🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2855055 9 M NY 08/21/2025 HPV9
 MERCK & CO. INC.
 Z002399
Rash Rash
Noticed rash on the right side of face. No other rash or symptoms. Parent administered benadryl at... Noticed rash on the right side of face. No other rash or symptoms. Parent administered benadryl at home and the rash resolved by next day morning. More
2855056 1.25 M UT 08/21/2025 MMR
 MERCK & CO. INC.
 Y015834
Injection site rash Injection site rash
Patient started developing a rash on left leg 2 weeks after getting vaccine. Mom did send over pictu... Patient started developing a rash on left leg 2 weeks after getting vaccine. Mom did send over pictures and the doctor did review and confirm reaction to MMR vaccine. More
2855057 0.17 M KS 08/21/2025 DTAPHEPBIP
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Pyrexia; Pyrexia Pyrexia; Pyrexia
Just hours after the vaccine pt was inconsolably crying. He began running a very high fever of 105-1... Just hours after the vaccine pt was inconsolably crying. He began running a very high fever of 105-105.3. In November, pt began running extremely high fevers for 2-3 days with no other symptoms. They started at 4 months old, 2 months after he received his first vaccination. He experienced cyclical fevers. I took him to hospital and another hospital for additional testing. All bloodwork appeared normal. This went on for 5 years. After much research on my part and pt suffering high fevers of 104-106.5 and many doctor visits and ER visits we found Dr. He agreed that removing his tonsils might possibly help put the PFAPA. into remission. He advised me to not have pt receive anymore of the Acellular Pertussis component. He believed that was the trigger. By age 6 pt finally recovered. More
2855058 11 M MO 08/21/2025 COVID19
 PFIZER\BIONTECH
 LM2045
Expired product administered, No adverse event Expired product administered, No adverse event
Vaccine give after 10 week expiration date. No reactions or illness symptoms took place. Vaccine give after 10 week expiration date. No reactions or illness symptoms took place.
2855059 12 M NY 08/21/2025 MNQ
 SANOFI PASTEUR
 U8494AA
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
On 8/20/2025 Patient's Mom called stating that the patient had the Meningococcal vaccine admini... On 8/20/2025 Patient's Mom called stating that the patient had the Meningococcal vaccine administered 2 days ago, woke up yesterday with it red, swollen "the size of a grapefruit" and is worse today. She stated he is not complaining of any pain. Patient was seen 8/20/2025 by acute care provider in our facility and noted redness, possible cellulitis and was treated with antibiotic. More
2855060 13 F MO 08/21/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 X7R4Z
Extra dose administered Extra dose administered
Pt received a menveo on 8/14/25 at our open house vaccine clinic at the school. System was checked a... Pt received a menveo on 8/14/25 at our open house vaccine clinic at the school. System was checked and no meningococcal on file. After administered and when documenting back at the clinic checked local EMRs for other records due to having a boostrix on file and found a Menqaudfi had been administered on 8/2024 through clinic, that was not showing up in system. School notified and mom notified. More
2855061 17 F WI 08/21/2025 UNK
 UNKNOWN MANUFACTURER
Food allergy Food allergy
After she got the vaccine she had food allergies that she never had before, she had a reaction and h... After she got the vaccine she had food allergies that she never had before, she had a reaction and had to go to the ER, They gave her shot in the ER and she recovered. More
