🏥 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 💀 🏥 🚑 ⚠️
2804460 31 M CA 10/31/2024 ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
ANTH
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS
EMERGENT BIOSOLUTIONS










Arthralgia, Bone pain, Chest discomfort, Dyspnoea, Myalgia; Toothache; Burning s... Arthralgia, Bone pain, Chest discomfort, Dyspnoea, Myalgia; Toothache; Burning sensation, Chest X-ray normal, Chest discomfort, Chest pain, Dizziness; Dyspnoea, Dyspnoea exertional, Echocardiogram normal, Electrocardiogram normal, Immediate post-injection reaction; Injection site erythema, Injection site pain, Injection site pruritus, Nausea, Pain in extremity; Paraesthesia, Skin tightness, Toothache; Burning sensation, Chest X-ray normal, Chest discomfort, Chest pain, Dizziness; Dyspnoea, Dyspnoea exertional, Echocardiogram normal, Electrocardiogram normal, Immediate post-injection reaction; Injection site erythema, Injection site pain, Injection site pruritus, Nausea, Pain in extremity; Paraesthesia, Skin tightness, Toothache More
Muscle pain, chest tightness, shortness of breath, teeth pain and bone/joint pain Muscle pain, chest tightness, shortness of breath, teeth pain and bone/joint pain
2705265 U CA 10/28/2023 COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH


Blood disorder, Blood test; Blood test, Blood test abnormal Blood disorder, Blood test; Blood test, Blood test abnormal
wrong with my blood work; This is a spontaneous report received from a contactable reporter(s) (Cons... wrong with my blood work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: BLOOD DISORDER (non-serious), outcome "unknown", described as "wrong with my blood work". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Additional information: the patient received an injection for the COVID-19 virus and afterwards there was a "thing wrong with my blood work." The information on the batch/lot number for bnt162b2 omi xbb.1.5, has been requested and will be submitted if and when received. More
2847154 16 M AZ 06/24/2025 HPV9
MENB
MNQ
MERCK & CO. INC.
PFIZER\WYETH
SANOFI PASTEUR
X024560
GF4143
U8375AA
Fall, Feeling abnormal, Pallor, Syncope, Tongue biting; Fall, Feeling abnormal, ... Fall, Feeling abnormal, Pallor, Syncope, Tongue biting; Fall, Feeling abnormal, Pallor, Syncope, Tongue biting; Fall, Feeling abnormal, Pallor, Syncope, Tongue biting More
16 year old male fainted after reciving vaccines, and fell on the floor face first. bit his tongue.... 16 year old male fainted after reciving vaccines, and fell on the floor face first. bit his tongue. blood pressure 99/64 pulse 55, Patient awake and oriented, looks pale and feels daze. More
2847155 74 F IA 06/24/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
00358160848117
Limb mass Limb mass
Noticed she had about a 1/4-1/2 inch bump on her right wrist. It wasn't painful, but only appea... Noticed she had about a 1/4-1/2 inch bump on her right wrist. It wasn't painful, but only appeared this afternoon. She put ice on it, which did appear to help. She described it as being like a ""burst blood vessel." More
2847156 25 F CA 06/24/2025 COVID19
PFIZER\BIONTECH
me6072
Blood test, Contusion, Eye pain, Headache, Influenza like illness Blood test, Contusion, Eye pain, Headache, Influenza like illness
Flu like symptoms, bruising of legs/arms, and severe headache/ocular pain Flu like symptoms, bruising of legs/arms, and severe headache/ocular pain
2847157 38 F AZ 06/24/2025 HEPA
GLAXOSMITHKLINE BIOLOGICALS
Z27PB
Dizziness, Hyperhidrosis, Nausea, Pallor Dizziness, Hyperhidrosis, Nausea, Pallor
Patient received vaccine and sat in waiting room after. She became very pale, dizzy, sweaty and nau... Patient received vaccine and sat in waiting room after. She became very pale, dizzy, sweaty and nauseated. Called 911 but patient stated she did not want to ride in an ambulance. Her eyes looked dilated and her vision was blurry. She said she felt a "ball in her throat". She was able to speak and swallow and was given orange juice and a glucose tablet to make sure her sugar was not low. An Epi-pen was available for use if necessary. Patient was in waiting room for approximately an hour. As she was coming around, she mentioned pain in her lower abdomen. Her father, who was with her, stated he was going to take her to the ER to get checked out. I encouraged her to be seen even though she was improving to rule out any other complications. More
2847158 29 F OH 06/24/2025 COVID19
