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
2840095 16 M TX 05/08/2025 MNP
 PFIZER\WYETH
 HC5020
Headache, Nausea, Pain in extremity Headache, Nausea, Pain in extremity
Arm pain, nausea, headache Arm pain, nausea, headache
2840096 27 M OR 05/08/2025 SMALLMNK
 BAVARIAN NORDIC
 96868
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
Vaccine given intramuscularly NOT subcutaneously. No adverse effects reported. Vaccine given intramuscularly NOT subcutaneously. No adverse effects reported.
2840097 17 M CA 05/08/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2PG39
2PG39
Antibody test positive, Product administered to patient of inappropriate age; An... Antibody test positive, Product administered to patient of inappropriate age; Antibody test positive, Product administered to patient of inappropriate age More
TwinRix given outside of indicated age range, in addition patient had a positive titer to Hepatitis ... TwinRix given outside of indicated age range, in addition patient had a positive titer to Hepatitis A More
2840098 60 F CA 05/08/2025 PNC20
 PFIZER\WYETH
 LX4483
Erythema, Peripheral swelling, Pruritus, Rash Erythema, Peripheral swelling, Pruritus, Rash
Rash on entire left arm with redness, itchiness, tenderness and swelling. Continuing for 4 days (unt... Rash on entire left arm with redness, itchiness, tenderness and swelling. Continuing for 4 days (until today and is still occurring) with decreasing severity. Self treated with an antihistamine cream with limited success. More
2840099 34 M 05/08/2025 FLU3
 SANOFI PASTEUR
 U8665EA
Rash, Rash pruritic, Urticaria Rash, Rash pruritic, Urticaria
Experienced a rash, hive-like break out around my shoulders, upper back, neck and chest and some itc... Experienced a rash, hive-like break out around my shoulders, upper back, neck and chest and some itching in the areas the bumps appeared. More
2840100 40 F CA 05/08/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Change of bowel habit, Gastrointestinal disorder, Laboratory test Change of bowel habit, Gastrointestinal disorder, Laboratory test
2.5 weeks later onset stomach distress, change in bowel habits. Under investigation for irritable bo... 2.5 weeks later onset stomach distress, change in bowel habits. Under investigation for irritable bowel disease or colitis. More
โœ“
2840113 F UT 05/08/2025 HBHEPB
HBHEPB
HBHEPB
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y005248
Injection site erythema, Injection site mass; Injection site erythema, Injection... Injection site erythema, Injection site mass; Injection site erythema, Injection site mass; Injection site erythema, Injection site mass More
the patient received a third dose of PEDVAXHIB at 6 months of age; a lump on the left thigh (2cm)/sl... the patient received a third dose of PEDVAXHIB at 6 months of age; a lump on the left thigh (2cm)/slightly irregular shaped; with redness; This spontaneous report was received from a nurse and refers to a 6-month-old female patient. The patient had no medical history, concomitant therapies and no known drug reactions or allergies. On unknown dates, the patient was vaccinated with 1st and 2nd dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) suspension for injection (dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis. On 27-FEB-2025, the patient was vaccinated with 3rd dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) suspension for injection at a dose of 0.5 mL, administered intramuscularly, lot #Y005248, expiration date 17-SEP-2026, for prophylaxis (anatomical location was not reported) (Inappropriate schedule of vaccine administered). Three other unknown vaccines were given that day. On an unspecified date in 2025, the patient experienced a 2-centimeter, slightly irregular shaped lump on the left thigh with redness. On 01-MAR-2025, the patient went to urgent care with aforementioned symptoms. The patient was not hospitalized and no treatment was rendered. The patient's current status and the outcome of the events was unknown. Causality assessment was not provided. This is one of several reports received from the same reporter. Additional information is not expected. More
2840114 F IL 05/08/2025 MMR
 MERCK & CO. INC.
 W029538
Expired product administered, No adverse event Expired product administered, No adverse event
no side effects or other symptoms; Medical Assistant reports MMRII expired 9/15/2024 and was adminis... no side effects or other symptoms; Medical Assistant reports MMRII expired 9/15/2024 and was administered to a patient on 4/12/2025. No previous temperature excursion, n; This spontaneous report was received from an Other health professional (medical assistatn) and refers to a female 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 12-Apr-2025, the patient started therapy with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), injection, lot #W029538 was confirmed to be valid, expiration date reported and confirmed as 15-SEP-2024, 0.5 mL (route and site of administration not provided)for prophylaxis (expired product administered); administered with sterile diluent (MERCK STERILE DILUENT) (strength dose, route and site of administration, lot # and expiration date were not reported). There were no previous temperature excursion, no side effects or other symptoms (no adverse event). More
2840115 M HI 05/08/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y017511
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AE; Temperature excursion; This spontaneous report was received from a physician assis... No additional AE; Temperature excursion; This spontaneous report was received from a physician assistant and refers to a 13-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis A Vaccine, Inactivated (VAQTA). On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) reconstituted with sterile diluent (BAXTER STERILE DILUENT), lot #Y017511, expiration date: 15-Apr-2026, administered by subcutaneous route in the left thigh for prophylaxis. The vaccine administered experienced a temperature excursion of -9.8 degree celsius (๏ฟฝC) for a time frame of 2 hours and 3 minutes. No other information provided. No additional adverse event (no adverse event) and no previous temperature excursion reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-04-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2840116 CA 05/08/2025 MMRV
 MERCK & CO. INC.
 Z002989
No adverse event, Product storage error No adverse event, Product storage error
no additional AEs; PROQUAD administered after temperature excursion; This spontaneous report was rec... no additional AEs; PROQUAD administered after temperature excursion; This spontaneous report was received from a registered nurses 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 28-Apr-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z002989, expiration date: 14-Jul-2026), 0.5 mL administered by subcutaneous route for prophylaxis by a health professional (strength was not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date not provided). The vaccine was administered after temperature excursion at 4.6 C for 137 hours (Product storage error). There was no previous temperature excursion. No additional adverse event was reported. More
2840117 F 05/08/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration Inappropriate schedule of product administration
innapropriate schedule of vaccine administered; no adverse event; This spontaneous report has been r... innapropriate schedule of vaccine administered; no adverse event; This spontaneous report has been received from a consumer regarding a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On an unspecified date, the patient received the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) for prophylaxis (strength, dose, anatomical site, route of administration, lot number and expiration date not reported). On an unknown date after 2 years of first vaccination, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) for prophylaxis (strength, dose, anatomical site, route of administration, lot number and expiration date not reported) (Inappropriate schedule of vaccine administered) (no adverse event). More
2840118 05/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Blindness Blindness
blinded; This serious case was reported by a consumer via interactive digital media and described th... blinded; This serious case was reported by a consumer via interactive digital media and described the occurrence of blind 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 blind (Verbatim: blinded) (serious criteria GSK medically significant). The outcome of the blind was not reported. The reporter considered the blind to be related to Shingles vaccine. The company considered the blind to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by a consumer via interactive digital media. The reporter stated to avoid the shingles vaccine as his/her cousin was blinded by the shingles vaccine.; Sender's Comments: Blindness is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. More
2840119 M AZ 05/08/2025 TDAP
 UNKNOWN MANUFACTURER
 m77cc
Fatigue, Somnolence, Urticaria Fatigue, Somnolence, Urticaria
Hives; tiredness; This non-serious case was reported by a other health professional via patient supp... Hives; tiredness; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of hives in a 20-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number m77cc) for prophylaxis. On 07-MAR-2025, the patient received Tdap Vaccine (intramuscular). On 14-MAR-2025, 7 days after receiving Tdap Vaccine, the patient experienced hives (Verbatim: Hives). In MAR-2025, the patient experienced tiredness (Verbatim: tiredness). The patient was treated with prednisone. The outcome of the hives was resolving and the outcome of the tiredness was not reported. It was unknown if the reporter considered the hives and tiredness to be related to Tdap Vaccine. It was unknown if the company considered the hives and tiredness to be related to Tdap Vaccine. Additional Information: GSK Receipt Date: 28-MAR-2025 Hives lasting about an hour, then migrating to different locations for a week. Treated with prednisone and antihistamines with resolution of hives. Experiencing tiredness requiring frequent sleeping but is improving. More
