🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2829707 51 F NJ 03/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93kk4
Eye irritation, Eyelid margin crusting Eye irritation, Eyelid margin crusting
patient experiencing eye burning, eye crustiness, started Saturday/Sunday after vaccine and continue... patient experiencing eye burning, eye crustiness, started Saturday/Sunday after vaccine and continues today Wednesday after More
2829708 66 F GA 03/05/2025 PNC21
PPV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y013009
Y016291
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient was inadvertenly given 2 pneumonia shots in one day. Patient has been informed and is not ex... Patient was inadvertenly given 2 pneumonia shots in one day. Patient has been informed and is not experiencing any complications. More
2829709 66 M CO 03/05/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMBV043A
No adverse event, Product preparation error No adverse event, Product preparation error
An error occurred in mixing the vaccine with the incorrect diluent, which resulted in the patient no... An error occurred in mixing the vaccine with the incorrect diluent, which resulted in the patient not receiving the full vaccine. Although the patient experienced no adverse effects, they had to return to receive the vaccine with the correct diluent to be fully vaccinated. More
2829710 70 F SC 03/05/2025 COVID19
MMR
VARZOS
 MODERNA
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 8081564
Y007613
74NC9
Oral pain, Stomatitis; Oral pain, Stomatitis; Oral pain, Stomatitis Oral pain, Stomatitis; Oral pain, Stomatitis; Oral pain, Stomatitis
Patient reports that the upper roof of her mouth became very painful ,sore and raw 2 days after she ... Patient reports that the upper roof of her mouth became very painful ,sore and raw 2 days after she received the above 3 mentioned vaccinations. More
2829711 75 F OH 03/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site mass, Injection site pruritus, Injection site swelling Injection site mass, Injection site pruritus, Injection site swelling
Lump swollen itching at site Lump swollen itching at site
✓
2829753 67 F AZ 03/05/2025 MMR
PPV
UNK
UNK
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Injection site swelling, Lymphadenopathy, Pain; Injection site swelling, Lymphad... Injection site swelling, Lymphadenopathy, Pain; Injection site swelling, Lymphadenopathy, Pain; Injection site swelling, Lymphadenopathy, Pain; Injection site swelling, Lymphadenopathy, Pain More
reaction at injection site of swelling the size of the palm of her hand in her right arm; painful; s... reaction at injection site of swelling the size of the palm of her hand in her right arm; painful; swelling the size of the lymph nodes under right arm; This spontaneous report was received from a consumer referring to herself, a 67-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included guaifenesin (DIMETAPP) reaction and latex allergy. Concomitant therapies were not reported. On an unknown date in 2020 (reported as 5 years ago), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) solution for injection, administered as vaccine in right arm (strength, dose, route, lot #, and expiration date were not reported). On the same date, the patient was also vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) lyophilisate and solvent for solution for injection and unspecified hepatitis vaccine (Hepatitis A Vaccine, Inactivated (manufacturer unknown) suspension for injection or Hepatitis B Vaccine (Recombinant) (manufacturer unknown) suspension for injection), administered for prophylaxis (formulation, strength, dose, route, lot#, and expiration date were not reported). On an unknown date in 2020 (reported as about five years ago), the patient experienced reaction at injection site of swelling the size of the palm of her hand in her right arm (Vaccination site swelling) and the lymph nodes under right arm (injected on right side) (Lymphadenopathy). The events did not happen immediately, but they ended up swollen the whole upper portion of her arm. Painful was for 3-5 days then subsided. The patient had sought medical attention. No treatment was given. Outcome of the events was recovered 3-5 days later. Causality between the events and all the suspect vaccines was not reported. Lot# is being requested and will be submitted if received. More
2829754 22 MO 03/05/2025 HEPA
 MERCK & CO. INC.
 Y006122
No adverse event, Underdose No adverse event, Underdose
no symptomatic AE; an adult patient received a pediatric dose of VAQTA instead of an adult dose; Thi... no symptomatic AE; an adult patient received a pediatric dose of VAQTA instead of an adult dose; This spontaneous report was received from a nurse and refers to a 22-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 25-JAN-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) suspension for injection, 0.5 ml, administered for prophylaxis by a health professional (lot #Y006122, expiration date: 17-MAY-2025; strength and route were not reported). The adult patient received a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) instead of an adult dose (Incorrect dose administered). No symptomatic adverse event (AE) was reported. More
2829755 KY 03/05/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Medical Assistant calling with a report of an adverse event regarding improperly s... No additional AE; Medical Assistant calling with a report of an adverse event regarding improperly stored and administered VARIVAX.; 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 09-Jan-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), 0.5 mL (lot #Y015108, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 06-Sep-2026) dose description reported as 0.5 mL / Two dose series, administered for prophylaxis; with sterile diluent (BAXTER Sterile Diluent). It was reported that the vaccine was involved in multiple temperature excursions beginning on (05-DEC-2024), and the product was administered to the patient involved on 09-Jan-2025 (Product storage error). The reporter confirmed no reports of medical concerns or symptoms from the patient involved. No additional information provided. There was no additional adverse event (AE) or product quality complaint (PQC) provided. More
2829756 KY 03/05/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; the VARIVAX was involved in multiple temperature excursions beginning on 12/5/2024... No additional AE; the VARIVAX was involved in multiple temperature excursions beginning on 12/5/2024, and the product was administered to the patient involved on 1/9/2025; This spontaneous report was received from an Other health professional and refers to a(n) 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. Beginning on 05-DEC-2024, Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) was involved in multiple temperature excursions. On 09-JAN-2025, the patient was vaccinated with the improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y015108, expiration date: 06-SEP-2026) 0.5 mL (0.5 mL / Two dose series) (route was not reported) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event). More
2829757 KY 03/05/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
no reports of medical concerns or symptoms; improperly stored and administered VARIVAX; This spontan... no reports of medical concerns or symptoms; improperly stored and administered VARIVAX; This spontaneous report was received from a medical assistant referring 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 03-JAN-2025, the patient was administered a dose of improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (0.5 mL, two dose series, lot # Y015108, expiration date: 06-SEP-2026; dose number, route and anatomical site were unknown) for prophylaxis (product storage error), which was reconstituted with sterile diluent (BAXTER Sterile Diluent) (dose, strength, batch/lot#, expiration date, routed and indication were unknown). The vaccine was involved in multiple temperature excursions beginning on 05-DEC-2024. No reports of medical concerns or symptoms from the patient involved (no adverse event). The outcome of the events was unknown. More
2829758 KY 03/05/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Medical Assistant calling with a report of an adverse event regarding improperly s... No additional AE; Medical Assistant calling with a report of an adverse event regarding improperly stored and administered VARIVAX.; This spontaneous report has been received from other health care professional (medical assistant) concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter. On 09-JAN-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 mL, lot# Y015108 that was verified to be a valid lot # (expiration date reported and validated as 06-SEP-2026) administered as prophylaxis (routed and anatomical location of administration were not provided). The dose was administered after underwent multiple temperature excursions (beginning on 05-DEC-2024) (product storage error). No medical concerns or symptoms from the patient involved were reported. No additional adverse event reported. More
2829759 KY 03/05/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; improper storage of product in use; This spontaneous report was received from a me... no adverse event; improper storage of product in use; This spontaneous report was received from a medical assistant referring to patient of unknown age and gender. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided. On 14-JAN-2025, the patient was vaccinated with an improperly stored dose of vaccine Varicella Virus Vaccine Live (Oka-Merck) injection, 0.5 milliliters, for prophylaxis, lot number Y015108 which has been verified to be valid, expiration date reported and validated as 06-SEP-2026 (strength, scheme, route of administration and expiration date not provided). The vaccine was improperly stored since 05-DEC-2024. The previous temperature excursions of the vaccine were unknown (improper storage of product in use). There were no symptoms reported. More
2829760 OK 03/05/2025 HPV9
 MERCK & CO. INC.
 1957407
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs; GARDASIL 9 were administered to two patients after experiencing a temperature ex... No additional AEs; GARDASIL 9 were administered to two patients after experiencing a temperature excursion; This spontaneous report has been received from a health care professional regarding a 12-year-old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On January 2025 , the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number 1957407 which has been verified to be valid, expiration date reported and validated as 23-JAN-2026(dose, strength, scheme, route of administration and anatomical site not provided). The administered dose of the vaccine was stored at 31.6 degrees Celsius (C), during 240 hours. There were not previous temperature excursions. There were no symptoms reported. More
2829761 OK 03/05/2025 HIBV
PNC15
RV5
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 X028614
Y005465
Y005878
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; calling to report T/E for PEDVAX HIB , ROTATEQ, VAXNEUVANCE that was administered.... No adverse event; calling to report T/E for PEDVAX HIB , ROTATEQ, VAXNEUVANCE that was administered.; This spontaneous report was received from a health care professional referring to a patient, age and gender was not provided. Information regarding the patient's pertinent medical history, drug allergies or reactions, or concomitant medications was not provided. On 20-FEB-2025, the patient was vaccinated with an improperly stored dose of Pneumococcal 15-valent Conjugate (VAXNEUVANCE) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported, lot number Y005465 with an expiration date on 08-JAN-2027) with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported, lot number Y005878 with an expiration date on 28-OCT-2025) and with a dose of haemophilus b conjugate vaccine (Meningococcal protein conjugate) (PEDVAXHIB-LIQUID) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported, lot number X028614 with an expiration date on 07-NOV-2026). The administered dose of the vaccine experienced a temperature excursion 32.0 degrees Fahrenheit for 2 hours and 12minutes.It was not reported if the information was recorded by a data logger or not. There was no adverse effect reported. More
2829762 OK 03/05/2025 HEPA
HIBV
PNC15
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y008483
Y006393
Y005465
No adverse event; No adverse event; No adverse event No adverse event; No adverse event; No adverse event
No additional AE reported; immunization coordinator calling to report T/E for VAQTA , PEDVAX HIB , V... No additional AE reported; immunization coordinator calling to report T/E for VAQTA , PEDVAX HIB , VAXNEUVANCE that was administered. T/E date was on 2/18/2025 and VAQTA , PEDVAX HIB , VAXNEUVANCE were administered on 2/19/2025.; This spontaneous report was received from a Nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 18-FEB-2025, a temperature excursion (TE) occurred for Hepatitis A Vaccine, Inactivated (VAQTA), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) and Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) at 32 degree Fahrenheit (F) for 2 hours and 12 minutes, with not previous TE. After the TE, on 19-FEB-2025, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25U/0.5 ml Injection, prefilled syringe, first dose (lot number Y008483 has been verified to be valid for Hepatitis A Vaccine, Inactivated [VAQTA], expiration date 26-Nov-2025); with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), second dose (lot number Y006393 has been verified to be valid for Haemophilus b Conjugate Vaccine [Meningococcal Protein Conjugate] [LIQUID PEDVAX HIB], expiration date 07-Nov-2026; formulation was not provided) and with an improperly stored dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE), 0.5 ml Injection, prefilled syringe, third dose (lot number Y005465 has been verified to be a valid number for Pneumococcal 15-valent Conjugate Vaccine [VAXNEUVANCE], expiration date 08-Jan-2027); all vaccines were administered as prophylaxis (exact dose, route of administration and anatomical site of injection were not reported for any of the vaccines) (Product storage error). No additional adverse event was reported for the patient (No adverse event). This is one of several reports from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02763807-02763516 , CLIC number : , ESTAR number : , IRMS number : 500UW00000VCgbGYAT|04032025230033|5967 , Central date : 2025-03-05 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02763807 , MNSC interaction number : 02763516 , Integration log UniqueID : 500UW00000VCgbGYAT|04032025230033|5967 , Service cloud CaseID : 500UW00000VCgbGYAT More
2829763 33 F MA 03/05/2025 HPV9
 MERCK & CO. INC.
 y007322
Accidental underdose, No adverse event, Poor quality device used Accidental underdose, No adverse event, Poor quality device used
no adverse event; Accidental underdose; poor quality device used; This spontaneous report has been r... no adverse event; Accidental underdose; poor quality device used; This spontaneous report has been received from a health care professional regarding a 33-year-old female patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 04-MAR-2025, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (reported as GARDASIL 9 INJ 1DS X 10 SYRINGES), 0.5 mL for prophylaxis, lot number Y007322 which has been verified to be valid, expiration date reported and validated as 18-AUG-2026(strength, scheme, route of administration and anatomical site not provided). On the same date the health care professional reported that the vaccine leaked between the syringe hub luer lock and syringe needle while being administered. No physical defects in the syringe were noted. (accidental underdose) (poor quality device used) (no adverse event). More
2829764 NC 03/05/2025 TYP
 BERNA BIOTECH, LTD.
 3004007
Abdominal pain, Diarrhoea, Product storage error Abdominal pain, Diarrhoea, Product storage error
The patient felt abdominal pain and diarrhea; The patient felt abdominal pain and diarrhea; The Vivo... The patient felt abdominal pain and diarrhea; The patient felt abdominal pain and diarrhea; The Vivotif vaccine was stored nine days out of refrigerator, maximum temperature reached 70 Fahrenheit and patient took three doses of this vaccine; The Vivotif vaccine was stored nine days out of refrigerator, maximum temperature reached 70 Fahrenheit and patient took three doses of this vaccine; Case reference number US-BN-2024-001885 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0955) on 07-May-2024 and concerns a patient of unspecified gender or age. The patient's medical history and concomitant medication was not provided. On an unspecified date, the Vivotif vaccine was stored nine days out of the refrigerator, maximum temperature reached 70 Fahrenheit (explicitly coded as 'product storage error'). On 30-Apr-2024, the patient took first dose of Vivotif (batch number: 3004007), at unknown dose, orally, for unknown indication (explicitly coded as 'Product administration error'). On 02-May-2024, two days after first dose of Vivotif, the patient took second dose of Vivotif (batch number: 3004007), at unknown dose, orally (explicitly coded as 'Product administration error'). On 04-May-2024, two days after second dose of Vivotif, the patient took third dose of Vivotif (batch number: 3004007), at unknown dose, orally (explicitly coded as 'Product administration error'). On an unspecified date, the patient felt abdominal pain and diarrhea. As reported, the patient didn't get any treatment for the symptoms and had no laboratory results. At the time of initial report, it was unknown if the patient recovered from events of abdominal pain and diarrhea. The reporter assessed the events of abdominal pain and diarrhea as non-serious and possibly related to the product of Vivotif. No further information was provided.; Reporter's Comments: A patient of unspecified gender or age took the first, second and the third dose of Vivotif for unknown indication, after the Vivotif vaccine was stored nine days out of the refrigerator, maximum temperature reached 70 Fahrenheit, which is considered as product administration error and product storage error. On an unspecified date, the patient felt abdominal pain and diarrhoea. Diarrhoea and abdominal pain are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst product storage error and product administration error. The patient's medical history and concomitant medication was not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the reported events have been considered as related to Vivotif. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified gender or age took the first, second and the third dose of Vivotif for unknown indication, after the Vivotif vaccine was stored nine days out of the refrigerator, maximum temperature reached 70 Fahrenheit, which is considered as product administration error and product storage error. On an unspecified date, the patient felt abdominal pain and diarrhoea. Diarrhoea and abdominal pain are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst product storage error and product administration error. The patient's medical history and concomitant medication was not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the reported events have been considered as related to Vivotif. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829765 F 03/05/2025 TYP
TYP
 BERNA BIOTECH, LTD.
BERNA BIOTECH, LTD.
 Unknown
Unknown
Arthralgia, Arthritis, Chills, Diarrhoea, Incomplete course of vaccination; Myal... Arthralgia, Arthritis, Chills, Diarrhoea, Incomplete course of vaccination; Myalgia, Pyrexia More
Arthritis in hands; Chills; Joint pain; Muscle ache; Fever of 101 (units not specified); several epi... Arthritis in hands; Chills; Joint pain; Muscle ache; Fever of 101 (units not specified); several episodes of diarrhoea; The patient stopped taking the Vivotif vaccine; Case reference number US-BN-2024-002813 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: BN_2024_03098) on 24-Nov-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication were not provided. The patient's current condition included measles. On an unspecified date, reported as Tuesday, the patient received co-suspect unspecified vaccine (brand name: Unknown; batch number: unknown) at an unknown dose, route, or site of administration for an unknown indication. On an unspecified dates, the patient took the first and second dose of Vivotif (batch number: unknown) at an unknown dose, orally for immunization, as reported, the patient got oral typhoid to get better immunity of intestines. On an unspecified date, reported as last night, unknown amount of time after vaccination, the patient got fever of 101 (units not specified). On an unspecified date, unknown amount of time after vaccination, the patient experienced chills, some arthritis in hands, and joint pain, muscle ache and several episodes of diarrhoea. As reported, the patient stopped taking the Vivotif vaccine and did not know if should continue (explicitly coded as 'incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient was recovered from the events of fever, hand arthritis, joint pain, muscle ache, chills, and diarrhoea. The reporter assessed the events of fever, hand arthritis, joint pain, muscle ache, chills, and diarrhoea as non-serious and while the causality assessment between the events was not reported. Additional information received from Bavarian Nordic on 25-Nov-2024: included reference number. Additional information received from the consumer via Med Communications (reference USBAV24-3109) on 25-Nov-2024: added additional events and seriousness criteria, confirmation that the patient stopped taking Vivoitf, patient's gender and confirmation for country of occurrence.; Reporter's Comments: A female patient of unknown age got fever of 101 (units not specified) and experienced chills, some arthritis in hands, joint pain, muscle ache and several episodes of diarrhoea, unknown time after taking the first and second dose of Vivotif, at an unknown dose, orally for immunization. Reportedly, the patient stopped taking the Vivotif vaccine and did not know if should continue which is considered as incomplete course of vaccination. According to CCDS v8 and USPI arthritis is unlisted and unexpected, chills, myalgia and arthralgia are listed however unexpected while pyrexia and diarrhoea are listed and expected. Incomplete course of vaccination is considered listed according to company convention. The outcome was unknown. The patient's medical history and concomitant medication were not provided while current condition included measles. Arthritis, chills, myalgia, arthralgia, pyrexia and diarrhoea are all assessed as related due to lack of alternative explanation at this point, and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age got fever of 101 (units not specified) and experienced chills, some arthritis in hands, joint pain, muscle ache and several episodes of diarrhoea, unknown time after taking the first and second dose of Vivotif, at an unknown dose, orally for immunization. Reportedly, the patient stopped taking the Vivotif vaccine and did not know if should continue which is considered as incomplete course of vaccination. According to CCDS v8 and USPI arthritis is unlisted and unexpected, chills, myalgia and arthralgia are listed however unexpected while pyrexia and diarrhoea are listed and expected. Incomplete course of vaccination is considered listed according to company convention. The outcome was unknown. The patient's medical history and concomitant medication were not provided while current condition included measles. Arthritis, chills, myalgia, arthralgia, pyrexia and diarrhoea are all assessed as related due to lack of alternative explanation at this point, and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829766 03/05/2025 SMALLMNK
 BAVARIAN NORDIC
 96867
Expired product administered Expired product administered
Last week two individuals were vaccinated using Jynneos that should have been marked with a BUD but ... Last week two individuals were vaccinated using Jynneos that should have been marked with a BUD but was not, the shipment was placed in refrigerator, BUD was on 20-Dec-2024; Case reference number US-BN-2025-000126 is a spontaneous case initially received from other health care professional via Med Communication (reference number: USBAV25-0116) on 15-Jan-2025 and concern a patients with unspecified age and gender (MULTI 2). The patients medical history and concomitant medication details were not provided. On 09-Jan-2025, two patients received Jynneos vaccine, (batch number: 96867; expiration date: Apr-2026 and beyond use date (BUD): 20-Dec-2024), at unknown dose, route or site of administration for unknown indication. The shipment was received on 25-Oct-2024 and placed in refrigerator, so the BUD was 20-Dec-2024 (explicitly coded as 'Expired product administered'). At the time of initial report, it was unknown if the patient experienced any adverse events due Jynneos. No further information was provided.; Reporter's Comments: This case concerns two patients with unspecified age and gender who received Jynneos vaccine on 09-Jan-2025 (batch number: 96867; expiration date: Apr-2026 and beyond use date (BUD): 20-Dec-2024), at unknown dose, route or site of administration for unknown indication. The shipment was received on 25-Oct-2024 and placed in refrigerator, so the BUD was 20-Dec-2024 which is considered as expired product administered. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due Jynneos. The patients medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns two patients with unspecified age and gender who received Jynneos vaccine on 09-Jan-2025 (batch number: 96867; expiration date: Apr-2026 and beyond use date (BUD): 20-Dec-2024), at unknown dose, route or site of administration for unknown indication. The shipment was received on 25-Oct-2024 and placed in refrigerator, so the BUD was 20-Dec-2024 which is considered as expired product administered. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due Jynneos. The patients medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829767 F FL 03/05/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Received First Dose June 2024, More than 1 Month and Hasn't Received Second; Initial report rec... Received First Dose June 2024, More than 1 Month and Hasn't Received Second; Initial report received on 12-Feb-2025. A pharmacist reported that a male patient (race and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Jun-2024 but had not received the second dose yet. No medical history or concomitant medications were reported. In Jun-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLIAV-B (NDC # 43528-002-01, lot #, expiration date, route, and site not reported). At the time of reporting, the patient had not received the second dose of HEPLISAV-B yet, more than a month after receiving the first dose. No adverse reactions were reported. The reporter had no other information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2829768 AZ 03/05/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Pediatric Patient (7 day old) Received Heplisav-B; Initial report received on 12-Feb-2025. A medica... Pediatric Patient (7 day old) Received Heplisav-B; Initial report received on 12-Feb-2025. A medical assistant reported that a 7-day-old (gender, race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 12-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)]. The patient was 7 days old when vaccinated with HEPLISAV-B. No adverse reactions were reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2829769 F NY 03/05/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945660
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Received First Dose , and Second Dose 9 Days Apart; Initial report received on 24-Feb-2025. A nur... Received First Dose , and Second Dose 9 Days Apart; Initial report received on 24-Feb-2025. A nurse reported that a 21-year-old female (race, ethnicity not reported) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 9 days after receiving the first 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 # 945660, expiration date 31-Jan-2025, NDC # 43528-0003-01) intramuscularly in the left deltoid. On 22-Feb-2025, 9 days after receiving after having been vaccinated with HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot # 945660, expiration date 31-Jan-2027, NDC# 43528-003-01) intramuscularly in the left deltoid. No adverse effects were reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2829770 F NV 03/05/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Dizziness Dizziness
Dizziness; Initial report received on 24-Feb-2025. A nurse reported that a 26-year-old female (ra... Dizziness; Initial report received on 24-Feb-2025. A nurse reported that a 26-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced dizziness. No medical history or concomitant medications were reported. In Jan-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)]. On an unknown date, a week after the first dose of HEPLISAV-B, the patient experienced dizziness. The patient is due for her second dose but has been referred to her primary care provider for follow-up. No additional information was provided. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2829771 M TX 03/05/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Extra dose administered Extra dose administered
Received First Dose, Do I Need Second Dose; Initial report received on 24-Feb-2025. A consumer re... Received First Dose, Do I Need Second Dose; Initial report received on 24-Feb-2025. A consumer reported that he, a 25-year-old male (race, 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 18-Dec-2024, 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 this report, the patient has not received the second dose yet. 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
2829773 03/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Epistaxis, Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zo... Epistaxis, Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster, Oral herpes zoster More
Got the right eye; down his/her throat and roof of his/her mouth; Herpes zoster; inside of his/her n... Got the right eye; down his/her throat and roof of his/her mouth; Herpes zoster; inside of his/her nose had a spot where blood was coming out of; Herpes zoster; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. In NOV-2023, an unknown time after receiving Shingles vaccine, the patient experienced herpes zoster (Verbatim: Herpes zoster). In APR-2024, the patient experienced herpes zoster (Verbatim: Herpes zoster). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: Got the right eye) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: down his/her throat and roof of his/her mouth) and epistaxis (Verbatim: inside of his/her nose had a spot where blood was coming out of). In NOV-2024, the outcome of the herpes zoster was resolved. The outcome of the ophthalmic herpes zoster, oral herpes zoster, herpes zoster and epistaxis were resolving. It was unknown if the reporter considered the ophthalmic herpes zoster, oral herpes zoster, herpes zoster, herpes zoster and epistaxis to be related to Shingles vaccine. The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the oral herpes zoster, herpes zoster, herpes zoster and epistaxis to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-FEB-2025 This case was reported by a patient via interactive digital media. The patient had shingles in his/her head. Patient had one shot before but never got the second, as he/she was afraid it would come back. However, it did return. The first occurrence was in November, and the second time was in April the following year, lasting until November 2024. It affected his/her right eye, the right side of his/her face, the top of his/her head, down his/her throat, the roof of his/her mouth, and even ate a hole in his/her nose. Inside his/her nose, there was a spot where blood was coming out. Eventually, it started to get better, but it took time.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. More
2829774 45 F CA 03/05/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 M2RH3
Underdose Underdose
patient was given the pediatric dose; patient was given the pediatric dose; This non-serious case wa... patient was given the pediatric dose; patient was given the pediatric dose; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of underdose in a 45-year-old female patient who received HBV (Engerix B pediatric) (batch number M2RH3, expiry date 21-FEB-2026) for prophylaxis. On 24-FEB-2025, the patient received Engerix B pediatric. On 24-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: patient was given the pediatric dose) and adult use of a child product (Verbatim: patient was given the pediatric dose). The outcome of the underdose and adult use of a child product 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: 25-FEB-2025 The other health professional reported that 45 year old patient was given the pediatric dose which led to underdose and adult use of a child product. More
2829775 F 03/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Headache, Pain in extremity Headache, Pain in extremity
sore arm; headache; This non-serious case was reported by a consumer via sales rep and described the... sore arm; headache; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 25-FEB-2025, the patient received Shingrix. On 26-FEB-2025, 1 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm) and headache (Verbatim: headache). The outcome of the pain in arm and headache were not resolved. It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix. It was unknown if the company considered the pain in arm and headache to be related to Shingrix. Additional Information: GSK Receipt Date: 26-FEB-2025 The patient received a subsequent dose of Shingrix and experienced sore arm and headache. More
2829776 03/05/2025 FLUX
FLUX
RVX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Bone pain, Decreased appetite, Influenza, Pyrexia, Respiratory syncytial virus i... Bone pain, Decreased appetite, Influenza, Pyrexia, Respiratory syncytial virus infection; Respiratory tract congestion, Vaccination failure; Bone pain, Decreased appetite, Influenza, Pyrexia, Respiratory syncytial virus infection; Respiratory tract congestion, Vaccination failure More
Suspected vaccination failure; Got RSV; Flu; This serious case was reported by a consumer via intera... Suspected vaccination failure; Got RSV; Flu; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis. On an unknown date, the patient received RSV vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: Got RSV) and influenza (Verbatim: Flu). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection and influenza were resolved (duration 1 week). It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and influenza to be related to RSV vaccine. The company considered the vaccination failure, respiratory syncytial virus infection and influenza to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 07-FEB-2025 This case was reported by a patient via interactive digital media. The patient got the Flu and RSV vaccine and still got RSV (respiratory syncytial virus infection), very congested, fevers, no appetite, ache bones was lasting a week. The patient did not know if it was RSV or the flu. It was unknown if the reporter considered the adverse events to be related to Flu (Influenza) vaccine. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Respiratory syncytial virus infection and Influenza are unlisted events which are considered unrelated to GSK vaccine RSV vaccine. More
2829777 03/05/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected Vaccination failure; Got my shot and still got it; This serious case was reported by a con... Suspected Vaccination failure; Got my shot and still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Got my shot and still got it). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 23-FEB-2025 This case was reported by a patient via interactive digital media. The patient had got RSV shot and still got it and it was terrible and shut you down for days at a time. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding respiratory syncytial virus infection 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 and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. More
2829778 03/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected Vaccination failure; I've had shingles 5 times received both Shingrix vaccines get mi... Suspected Vaccination failure; I've had shingles 5 times received both Shingrix vaccines get milder each time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles 5 times). Concurrent medical conditions included leukemia. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've had shingles 5 times received both Shingrix vaccines get milder each time). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. The patient had shingles 5 times and yes then patient received both Shingrix vaccines and they get milder each time. The patient's hematology oncologist attributed this to his/her leukemia. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). More
2829779 03/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-FEB-2025 This case was reported by a patient via interactive digital media. Patient had the shots two years ago and still got shingles. It was the worst pain he/she had ever experienced. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2829780 03/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Oral herpes Oral herpes
had severe fever blisters on his/her lips; This non-serious case was reported by a consumer via inte... had severe fever blisters on his/her lips; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever blister (Verbatim: had severe fever blisters on his/her lips). The outcome of the fever blister was not reported. It was unknown if the reporter considered the fever blister to be related to Shingrix. It was unknown if the company considered the fever blister to be related to Shingrix. Additional Information: GSK Receipt Date: 26-FEB-2025 The patient self reported this case for himself/herself. This case was reported by a patient via (shingrix GSK chatbot) interactive digital media. After his/her first shingles shot 2-3 days later he/she had severe fever blisters on his/her lips and was asking was that normal. More
2829781 03/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
Pain; This non-serious case was reported by a consumer via interactive digital media and described t... Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (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 pain (Verbatim: Pain). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-FEB-2025 The case was received from the patient via interactive digital media. The reporter had the shingle shot and am having the side effects so the reporter was wondering if he/she could take gabapentin for pain. More
2829782 0.33 M NV 03/05/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration, Wrong product administered Inappropriate schedule of product administration, Wrong product administered
instead of pneumococcal vaccine they administered a Pediarix dose; instead of pneumococcal vaccine t... instead of pneumococcal vaccine they administered a Pediarix dose; instead of pneumococcal vaccine they administered a Pediarix dose; patient received 2 prior Pediarix doses on November 18th 2024 and February 12th 2025; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and Pneumococcal vaccine for prophylaxis. Previously administered products included Hepatitis B (Received on 18-SEP-2024). Concomitant products included PEDIARIX. On 18-FEB-2025, the patient received the 3rd dose of Pediarix. On 12-FEB-2025, the patient received the 2nd dose of Pediarix. On an unknown date, the patient received Pneumococcal vaccine. On 12-FEB-2025, not applicable after receiving Pediarix and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: patient received 2 prior Pediarix doses on November 18th 2024 and February 12th 2025). On 18-FEB-2025, the patient experienced wrong vaccine administered (Verbatim: instead of pneumococcal vaccine they administered a Pediarix dose) and drug dose administration interval too short (Verbatim: instead of pneumococcal vaccine they administered a Pediarix dose). The outcome of the drug dose administration interval too long, wrong vaccine administered and drug dose administration interval too short 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: 19-FEB-2025 The physician reported that a patient came for a pneumococcal vaccine but instead of that one they administered a Pediarix dose (as 3rd dose) which led to wrong vaccine administered and shortening of vaccine schedule. The patient received 2nd dose of Pediarix later than the recommended interval, which led to lengthening of vaccine schedule. The reporter did not have lot numbers or expiration dates for any of the vaccines. More
2829783 76 M NC 03/05/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 m4b34
Inappropriate schedule of product administration Inappropriate schedule of product administration
a patient received the first 2 doses 6 months apart; This non-serious case was reported by a pharmac... a patient received the first 2 doses 6 months apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old male patient who received HAB (Twinrix) (batch number m4b34) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 01-JUN-2024). On 02-DEC-2024, the patient received the 2nd dose of Twinrix. On 02-DEC-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received the first 2 doses 6 months apart). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-FEB-2025 The pharmacist contacted GlaxoSmithKline to report that a patient received the first 2 doses 6 months apart, which led to lengthening of vaccination schedule. The patient still has not received the third dose of Twinrix. They asked to know how to proceed. The vaccine administration facility was the same as primary reporter. More
2829784 41 F IL 03/05/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 GH32J
Expired product administered Expired product administered
received an expired dose of Boostrix; This non-serious case was reported by a other health professio... received an expired dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 41-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GH32J, expiry date 29-NOV-2024) for prophylaxis. On 26-FEB-2025, the patient received Boostrix. On 26-FEB-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Boostrix). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 26-FEB-2025 The other health professional reported that they administered an expired dose of Boostrix to a female patient on the day of reporting. The other health professional asked does the patient needs to be revaccinated. More
2829785 1 F 03/05/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 Y3NE2
Expired product administered Expired product administered
Engerix-B administration after expiration date; This non-serious case was reported by a other health... Engerix-B administration after expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-month-old female patient who received HBV (Engerix B) (batch number Y3NE2, expiry date 23-FEB-2025) for prophylaxis. On 26-FEB-2025, the patient received Engerix B. On 26-FEB-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B administration after expiration date). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 26-FEB-2025 The medical assistant asked if a patient should be revaccinated with Engerix-B after receiving an expired dose which led to expired vaccine used. More
2829786 68 F TX 03/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PC5Y3
Extra dose administered Extra dose administered
inadvertently administered with a third dose; This non-serious case was reported by a pharmacist via... inadvertently administered with a third dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number PC5Y3, expiry date 30-JAN-2027) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 23rd December 2023 of batch number N425G and expiry date of 7 December 2025) and Shingrix (received 2nd dose on 27 February 2024 of batch number 49EB3 and expiry date of 18 April 2026). On 27-FEB-2025, the patient received the 3rd dose of Shingrix. On 27-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: inadvertently administered with a third dose). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 27-FEB-2025 The patient inadvertently administered with a third dose of Shingrix, which led to extra dose administered. More
2829787 13 F CA 03/05/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 F3Y25
Expired product administered Expired product administered
an expired dose of Havrix was administered to a patient; This non-serious case was reported by a oth... an expired dose of Havrix was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HAV (Havrix) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis. On 25-FEB-2025, the patient received Havrix. On 25-FEB-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: an expired dose of Havrix was administered to a patient). The outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 27-FEB-2025 The operations supervisor reported that an expired dose of Havrix was administered to a patient, which led to expired vaccine used The Vaccine Administration Facility is the same as Primary Reporter. More
2829788 14 M WI 03/05/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 Y3ME2
Expired product administered Expired product administered
patients were administered with expired doses of Havrix; This non-serious case was reported by a oth... patients were administered with expired doses of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HAV (Havrix pediatric) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis. On 27-FEB-2025, the patient received the 1st dose of Havrix pediatric. On 27-FEB-2025, an unknown time after receiving Havrix pediatric, the patient experienced expired vaccine used (Verbatim: patients were administered with expired doses of Havrix). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-FEB-2025 The patient was administered with expired dose which led expired vaccine used. This was the first Hepatitis A vaccine for the patient. The reporter consented to follow up. This case was linked with case US2025025537 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025025537:Same reporter/Different patient More
2829789 DC 03/05/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 95DB2
Expired product administered Expired product administered
Havrix expired dose administration; This non-serious case was reported by a other health professiona... Havrix expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis. On 28-FEB-2025, the patient received Havrix. On 28-FEB-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix expired dose administration). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-FEB-2025 The nurse practitioner reported that there was an expired dose administration of Havrix vaccine to patient, which led to expired vaccine used. The reporter wanted to knew if there was any kind of half-life extension and if it will lose its property and if it was any medical concern that they need to know. The Vaccine Administration Facility was the same as Primary Reporter. More
2829790 M CT 03/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
came back to request the second one; This non-serious case was reported by a physician via call cent... came back to request the second one; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 6 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: came back to request the second one). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 28-FEB-2025 The physician reported that a patient received their first dose of Shingrix over 6 years ago and came back to request the second one and wanted to know if a third one was necessary after the long lapse between doses. not information was given about the previous dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2829792 F 03/05/2025 COVID19
 UNKNOWN MANUFACTURER
Dizziness, Heart rate increased, Myocarditis Dizziness, Heart rate increased, Myocarditis
myocarditis; she gets light headed; rapid heart beat; This is a spontaneous report received from a C... myocarditis; she gets light headed; rapid heart beat; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; DIZZINESS (non-serious), outcome "not recovered", described as "she gets light headed"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart beat". Clinical course: Caller was looking for the side effects related to the Pfizer covid 19 vaccine from 2022, he states, she couldn't get anything, only information found was for 2024/2025 vaccine. He was calling on behalf of his wife who had two covid vaccine. Caller states, Reporter not sure if patient took Moderna or Pfizer covid 19 vaccine. She was been having this side effect, rapid heart beat, started right after she had gotten it, after the 2nd shot, after she had the booster. Caller clarified and states, she went for the first shot and went back for the second shot some time after about 2 months. What she was having it was intermittent, not happening all the time, intermittently sometimes every two or three months, she gets light headed. Reporter thought she might have myocarditis. They didn't think anything, at first it went away and then it came back and went a way for a little while and came back again and was happening now more and more. She started having them with in a month from the taking shot. Caller declined to report and would like to verify first if was the Pfizer covid vaccine, he was not sure at this time. We got a card, we need to find it. He doesn't want to false report. She had an appointment with her regular physician and will possibly be referred to Cardiologist to see. Patient suspects it was the vaccine because it started happening after the second shot. Reporter just wanted to see the side effects because it did show myocarditis but it was for the 2024/2025 vaccine. The information on the batch/lot number for [bnt162b2] will be requested and submitted if and when received. More
2829793 F 03/05/2025 COVID19
 PFIZER\BIONTECH
Dizziness, Heart rate increased, Myocarditis Dizziness, Heart rate increased, Myocarditis
Myocarditis; rapid heart beat; she gets light headed; This is a spontaneous report received from a C... Myocarditis; rapid heart beat; she gets light headed; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine - manufacturer unknown (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "she gets light headed", "rapid heart beat", "Myocarditis". The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart beat"; DIZZINESS (non-serious), outcome "unknown", described as "she gets light headed". Additional information: Caller stated, he was not sure if his wife took Moderna or Pfizer covid 19 vaccine. She had been having this side effect, rapid heart beat, started right after she had gotten it, after the 2nd shot, after she had the booster. Caller clarified and stated, she went for the first shot and went back for the second shot some time after about 2 months. What she was having it was intermittent, not happening all the time, intermittently sometimes every two or three months, she got light headed. He thought she might have myocarditis. They didn't think anything, at first it went away and then it came back and went a way for a little while and came back again and was happening now more and more. She started having them with in a month from the taking shot. Caller declined to report and would like to verify first if was the Pfizer covid vaccine, he was not sure at this time. We got a card, we need to find it. He did not want to false report. She had an appointment with her regular physician and will possibly be referred to Cardiologist to see. His wife suspects it was the vaccine because it started happening after the second shot. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500045590 same patient, different dose number and events; More
2829798 03/05/2025 PNC13
 PFIZER\WYETH
Death, Meningitis pneumococcal Death, Meningitis pneumococcal
Pneumococcal meningitis; This is a spontaneous report received from a Physician. A 2-year-old patie... Pneumococcal meningitis; This is a spontaneous report received from a Physician. A 2-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENINGITIS PNEUMOCOCCAL (death), outcome "fatal", described as "Pneumococcal meningitis". The patient date of death was unknown. Reported cause of death: "Pneumococcal meningitis". It was not reported if an autopsy was performed. Clinical course: The patient passed away several months ago from pneumococcal meningitis. This is relevant because the parent reported back to the withheld that it was Sero-Type 15B that caused the fatal case of pneumococcal meningitis. ST-15B is not contained in PCV13 or PCV15 but it is contained in PCV20. According to doctor the medical clinics across (redacted) continued to use PCV13 for childhood vaccinations after PCV20 was approved and available in order to deplete PCV13 stock before ordering the newer PCV20 vaccine. The parents believe the child may not have died if the withheld had begun using PCV20 as soon as it was available instead of continuing to use PCV13. This is all reported second hand from doctor during the vaccines field medical interaction. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Pneumococcal meningitis with non PREVNAR 13 covered serotype (15B ) represents an intercurrent bacterial infection; no lack of efficacy with the suspect vaccine was evidenced. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumococcal meningitis More
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2829799 F 03/05/2025 COVID19
 PFIZER\BIONTECH
Body temperature, COVID-19, Drug ineffective Body temperature, COVID-19, Drug ineffective
terrible COVID/now the baby has it/they give half a covid shot so two weeks ago; terrible COVID/now ... terrible COVID/now the baby has it/they give half a covid shot so two weeks ago; terrible COVID/now the baby has it/they give half a covid shot so two weeks ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 6-month-old female patient received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), in Feb2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2025, latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "terrible COVID/now the baby has it/they give half a covid shot so two weeks ago". The patient underwent the following laboratory tests and procedures: Body temperature: 102. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: reporter's son and daughter-in-law both have terrible COVID. They got a prescription from their doctor's office. Now they have a baby, a little baby that's 6 months old, and now the baby has it, and they have a 102 fever, and they're coughing. They're locked up in they're house in a little apart, they live with the mom, they're coughing they've got a high 102 fever their eyes are all, they can't even...one got it Wednesday, and one got it today (28Feb2025), and now the baby's got it. The baby can not have any medication she's just going to turn 7 months the baby can not have any medication her paediatrician said except Tylenol and she's had the fever of a 102 the baby, but they gave her, "I guess now they give half a covid shot so two weeks ago (Feb2025), so I'm hoping that's going to help her". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2829800 M 03/05/2025 COVID19
 PFIZER\BIONTECH
Myopericarditis Myopericarditis
perimyocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.... perimyocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: MYOPERICARDITIS (medically significant), outcome "unknown", described as "perimyocarditis". The event "perimyocarditis" required physician office visit. The patient (reporter's son) was diagnosed with perimyocarditis after receiving his second Pfizer covid vaccine in Jun2021. He was in [Withheld] and has to follow up yearly with a cardiologist. He is entering college this fall. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2829809 33 F PA 03/05/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV9
HPV9
HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.











Abdominal pain upper, Anxiety, Dizziness, Influenza virus test negative, Malaise... Abdominal pain upper, Anxiety, Dizziness, Influenza virus test negative, Malaise; Oropharyngeal discomfort, Respiratory disorder, SARS-CoV-2 test negative; Abdominal pain upper, Anxiety, Dizziness, Influenza virus test negative, Malaise; Oropharyngeal discomfort, Respiratory disorder, SARS-CoV-2 test negative; Abdominal pain upper, Anxiety, Dizziness, Influenza virus test negative, Malaise; Oropharyngeal discomfort, Respiratory disorder, SARS-CoV-2 test negative; Abdominal pain upper, Anxiety, Dizziness, Influenza virus test negative, Malaise; Oropharyngeal discomfort, Respiratory disorder, SARS-CoV-2 test negative; Abdominal pain upper, Anxiety, Dizziness, Influenza virus test negative, Malaise; Oropharyngeal discomfort, Respiratory disorder, SARS-CoV-2 test negative; Abdominal pain upper, Anxiety, Dizziness, Influenza virus test negative, Malaise; Oropharyngeal discomfort, Respiratory disorder, SARS-CoV-2 test negative More
is experiencing light headedness; breathing issues; sharp pains in her stomach; She also feels anxi... is experiencing light headedness; breathing issues; sharp pains in her stomach; She also feels anxious; her throat has been bothering her; she feels generally unwell; Consumer called to report that they received extra doses of HPV vaccine. Consumer stated that her HCP told her she had not been previously vaccinated for HPV and recommended GARDASIL 9. After receiving all 3 doses of GARDASIL 9, with the first dose; This spontaneous report was received from a 34-year-old non pregnant female patient reporting on herself. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-MAY-2007, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), then on unspecified dates in 2007, the patient received the other doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, route, lot #, expiration date and anatomical location were not provided) for prophylaxis. On 25-JUN-2024, the patient received the first dose (Extra dose administered) of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided), then on 27-AUG-2024, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided), then on 17-DEC-2024, the patient received the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided). All doses for prophylaxis. It was mentioned that the patient's health care professional stated that she had not been previously vaccinated for any HPV vaccine and recommended Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), then she discovered she had previously received the full series of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (first dose administered on 04-MAY-2007); the prior administration of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was discovered while she was reviewing her immunization records. Her HCP stated that he did not see that in her history. After vaccination of 3 doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) in December 2024, she experienced generally unwell, light headedness, breathing issues, sharp pain in her stomach, anxiety and her throat had been bothering her. On unspecified date the patient's flu and COVID tests were negative. The outcome of all adverse events was considered as not recovered as it was mentioned that they happened on and off. The causal relationship between all adverse events and both suspect therapies was not reported. More
2829810 OK 03/05/2025 HIBV
PNC15
RV5
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 X028614
Y005465
Y009341
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No additional AE reported; T/E for PEDVAX HIB , ROTATEQ, VAXNEUVANCE that was administered; This spo... No additional AE reported; T/E for PEDVAX HIB , ROTATEQ, VAXNEUVANCE that was administered; This spontaneous report was received from a nurse, concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-FEB-2025, a the vaccines Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), and Pneumococcal 15-valent Conjugate Vaccine (Vaxneuvance); suffered a temperature excursion (TE) of 2 hours and 12 minutes at 32.0 F. On 25-Feb-2025, the patient was vaccinated with the vaccines involved in the TE: first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Y009341 has been verified to be valid for this vaccine, expiration date reported and confirmed as 24-Nov-2025), administered orally; with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #X028614 has been verified to be valid for this vaccine, expiration date reported as 24-Nov-2025 and confirmed as 05-Jul-2026) (dose and route of administration not provided); and with the first dose of pneumococcal 15-valent Conjugate Vaccine (Vaxneuvance) (lot #Y005465 has been verified to be valid for this vaccine, expiration date reported and confirmed as 08-Jan-2027) (dose and route of administration not provided). All of them administered as prophylaxis. (Product storage error). No additional adverse events were reported (No adverse event). More
2829811 OK 03/05/2025 HIBV
PNC15
RV5
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 X028614
Y005465
Y005878
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No additional adverse event; VFC immunization coordinator calling to report T/E for PEDVAX HIB , RO... No additional adverse event; VFC immunization coordinator calling to report T/E for PEDVAX HIB , ROTATEQ, VAXNEUVANCE that was administered. T/E date was on 2/18/2025 and PEDVAX HIB , ROTATEQ, VAXNEUVANCE were administered on 2/25/2025. Permission was given to contact HCP; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On 18-Feb-2025 a temperature excursion of above 32.0 Fahrenheit (F) for a time frame of 2 hours, 12 minutes and 0 seconds occurred. On 25-Feb-2025, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), lot #Y005878, expiration date: 28-Oct-2025 (strength and dose were not provided); with the first dose of Pneumococcal 15-valent Conjugate Vaccine lot #Y005465, expiration date: 08-Jan-2027 (strength, dose, route of administration and anatomical site of injection were not provided); and with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), lot #X028614, expiration date: 05-Jul-2026 (strength, dose, route of administration and anatomical site of injection were not provided). All vaccines were administered for prophylaxis (Product storage error). No additional adverse event was reported (no adverse event). No previews temperature excursions were reported. More
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