🏥 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 💀 🏥 🚑 ♿ ⚠️
2845355 06/17/2025 PNC20
 PFIZER\WYETH
Cellulitis Cellulitis
Suspected of having localized cellulitis; This is a spontaneous report received from an Other HCP fr... Suspected of having localized cellulitis; This is a spontaneous report received from an Other HCP from medical information team. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "Suspected of having localized cellulitis". Additional information: It was noted that another patient who was suspected of having localized cellulitis. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500121558 same reporter/product/AE, different patient; More
2845356 F 06/17/2025 COVID19
 PFIZER\BIONTECH
Back pain, Spinal pain, Vomiting Back pain, Spinal pain, Vomiting
she is having terrible pain in her back, the lower spine and it is excruciating/can't roll out ... she is having terrible pain in her back, the lower spine and it is excruciating/can't roll out of her bed or roll over; she is having terrible pain in her back, the lower spine and it is excruciating/can't roll out of her bed or roll over; vomiting; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Jun2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for immunization; Comirnaty (dose number unknown (booster), single), for immunization, reaction(s): "no adverse effect". The following information was reported: BACK PAIN (medically significant); SPINAL PAIN (medically significant), outcome "unknown", both described as "she is having terrible pain in her back, the lower spine and it is excruciating/can't roll out of her bed or roll over"; VOMITING (non-serious), outcome "unknown". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2845357 M 06/17/2025 COVID19
 PFIZER\BIONTECH
Disease recurrence, Neurodermatitis Disease recurrence, Neurodermatitis
after receiving his 2 Covid-19 vaccines his symptoms came back so he restarted; after receiving his ... after receiving his 2 Covid-19 vaccines his symptoms came back so he restarted; after receiving his 2 Covid-19 vaccines his symptoms came back so he restarted; This is a spontaneous report received from a Consumer or other non HCP from License Party. A 74-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since 26Mar2021 (Lot number: 3F306A, Expiration Date: 30Sep2025) at 300 mg (300 mg, qow (every other week), single dose prefilled pen, strength: 300 mg/2 ml) and second regimen since 06Jan2023) at 300 mg (300 mg, qow (every other week), single dose prefilled pen), all subcutaneous for neurodermatitis. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE HYCLATE; AQUAPHOR [XIPAMIDE]; SAW PALMETTO [SERENOA REPENS]; VITAMIN D3; VITAMIN E [VITAMIN E NOS]; MUPIROCIN; CLOBETASOL; CETAPHIL [ALOE VERA;PANTHENOL]; CETAPHIL [CETYL ALCOHOL;SODIUM LAURYL SULFATE;STEARYL ALCOHOL]; ROBITUSSIN COLD & COUGH; AQUAPHOR [MINERAL OIL LIGHT;PARAFFIN;PETROLATUM;WOOL ALCOHOLS]. The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (DOSE 1, unknown manufacturer), for COVID-19 immunization. The following information was reported: NEURODERMATITIS (non-serious), DISEASE RECURRENCE (non-serious), outcome "recovering" and all described as "after receiving his 2 Covid-19 vaccines his symptoms came back so he restarted". Therapeutic measures were taken as a result of neurodermatitis, disease recurrence. Additional information: Concomitant medications also included vitamins NOS and Cerave daily moisturizing lolion. Patient stated he started Dupixent about 3 years before an unknown date. He was symptoms free after about 1 year and stopped Dupixent, but after receiving his 2 Covid-19 vaccines his symptoms came back so he restarted. His symptoms were again well controlled and doctor agreed to have patient try to stop Dupixent to see if he could go without it. The event was reported as non-serious by Sanofi. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. BNT162b2 is under agreement with BIONTECH SE. More
2845358 F MI 06/17/2025 COVID19
 PFIZER\BIONTECH
Bundle branch block left, Electrocardiogram Bundle branch block left, Electrocardiogram
new diagnosis of left bundle branch block; This is a spontaneous report received from a Nurse, Progr... new diagnosis of left bundle branch block; This is a spontaneous report received from a Nurse, Program ID. A 74-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: "COVID-19 infections" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Pfizer covid vaccine (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: BUNDLE BRANCH BLOCK LEFT (non-serious), outcome "unknown", described as "new diagnosis of left bundle branch block". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller is an RN and calling one behalf of herself asking medical question regarding a new diagnosis of left bundle branch block (LBBB). She expresses concern about the possible causes, particularly in relation to her history of COVID-19 infections (four lab-confirmed cases since 2019) and having received three doses of the Pfizer COVID vaccine. She clarifies that she is not blaming the vaccine but is trying to understand if there is any known link between LBBB and either getting COVID-19 or Pfizer Covid vaccine. She notes that she is otherwise cardiovascularly healthy, with no plaque buildup or evidence of infarct in short Asymptomatic, and this is the first time LBBB has appeared on her EKG. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2845359 11 F TX 06/17/2025 DTAP
 SANOFI PASTEUR
 3CA20C
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