MODERNA

Heart rate increased Heart rate increased
Sustained increased resting heart rate starting after administration. Increased ~15 bpm over a few m... Sustained increased resting heart rate starting after administration. Increased ~15 bpm over a few months and has remained increased. More
2847159 63 F WA 06/24/2025 COVID19
HEPA
PNC20
PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
ME6072
Z27PB
LN4930
Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripher... Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripheral swelling More
red arm and a little swollen (recommended Benadryl and monitor injection site) red arm and a little swollen (recommended Benadryl and monitor injection site)
2846818 M PA 06/23/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Myalgia, Rash, Rash erythematous Myalgia, Rash, Rash erythematous
Rash; Muscle soreness; red rash on arm; This non-serious case was reported by a consumer via call c... Rash; Muscle soreness; red rash on arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included heart rate irregular (Irregular heart beat). Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included blood pressure high (Blood pressure high), blood cholesterol increased (High cholesterol), diabetes (Diabetes), crohn's disease (Crohn's disease) and hidradenitis (Hidradenitis). Concomitant products included amlodipine, apixaban, clindamycin, dulaglutide (Trulicity), esomeprazole sodium (Nexium), furosemide (Lasix), gabapentin, hydrochlorothiazide, losartan, metformin, simvastatin, ustekinumab (Stelara) and colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos (Multivitamin). In MAY-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash), muscle soreness (Verbatim: Muscle soreness) and red rash (Verbatim: red rash on arm). The outcome of the rash, muscle soreness and red rash were not resolved. It was unknown if the reporter considered the rash, muscle soreness and red rash to be related to Shingrix. It was unknown if the company considered the rash, muscle soreness and red rash to be related to Shingrix. Additional Information: GSK Receipt Date: 12-JUN-2025 The case was self reported by patient. The patient received Shingrix vaccine 3.5 weeks ago after that he experienced muscle soreness in his right arm which has not gone away. This now extends down to his right wrist and to the back of his arm. He had a red rash on this arm as well as on his waist. More
2846819 74 F MD 06/23/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
UNK
Injection site erythema, Injection site rash, Injection site swelling Injection site erythema, Injection site rash, Injection site swelling
Injection site rash; Injection site redness; Injection site swelling; This non-serious case was rep... Injection site rash; Injection site redness; Injection site swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included gastric bypass (Gastric Bypass 20 years ago) and breast cancer (history of Breast cancer). Concomitant products included anastrozole, folic acid, escitalopram oxalate (Lexapro), ubidecarenone (Co Q-10), vitamin c and vitamin b12. On 11-JUN-2025, the patient received Arexvy (left arm). On 12-JUN-2025, 1 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Injection site rash), injection site erythema (Verbatim: Injection site redness) and injection site swelling (Verbatim: Injection site swelling). The outcome of the injection site rash, injection site erythema and injection site swelling were not resolved. It was unknown if the reporter considered the injection site rash, injection site erythema and injection site swelling to be related to Arexvy. It was unknown if the company considered the injection site rash, injection site erythema and injection site swelling to be related to Arexvy. Additional Information: GSK receipt date: The reporter was the husband of the patient. The patient received Arexvy on Wednesday 11 June 2025 in the left arm. The next day, the patient noticed a rash, redness and swelling at the injection site. The reporter had very limited contact information for the HCP. More
2846820 75 M MD 06/23/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
UNK
Injection site erythema Injection site erythema
