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
2858022 71 F WI 09/10/2025 PNC21
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Z006889
95P4M
Contusion, Induration, Rash, Skin warm; Contusion, Induration, Rash, Skin warm Contusion, Induration, Rash, Skin warm; Contusion, Induration, Rash, Skin warm
Pt had a bruise of upper deltoid believed to be due to the Boostrix. Below the bruise was a rash tha... Pt had a bruise of upper deltoid believed to be due to the Boostrix. Below the bruise was a rash that had been getting larger over the past few days, warm to the touch and with an area of more firm tissue below the skin. More
2858023 18 M WA 09/10/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
 MY9547
MY9547
U8790AA
U8790AA
Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea, Pallor; Sen... Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea, Pallor; Sensory disturbance; Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea, Pallor; Sensory disturbance More
immediately after vaccinations pt started became pale and started feeling faint, nauseous, sweaty, a... immediately after vaccinations pt started became pale and started feeling faint, nauseous, sweaty, and felt pulsing in his fingers. pt was advised to lie down with feet elevated on the wall, a cold compress was applied to the wrists and pt drank water. after several minutes of lying down pt regained color to the face, stopped sweating, and was able to go home. More
2858024 72 F MA 09/10/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
 3052036
3052036
U8764DB
U8764DB
Abdominal distension, Abdominal pain upper, Body temperature decreased, Diarrhoe... Abdominal distension, Abdominal pain upper, Body temperature decreased, Diarrhoea, Hyperhidrosis; Nausea, Vomiting; Abdominal distension, Abdominal pain upper, Body temperature decreased, Diarrhoea, Hyperhidrosis; Nausea, Vomiting More
Precisely 24 hours after vaccine, sudden onset of profuse sweating, severe stomach cramping and pain... Precisely 24 hours after vaccine, sudden onset of profuse sweating, severe stomach cramping and pain, bloating, followed by nausea, vomiting and explosive diarrhea. There was no fever throughout the event. After 15 to 20 minutes symptoms quieted down but returned again an additional 3 times throughout the remainder of the afternoon. My temperature remained at between 96.4 and 97.6 degrees. Nausea continued throughout the night at which time I took Dramamine. The following day I was able to go to work, but felt slight nausea and continued with stomach distention and cramping. More
2858025 69 F CA 09/10/2025 COVID19
 PFIZER\BIONTECH
Urticaria Urticaria
Delayed hives all over. Delayed hives all over.
2858026 62 F WA 09/10/2025 COVID19
PNC21
 PFIZER\BIONTECH
MERCK & CO. INC.
 MY9547
Z006889
Pain in extremity, Pyrexia, Rash, Rash macular; Pain in extremity, Pyrexia, Rash... Pain in extremity, Pyrexia, Rash, Rash macular; Pain in extremity, Pyrexia, Rash, Rash macular More
On 9/10/25, patient called the pharmacy to report fever, arm pain and splotchy rash on arm, legs, tr... On 9/10/25, patient called the pharmacy to report fever, arm pain and splotchy rash on arm, legs, trunk and back. She said the onset was the evening of 9/9/25. Patient advised to try cold compress, Tylenol or ibuprofen for fever and benadryl to help rash subside. More
2858027 5 M NY 09/10/2025 DTAPIPV
 SANOFI PASTEUR
 U8209CB
Injection site induration, Injection site pain, Injection site pruritus, Injecti... Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth, Peripheral swelling More
Patient woke up the following day with a swollen arm 3x the size of his other arm. His arm swelled f... Patient woke up the following day with a swollen arm 3x the size of his other arm. His arm swelled from the shoulder down to the wrist. The injection site was firm, and extremely hot to the touch, itchy and painful. The swelling remained through the weekend into Monday and is now a week later seems to be going down but the arm is still warm to the touch. More
2857454 35 NC 09/09/2025 HPV4
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No additional AE details reported; their first dose of GARDASIL (unknown if 2-, 4-, or 9- valent vac... No additional AE details reported; their first dose of GARDASIL (unknown if 2-, 4-, or 9- valent vaccine) about 10 years ago and administered their second dose of GARDASIL 9 on 04/30/2025; This spontaneous report was received from a pharmacist, concerning to a 35-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2015 (10 years ago), the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) or with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), 1 dosage form, total (route, lot# and expiration date not provided. On 30-Apr-2025, received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), 1 dosage form, total, (route, lot # and expiration date were not reported). All as prophylaxis. Since doses were administered within more than 13 months as recommended, inappropriate schedule of product administration on 30-Apr-2025. No additional AE details reported (No adverse event). More
2857455 F FL 09/09/2025 COVID19
 UNKNOWN MANUFACTURER
Viral infection Viral infection
The virus reactivated; This initial spontaneous safety report was reported by a Consumer or other no... The virus reactivated; This initial spontaneous safety report was reported by a Consumer or other non-health professional and concerns an individual of unspecified age and gender who experienced the virus reactivated on an unspecified date after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on an unspecified date. At the time of the report, the outcome of the Viral infection was Unknown. On 29-Aug-2025, significant information was received from consumer via contact center (MI No. NOV25-00697): The following Reporter updates were made: The primary reporter's city was updated. The postal code was updated The following patient demographics were updated: The patient's gender was updated to female.; Sender's Comments: This Female of an unspecified age experienced Viral infection after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Viral infection was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Viral infection is considered Possible. More
2857456 F UT 09/09/2025 COVID19
 PFIZER\BIONTECH
Bell's palsy Bell's palsy
Patient said she ended up with Bells Palsy after receiving vaccines; This is a spontaneous report re... Patient said she ended up with Bells Palsy after receiving vaccines; This is a spontaneous report received from an Other HCP from a sales representative. An adult 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. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "Patient said she ended up with Bells Palsy after receiving vaccines". It was unknown if therapeutic measures were taken as a result of bell's palsy. Clinical course: Patient said she ended up with Bells Palsy after receiving vaccines. Patient received any other vaccines on the same date as the vaccine was "Unknown". Patient received any other vaccines within 4 weeks prior to the vaccine was "Unknown". patient took any other medications within 2 weeks of the event starting was "Unknown". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event bells palsy based on the known safety profile The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate. More
2857457 60 F MI 09/09/2025 PNC20
 PFIZER\WYETH
Arthralgia Arthralgia
my shoulder was hurting more than expected last night. It's doing better today; This is a spon... my shoulder was hurting more than expected last night. It's doing better today; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for immunisation. The patient's relevant medical history included: "cystic fibrosis related disorder" (unspecified if ongoing). Concomitant medication(s) included: IVACAFTOR; ALBUTEROL SULFATE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Sep2025 at 14:00, outcome "recovering", described as "my shoulder was hurting more than expected last night. It's doing better today". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: vaccine location reported as left shoulder. 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
2857458 78 F OR 09/09/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Vaccination failure COVID-19, Vaccination failure
COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a Consumer or oth... COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a Consumer or other non HCP,. A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Aug2025 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 infection". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient stated that she have a prescription for Paxlovid. Toward the end of the call stated that patient got the Pfizer vaccines all around and patient just got a booster on 06Aug2025 and patient ended up getting it but patient guess that would going around. COVID after Pfizer Vaccines. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2857459 PA 09/09/2025 COVID19
 PFIZER\BIONTECH
Cardiac disorder Cardiac disorder
Heart Troubles; This is a spontaneous report received from a Consumer or other non HCP. A patient (... Heart Troubles; This is a spontaneous report received from a Consumer or other non HCP. 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. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart Troubles". Additional information: The patient have been having heart troubles since his/her second Pfizer covid vaccine shot. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2857460 09/09/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
still got covid; still got covid; This is a spontaneous report received from a Consumer or other non... still got covid; still got covid; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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), outcome "unknown" and all described as "still got covid". Clinical course: Reporter said she took all the covid vaccine but still got covid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2857461 09/09/2025 PNC20
 PFIZER\WYETH
Allergy to vaccine, Rash Allergy to vaccine, Rash
allergy with Prevnar 20 Adult; This is a spontaneous report received from a Pharmacist, Program ID. ... allergy with Prevnar 20 Adult; This is a spontaneous report received from a Pharmacist, Program ID. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy with Prevnar 20 Adult". Additional information: Product name reported as 'Prevnar 20 Adult'. Caller's Inquiry: Caller, a pharmacist is calling about a 'Prevnar 20 Adult' Allergy. They couldn't confirm what it was rather than a rush. Doesn't look anything severe but they have the same patient that they want to give the RSV vaccine to. HCP couldn't see anything that would be across the sensitivity of the medication. They would like to confirm if they are going to hold the RSV vaccine if there are patients who had allergy with Prevnar 20 Adult. 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
2857476 0.08 M FL 09/09/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
Haematochezia, Pyrexia Haematochezia, Pyrexia
bloody stools for over 1 month, fever bloody stools for over 1 month, fever
2857477 0.17 F CA 09/09/2025 RV5
 MERCK & CO. INC.
 Y015021
Diarrhoea, Gastrointestinal pathogen panel, Rotavirus test positive, Weight gain... Diarrhoea, Gastrointestinal pathogen panel, Rotavirus test positive, Weight gain poor More
Moderate diarrhea requiring 3 extra visits to our clinic, ER visit requiring IV hydration, weight ga... Moderate diarrhea requiring 3 extra visits to our clinic, ER visit requiring IV hydration, weight gain deceleration More
2857480 M PA 09/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via... Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (First dose was received in SEP-2024). On 03-SEP-2025, the patient received the 2nd dose of Shingrix. On 03-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 03-SEP-2025 The patient was scheduled to receive his second dose the morning of 3rd September 2025. More
2857481 F OH 09/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 FT95N
Fatigue, Product use in unapproved indication, Pyrexia Fatigue, Product use in unapproved indication, Pyrexia
Fever; Fatigue; Shingrix first dose administration during an episode of Shingles; This non-serious c... Fever; Fatigue; Shingrix first dose administration during an episode of Shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fever in an adult female patient who received Herpes zoster (Shingrix) (batch number FT95N, expiry date 25-APR-2027) for prophylaxis. Concurrent medical conditions included shingles. 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 fever (Verbatim: Fever), fatigue (Verbatim: Fatigue) and product use in unapproved indication (Verbatim: Shingrix first dose administration during an episode of Shingles). The outcome of the fever and fatigue were resolved and the outcome of the product use in unapproved indication was not applicable. It was unknown if the reporter considered the fever and fatigue to be related to Shingrix. It was unknown if the company considered the fever and fatigue to be related to Shingrix. Additional Information: GSK Receipt Date: 12-AUG-2025 A pharmacist wanted to get safety information related to the administration of the first dose of Shingrix during an episode of Herpes Zoster. The patient alerted the health care provider of this, 45 days after the vaccination and mentioned to have had fever and fatigue after its administration, claiming that she shouldn't have received the first dose. More
2857489 79 F NY 09/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Somnolence Somnolence
Sleepiness; This non-serious case was reported by a consumer via call center representative and desc... Sleepiness; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 29-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 29-MAY-2025, less than a day after receiving Shingrix, the patient experienced sleepiness (Verbatim: Sleepiness). On 30-MAY-2025, the outcome of the sleepiness was resolved (duration 24 hrs). It was unknown if the reporter considered the sleepiness to be related to Shingrix. It was unknown if the company considered the sleepiness to be related to Shingrix. Additional Information: GSK receipt date: 20-AUG-2025 Reporter and his wife both received their first dose and are scheduled for the second dose as PI recommends. Reporter stated that his wife was very sleepy the entire day.; Sender's Comments: US-GSK-US2025107983:same reporter More
2857490 F 09/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site reaction, Pain in extremity Injection site reaction, Pain in extremity
a reaction around the injection site; a sore arm for 1-2 days; This non-serious case was reported b... a reaction around the injection site; a sore arm for 1-2 days; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site reaction in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site reaction (Verbatim: a reaction around the injection site) and pain in arm (Verbatim: a sore arm for 1-2 days). The outcome of the injection site reaction was resolved and the outcome of the pain in arm was resolved (duration 2 days). It was unknown if the reporter considered the injection site reaction and pain in arm to be related to Shingrix. It was unknown if the company considered the injection site reaction and pain in arm to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR111180 Additional Information: GSK Receipt Date: 22-AUG-2025 The patient got a reaction around the injection site and had a sore arm for 1-2 days, since she got dose 2 of Shingrix. The patient recovered and was glad she got the Shingrix vaccine. For the tolerance of the first dose please refer to the case US2025AMR111180.; Sender's Comments: US-GSK-US2025AMR111180:Shingrix dose 1 More
2857491 86 M 09/09/2025 COVID19
 MODERNA
 203F23A-1
Immunodeficiency, White blood cell count Immunodeficiency, White blood cell count
unsure if his low immune system was pre-existing since they just started checking it a year ago; Thi... unsure if his low immune system was pre-existing since they just started checking it a year ago; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) in an 86-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203F23A-1) for COVID-19 prophylaxis. Concurrent medical conditions included Chronic leukemia (x20 years) and Breathing difficult. On 02-Oct-2023, the patient received eighth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On an unknown date, the patient experienced IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: white count being so high (over 100,000) for 20 years. No concomitant medication was reported. The patient received every Moderna vaccine that had come out since it was all started and the last one, he had was September 2024. Patient previously received Moderna vaccines on 01-Jan-2021 (lot#025L20A), 13-Jan-2021 (lot#025L20A), 10-Feb-2021 (lot#024M20A), 27-Sep-2021 (lot#041B21A), 07-Feb-2022 (lot#007J21-2A), 09-Sep-2022 (AS7140C) and 20-Apr-2023 (lot#065H22A). The patient's doctor told him he needed to get another COVID vaccine this year. His health problems - breathing problems and chronic leukemia were pre-existing before receiving the COVID vaccines but was unsure if his low immune system was preexisting since they just started checking it a year ago. The patient needed infusions to bring his hemoglobin and IgG back up every 3 months. The patient's most of the problems were on account of his chronic leukemia and his white count being so high (over 100,000) for 20 years. The patient was never had any ill effects from any of his vaccines. This case was linked to MOD-2025-789056 (Patient Link).; Reporter's Comments: Patients Chronic leukemia is a strong confounder for the event immunodeficiency. The benefit-risk relationship of product is not affected by this report. More
2857492 89 M 09/09/2025 COVID19
 MODERNA
 3043156
Immunodeficiency, White blood cell count Immunodeficiency, White blood cell count
unsure if his low immune system was pre-existing since they just started checking it a year ago; Thi... unsure if his low immune system was pre-existing since they just started checking it a year ago; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) in an 89-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043156) for COVID-19 prophylaxis. Concurrent medical conditions included Breathing difficult and Chronic leukemia (x20 years). On 23-Sep-2024, the patient received ninth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: white count being so high (over 100,000) for 20 years. No concomitant medication was reported. The patient received every Moderna vaccine that had come out since it was all started and the last one, he had was September 2024. Patient previously received Moderna vaccines on 01-Jan-2021 (lot#025L20A), 13-Jan-2021 (lot#025L20A), 10-Feb-2021 (lot#024M20A), 27-Sep-2021 (lot#041B21A), 07-Feb-2022 (lot#007J21-2A), 09-Sep-2022 (AS7140C), 20-Apr-2023 (lot#065H22A) and 02-Oct-2023 (lot#203F23A-1). The patient's doctor told him he needed to get another COVID vaccine this year. His health problems - breathing problems and chronic leukemia were pre-existing before receiving the COVID vaccines but was unsure if his low immune system was preexisting since they just started checking it a year ago. The patient needed infusions to bring his hemoglobin and IgG back up every 3 months. The patient's most of the problems were on account of his chronic leukemia and his white count being so high (over 100,000) for 20 years. The patient was never had any ill effects from any of his vaccines. This case was linked to MOD-2025-789056 (Patient Link).; Reporter's Comments: Patients Chronic leukemia is a strong confounder for the event immunodeficiency. The benefit-risk relationship of product is not affected by this report. More
2857559 34 F VA 09/09/2025 FLU3
 SANOFI PASTEUR
 u8823ca
Injection site erythema, Injection site mass, Injection site pain, Injection sit... Injection site erythema, Injection site mass, Injection site pain, Injection site swelling More
Hard lump at injection site, with redness, tenderness and swelling, lasted over 24 hours Hard lump at injection site, with redness, tenderness and swelling, lasted over 24 hours
2857560 67 F 09/09/2025 TYP
 BERNA BIOTECH, LTD.
 3004334
Urticaria Urticaria
Broke out in hives. Hives were treated with Zyrtec and prednisone from patient's allergist and ... Broke out in hives. Hives were treated with Zyrtec and prednisone from patient's allergist and resolved within a week. More
2857561 94 M IA 09/09/2025 COVID19
 MODERNA
 3032233
Death Death
resident passed away resident passed away
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2857562 30 F MI 09/09/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 MB599
Underdose, Wrong technique in product usage process Underdose, Wrong technique in product usage process
Client was administered a Pediatric dose of Hep A instead of an Adult dose of Hep A. When error not... Client was administered a Pediatric dose of Hep A instead of an Adult dose of Hep A. When error noted the client was brought back into immunization room (during same visit), situation explained to client, who was agreeable to receiving #2 Pediatric Hep A dose and was then administered #2 Pediatric dose Hep A to equal the Adult dose of Hep A. Prior to receiving #2 dose nurse brought both Pediatric Hep A and Adult Hep A boxes in to show client. The Pediatric dose is: 720ELU/0.5ml and Adult dose is: 1440 ELU/ml. Medical director was notified of event. Client did waiting period post vaccination in clinic lobby for 10-15 minutes and denied any difficulties/discomforts prior to exiting health department building, ambulating without difficulty. More
2857563 39 F NY 09/09/2025 COVID19
COVID19
 MODERNA
MODERNA
 078C2IA
004F21A
Fatigue, Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Vomiting... Fatigue, Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Vomiting; Fatigue, Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Vomiting More
After my 2nd shot I had an immediate reaction of hot sweats, vomit and extreme exhaustion. I have pr... After my 2nd shot I had an immediate reaction of hot sweats, vomit and extreme exhaustion. I have proof of that experience. More
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2857564 43 M AK 09/09/2025 COVID19
COVID19
 MODERNA
MODERNA
 040C21A
048F21A
Biopsy thyroid gland, Thyroid mass, Ultrasound thyroid abnormal; Biopsy thyroid ... Biopsy thyroid gland, Thyroid mass, Ultrasound thyroid abnormal; Biopsy thyroid gland, Thyroid mass, Ultrasound thyroid abnormal More
After shot I noticed lumps on my thyroid as they grew I went to the facility where they did ultrasou... After shot I noticed lumps on my thyroid as they grew I went to the facility where they did ultrasound and biopsy. More
2857565 0.42 M FL 09/09/2025 PNC20
 PFIZER\WYETH
 LK6653
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
Vaccine route should've been intramuscular but inadvertently given orally instead. Patient exa... Vaccine route should've been intramuscular but inadvertently given orally instead. Patient examined by doctor and parents were instructed to return to clinic that same afternoon then again, the following morning with no adverse reactions noted at any time. More
2857566 65 F KY 09/09/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052663
407242
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
Patient states in the arm she received her Spikevax vaccine (right arm) she experienced a raised red... Patient states in the arm she received her Spikevax vaccine (right arm) she experienced a raised red, itchy, bump about 1-2 inches in diameter. It started about 8 hours after receiving the vaccine. Overnight the swelling went down some and has improved so far as of 10am day after administration. Patient does not seem concerned about her safety but reported just to be sure. We are reporting patient recovered field as unknown since it's not gone away completely but it is improving. More
2857568 38 F MO 09/09/2025 VARCEL
 MERCK & CO. INC.
No adverse event, Wrong product administered No adverse event, Wrong product administered
She did not need to receive the Varicella vaccine. Her Varicella Antibody was positive indicating im... She did not need to receive the Varicella vaccine. Her Varicella Antibody was positive indicating immunity. Varicella was inadvertently administered during date of hire appointment. No adverse reactions reported. She only questioned on 9/8/25 why Varicella was administered on 9/2/25. More
2857569 22 M WI 09/09/2025 MMR
 MERCK & CO. INC.
 Z002520
Extra dose administered, No adverse event Extra dose administered, No adverse event
Pt was administered dose of MMR, when was fully vaccinated to MMR based on immunization records. Pt ... Pt was administered dose of MMR, when was fully vaccinated to MMR based on immunization records. Pt has not reported any issues or symptoms. More
2857570 18 F KY 09/09/2025 FLU3
 SEQIRUS, INC.
Dizziness, Syncope Dizziness, Syncope
Two minutes after administering the shot, the patient felt dizzy and fainted for few seconds. Two minutes after administering the shot, the patient felt dizzy and fainted for few seconds.
2857571 2 F KY 09/09/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 y49bz
Product administered to patient of inappropriate age, Wrong patient received pro... Product administered to patient of inappropriate age, Wrong patient received product More
Both siblings in the room, both receiving vaccines. Nurse asked for 5 year old sister, parents place... Both siblings in the room, both receiving vaccines. Nurse asked for 5 year old sister, parents placed the 2 year old child on the exam table for vaccinations. Vaccinations were administered. Next nurse came in to give 2 year old sister vaccines and seen the bandaids. At this time it was realized that the vaccines for the 5 year old were given to the 2 year old. (all vaccines were correct except the Kinrix) More
2857572 79 M IA 09/09/2025 COVID19
 MODERNA
 3046731
Death Death
Resident passed away Resident passed away
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2857573 67 F TX 09/09/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Asthenia, Cough, Dizziness, Dyspepsia, Headache; Malaise, Nausea, Pyrexia Asthenia, Cough, Dizziness, Dyspepsia, Headache; Malaise, Nausea, Pyrexia
next morning woke up with a cough that lasted about 30 minutes with a fever, headache, dizziness, na... next morning woke up with a cough that lasted about 30 minutes with a fever, headache, dizziness, nausea, and weakness. As the week went on she also developed severe heartburn when attempting to eating anything even though she already takes daily medicine for it. She feels very unwell and continues to have these symptoms for a week with no improvement. Will follow up with her physician. More
2857574 0.33 M PA 09/09/2025 DTAPHEPBIP
HIBV
PNC20
RSV
RV1
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS




Ear infection, Electroencephalogram, Infantile spasms; Ear infection, Electroenc... Ear infection, Electroencephalogram, Infantile spasms; Ear infection, Electroencephalogram, Infantile spasms; Ear infection, Electroencephalogram, Infantile spasms; Ear infection, Electroencephalogram, Infantile spasms; Ear infection, Electroencephalogram, Infantile spasms More
Vaccines received on 10/2/2024, prescribed amoxicillin-clavulanate (Augmentin ES-600) for an ear in... Vaccines received on 10/2/2024, prescribed amoxicillin-clavulanate (Augmentin ES-600) for an ear infection on 10/25/2024, and diagnosed with infantile spasms on 11/07/2024. He may have been having spasms prior to 11/07 that were missed. More
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2857575 64 M FL 09/09/2025 FLU3
 SANOFI PASTEUR
 u8790aa
Myalgia, Pain Myalgia, Pain
Patient felt muscle paint and soreness over a week after the vaccine Patient felt muscle paint and soreness over a week after the vaccine
2857576 90 F MD 09/09/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8800DA
U8800DA
Anaemia, Blood alkaline phosphatase increased, Chills, Chronic kidney disease, G... Anaemia, Blood alkaline phosphatase increased, Chills, Chronic kidney disease, Glomerular filtration rate decreased; Hypotension, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Vomiting More
Severe hypotension (69/34) with 2 episodes of vomiting and chills a few hours after vaccination requ... Severe hypotension (69/34) with 2 episodes of vomiting and chills a few hours after vaccination requiring More
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2857577 42 F CO 09/09/2025 COVID19
 PFIZER\BIONTECH
 Na
Condition aggravated, Epilepsy Condition aggravated, Epilepsy
The vaccines caused or exacerbated my epilepsy The vaccines caused or exacerbated my epilepsy
2857578 5 M ME 09/09/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 Y49BZ
Z009075
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient received an extra dose of Dtap/IPV and MMRV because documentation from previous PCP was not ... Patient received an extra dose of Dtap/IPV and MMRV because documentation from previous PCP was not received. Family aware, child is asymptomatic. More
2857579 15 M IA 09/09/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 X4T99
25A2F
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 adverse event was noted. This was given in error as the person already had these vaccines in 2022... No adverse event was noted. This was given in error as the person already had these vaccines in 2022. More
2857580 65 F MI 09/09/2025 PNC21
 MERCK & CO. INC.
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria More
Redness, swelling, soreness, itching, hives at injection site lasting 2 weeks. Area of redness a... Redness, swelling, soreness, itching, hives at injection site lasting 2 weeks. Area of redness and swelling approx 6? in diameter. Looked like cellulitis. More
2857581 16 F IA 09/09/2025 FLU3
 SANOFI PASTEUR
 UT8794BA
Incorrect dose administered Incorrect dose administered
High dose influenza accidentally given instead of regular flu dose. High dose influenza accidentally given instead of regular flu dose.
2857582 11 F NJ 09/09/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Heavy menstrual bleeding, Laboratory test, Menstruation irregular, Migraine, Pai... Heavy menstrual bleeding, Laboratory test, Menstruation irregular, Migraine, Pain; Tremor More
Body shakes, migraines, irregular very heavy periods, tremors, none aches Body shakes, migraines, irregular very heavy periods, tremors, none aches
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2857583 16 M PA 09/09/2025 HEP
IPV
MMR
MNQ
TDAP
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 GC3N4
X1D141M
N3429
U8361AA
LX494
Y011019
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
Student and older sister (21years old) came to get vaccinated. Student brought in his immigration v... Student and older sister (21years old) came to get vaccinated. Student brought in his immigration vaccine records only. Asked multiple times if they had other records and sister said no. Someone else was also checked after student was vaccinated sister then said student was just vaccinated a few weeks ago and showed records More
2857584 0.75 F CO 09/09/2025 HIBV
IPV
PNC20
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
SANOFI PASTEUR
 UK328AA
Y1A212M
MF0415
U8564AA
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered More
Administered Tdap, as opposed to DTaP, improper dosage Administered Tdap, as opposed to DTaP, improper dosage
2857585 16 F IL 09/09/2025 MENB
MNQ
 PFIZER\WYETH
SANOFI PASTEUR
 GX1463
U8193AB
Arthralgia, Injected limb mobility decreased, Magnetic resonance imaging abnorma... Arthralgia, Injected limb mobility decreased, Magnetic resonance imaging abnormal, Tendonitis; Arthralgia, Injected limb mobility decreased, Magnetic resonance imaging abnormal, Tendonitis More
Vaccine was given 8/16/24. Mom called our office 12/11/24 and said that she has been having left sho... Vaccine was given 8/16/24. Mom called our office 12/11/24 and said that she has been having left shoulder pain since the injection was given. She was seen in our office 12/20/24 and states that she had intermittent pain and range of motion of L shoulder. She was referred to an orthopedic specialist who she has seen in January 2025, July 2025, September 2025. She has tried physical therapy. She has undergone an MRI and is scheduled for MRI arthrogram More
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2857586 1.25 F IN 09/09/2025 DTAP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
 5KR3R
UK151AA
LN4928
Injection site urticaria; Injection site urticaria; Injection site urticaria Injection site urticaria; Injection site urticaria; Injection site urticaria
Patient developed large, red, raised, irregular, wheals in the evening of 09/05/2025 at injection si... Patient developed large, red, raised, irregular, wheals in the evening of 09/05/2025 at injection sites bilaterally after receiving vaccines on 09/03/2025. Right site's wheal approx. 9 cm in length and width; left site's wheal approx. 7 cm in length and width. Patient's parent applied hydrocortisone cream topically to sites bilaterally before bedtime. Wheals were improved upon waking on 09/06/2025, with only slight erythema remaining measuring approx. 5 cm in diameter around injection sites bilaterally. Patient seen in office in morning of 09/06/2025. More
2857587 1.67 M IA 09/09/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Dyspnoea, Erythema, Urticaria Dyspnoea, Erythema, Urticaria
5 days later 4 spots appeared, 7 days later full body covered in red welts. On the 8th day continues... 5 days later 4 spots appeared, 7 days later full body covered in red welts. On the 8th day continues to get worse and has labored breathing. More
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