2855062 47 F CA 08/21/2025 DTAP
 SANOFI PASTEUR
Syncope Syncope
syncope syncope
2855063 59 M GA 08/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93KK4
Rash Rash
Patient came in to get 2nd Shingles vaccine and stated that on the 1st vaccine, he had a reaction ca... Patient came in to get 2nd Shingles vaccine and stated that on the 1st vaccine, he had a reaction causing severe rash that started on the arm of the left arm and spread across his chest, back, and right arm. Patient stated that the rash would not go away on its own and he had to get a steroid shot at the doctor's office to finally help make the rash go sway. Patient stated that this rash came and went for over a month before seeking additional treatment (steroid shot). Pharmacist decided not to give patient next shingles vaccine and recommended that he not get one in the future either. More
2855064 M CA 08/21/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 3N2ND
3N2ND
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
No ADR noted. Hep B vaccine was unnecessarily administered twice within 6 days apart from each othe... No ADR noted. Hep B vaccine was unnecessarily administered twice within 6 days apart from each other. 1st dose on 7/22/25, 2nd dose on 7/28/25. More
2855065 13 F CA 08/21/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 z005055
9x7cd
xn575
Loss of consciousness, Pallor, Tinnitus; Loss of consciousness, Pallor, Tinnitus... Loss of consciousness, Pallor, Tinnitus; Loss of consciousness, Pallor, Tinnitus; Loss of consciousness, Pallor, Tinnitus More
Patient received her Tdap & Menveo vaccine, stated her ears were ringing, but did not seem conce... Patient received her Tdap & Menveo vaccine, stated her ears were ringing, but did not seem concerned, went forward with last vaccine of Gardasil9, which she then passed out afterward. Monitored in the pharmacy for fifteen minutes, provided water and snacks and cold paper towel. She was not pale for very long, and said she felt okay before leaving. More
2855066 13 M GA 08/21/2025 MNQ
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U8573AA
9JT4S
Dizziness, Nausea, Pallor; Dizziness, Nausea, Pallor Dizziness, Nausea, Pallor; Dizziness, Nausea, Pallor
About 5 mins after patient received last vaccine he became dizzy, lightheaded, and pale. 1:40pm BP-... About 5 mins after patient received last vaccine he became dizzy, lightheaded, and pale. 1:40pm BP-71/37 P-46. Cool cloth placed on patients face and neck. Patient c/o feeling nauseated. Patient was able to stand up and we had him lay on pad on floor on his left side. 1:45pm BP-71/46 P-51. Patient was able to eat some peanut crackers and drink a few sips of coke. 1:47 pm BP-83/50 P- 65. Patient began to feel better. Color was back in his face. Patient was able to sit up and he felt okay. 1:50 pm BP-115/71 P-86. Advised dad via interpreter that patient needed to wait an additional 15 mins in lobby for us to monitor him. Dad voiced understanding. More
2855067 11 M UT 08/21/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS

Erythema, Muscle swelling; Erythema, Muscle swelling Erythema, Muscle swelling; Erythema, Muscle swelling
redness and swelling of deltoid redness and swelling of deltoid
2855068 4 M OH 08/21/2025 DTAPIPV
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 5G23D
Y013274
Erythema, Induration, Swelling; Erythema, Induration, Swelling Erythema, Induration, Swelling; Erythema, Induration, Swelling
SWOLLEN IN THE SIZE OF A HALF DOLLAR, HARD, AND RED, SWOLLEN IN THE SIZE OF A HALF DOLLAR, HARD, AND RED,
2855069 11 M MD 08/21/2025 HPV9
 MERCK & CO. INC.