redness at the injection site; This non-serious case was reported by a consumer via call center repr... redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included supraventricular tachycardia (History of SVT - had ablation done to treat). Concomitant products included Multivitamin. On 11-JUN-2025, the patient received Arexvy (right arm). On 11-JUN-2025, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at the injection site). On 12-JUN-2025, the outcome of the injection site erythema was resolved (duration 1 day). It was unknown if the reporter considered the injection site erythema to be related to Arexvy. It was unknown if the company considered the injection site erythema to be related to Arexvy. Additional Information: GSK Receipt Date: 13-JUN-2025 The reporter was the patient. The patient received Arexvy on Wednesday 11 June 2025 in the right arm. The patient noticed redness at the injection site the day of the vaccination, and it was gone the next day. More
2846821 06/23/2025 MNQ
NOVARTIS VACCINES AND DIAGNOSTICS
UNK
Product preparation issue Product preparation issue
With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .; With ... With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .; With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .) and inappropriate dose of vaccine administered (Verbatim: With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 12-JUN-2025 This case was reported by a consumer via interactive digital media. The reporter reported that with the Menveo vaccine if they only gave the liquid part and did not mix with the other vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered More
2846822 1 F MN 06/23/2025 DTAP
GLAXOSMITHKLINE BIOLOGICALS
GG39D
Expired product administered Expired product administered
maladministration of Infanrix after the expiration date; This non-serious case was reported by a nur... maladministration of Infanrix after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis. On 13-JUN-2025, the patient received Infanrix. On 13-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: maladministration of Infanrix after the 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: 13-JUN-2025 Registered Nurse called to ask if they had to revaccinate after the maladministration of Infanrix after the expiration date which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. More
2846823 MD 06/23/2025 MMR
GLAXOSMITHKLINE BIOLOGICALS

Product preparation issue Product preparation issue
Incomplete dose/They have no way of knowing if patients just got the diluent; Incomplete dose/They h... Incomplete dose/They have no way of knowing if patients just got the diluent; Incomplete dose/They have no way of knowing if patients just got the diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Incomplete dose/They have no way of knowing if patients just got the diluent) and inappropriate dose of vaccine administered (Verbatim: Incomplete dose/They have no way of knowing if patients just got the diluent). 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: 16-JUN-2025 and 17-JUN-2025 The other health professional reported that they had several patients who may not have received full doses of Priorix vaccine. The other health professional asked what the recommendation regarding revaccination was. The other health professional stated that they bag the 2 components of Priorix together and put them in the box protected from light. They have no way of knowing if patients just got the diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. She stated they bag them and band them together because this was an ongoing issue with the 2 component vaccines. More
2846824 NJ 06/23/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Incomplete course of vaccination Incomplete course of vaccination
Delaying second dose of shingrix; This non-serious case was reported by a physician via sales rep an... Delaying second dose of shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose five 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: Delaying second dose of shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 16-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter The reporter mentioned that a patient had first dose of Shingrix vaccine 5 years ago. The reporter asked how long after delaying second dose of Shingrix would the patient need to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2846826 50 F TX 06/23/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS

Diarrhoea, Headache, Oral herpes Diarrhoea, Headache, Oral herpes
Fever 1p1.7�f , headache, diarrhea. Will wait out at home and call dr if condition worsens. Fever 1p1.7�f , headache, diarrhea. Will wait out at home and call dr if condition worsens.