2840120 65 F KY 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 47n3y
Herpes zoster, Pustule Herpes zoster, Pustule
vesicles on her back which was diagnosed as shingles/pustules; This non-serious case was reported by... vesicles on her back which was diagnosed as shingles/pustules; This non-serious case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number 47n3y, expiry date 30-MAR-2027) for prophylaxis. On 16-APR-2025, the patient received the 1st dose of Shingrix. In APR-2025, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: vesicles on her back which was diagnosed as shingles/pustules). The outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 28-APR-2025 The reporter stated that a patient received her first dose of Shingrix and 3 days later, she came back with vesicles on her back which was diagnosed as shingles. Also stated that there were 10 little pustules with the area with the diameter of about 2 in in the left upper quadrant on the patient's back below the left scapula. This case is linked with case US2025051115, reported by the same reporter.; Sender's Comments: US-GSK-US2025051115:SAME REPORTER More
2840121 6 F TN 05/08/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
received Kinrix at 7 years and 5 days old; This non-serious case was reported by a nurse via call ce... received Kinrix at 7 years and 5 days old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B) for prophylaxis. On 22-APR-2025, the patient received Kinrix. On 22-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: received Kinrix at 7 years and 5 days 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: 28-APR-2025 Health care professional reported that a child received Kinrix at 7 years and 5 days old, which led to inappropriate age at vaccine administration. More
2840122 57 M TX 05/08/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Chills, Fatigue, Headache, Injection site pain, Pyrexia; Skin irritation, Tender... Chills, Fatigue, Headache, Injection site pain, Pyrexia; Skin irritation, Tenderness, Urticaria More
Irritation skin; hurts like he has been scratched; Welts; Headache; Tiredness; Fever; Chills/shiveri... Irritation skin; hurts like he has been scratched; Welts; Headache; Tiredness; Fever; Chills/shivering; Soreness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included pulled muscle (on his right flank). Concomitant products included alfuzosin. On 26-APR-2025, the patient received the 1st dose of Shingrix (left arm). In APR-2025, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), tiredness (Verbatim: Tiredness), fever (Verbatim: Fever), chills (Verbatim: Chills/shivering), injection site pain (Verbatim: Soreness at injection site), skin pain (Verbatim: hurts like he has been scratched) and welts (Verbatim: Welts). On 30-APR-2025, the patient experienced skin irritation (Verbatim: Irritation skin). The patient was treated with methoxamine hydrochloride, neomycin sulfate, polymyxin b sulfate (Neosporin). The outcome of the headache, tiredness, fever and chills were unknown and the outcome of the injection site pain was resolved and the outcome of the skin irritation, skin pain and welts were not resolved. It was unknown if the reporter considered the headache, tiredness, fever, chills, injection site pain, skin irritation, skin pain and welts to be related to Shingrix. It was unknown if the company considered the headache, tiredness, fever, chills, injection site pain, skin irritation, skin pain and welts to be related to Shingrix. Additional Information: GSK Receipt Date: 30-APR-2025 The reporter was the patient. The patient received the first dose of Shingrix on 26th April 2025. The patient experienced headache, tiredness, fever, chills, shivering, and soreness at the injection site (Left arm). On the day of reporting, 30th April 2025, the patient noticed that he was experiencing skin irritation on the right side of his abdomen. The patient stated that the skin irritation looks like there were cuts/thin lines across his abdomen, they look like scratches or claw marks. The irritation also hurts like he had been scratched. The patient stated he had welts on his right side. The patient put Neosporin to the skin irritation, which he believed initially irritated the area even more, but towards the end of the call it calmed down. The patient stated that he had been sleeping on a heating pad to alleviate a pulled muscle on his right flank. The pulled muscle happened prior to receiving Shingrix. More
2840123 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Oropharyngeal pain Oropharyngeal pain
Is a sore throat post shingrix a common side effect or allergic; This non-serious case was reported ... Is a sore throat post shingrix a common side effect or allergic; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sore throat (Verbatim: Is a sore throat post shingrix a common side effect or allergic). The outcome of the sore throat was not reported. It was unknown if the reporter considered the sore throat to be related to Shingrix. It was unknown if the company considered the sore throat to be related to Shingrix. Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via (Shingrix GSK CHATBOT) interactive digital media. he reporter asked was the sore throat after Shingrix vaccine a common side effect or allergic. More
2840124 F 05/08/2025 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; shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and 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. Additional Information: GSK Receipt Date: 31-MAR-2025 This case was reported by a patient via interactive digital media. Reporter stated that unfortunately it was happening very frequently more than ever and the patient got it and it was horrible, she was vaccinated twice. Physician told them that you could get it but not as severe if you did not but patient said it hurt like hell and also they gave her meds to put on it and take but she said it was horrible. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine ( dose 1 and dose 2) More
