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
2842895 NJ 05/28/2025 HEPA
 MERCK & CO. INC.
 X023974
Expired product administered, No adverse event Expired product administered, No adverse event
No additional adverse event reported; A HCP called and reported that an expired dose of VAQTA was ad... No additional adverse event reported; A HCP called and reported that an expired dose of VAQTA was administered to patient on 02MAY2025 with expiry date of 18APR2025. The caller confirmed the dose has never been stored outside of the recommended storage range.; This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 02-May-2025, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), (strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot #X023974, expiration date: 18-Apr-2025), as prophylaxis (expired vaccine used). No additional adverse event reported. More
2842896 1.08 WV 05/28/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

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 symptomatic, no additional AE; report administrations of VARIVAX and PROQUAD on 05/02/2026 for 13... no symptomatic, no additional AE; report administrations of VARIVAX and PROQUAD on 05/02/2026 for 13-month-old twin patients.; HCP calling to report administrations of VARIVAX and PROQUAD for 13-month-old twin patients. Patients are not symptomatic; This spontaneous report was received from a Nurse and refers to 13-months 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 02-MAY-2025, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # and expiration date were not reported); along with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot # and expiration date were not reported) diluted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported); all vaccines were administered for prophylaxis (inappropriate schedule/ accidental overdose). The patient was asymptomatic, and no additional adverse event was reported. This is one of 2 reports from the same reporter. More
2842897 1.08 WV 05/28/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

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
not symptomatic, no addtional AE; HCP calling to report administrations of VARIVAX and PROQUAD on 05... not symptomatic, no addtional AE; HCP calling to report administrations of VARIVAX and PROQUAD on 05/02/2026 for 13-month-old twin patients. Patients are not symptomatic. Unable to collect LOT/EXP for the VARIVAX and PROQUAD. No other information at this time. Permission to contact g; This spontaneous report was received from a Nurse and refers to a 13-months-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 02-May-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (Strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot #, and expiration date were not reported), as prophylaxis. On the same date, the patient was also vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (Strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot #, and expiration date were not reported), as prophylaxis (inappropriate schedule of vaccina administered). The patient was not symptomatic, and no additional adverse event reported. This is one of two reports from the same reporter. Lot # is being requested and will be submitted if received. More
2842898 38 F NH 05/28/2025 HPV9
 MERCK & CO. INC.
 X019625
Expired product administered, No adverse event Expired product administered, No adverse event
No side effects or symptoms reported/No Additional AE; Caller states the product expired 04/23/2025 ... No side effects or symptoms reported/No Additional AE; Caller states the product expired 04/23/2025 and was administered 05/19/2025; This spontaneous report was received from a Nurse 19-MAY-2025 and refers to a 38-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-MAY-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (lot #X019625, expiration date: 23-APR-2025), prefilled syringe, dose: 0.5 mL for prophylaxis (route of administration and dose number was not reported)(Expired product administered). The reporter confirmed that the vaccine was stored at the appropriate condition. No further information. No side effects or symptoms reported. More
2842899 CA 05/28/2025 HEPA
 MERCK & CO. INC.
 Y013274
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP reported that improperly stored VAQTA was administered.; This spontaneous repo... No additional AE; HCP reported that improperly stored VAQTA was administered.; This spontaneous report has been received from an other health professional, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 23-MAY-2025, the patient was vaccinated with an improperly stored dose of with improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) suspension for injection, at a dose of 0.5 milliliter (ml), as prophylaxis, lot number Y013274 which was determined to be valid, with an expiration date on 26-DEC-2025(vaccination scheme, route of administration, and anatomical site of injection were not reported). Administered doses were stored at a temperature of 35.04 degrees Fahrenheit (F), during a time frame of 2 hours and 14 minutes (product storage error). No additional adverse events were reported in the patient. More
2842900 HI 05/28/2025 FLU3
 SANOFI PASTEUR
 UT843UJA
No adverse event, Product storage error No adverse event, Product storage error
received vaccine that was stored at -0 with no reported adverse event; Initial information received ... received vaccine that was stored at -0 with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and gender patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] that was stored at -0 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of influenza USP TRIVAL A-B subvirion vaccine Suspension for injection (strength- unknown, expiry date- 30-Jun-2025 and lot UT843UJA) via unknown route in unknown administration site for Influenza immunization that was stored at -0 with no reported adverse event (poor quality product administered) (same day latency). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2842907 68 F NJ 05/28/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 27LR2