2846827 59 F GA 06/23/2025 VARZOS
VARZOS
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Abdominal discomfort, Back pain, Chills, Decreased appetite, Fatigue; Headache, ... Abdominal discomfort, Back pain, Chills, Decreased appetite, Fatigue; Headache, Hyperhidrosis, Pain in extremity, Paraesthesia, Pruritus; Rosacea More
Sweating & chills; fatigue; leg and back pain; headache; upset stomach; loss of appetite; extrem... Sweating & chills; fatigue; leg and back pain; headache; upset stomach; loss of appetite; extreme fatigue; itching & rosacea (about 10 days post-vaccine); tingling in 3 fingers on left hand + left forearm + left shoulder + 2 fingers on right hand (about 11 days post-vaccine) More
2846828 KY 06/23/2025 VARCEL
VARCEL
MERCK & CO. INC.
MERCK & CO. INC.

X012268
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
No symptoms or side effects; HCP called to report an expired dose of VARIVAX was administered to a p... No symptoms or side effects; HCP called to report an expired dose of VARIVAX was administered to a patient on 6/18/2025.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-JAN-2023, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) with sterile diluent (MERCK STERILE DILUENT) administered for prophylaxis (strength, lot number, expiration date, route and anatomical site of administration were not provided). On 18-JUN-2025, the patient was vaccinated with a second expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5 mL, lot #X012268 [which has been verified go be valid lot number for Varicella Virus Vaccine Live (Oka-Merck)], expiration date reported and upon internal validation establish as 30-APR-2025. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), lot #Y016370, expiration date: 13-MAY-2027 upon internal validation. Both were administered for prophylaxis (strength, route and anatomical site of administration were not provided). Expired dose supported by post expiry memo (Expired product administered). Despite multiple reiterations of the supported outcome, customer not comprehending outcome and hung up despite offer to look into further resources if unclear. No symptoms or side effects (No adverse event). No previous temperature excursion. More
2846829 2 M MA 06/23/2025 COVID19
HEPA
PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
LN8272
J4K4X
Product storage error; Product storage error Product storage error; Product storage error
None reported symptoms- COVID vaccine given over 10 weeks after thawed and storage. None reported symptoms- COVID vaccine given over 10 weeks after thawed and storage.
2846833 0.33 M GA 06/23/2025 DTAPHEPBIP
GLAXOSMITHKLINE BIOLOGICALS
9D25P
Dyskinesia, Hypotonia, Infant irritability, Nystagmus Dyskinesia, Hypotonia, Infant irritability, Nystagmus
After receiving vaccine -IRRITBILITY/ Not himself x 2 wks - Not as expressive Also noted what sounds... After receiving vaccine -IRRITBILITY/ Not himself x 2 wks - Not as expressive Also noted what sounds like nystagmus/and random jerking movement of extremity More
2846891 1 M CO 06/23/2025 HEPA
HEPA
MERCK & CO. INC.
MERCK & CO. INC.

Y013274
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 additional AE reported; E-mail received in the MNSC Contact Center mailbox on 03JUN2025 at 9:14 P... No additional AE reported; E-mail received in the MNSC Contact Center mailbox on 03JUN2025 at 9:14 PM with RMPDS after hours case MRK-2025-0063 reporting an AE for VAQTA. Verbatim: "This medical assistant reported that a "15 month old" patient received his first dose of VAQTA; This spontaneous report was received from a Medical Assistant and refers to a 16-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-Feb-2025 (conflicting information as it was also reported as 28-Jan-2025), the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA),, dose number 1, 0.5 mL (0.5 mL), administered by Intramuscular route (lot # and expiration date were not reported). On 23-May-2025, the patient was vaccinated with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA), (lot #Y013274, expiration date: 26-Dec-2025), dose number 2, 0.5 mL (0.5 mL), administered by Intramuscular route, both administered for prophylaxis, which was too early (inappropriate schedule of product administration). No adverse event was reported. Lot # for the first dose is being requested and will be submitted if received. More
2846892 TX 06/23/2025 HPV9
HPV9
HPV9
HPV9
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
Y015599



Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
patient reported no symptoms; Inadvertently administering a 4th dose of GARDASIL 9 to a 20 year old ... patient reported no symptoms; Inadvertently administering a 4th dose of GARDASIL 9 to a 20 year old patient; This spontaneous report was received from a Nurse and refers to a(n) patient of unknown age and gender. The patient's medical history, concurrent conditions AND Concomitant therapies were not reported. On 30-Jan-2017, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, on 03-Apr-2017, dose number 2, and in August 2017, dose number 3, administered by Unknown route (lot # and expiration date were not reported). On 10-Jun-2025, the patient was inadvertently administered a fourth dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y015599, expiration date: 10-Feb-2027), administered by Unknown route (Extra dose administered). All doses administered for prophylaxis. The patient reported no symptoms or adverse events. More
2846893 NV 06/23/2025 PNC15
PNC15
MERCK & CO. INC.
