๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

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

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2844976 F AZ 06/13/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
Y015100
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No side effects or symptoms reported; HCP called to report a 25-year-old patient received their firs... No side effects or symptoms reported; HCP called to report a 25-year-old patient received their first does of VARIVAX in 2018 (exact date unknown, lot and exp date unknown) and did not receive their second dose until 06/03/2025. No side effects or symptoms reported. No Additional AE/ No; This spontaneous report was received from a pharmacist and refers to a 25-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. In 2018, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) as prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported). Then on 03-JUN-2025, the patient was vaccinated with the second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at a dose of 0.5 mL as prophylaxis (valid lot #Y015100, expiration date: 06-SEP-2026) (inappropriate schedule of product administration). Both reconstituted with sterile diluent (dose, lot number, anatomical location, and indication were not provided). No side effects or symptoms reported (no adverse event). Lot # is being requested and will be submitted if received (dose #1) More
2844977 M AZ 06/13/2025 MMR
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
one patient received his first dose before the age of 18, then an additional dose after 18; no AEs; ... one patient received his first dose before the age of 18, then an additional dose after 18; no AEs; This spontaneous report was received from a Pharmacist and refers to a male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) for prophylaxis. The Pharmacist reported that the patient received his first dose before the age of 18, then an additional dose after 18, outside of the PI's recommended age range. The patient experienced no Adverse Events. At the reporting time, the outcome of the events was unknown. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable. More
2844978 M TN 06/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
reports not feeling well for a day or so after each dose; This non-serious case was reported by a co... reports not feeling well for a day or so after each dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on an unknown date, for tolerance of 1st dose of Shingrix, refer case US2025AMR072293). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: reports not feeling well for a day or so after each dose). Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved (duration 1 day). It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. Linked case(s) involving the same patient:US2025AMR072293 Additional Information: GSK Receipt Date: 02-JUN-2025 The Patient reported that he had a dose of Shingrix. The patient reported not feeling well for a day or so after each dose.; Sender's Comments: US-GSK-US2025AMR072293:Same Patient/ 1st dose More
2844979 F GA 06/13/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 9x7cd
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
a 63-year-old patient was accidentally administered a dose of Menveo; This non-serious case was repo... a 63-year-old patient was accidentally administered a dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 63-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9x7cd, expiry date 31-JAN-2026) for prophylaxis. On 06-JUN-2025, the patient received the 1st dose of Menveo. On 06-JUN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: a 63-year-old patient was accidentally administered a dose of Menveo). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 06-JUN-2025 A pharmacist called in to report that a 63-year-old patient was accidentally administered a dose of Menveo and requested recommendations, which led to Inappropriate age at vaccine administration. The reporter was consented to Follow-up. More
2844980 M 06/13/2025 COVID19
 PFIZER\BIONTECH
Asthenia, Loss of personal independence in daily activities Asthenia, Loss of personal independence in daily activities
weakness; not being able to perform normal tasks; This is a spontaneous report received from a Consu... weakness; not being able to perform normal tasks; This is a spontaneous report received from a Consumer or other non HCP. An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 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: ASTHENIA (non-serious), outcome "recovering", described as "weakness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovering", described as "not being able to perform normal tasks". Therapeutic measures were not taken as a result of asthenia, loss of personal independence in daily activities. Additional Information: the patient did not receive any other vaccines on the same date as the suspect vaccine and he was taking other medications within 2 weeks of the event starting. The patient reported weakness to the extent of not being able to perform normal tasks after receiving the vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2844981 22 F PA 06/13/2025 MMR
 MERCK & CO. INC.
 Y015020
Fall, Feeling abnormal, Loss of consciousness, Syncope Fall, Feeling abnormal, Loss of consciousness, Syncope
Administered vaccine to patient at approximately 4:20 pm. Patient walked to cash register shortly af... Administered vaccine to patient at approximately 4:20 pm. Patient walked to cash register shortly after administration, and while standing, 3 to 5 minutes after vaccination, pt told her mom she did not feel good. Mom told her to sit. she turned to go sit down and slowly fainted and fell on the ground. Patient returned to consciousness 15 to 30 seconds later. 911 was called. Patient recovered at the scene and declined a need for further medical intervention. More
2844982 12 M NV 06/13/2025 PNC15
 MERCK & CO. INC.
 z003633
Wrong product administered Wrong product administered
The medical assistant was moving to fast and grabbed the wrong vaccine. The medical assistant was moving to fast and grabbed the wrong vaccine.
