๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2400529 74 M CA 11/21/2023 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 F08757
FJ8757
Bell's palsy, Computerised tomogram, Deafness, Ear discomfort, Magnetic res... Bell's palsy, Computerised tomogram, Deafness, Ear discomfort, Magnetic resonance imaging; Bell's palsy; Bell's palsy, Deafness unilateral More
left ear to plug; I developed Bells Palsy; permanent hearing loss; This is a spontaneous report rece... left ear to plug; I developed Bells Palsy; permanent hearing loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old male patient received bnt162b2 (BNT162B2), on 13Jan2022 as dose 3 (booster), single (Lot number: F08757) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6201, Anatomical location: Arm Left), administration date: 24Feb2021, for Covid-19 immunization; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6205, Anatomical location: Arm Left), administration date: 19Mar2021, for COVID-19 Immunization. The following information was reported: BELL'S PALSY (disability) with onset 31Jul2022, outcome "not recovered", described as "I developed Bells Palsy"; DEAFNESS (disability) with onset 31Jul2022, outcome "not recovered", described as "permanent hearing loss"; EAR DISCOMFORT (disability), outcome "not recovered", described as "left ear to plug". The events "i developed bells palsy", "permanent hearing loss" and "left ear to plug" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: unknown results; Magnetic resonance imaging: unknown results. Therapeutic measures were taken as a result of bell's palsy, deafness, ear discomfort. Clinical course: Patient reported after his third vaccination that he developed Bells Palsy. It affected his hearing as it caused his left ear to plug. In more than a year of having this problem and seeing two ENT specialists, it had been determined that It caused permanent hearing loss. No COVID prior vaccination. COVID not tested prior vaccination. No other vaccine in four weeks. More
โœ“
2794185 40 F 09/27/2024 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Chills, Fatigue, Headache, Myalgia; COVID-19, Vaccination failure Chills, Fatigue, Headache, Myalgia; COVID-19, Vaccination failure
Arm soreness; fatigue; headache; chills; This is a spontaneous report received from a Physician. A ... Arm soreness; fatigue; headache; chills; This is a spontaneous report received from a Physician. A 40-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Sep2024 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Dilantin, reaction(s): "Allergies: Dilantin". The following information was reported: MYALGIA (non-serious) with onset 24Sep2024, outcome "recovered" (Sep2024), described as "Arm soreness"; CHILLS (non-serious) with onset 24Sep2024, outcome "recovered" (Sep2024); FATIGUE (non-serious) with onset 24Sep2024, outcome "recovered" (Sep2024); HEADACHE (non-serious) with onset 24Sep2024, outcome "recovered" (Sep2024). Therapeutic measures were taken as a result of myalgia, fatigue, headache, chills. Clinical course: Patient experienced rm soreness, fatigue, headache, chills for 36 hours after vaccination Patient has not received any other vaccine on the same date nor four weeks. Patient has received treatment with Ibuprofen. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2833259 13 M GA 04/09/2025 UNK
 UNKNOWN MANUFACTURER
 X025115
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; Product storage error; This spontaneous report was received from a vaccine provide... No adverse event; Product storage error; This spontaneous report was received from a vaccine provider and refers to a(n) 13-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included ADHD. Concomitant medications included Meningococcal vaccine B . On 24-OCT-2024, the patient was vaccinated with an improperly stored Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), ((lot #X025115, expiration date reported as 12-MAY-2026, but upon internal validation established as 19-MAY-2026) for Prophylaxis (Product storage error). The fridge had felt below freezing over the weekend while the office was closed. The temperature was 25 F for 1 hour. No adverse event was reported. More
2834946 4 M AZ 04/09/2025 MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 X026404
Y014182
Product storage error; Product storage error Product storage error; Product storage error
No symptomatic events were reported.; administered to a patient after suffering Temperature excursio... No symptomatic events were reported.; administered to a patient after suffering Temperature excursion; This spontaneous report was received from registered nurse (RN) concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On unspecified date, doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) underwent a temperature excursion at a temperature of 70 (units not provided) during a time frame of 72 hours, 0 minutes, and 0 seconds. Previous temperature excursions were reported as not applicable (N/A.) On 21-FEB-2025, the patient was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, lot #X026404, expiration date: 08-NOV-2025) 0.5 mL (0.5mL/series) (dosage regimen, anatomical location and route of administration were not provided), and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, lot #Y014182, expiration date: 20-AUG-2026, 0.5 mL (0.5mL/series) (dosage regimen, anatomical location and route of administration were not provided), both administered a prophylaxis (product storage error) which were reconstituted with an unknown sterile diluent (manufacturer unknown) injection (dose, indication, expiration date, and lot # were not reported.) No symptomatic events were reported (no adverse event). No additional information was provided. Lot # is being requested and will be submitted if received. Follow-up information has been received from RN on 31-MAR-2025 concerning 4-years-old male patient. The patient's medical historu included "NKA" and allantonic cyst. His concurrent conditions included gross motor development delay and cow's milk intolerance. Concomitant vaccine included dtap ๏ฟฝ polio vaccine (QUADRACEL). All suspect vaccines were administered by subcutaneous route. Lot # #X026404 and lot #Y014182 has been established as valid. More
2834947 F AL 04/09/2025 HEP
 MERCK & CO. INC.
 Y009551
No adverse event, Syringe issue No adverse event, Syringe issue
No additional AE; leaked out of a hole at the top of the syringe where the break occurred on her han... No additional AE; leaked out of a hole at the top of the syringe where the break occurred on her hand but did not report any other adverse issues or side effects related to the exposure; 1 of 10 vaccine syringes tip/leur lock was broken; leaked out of a hole at the top of the syringe where the break occurred on her hand but did not report any other adverse issues or side effects related to the exposure; This spontaneous report was received from the Nurse, 47-year-old female, who refers to herself. Her medical history, concurrent conditions and concomitant therapies were not reported. On 07-MAR-2025, the nurse opened a sealed previously unopened carton of Hepatitis B Vaccine (Recombinant) Suspension for injection (RECOMBIVAX HB) (strength 5MCG/0.5ML, lot #Y009551, expiration date: 08-DEC-2026) and 1 of 10 vaccine syringes tip/ luer lock was broken, "clean off and like it was decapitated" (Syringe issue). The tray was sealed with a cellophane cover and there was no damage to the shipping container that the reporter could recall and no damage to the carton, tray or cellophane either. There were no other syringes in the tray/ carton that were broken or damaged. The HCP stated there were no obvious shards of glass in the broken syringe or tray, but she could not be sure. A defect was noticed prior to breaking the seal of cellophane, but she did open the tray to inspect further. The HCP reported there was a hole at the top of the syringe where the tip/ luer lock broke off that was about the size of the hole that would be present if the tip was still intact, and the vaccine could leak out. The HCP stated there was no obvious fluid or dried residue in the tray, but upon picking up the syringe she stated the syringe felt wet and some of the vaccine might leaked out of a hole (at the top of the syringe where the break occurred) on her hand, but did not report any other adverse issues or side effects related to the exposure (Accidental exposure to product, Occupational exposure to product). None of the doses of Hepatitis B Vaccine (Recombinant) Suspension for injection (RECOMBIVAX HB) in the affected carton were administered. No additional adverse events. More
2834948 F ME 04/09/2025 HEP
HEP
 MERCK & CO. INC.
MERCK & CO. INC.
 X017743
Y003449
Incomplete course of vaccination, No adverse event, Product administered to pati... Incomplete course of vaccination, No adverse event, Product administered to patient of inappropriate age; Incomplete course of vaccination, No adverse event, Product administered to patient of inappropriate age More
no adverse event; first dose in August ,2024 and their second dose in October 2024 but have not rece... no adverse event; first dose in August ,2024 and their second dose in October 2024 but have not received their third dose at this time; This spontaneous report was received from a physician and refers to a 19-year-old female patient. Her concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date in August 2024, the patient was vaccinated with the first dose of hepatitis B vaccine (RECOMBIVAX HB) 0.5 ml, lot x017743, expiration date 21-FEB-2026 (route of administration and anatomical location were not provided) for prophylaxis. On an unknown date in October 2024, she was administered the second dose of hepatitis B vaccine (RECOMBIVAX HB) 0.5 ml, lot # y003449, expiration date 16-OCT-2026 (route of administration and anatomical location were not provided) for prophylaxis (Inappropriate schedule of product administration). At the time of the report, she did not receive the third dose of the suspect vaccine. No adverse events were reported. More
2834949 M TX 04/09/2025 MMR
MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.

X027902
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AE reported; Nurse reported patient was mistakenly administered a third dose of MMR II... No additional AE reported; Nurse reported patient was mistakenly administered a third dose of MMR II on Mar 10, 2025. Patient received first dose of MMR II on Sep 24, 2024 and second dose of MMR II on Jan 20, 2025. No further information provided by nurse. No additional AE rep; This spontaneous report was received from a nurse and refers to a 64-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 24-Sep-2024, the patient received the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection (lot # and expiration date were not reported) and on 20-Jan-2025, the patient received the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection (lot # and expiration date were not reported), both diluted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (indication, expiration date, and lot # were not reported). On 10-Mar-2025, the patient was mistakenly vaccinated with the third dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection (lot #X027902, expiration date: 04-Dec-2025) diluted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (indication, expiration date, and lot # were not reported). No additional adverse event was reported. Lot # is being requested and will be submitted if received. More
2834950 3 FL 04/09/2025 HPV4
 MERCK & CO. INC.
 K006447
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
a patient possibly received GARDASIL quadrivalent when the patient was 3 years old at the time of th... a patient possibly received GARDASIL quadrivalent when the patient was 3 years old at the time of the vaccination; No additional AEs were reported; This spontaneous report was received from an office manager in the physician's office and refers to a 3-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were were not reported. On an unknown date, the 3-year-old patient was possibly vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (lot #K006447, expiration date: 19-Jun-2016; strength, dose and route were not provided) for Prophylaxis (Product administered to patient of inappropriate age). No additional adverse events (AEs) were reported. More
2834951 F IL 04/09/2025 HPV9
 MERCK & CO. INC.
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
Customer reported a 32-year-old female patient received one dose of GARDASIL 9 in 2019 and has not r... Customer reported a 32-year-old female patient received one dose of GARDASIL 9 in 2019 and has not received additional doses since. No symptoms reported. No other information available at time of report. Caller consented to correspondence. No add; Noadditional AE/No PQC reported; This spontaneous report was received from a Pharmacist and refers to a(n) 32-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 an unknown date in 2019, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), 0.5 mL (0.5ML), administered by Unknown route (lot # and expiration date were not reported), as Prophylaxis, and had not received additional doses since. No symptoms or adverse events reported. Lot # is being requested and will be submitted if received. More
2834952 F 04/09/2025 HPV4
 MERCK & CO. INC.
Colonoscopy, Smear cervix abnormal Colonoscopy, Smear cervix abnormal
She had an "abnormal pap smear"; This spontaneous report was received from other health pr... She had an "abnormal pap smear"; This spontaneous report was received from other health professional and refers to a 37-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date (reported as received the first generation Gardasil vaccine series in year 2006/2007), the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), administered by Unknown route (dose, anatomical location, lot #, and expiration date were not reported) as prevention of human papilloma virus (HPV). On an unknown date, the patient experienced an abnormal pap smear requiring colonoscopy for further evaluation on 01-APR-2025. At the reporting time, the outcome of event was not provided. Additional information was not known at that time. The causal relationship between the event and the suspect vaccine was not reported. Additional information is not expected. More
2834953 M GA 04/09/2025 UNK
 UNKNOWN MANUFACTURER
 X025115
No adverse event, Product storage error No adverse event, Product storage error
No additional AE/PQC; administered improperly stored GARDASIL 9; This spontaneous report was receive... No additional AE/PQC; administered improperly stored GARDASIL 9; This spontaneous report was received from a consumer (reported as vaccine coordinator), referring to a 10-year-old male patient. The patient's medical history and concomitant therapies was not reported. The patient's concurrent conditions included asthma, and allergies. On 23-OCT-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #X025115, expiration date: 19-May-2026, dose and strength were unknown), administered by Intramuscular route for prophylaxis. No additional AE/PQC. The suspect vaccine was improperly stored the fridge temperature dropped below freezing while the office was closed (Improper storage of product in use). More
2834954 9 M GA 04/09/2025 IPV
TDAP
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 X1D141M
UT976AA
Y007193
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No adverse event; Improper storge of product in use; This spontaneous report was received from a con... No adverse event; Improper storge of product in use; This spontaneous report was received from a consumer or and refers to a 10-year-old male patient. The patient's medical history, concomitant therapies were not reported. The patient's concurrent condition included autism. On 23-Oct-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y007193, expiration date: 06-Jun-2026) administered by intramuscular route as prophylaxis (strength and dose were not provided); Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) (lot #UT976AA, expiration date: 03-Oct-2026) administered by intramuscular route for an unknown indication (strength and dose were not provided); and Ipv (Polio vaccine inact) (lot #X1D141M, expiration date: 31-Oct-2026) administered by intramuscular route for an unknown indication (strength and dose were not provided) after temperature excursion (TE) (Product storage error). Fridge temperature dropped below freezing over the weekend while office was closed. Temperature was 25F, time frame was 1 hour. No additional adverse event (AE) (No adverse event). More
2834960 UT 04/09/2025 HIBV
 MERCK & CO. INC.
 Y005248
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
HCP called to state that the patient received a third dose of PEDVAXHIB at 6 months of age. No sympt... HCP called to state that the patient received a third dose of PEDVAXHIB at 6 months of age. No symptomatic adverse events were reported.; HCP called to state that the patient received a third dose of PEDVAXHIB at 6 months of age. No symptomatic adverse events were reported.; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 27-Jan-2025, the patient received the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (lot #Y005248, which upon internal review confirmed to be a valid lot#; expiration date: 17-Sep-2026), at a dose of 0.5 mL (0.5ml/ series) at 6 months of age (Product administered to patient of inappropriate age) for prophylaxis. No symptomatic adverse events were reported (No adverse event). HCP has declined to answer any further questions and has also declined any AE follow-up. More
2834961 M FL 04/09/2025 HPV9
 MERCK & CO. INC.
Rash Rash
full blown rash; This spontaneous report was received from a physician and refers to a 14-year-old m... full blown rash; This spontaneous report was received from a physician and refers to a 14-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, lot #, and expiration date were not reported) for prophylaxis. On an unknown date (also reported as the same date in the evening after receiving the vaccine), the patient experienced full blown rash. The patient recovered/resolved from the event of full-blown rash on an unspecified date. Nothing changed in the patient's diet other than receiving the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). The patient received a unknown antihistamine for the rash. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. Lot # is being requested and will be submitted if received. More
2834964 F 04/09/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Fatigue, Headache, Hypersensitivity, Injection site irritation, Injection site s... Fatigue, Headache, Hypersensitivity, Injection site irritation, Injection site swelling; Sinus disorder, Sluggishness More
She reports swelling in the arm that received the vaccine, irritation and a "raised" area ... She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; She also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; This spontaneous report was received from the consumer and refers to herself, a 62-year-old female patient. The patient's medical history included drug reactions/allergies to lisinopril and other unspecified medications. The patient's concurrent conditions included high blood pressure and high cholesterol. Historical drugs included lisinopril. Concomitant medications included Carvedilolo, Atorvastatin, Vitamin E, Vitamin D, and Acyclovir. On an unspecified date in February 2025 (3 weeks ago but the patient was unsur of the exact date), the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site lot # and expiration date were not reported) administered for prophylaxis. On an unspecified date in 2025, the patient experienced swelling in the arm that received the vaccine, irritation and a "raised" area around the site (vaccination site swelling; vaccination site irritation; vaccination site mass). She reached out to the pharmacy where she received the vaccine and she stated that she received a cortisone shot and has been taking benadryl. She reported the swelling has decreased but is not resolved. She also reported having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns (headache; fatigue; sinus disorder; hypersensitivity). She stated that she did not receive any patient education from the pharmacist at the pharmacy prior to or after receiving the vaccine. She stated that she was going to attempt to get in contact and make an appointment with a primary care provider today as her symptoms have not responded. Therefore, at the time of reporting, the patient had not recovered from the reported adverse events. No additional adverse event (AE) and no product quality compliant (PQC) was noted. No additional information was reported. The causal relationship between the reported adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot # is being requested and will be submitted if received. More
2834966 F GA 04/09/2025 HEPA
HEPA
HEPA
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 X025908
X023974
X010374
Y007193
Incorrect dose administered, No adverse event; Incorrect dose administered, No a... Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event More
dministered improperly stored GARDASIL 9 and VAQTA following a TE; No additional AE; This spontaneou... dministered improperly stored GARDASIL 9 and VAQTA following a TE; No additional AE; This spontaneous report was received from a consumer or other non health professional on 10-Mar-2025 and refers to 16-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The vaccines experienced temperature excursion on 26-Oct-2024 at 25 F for 1 hour. There was no pereious temperature excursion. On an unknown date, the patient may be vaccinated with Hepatitis A Vaccine, Inactivated (lot #X025908, expiration date: 24-Apr-2025), or Human Papillomavirus 9-valent Vaccine, Recombinant (lot #Y007193, expiration date: 06-Jun-2026), or Hepatitis A Vaccine, Inactivated (lot #X023974, expiration date: 18-Apr-2025) (unknown), or Hepatitis A Vaccine, Inactivated (lot #X010374, expiration date: 13-Nov-2024) (unknown), administered as prophylaxis (due to incomplete source document, it was unknown whech specific vaccine was administered) (Product storage error). No additional AE (no adverse event). More
2834967 25 F UT 04/09/2025 HPV9
 MERCK & CO. INC.
 W026152
Expired product administered, No adverse event Expired product administered, No adverse event
No symptoms reported.; Customer called to report expired GARDASIL 9 administered to a patient post p... No symptoms reported.; Customer called to report expired GARDASIL 9 administered to a patient post product expiration. Expiration date was 29JAN2025. Product was administered on 07FEB2025.; This spontaneous report was received from a nurse and refers to a 25-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-FEB-2025, the patient was vaccinated with an expired second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 milliliters (mL) administered intramuscularly, lot #W026152; which has been verified to be valid lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal validation establish as 29-JAN-2025 (strength and anatomical site of administration were not reported) administered for Prophylaxis (Expired product administered). No temperature excursion occurred. No symptoms reported (No adverse event). More
2834968 52 F TN 04/09/2025 PPV
 MERCK & CO. INC.
 X014729
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; administration of an expired dose of PNEUMOVAX-23 on 18-MAR-2025; This spontaneous... No additional AE; administration of an expired dose of PNEUMOVAX-23 on 18-MAR-2025; This spontaneous report was received from a registered nurse and refers to a 51-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 18-MAR-2025, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), (lot #X014729, expiration date: 22-Nov-2024), 1 dose/once (strength, dose, anatomical location not reported) for prophylaxis. No symptomatic adverse events were reported. There were no temperature excursions during the product lifetime. More
2834970 13 F MT 04/09/2025 HPV4
HPV4
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Inappropriate schedule of product administration, Interchange of vaccine product... Inappropriate schedule of product administration, Interchange of vaccine products; Inappropriate schedule of product administration, Interchange of vaccine products; Inappropriate schedule of product administration, Interchange of vaccine products More
patient was recently diagnosed with HPV e6 and e7; patient had 2 doses at age 13 of GARDASIL dates o... patient was recently diagnosed with HPV e6 and e7; patient had 2 doses at age 13 of GARDASIL dates of administration as follows: 8/28/2012 and second dose 12/3/2012, and third dose (GARDASIL 9) on 9/19/2016; Originally, patient had 2 doses at age 13 of GARDASIL dates of administration as follows: 8/28/2012 and second dose 12/3/2012, and third dose (GARDASIL 9) on 9/19/2016; This spontaneous report was received from a nurse via company representative and referred to a 23-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were unknown. On 03-Dec-2012, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, route, anatomical site, lot # and expiration date were not reported) for the treatment of prophylaxis. On 28-Aug-2012, the patient was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, route, anatomical site, lot # and expiration date were not reported) for the treatment of prophylaxis. On 19-Sep-2016, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route, anatomical site, lot # and expiration date were not reported) for the treatment of prophylaxis (inappropriate schedule of product administration; interchange of vaccine products). On an unknown date in 2025 (reported as recently), the patient was recently diagnosed with HPV e6 and e7 (papilloma viral infection). At the reporting time, the outcome of papilloma viral infection was not reported. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not applicable. The causal relationship between the event of papilloma viral infection and both suspect therapies was not reported. Lot # is being requested and will be submitted if received. More
2834971 MA 04/09/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y011712
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional adverse event; Precautionary AE being filed due to HCP being unable to determine if pr... No additional adverse event; Precautionary AE being filed due to HCP being unable to determine if products were administered to any patients during a temperature excursion; Information has been received from Business Partner/CRO on 31-Mar-2025. This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Feb-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y011712) 0.5 mL (expiration date was not reported) for prophylaxis. On 07-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported)for prophylaxis. The vaccine underwent temperature excursion (Product storage error). No additional adverse event was reported.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02762511-02762488 , CLIC number : , ESTAR number : , IRMS number : 500UW00000V5avRYAR|19032025170024|9692 , Central date : 2025-03-19 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2260591 , MNSC case number : 02762511 , MNSC interaction number : 02762488 , Integration log UniqueID : 500UW00000V5avRYAR|19032025170024|9692 , Service cloud CaseID : 500UW00000V5avRYAR More
2834972 MA 04/09/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y011712
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional adverse event; Precautionary AE being filed due to HCP being unable to determine if pr... No additional adverse event; Precautionary AE being filed due to HCP being unable to determine if products were administered to any patients during a temperature excursion; Information has been received from Business Partner/CRO on 31-Mar-2025. This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Feb-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y011712) 0.5 mL (expiration date was not reported) for prophylaxis. On 07-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) for prophylaxis. This vaccine underwent temperature excursion (Product storage error). No additional adverse event was reported. More
2834974 IL 04/09/2025 HPV9
 MERCK & CO. INC.
 X014788
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE reported; an expired GARDASIL 9 vaccine was inadverntly administered to a patient; ... No additional AE reported; an expired GARDASIL 9 vaccine was inadverntly administered to a patient; This invalid spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAR-2025, the patient was inadvertently vaccinated with an expired dose with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #X014788, expiration date: 07-MAR-2025 for prophylaxis (exact dose, route of administration, and anatomical location were not reported). No adverse event was reported. This case is invalid due to unidentifiable patient. This is an amended report. Causality assessment for the event of no adverse event was added. More
2834975 5 KS 04/09/2025 UNK
 UNKNOWN MANUFACTURER
 W001598
No adverse event, Product storage error No adverse event, Product storage error
incorrect storage; no patients had any adverse affects; This spontaneous report was received from a ... incorrect storage; no patients had any adverse affects; This spontaneous report was received from a licensed practical nurse and refers to a 6-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 15-AUG-2023, at 10:56 hours the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot #W001598, expiration date: 14-Jan-2024 (strength, dose number, dose, route and anatomical location were not provided) for prophylaxis; the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). The temperature excursion was: 13.6๏ฟฝC during 6 hours 31 minutes. No adverse events reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-24 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : W001598 HB , Central date : 2025-03-21 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number : More
2834976 F UT 04/09/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
they have a 48 year old female patient who is single and sexually active who wants to complete the ... they have a 48 year old female patient who is single and sexually active who wants to complete the GARDASIL 9 series; No other AE/PQC.; This spontaneous report was received from a Medical Assistant and refers to a 48-year-old (Product use issue) female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. No adverse event reported. Additionally, it was mentioned that the patient is single and sexually active and wanted to complete the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) series. More
2834977 AR 04/09/2025 MMRV
 MERCK & CO. INC.
 Y010306
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; administered PROQUAD with a possible TE; This spontaneous report was received from... No additional AE; administered PROQUAD with a possible TE; This spontaneous report was received from a Physician and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-Mar-2025, the patient was vaccinated with a possible improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot #Y010306, expiration date: 01-Dec-2025 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis; the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). The data logger went out overnight but freezer stayed running. No data to ensure proper storage conditions. No confirmed case of TE as temperatures stayed within range the day before and the morning after. No adverse event reported. More
2834978 1 F NH 04/09/2025 MMR
 MERCK & CO. INC.
 X011632
Feeling abnormal, Irritability, Pyrexia, Rash Feeling abnormal, Irritability, Pyrexia, Rash
Nurse called to report AE for a patient after receiving their first dose of MMR II. Patient received... Nurse called to report AE for a patient after receiving their first dose of MMR II. Patient received her MMR II dose on 03/03/2025, the dose was given subcutaneous on the right thigh. Nurse reports patient experienced a rash on her torso, irritabilit; Nurse called to report AE for a patient after receiving their first dose of MMR II. Patient received her MMR II dose on 03/03/2025, the dose was given subcutaneous on the right thigh. Nurse reports patient experienced a rash on her torso, irritabilit; Nurse called to report AE for a patient after receiving their first dose of MMR II. Patient received her MMR II dose on 03/03/2025, the dose was given subcutaneous on the right thigh. Nurse reports patient experienced a rash on her torso, irritabilit; Nurse called to report AE for a patient after receiving their first dose of MMR II. Patient received her MMR II dose on 03/03/2025, the dose was given subcutaneous on the right thigh. Nurse reports patient experienced a rash on her torso, irritabilit; This spontaneous report was received from a nurse concerning 1-year-old female patient. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On 03-MAR-2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) that was diluted with a sterile diluent, subcutaneous Injection (lot #X011632, expiration date: 23-APR-2025), dose number 1, 0.5 mL, administered by Subcutaneous route in Right Thigh as prophylaxis. On 13-MAR-2025, the nurse reported that after receiving their first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the patient experienced a rash on her torso, irritability and fever of 100.2 F on that day. Then on the following day (14-MAR-2025), the patient still had a fever and rash got worse and was covering her from head to toe. Nurse explained the rash covered her face, chest, torso, hands, all the way down her legs and her feet. Nurse explained the rash was pretty much everywhere and the patient was miserable. Patient was examined by the doctor and no treatment was given. Doctor advised parents of the patient to give acetaminophen (TYLENOL) if needed for fever control and to reach back out if any questions. Consequently, on unspecified date in March 2025 (reported as now) the patient recovered from the events. The causal relationship was not provided. More
2834979 WI 04/09/2025 VARCEL
 MERCK & CO. INC.
 X007373
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; Expired VARIVAX administered today for one patient.; This spontaneous report was r... No additional AE; Expired VARIVAX administered today for one patient.; This spontaneous report was received from a Pharmacist and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 26-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X007373, expiration date: 12-Mar-2025) 0.5 mL (0.5 mL once) and sterile diluent (MERCK STERILE DILUENT) (Expired vaccine administration) for prophylaxis. No additional AE (no adverse event). This is an invalidity case due to lack of patient's identifiers. More
2834980 M AZ 04/09/2025 PNC21
 MERCK & CO. INC.
Asthenia, Confusional state, Fatigue, Lethargy Asthenia, Confusional state, Fatigue, Lethargy
confusion; severe lethargy; weakness; fatigue; This spontaneous report was received from a physician... confusion; severe lethargy; weakness; fatigue; This spontaneous report was received from a physician assistant and refers to an adult male patient in his 50's. The patient's medical history was not reported. The patient's concurrent conditions were not specified. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection, strength: 168 mcg/mL, at a dose of 0.5 mL, administered by intramuscular route for prophylaxis (anatomical location, lot # and expiration date were not reported). On an unknown date, within an hour of receiving the vaccine, the patient experienced confusion, severe lethargy, fatigue and weakness. On the following day, the patient had an office visit. At the time of reporting, the patient recovered from all reported events. Causality assessment was not provided. Lot# has been requested and will be submitted if received. More
2834981 F AZ 04/09/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Confusional state, Fatigue, Lethargy, Neurological symptom, Pneumococcal infecti... Confusional state, Fatigue, Lethargy, Neurological symptom, Pneumococcal infection; Product use in unapproved indication More
stroke-like symptoms; indication : Pneumococcal Disease; confusion; fatigue; severe lethargy; This s... stroke-like symptoms; indication : Pneumococcal Disease; confusion; fatigue; severe lethargy; This spontaneous report was received from a medical assistant via company representative and refers to a female patient in her 50's. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, she was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) 168 mcg/ml injection, 0.5 ml intramuscularly (lot # and expiration date were not provided) for "Pneumococcal Disease" (Product use in unapproved indication). On an unknown date, the patient experienced severe lethargy, fatigue, confusion, and stroke-like symptoms. She went to the emergency department. The outcome of the events was not provided. Causality assessment was not reported. Upon internal review, the event of stroke-like symptoms was considered to be medically significant. Lot # is being requested and will be submitted if received. More
2834982 15 F NC 04/09/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.





Adrenal androgen excess, Autoimmune disorder, Hirsutism, Hypomenorrhoea, Menstru... Adrenal androgen excess, Autoimmune disorder, Hirsutism, Hypomenorrhoea, Menstrual disorder; Menstruation irregular, Polycystic ovarian syndrome, Weight increased; Adrenal androgen excess, Autoimmune disorder, Hirsutism, Hypomenorrhoea, Menstrual disorder; Menstruation irregular, Polycystic ovarian syndrome, Weight increased; Adrenal androgen excess, Autoimmune disorder, Hirsutism, Hypomenorrhoea, Menstrual disorder; Menstruation irregular, Polycystic ovarian syndrome, Weight increased More
polycystic ovary syndrome (PCOS); Autoimmune Injuries; Information has been received from a lawyer r... polycystic ovary syndrome (PCOS); Autoimmune Injuries; Information has been received from a lawyer regarding a case in litigation referring to an adult female patient (pt) of unknown age. Prior to receiving the suspect vaccine, the pt was a healthy, active, and enthusiastic teenager who loved playing club volleyball, being involved in math and science clubs, socializing with friends, and excelling academically. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, at the age of 15-year-old, the pt received three doses of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer, upon the recommendation of a physician and with the consent of her mother. On an unknown date, following the third quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt experienced irregular periods excess androgens (hirsutism), and weight gain. The pt's periods became light and abnormal, even with the help of medroxyprogesterone. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to polycystic ovary syndrome (PCOS). The pt also contended that she sustained serious autoimmune injuries (Autoimmune disorder) as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. As a proximate result the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and would continue to incur these losses and expenses in the future. The outcome of the events was considered to be not recovered. The lawyer considered the events of PCOS and autoimmune disorder to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The events of PCOS and autoimmune disorder were considered to be disabling by the lawyer. More
โœ“
2834983 F NJ 04/09/2025 HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Autoimmune disorder, Dermatitis atopic, Dry skin, Erythema, Muscle twitching; Pr... Autoimmune disorder, Dermatitis atopic, Dry skin, Erythema, Muscle twitching; Pruritus, Skin fissures, Skin haemorrhage; Autoimmune disorder, Dermatitis atopic, Dry skin, Erythema, Muscle twitching; Pruritus, Skin fissures, Skin haemorrhage More
atopic dermatitis/autoimmune dermatological issues with hands, red dry hands and fingers resulting i... atopic dermatitis/autoimmune dermatological issues with hands, red dry hands and fingers resulting in both hands having severe cracking, dryness, itching, redness; both hands bleeding; hands autoimmune dermatological issues; uncontrollable face and body twitching; Information has been received from a lawyer regarding a case in litigation referring to a 14-year-old female patient (pt). The pt's medical history was not reported. The pt's concurrent conditions were not reported. Concomitant therapies were not reported. On unknown date, at the age of 14, the pt received the first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date was not reported) for preventing cervical cancer, upon the recommendation of a physician and with the consent of her mother. Following the administration of the first dose, the pt developed autoimmune dermatological issues with hands. On unknown date, the pt received the second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date was not reported) for preventing cervical cancer. After the second dose, the pt's symptoms continued to persist and worsen with new developments including red dry hands and fingers resulting in both hands having severe cracking, dryness, itching, redness, and bleeding. The pt also developed uncontrollable face and body twitching. The pt was ultimately diagnosed with atopic dermatitis. The pt sought treatment from a variety of medical specialists to manage the conditions. The pt also contended sustained serious autoimmune injuries (autoimmune disorder) as a result of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. As a proximate result the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and would continue to incur these losses and expenses in the future. The outcome of all events was considered to be not recovered. The lawyer considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The events of uncontrollable face and body twitching, atopic dermatitis, autoimmune disorder, skin bleeding were considered to be disabling by the lawyer. More
โœ“
2834985 NY 04/09/2025 DTPPVHBHPB
HEP
 MSP VACCINE COMPANY
MERCK & CO. INC.
Y004552
No adverse event; No adverse event No adverse event; No adverse event
No additional AE reported.; Customer called and reported that at a 2 month well baby checkup, a 1 mo... No additional AE reported.; Customer called and reported that at a 2 month well baby checkup, a 1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine. No additional AE reported. No PQC reported. No additional information; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-Apr-2025, the patient was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #Y004552, expiration date: 14-Oct-2026) (dose, route of administration and vaccination site were not reported) for prophylaxis; and with a dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Outer Membrane Protein Complex), and Hepatitis B (Recombinant) Vaccine (VAXELIS) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered from prophylaxis. On that day, a 1 month and 30-day old consumer inadvertently received the Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) concomitantly with the Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Outer Membrane Protein Complex), and Hepatitis B (Recombinant) Vaccine (VAXELIS) (overdose). No additional adverse event (AE) was reported (no adverse event). No product quality complaint (PQC) was reported. No additional information was provided. Lot # is being requested and will be submitted if received.; Reporter's Comments: More
2834987 13 M FL 04/09/2025 UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Abnormal behaviour, Autoimmune disorder, Cognitive disorder, Dyskinesia, Eye pai... Abnormal behaviour, Autoimmune disorder, Cognitive disorder, Dyskinesia, Eye pain; Fine motor skill dysfunction, Genital pain, Hallucination, Inappropriate affect, Injury; Paranoia, Photophobia, Schizophrenia, Tic, Unresponsive to stimuli More
Catatonic Schizophrenia: tics (arms to move in unusual ways, laugh randomly at nothing and, at inapp... Catatonic Schizophrenia: tics (arms to move in unusual ways, laugh randomly at nothing and, at inappropriate times, and scrunch his face almost as if he was wincing in pain), loss of motor skills, behavioral changes, cognitive decline, hallucinations; Paranoia; eye pain with light sensitivity; Autoimmune, Autonomic, and Neurological Injuries; genital pain; eye pain with light sensitivity; Autoimmune, Autonomic, and Neurological Injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning male patient of a not reported age (reported as a minor). Patient's current conditions, medical history and concomitant therapy was not reported. On an unknown date (at 13 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cervical cancer. On an unknown date, following his vaccination, pts mother sustained serious autoimmune, autonomic, and neurological injuries as a result of his injection; began experiencing genital pain and eye pain with light sensitivity. He began to experience tics that caused his arms to move in unusual ways, laugh randomly at nothing and, sometimes, at inappropriate times, and scrunch his face almost as if he was wincing in pain. He began suffering from paranoia and was unresponsive during school. He began experiencing hallucinations. As the months progressed, so did the pt's symptoms. He was seen by multiple physicians and specialists for his complaints which included loss of motor skills, tics, behavioral changes, cognitive decline, light sensitivity, genital pain, and hallucinations. Based upon his chronic and severe post-Gardasil symptoms, Plaintiff has been diagnosed with various medical conditions, including but not limited to Catatonic Schizophrenia as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to his quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of company's failure to warn pt's mother and pt's healthcare providers, pt has suffered and continues to suffer severe and permanent physical injuries, including pain and suffering. Pt also has a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). As a direct and proximate result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL -induced injuries, pt has suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and he will continue to incur these losses and expenses in the future. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). All the events were considered as disabling by reporter. More
โœ“
2835003 MD 04/09/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 Unknown
Diarrhoea Diarrhoea
Diarrhea; A spontaneous report has been received from a physician. The report concerns a female pati... Diarrhea; A spontaneous report has been received from a physician. The report concerns a female patient of (redacted) ethnic origin born in 1980 (age 44 years, height 160 cm, weight 58.966 kg). The patient's past and current medical history included diarrhea (ongoing). No concomitant products were reported. The patient received Flumist (batch number(s) Unknown), via unspecified route, on 19-OCT-2024. The patient received 1 dose(s). On 19-OCT-2024, the patient experienced diarrhea (preferred term: Diarrhoea). The patient recovered from the event(s) diarrhea after 1 day on 19-OCT-2024. The event was considered non-serious. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUENZ TETRA, FLUENZ TETRA, FLUMIST Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Non-Significant correction on 06-Jan-2025: Vaccine Facility Information added. Narrative amended. DCR-008762-A More
2835004 M NY 04/09/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945659
Chest discomfort, Dyspnoea, Pyrexia Chest discomfort, Dyspnoea, Pyrexia
Chest Tightness; Difficulty Breathing; Feverish; Initial report received on 13-Mar-2025. A nurse ... Chest Tightness; Difficulty Breathing; Feverish; Initial report received on 13-Mar-2025. A nurse reported that a 33-year-old male (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced chest tightness, difficulty breathing, and felt feverish. No medical history or concomitant medications were reported. On 05-Mar-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot # 945659, 31-Jan-2025, NDC # 43528-003-05)] intramuscularly in the right deltoid. Concomitant vaccines administered included an unknown dose of a typhoid vaccine (Lot #, expiration date, NDC #, route not reported)] in the right deltoid, and an unknown dose of a hepatitis A vaccine (Lot #, expiration date, NDC #, route not reported) in the left deltoid. The vaccines were given in preparation for travel. On 07-Mar-2025, the patient called and reported that he went to the ER with chest tightness and difficult breathing. The patient also reported feeling feverish. The patient had "testing" completed at the ER which ruled out any potential issues. The patient was discharged home. No other information was reported. Company Comment: ?The company assessed the events as non-serious.; Sender's Comments: ?The company assessed the events as non-serious. More
2835005 F UT 04/09/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Erythema, Eye swelling, Swelling face, Urticaria Erythema, Eye swelling, Swelling face, Urticaria
Face Swelling, 2-3 Times Larger; Eye Swelling; Redness All Over; 1st Injection in July 2024 and Neve... Face Swelling, 2-3 Times Larger; Eye Swelling; Redness All Over; 1st Injection in July 2024 and Never Returned; Hives All Over; Initial report received on 18-Mar-2025. A reporter reported that a 22-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced incomplete course of vaccination, facial swelling, eye swelling, hives all over, and redness all over. No medical history or concomitant medications were reported. In Jul-2024, dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported)]. The patient never returned for the next dose. On 18-Feb-2025, dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported)] to begin a new series. On 18-Mar-2025, 28 days after the first dose, dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot # 945663, expiration date 31-Jan-2027, NDC # not reported) was administered intramuscularly in the right deltoid. On 18-Mar-2025, two hours after injection, the patient came back to the clinic with facial swelling (described as 2-3 times larger), eye swelling, hives all over, and redness all over. The patient was treated with 50 mg of BENADRYL (diphenhydramine) intramuscularly. The patient left the facility with a parent. No other information was reported. Company Comment: ?The company assessed the events as non-serious.; Sender's Comments: ?The company assessed the events as non-serious. More
2835006 F NJ 04/09/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination Incomplete course of vaccination
Had the first dose of Heplisav-B on 24JAN2025, and has not had the second dose yet; Initial report r... Had the first dose of Heplisav-B on 24JAN2025, and has not had the second dose yet; Initial report received on 19-Mar-2025. A consumer reported that she, a female (race, age, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet. No medical history or concomitant vaccines were reported. On 24-Jan-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not available). At the time of the report, 54 days after receiving dose 1 of HEPLISAV-B, the patient had not received the second dose yet. The reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2835007 M NY 04/09/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 943191
Interchange of vaccine products, No adverse event Interchange of vaccine products, No adverse event
Received Heplisav-B As First Dose, and Second Dose was Engerix-B; Initial report received on 19-Mar-... Received Heplisav-B As First Dose, and Second Dose was Engerix-B; Initial report received on 19-Mar-2025. A nurse reported that a 21-year-old male (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and ENGERIX-B as the second dose. No medical history or concomitant medications were reported. On 13-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 943191, expiration date 21-Feb-2026, NDC # not reported)] intramuscularly in left deltoid. On an unknown date, the patient received ENGERIX-B (no details provided) as the second dose. There were no other side effects. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2835008 F TX 04/09/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Inappropriate schedule of product administration Inappropriate schedule of product administration
Received 1st Dose on 04NOV2023 and now She is Here for the Second Dose; Initial report received on 2... Received 1st Dose on 04NOV2023 and now She is Here for the Second Dose; Initial report received on 21-Mar-2025. A pharmacist reported that a 53-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 04-Nov-2023 and returned to receive the second dose on 21-Nov-2025. No medical history or concomitant medications were reported. On 04-Nov-2023, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, site not reported)]. On 21-Mar-2025, 503 days after having been vaccinated with HEPLISAV-B, the patient presented to the pharmacy to receive the second dose. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2835009 F CA 04/09/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Viral titre decreased Viral titre decreased
Titer Drawn and it was Low; Initial report received on 21-Mar-2025. A pharmacist reported that a ... Titer Drawn and it was Low; Initial report received on 21-Mar-2025. A pharmacist reported that a 57-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had a titer drawn and it was low. Medical history and concomitant medications at the time of vaccination were not reported. On 28-Jul-2023, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not available)]. 29-Aug-2023, 32 days after having been vaccinated with first dose of HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not available)]. On an unknown date, the patient had a titer drawn and it was low. Her physician recommended to get another dose of HEPLISAV-B. No additional information was reported. Company Comment: The company assessed the event as non-serious. The event is not immunologically confirmed for vaccination failure since the serological marker and time to serological testing was not reported.; Sender's Comments: The company assessed the event as non-serious. The event is not immunologically confirmed for vaccination failure since the serological marker and time to serological testing was not reported. More
2835010 F WI 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3BD9E
Dyspnoea, Swollen tongue Dyspnoea, Swollen tongue
Shortness of Breath; Tongue Swelling; This serious case was reported by a pharmacist via sales rep a... Shortness of Breath; Tongue Swelling; This serious case was reported by a pharmacist via sales rep and described the occurrence of shortness of breath in a female patient who received Herpes zoster (Shingrix) (batch number 3BD9E) for prophylaxis. On 22-NOV-2021, the patient received the 1st dose of Shingrix. On 22-NOV-2021, less than a day after receiving Shingrix, the patient experienced shortness of breath (Verbatim: Shortness of Breath) (serious criteria hospitalization) and swollen tongue (Verbatim: Tongue Swelling) (serious criteria hospitalization). The outcome of the shortness of breath and swollen tongue were resolved. The reporter considered the shortness of breath and swollen tongue to be related to Shingrix. The company considered the shortness of breath and swollen tongue to be related to Shingrix. Additional Information: GSK Receipt Date: 25-MAR-2025 The patient accepted the first dose of Shingrix. She waited 15 minutes in office after. The patient drove home and had tongue swelling and shortness of breath. Immediately she drove back to the hospital because of reaction.; Sender's Comments: Dyspnoea is an unlisted event, due to the following criteria (strong temporal association) is considered related to GSK vaccine Shingrix Swollen tongue is a listed event which is considered related to a GSK vaccine Shingrix More
โœ“
2835011 M 04/09/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Asthenia, Cardiac dysfunction, Echocardiogram abnormal, Ejection fraction, Hypot... Asthenia, Cardiac dysfunction, Echocardiogram abnormal, Ejection fraction, Hypotension; Myocardial necrosis marker increased, N-terminal prohormone brain natriuretic peptide increased, Pyrexia More
reduced cardiac function; elevated cardiac enzymes; low blood pressure; weakness; low grade fever; e... reduced cardiac function; elevated cardiac enzymes; low blood pressure; weakness; low grade fever; elevated pro-BNP; This serious case was reported by a physician via sales rep and described the occurrence of cardiac function decreased in a 22-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included heart transplant (Patient undergone Heart transplant 2 years ago). On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced cardiac function decreased (Verbatim: reduced cardiac function) (serious criteria GSK medically significant), cardiac enzymes increased (Verbatim: elevated cardiac enzymes) (serious criteria GSK medically significant), blood pressure decreased (Verbatim: low blood pressure), weakness (Verbatim: weakness), low grade fever (Verbatim: low grade fever) and nt-probnp increased (Verbatim: elevated pro-BNP). The outcome of the cardiac function decreased was not reported and the outcome of the cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased were resolved. It was unknown if the reporter considered the cardiac function decreased to be related to Shingrix. The reporter considered the cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased to be related to Shingrix. The company considered the cardiac function decreased, cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 02-APR-2025 Reporter stated that patient who is about 22-year-old and 2 years post-heart transplant on IC who received second dose of Shingrix vaccine and within 12 hours started having symptoms low BP, weakness and low-grade fever. He was seen at ED, ECHO performed showed reduced cardiac function no values provided for LVEF. Lab work showed elevated pro-BNP and cardiac enzymes. The patient did not require hospitalization and was only seen for follow-up at the clinic.; Sender's Comments: Cardiac dysfunction and Myocardial necrosis marker increased are unlisted events which are considered unrelated to GSK vaccine Shingrix. More
2835012 F 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Burning sensation, Hypoaesthesia, Neuropathy peripheral, Paraesthesia Burning sensation, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
peripheral neuropathy in feet and leg.; This serious case was reported by a consumer via interactive... peripheral neuropathy in feet and leg.; This serious case was reported by a consumer via interactive digital media and described the occurrence of peripheral neuropathy in a adult 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 peripheral neuropathy (Verbatim: peripheral neuropathy in feet and leg.) (serious criteria disability and GSK medically significant). The outcome of the peripheral neuropathy was not resolved. The reporter considered the peripheral neuropathy to be related to Shingles vaccine. The company considered the peripheral neuropathy to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 26-MAR-2025 This case was reported by a patient via interactive digital media. The patient wished she would have never taken the Shingles vaccine. She reported that she had been dealing with the effects for several years. Almost like having inner shingles. The patient experienced burning tingling and loss of feeling in feet and legs. She continued to have peripheral neuropathy in feet and legs. She stated that the physician just treated symptoms with every drug imaginable.; Sender's Comments: Neuropathy peripheral is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine More
โœ“
2835013 F 04/09/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Gait inability Gait inability
next day could not walk still can not; This serious case was reported by a consumer via interactive ... next day could not walk still can not; This serious case was reported by a consumer via interactive digital media and described the occurrence of unable to walk in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In OCT-2023, the patient received RSV vaccine. In OCT-2023, 1 day after receiving RSV vaccine, the patient experienced unable to walk (Verbatim: next day could not walk still can not) (serious criteria disability). The outcome of the unable to walk was not resolved. It was unknown if the reporter considered the unable to walk to be related to RSV vaccine. The company considered the unable to walk to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 25-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his wife got the shot in October 2023 next day could not walk still could not. The doctor said nothing could do help, be very careful of this shot.; Sender's Comments: Gait inability is an unlisted event which is considered unrelated to GSK RSV vaccine. More
โœ“
2835014 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Gait inability, Vertigo Gait inability, Vertigo
worst case of vertigo (hospital stay); Over a month before I could walk carefully again never had be... worst case of vertigo (hospital stay); Over a month before I could walk carefully again never had before; This serious case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a 74-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (shingles is bad). 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 vertigo (Verbatim: worst case of vertigo (hospital stay)) (serious criteria hospitalization) and unable to walk (Verbatim: Over a month before I could walk carefully again never had before) (serious criteria hospitalization). The outcome of the vertigo was not reported and the outcome of the unable to walk was resolving. It was unknown if the reporter considered the vertigo and unable to walk to be related to Shingles vaccine. The company considered the vertigo and unable to walk to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient stated that shingles was bad and did got one shot of Shingles vaccine (after years of suffering) when it was basically over. The patient got something from shot and his/her doctor told him/her to hold back on second and nobody came up with an answer, but after shot the patient got the worst case of vertigo and had a hospital stay. Over a month before I could walk carefully again never had before, otherwise in good health.; Sender's Comments: Vertigo and Gait inability are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine More
โœ“
2835015 21 F NM 04/09/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 423NL
Underdose Underdose
the pediatric dose of haverix instead of the adult dose; received a pediatric dose of Havrix; This n... the pediatric dose of haverix instead of the adult dose; received a pediatric dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 21-year-old female patient who received HAV (Havrix 720) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis. Previously administered products included Hepatitis A vaccine (got a previous Hepatitis A pediatric dose on 6 March 2009). On 07-MAR-2025, the patient received Havrix 720 (intramuscular, left deltoid) .5 ml. On 07-MAR-2025, an unknown time after receiving Havrix 720, the patient experienced adult use of a child product (Verbatim: the pediatric dose of haverix instead of the adult dose) and underdose (Verbatim: received a pediatric dose of Havrix). The outcome of the adult use of a child product and underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-MAR-2025 The reporter was a Medical Assistant for a medical office. An adult patient received the pediatric dose of HAVRIX (0.5ml) instead of the adult dose which led to adult use of a child product and underdose. Further, when the call was transferred to Medical Information line, the Medical Assistant explained that it was not the first Hepatitis A dose as mentioned to the prior agent but patient got a previous Hepatitis A pediatric dose on March 6th 2009. More
2835016 56 F FL 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 425CR
Exposure during pregnancy, Pain, Pain in extremity, Rash, Rash vesicular Exposure during pregnancy, Pain, Pain in extremity, Rash, Rash vesicular
pregnant patient received Shingrix; vesicular rash on both arms, neck and chest; burning pain simila... pregnant patient received Shingrix; vesicular rash on both arms, neck and chest; burning pain similar to sunburn/painful arm; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 425CR, expiry date 10-AUG-2026) for prophylaxis. On 03-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 14-MAR-2025, 11 days after receiving Shingrix, the patient experienced vesicular rash (Verbatim: vesicular rash on both arms, neck and chest) and pain burning (Verbatim: burning pain similar to sunburn/painful arm). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received Shingrix). The outcome of the vesicular rash and pain burning were unknown and the outcome of the vaccine exposure during pregnancy was not applicable. It was unknown if the reporter considered the vesicular rash and pain burning to be related to Shingrix. It was unknown if the company considered the vesicular rash and pain burning to be related to Shingrix. Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 19-MAR-2025 The reporter stated that the patient received her first Shingrix injection in her left deltoid on 3-Mar-2025. On 14-Mar-2025 she presented with a vesicular rash on both arms, neck and chest and the rash was giving her burning pain similar to sunburn. Pregnant patient received Shingrix, which led to vaccine exposure during pregnancy. More
2835017 F NY 04/09/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 B32NG
B32NG
Breast cancer female, Chest pain, Dyspnoea, Muscle spasms, Tetanus; Thrombosis, ... Breast cancer female, Chest pain, Dyspnoea, Muscle spasms, Tetanus; Thrombosis, Trismus More
Tetanus-like; Lockjaw; Clot blood; Muscle spasms; Chest pain; Shortness of breath; Breast cancer in ... Tetanus-like; Lockjaw; Clot blood; Muscle spasms; Chest pain; Shortness of breath; Breast cancer in 2024; This serious case was reported by a consumer via call center representative and described the occurrence of tetanus-like in a 53-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis. Concurrent medical conditions included hyperlipidemia and type ii diabetes mellitus (NIDDM). Concomitant products included rosuvastatin, ezetimibe (Zetia), fenofibrate and tirzepatide (Mounjaro). In APR-2023, the patient received Boostrix (intramuscular, left deltoid). On 05-MAR-2025, between 1 and 2 years after receiving Boostrix, the patient experienced tetanus-like (Verbatim: Tetanus-like) (serious criteria hospitalization and GSK medically significant), lockjaw (Verbatim: Lockjaw) (serious criteria hospitalization), clot blood (Verbatim: Clot blood) (serious criteria hospitalization and GSK medically significant), muscle spasm (Verbatim: Muscle spasms) (serious criteria hospitalization), chest pain (Verbatim: Chest pain) (serious criteria hospitalization) and shortness of breath (Verbatim: Shortness of breath) (serious criteria hospitalization). On an unknown date, the patient experienced breast cancer (Verbatim: Breast cancer in 2024) (serious criteria GSK medically significant). On 12-MAR-2025, the outcome of the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain and shortness of breath were unknown (duration 7 days). The outcome of the breast cancer was resolved. It was unknown if the reporter considered the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain, shortness of breath and breast cancer to be related to Boostrix. The company considered the tetanus-like, lockjaw, clot blood, muscle spasm, chest pain, shortness of breath and breast cancer to be unrelated to Boostrix. Additional Information: GSK Receipt Date: 19-MAR-2025 The patient self-reported this case. The patient reported that she received a Boostrix injection in April 2023. On 5-Mar-2025, she was admitted to the hospital with tetanus-like symptoms. She was not officially diagnosed with tetanus but suffered with lockjaw, blood clots, muscle spasms, chest pain and shortness of breath.; Sender's Comments: Tetanus, Trismus, Thrombosis, Muscle spasms, Chest pain, Dyspnoea and Breast cancer are unlisted events which are considered unrelated to GSK vaccine Boostrix. More
โœ“
2835018 F PA 04/09/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Hypohidrosis, Vaccination failure; Herpes zoster, Hypohidrosis, V... Herpes zoster, Hypohidrosis, Vaccination failure; Herpes zoster, Hypohidrosis, Vaccination failure More
suspected vaccination failure; Shingles; not sweating; This serious case was reported by a consumer ... suspected vaccination failure; Shingles; not sweating; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and valaciclovir hydrochloride (Valtrex) cream for shingles. On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Valtrex. On an unknown date, less than a year after receiving Shingrix and Shingrix and not applicable after starting Valtrex, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and sweating decreased (Verbatim: not sweating). The action taken with Valtrex was unknown. The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving and the outcome of the sweating decreased was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and sweating decreased to be related to Shingrix and Shingrix. It was unknown if the reporter considered the sweating decreased to be related to Valtrex. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and sweating decreased to be related to Shingrix and Shingrix. It was unknown if the company considered the sweating decreased to be related to Valtrex. Additional Information: GSK Receipt Date: 19-MAR-2025 The patient received 1st and 2nd dose of Shingrix vaccine in 2024 and was feeling fine. In 2024, the patient experienced Shingles. In 2025, the patient was not sweating. The reporter reported sweating as usual. Patient stated the health care professional prescribed her Valtrex for her Shingles, and she noticed after starting the Valtrex in 2025 that her body stopped sweating as usual. She had gone to 4 health care professional and wondered why this was happening and no one seems to answer. The reporter did not to release any health care professional name and numbers. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and dose 2) More
2835019 54 F 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Hypoaesthesia, Paraesthesia Hypoaesthesia, Paraesthesia
she noticed tingling and numbness in her fingertips on both arms; she noticed tingling and numbness ... she noticed tingling and numbness in her fingertips on both arms; she noticed tingling and numbness in her fingertips on both arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-MAR-2025, the patient received the 2nd dose of Shingrix (left arm). In MAR-2025, less than 2 weeks after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: she noticed tingling and numbness in her fingertips on both arms) and numbness of upper arm (Verbatim: she noticed tingling and numbness in her fingertips on both arms). The outcome of the tingling of extremity and numbness of upper arm were unknown. It was unknown if the reporter considered the tingling of extremity and numbness of upper arm to be related to Shingrix. It was unknown if the company considered the tingling of extremity and numbness of upper arm to be related to Shingrix. Additional Information: GSK Receipt Date: 19-MAR-2025: Reporter was the patient who states that she received her second dose of Shingrix on 7 March 2025 on her left arm. This past week, she noticed tingling and numbness in her fingertips on both arms. More
๐Ÿ“‹ Privacy Policy & Data Disclaimer