MERCK & CO. INC.
Z003633

Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AE; extra dose of VAXNEUVANCE; This spontaneous report was received from a medical ass... No additional AE; extra dose of VAXNEUVANCE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) Suspension for injection (dose, route of administration, lot # and expiration date were not reported) as prophylaxis and completed 4-dose series. Then, on 13-Jun-2025, the patient was inadvertently administered an extra dose of this vaccine (lot #Z003633, expiration date: 24-May-2027) (dose and route of administration were not reported) also as prophylaxis (Extra dose administered). The patient did not report any symptoms (No adverse event). More
2846894 F 06/23/2025 HPV9
MERCK & CO. INC.

Incomplete course of vaccination Incomplete course of vaccination
the second was postponed twice due to surgeries; This spontaneous report was received from a 44-year... the second was postponed twice due to surgeries; This spontaneous report was received from a 44-year-old female patient, referring to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-DEC-2024, the patient was vaccinated with 1st dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection, administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported). The 2nd dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) was postponed twice due to unspecified surgeries (performed on unspecified dates). The outcome of the event was not reported. Causality assessment was not provided. Additional information is not expected. More
2846895 VA 06/23/2025 DTPPVHBHPB
RVX
MSP VACCINE COMPANY
UNKNOWN MANUFACTURER


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; HCP called to report inadvertent administration of ROTATEQ and VAXELIS after a tem... No adverse event; HCP called to report inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025. ROTATEQ and VAXELIS were administered to a patient on 21MAY2025. Limited demographics provided. HCP originally called on; This spontaneous report was received from a nurse practitioner and refers to a 5-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-MAY-2025, the patient was inadvertently vaccinated with improper stored dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution administered by oral route (dose, lot # and expiration date were not reported); both administered as prophylaxis after a temperature excursion (that occurred on 07-MAY-2025) reported as 1.4 degree Celsius for 18 minutes. There was no previous temperature excursions. No additional adverse events reported. Lot# is being requested and will be submitted if received. This is one of the several reports received form the same reporter.; Reporter's Comments More
2846896 M 06/23/2025 DTAPIPV
GLAXOSMITHKLINE BIOLOGICALS
3RT93
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Kinrix was accidentally given to 11-year-old; This non-serious case was reported by a nurse via sale... Kinrix was accidentally given to 11-year-old; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis. On 11-JUN-2025, the patient received Kinrix. On 11-JUN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was accidentally given to 11-year-old). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 12-JUN-2025 Other HCP reported that Kinrix was accidentally given to 11-year-old, no symptoms were reported. More
2846897 4 M TX 06/23/2025 DTAPIPV
GLAXOSMITHKLINE BIOLOGICALS
4L454
Gait disturbance, Injection site swelling, Product administered at inappropriate... Gait disturbance, Injection site swelling, Product administered at inappropriate site More
Limping; administered a dose of Kinrix into the left thigh; Swollen Thigh; This non-serious case was... Limping; administered a dose of Kinrix into the left thigh; Swollen Thigh; This non-serious case was reported by a physician via call center representative and described the occurrence of swelling of legs in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454) for prophylaxis. Concomitant products included Mmr ii and Varicella zoster vaccine live (Oka/Merck) (Varivax). On 12-JUN-2025, the patient received Kinrix (left thigh). On 12-JUN-2025, less than a week after receiving Kinrix, the patient experienced limping (Verbatim: Limping) and vaccine administered at inappropriate site (Verbatim: administered a dose of Kinrix into the left thigh). In JUN-2025, the patient experienced swelling of legs (Verbatim: Swollen Thigh). The outcome of the swelling of legs was not resolved and the outcome of the limping was unknown and the outcome of the vaccine administered at inappropriate site was not applicable. It was unknown if the reporter considered the swelling of legs and limping to be related to Kinrix and Kinrix Pre-Filled Syringe Device. The reporter considered the vaccine administered at inappropriate site to be unrelated to Kinrix. It was unknown if the company considered the swelling of legs and limping to be related to Kinrix and Kinrix Pre-Filled Syringe Device. The company considered the vaccine administered at inappropriate site to be unrelated to Kinrix. 