27LR2
Biopsy skin abnormal, Blister, Hyperkeratosis, Melanocytic naevus, Rash vesicula... Biopsy skin abnormal, Blister, Hyperkeratosis, Melanocytic naevus, Rash vesicular; Squamous cell carcinoma, Surgery More
Squamous cell carcinoma; developed a blister on my back that evolved into what looked like a chicken... Squamous cell carcinoma; developed a blister on my back that evolved into what looked like a chickenpox; This serious case was reported by a consumer via call center representative and described the occurrence of squamous cell carcinoma in a female patient who received Herpes zoster (Shingrix) (batch number 27LR2, expiry date 25-MAR-2027) for prophylaxis. Previously administered products included Shingrix (The patient received the first dose of Shingrix on 13 September 2024 (Lot number GK2AZ; expiration date 21 April 2026) Intramuscularly, in the left upper arm.The dose given was unknown). Concomitant products included ezetimibe (Zetia) and pitavastatin calcium (Livalo). On 27-FEB-2025, the patient received the 2nd dose of Shingrix. In MAR-2025, 1 week after receiving Shingrix, the patient experienced chickenpox (Verbatim: developed a blister on my back that evolved into what looked like a chickenpox). On an unknown date, the patient experienced squamous cell carcinoma (Verbatim: Squamous cell carcinoma) (serious criteria GSK medically significant and clinically significant/intervention required). The outcome of the squamous cell carcinoma was unknown and the outcome of the chickenpox was resolved. It was unknown if the reporter considered the squamous cell carcinoma and chickenpox to be related to Shingrix. The company considered the squamous cell carcinoma and chickenpox to be unrelated to Shingrix. Additional Information: GSK receipt date: 22-MAY-2025 Consumer reported that about 1 week after receiving the second dose of Shingrix, the patient developed a blister on her back. Shortly after, a blister developed on her upper thigh. The blister on her back resolved, but the blister on her thigh developed into a mole, which grew very quickly. This mole had a hole in the center and a horn like growth coming from it. The patient had this mole biopsied in April, 2025. By the time the patient had surgery on May 6, 2025, the mole had grown back to 1cm. The mole on her thigh was Squamous Cell Carcinoma.; Sender's Comments: Squamous cell carcinoma and Varicella are unlisted events which are considered unrelated to GSK vaccine Shingrix. More
2842908 05/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Cerebrovascular accident Cerebrovascular accident
stroke; This serious case was reported by a consumer via interactive digital media and described the... stroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced stroke (Verbatim: stroke) (serious criteria GSK medically significant). The outcome of the stroke was not reported. It was unknown if the reporter considered the stroke to be related to Shingrix. The company considered the stroke to be unrelated to Shingrix. Additional Information: GSK receipt date: 21-MAY-2025 This case was reported by a patient via interactive digital media. Physician gave the first round of Shingrix vaccine to reporter and patient had horrible scary side effects. Patient stated that he/she would not get the second round. Patient heard that it was worst than the first. Patient thought he/she was having a stroke. Patient's husband was getting ready to call an ambulance.; Sender's Comments: Cerebrovascular accident is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2842909 05/28/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Ear pain, Herpes zoster, Herpes zoster oticus, Pain, Rash; Vaccination failure Ear pain, Herpes zoster, Herpes zoster oticus, Pain, Rash; Vaccination failure
Suspected vaccination failure; Though I had gotten shingles/ rash on my right ear; Though I had gott... Suspected vaccination failure; Though I had gotten shingles/ rash on my right ear; Though I had gotten shingles/ rash on my neck; right ear lobe, top to bottom, started paining me with excruciating sharp shooting pains; rash on my right ear and my neck; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In MAY-2025, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster oticus (Verbatim: Though I had gotten shingles/ rash on my right ear) (serious criteria GSK medically significant), herpes zoster (Verbatim: Though I had gotten shingles/ rash on my neck), ear pain (Verbatim: right ear lobe, top to bottom, started paining me with excruciating sharp shooting pains) and rash (Verbatim: rash on my right ear and my neck). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster oticus, herpes zoster, ear pain and rash were not resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster oticus, herpes zoster, ear pain and rash to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure, herpes zoster oticus, herpes zoster, ear pain and rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAY-2025 This case was reported by a patient via interactive digital media. Patient was 69 and had Shingles vaccines years ago (from the date of reporting). Two days ago (from the date of reporting) patient's right ear lobe, from top to bottom, began paining him/her with excruciating sharp shooting pains. This morning (on the day of reporting morning), patient saw his/her physician and it seemed as though he/she has got shingles. There was the start of a rash on his/her right ear and neck and had he/she not been seen today it could have moved to his/her face which they call Ramsay Hunt syndrome which affects the facial nerves. He/she hoped the antiviral medication would work quickly. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding herpes zoster oticus and herpes zoster were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles Herpes zoster oticus is an unlisted event which is considered unrelated to GSK vaccine Shingles " More
2842910 F 05/28/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; Someone I know very well got shingles and she had 2 shots for it; Thi... Suspected vaccination failure; Someone I know very well got shingles and she had 2 shots for it; 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: Someone I know very well got shingles and she had 2 shots for it). 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: 24-MAY-2025 This case was reported by a patient via interactive digital media. Reporter stated that someone he/she know very well got shingles and she had 2 shots for it. This case was considered as suspected vaccination failure as details regarding completion 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 Shingles vaccine (dose 2). More
2842911 56 05/28/2025 RAB
 SANOFI PASTEUR
No adverse event, Off label use No adverse event, Off label use
Intentional Off Label Prescription by HCP: Imovax prescribed with off label diagnosis Open bite of r... Intentional Off Label Prescription by HCP: Imovax prescribed with off label diagnosis Open bite of right ring finger without damage to nail, initial encounter with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 56 years old and unknown gender patient who had prescribed with IPV (VERO) [IMOVAX] off label with diagnosis open bite of right ring finger without damage to nail, initial encounter with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was prescribed with 2.5 u dose of suspect IPV (VERO), Suspension for injection,frequency:3 times (lot number, strength and expiry date not reported) for open bite of right ring finger without damage of nail, initial encounter (bite) which was intentional off label diagnosis with no reported adverse event (off label use). Information on the batch number cannot be requested corresponding to the one at time of event occurrence Reportedly, Imovax prescribed with off label diagnosis S61.254A Open bite of right ring finger without damage to nail, initial encounter. Action taken was not applicable. More
2842914 14 F CA 05/28/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Alopecia, Autoantibody positive, Autoimmune thyroiditis, Blood iron decreased, D... Alopecia, Autoantibody positive, Autoimmune thyroiditis, Blood iron decreased, Dark circles under eyes; Injection site inflammation, Injection site mass, Lethargy, Oropharyngeal pain, Vitamin D decreased More
Our daughter was well prior to the shot. she had had a minor sniffle cold few weeks prior. She had a... Our daughter was well prior to the shot. she had had a minor sniffle cold few weeks prior. She had a nearly immediate reaction to the booster. The site of where the shot was administered became highly inflamed and over a couple days turned into a base ball shaped mass under her skin. Then an onslaught of symptoms followed within a week of the shot, and continued since. First dark circles under her eyes, a sore throat and became very lethargic and almost depressed. Then her hair started shedding in small clumps and strands. We had blood tests done, which showed low vitamin D and iron and more were ordered, showing a rapid onset of an autoimmune response with high levels of antibodies present and Hashimoto's Disease. More
2842959 2 M NJ 05/28/2025 VARCEL
 MERCK & CO. INC.
 Y014868
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs were reported; Patient received improperly stored vaccine; This spontaneous report... No additional AEs were reported; Patient received improperly stored vaccine; This spontaneous report was received from a health care professional referring to a patient, age and gender not reported. Information regarding the patient's pertinent medical history, drug allergies or reactions, or concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (VARIVAX), for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, were not reported, valid lot number Y014868, with an expiration date on 03-SEP-2026) which was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) (lot number and expiration date not provided). The administered dose of the vaccine experienced a temperature excursion 5.5๏ฟฝF up to 14.4๏ฟฝF degrees Fahrenheit for 40 minutes, 14.5๏ฟฝF up to 46.4๏ฟฝF and 15. 8 degrees Fahrenheit for 10 minutes. It was not reported if the information was recorded by a data logger or not. There was no adverse effect reported. Follow-up information was received from an other health care professional on 05-MAY-2025. The patient was a 2-year-old male. He received varicella virus vaccine live (VARIVAX) on 24-APR-2025 in the left upper, outer arm, lot# Y014868, expiration date 03-SEP-2026. The patient also received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R II) on the same day, lot# Y010372, expiration date 05-JUN-2026, given in the left upper, outer arm. No side effects were reported. Patient had no significant past medical history. No illness at time of vaccination. No daily medications. No further information was available. More
2842960 45 M TX 05/28/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
no adverse event; HCP calling to request information regarding GARDASIL 9. Request case 02800767. ... no adverse event; HCP calling to request information regarding GARDASIL 9. Request case 02800767. HCP reported a male patient received first dose of GARDASIL 9 on 9/14/2024, a second dose on 10/19/2024, and is currently requesting the 3rd dose. HCP reported that; HCP calling to request information regarding GARDASIL 9. Request case 02800767. HCP reported a male patient received first dose of GARDASIL 9 on 9/14/2024, a second dose on 10/19/2024, and is currently requesting the 3rd dose. HCP reported that; This spontaneous report was received from a Pharmacist and refers to a 46-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 14-Sep-2024, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL (lot # and expiration date were not reported)( Inappropriate age at vaccine administration). On 19-Oct-2024, the patient received second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL (lot # and expiration date were not reported) (Inappropriate age at vaccine administration). No adverse event was reported. More
2842962 WI 05/28/2025 PPV
 MERCK & CO. INC.
 X023561
No adverse event, Wrong product administered No adverse event, Wrong product administered
No additional AEs were reported,; a patient supposed to receive PREVNAR 20 but received PNEUMOVAX 23... No additional AEs were reported,; a patient supposed to receive PREVNAR 20 but received PNEUMOVAX 23 instead due to a human error.; This spontaneous report was received from an other health professional and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-MAY-2025, the patient supposed to receive pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20), but received instead pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), 1 dose, lot# X023561, expiry date 17-NOV-2025, for prophylaxis (route of administration and anatomical location were not reported) due to a human error (Wrong product administered). No additional adverse events were reported. More
2842963 05/28/2025 COVID19
FLUN3
 UNKNOWN MANUFACTURER
MEDIMMUNE VACCINES, INC.

Diarrhoea, Frustration tolerance decreased, Hypotension; Diarrhoea, Frustration ... Diarrhoea, Frustration tolerance decreased, Hypotension; Diarrhoea, Frustration tolerance decreased, Hypotension More
diarrhea; feel like crap; low blood pressure; A spontaneous report has been received from a consumer... diarrhea; feel like crap; low blood pressure; A spontaneous report has been received from a consumer. The report concerns a male elderly patient (age 71 years). No medical history was reported. No concomitant products were reported. The patient received Covid-19 Vaccine, via unspecified route, on an unknown date. The patient received 1 dose(s). The patient started treatment with Lenvima (lenvatinib mesilate) (batch number(s) 36066 09) 10 milligram qd, Oral use, on 11-AUG-2023 for liver cell carcinoma and with Flumist (flumist, influenza virus vaccine polyvalent, q/laiv), on an unknown date. A OTHER administered NA. On an unknown date, the patient experienced diarrhea (preferred term: Diarrhoea), low blood pressure (preferred term: Hypotension) and feel like crap (preferred term: Frustration tolerance decreased). It is unknown if any action was taken with Covid-19 Vaccine (covid-19 vaccine), Flumist (flumist, influenza virus vaccine polyvalent, q/laiv) and Lenvima (lenvatinib mesilate). The outcome of the event(s) of diarrhea, feel like crap and low blood pressure was unknown. The events were considered non-serious. The reporter considered that there was a reasonable possibility of a causal relationship between Covid-19 Vaccine and the following event(s): diarrhea. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): diarrhea. The reporter considered that there was a reasonable possibility of a causal relationship between Luer Pre-Filled Syringe and the following event(s): diarrhea. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUENZ TETRA, FLUENZ TETRA, FLUMIST Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No All required follow-up attempts have been completed to obtain the Lot / Batch number for Flumist and Covid-19 Vaccine, however the Lot / Batch number was not received. Summary of follow-up information received by AstraZeneca on 05-Dec-2024 from Marketing company: Summary of unsuccessful Lot/Batch number attempts added. Narrative updated. More
2842964 M 05/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Limb mass, Mobility decreased, Pain in extremity Limb mass, Mobility decreased, Pain in extremity
Arm hurts to sleep on it. Lean on it. Starts to feel like I have been punched in the arm. Received p... Arm hurts to sleep on it. Lean on it. Starts to feel like I have been punched in the arm. Received pusical therapy discontinued therapist said it wasn't helping; Limited range of motion; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included loperamide hydrochloride (Lopermide). On 14-JUN-2024, the patient received Shingrix. On 14-JUN-2024, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm hurts to sleep on it. Lean on it. Starts to feel like I have been punched in the arm. Received pusical therapy discontinued therapist said it wasn't helping) and mobility decreased (Verbatim: Limited range of motion). The outcome of the pain in arm and mobility decreased were not resolved. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix. It was unknown if the company considered the pain in arm and mobility decreased to be related to Shingrix. Additional Information: GSK receipt date: 26-MAY-2025 The reporter reported that the arm hurts to sleep on it, lean on it. Started to feel like he had been punched in the arm. Received physical therapy discontinued therapist said it was not helping. Therapist tried several therapist said she felt something lime a knot in my shoulder that did not change. Several weeks of therapy only yielded temporary relief. Therapist said she would continue for the temporary relief a couple more weeks he wanted for temporary relief but did not expect any long term benefits from it. The duration of relief was not worth the trip to the office so it was discontinued. This had been ongoing for almost a year now. He could not sleep without being woke up constantly due to pain in his arm from laying in it and he tend to move on it in his sleep. More
2842965 05/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I have had the vaccines and still have them; This serious case was re... Suspected vaccination failure; I have had the vaccines and still have them; 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 have had the vaccines and still have them). 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: 23-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the vaccines and still had them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2842966 F 05/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; my wife had the shingles vaccines and still got it; This serious case... Suspected vaccination failure; my wife had the shingles vaccines and still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: my wife had the shingles vaccines and still got it). 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: 23-MAY-2025 This case was reported by a patient's husband via interactive digital media. The patient had the shingles vaccines and still had them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2842967 05/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Extra dose administered Extra dose administered
on my third round of shingles since February.; This non-serious case was reported by a consumer via ... on my third round of shingles since February.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine (received 2 dose in 2020). On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced extra dose administered (Verbatim: on my third round of shingles since February.). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 23-MAY-2025 The patient paid 100 dollars each for a shot in the 90's before our insurance would pay for it. Then in 2020 took the two shot series because it was supposed to be better. Well, the patient on third round of shingles since February, which led to extra dose administered. More
2842968 05/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
I got them a few months after my first shot; This non-serious case was reported by a consumer via in... I got them a few months after my first shot; 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, several months after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got them a few months after my first shot). 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: 25-MAY-2025 This case was reported by a patient via interactive digital media. The patient got shingles a few months after my first shot of Shingles vaccine. More
2842969 05/28/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Rash, Vaccination failure Herpes zoster, Pain, Rash, Vaccination failure
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In DEC-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 24-MAY-2025 This case was reported by a patient via interactive digital media. The patient had a mild case of shingles at the end of December. The patient reported that initially he/she thought it was just a rash, as there was not much pain. Fortunately, he/she had received the vaccine years earlier. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2842970 05/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I received my 1st dose of Shingrix vaccine almost 7 months ago; This non-serious case was reported b... I received my 1st dose of Shingrix vaccine almost 7 months ago; 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 of Shingrix vaccine almost 7 months 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: I received my 1st dose of Shingrix vaccine almost 7 months ago). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 21-MAY-2025 The patient had received their first dose of the Shingrix vaccine almost seven months ago, just beyond the six-month limit. They had inquired whether they could receive the second dose or if they needed to start over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2842971 05/28/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Illness, Rash, Vaccination failure; Herpes zoster, Illness, Rash,... Herpes zoster, Illness, Rash, Vaccination failure; Herpes zoster, Illness, Rash, Vaccination failure More
Suspected vaccination failure; I had both vaccinations now I have shingles real bad, broke out now; ... Suspected vaccination failure; I had both vaccinations now I have shingles real bad, broke out now; Sickness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 64-year-old 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: I had both vaccinations now I have shingles real bad, broke out now) and sickness (Verbatim: Sickness). The outcome of the vaccination failure and sickness were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and sickness 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 and sickness to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 25-MAY-2025 This case was reported by a patient via interactive digital media. The patient had both vaccinations and now have shingles real bad, broke out now and have them on left arm covered, left leg two just came up, and two on left side of chest. The patient said that did not took the vaccination. The patient super sick with these, this had been 100 percent worse since the shots. This case was considered as suspected vaccination failure since the details regarding 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine( Dose 1 & 2). More
2842972 F 05/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Hypersensitivity Hypersensitivity
am allergic to everything in the vaccine/allergic reaction to the vaccine; This non-serious case was... am allergic to everything in the vaccine/allergic reaction to the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a 77-year-old female 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 allergic reaction (Verbatim: am allergic to everything in the vaccine/allergic reaction to the vaccine). The outcome of the allergic reaction was not reported. It was unknown if the reporter considered the allergic reaction to be related to Shingrix. It was unknown if the company considered the allergic reaction to be related to Shingrix. Additional Information: GSK receipt date: 24-MAY-2025 The reporter reported that she had them recently and was allergic to everything in the vaccine and it was awful she was 77. After her close friend developed shingles, she saw how painful it could really be. She lives a full life, and she did not want shingles to get in the way. Here was her story on why she started a conversation with her doctor about her shingles risk. More
2842973 NM 05/28/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Rash, Rash vesicular; Rash, Rash vesicular Rash, Rash vesicular; Rash, Rash vesicular
blustery rash on hands and feet with severe pain; blustery rash on hands and feet with severe pain; ... blustery rash on hands and feet with severe pain; blustery rash on hands and feet with severe pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Shingrix and Arexvy. On an unknown date, an unknown time after receiving Shingrix and Arexvy, the patient experienced rash (Verbatim: blustery rash on hands and feet with severe pain) and pain (Verbatim: blustery rash on hands and feet with severe pain). The outcome of the rash was unknown and the outcome of the pain was not reported. It was unknown if the reporter considered the rash and pain to be related to Shingrix and Arexvy. It was unknown if the company considered the rash and pain to be related to Shingrix and Arexvy. Additional Information: GSK Receipt Date: 21-MAY-2025 The patient was vaccinated with Shingrix and Arexvy at the pharmacy in the same day. The patient later developed a blustery rash on hands and feet with severe pain.; Sender's Comments: US-GSK-US2025063431:same reporter More
2842974 CA 05/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Three year gap between two doses (Inappropriate schedule of vaccine); This non-serious case was repo... Three year gap between two doses (Inappropriate schedule of vaccine); 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 Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 11-OCT-2021). On 04-MAR-2025, the patient received the 2nd dose of Shingrix. On 11-OCT-2021, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Three year gap between two doses (Inappropriate schedule of vaccine)). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 23-MAY-2025 The reporter reported that a patient received the two doses of Shingrix with a three-year gap, did have to revaccinate. 1st vaccination was on October 11th 2021 and 2nd was on March 04th 2025. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2842975 TX 05/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
SHINGRIX in immunocompetent people less than 50 years; This non-serious case was reported by a pharm... SHINGRIX in immunocompetent people less than 50 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 a 19-year-old 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 inappropriate age at vaccine administration (Verbatim: SHINGRIX in immunocompetent people less than 50 years). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 25-MAY-2025 The reporter inadvertently gave a 19 year old healthy patient a Shingrix vaccine. The reporter knew it could be given to immunocompromised situations. The reporter asked any information on response in healthy individuals. The patient received Shingrix below the recommended age schedule, which led to inappropriate age at vaccine administration. More
2842976 CA 05/28/2025 COVID19
 MODERNA
Migraine, Photophobia Migraine, Photophobia
photophobia; migraines; This spontaneous case was reported by a consumer and describes the occurrenc... photophobia; migraines; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (photophobia) and MIGRAINE (migraines) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHOTOPHOBIA (photophobia) and MIGRAINE (migraines). At the time of the report, PHOTOPHOBIA (photophobia) and MIGRAINE (migraines) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The reporter stated that the physician only knew one other person that had was going through the same condition. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2021-187590 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-187590:Same reporter, different patient More
2842978 73 F 05/28/2025 COVID19
 MODERNA
Asthenia, Fatigue, Pain Asthenia, Fatigue, Pain
experienced ongoing pain, fatigue, and weakness; experienced ongoing pain, fatigue, and weakness; ex... experienced ongoing pain, fatigue, and weakness; experienced ongoing pain, fatigue, and weakness; experienced ongoing pain, fatigue, and weakness; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (experienced ongoing pain, fatigue, and weakness), PAIN (experienced ongoing pain, fatigue, and weakness) and FATIGUE (experienced ongoing pain, fatigue, and weakness) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine; for Product used for unknown indication: Pfizer vaccine and Pfizer vaccine. Past adverse reactions to the above products included Fatigue with Pfizer vaccine; Feeling unwell with Pfizer vaccine; and No adverse effect with Moderna COVID-19 vaccine. On 21-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In May 2025, the patient experienced ASTHENIA (experienced ongoing pain, fatigue, and weakness), PAIN (experienced ongoing pain, fatigue, and weakness) and FATIGUE (experienced ongoing pain, fatigue, and weakness). At the time of the report, ASTHENIA (experienced ongoing pain, fatigue, and weakness), PAIN (experienced ongoing pain, fatigue, and weakness) and FATIGUE (experienced ongoing pain, fatigue, and weakness) had not resolved. No concomitant medication was reported. The patient started getting COVID-19 vaccinations in early 2021. At first, chose Pfizer and stuck with it, even though it usually made unwell for about half a day and often needing to leave work early due to fatigue. Later, during a busy holiday period, she received a Moderna shot by accident because forgot to ask which brand was being administered. To their surprise, she had no side effects at all with Moderna. Since then, she chose to continue with Moderna, as it seemed to work better for them. Most recently, she received the 2024/2025 Moderna vaccine late on a 21-May-2025 evening, around 6 PM. She experienced ongoing pain, fatigue, and weakness and much stronger symptoms than any she had with Moderna before. She was asking what the difference was between the 2023 and the new 2024/2025 Moderna vaccines. She was concerned because she never had this kind of reaction to Moderna before. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. Reporter did not allow further contact More
2842979 20 F 05/28/2025 HEPA
MENB
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 Z27PB
GX1463
Erythema, Pruritus, Skin warm; Erythema, Pruritus, Skin warm Erythema, Pruritus, Skin warm; Erythema, Pruritus, Skin warm
Patient refers that on the date of the vaccination, during the afternoon, a red point appeared on th... Patient refers that on the date of the vaccination, during the afternoon, a red point appeared on the arm and the next day the whole shoulder turned red, itched and was hot to the touch. The mother of the patient gave her Panadol and Benadryl but she has not seen improvement. The clinic's physician evaluated the patient and told her to monitor the area, keep taking Benadryl and if it is need it also Panadol and if she still don't see improvement to go to e the ER. More
2842980 76 M FL 05/28/2025 COVID19
 MODERNA
Blood urine present Blood urine present
BLOOD IN URINE FOR 3 DAYS BLOOD IN URINE FOR 3 DAYS
2842981 37 F TX 05/28/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8366AA
U8366AA
Injection site pain, Injection site rash, Injection site scab, Injection site wa... Injection site pain, Injection site rash, Injection site scab, Injection site warmth, Pain; Pruritus, Pyrexia, Rash erythematous More
Received vaccine on 5/20/25 at 8:06 and on next day employee reported fever, body aches, increase pa... Received vaccine on 5/20/25 at 8:06 and on next day employee reported fever, body aches, increase pain to right deltoid, swelling radiating to mid upper arm, and hot to touch. Reported red rash radiating to shoulder area lasting until 5/24/25 and on 5/25/25 she c/o severe itching began. More
2842982 24 F OH 05/28/2025 COVID19
 MODERNA
 3043836
Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding
Patient started with heavy vaginal bleeding and intermittent moderate cramping approximately 4-5 hrs... Patient started with heavy vaginal bleeding and intermittent moderate cramping approximately 4-5 hrs after vaccine admin. Symptoms reported to office on 5/27/25- 5 days later and she continues to have heavy bleeding. Patient is mid cycle in mestrual schedule and does not typically have breakthrough bleeding.. More
2842983 63 M VT 05/28/2025 PNC20
 PFIZER\WYETH
 MF0416
Erythema, Hyperhidrosis, Pruritus, Skin warm Erythema, Hyperhidrosis, Pruritus, Skin warm
5/20 received pneumonia vaccine, noticed 2 days ago it was red and itchy, woke up warm and sweaty, d... 5/20 received pneumonia vaccine, noticed 2 days ago it was red and itchy, woke up warm and sweaty, did not have a fever. Area looks red to this RN with some scratching from patient, ensuring he is not laying on it. More
2842984 6 F PA 05/28/2025 COVID19
 PFIZER\BIONTECH
Laboratory test abnormal, Skin discolouration, Vitiligo Laboratory test abnormal, Skin discolouration, Vitiligo
We found a white spot on my daughter a few months after second dose, but didn't think anything ... We found a white spot on my daughter a few months after second dose, but didn't think anything of it. Then we went on vacation in January and she came back with a huge white spot on her back. She was later diagnosed with vitiligo. It has spread rapidly, and has really affected her mental health. More
2842985 57 F CA 05/28/2025 PNC21
 MERCK & CO. INC.
 z002626
Injection site pain, Injection site swelling, Pain Injection site pain, Injection site swelling, Pain
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Pain is wors... Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Pain is worsening and range of motion is now limited-Medium, Additional Details: Felt immediate pain when shot was given . Said she felt like immunizer just jabbed it in and kept pushing. Has taken tylenol with no improvement. I recommended she see her MD. she is applying ice. Pt said she will give it 2 more days, and if no improvement will see MD. Recommended she go sooner, especially if pain keeps worsening since now going up her neck and range on motion of arm declining. can't fully raise arm More
2842986 66 M CA 05/28/2025 COVID19
 MODERNA
 3043160
Fatigue, Lethargy Fatigue, Lethargy
Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient states still gets tired very qui... Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient states still gets tired very quickly & belies it started around the same time as rec'd Vaccine More
2842987 69 F GA 05/28/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
 MD5465
MD5465
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus; Rash More
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject... Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: rash started as a bump then spreaded on arm-Medium, Other Vaccines: VaccineTypeBrand: Covid; Manufacturer: Moderna; LotNumber: 8081260; Route: Intramuscular; BodySite: Right Deltoid; Dose: ; VaxDate: 04/13/2025 More
2842988 76 F PA 05/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 55TH4
Injection site pain Injection site pain
Site: Pain at Injection Site-Medium Site: Pain at Injection Site-Medium
2842989 32 F WV 05/28/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946888
Abdominal pain, Dizziness, Dyskinesia, Moaning, Nausea Abdominal pain, Dizziness, Dyskinesia, Moaning, Nausea
Systemic: Abdominal Pain-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mediu... Systemic: Abdominal Pain-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Severe, Additional Details: Within 5 minutes of HEPLISAV-B administration, patient began to complain that she felt dizzy and "like she was going to pass out". She sat down and said she felt like she was going to throw up. She was moaning and throwing her head back and closing her eyes. Pharmacy staff provided a trash can, paper towels, water, and stayed with her while she phoned a family member who picked her up 15 min later. She said she was going to the emergency room but we have not confirmed that she went. More
2842990 39 F CA 05/28/2025 HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 y015180
y015180
y015180
y015180
Injection site pain; Injection site mass, Injection site pain, Injection site sw... Injection site pain; Injection site mass, Injection site pain, Injection site swelling; Injection site pain; Injection site mass, Injection site pain, Injection site swelling More
Site: Pain at Injection Site-Medium, Additional Details: Patient received the first dose overseas wi... Site: Pain at Injection Site-Medium, Additional Details: Patient received the first dose overseas with no issues. After the second dose her arm was very sore. She checked in after a week and her arm was still sore and red at the time. At the 2 week mark, patient called again to report the pain had subsided but was still painful if she pressed on it. She stated "its hurts if I stand still and think about it" No otther symptoms were reported at the time. No redness or bruises. Patient was cousneled to continue monitoring and take advil for the pain. More
2842991 59 M TX 05/28/2025 PNC21
 MERCK & CO. INC.
 Y019158
Hypoaesthesia, Injection site pain Hypoaesthesia, Injection site pain
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, ... Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Numbness is wrist/hand area, Other Vaccines: VaccineTypeBrand: Zoster (Shingrix); Manufacturer: Glaxosmithkline; LotNumber: H97H2; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 04/18/2025 More
2842992 51 F HI 05/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3334Y
Injection site pain, Pruritus, Pyrexia, Rash, Rash pruritic Injection site pain, Pruritus, Pyrexia, Rash, Rash pruritic
Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: ... Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Fever-Mild, Additional Details: pt developed fever the night of the injection, the next day a itchy rash appeared on neck and chest. it was severe for about 7 days and didnt go aware for about 30 days. it is still itchy under the skin today with no redness. pt took zyrtec with little relief, oral benadryl seemed to help a little, also used hydrocortisone cream and benadryl cream. later pt switched to allegra which seemed to help more than the zyrtec. More
2842993 28 F MD 05/28/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 49m2f
Abdominal pain, Dizziness, Nausea, Vomiting Abdominal pain, Dizziness, Nausea, Vomiting
Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Addi... Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: MMR ( priorix) was administerd and few minutes atfer patient started feeling nauseaus, lightheaded, she rested on her back with feet held up, we cal 911 as well. Patient vomitted and used restroom, paramedics assess patient, placed ice pack on back of her head, took vitals, assess and determine she was ok. patient left after some time and actually returned next day ( May 16 th) for her last vaccine. More
2842994 23 M CA 05/28/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946060
Dysphagia, Throat tightness Dysphagia, Throat tightness
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: Several minute... Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: Several minutes after getting vaccine patient comes back to pharmacy to state that he felt he was having an allergic rxn from the vaccine. I offered to give benadryl, but patient stated he had "steroids" in the car as this has happened to him and his dad in the past from vaccines. Pt comes back to pharmacy hours later stating he had used epipen in the car from an anaphylaxic rxn. More
2842995 62 M 05/28/2025 PNC20
 PFIZER\WYETH
Injection site rash, Pain, Pyrexia, Tenderness Injection site rash, Pain, Pyrexia, Tenderness
Fever; pain; tenderness; irregular rash area extending in to mid arm; This is a spontaneous report r... Fever; pain; tenderness; irregular rash area extending in to mid arm; This is a spontaneous report received from an Other HCP. A 62-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for immunisation. The patient's relevant medical history included: "Allergic rhinitis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 20May2025, outcome "not recovered", described as "Fever"; RASH (non-serious) with onset 20May2025, outcome "not recovered", described as "irregular rash area extending in to mid arm"; PAIN (non-serious) with onset 20May2025, outcome "not recovered"; TENDERNESS (non-serious) with onset 20May2025, outcome "not recovered". Therapeutic measures were not taken as a result of pyrexia, pain, tenderness, rash. Additional information: The patient did not receive any other vaccines on the same date as PREVNAR 20, the patient did not receive any other vaccines within 4 weeks PRIOR to the PREVNAR 20, the patient did not take any other medications within 2 weeks of the event starting. Vaccine location reported as right shoulder area. Patient experienced fever, pain and tenderness in addition to irregular rash area extending in to mid arm. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. More
2842996 68 F CA 05/28/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
 LL8393
LL8393
Arthralgia, Dizziness, Headache, Injection site erythema, Injection site pain; I... Arthralgia, Dizziness, Headache, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Pyrexia More
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject... Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Additional Details: PATIENT IS super tired, Other Vaccines: VaccineTypeBrand: SHINGRIX; Manufacturer: GLAXCO; LotNumber: 9RC7A; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN More
2842997 66 F OH 05/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 000000
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling More
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject... Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium More
2842998 78 F FL 05/28/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 ts525
ts525
ts525
Asthenia, Diarrhoea, Dizziness, Fatigue, Flushing; Hyperhidrosis, Injection site... Asthenia, Diarrhoea, Dizziness, Fatigue, Flushing; Hyperhidrosis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Lethargy, Pain, Pruritus, Pyrexia, Rash More
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Inject... Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium More
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