administered with DAPTACEL instead of Tdap (ADACEL) with no reported AE; Initial information receive... administered with DAPTACEL instead of Tdap (ADACEL) with no reported AE; Initial information received on 13-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old female patient who had administered Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of tdap (adacel) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Jun-2025, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot 3CA20C, Frequency:once, strength: standard, via intramuscular route in the left arm for immunisation instead of tdap (adacel) with no reported adverse event (wrong product administered) (latency: same day). Reportedly, patient was administered with DAPTACEL instead of Tdap (ADACEL). Caller wanted to know if the dose should be repeated. 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
2845360 F IN 06/17/2025 YF
 SANOFI PASTEUR
 UK137AA
No adverse event, Product preparation error No adverse event, Product preparation error
administered a YF-Vax reconstituted using sterile water with no reported adverse event; Initial info... administered a YF-Vax reconstituted using sterile water with no reported adverse event; Initial information received on 13-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age female patient who was administered a yellow fever vaccine -[YF-VAX] reconstituted using sterile water 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 yellow fever vaccine - reconstituted using sterile water (formulation: Solution for injection) (lot UK137AA and expiry date 31-Jan-2026) (strength not reported) via unknown route in unknown administration site for immunization with no reported adverse event (product preparation error) (Latency: same day). Reportedly, she was administered yellow fever vaccine and noticed there was two vials of the sodium chloride left which should have been used with the vaccine. 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
2845361 36 F FL 06/17/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Unevaluable event; Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event; Unevaluable event
None stated. None stated.
✓ ✓ ✓
2845362 18 F NC 06/17/2025 MENB
 PFIZER\WYETH
 LF5302
Injection site erythema, Myalgia, Pain, Swelling Injection site erythema, Myalgia, Pain, Swelling
Started having swelling, pain, muscular pain when pulling up pants, started once she got home. Mom ... Started having swelling, pain, muscular pain when pulling up pants, started once she got home. Mom also endorsed redness as well at the site. More
2845363 62 F MA 06/17/2025 COVID19
 PFIZER\BIONTECH
 me6072
Cellulitis, Injection site erythema, Injection site swelling, Injection site war... Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth More
Patient received Comirnaty vaccine on 6/14/2025 and noticed injection site redness starting the next... Patient received Comirnaty vaccine on 6/14/2025 and noticed injection site redness starting the next day. On 6/17/25 the patient returned to the pharmacy to show the reaction. The injection site was red, swollen, and warm to the touch. The patient was seen at her PCP office on 6/17/25 for suspected cellulitis. The prescriber advised the patient to watch the injection site for another 1-2 days and take an antibiotic only if the reaction worsens or does not improve. More
2845364 84 F ID 06/17/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 ak334
75d3a
Malaise; Malaise Malaise; Malaise
full body malaise - pt did /does not have enough time to discuss further full body malaise - pt did /does not have enough time to discuss further
2845365 74 M IA 06/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
THIRD DOSE OF SHINGLES VACCINE THIRD DOSE OF SHINGLES VACCINE
2845367 F CA 06/17/2025 PNC21
 MERCK & CO. INC.
Immediate post-injection reaction, Injection site pain Immediate post-injection reaction, Injection site pain
FBE calling to report AE for CAPVAXIVE on behalf HCP who is also the patient. Patient reports experi... FBE calling to report AE for CAPVAXIVE on behalf HCP who is also the patient. Patient reports experiencing injection site pain immediately after receiving CAPVAXIVE. Patient reports the pain did not subside for a couple of days and still feels linger; This spontaneous report was received from a Consumer and refers to a Elderly female patient over 65 years of age. The patient's concurrent conditions/medical history included arthritis rheumatoid. Concomitant therapies, drug reactions or allergies were not provided. On an unspecified date in April 2025 (reported as "sometime in April"), the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), administered Intramuscularly (strength, lot #, expiration date, dose number, anatomical location not provided) as vaccination. The patient reported that immediately after receiving the vaccine, she experienced injection site pain, and the pain did not subside for a couple of days. On an unspecified date in 2025, the patient recovered from the event, but she stated that still felt lingering pain to this day. The causal relationship between vaccination site pain and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. More
2845368 GA 06/17/2025 VARCEL
 MERCK & CO. INC.
 Z003882
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; HCP called to report T/E for VARIVAX on dates 5/30/2025 and 6/10/202. VAR... No additional AE reported; HCP called to report T/E for VARIVAX on dates 5/30/2025 and 6/10/202. VARIVAX was administered on 6/11/2025.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 11-Jun-2025, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka-merck) (VARIVAX) injection, administered as prophylaxis (Lot No. Z003882 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date reported and upon internal validation established as 03-Feb-2027)(strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (MERCK STERILE DILUENT) (indication, Lot No., and expiration date were not provided); after a temperature excursion of 8.0 degree Fahrenheit (F) during a time frame of 15 minutes that occurred (on 30-May-2025 and 10-Jun-2025) (reported as 10-Jun-202, conflicting information). Previous temperature excursion reported of 9.0 degree Fahrenheit (F) during a time frame of 15 minutes. No additional information or adverse events or PQC were provided (no adverse event). More
2845369 GA 06/17/2025 VARCEL
 MERCK & CO. INC.
 Z003882
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; HCP called to report T/E for VARIVAX on dates 5/30/2025 and 6/10/2025. VA... No additional AE reported; HCP called to report T/E for VARIVAX on dates 5/30/2025 and 6/10/2025. VARIVAX was administered on 6/09/2025.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 09-Jun-2025, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka-merck) (VARIVAX) injection, administered as prophylaxis (Lot No. Z003882 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date reported and upon internal validation established as 03-Feb-2027)(strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (MERCK STERILE DILUENT) (indication, Lot No., and expiration date were not provided); after a temperature excursion of 8.0 degree Fahrenheit (F) during a time frame of 15 minutes that occurred (on 30-May-2025 and 10-Jun-2025). Previous temperature excursion reported of 9.0 degree Fahrenheit (F) during a time frame of 15 minutes. No additional information or adverse events or PQC were provided (no adverse event). More
2845370 MA 06/17/2025 IPV
 SANOFI PASTEUR
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion on punctured mdv of ipol temperature of 8.5 degrees Celsius and were out of ra... temperature excursion on punctured mdv of ipol temperature of 8.5 degrees Celsius and were out of range for a total of 14 minutes with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered with a vaccine that had temperature excursion on punctured MDV of IPV (VERO) [IPOL] temperature of 8.5 degrees Celsius and were out of range for a total of 14 minutes with no reported adverse event. On an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date-unknown) for prophylactic vaccination (Immunisation) was exposed to temperature of 8.5 degrees Celsius and were out of range for a total of 14 minutes with no reported adverse event (product storage error). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly- Human error was involved (refrigerator being unplugged by mistake). Previous excursion on 24-apr-2025 max of 8.44 degrees Celsius for 13 minutes, due to the refrigerator door being left open. 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. Additional information was received on 13-Jun-2025 from other healthcare professional: case was updated to valid from non-valid; text amended accordingly. More
2845371 17 F CA 06/17/2025 MEN
 UNKNOWN MANUFACTURER
Extra dose administered, No adverse event Extra dose administered, No adverse event
pre-assessed as a medication error/an inappropriate use due to prescription of inappropriate vaccine... pre-assessed as a medication error/an inappropriate use due to prescription of inappropriate vaccine and receiving unindicated extra dose of MENQUADFI with no reported adverse event; Initial information received on 13-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 year old female patient who received unindicated extra dose of Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Mar-2019, the patient received an unknown dose (dose 1) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection and On 12-Jul-2024 she also received an unknown dose (dose 2) of vaccine both with (lot number and expiry date-unknown) via unknown route in unknown administration site. On 13-Jun-2025 she received an extra dosed 0.5ml (dose 3) standard strength of vaccine (lot-U8194AA) (expiry date-unknown) via intramuscular route in left deltoid for Immunization with no reported adverse event (extra dose administered). Reportedly- Nurse stated that the patient should have received MenB (Bexsero) but the provider mistakenly ordered Menquadfi instead. 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
2846366 44 M 06/17/2025 HEP
 MERCK & CO. INC.
 P-Y009436
Inappropriate schedule of product administration Inappropriate schedule of product administration
gave the patient their 3rd dose sooner than 6 months from 1st but was given at least 8 weeks from 2n... gave the patient their 3rd dose sooner than 6 months from 1st but was given at least 8 weeks from 2nd dose More
2846367 59 M OR 06/17/2025 FLU3
 SANOFI PASTEUR
 U8447AA
Expired product administered Expired product administered
Patient was given an expired displayed no symptoms. Patient was given an expired displayed no symptoms.
2846368 21 M CA 06/17/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Wrong product administered Wrong product administered
None at time of initial check in with pt. Pt is to return and get ordered vaccine as provider state... None at time of initial check in with pt. Pt is to return and get ordered vaccine as provider states the vaccine that was administered on 6/17 is a booster and can be followed up with the originally ordered vaccine. More
2846369 21 F NC 06/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 011035816082143
No adverse event, Wrong product administered No adverse event, Wrong product administered
Pt was supposed to receive Hep B Vaccine but received Hep A vaccine instead. No adverse reactions we... Pt was supposed to receive Hep B Vaccine but received Hep A vaccine instead. No adverse reactions were noted by the pt or healthcare provider. More
2846374 40 F IL 06/17/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EJ1685
EL3249
FF8841
Computerised tomogram normal, Electroencephalogram normal, Generalised tonic-clo... Computerised tomogram normal, Electroencephalogram normal, Generalised tonic-clonic seizure, Laboratory test normal, Postictal state; Computerised tomogram normal, Electroencephalogram normal, Generalised tonic-clonic seizure, Laboratory test normal, Postictal state; Computerised tomogram normal, Electroencephalogram normal, Generalised tonic-clonic seizure, Laboratory test normal, Postictal state More
On 8/17/2022, I had a tonic clonic seizure around 6am. I was sleeping in bed, and the event woke my ... On 8/17/2022, I had a tonic clonic seizure around 6am. I was sleeping in bed, and the event woke my husband up. I do not remember the immediate moments thereafter as I was postictal. I was taken via ambulance to the nearest hospital where I stayed overnight. I had numerous tests including lab work, CT scan, and EEG. After discharge I then had a sleep-deprived EEG and had to see a neurologist. I was started on an increasing taper dose of Lamictal that I still take BID. I continue to follow up with the Neurologist yearly. The cause of the seizure has never been determined. More
✓
2846377 0.33 M 06/17/2025 DTAPIPV
HIBV
PNC20
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 5G23D
97F4B
HR3650
GG2XS
No adverse event; No adverse event; No adverse event; No adverse event No adverse event; No adverse event; No adverse event; No adverse event
No adverse events/treatment or outcome No adverse events/treatment or outcome
2845029 F 06/16/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Herpes zoster, Serology negative; Herpes zoster, Serology negative Herpes zoster, Serology negative; Herpes zoster, Serology negative
recent serology testing indicated that she does not have immunity against chickenpox; came down wit... recent serology testing indicated that she does not have immunity against chickenpox; came down with Shingles after receiving the vaccine; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Varicella virus vaccine live (Oka-Merck) (VARIVAX) (strength, dose, lot #, expiration date, anatomical location, and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot #, and expiration date were not provided). On an unspecified date in 1999, the patient experienced Shingles after receiving the vaccine (reported also as patient's pertinent medical history, conflicting information). On an unknown date (also reported as recent), serology testing showed no immunity against chickenpox (Antibody test negative). The patient would like to get the chickenpox vaccine but concerned she would get shingles. At the reporting time, the outcome of the events was unknown. The causal relationship between the events of antibody test negative and shingles and the suspect vaccine (Varicella virus vaccine live (Oka-Merck) (VARIVAX)), reconstituted suspect sterile diluent (MERCK STERILE DILUENT) was not reported. More
2845030 55 F NC 06/16/2025 PPV
 MERCK & CO. INC.
Brain fog, Fatigue, Injection site pain, Injection site swelling, Pyrexia Brain fog, Fatigue, Injection site pain, Injection site swelling, Pyrexia
Consumer called to report they received a PNEUMOVAX23 injection on 06/04/2025 and later that evening... Consumer called to report they received a PNEUMOVAX23 injection on 06/04/2025 and later that evening started experiencing painful burning and swelling at the injection site. The caller also reported having a fever, feeling fatigued, and experiencing; The caller also reported having a fever, feeling fatigued, and experiencing brain fog.; The caller also reported having a fever, feeling fatigued, and experiencing brain fog.; experiencing painful burning and swelling at the injection site; The caller also reported having a fever, feeling fatigued, and experiencing brain fog.; experiencing painful burning and swelling at the injection site; This spontaneous report was received from a consumer and refers to a(n) 55-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Jun-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), formulation: injection, administered by intramuscular route (lot #, expiration date, exact dose and anatomical location were not provided). On 04-Jun-2025, the patient experienced brain fog, fatigue, pyrexia, vaccination site pain (vaccination site burning), vaccination site pain and vaccination site swelling (reported as: later that evening started experiencing painful burning and swelling at the injection site. The caller also reported having a fever, feeling fatigued, and experiencing brain fog). At the reporting time, the reported events. The causal relationship between the events of brain fog, fatigue, pyrexia, vaccination site pain (vaccination site burning), vaccination site pain and vaccination site swelling and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was unknown/not reported/not provided. More
2845031 1.25 IN 06/16/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AE; Nurse calling with a report of an adverse event involving a 15 month old patient w... No additional AE; Nurse calling with a report of an adverse event involving a 15 month old patient who was inadvertently administered PROQUAD and VARIVAX during the same vaccination appointment. Nurse stated that the patient was inadvertently administered the vaccine; This spontaneous report was received from a nurse and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 09-JUN-2025, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5 mL (in two dose series), administered by intramuscular route for prophylaxis (anatomical location, lot # and expiration date were not reported); and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, 0.5 mL (in two dose series), administered by intramuscular route as Measles, Mumps, Rubella, Varicella vaccination (anatomical location, lot # and expiration date were not reported); both vaccines were given along with sterile diluents (Merck Sterile Diluent) solution for injection (no administration details), during the same vaccination appointment (Accidental overdose). 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
2845032 IN 06/16/2025 HEP
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 X027728
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
No additional AE; Caller confirmed that patient was not administered GARDASIL 9 same-day (missed dos... No additional AE; Caller confirmed that patient was not administered GARDASIL 9 same-day (missed dose); a patient who was inadvertently administered a pediatric dose of RECOMBIVAXHB instead of GARDASIL 9; This spontaneous report has been received from an other health professional, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 10-JUN-2025, the patient who was inadvertently administered at a dose of Hepatitis B Vaccine (RECOMBIVAXHB) suspension for injection, at a dose of 0.5 milliliters (ml), lot number X027728, instead which has been verified to be valid, expiration date reported and established as 16-OCT-2026) route of administration, and anatomical site of injection were not provided) instead of Human Papillomavirus 9-valent (GARDASIL 9) (dose, route of administration, anatomical site of injection, lot number and expiration date were not reported), both vaccine administered as prophylaxis (Wrong product administered). Also, it was reported that the patient was not administered Human Papillomavirus 9-valent (GARDASIL 9) same-day (Product dose omission issue) and will come back a different day to continue vaccination with Human Papillomavirus 9-valent (GARDASIL 9). No additional adverse events were reported in the patient. More
2845033 F 06/16/2025 HEP
HEP
HPVX
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
Extra dose administered, Nodule; Extra dose administered, Nodule; Extra dose adm... Extra dose administered, Nodule; Extra dose administered, Nodule; Extra dose administered, Nodule More
Nodule/ They developed a nodule in the arm; administered a double dose (2 separate administrations) ... Nodule/ They developed a nodule in the arm; administered a double dose (2 separate administrations) of Engerix B; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of nodule on extremity in a adult female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis. Concurrent medical conditions included hiv infection. On an unknown date, the patient received Engerix B (right arm), Engerix B (right arm) and HPV vaccine. On an unknown date, an unknown time after receiving Engerix B, Engerix B and HPV vaccine, the patient experienced nodule on extremity (Verbatim: Nodule/ They developed a nodule in the arm) and overdose (Verbatim: administered a double dose (2 separate administrations) of Engerix B). The outcome of the nodule on extremity was resolved and the outcome of the overdose was not applicable. The reporter considered the nodule on extremity to be related to Engerix B, Engerix B and HPV vaccine. The company considered the nodule on extremity to be related to Engerix B, Engerix B and HPV vaccine. Additional Information: GSK receipt date: 10-JUN-2025 The patient was administered a double dose (2 separate administrations) of Engerix B to an HIV patient in the same arm, which led to overdose. The patient developed a nodule in the arm at next visit, but it resolved spontaneously without any additional intervention. A HPV vaccine was also given on the same day as the Engerix vaccines. More
2845034 F 06/16/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Condition aggravated, Headache, Migraine Condition aggravated, Headache, Migraine
gives me a headache and aggravates migraine and bothers dog; gives me a headache and aggravates migr... gives me a headache and aggravates migraine and bothers dog; gives me a headache and aggravates migraine and bothers dog; This non-serious case was reported by a other health professional and described the occurrence of headache in a 74-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 12-JUN-2025, the patient received RSV vaccine. In JUN-2025, an unknown time after receiving RSV vaccine, the patient experienced headache (Verbatim: gives me a headache and aggravates migraine and bothers dog) and migraine aggravated (Verbatim: gives me a headache and aggravates migraine and bothers dog). The outcome of the headache and migraine aggravated were unknown. It was unknown if the reporter considered the headache and migraine aggravated to be related to RSV vaccine. It was unknown if the company considered the headache and migraine aggravated to be related to RSV vaccine. Additional Information: GSK receipt date: 12-JUN-2025 It sounds very irritating and need to shut off as soon as it comes on the TV. The patient not sure why it is necessary to include it in your RSV advertising. I finally decided to inform you of this. I am a retired MD. It gives me a headache and aggravates migraine and bothers dog. More
2845035 06/16/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
I got the RSV shot and got super sick from it; This non-serious case was reported by a consumer via ... I got the RSV shot and got super sick from it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 sickness (Verbatim: I got the RSV shot and got super sick from it). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to RSV vaccine. It was unknown if the company considered the sickness to be related to RSV vaccine. Additional Information: GSK receipt date: 11-JUN-2025 The case was received from the patient via interactive digital media. The patient got the RSV shot and got super sick from it. More
2845036 65 F MI 06/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93N4J
Extra dose administered Extra dose administered
Shingrix dose 3 on 6/6/25; This non-serious case was reported by a other health professional via cal... Shingrix dose 3 on 6/6/25; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 93N4J) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 11-FEB-2021 with batch number 3K743) and Shingrix (received 2nd dose on 18-AUG-2021 with batch number PG35Z). On 06-JUN-2025, the patient received the 3rd dose of Shingrix. On 06-JUN-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix dose 3 on 6/6/25). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 09-JUN-2025 The health care professional reported that a female patient who was given 3rd vaccination of Shingrix and they did not need it, which led to extra dose administered. The vaccine administration facility was the same as primary reporter. More
2845037 F CA 06/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and... Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 09-JUN-2025 The reporter called to inform that a patient that had gotten only the 1st dose of Shingrix back in 2019 had not gotten their 2nd dose yet, and that it was programmed for later that same day. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2845038 MD 06/16/2025 DTAPHEPBIP
HEP
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4L544
42B22
J4K4X
Product storage error; Product storage error; Product storage error Product storage error; Product storage error; Product storage error
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was... Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 42B22, expiry date 07-MAR-2026), (batch number 79CX37, expiry date 12-DEC-2026), (batch number 47XP4, expiry date 16-JUL-2026), (batch number 39C29CD, expiry date 16-JAN-2027) and (batch number 42B22, expiry date 07-MAR-2022) for prophylaxis. Co-suspect products included HAV (Havrix) (batch number J4K4X, expiry date 20-DEC-2026), (batch number 22GP3, expiry date 11-SEP-2026) and (batch number H39C97, expiry date 01-JAN-2027) for prophylaxis and DTPa-HBV-IPV (Pediarix) (batch number 4L544, expiry date 10-OCT-2027) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, the patient received Havrix. On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Engerix B, Havrix and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-JUN-2025 The nurse reported that she had an excursion on the 26th of the last month for 84 minutes and reporter just want to see if these vaccinations that were administered are viable. The nurse did not know the patients information, she only knew that the vaccines went through a temperature excursion on May 26th, 2025 and were administered to different patients, which led to incorrect storage of drug. Excursion information duration of 84 min with temperature is 13.4 degree Celsius no prior excursions. More
2845039 49 M CA 06/16/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 49M2F
Product preparation issue Product preparation issue
Priorix Diluent administered to patient alone (without powder); Priorix Diluent administered to pati... Priorix Diluent administered to patient alone (without powder); Priorix Diluent administered to patient alone (without powder); Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 49-year-old male patient who received MMR (Priorix) (batch number 49M2F, expiry date 01-DEC-2026) for prophylaxis. On 17-MAY-2025, the patient received Priorix. On 17-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Priorix Diluent administered to patient alone (without powder)), inappropriate dose of vaccine administered (Verbatim: Priorix Diluent administered to patient alone (without powder)) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration 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: 09-JUN-2025 Pharmacist called to inquire when to re-administer Priorix if two patients (male and a female) received only the diluent part of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient received a dose of Priorix at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. Permission to storage personal information within medical information database was declined. The case was linked with case US2025071740, reported by the same reporter.; Sender's Comments: US-GSK-US2025071740:same reporter More
2845040 45 F CA 06/16/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 49M2F
Product administered to patient of inappropriate age, Product preparation issue Product administered to patient of inappropriate age, Product preparation issue
Priorix Diluent administered to patient alone (without powder); Priorix Diluent administered to pati... Priorix Diluent administered to patient alone (without powder); Priorix Diluent administered to patient alone (without powder); Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 45-year-old female patient who received MMR (Priorix) (batch number 49M2F, expiry date 01-DEC-2026) for prophylaxis. On 17-MAY-2025, the patient received Priorix. On 17-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Priorix Diluent administered to patient alone (without powder)), inappropriate dose of vaccine administered (Verbatim: Priorix Diluent administered to patient alone (without powder)) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration 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: 09-JUN-2025 Pharmacist called to inquire when to re-administer Priorix if two patients (male and a female) received only the diluent part of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient received a dose of Priorix at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. Permission to storage personal information within medical information database was declined. The case was linked with case US2025071738, reported by the same reporter.; Sender's Comments: US-GSK-US2025071738:same reporter More
2845041 75 F OK 06/16/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 P2443
Inappropriate schedule of product administration Inappropriate schedule of product administration
Early dose administration; This non-serious case was reported by a pharmacist via call center repres... Early dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis. Previously administered products included Twinrix (received 1st dose on an unknown date). Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 06-JUN-2025, the patient received the 3rd dose of Twinrix. On 06-JUN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: Early dose administration). The outcome of the drug dose administration interval too short 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: 09-JUN-2025 The pharmacist reported that a patient had administration of an early schedule dose of Twinrix to a female patient on 6th June 2025, which led to drug dose administration interval too short. According to the health care provider, the second dose was administered on 4th April 2025, and the third dose was scheduled for September 2025. The vaccine administration facility was the same as primary reporter. More
2845042 68 F FL 06/16/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 2553X
Inappropriate schedule of product administration Inappropriate schedule of product administration
Twinrix early third dose; This non-serious case was reported by a other health professional via call... Twinrix early third dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 68-year-old female patient who received HAB (Twinrix) (batch number 2553X, expiry date 25-SEP-2026) for prophylaxis. Previously administered products included Twinrix (first dose taken on 27 Dec 2024) and Twinrix (second dose taken on 28 Jan 2025). On 20-MAR-2025, the patient received the 3rd dose of Twinrix. On 20-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: Twinrix early third dose). The outcome of the drug dose administration interval too short 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: 11-JUN-2025 The patient that received the third dose of Twinrix on 20 Mar 2025, 3 months earlier than recommended which led to Drug dose administration interval too short. First and second dose were given following the proper schedule on 27 Dec 2024 and 28 Jan 2025. More
2845043 NC 06/16/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late 2nd dose.; This non-serious case was reported by a pharmacist via call center representative an... Late 2nd 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 patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd 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: 12-JUN-2025 A pharmacist called to ask a question about Twinrix, she asked If a patient missed the mark for the 2nd dose of Twinrix and get it 3 months later, when to administer the 3rd dose which led to drug dose interval too long. Pharmacist mentioned that this scenario has happened in the past at their facility. More
2845044 IL 06/16/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 3E99M
Product storage error Product storage error
Inadvertent Administration of a Vaccine Following a Temperature Excursion; This non-serious case was... Inadvertent Administration of a Vaccine Following a Temperature Excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number 3E99M, expiry date 31-DEC-2025) for prophylaxis. On 12-JUN-2025, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Inadvertent Administration of a Vaccine Following a Temperature Excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 12-JUN-2025 Registered Nurse reports temperature excursion for several vaccines including Menveo two vial vaccine. One dose of the vaccine was inadvertently Administration of a Vaccine Following a Temperature Excursion (above range: nine point nine degrees Celsius for forty five minutes) which led to incorrect storage of drug. Vaccination date and vaccine detail were obtained in this call. No further information was obtained in this call. No patient demographics were obtained in this call from the Registered Nurse's end. No further information was obtained in this call. More
2845045 78 F IA 06/16/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9HP9Z
Expired product administered Expired product administered
Expired dose administered; Infanrix administered instead of Boostrix to adult patient; This non-ser... Expired dose administered; Infanrix administered instead of Boostrix to adult patient; 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 78-year-old female patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. Previously administered products included Dtpa (first dose given on July 22nd 2013, unknown brand name, manufactured by Sanofi, lot number C4432AB) and Adacel (second dose was Adacel given on January 20th 2015). On 11-JUN-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 11-JUN-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered) and wrong vaccine administered (Verbatim: Infanrix administered instead of Boostrix to adult patient). The outcome of the expired vaccine used and wrong vaccine administered 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: 12-JUN-2025 Practice Manager explained they accidentally administered Infanrix instead of Boostrix to an adult patient on June 11th 2025 which led to wrong vaccine administered. During the call it was also discovered that Infanrix was already expired, it expired on April 21st 2024 which led to expired vaccine used. There were 2 prior Diphtheria, Tetanus and Pertussis vaccines administered to this patient, first dose given on July 22nd 2013 (unknown brand name, manufactured by Sanofi, lot number C4432AB), and second dose was Adacel given on January 20th 2015. More
2845052 58 M CO 06/16/2025 DTAP
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
giving DAPTACEL to a 58 year old male with no reported adverse event; Initial information received o... giving DAPTACEL to a 58 year old male with no reported adverse event; Initial information received on 11-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 58 years old male patient who had diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] 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-15/tetanus/5 ac pertussis vaccine; Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age). Information on the batch number was requested corresponding to the one at time of event occurrence. 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
2845053 51 M 06/16/2025 YF
 SANOFI PASTEUR
 UK118AA
Injection site erythema, Injection site induration, Pain, Pyrexia Injection site erythema, Injection site induration, Pain, Pyrexia
Body aches, fever (104.2 reported at home day after), induration and erythema at injection site 12cm... Body aches, fever (104.2 reported at home day after), induration and erythema at injection site 12cm x 8.5 cm More
2845055 F OH 06/16/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 KR75K
Malaise Malaise
Patient was given Tdap @ 13:10. Patient started to feel unwell and was laid on exam table. PCP came ... Patient was given Tdap @ 13:10. Patient started to feel unwell and was laid on exam table. PCP came into examine and patient was okay to leave after 15 min. More
2845056 4 F MN 06/16/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U8204CB
Z007213
Injection site erythema; Injection site erythema Injection site erythema; Injection site erythema
redness surrounding vaccine sites redness surrounding vaccine sites
2845057 52 M TX 06/16/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 4BX39
Wrong product administered Wrong product administered
Physician ordered Tdap vaccine for patient, however, after patient left clinic, physician was made a... Physician ordered Tdap vaccine for patient, however, after patient left clinic, physician was made aware that instead a dose of Hepatitis B vaccine was given in error by MA staff. Patient alerted, do not suspect any medical harm. Signs/symptoms reviewed to monitor for. More
2845094 36 F PA 06/16/2025 HPV9
 MERCK & CO. INC.
Extrasystoles, Palpitations Extrasystoles, Palpitations
I received my first shot in the series on 04/12/25. Two weeks later, I experienced skipped heartbeat... I received my first shot in the series on 04/12/25. Two weeks later, I experienced skipped heartbeats and palpitations for almost a month. It is now two days past my second dose, and my heart has begun skipping beats again. It happens multiple times a day, whether I am resting or active. More
2845095 49 F OH 06/16/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 011J20A
011J20A
011J20A
012L20A
012L20A
012L20A
033F21A
033F21A
033F21A
014B22A
014B22A
014B22A
on file in Occ
on file in Occ
on file in Occ
on file in Occ
on file in Occ
on file in Occ
Acoustic stimulation tests, Balance disorder, Cerebrospinal fluid leakage, Compu... Acoustic stimulation tests, Balance disorder, Cerebrospinal fluid leakage, Computerised tomogram, Craniofacial fracture; Ear tube insertion, Fall, Herpes zoster, Laboratory test, Loss of consciousness; Magnetic resonance imaging, Myringotomy, Postural orthostatic tachycardia syndrome, Surgery; Acoustic stimulation tests, Balance disorder, Cerebrospinal fluid leakage, Computerised tomogram, Craniofacial fracture; Ear tube insertion, Fall, Herpes zoster, Laboratory test, Loss of consciousness; Magnetic resonance imaging, Myringotomy, Postural orthostatic tachycardia syndrome, Surgery; Acoustic stimulation tests, Balance disorder, Cerebrospinal fluid leakage, Computerised tomogram, Craniofacial fracture; Ear tube insertion, Fall, Herpes zoster, Laboratory test, Loss of consciousness; Magnetic resonance imaging, Myringotomy, Postural orthostatic tachycardia syndrome, Surgery; Acoustic stimulation tests, Balance disorder, Cerebrospinal fluid leakage, Computerised tomogram, Craniofacial fracture; Ear tube insertion, Fall, Herpes zoster, Laboratory test, Loss of consciousness; Magnetic resonance imaging, Myringotomy, Postural orthostatic tachycardia syndrome, Surgery; Acoustic stimulation tests, Balance disorder, Cerebrospinal fluid leakage, Computerised tomogram, Craniofacial fracture; Ear tube insertion, Fall, Herpes zoster, Laboratory test, Loss of consciousness; Magnetic resonance imaging, Myringotomy, Postural orthostatic tachycardia syndrome, Surgery; Acoustic stimulation tests, Balance disorder, Cerebrospinal fluid leakage, Computerised tomogram, Craniofacial fracture; Ear tube insertion, Fall, Herpes zoster, Laboratory test, Loss of consciousness; Magnetic resonance imaging, Myringotomy, Postural orthostatic tachycardia syndrome, Surgery More
I was required by my employer to have the vaccine, or be fired. Within 4-6 hours of the first injec... I was required by my employer to have the vaccine, or be fired. Within 4-6 hours of the first injection, I broke out into shingles on the back of my neck, right side. As I was already on Gabapentin, Dr. (now deceased) called in a rx of Valtrex to help alleviate the issue with shingles. As time went on, I began developing issues with balance, frequent falls that landed me in the ER, passing out, and multiple specialty visits. I was officially diagnosed with POTS in April 2025; it is a general consensus this is likely d/t the COVID vaccines I was required to take in order to maintain my job. My PCP did not permit me to have a COVID vaccine in 2024 as a result of the +2 years of testing / follow-ups I had been going through to find a diagnosis. More
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2845096 13 F MI 06/16/2025 MMRV
 MERCK & CO. INC.
 Y009105
No adverse event No adverse event
There were no adverse effects to the patient. The patient was given Proquad and should have received... There were no adverse effects to the patient. The patient was given Proquad and should have received MMR and varicella as the patient was 13 years old at the time vaccine was administered. More
2845097 16 F MI 06/16/2025 MMRV
 MERCK & CO. INC.
 Y009105
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
There was no adverse effects to the patient. The patient received Proquad, which should not have bee... There was no adverse effects to the patient. The patient received Proquad, which should not have been administered as the patient was 16 at the time Proquad was administered. More
2845098 69 M 06/16/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH

Asthenia, Decreased appetite, Fatigue, Injection site erythema, Injection site r... Asthenia, Decreased appetite, Fatigue, Injection site erythema, Injection site rash; Pyrexia More
patient developed significant redness / rash around vaccine site throughout day of vaccination, as w... patient developed significant redness / rash around vaccine site throughout day of vaccination, as well as the following day. also reports significant fatigue, fever, decreased appetite and significant weakness. More
2845099 29 F IA 06/16/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 kr75k
Erythema, Fatigue, Skin warm Erythema, Fatigue, Skin warm
Pt. developed redness, warmth to touch, and fatigue 6 days after vaccination. Pt. developed redness, warmth to touch, and fatigue 6 days after vaccination.
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