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: 13-JUN-2025 Physician stated that on 12th June 2025, she administered a dose of Kinrix into the left thigh of a pediatric patient, and mom noticed the patient was limping and complaining last night on 12th June 2025. The reporter stated that the patient did not let mom see the left thigh until today, 13th June 2025, and mom stated the left thigh was very, very big or swollen. Reporter stated that's all that was provided about these adverse events. More
2846898 F 06/23/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Diarrhoea, Rash Diarrhoea, Rash
Diarrhea; Rash over torso, arms, face; This non-serious case was reported by a consumer and describe... Diarrhea; Rash over torso, arms, face; This non-serious case was reported by a consumer and described the occurrence of diarrhea in a 57-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 30-MAY-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced diarrhea (Verbatim: Diarrhea) and rash (Verbatim: Rash over torso, arms, face). The outcome of the diarrhea was resolved and the outcome of the rash was not resolved. It was unknown if the reporter considered the diarrhea and rash to be related to Shingles vaccine. It was unknown if the company considered the diarrhea and rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-JUN-2025 The patient self-reported this case for herself. The patient had diarrhea and rash over torso, arms, face. The symptoms were not treated. More
2846899 06/23/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Pain Pain
Excruciating Pain for 6 weeks; This non-serious case was reported by a consumer via interactive digi... Excruciating Pain for 6 weeks; 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: Excruciating Pain for 6 weeks). The outcome of the pain was resolved (duration 6 weeks). 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: 16-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the most excruciating pain for 6 weeks, not letting up pain pills, did not help at all. The patient's family thought that he/she was going to die, and he/she had the shot maybe that's why the patient never got the cash. More
2846900 06/23/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; had the shot, but I am getting the shingles as often as before; This ... suspected vaccination failure; had the shot, but I am getting the shingles as often as before; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. 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: had the shot, but I am getting the shingles as often as before). 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: 16-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that it was a personal choice he/she had received the shot, but he/she kept getting shingles as often as before. The patient reported that he/she just kept going back for the antiviral. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2846901 F 06/23/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; very painful attack of shingles; This serious case was reported by a ... Suspected vaccination failure; very painful attack of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: very painful attack of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was 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: 16-JUN-2025 This case was reported by a patient via interactive digital media. Reporter's mother-in-law had thought it was a great idea, and it had been highly recommended by her doctor. However, in less than a year, she suffered a very painful attack of shingles. She continued to suffer for many years. It left us wondering what good the shot had been if it had not offered protection. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2846902 06/23/2025 VARZOS