 Y013407
Dizziness, Hyperhidrosis Dizziness, Hyperhidrosis
Client became diaphoretic and light headed. Given fluids, transported to Nurse?s Suite. 2:45 pm-VS-... Client became diaphoretic and light headed. Given fluids, transported to Nurse?s Suite. 2:45 pm-VS-96.6-94-16-98/54. No injuries noted. No further c/o dizziness, no sweating noted. Accompanied home by family. More
2855070 29 F OK 08/21/2025 RSV
 PFIZER\WYETH
 HF5012
Expired product administered, Exposure during pregnancy Expired product administered, Exposure during pregnancy
Received expired dose of vaccine from pharmacy. Was unknown until after patient left clinic Patien... Received expired dose of vaccine from pharmacy. Was unknown until after patient left clinic Patient is 34 weeks pregnant estimated due date 10/07/2025. Nurse reached out to patients OB provider. Per provider was recommended to repeat dose. Patient was notified but will further discuss with her OB before receiving another dose. More
2855071 52 M IL 08/21/2025 HEP
TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 4BX39
U8122AA
354M3
Swelling face; Swelling face; Swelling face Swelling face; Swelling face; Swelling face
Ongoing right side facial swelling noted 8 days post vaccination. Denies pain, notes drinks dribble... Ongoing right side facial swelling noted 8 days post vaccination. Denies pain, notes drinks dribble out of mouth. Patient encouraged to be seen in Emergency department. Pt states swelling persists and worsens on hot / sunny days. More
2855072 59 F NM 08/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2a3hy
Injection site bruising, Injection site mass, Pain Injection site bruising, Injection site mass, Pain
patient states arm is in shooting pain with a lump under the injection site and a bruise about the s... patient states arm is in shooting pain with a lump under the injection site and a bruise about the size of a silver dollar. She uses ice to numb the pain and it helps significantly. Pain is constant since the vaccination. Patient states she will go into the doctors office in the next couple of days More
2855073 34 F IN 08/21/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 P2443
Hyperhidrosis, Hypotonia, Nausea, Syncope, Vomiting Hyperhidrosis, Hypotonia, Nausea, Syncope, Vomiting
pt reported anxiety before administration. After administration, pt experienced syncope and slumped ... pt reported anxiety before administration. After administration, pt experienced syncope and slumped forward, her head bobbed backwards and then she snapped upright. Pt was not alert for approximately 5 seconds. When patient became alert, she was sweaty and complained of nausea and vomited. Patient remained seated for approximately 15 minutes. Pt stated she was being picked up by a friend and will remain with her for a while. More
2855078 NY 08/21/2025 HEP
 MERCK & CO. INC.
 Y014090
No adverse event, Product storage error No adverse event, Product storage error
No adverse event; TE. RECOMBIVAX HB was administered to one patient; This spontaneous report was rec... No adverse event; TE. RECOMBIVAX HB was administered to one patient; This spontaneous report was received from a Physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-Jul-2025, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 2.5/0.5 injection (lot #Y014090, expiration date: 01-Jun-2027) 0.5 mL administered by Unknown route as Prophylaxis. It was reported that the vaccine administered had a temperature excursion. No additional adverse events were reported. More
2855080 38 M PA 08/21/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 Ew0171
Fe3594
Chest pain, Dyspnoea, Heart rate increased; Chest pain, Dyspnoea, Heart rate inc... Chest pain, Dyspnoea, Heart rate increased; Chest pain, Dyspnoea, Heart rate increased More
Chest pain heart beats fast fatigue shortness of breath. Chest pain heart beats fast fatigue shortness of breath.
2855081 5 M MT 08/21/2025 MMRV
 MERCK & CO. INC.
 Y009982
Extra dose administered, No adverse event Extra dose administered, No adverse event
MMRV WAS GIVEN WHEN PATIENT WAS ONLY DUE TO HAVE VZV GIVEN. NO ADVERSE REACTIONS REPORTED AT THIS TI... MMRV WAS GIVEN WHEN PATIENT WAS ONLY DUE TO HAVE VZV GIVEN. NO ADVERSE REACTIONS REPORTED AT THIS TIME BUT AN EXTRA DOSE OF MMR WAS RECIEVED. More
2855082 79 F CA 08/21/2025 CHIK
 VALNEVA USA, INC.
 24B011
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No actual adverse events reported just gave to person above age recommendation No actual adverse events reported just gave to person above age recommendation
2855083 81 M CA 08/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 F95YS
Fatigue, Myalgia, Pain in extremity, Peripheral swelling Fatigue, Myalgia, Pain in extremity, Peripheral swelling
Patient states he had severe fatigue, muscle aches, soreness in arm and swelling in arm (same arm as... Patient states he had severe fatigue, muscle aches, soreness in arm and swelling in arm (same arm as injection site) for ~1 week More
2855084 5 M WA 08/21/2025 DTAPIPV
DTAPIPV
DTAPIPV
HEPA
HEPA
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 42Y93
42Y93
42Y93
7PK53
7PK53
7PK53
Chest pain, Electrocardiogram normal, Full blood count normal, Headache, Metabol... Chest pain, Electrocardiogram normal, Full blood count normal, Headache, Metabolic function test normal; Myalgia, Pain, Platelet count decreased, Pyrexia, Thrombocytopenia; Troponin; Chest pain, Electrocardiogram normal, Full blood count normal, Headache, Metabolic function test normal; Myalgia, Pain, Platelet count decreased, Pyrexia, Thrombocytopenia; Troponin More
pt complained of HA, chest pain, injection site pain and fever (100.0). Pt sent to ER, MD there fel... pt complained of HA, chest pain, injection site pain and fever (100.0). Pt sent to ER, MD there felt generalized aches and mucle pain were likely related to immunizations. EKG WNL, workup of labs showed only mild thrombocytopenia. More
2855085 0.08 M GA 08/21/2025 DTPPVHBHPB
RV1
UNK
 MSP VACCINE COMPANY
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 U7776AA
LN425
X019624
Death, Sudden infant death syndrome; Death, Sudden infant death syndrome; Death,... Death, Sudden infant death syndrome; Death, Sudden infant death syndrome; Death, Sudden infant death syndrome More
My son passed away on May 11th 2024 his cause of death has been ruled SUID undetermined My son passed away on May 11th 2024 his cause of death has been ruled SUID undetermined
✓
2855086 56 F AL 08/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 GJ952
Pharyngeal swelling Pharyngeal swelling
Patient complained that throat felt swollen. Patient complained that throat felt swollen.
2855087 34 M AL 08/21/2025 FLU3
 SANOFI PASTEUR
 A1MKNE4E93RN64
Injection site erythema, Injection site induration, Injection site mass, Injecti... Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth More
Patient had pain, redness, and heat coming from injection site, as well as the presence of a hard lu... Patient had pain, redness, and heat coming from injection site, as well as the presence of a hard lump. Patient was treated with ibuprofen and Benadryl and was told that if symptoms do improve over the course of 24 hours, to go to the doctor. More
2855088 65 F FL 08/21/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Fatigue, Headache, Injection site erythema, Injection site pain, Injection site ... Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling; Injection site warmth More
Pain, redness, swelling, fever at injection site. Tiredness and headache. Pain, redness, swelling, fever at injection site. Tiredness and headache.
2855089 63 F GA 08/21/2025 FLU3
 SANOFI PASTEUR
 U88478A
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Error in mistakenly using husband's birthdate instead of patient's birthdate. He is 65+... Error in mistakenly using husband's birthdate instead of patient's birthdate. He is 65+. More
2855090 17 F VA 08/21/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 LG749
Dizziness, Hyperhidrosis, Immediate post-injection reaction Dizziness, Hyperhidrosis, Immediate post-injection reaction
Patient received 1 dose of 0.5ml IM injection left deltoid Engerix B. Immediately after injection, p... Patient received 1 dose of 0.5ml IM injection left deltoid Engerix B. Immediately after injection, patient experienced lightheadedness, dizziness, and sweaty hands. Patient was instructed to sit down for additional 15 minutes for observing. After 15 minutes, patient stated she felt better and wanted to leave with her mom. More
2855091 76 F FL 08/21/2025 FLU3
 SANOFI PASTEUR
 u8764bb
Injection site reaction, Pain, Scab, Urticaria Injection site reaction, Pain, Scab, Urticaria
Patient had a slight injection site reaction at first and then broke out in welts all over her legs,... Patient had a slight injection site reaction at first and then broke out in welts all over her legs, arms and back. She initially thought they were bug bites but they were not itchy just very painful. She called and spoke to the pharmacist on duty who suggested she call her doctor and make an appointment for a visit. The patient said the doctor gave her an antibiotic ointment which is kind of helping but the welts have started to scab over. More
2855092 71 F PA 08/21/2025 PNC21
 MERCK & CO. INC.
 Y019158
Injection site erythema, Injection site pain, Injection site streaking, Tenderne... Injection site erythema, Injection site pain, Injection site streaking, Tenderness More
I developed a pink streak running from the vaccination site along the inside of the arm to the armpi... I developed a pink streak running from the vaccination site along the inside of the arm to the armpit. It was tender to touch; the armpit was painful to touch (2 on a scale of 10). There was no error in the immunization process - it was the correct site and needle length with only minimal bleeding. There was no fever or systemic body ache or any other body symptom. After 2 days, it is slowly resolving. I notified my physician and she agreed it should be reported as an adverse event. More
2855093 45 F NC 08/21/2025 FLU3
 SANOFI PASTEUR
 u8764d8
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient got High Dose flu vaccine instead of regular strength for under 65 Patient got High Dose flu vaccine instead of regular strength for under 65
2855094 61 F NM 08/21/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 37R35
Dyspnoea, Urticaria Dyspnoea, Urticaria
p-t had hives all over the body and shortness of breath after receiving injection, reported on 8/... p-t had hives all over the body and shortness of breath after receiving injection, reported on 8/20. More
2855095 70 M AL 08/21/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 F4AC3
Asthenia, Fall Asthenia, Fall
Patient fell down the following day and was extremely weak. The paramedics were called. Patient fell down the following day and was extremely weak. The paramedics were called.
2855097 64 F CA 08/21/2025 RSV
RSV
UNK
UNK
 PFIZER\WYETH
PFIZER\WYETH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 Mf2162
Mf2162
33FD3
33FD3
Brain fog, Chills, Condition aggravated, Dizziness, Headache; Motion sickness, N... Brain fog, Chills, Condition aggravated, Dizziness, Headache; Motion sickness, Nausea, Post-acute COVID-19 syndrome, Pyrexia, Vomiting; Brain fog, Chills, Condition aggravated, Dizziness, Headache; Motion sickness, Nausea, Post-acute COVID-19 syndrome, Pyrexia, Vomiting More
Normal side effect of fever and chills, but the next day the long COVID symptoms of headache, foggy ... Normal side effect of fever and chills, but the next day the long COVID symptoms of headache, foggy head, severe dizziness and motion sickness with movement, nausea and vomitting as I had from June 2024 until seemingly resolved in June 2025. Symptoms still present but has only been 8 days so far. I also received RSV vaccine the same day but when I developed these symptoms and researched, I found that people have had exacerbation of long covid with shingles but not RSV, but especially those whose symptoms are closely related to the immune system. Mine are and i have a more mild similar reaction to having URI's and the annual required flu vaccine last year. I think if it were stated as a possible reaction, I would have delayed this longer but now am facing having to get a second dose. More
2854803 F CT 08/20/2025 HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
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; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AE; HCP called and reported inadvertent administration of a total of 4 doses of GARDAS... No additional AE; HCP called and reported inadvertent administration of a total of 4 doses of GARDASIL 9. Adult patient received a dose of GARDASIL 9 on 19SEP2024, 06NOV2024, 19MAR2025, and 07AUG2025.; This spontaneous report was received from a Physician on 07-Aug-2025 and refers to a 37 year old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-Sep-2024,06-Nov-2024, and 19-Mar-2025, the patient was vaccinated with a first, second, and third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9),(dose, indication, expiration date, and lot # were not reported) for prophylaxis And 07-Aug-2025, the patient was inadvertently vaccinated with a fourth dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) (dose, indication, expiration date, and lot # were not reported) for prophylaxis (Extra dose administered). No additional adverse event or PQC reported. More
2854804 FL 08/20/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Incomplete course of vaccination; Incomplete course of vaccination Incomplete course of vaccination; Incomplete course of vaccination
HCP reported that a patient who received their first dose of GARDASIL 9 in January 2023 missed their... HCP reported that a patient who received their first dose of GARDASIL 9 in January 2023 missed their second dose. The patient went to the pharmacy today, 08/15/2025, to get their second dose. This is when the missed dose was identified. No symptoms r; No symptoms reported.; This spontaneous report was received from a pharmacist regarding a 31-year-old patient of unknown gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 09-Jan-2023, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), suspension for injection, 0.5 mL (route of administration, lot # and expiration date were not reported). The patient Missed their next dose, but then on 15-Aug-2025 (also reported as today), the patient went to pharmacy to receive their second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), suspension for injection, 0.5 mL (route of administration, lot # and expiration date were not reported), both doses were given as prophylaxis. This is when the missed dose was identified. No symptoms reported. No additional information provided. Lot # is being requested and will be submitted if received. More
2854805 M CT 08/20/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946013
Extra dose administered, No adverse event Extra dose administered, No adverse event
Had First Dose of ENGERIX 5/25/2025, Second Dose was HEPLISAV-B on 6/27/2025; Initial report receive... Had First Dose of ENGERIX 5/25/2025, Second Dose was HEPLISAV-B on 6/27/2025; Initial report received on 28-Jul-2025. A pharmacist reported that a 43-year-old male received ENGERIX-B for the first dose of hepatitis B immunization, and HEPLISAV-B (hepatitis B vaccine) for his second dose. No medical history or concomitant medications were reported. On 25-May-2025, the patient received dose 1 of a hepatitis B vaccine [ENGERIX-B (lot number, expiration date, NDC number, route, and site not available)]. On 27-Jun-2025, 34 days after receiving ENGERIX-B, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot number 946013, expiration date 31-Aug-2027, and NDC number 43528-003-05)] intramuscularly in the left deltoid. The patient has not had any HEPLISAV-B since then. No other side effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2854806 WA 08/20/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Interchange of vaccine products, No adverse event Interchange of vaccine products, No adverse event
Had HEPLISAV-B then a Dose of RECOMBIVAX; Initial report received on 06-Aug-2025. A pharmacist repo... Had HEPLISAV-B then a Dose of RECOMBIVAX; Initial report received on 06-Aug-2025. A pharmacist reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and six months later received a dose of RECOMBIVAX. No medical history or concomitant medications were reported. On an unknown date, the patient received a dose of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On an unknown date, six months after receiving HEPLISAV-B, the patient received a dose of a hepatitis B vaccine [RECOMBIVAX (lot number, route, and site not available)]. No side effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2854807 F TX 08/20/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946062
Inappropriate schedule of product administration Inappropriate schedule of product administration
Receive Engerix B and then Heplisav-B; Initial report received on 12-Aug-2025. A pharmacist report... Receive Engerix B and then Heplisav-B; Initial report received on 12-Aug-2025. A pharmacist reported that a 36-year-old female received the first dose of ENGERIX-B for (hepatitis B vaccine) for hepatitis B immunization, then received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. In May- 2023, the patient received dose 1 of a hepatitis B vaccine [ENGERIX-B (lot #, expiration date, NDC #, route, and site not available). On 12-Jun-2025, 745 days after having been vaccinated with ENGERIX-B, the patient received a dose of a hepatitis b vaccine [HEPLISAV-B (lot # 946062, expiration date 18-May-2027, NDC # 43528-0003-05)] intramuscularly in the right arm. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2854808 74 F MA 08/20/2025 COVID19
 PFIZER\BIONTECH
 EW0150
Fatigue, Pyrexia, Vaccination site pain Fatigue, Pyrexia, Vaccination site pain
pain at injection site; fever; tiredness; This is a spontaneous report received from a Consumer or o... pain at injection site; fever; tiredness; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 2, single (Lot number: EW0150) at the age of 74 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis", start date: Feb2017 (ongoing); "Interstitial lung disease", start date: Feb2017 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 13Mar2021, for COVID-19 Immunization, reaction(s): "tiredness", "pain at injection site", "fever". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown", described as "tiredness". More
2854809 F MO 08/20/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A... Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 74-year-old 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 (Primary immunization series complete). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: COVID-19: positive. Clinical course: During an inbound call for financial assistance, the patient, stated, "she felt real lousy and for the first time, in her entire life this is the first time she tested positive for COVID. She dodged all the bullets but today. She worked part-time. She left there without the medicine, and she would still like to get it cause she felt really lousy, and she just started feeling sick yesterday." When gathering her demographics to enroll in the program, stated, her voice, she had got another issue with (inaudible) her throat was really, really sore." After playing the patient authorization for electronic income verification recording, stated, "Yes, she did, she was confused but she don't care if she was confused, she would be honest with them, Pfizer has saved her life. She have had all the vaccines that she could possibly get, and She had never caught it until today, in 5 years. She was a little shocked, she thought she was going to get away with not getting it". The coughing was coming in now...she need that Paxlovid, she need the Paxlovid, she need it". Later stated, "as long as she don't feel sick." Towards the end of the call, stated," pretty soon the symptoms just started yesterday so. She wanted to get that drug." When offering to transfer the call to the DSU, stated, "Briefly, her throat was very sore, but she can sing. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2854810 39 F NC 08/20/2025 IPV
 SANOFI PASTEUR
 X1C891M
Incorrect route of product administration Incorrect route of product administration
female patient administered 0.1mL of IPOL intradermally rather than intramuscularly with no reported... female patient administered 0.1mL of IPOL intradermally rather than intramuscularly with no reported adverse event; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case is linked to this case US-SA-2025SA244517. This case involves a 39 years old female patient who was administered with 0.1 ml dose of IPV (VERO) [IPOL] intradermally rather than intramuscularly with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Aug-2025, the patient received 0.1 ml dose of suspect IPV (VERO), Suspension for injection, lot X1C891M, expiry date:31-Oct-2026, strength: standard, frequency: once, via intradermal route in the left arm for immunisation, intradermally rather than intramuscularly with no reported adverse event (incorrect route of product administration) (latency: same day). Reportedly, She is inquiring about the side effects, reactions, and adverse events that they should watch out for and the effects to the child of a nursing mother administered with IPOL. Medical Assistant also mentioned that the mother is unsure if she is unvaccinated or under vaccinated.No other vaccines, AE symptoms or no AE: None. 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.; Sender's Comments: US-SA-2025SA244517: More
2854811 NY 08/20/2025 HIBV
 SANOFI PASTEUR
No adverse event, Product preparation error No adverse event, Product preparation error
inappropriate use due to act-hib was reconstituted with sterile water and administered to a patient ... inappropriate use due to act-hib was reconstituted with sterile water and administered to a patient with no reported adverse event; Initial information received on 15-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient received Hib (Prp/T) Vaccine [Act-Hib] which was reconstituted with sterile water 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 suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization, which was reconstituted with sterile water and administered to a patient with no reported adverse event (product preparation error) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence was requested. 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
2854822 08/20/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
COVID-19, Herpes zoster, Post-acute COVID-19 syndrome, Vaccination failure; COVI... COVID-19, Herpes zoster, Post-acute COVID-19 syndrome, Vaccination failure; COVID-19, Herpes zoster, Post-acute COVID-19 syndrome, Vaccination failure More
suspected vaccination failure; I got shingles; COVID; This serious case was reported by a consumer v... suspected vaccination failure; I got shingles; COVID; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got shingles) and covid-19 (Verbatim: COVID). The outcome of the vaccination failure and shingles were not reported and the outcome of the covid-19 was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and covid-19 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 covid-19 to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 05-AUG-2025 This case was reported by a patient via interactive digital media. The patient got shingles after having coronavirus disease. The patient's doctor came her/his pills for virus and the medicine worked. Before he/she had the coronavirus disease he/she had the 1st and 2nd vaccines and got bad side effects and the patient had the coronavirus disease twice and now had long term coronavirus disease. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (dose 1 and 2) More
2854823 31 08/20/2025 TDAP
 SANOFI PASTEUR
 U8503AA
No adverse event, Product storage error No adverse event, Product storage error
Patient received adacel after vaccine fridge temperature out of range with no adverse event; Initial... Patient received adacel after vaccine fridge temperature out of range with no adverse event; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 31 years old and unknown gender patient (20.32 cm and 104.78 kg) who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] after vaccine fridge temperature out of range with no 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 Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength, dose unknown) lot U8503AA expiry date-30-Apr-2027 via unknown route in unknown administration site for prophylactic vaccination (Immunisation) after vaccine fridge temperature out of range with no adverse event (poor quality product administered) (same day latency). Action taken- 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
2854864 TX 08/20/2025 HEP
HEP
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
Child was administered a 2nd dose, too early, 1 week after the first dose.; FBE said there were no a... Child was administered a 2nd dose, too early, 1 week after the first dose.; FBE said there were no adverse side effects reported.; This spontaneous report was received from a nurse and refers to an adolescent patient (also reported as child, discrepancy) of unknown exact age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), suspension for injection (dose, route of administration, lot # and expiration date were not reported) as prophylaxis; then, 1 week after the first dose, the patient was vaccinated with the second dose of this vaccine which was too early (dose, route of administration, lot # and expiration date were not reported) as prophylaxis (inappropriate schedule of product administration). No adverse side effects reported (No adverse event). Batch/Lot number is being requested and will be submitted if received. More
2854865 17 F TX 08/20/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 D2343
Echocardiogram normal, Headache, Hypertensive emergency, Troponin increased, Vis... Echocardiogram normal, Headache, Hypertensive emergency, Troponin increased, Vision blurred More
she was in a hypertensive emergency/hypertension /headache/ blurred vision; Her Troponin level is el... she was in a hypertensive emergency/hypertension /headache/ blurred vision; Her Troponin level is elevated; This serious case was reported by a physician via call center representative and described the occurrence of hypertensive emergency in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number D2343, expiry date 31-JAN-2026) for prophylaxis. On 28-JUL-2025 15:00, the patient received Menveo (intramuscular). On 29-JUL-2025 03:00, 1 days after receiving Menveo, the patient experienced hypertensive emergency (Verbatim: she was in a hypertensive emergency/hypertension /headache/ blurred vision) (serious criteria hospitalization and GSK medically significant) and troponin increased (Verbatim: Her Troponin level is elevated) (serious criteria hospitalization). The outcome of the hypertensive emergency and troponin increased were not resolved. The reporter considered the hypertensive emergency and troponin increased to be related to Menveo. The company considered the hypertensive emergency and troponin increased to be related to Menveo. Additional Information: GSK Receipt Date: 05-AUG-2025 and 06-AUG-2025 The Medical Doctor reported that her patient had blurring vision and headaches shortly after receiving the dose of Menveo vaccine. The reporter stated 12 hours after the vaccination she was in a hypertensive emergency at the Emergency Room with hypertension and hospitalized for a week. Her blood pressure had risen from 112/80 to over 200/110 and her Troponin level was elevated but the echogram is normal. The doctor requested as soon as possible any report of hypertension extremely refractory with no response to medication, and blurry vision in adolescent or young adults after Menveo shots. The need to find an urgent cause to this situation; Sender's Comments: A case of Hypertensive emergency and troponin increased, 1 days after receiving Menveo. in a 18-year-old female patient Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
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