2840125 05/08/2025 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; shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and 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. Additional Information: GSK Receipt Date: 01-APR-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient stated that despite having 2 series of shots they had Shingles 3 times and it was very painful. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine ( dose 1 and dose 2) More
2840126 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
did not recived 2nd dose yet; This non-serious case was reported by a consumer via interactive digit... did not recived 2nd dose yet; This non-serious case was reported by a consumer via interactive digital media 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 1st dose on an unknown date). 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: did not recived 2nd dose yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she wondered what would happen if he/she did not get the second dose of the vaccine within 6 months. The patient had a questioned could he/she had gotten the second dose of the shingles vaccine 17 months after the first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2840127 05/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Eye disorder, Ophthalmic herpes zoster, Vaccination failure Eye disorder, Ophthalmic herpes zoster, Vaccination failure
Suspected vaccination failure; got shingles in my eye; This serious case was reported by a consumer ... Suspected vaccination failure; got shingles in my eye; 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, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: got shingles in my eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 01-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shots and 2 years later got shingles in eye. The patient heard vaccine was about 90 percent effective. The reporter stated that it had been a bitch, the patient eye would never be normal. This case was considered as suspected vaccination failure as details regarding 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 completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. More
2840128 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
painful side effects; This non-serious case was reported by a consumer via interactive digital media... painful side effects; 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: painful side effects). The outcome of the pain was not resolved. 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: 29-APR-2025 This case was reported by a patient via interactive digital media. Patient was suffering 2 weeks post Shingrix a slew of painful side effects. More
2840129 05/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
first one gave me shingles; This non-serious case was reported by a consumer via interactive digital... first one gave me shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: first one gave me shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated that first one gave him/her shingles. More
2840130 05/08/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Intensive care, Respiratory syncytial virus infection, Vaccination failure Intensive care, Respiratory syncytial virus infection, Vaccination failure
Had RSV; suspected vaccination failure; This serious case was reported by a consumer via interactive... Had RSV; suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, 6 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Had RSV) (serious criteria hospitalization). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by a patient via interactive digital media. The patient had respiratory syncytial virus infection (RSV) and was put into intensive care unit (ICU). The patient had the shot 6 months earlier. It was reported as the patient had the hospital, if not have had a premier staff, he/she was would have died. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK RSV vaccine. More
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2840131 HI 05/08/2025 HEPAB
 UNKNOWN MANUFACTURER
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient received Twinrix on 4/10/2023, then the patient received a separated HepA and HepB on 10/15/... Patient received Twinrix on 4/10/2023, then the patient received a separated HepA and HepB on 10/15/2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis. Previously administered products included Twinrix (received Twinrix vaccine on 10-APR-2023). On 15-OCT-2024, the patient received Hepatitis A and Hepatitis B vaccine. On 15-OCT-2024, an unknown time after receiving Hepatitis A and Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: Patient received Twinrix on 4/10/2023, then the patient received a separated HepA and HepB on 10/15/2024). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 28-APR-2025 The pharmacist reported that a patient received Twinrix on 10th April 2023 and then the patient received a separated HepA and HepB on 15th October 2024 (She did not confirm if it was Havrix and Engerix-B). The reporter reported that and then the patient received Havrix 14th April 2025. The patient received a dose of Hepatitis A and Hepatitis B vaccine later than the recommended interval, which led to lengthening of vaccination schedule. The reporter had a questioned how did they had to proceed, was she considered complete with her doses. More
2840132 29 F IL 05/08/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 DN273
Underdose Underdose
29 years old Patient and she received the pediatric dose; 29 years old Patient and she received the ... 29 years old Patient and she received the pediatric dose; 29 years old Patient and she received the pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 29-year-old female patient who received HAV (Havrix pediatric) (batch number DN273, expiry date 28-AUG-2026) for prophylaxis. On 16-APR-2025, the patient received the 1st dose of Havrix pediatric. On 16-APR-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: 29 years old Patient and she received the pediatric dose) and underdose (Verbatim: 29 years old Patient and she received the pediatric dose). The outcome of the adult use of a child product and underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-APR-2025 Nurse reported they had a patient of 29 years old and she received the pediatric dose of Havrix. So wanted to know what the next step is to restart the series with the adult dose. Adult patient received pediatric dose of Havrix, which led to adult use of child product and underdose. More
2840133 16 M NM 05/08/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 8274J
XL223
Product storage error; Product storage error Product storage error; Product storage error
Administration after temperature excursion; This non-serious case was reported by a other health pro... Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number XL223) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) (batch number 8274J) for prophylaxis. On 23-APR-2025, the patient received Menveo and Bexsero. On an unknown date, an unknown time after receiving Menveo and Bexsero, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-APR-2025 Reporter stated that between the time that the excursion happened there was 8 vaccines vaccines administered and asked if that's completely fine. The patient received Bexsero and Menveo (1 vial). Patient received vaccines after temperature excursion, which led to incorrect storage of drug. This case is one of the three linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025051843:same reporter/different patient US-GSK-US2025051844:same reporter/different patient More
2840134 65 F WA 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 F35YS
Erythema, Skin warm, Swelling Erythema, Skin warm, Swelling
a little bit of redness; a little bit of swelling; warm to the touch; This non-serious case was repo... a little bit of redness; a little bit of swelling; warm to the touch; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of redness in a female patient who received Herpes zoster (Shingrix) (batch number F35YS, expiry date 31-MAR-2027) for prophylaxis. On 26-APR-2025, the patient received the 1st dose of Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced redness (Verbatim: a little bit of redness), swelling (Verbatim: a little bit of swelling) and skin warm (Verbatim: warm to the touch). The outcome of the redness, swelling and skin warm were unknown. It was unknown if the reporter considered the redness, swelling and skin warm to be related to Shingrix. It was unknown if the company considered the redness, swelling and skin warm to be related to Shingrix. Additional Information: GSK Receipt Date: 29-APR-2025 The pharmacist reported that female patient received Shingrix first dose. The patient started with a little bit of redness and swelling, and then it did sort of continue in the Sunday. It was pretty warm to the touch and the border has expanded over those few days. On Monday, Doctor checked the patient and it was treated as cellulitis and now was trying to determine whether this was vaccine severe reaction or a formal culture infection. They want to know it had been other reports to this lot number. The vaccine administration facility was the same as primary reporter. More
2840135 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash More
injection site is very itchy; injection site is painful; injection site is red and looks like a rash... injection site is very itchy; injection site is painful; injection site is red and looks like a rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 28-APR-2025, the patient received Shingrix. In APR-2025, less than a week after receiving Shingrix, the patient experienced injection site itching (Verbatim: injection site is very itchy), injection site pain (Verbatim: injection site is painful) and injection site rash (Verbatim: injection site is red and looks like a rash). The outcome of the injection site itching, injection site pain and injection site rash were unknown. It was unknown if the reporter considered the injection site itching, injection site pain and injection site rash to be related to Shingrix. It was unknown if the company considered the injection site itching, injection site pain and injection site rash to be related to Shingrix. Additional Information: GSK Receipt Date: 30-APR-2025 Patient had received the vaccine on Monday. By wednesday, the injection site had become very itchy, red, and painful, and it had appeared as a rash. More
2840136 NY 05/08/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Menveo-Administration in patients older than 55 years; This non-serious case was reported by a pharm... Menveo-Administration in patients older than 55 years; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patients received Menveo. On an unknown date, an unknown time after receiving Menveo, the patients experienced inappropriate age at vaccine administration (Verbatim: Menveo-Administration in patients older than 55 years). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK receipt date: 01-MAY-2025 Pharmacist was concerned because some patients were going to travel abroad, and they had been administered Menveo to people other than 55 years because they need it the vaccine to travel abroad, which led to inappropriate age at vaccine administration. Centers for disease control and prevention (CDC) did not mentioned an specific vaccine brand for this population over 55 years. Follow up was not requested during the call. More
2840137 F NE 05/08/2025 RSV
 PFIZER\WYETH
 LL8391
Accidental exposure to product, Device connection issue, Erythema, Pruritus Accidental exposure to product, Device connection issue, Erythema, Pruritus
Spilled it all over my hands and that are turning red and itching; Spilled it all over my hands and ... Spilled it all over my hands and that are turning red and itching; Spilled it all over my hands and that are turning red and itching; Completely broke off of the thread; the syringe did off of the lower lock part; It went all over the place; did not even go in and it got all over me; Completely broke off of the thread; the syringe did off of the lower lock part; It went all over the place; did not even go in and it got all over me; This is a spontaneous report received from a Pharmacist. A 42-year-old female patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: LL8391, Expiration Date: May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "Spilled it all over my hands and that are turning red and itching"; SYRINGE ISSUE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown" and all described as "Completely broke off of the thread; the syringe did off of the lower lock part; It went all over the place; did not even go in and it got all over me". Additional information: reporter was preparing Abrysvo for a patient and when she attached the syringe to the vial adapter, it like completely broke off of the thread. The syringe did off of the lower lock part. The tip of the syringe separated from the lower lock of the syringe and it had never had that happened before her life. So, reporter thought well, she can always put on one of her own syringes. So, she put the syringe back on and pushed the liquid in. So, she could at least mix it but it went all over the place. It did not even go in and it got all over the reporter. Reporter had two questions: should she worry that the diluent all got over her and if there is a way for her to get a replacement from Pfizer. Reporter gave a different one to the patient, not the one that exploded all over her. Reporter was asking if she needs to go to the hospital since she spilled it all over her hands and that are turning red and itching. Causality for "spilled it all over my hands and that are turning red and itching" and "completely broke off of the thread; the syringe did off of the lower lock part; it went all over the place; did not even go in and it got all over me" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). More
2840138 F MN 05/08/2025 COVID19
 PFIZER\BIONTECH
Endotracheal intubation Endotracheal intubation
COVID vaccine was the very first one and the patient ended up in ICU and they had to intubate her; T... COVID vaccine was the very first one and the patient ended up in ICU and they had to intubate her; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ENDOTRACHEAL INTUBATION (hospitalization, life threatening), outcome "unknown", described as "COVID vaccine was the very first one and the patient ended up in ICU and they had to intubate her". 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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2840139 05/08/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Disease recurrence, Drug ineffective COVID-19, Disease recurrence, Drug ineffective
its caused nothing but pain and suffering I even after getting it and I'm talking about both sh... its caused nothing but pain and suffering I even after getting it and I'm talking about both shots not even 2 weeks later and I was sick with COVID then 6 months later I got COVID again; its caused nothing but pain and suffering I even after getting it and I'm talking about both shots not even 2 weeks later and I was sick with COVID then 6 months later I got COVID again; its caused nothing but pain and suffering I even after getting it and I'm talking about both shots not even 2 weeks later and I was sick with COVID then 6 months later I got COVID again; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "its caused nothing but pain and suffering I even after getting it and I'm talking about both shots not even 2 weeks later and I was sick with COVID then 6 months later I got COVID again". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2840146 05/08/2025 COVID19
 PFIZER\BIONTECH
Autoimmune hepatitis Autoimmune hepatitis
Autoimmune hepatitis; This is a spontaneous report received from a consumer, Program ID. A patient ... Autoimmune hepatitis; This is a spontaneous report received from a consumer, Program ID. A patient (age and gender not provided) received BNT162b2 Omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE HEPATITIS (medically significant), outcome "unknown". The patient had been recently diagnosed with autoimmune hepatitis and believed he/she got it from the COVID-19 vaccines (as reported) the patient received. The information on the batch/lot number for BNT162b2 Omicron (KP.2) will be requested and submitted if and when received. More
2840147 M 05/08/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.

Pyrexia, Rash; Pyrexia, Rash Pyrexia, Rash; Pyrexia, Rash
t after receiving his second dose of MMR-II, the patient "developed a rash and had fevers.&quo... t after receiving his second dose of MMR-II, the patient "developed a rash and had fevers."; t after receiving his second dose of MMR-II, the patient "developed a rash and had fevers."; This spontaneous report was received from patient's grandmother and refers to a(n) 6-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection 0.5 mL administered by intramuscular route (lot # and expiration date were not reported) as prophylaxis which was diluted with a sterile diluent (expiration date, and lot # were not reported). On an unknown date, after receiving his second dose of this vaccine, he developed a rash and had fevers. No other symptoms were reported by the patient's grandmother. The patient received some fever medication as treatment. The patient recovered from the events on an unspecified date. The causal relationship between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided. More
2840148 WA 05/08/2025 MMRV
 MERCK & CO. INC.
 Y009982
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Caller reported AE on behalf of a patient who was administered improperly stored P... No additional AE; Caller reported AE on behalf of a patient who was administered improperly stored PROQUAD on 4/9/2025 following a TE that started on 3/17/2025. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. TE Filed (Case #0; This spontaneous report was received from another health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 09-APR-2025, the patient was vaccinated with an improper stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at a dose of 0.5 ml (lot #Y009982, which had been verified to be a valid lot number; expiration date reported and confirmed as 24-NOV-2025; route of administration and anatomical location were not provided) as prophylaxis which was diluted with a sterile diluent (lot and expiry date not provided). The suspect vaccine was administered following a temperature excursion of 13.91 degrees Celsius / 14.4 degrees Celsius up to -10.4 degrees Celsius with a time frame of 360 Hours 0 Minutes 0 Seconds (on 17-MAR-2025). No symptoms reported (no adverse event). No previous temperature excursion was reported. More
2840150 M MD 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
He states he will be getting dose 2 today but it will be 10 days late; This non-serious case was rep... He states he will be getting dose 2 today but it will be 10 days late; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 19-OCT-2024). 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: He states he will be getting dose 2 today but it will be 10 days late). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 29-APR-2025 The patient self-reported this case for himself. The patient received 1st dose of Shingrix and he stated he would be getting dose 2 today (on the day of reporting) but it would be 10 days late. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. More
2840151 62 F CA 05/08/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 7PK53
No adverse event, Underdose No adverse event, Underdose
ADMINISTERED HALF THE DOSE OR 0.5ML ONLY INSTEAD OF THE FULL 1ML DOSE. NO ADVERSE REACTIONS REPORTE... ADMINISTERED HALF THE DOSE OR 0.5ML ONLY INSTEAD OF THE FULL 1ML DOSE. NO ADVERSE REACTIONS REPORTED BY THE PATIENT. More
2840152 57 F TX 05/08/2025 PNC20
 PFIZER\WYETH
Chills, Injection site erythema, Injection site pain, Injection site swelling, P... Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia More
Local hypersensitivity reaction to injection site (redness, swelling, pain, mild fever/chills) Local hypersensitivity reaction to injection site (redness, swelling, pain, mild fever/chills)
2840153 54 M ND 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 X72D2/7LC49
Fatigue, Illness, Painful respiration Fatigue, Illness, Painful respiration
Patient developed painful breathing and extreme fatigue/general illness within 24 hours of vaccine a... Patient developed painful breathing and extreme fatigue/general illness within 24 hours of vaccine administration. He was seen in the ER, provided antibiotics and given the all clear, but still feels like the general fatigue is not going away one month later. More
2840161 64 F AZ 05/08/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LX4484
E7335
Injection site erythema, Injection site pain, Pyrexia; Injection site erythema, ... Injection site erythema, Injection site pain, Pyrexia; Injection site erythema, Injection site pain, Pyrexia More
Fever starting night of vaccination, 5/2-5/5. Redness at injection sit with distinct edges that prog... Fever starting night of vaccination, 5/2-5/5. Redness at injection sit with distinct edges that progressed down patients arm. Intermittent stinging sensation at the site. More
2840162 73 M CO 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 92nn2
No adverse event, Product preparation issue No adverse event, Product preparation issue
Pt received just diluent. The vaccine was not reconstituted. Vaccine error has been reported. No adv... Pt received just diluent. The vaccine was not reconstituted. Vaccine error has been reported. No adverse effects reported. More
2840163 52 F PA 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93N4J
Diarrhoea, Feeling of body temperature change, Injection site rash, Injection si... Diarrhoea, Feeling of body temperature change, Injection site rash, Injection site swelling More
Hot and cold flashes, swelling and rash at injection site and diarrhea Hot and cold flashes, swelling and rash at injection site and diarrhea
2840164 62 M PA 05/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 f95ys
Bell's palsy, Dark circles under eyes, Malaise, Muscular weakness Bell's palsy, Dark circles under eyes, Malaise, Muscular weakness
pt felt unwell and had to go to hospital. per pt they told him he had bells palsy. he got some muscl... pt felt unwell and had to go to hospital. per pt they told him he had bells palsy. he got some muscle weakness and deep dark circles under his eyes. pt is getting better but still recovering More
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2840165 8 M MN 05/08/2025 PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH



LN4931
LN4931
LN4931
LN4931
Gait disturbance, Injection site pain, Weight bearing difficulty; Cardiac failur... Gait disturbance, Injection site pain, Weight bearing difficulty; Cardiac failure, Injection site oedema, Injection site pain, Injection site swelling, Limb discomfort; Limb ultrasound, Localised oedema, Oedema peripheral, Pain in extremity, Ultrasound joint normal; Ultrasound scan abnormal, Weight bearing difficulty, Wheelchair user, X-ray limb normal; Gait disturbance, Injection site pain, Weight bearing difficulty; Cardiac failure, Injection site oedema, Injection site pain, Injection site swelling, Limb discomfort; Limb ultrasound, Localised oedema, Oedema peripheral, Pain in extremity, Ultrasound joint normal; Ultrasound scan abnormal, Weight bearing difficulty, Wheelchair user, X-ray limb normal More
Patient has pain at the injection site less than 24 hours after immunization, making him reticent to... Patient has pain at the injection site less than 24 hours after immunization, making him reticent to bear full weight and unwilling to walk More
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2840166 4 M OR 05/08/2025 TDAP
 SANOFI PASTEUR
 U8352AA
Wrong product administered Wrong product administered
Adacel vaccine was administered instead of Quadracel.Parent was notified by primary care provider an... Adacel vaccine was administered instead of Quadracel.Parent was notified by primary care provider and informed that patient will still need a TDAP vaccine at the age of 11/12 years old. More
2840167 11 M CA 05/08/2025 HEPA
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 h3n97
u8494aa
9yb4g
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
I took my patient vitals he was roomed in room 7, I printed a form and went based of off that form, ... I took my patient vitals he was roomed in room 7, I printed a form and went based of off that form, pt was due for HPV, Tdap, MenQ. i went ahead and grabbed Hep A instead of HPV. I always verify for some reason I didn't this time I administered the extra Dose of Hep A in the Rt deltoid instead of of HPV. More
2840168 11 F CA 05/08/2025 HEPA
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 H3N97
U8494AA
9YB4G
Vaccination error; Vaccination error; Vaccination error Vaccination error; Vaccination error; Vaccination error
Patient was seen today 05/08/2025 for 11 y/o well child, patient was brought back, and vitals and ph... Patient was seen today 05/08/2025 for 11 y/o well child, patient was brought back, and vitals and physical was done/taken. Patient was only due for HPV, Tdap, and Meningococcal vaccines. Person then drew all vaccine and ordered all vaccines. I helped administer vaccine because person said mom wants both at the same time, I then helped her administer vaccine and caught the mistake once I was entering the vaccine information. More
2840169 11 M OH 05/08/2025 HEPA
HPV9
IPV
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 423NL
W036928
Y1AZ01M
U7949AC
U8122AA
Hypoaesthesia, Injected limb mobility decreased; Hypoaesthesia, Injected limb mo... Hypoaesthesia, Injected limb mobility decreased; Hypoaesthesia, Injected limb mobility decreased; Hypoaesthesia, Injected limb mobility decreased; Hypoaesthesia, Injected limb mobility decreased; Hypoaesthesia, Injected limb mobility decreased More
voiced concern for numbness and decreased movement from the left arm voiced concern for numbness and decreased movement from the left arm
2840170 79 F SD 05/08/2025 COVID19
 MODERNA
Myalgia, Neck pain Myalgia, Neck pain
Had Pfizer before without problem, this time I ache bad neck and all muscles after me derma. No rash... Had Pfizer before without problem, this time I ache bad neck and all muscles after me derma. No rash, no vomiting, no headache so far More
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