VARZOS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNK
UNK
Eye pain, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure; Eye pain... Eye pain, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure; Eye pain, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure More
Suspected Vaccination failure; Shingles suffering with eye; both shots and came down with shingles; ... Suspected Vaccination failure; Shingles suffering with eye; both shots and came down with 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles suffering with eye) (serious criteria GSK medically significant) and shingles (Verbatim: both shots and came down with shingles). The outcome of the vaccination failure and shingles were not reported and the outcome of the ophthalmic herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a patient via interactive digital media. The patient had both shots and came down with shingles. 2 years later still suffering with eye. They thought he/she was going to lose eyesight. Thank heavens he/she did not. Still in pain every day with eye. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). More
2846903 06/23/2025 VARZOS
VARZOS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
Suspected Vaccination failure; now got shingles; 1st one was painful; This serious case was reporte... Suspected Vaccination failure; now got shingles; 1st one was painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: now got shingles) and pain (Verbatim: 1st one was painful). The outcome of the vaccination failure and pain were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the pain to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-JUN-2025 This case was reported by a patient via interactive digital media The patient got shots last year in 2024 but now got shingles and was not happy that he/she got shot and the 1st one was painful The patient was so not sure if he/she should have gotten it and supposedly made it milder. 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 Shingles vaccine (Dose 1 and Dose 2). More
2846904 M 06/23/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; vaccinated for shingles�and then got shingles; This serious case wa... Suspected vaccination failure; vaccinated for shingles�and then got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: vaccinated for shingles�and then got shingles). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 14-JUN-2025 This case was reported by a patient via interactive digital media. The patient was vaccinated for shingles and then got shingles. The reporter suspect it was a reaction to the vaccine. Now, reporter was very hesitant to get the shingles vaccine. The reporter said that yes, patient got shingles as a reaction to the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2846905 74 F NC 06/23/2025 PNC21
MERCK & CO. INC.
Y019158
Injection site pain Injection site pain
Site: Pain at Injection Site-Mild, Additional Details: Prevnar-20 given at doctors appointment earli... Site: Pain at Injection Site-Mild, Additional Details: Prevnar-20 given at doctors appointment earlier in the day, patient came to store to receive different vaccines, and asked about Capvaxive, patient accepted and was given additional pneumonia type vaccine in same day. Doctors office called in to investigate., Other Vaccines: VaccineTypeBrand: Prevnar-21; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/10/2025, VaccineTypeBrand: Shingrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/10/2025, VaccineTypeBrand: Boostrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/10/2025 More
2846907 75 F CA 06/23/2025 TDAP
GLAXOSMITHKLINE BIOLOGICALS
793pt
Rash Rash
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient got... Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient got a rash on upper and lower extremities, not too severe, told to take benedryl- not hot or spreading, no fever More
2846908 50 M IL 06/23/2025 TDAP
GLAXOSMITHKLINE BIOLOGICALS
KR75K
Fatigue, Injection site pain, Injection site swelling, Lethargy, Limb injury Fatigue, Injection site pain, Injection site swelling, Lethargy, Limb injury
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion /... Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines: VaccineTypeBrand: CAPVAXIVE; Manufacturer: MERCK; LotNumber: Z002626; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN More
2846909 23 F GA 06/23/2025 HPV9
MERCK & CO. INC.