2844983 56 M UT 06/13/2025 UNK
UNK
PNC20
PNC20
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
PFIZER\WYETH
PFIZER\WYETH

lg5579
lg5579
Blood test, Chest X-ray, Chest pain, Dizziness, Vomiting; Chest pain, Nausea, Ph... Blood test, Chest X-ray, Chest pain, Dizziness, Vomiting; Chest pain, Nausea, Pharyngeal swelling; Blood test, Chest X-ray, Chest pain, Dizziness, Vomiting; Chest pain, Nausea, Pharyngeal swelling More
After having vaccine, started having some dizziness. The day after started having chest pain over t... After having vaccine, started having some dizziness. The day after started having chest pain over the heart. EMS was called and was taken the cardiology dept in the hospital. After being released from hospital, started vomiting at home. still having chest pain. More
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2844985 52 F HI 06/13/2025 HEPAB
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Periorbital swelling, Skin erosion, Skin exfoliation; Periorbital swelling, Skin... Periorbital swelling, Skin erosion, Skin exfoliation; Periorbital swelling, Skin erosion, Skin exfoliation More
Facial skin peeling, raw feeling. Puffy eyes Facial skin peeling, raw feeling. Puffy eyes
2844986 1.58 F CA 06/13/2025 DTAP
HEPA
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 3CA55C1
J4K4X
Injection site rash; Injection site rash Injection site rash; Injection site rash
About 3 minutes after administering both vaccines patient presented a localized rash on bilateral t... About 3 minutes after administering both vaccines patient presented a localized rash on bilateral thighs, approximately 3 inches not urticarial (not hives), she had no other signs of reaction๏ฟฝno shortness of breath, no lip/tongue swelling. Patient was assesed by Provider, rash was decreasing as time passed. Provider administer Benadryl to prevent worsening rash symptoms, patient was observed for 15 minutes. No other reactions observed or reported, localized rash decreased significantly; patient went home without any issues. More
2844990 77 F FL 06/13/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 L5229
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
It was reported through our pharmacy corporate office during an audit that patient had received Boos... It was reported through our pharmacy corporate office during an audit that patient had received Boostrix on 02/26/25 and should not have received another dose on 6/12/25. Patient was called, and she reported no side effects. More
2844991 77 F IN 06/13/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 4J53C
Arthritis, Rash Arthritis, Rash
The patient was here to receive the Arexvy vaccine on 6/7. She called today and reported developing ... The patient was here to receive the Arexvy vaccine on 6/7. She called today and reported developing a rash on Monday, followed by inflammation in her thumb and index finger joints. She visited urgent care on 6/13, where she was prescribed doxycycline. She is scheduled to follow up with her primary care doctor on Wednesday. More
2844992 63 F CA 06/13/2025 PNC20
 PFIZER\WYETH
 LN4929
Erythema, Pain Erythema, Pain
Pt had PCV 20 on 6/6/205. Reported noticing pain and redness on 6/12/25. No blisters/pus noted. Pt r... Pt had PCV 20 on 6/6/205. Reported noticing pain and redness on 6/12/25. No blisters/pus noted. Pt reported pain and redness improved today (6/13/25). Advised pt to continue monitor sx, advised to use cold compress, return/UCC/ED precautions reviewed, pt v/u. More
2844993 40 F KS 06/13/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8734
EW0167
Arrhythmia, Atrioventricular block complete, Blood test, Echocardiogram, Electro... Arrhythmia, Atrioventricular block complete, Blood test, Echocardiogram, Electrocardiogram; Arrhythmia, Atrioventricular block complete, Blood test, Echocardiogram, Electrocardiogram More
I developed cardiac arrhythmias in the middle of May 2021. Upon seeing a cardiologist it was determi... I developed cardiac arrhythmias in the middle of May 2021. Upon seeing a cardiologist it was determined that I was in 3rd degree heart block and would require a permanent pacemaker. More
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2844994 51 F VA 06/13/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SEQIRUS, INC.
SEQIRUS, INC.
 FG3527
FG3527
946618
946618
Acoustic stimulation tests abnormal, Balance disorder, Deafness neurosensory, La... Acoustic stimulation tests abnormal, Balance disorder, Deafness neurosensory, Laboratory test normal, Labyrinthitis; Magnetic resonance imaging head, Sudden hearing loss, Vertigo; Acoustic stimulation tests abnormal, Balance disorder, Deafness neurosensory, Laboratory test normal, Labyrinthitis; Magnetic resonance imaging head, Sudden hearing loss, Vertigo More
Sudden sensorineural hearing loss, vertigo beginning 10/29/2024. Treated at ER, followed up with ENT... Sudden sensorineural hearing loss, vertigo beginning 10/29/2024. Treated at ER, followed up with ENT, diagnosed with labyrinthitis. Oral steroids, steroid injection in ear, MRI. Balance restored to 90% but hearing loss is permanent. More
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2844995 29 M CA 06/13/2025 HEP
TDAP
 DYNAVAX TECHNOLOGIES CORPORATION
SANOFI PASTEUR
 946060
U8389AA
Dyspnoea, Urticaria; Dyspnoea, Urticaria Dyspnoea, Urticaria; Dyspnoea, Urticaria
- Patient having hives within 15 minutes after heplisav and tdap vaccines - Benadryl 50mg given in o... - Patient having hives within 15 minutes after heplisav and tdap vaccines - Benadryl 50mg given in office and instruction was given to provider partners to monitor for 30 min - about 20 min after administration of benadryl patient reported respiratory difficulty, 0.3mg intramuscular epi was given at that time. - Patient endorsed improvement of symptoms, team continued to monitor patient for 30 minutes after epi administration. - Patient reported symptoms had not returned at time of discharge, 30 min after intramuscular epi injection - Patient discharged in stable condition with strict ED precautions. More
2844996 68 F CO 06/13/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 y7xg3
y7xg3
y7xg3
y7xg3
Erythema, Skin indentation, Swelling, Urticaria; Injection site rash, Rash; Eryt... Erythema, Skin indentation, Swelling, Urticaria; Injection site rash, Rash; Erythema, Skin indentation, Swelling, Urticaria; Injection site rash, Rash More
Per patient - Swollen, red, quarter size welts on skin with hollow pit at center. Welts do not ooze... Per patient - Swollen, red, quarter size welts on skin with hollow pit at center. Welts do not ooze, but are itchy. Welts go away after 4 to 5 days and have occurred following vaccination (pharmacist reporting is unsure when symptoms began) on belly, legs and both arms. More
2844997 61 F NY 06/13/2025 COVID19
COVID19
 MODERNA
MODERNA
 025J20A
025J20A
Atrial fibrillation, Dizziness, Echocardiogram, Hypertrophic cardiomyopathy, Lab... Atrial fibrillation, Dizziness, Echocardiogram, Hypertrophic cardiomyopathy, Laboratory test; Magnetic resonance imaging More
started having a fib and then i ended up with serous heart issue cardiomyopathy, hypertrophic and li... started having a fib and then i ended up with serous heart issue cardiomyopathy, hypertrophic and light headness. I have to take pills the rest of my life just to live More
โœ“
2844677 NY 06/12/2025 MMR
MMR
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
X022411
Y014868
No adverse event, Product storage error; No adverse event, Product storage error... No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
no adverse event; HCP calling to report that patient received improperly stored VARIVAX and MMR II o... no adverse event; HCP calling to report that patient received improperly stored VARIVAX and MMR II on 5/14/2025. No adverse effects reported. Caller was not able to provide time and temp details at time of call so precautionary AE filed. No additional AE. No PQC.; This spontaneous report was received from Nurse and refers to a specific 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 14-May-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y014868, expiration date: 03-Sep-2026, (strength, dose, dose number, route, anatomical location and vaccination scheme were not reported), as prophylaxis. On the same date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X022411, expiration date: 05-Jun-2025, (strength, dose, dose number, route, anatomical location and vaccination scheme were not reported), as prophylaxis. It was not reported temperature excursion details. No adverse events was reported. More
2844678 19 TX 06/12/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No symptoms reported; Caller reported AE on behalf of a patient who experienced a schedule interrupt... No symptoms reported; Caller reported AE on behalf of a patient who experienced a schedule interruption with GARDASIL 9 vaccination. Caller reported that a patient received their first dose at 19-years old and second dose on 05/28/2025 at 24-years-old. No additional patie; This spontaneous report was received from a pharmacist and refers to a 24-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date (at the age of 19 years), the patient was vaccinated with the first dose Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL/dose (route of administration, anatomical location, lot # and expiration date were not reported) as prophylaxis. Then, on 28-MAY-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL/dose (route of administration, anatomical location, lot # and expiration date were not reported) as prophylaxis (inappropriate schedule of product administration). No symptoms reported (no adverse event). Lot # is being requested and will be submitted if received. More
2844679 06/12/2025 MENB
VARZOS
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Herpes zoster; Herpes zoster Herpes zoster; Herpes zoster
Shingles; This non-serious case was reported by a other health professional via patient support prog... Shingles; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of shingles in a 49-year-old patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included immunocompromised. On an unknown date, the patient received Bexsero and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Bexsero and Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Shingrix. It was unknown if the company considered the shingles to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Shingrix. 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:04-JUN-2025 The patient received Shingrix shot and insurance denied coverage due to treatment not deemed to be effective. More
2844683 42 M AZ 06/12/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA




Blood test, Communication disorder, Dopamine transporter scintigraphy, Dysphagia... Blood test, Communication disorder, Dopamine transporter scintigraphy, Dysphagia, Gait inability; General physical health deterioration, Genetic testing, Heavy metal test, Hypoaesthesia, Impaired work ability; Laboratory test, Loss of personal independence in daily activities, Lumbar puncture, Magnetic resonance imaging, Memory impairment; Neurological symptom, Pain, Paraesthesia, Positron emission tomogram, Skin test; Speech disorder, Tremor, X-ray More
Over the following few months, I began to experience neurological changes, which ultimately led to t... Over the following few months, I began to experience neurological changes, which ultimately led to the inability to walk an assisted, issues with swallowing, issues with memory, a tremor began to develop, issues with speaking and communication, and an overall change in feeling throughout my body, including tingling and numbness and extreme pain. This is all taken place approximately three years. I am no longer able to work and take care of myself. More
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2844685 19 F NY 06/12/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 H3N97
Underdose Underdose
pediatric dose of Havrix instead of an adult dose; Pediatric dose administered instead of an adult d... pediatric dose of Havrix instead of an adult dose; Pediatric dose administered instead of an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-year-old female patient who received HAV (Havrix pediatric) (batch number H3N97, expiry date 01-JAN-2027) for prophylaxis. Previously administered products included Havrix pediatric (1st dose received on 5th December 2024). On 05-JUN-2025, the patient received Havrix pediatric. On 05-JUN-2025, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: pediatric dose of Havrix instead of an adult dose) and adult use of a child product (Verbatim: Pediatric dose administered instead of an adult 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: 05-JUN-2025 Registered Nurse explained that a 19 year old patient received a pediatric dose of Havrix instead of an adult dose today on June 5th, 2025, which led to ult use of a child product and underdose. Patient received first pediatric dose of Havrix on December 5th, 2024. The caller did not have lot number or expiration date for the first dose. More
2844686 0.33 M TX 06/12/2025 DTPPVHBHPB
HIBV
 MSP VACCINE COMPANY
SANOFI PASTEUR
UK151AA
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
4 months and 12 days old patient was administered ACTHIB as well as VAXELIS in one day with no repor... 4 months and 12 days old patient was administered ACTHIB as well as VAXELIS in one day with no reported adverse event; Initial information received on 09-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months and 12 days old male patient who was administered Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) Vaxelis as well as Hib (Prp/T) Vaccine [Act-Hib] in one day with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine and Rotavirus Vaccine, both for Immunisation. On 09-Jun-2025, the patient received 0.5ml Dose 2 (once) of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, Strength standard, lot UK151AA and expiry date 30-Sep-2025 via intramuscular route in the left thigh for immunization and received an unknown dose of suspect Vaxelis, not produced by Sanofi Pasteur (unknown formulation, strength and expiry date) lot number not reported via unknown route in unknown administration site both for prophylactic vaccination (immunization) with no reported adverse event (extra dose administered) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2844687 20 F VA 06/12/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 019F21A
019F21A
95TH9
95TH9
Biopsy placenta, Blood test, Caesarean section, Exposure during pregnancy, Prema... Biopsy placenta, Blood test, Caesarean section, Exposure during pregnancy, Premature delivery; Premature labour, Preterm premature rupture of membranes; Biopsy placenta, Blood test, Caesarean section, Exposure during pregnancy, Premature delivery; Premature labour, Preterm premature rupture of membranes More
Prior to the vaccinations my pregnancy was normal including a normal ultrasound 2 weeks prior. I rec... Prior to the vaccinations my pregnancy was normal including a normal ultrasound 2 weeks prior. I received both the Covid and flu vaccine on 10/21/2021 and began going into labor in the middle of the night on 10/29/2021 into 10/30/2021. On 10/30/2021 I ended up having Preterm Premature Rupture of Memebranes and delivering my son via emergency c-section at 10:23 AM on 10/30/2021 at 26 weeks 3 days gestation. My due date wasn?t until 2/2/2022. My son was 2lbs 8oz at birth and passed away at 6:15 on 10/30/2021 due to his underdeveloped lungs from preterm birth. More
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2844736 F SC 06/12/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Incomplete course of vaccination, No adverse event; Incomplete course of vaccina... Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event More
No side effects or symptoms have been reported. No Additional AE/No PQC; HCP called to report a pati... No side effects or symptoms have been reported. No Additional AE/No PQC; HCP called to report a patient did not received their GARDASIL 9 doses according to the recommended dosing schedule. Caller states the patient recieved their first dose in 2020 (exact date unknown0, their second dose in 2021 (exact date unknown) and; This spontaneous report was received from a/an Pharmacist and refers to a(n) 22-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 2020, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), formulation: injection, 0.5 mL (lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 2021, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), formulation: injection, 0.5 mL (lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 2025, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), formulation: injection, 0.5 mL (lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). No side effects or symptoms have been reported (no adverse event). More
2844737 CA 06/12/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.

Y013407
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No other AE; HBP calling to report AE. 17 year old patient inadvertently received a 3rd dose of the ... No other AE; HBP calling to report AE. 17 year old patient inadvertently received a 3rd dose of the GARDASIL 9 vaccine. 1st dose: March 31st, 2021 2nd dose: October 25, 2022 3rd dose: May 19th, 2025 No further information provided. No other AE/No PQC.; 2nd dose: October 25, 2022; This spontaneous report was received from a/an Consumer or other non health professional and refers to a(n) 17-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 31-Mar-2021, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. On 25-Oct-2022, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). On 19-May-2025, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), lot #Y013407, expiration date: 01-Feb-2027, 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event reported (no adverse event). More
2844738 M 06/12/2025 PNC21
TDAP
 MERCK & CO. INC.
UNKNOWN MANUFACTURER

Headache, Pain in extremity; Headache, Pain in extremity Headache, Pain in extremity; Headache, Pain in extremity
arm pain; "throbbing headache"; This spontaneous report was received from a consumer and r... arm pain; "throbbing headache"; This spontaneous report was received from a consumer and refers to a 36-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-MAY-2025 around 5:40 PM, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection at a dose of 0.5 mL, once, administered by intramuscular route in left arm (lot # and expiration date were not reported), and with diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP), administered by intramuscular route in left arm (dose, lot # and expiration date were not reported); both vaccines were administered for prophylaxis. On the same day, roughly a hour later, at 6:47 PM, the patient started to have a "throbbing headache" and arm pain. His headache continued to get worse, but he stated he had no severe redness or swelling in the vaccinated arm. At the reporting time, the outcome of "throbbing headache" and arm pain was unknown. Causality assessment was not provided. Additional information is not expected. More
2844739 F MI 06/12/2025 PNC21
 MERCK & CO. INC.
Fatigue, Pain, Pyrexia Fatigue, Pain, Pyrexia
overall body aches; fever like symptoms; I felt fatigued; This spontaneous report was received from ... overall body aches; fever like symptoms; I felt fatigued; This spontaneous report was received from a female nurse of unknown age, referring to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) at a dose of 0.5 mL, once, administered by intramuscular route (anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had fever like symptoms, felt fatigued and had overall body aches. On an unknown date, after about 48 hours, the patient recovered from the events. Causality assessment was not provided. Lot# is being requested and will be submitted if received. More
2844740 PA 06/12/2025 MMRV
 MERCK & CO. INC.
 Y018156
Product storage error Product storage error
No additional AE reported; Customer called and reported that PROQUAD was administered to 1 patient f... No additional AE reported; Customer called and reported that PROQUAD was administered to 1 patient following a temperature excursion; This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-May-2025, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y018156, expiration date reported as: 29-Apr-2026) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection. On 29-May-2025, the vaccine was administered to one patient following a temperature excursion (temperature: -13.49C; time frame: 1 hour and 15 minutes) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) reported (no adverse event). No product quality complaint (PQC) was reported. No additional information was provided. This case was considered to be invalid due to lack of patient's identifiers. More
2844741 06/12/2025 HEP
 MERCK & CO. INC.
Adverse event following immunisation, Product administered to patient of inappro... Adverse event following immunisation, Product administered to patient of inappropriate age More
HCP was looking to see if a 23 year old who had previously received a single pediatric dose, have su... HCP was looking to see if a 23 year old who had previously received a single pediatric dose, have sufficient immunity for Hepatitis B.; No additional AE/PQC; This spontaneous report was received from a healthcare professional (HCP) and refers to a currently 23 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a single pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (exact dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis (inappropriate schedule of product administration). The reporter was looking to see if the patient had sufficient immunity for Hepatitis B. The reporter refused to provide demographic information and no additional information was provided. No additional adverse event (AE) or product quality complaint (PQC) was noted. More
2844742 0.17 M 06/12/2025 RV5
 MERCK & CO. INC.
Abdominal pain, Intussusception, Ultrasound abdomen abnormal Abdominal pain, Intussusception, Ultrasound abdomen abnormal
Ultrasound findings indicate: Intussusception: Small bowel-small bowel intussusception.; This sponta... Ultrasound findings indicate: Intussusception: Small bowel-small bowel intussusception.; This spontaneous report was received from a consumer or other non-health professional via company representative and refers to a 2-months-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 27-May-2025, the patient received the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally administered (lot # and expiration date were not reported) for prophylaxis. On 30-May-2025, he was taken to hospital for abdominal pain. Ultrasound was performed and findings indicated intussusception, small bowel-small bowel intussusception. No Ileocolic intussusception. He was released from the emergency department (ER) on 30-May-2025. At the reporting time, the outcome of the event was unknown. The causal relationship between the event Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided. Additional information is not expected. More
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2844744 M AZ 06/12/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7899AA
Circumstance or information capable of leading to medication error, Underdose Circumstance or information capable of leading to medication error, Underdose
The patient received a partial dose of VARIVAX due to the patient moving during administration.; Th... The patient received a partial dose of VARIVAX due to the patient moving during administration.; This spontaneous report has been received from other health professional, regarding to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 22-MAY-2025, the patient was vaccinated with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS) suspension for injection, at a dose of 0.5 milliliter (ml), as prophylaxis (lot number U7899AA, expiration date: 31-AUG-2026). Also, it was reported that the patient received a partial dose due to the patient moving during administration.; Reporter's Comments: More
2844745 KY 06/12/2025 RVX
 UNKNOWN MANUFACTURER
 2051974
No adverse event, Product storage error No adverse event, Product storage error
No Adverse event; ROTATEQ was administered to 1 consumer following a temperature excursion; This spo... No Adverse event; ROTATEQ was administered to 1 consumer following a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 22-May-2025, the patient received the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #2051974 expiration date: 16-Nov-2025 (dose was not reported), administered by oral route for prophylaxis following a temperature excursion of 18.8C for 9 hours and 20 minutes (product storage error). There was no previous temperature excursion. No adverse event was reported. More
2844746 MA 06/12/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 Y015834
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
inadvertent administration of MMR-2 after a temperature excursion; No additional AE/PQC; This sponta... inadvertent administration of MMR-2 after a temperature excursion; No additional AE/PQC; This spontaneous report was received from Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (lot #Y015834, expiration date: 20-SEP-2026) (strength, dose description, route of administration was not reported) reconstituted with sterile diluent (BAXTER STERILE DILUENT) (dose description, route of administration, lot # and expiration date were not reported) for prophylaxis following a temperature excursion of 14.8 C for 2 hours 42 minutes, no previous temperature excursion occurred. No additional adverse event reported. This case was considered invalid due to lack of patient identifiers. More
2844747 M PA 06/12/2025 HPV9
 MERCK & CO. INC.
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
Patient received the first dose at age 15 and then forgot about completing the series.; No additiona... Patient received the first dose at age 15 and then forgot about completing the series.; No additional AE; This spontaneous report was received from a health care professional referring to a 25-year-old male patient. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On an unknown date, reported as when the patient was 15-year-old, he received the first dose of Human papillomavirus 9-valent vaccine recombinant suspension for injection (GARDASIL 9) as a dose of 0.5 ml administered for prophylaxis (route of administration, anatomical location, lot number, and expiration date were not reported), the patient forgot about completing the vaccine series. (Inappropriate schedule of product administration). There was not adverse event reported. More
2844748 F NY 06/12/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient that was Given HEPLISAV-B, But She's 17; Initial report received on 02-Jun-2025. An of... Patient that was Given HEPLISAV-B, But She's 17; Initial report received on 02-Jun-2025. An office manager reported that a 17-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 05-May-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, and NDC number not available) intramuscularly. The patient was 17 at the time. The physician did not realize this at the time. The office had recently switched to using HEPLISAV-B. The patient did not experience any adverse reactions. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2844749 18 M TN 06/12/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
DD72H
Arthralgia, Dizziness, Ear pain, Injection site pain, Migraine; Pain, Pain in ex... Arthralgia, Dizziness, Ear pain, Injection site pain, Migraine; Pain, Pain in extremity, Paraesthesia More
Pain injection site; Migraine; Lightheadedness; tingling right arm; pain up right arm, shoulder ear;... Pain injection site; Migraine; Lightheadedness; tingling right arm; pain up right arm, shoulder ear; both hands throbbing and pulsating; pulsating in pain; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number DD72H) for prophylaxis. On 05-MAY-2025, the patient received Bexsero. On 05-MAY-2025, several hours after receiving Bexsero, the patient experienced injection site pain (Verbatim: Pain injection site), migraine (Verbatim: Migraine), light headedness (Verbatim: Lightheadedness), tingling of extremity (Verbatim: tingling right arm), pain in arm (Verbatim: pain up right arm, shoulder ear), throbbing pain (Verbatim: both hands throbbing and pulsating) and sensation of blood flow (Verbatim: pulsating in pain). The outcome of the injection site pain, migraine and light headedness were resolved and the outcome of the tingling of extremity, pain in arm, throbbing pain and sensation of blood flow were unknown. It was unknown if the reporter considered the injection site pain, migraine, light headedness, tingling of extremity, pain in arm, throbbing pain and sensation of blood flow to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, migraine, light headedness, tingling of extremity, pain in arm, throbbing pain and sensation of blood flow to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-MAY-2025 Other Health Professional reported that patient received Bexsero vaccine on 5-MAY-2025, a few hours later, he was lightheaded, right arm tingly and pain at injection site that migrated up arm shoulder to ear and Hands throbbing and pulsating in pain, He had migraine later that evening. This case US2025066674 reported by same reporter.; Sender's Comments: US-GSK-US2025066674:1 of 2 report More
2844750 M NY 06/12/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Back pain, Burning sensation, Computerised tomogram, Diverticulitis, Herpes zost... Back pain, Burning sensation, Computerised tomogram, Diverticulitis, Herpes zoster; Scar, Sleep disorder, Vaccination failure; Back pain, Burning sensation, Computerised tomogram, Diverticulitis, Herpes zoster; Scar, Sleep disorder, Vaccination failure More
Diverticulitis daignosed in 2024; Feels like bad sunburn; Scar; Sleep concerns; Shingles/shingles wa... Diverticulitis daignosed in 2024; Feels like bad sunburn; Scar; Sleep concerns; Shingles/shingles was located from the center of his back to his belly button around his left side, waist height.; Suspected vaccination failure; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JUL-2020, the patient received the 1st dose of Shingrix. In SEP-2020, the patient received the 2nd dose of Shingrix. On 09-APR-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/shingles was located from the center of his back to his belly button around his left side, waist height.). On an unknown date, the patient experienced diverticulitis (Verbatim: Diverticulitis daignosed in 2024) (serious criteria GSK medically significant), burning sensation (Verbatim: Feels like bad sunburn), scar (Verbatim: Scar) and sleep disorder (Verbatim: Sleep concerns). The patient was treated with valaciclovir hydrochloride (Valaciclovir Hcl), prednisone and lidocaine. The outcome of the vaccination failure was not reported and the outcome of the diverticulitis was unknown and the outcome of the shingles was resolved and the outcome of the burning sensation, scar and sleep disorder were not resolved. It was unknown if the reporter considered the vaccination failure, diverticulitis, shingles, burning sensation, scar and sleep disorder to be related to Shingrix and Shingrix. The company considered the vaccination failure and diverticulitis to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, burning sensation, scar and sleep disorder to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 03-JUN-2025 The patient reported that he was woke up with Shingles on, Wednesday, 9-APR- 2025, after receiving both doses of Shingrix, the first in July 2020, and the second September 2020 (no specific dates were provided). Patient was only provided the name of the pharmacy of the grocery store where he got Shingrix on 2020. The patient reported that the shingles was located from the center of his back to his belly button around his left side, waist height. The patient reported that he went to the emergency room on Friday, 11-APR-2025, and was diagnosed with shingles; and prescribed an antiviral, Valacyclovir HCL 1GM unknown product information, to take 1 tablet by mouth three times a day he believes for either 21 tablets or to take for two weeks it was unclear about duration. The patient reported the Valacyclovir did not do anything, so he went to urgent care and was prescribed a steroid, Prednisone 20mg the unknown product information to take 2 tablets by mouth in the morning for 7 days. The patient reported that the shingles was healed up, except maybe for a scar. The patient reported that he was still having aftereffects from shingles that was worse at night, and feels like a bad sunburn, and he could feel it when his clothes touch it . The patient was using an ice gel pack at night to help him sleep (AE Filed), and Lidocaine roll. The patient also reported that he was diagnosed with diverticulitis in 2024 no specific date was provided, at the emergency room where a CAT Scan was performed, after experiencing pain in his left lower back, after receiving both doses of Shingrix. The patient was given medication unknown product Information and later a pain killer (unknown product information) for the diverticulitis. The patient did not have a Lot Expiry ot route of Administration or Location of Administration for either the first or second dose of Shingrix. The reporter reported all that was provided about these adverse events. The patient was going to a new physician in July 2025 and was willing to provide the HCP information on the follow up from safety. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The case US2025069644 was found as duplicate of this case. All the information from the case US2025069644 was merged into this case. The case US2025069644 was deleted and this case stand as case of record for this patient.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). Diverticulitis is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2844751 M RI 06/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
felt achy; This non-serious case was reported by a consumer via call center representative and descr... felt achy; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: felt achy). The outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Additional Information: GSK receipt date: 05-JUN-2025 Consumer stated that patient received his first dose of Shingrix less than 6 months ago and he felt achy onset, resolve, area involved was not specified after receiving the vaccine. No other information was provided or obtained. More
2844752 53 F 06/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 MG5S9
Peripheral swelling Peripheral swelling
her whole arm (left) was swollen.; This non-serious case was reported by a pharmacist via call cente... her whole arm (left) was swollen.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number MG5S9) for prophylaxis. On 18-APR-2025, the patient received the 1st dose of Shingrix (intramuscular use, left arm) .5 ml. On 21-APR-2025, 3 days after receiving Shingrix, the patient experienced swelling arm (Verbatim: her whole arm (left) was swollen.). The outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to Shingrix. It was unknown if the company considered the swelling arm to be related to Shingrix. Additional Information: GSK Receipt Date: 06-JUN-2025 The pharmacist reported that a patient was vaccinated with her first dose of Shingrix on 18-APR-2025. Consumer informed to the health care professional that 72 hours later she had bad side effects and her whole arm (left) was swollen. No further information was obtained/provided. More
2844753 M TN 06/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
reports not feeling "well" for a day or so after each dose; This non-serious case was repo... reports not feeling "well" for a day or so after each dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: reports not feeling "well" for a day or so after each dose). The outcome of the feeling unwell was resolved. It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. Additional Information: GSK Receipt Date: 02-JUN-2025 The Patient reported that he had a dose of Shingrix. The patient reported not feeling well for a day or so after dose.; Sender's Comments: US-GSK-US2025AMR072940:Same Patient/ 2nd dose More
2844754 F 06/12/2025 MEN
 UNKNOWN MANUFACTURER
 UNK
Illness Illness
granddaughter was in the hospital for that, and she had got sick again; This non-serious case was re... granddaughter was in the hospital for that, and she had got sick again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced sickness (Verbatim: granddaughter was in the hospital for that, and she had got sick again). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Meningococcal B vaccine. It was unknown if the company considered the sickness to be related to Meningococcal B vaccine. Additional Information: GSK Receipt Date: 05-JUN-2025 This case was reported by a patient via interactive digital media. The reporter granddaughter was in the hospital for that and she had got sick again so they thought she did not get all the shots so asked what to do her now. More
2844755 06/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; broke out in shingles today; This serious case was reported by a cons... Suspected vaccination failure; broke out in shingles today; 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 06-JUN-2025, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: broke out in shingles today). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. 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: 06-JUN-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had his/her vaccine 5 years ago and broke out in shingles today (on the day of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2844756 06/12/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Rash, Vaccination failure Herpes zoster, Pain, Rash, Vaccination failure
Suspected vaccination failure; I'm just getting over shingles; This serious case was reported b... Suspected vaccination failure; I'm just getting over 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: I'm just getting over shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. 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: 06-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and he/she was just getting over shingles. The reporter stated that you did not want shingles. The rash was mild and the pain was horrible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine. More
2844757 M TN 06/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling abnormal, Pyrexia Feeling abnormal, Pyrexia
needed to take an over the counter fever reducer; within a few hours he started to feel badly; This ... needed to take an over the counter fever reducer; within a few hours he started to feel badly; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling bad in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On 30-MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, several hours after receiving Shingrix, the patient experienced feeling bad (Verbatim: within a few hours he started to feel badly). On an unknown date, the patient experienced fever (Verbatim: needed to take an over the counter fever reducer). The outcome of the feeling bad and fever were resolved. It was unknown if the reporter considered the feeling bad and fever to be related to Shingrix. It was unknown if the company considered the feeling bad and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 02-JUN-2025 Patient took first dose of Shingrix. He reported that within a few hours he started to feel badly and needed to take an over the counter fever reducer at 4:00 PM. He said he then went to bed and slept until the next morning and then felt fine the following day. More
2844758 0.58 M CA 06/12/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 Y49BZ
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Incorrect vaccine; Unapproved age; This non-serious case was reported by a other health professional... Incorrect vaccine; Unapproved age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 7-month-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. On 05-JUN-2025, the patient received Kinrix. On an unknown date, the patient received Pediarix. On 05-JUN-2025, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Incorrect vaccine) and inappropriate age at vaccine administration (Verbatim: Unapproved age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 05-JUN-2025 Office Manager called to report one of my Medical Assistants gave to, a 7 month old baby, a Kinrix vaccine instead of the Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration. We wanted to know if we need to revaccinate the baby or is there going to be any side effects or reactions to, I mean for the baby. The patient was supposed to receive the 1st dose of Pediarix. More
2844759 56 M CA 06/12/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4MG3E
Product preparation issue Product preparation issue
she had administered only the liquid portion of Priorix; she had administered only the liquid portio... she had administered only the liquid portion of Priorix; she had administered only the liquid portion of Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received MMR (Priorix) (batch number 4MG3E, expiry date 01-DEC-2026) for prophylaxis. On 01-JUN-2025, the patient received the 1st dose of Priorix. On 01-JUN-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: she had administered only the liquid portion of Priorix) and inappropriate dose of vaccine administered (Verbatim: she had administered only the liquid portion of Priorix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-JUN-2025 A pharmacist reported that she had administered only the liquid portion of priorix to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The shot was administered on 1 June 2025 and corresponded to the first dose. She wanted to know how to proceed and how to get a new diluent portion for reconstituting the lyophilized part as usual. More
2844760 59 F CA 06/12/2025 COVID19
 MODERNA
Cardiac disorder, Cardiac dysfunction Cardiac disorder, Cardiac dysfunction
Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications ca... Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024; Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024) and CARDIAC DISORDER (Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Kidney tumor (She was fighting a cancerous kidney tumor that was stable for four years through immunotherapy.). On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 18-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC DISORDER (Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced CARDIAC DYSFUNCTION (Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024) (seriousness criteria death, hospitalization and medically significant). The patient was treated with Surgery (After a year, they kept a pacemaker in her heart, which had severe consequences.) for Cardiac disorder. The patient died on 22-Jan-2024. The reported cause of death was blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the moderna covid-19 vaccine/she passed away on january 22, 2024 and blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the moderna covid-19 vaccine/she passed away on january 22, 2024. It is unknown if an autopsy was performed. Concomitant medication was not provided. It was reported that she started having side effects the following day after vaccination. Two weeks later, she ended up in the hospital for over a week, with a blood clot in her heart that took several months to dilute, but the damage to her heart was already done ad she was fighting for her life. After a year, they put a pacemaker in her heart, which had severe consequences as she was fighting a cancerous kidney tumor that was stable for four years through immunotherapy. Still, her medication was stopped due to the heart complications caused by the Moderna COVID-19 vaccine. Meanwhile, her hospital cardiologist had advised her not to take another vaccine because her life could be in jeopardy, and she never took another immunization. It was reported as in the last six months of patient's life; the reporter was her caregiver. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported.; Reporter's Comments: Concurrent medical condition Kidney tumor is a contributor for the events. As Cardiac dysfunction is likely a consequence of the cardiac disorder event, it was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024; Blood clot in her heart/damage to her heart/her heart function dropped to 15 More
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2844761 74 F OH 06/12/2025 COVID19
 PFIZER\BIONTECH
Chromaturia Chromaturia
urine that has turned a much brighter yellow; This is a spontaneous report received from a Consumer ... urine that has turned a much brighter yellow; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30May2025 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Leukemia", start date: 2004 (unspecified if ongoing), notes: Diagnosed 21 years ago. Concomitant medication(s) included: ROSUVASTATIN CALCIUM taken for blood cholesterol (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (had maybe 10 or 11 Covid shots up until now, Last Covid vaccine received was Oct2024), for COVID-19 immunization. The following information was reported: CHROMATURIA (non-serious) with onset 30May2025, outcome "unknown", described as "urine that has turned a much brighter yellow". Additional information: Caller was calling in regards to the covid vaccine booster. After caller got the covid vaccine booster last Friday i.e. 30May2025, noticed urine had turned a much brighter yellow. Agent wanting to know if there was any information about urine that has turned a much brighter yellow and if she should be concerned or what she should test for. Caller stated that she did see online there were some urological complications after the vaccine. Caller was wondering if she should be concerned. If she brought a urine sample into her doctor's office, what should they test for. Has been drinking a lot more so urine has gotten a little bit better but just her usual for her. The patient had might be 10 or 11 covid shots up until now. Later in call, clarified the last covid vaccine received was Oct2024. Caller cannot confirm manufacturer, has had both Moderna and Pfizer. No NDC, lot or expiry to provide on any covid vaccine received. Has all the paperwork but not with her. Takes a thyroid drug. It starts with an L, it was a generic, not Synthroid. Takes one of the lowest doses, a pill taken once a day. Has been taking several months and is currently taking. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
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