Ache). On 23-JUL-2025, the patient experienced nausea (Verbatim: Nausea) and fatigue (Verbatim: Fatigue). On 24-JUL-2025, the patient experienced low back pain (Verbatim: Low back pain (without radiation)). Rechallenge with Shingrix was positive. On 24-JUL-2025, the outcome of the nausea and fatigue were resolved (duration 1 day). The outcome of the low back pain and pain were not resolved. It was unknown if the reporter considered the nausea, fatigue, low back pain and pain to be related to Shingrix. It was unknown if the company considered the nausea, fatigue, low back pain and pain to be related to Shingrix. Additional Information: GSK receipt date: 25-JUL-2025 The patient received her second dose of Shingrix on 22-Jul-2025 and the following day she experienced nausea and fatigue along with overall achiness. The nausea and fatigue have subsided but on the day of reporting (today) she awoke with low back pain. Please refer case US2025096096 for the tolerance of the first dose.; Sender's Comments: US-GSK-US2025096096:1st dose More
2854481 F 08/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; still got shingles bad; This serious case was reported by a consumer... Suspected vaccination failure; still got shingles bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles bad). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-AUG-2025 This case was reported by a patient's nephew/niece via interactive digital media. The patient (aunt) got the Shingles shot and she still got shingles bad and said keep your shot. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case is linked with US2025AMR104469, by the same reporter; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GLAXOSMITHKLINE INC-US2025AMR104469:Original Case Number : US2025AMR104452_Same reporter More
2854482 08/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
Sick; This non-serious case was reported by a consumer via interactive digital media and described t... Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the first vaccine and was sick and out of work for 5 days and never got the second one More
2854483 08/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
worst pain; This non-serious case was reported by a consumer via interactive digital media and descr... worst pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: worst pain). Rechallenge with Herpes Zoster vaccine was negative. The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Herpes Zoster vaccine. It was unknown if the company considered the pain to be related to Herpes Zoster vaccine. Additional Information: GSK receipt date: 08-AUG-2025 The patient had the worst that which he/she had never had. More
2854484 08/18/2025 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; I now have shingles; This serious case was reported by a consumer via... Suspected Vaccination failure; I now have 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. 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: I now have shingles). 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 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: 13-AUG-2025 This case was reported by a patient via interactive digital media. Patient took both shots for shingles. Patient now had shingles. 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 Shingrix vaccine (Dose 1 & 2). More
2854485 12 OH 08/18/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB072A
Product preparation error Product preparation error
the lyophilized portion of Menveo (2-vial) presentation was reconstituted with sterile water and adm... the lyophilized portion of Menveo (2-vial) presentation was reconstituted with sterile water and administered to a pt.; the lyophilized portion of Menveo (2-vial) presentation was reconstituted with sterile water and administered to a pt.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB072A, expiry date 30-APR-2026) for prophylaxis. On 31-JUL-2025, the patient received Menveo. On 31-JUL-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: the lyophilized portion of Menveo (2-vial) presentation was reconstituted with sterile water and administered to a pt.) and inappropriate dose of vaccine administered (Verbatim: the lyophilized portion of Menveo (2-vial) presentation was reconstituted with sterile water and administered to a pt.). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 06-AUG-2025 The reporter reported that the lyophilized portion of Menveo (2-vial) presentation was reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered More
2854486 F TX 08/18/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Arthralgia, Injection site pain, Muscular weakness, Pain in extremity, Periphera... Arthralgia, Injection site pain, Muscular weakness, Pain in extremity, Peripheral swelling More
pain on injection site at left arm; weakness left arm; swollen left arm; pain left arm; wrist pain l... pain on injection site at left arm; weakness left arm; swollen left arm; pain left arm; wrist pain left arm/elbow pain left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced injection site pain (Verbatim: pain on injection site at left arm), weakness of arms (Verbatim: weakness left arm), swelling arm (Verbatim: swollen left arm), pain in arm (Verbatim: pain left arm) and wrist pain (Verbatim: wrist pain left arm/elbow pain left arm). The outcome of the injection site pain, weakness of arms, swelling arm, pain in arm and wrist pain were unknown. It was unknown if the reporter considered the injection site pain, weakness of arms, swelling arm, pain in arm and wrist pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, weakness of arms, swelling arm, pain in arm and wrist pain to be related to Boostrix and Boostrix 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: 06-AUG-2025 The member of the public or patient called concerning some side effects on the Boostrix vaccine and any advised on them. The vaccination date and patient demographics were obtained in this call. No vaccine detail was obtained in this call. No further information was obtained in this call. More
2854487 M IN 08/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 332L4
Product preparation issue Product preparation issue
with the adjuvant alone.; Inappropriate dose of vaccine administered; This non-serious case was repo... with the adjuvant alone.; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 332L4, expiry date 04-APR-2027) for prophylaxis. On 28-JUL-2025, the patient received Shingrix. On 28-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: with the adjuvant alone.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 08-AUG-2025 Clinical supervisor called to ask about the specific timeframe or additional vaccine administration for a valid dose of Shingrix, since five patients were potentially administered (they were not sure) with the adjuvant alone, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. No further information was provided. The vaccine administration facility was the same as primary reporter. This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025103162:same reporter GSK-US2025103644:Same reporter US-GSK-US2025103164:same reporter US-GSK-US2025103636:Same reporter More
2854488 78 F IN 08/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 332L4
Product preparation issue Product preparation issue
Maladministration of AS01B adjuvant of Shingrix without the lyophilized antigen component; were pote... Maladministration of AS01B adjuvant of Shingrix without the lyophilized antigen component; were potentially administered with the adjuvant alone; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 332L4, expiry date 04-APR-2027) for prophylaxis. On 29-JUL-2025, the patient received Shingrix. On 29-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of AS01B adjuvant of Shingrix without the lyophilized antigen component) and inappropriate dose of vaccine administered (Verbatim: were potentially administered with the adjuvant alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 08-AUG-2025 Clinical supervisor called to ask about the specific timeframe or additional vaccine administration for a valid dose of Shingrix, since five patients were potentially administered (they were not sure) with the adjuvant alone, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. No further information was provided. The vaccine administration facility was the same as primary reporter. This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025103644:Same reporter US-GSK-US2025103162:same reporter US-GSK-US2025103164:Same reporter US-GSK-US2025103160:Same reporter More
2854489 51 M IN 08/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 332L4
Product preparation issue Product preparation issue
Maladministration of AS01B adjuvant of Shingrix (without the lyophilized antigen component); Maladmi... Maladministration of AS01B adjuvant of Shingrix (without the lyophilized antigen component); Maladministration of AS01B adjuvant of Shingrix (without the lyophilized antigen component); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 332L4, expiry date 04-APR-2027) for prophylaxis. On 30-JUL-2025, the patient received Shingrix. On 30-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Maladministration of AS01B adjuvant of Shingrix (without the lyophilized antigen component)) and inappropriate preparation of medication (Verbatim: Maladministration of AS01B adjuvant of Shingrix (without the lyophilized antigen component)). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK receipt date: 08-AUG-2025 A clinical supervisor called to ask about the specific timeframe/additional vaccine administration for a valid dose of Shingrix, since five patients were potentially administered with the adjuvant alone which led to inappropriate preparation of medication and inappropriate dose of vaccine administration. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments: US-GSK-US2025103164:Same reporter US-GSK-US2025103636:Same reporter US-GSK-US2025103162:Same reporter US-GSK-US2025103160:Same reporter More
2854490 16 F NY 08/18/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Expired product administered Expired product administered
Maladministration of Menveo One-vial presentation after the expiration date; This non-serious case w... Maladministration of Menveo One-vial presentation after the expiration date; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (expiry date 31-JUL-2025) for prophylaxis. On 04-AUG-2025, the patient received Menveo. On 04-AUG-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Maladministration of Menveo One-vial presentation after the expiration date). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 08-AUG-2025 The doctor reported that on 04th August 2025, a patient received Menveo one dose vial presentation after the expiration date (expiration date: 31st July 2025) which led to expired vaccine use. There was no recording on lot number administered. More
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