Y012508
Injection site pain, Injection site swelling Injection site pain, Injection site swelling
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Inje... Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium More
2846910 72 F FL 06/23/2025 VARZOS
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
3X97J
3X97J
Fatigue, Flushing, Hyperhidrosis, Injection site erythema, Injection site pain; ... Fatigue, Flushing, Hyperhidrosis, Injection site erythema, Injection site pain; Lethargy, Nausea More
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion / ... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild More
2846911 26 F CA 06/23/2025 RAB
NOVARTIS VACCINES AND DIAGNOSTICS
FDP00683
Contusion, Loss of personal independence in daily activities, Rash, Urticaria Contusion, Loss of personal independence in daily activities, Rash, Urticaria
Systemic: Allergic: Rash Generalized-Severe, Systemic: welts, could not dress herself in the morning... Systemic: Allergic: Rash Generalized-Severe, Systemic: welts, could not dress herself in the morning painful welts, bruise feeling-Severe, Additional Details: Benadryl is helping patient a lot and symptoms are resolving., Other Vaccines: VaccineTypeBrand: n/a; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN More
2846912 67 F SC 06/23/2025 COVID19
MODERNA
3046731
Blister, Injection site pain, Injection site pruritus, Pruritus Blister, Injection site pain, Injection site pruritus, Pruritus
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Ge... Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: blisters that are drying up-Mild, Additional Details: pt states starting blistering that look like pimples several days after vaccine and it spread to other arm and cheek on face that is drying and still having pain at injection have not seeked medical care and just called me today about it. states will contact pcp in the morning and make appt. advsie to see medical attention sooner if condition worsens More
2846913 25 F FL 06/23/2025 COVID19
PFIZER\BIONTECH
md3414
Seizure Seizure
Systemic: Seizure-Mild, Additional Details: Patient seized for 15 seconds post vaccine. patient was... Systemic: Seizure-Mild, Additional Details: Patient seized for 15 seconds post vaccine. patient was ok and alert after event. Patient was taken to local ER by frient. , Other Vaccines: VaccineTypeBrand: havrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: heplisav; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN More
2846914 79 F IL 06/23/2025 TDAP
GLAXOSMITHKLINE BIOLOGICALS
E13499
Hypersensitivity, Injection site rash, Injection site swelling, Pruritus, Rash Hypersensitivity, Injection site rash, Injection site swelling, Pruritus, Rash
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties... Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Pt notified the pharmacy that she had swelling, itching, and rash occur around the injection site the next day. Pt states that ever since getting the first covid shot a couple years ago, she has developed allergies and sensitivities to unknown allergens. pt had not informed the pharmacist at the time of imz and just agreed to receive the Tdap as recommended. Pt has been taking oral antihistamin to help with the symptoms & stated will reach out to primary care for further management as necessary More
2846915 06/23/2025 VARZOS
UNKNOWN MANUFACTURER
UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I took the shots and still got shingles; This serious case was report... Suspected vaccination failure; I took the shots and still got 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 took the shots and still got 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: 15-JUN-2025 This case was reported by a patient via interactive digital media. The patient took the shingles shots and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary 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 regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine. More
2846916 21 F MO 06/23/2025 TDAP
GLAXOSMITHKLINE BIOLOGICALS
y3z9p
Presyncope, Syncope, Unresponsive to stimuli Presyncope, Syncope, Unresponsive to stimuli
Systemic: Fainting / Unresponsive-Mild, Additional Details: vasovagal response--pt knew it would hap... Systemic: Fainting / Unresponsive-Mild, Additional Details: vasovagal response--pt knew it would happen and precautions were taken to prevent falling/injury More
2846917 60 F GA 06/23/2025 PNC21
MERCK & CO. INC.
z005765
Injection site swelling Injection site swelling
Site: Swelling at Injection Site-Mild Site: Swelling at Injection Site-Mild
2846918 72 M IL 06/23/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
j9493
Arthralgia, Asthenia, Injection site pain, Paraesthesia Arthralgia, Asthenia, Injection site pain, Paraesthesia
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Tingling (specify: facia... Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium More
2846919 43 M PA 06/23/2025 HEP
HEP
DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
945664
945664
Impaired work ability, Injection site bruising, Injection site pain, Injection s... Impaired work ability, Injection site bruising, Injection site pain, Injection site swelling, Joint injury; Mobility decreased More
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Inje... Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: pt is unable to lift his arm or use shoulder. now unable to work his job-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)- More
2846921 72 M IL 06/23/2025 TDAP
GLAXOSMITHKLINE BIOLOGICALS
h4279
Injection site pain, Injection site swelling Injection site pain, Injection site swelling
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
2846922 66 F FL 06/23/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
ts525
Injection site erythema, Injection site pain, Injection site pruritus Injection site erythema, Injection site pain, Injection site pruritus
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec... Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe More