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
2863115 6 F OR 10/03/2025 COVID19
 MODERNA
 3052859
Musculoskeletal stiffness, Nausea, Pyrexia Musculoskeletal stiffness, Nausea, Pyrexia
pt developed fever of 105f, neck and leg stiffness, and nausea. pt developed fever of 105f, neck and leg stiffness, and nausea.
2863116 67 F FL 10/03/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT8781DA
UT8781DA
Body temperature decreased, Chills, Feeling cold, Heart rate decreased, Nasal di... Body temperature decreased, Chills, Feeling cold, Heart rate decreased, Nasal discomfort; Piloerection, Throat irritation, Tongue discomfort More
Patient stated within two hours of the shot given she started started feeling cold shivers and temp ... Patient stated within two hours of the shot given she started started feeling cold shivers and temp was low from her doing a temporal check with thermometer. Her HR was also very low, her nose/throat/tongue burned. The morning after she was still having low HR and goosebumps. She didn't get better till 3pm that next day. More
2863117 93 F FL 10/03/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Burning sensation, Feeling hot, Pruritus Burning sensation, Feeling hot, Pruritus
patient said last night her arms were hot and itch for few hours then went away. then tonight her l... patient said last night her arms were hot and itch for few hours then went away. then tonight her legs are itching and burning now. I recommended she contact her medical doctor for evaluation More
2863126 65 F OR 10/03/2025 COVID19
FLU3
PNC20
 MODERNA
SEQIRUS, INC.
PFIZER\WYETH


Appendicitis, Computerised tomogram abdomen abnormal; Appendicitis, Computerised... Appendicitis, Computerised tomogram abdomen abnormal; Appendicitis, Computerised tomogram abdomen abnormal; Appendicitis, Computerised tomogram abdomen abnormal More
Appendicitis diagnosis in hospital on 10/3/25 after receiving all three vaccines on Tuesday 9/30/25 Appendicitis diagnosis in hospital on 10/3/25 after receiving all three vaccines on Tuesday 9/30/25
2863127 F IL 10/03/2025 RSV
 PFIZER\WYETH
 49281-574-88
Incorrect dose administered Incorrect dose administered
Beyfortus (Nirsevimab) 50 mg/mL ordered. Beyfortus (Nirsevimab) 100 mg/mL given IM Beyfortus (Nirsevimab) 50 mg/mL ordered. Beyfortus (Nirsevimab) 100 mg/mL given IM
2863128 69 F NJ 10/03/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 B5NJ9
Feeling abnormal Feeling abnormal
Patient was having anxiety before the vaccine and a few minutes after receiving it, she said she was... Patient was having anxiety before the vaccine and a few minutes after receiving it, she said she was feeling a little weird and wanted us to check her blood pressure. Her blood pressure was 170/90 and then 190/99. I called her doctor as she did not want to go to the ER. The doctor said to send her to see her/give benadryl if mild allergy or epipen if severe allergy or send her to the ER. She went to see the doctor. More
2863129 69 F AL 10/03/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 94CC4
Dry mouth, Lethargy, Nausea, Rash Dry mouth, Lethargy, Nausea, Rash
Patient has called reporting Dry mouth, lethargy, nausea and full arm rash for 6 days, Patient did r... Patient has called reporting Dry mouth, lethargy, nausea and full arm rash for 6 days, Patient did receive 2 other vaccines that day, but she believes the RSV vaccine to be the one causing side effects because she has had the others(flu and pneumonia) in the past without issue. More
2863131 69 F PA 10/03/2025 RSV
 PFIZER\WYETH
 ln5480
Device leakage Device leakage
The vaccine was drawn up correctly. Upon administration the needle failed. Vaccine ran down arm inst... The vaccine was drawn up correctly. Upon administration the needle failed. Vaccine ran down arm instead of into muscle. Vaccine came out where needle connects to tip. Used BD Integra Syringe lot number 1106180/ 2026-03-31. Patient was not upset at all. Just readministered vaccine. Patient was not upset at all and did not have any other issues because of this incident More
2863132 0.33 F WA 10/03/2025 RSV
 PFIZER\WYETH
 LN5496
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Medical assistant gave Abrysvo to infant in error. No known adverse reactions yet. Medical assistant gave Abrysvo to infant in error. No known adverse reactions yet.
2863133 63 F IL 10/03/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 MA2505
MA2505
Blood iron decreased, Blood magnesium decreased, Chills, Dyspnoea, Hypertension;... Blood iron decreased, Blood magnesium decreased, Chills, Dyspnoea, Hypertension; Pain, Upper respiratory tract infection More
Patient received the Prevnar 20 vaccination in store on 09.29.2025 at around 13:51. Patient reporte... Patient received the Prevnar 20 vaccination in store on 09.29.2025 at around 13:51. Patient reported that same night she began experiencing trouble breathing, body aches, chills, but no fever; she contacted her doctor who told her to go to the emergency room. Patient was admitted to the hospital. Her iron and magnesium were low and she had hypertension (170/105 mmHg). She was later diagnosed with an upper respiratory infection and discharged on 10.03.2025 More
โœ“
2863134 57 M FL 10/03/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 na4452
u8823ba
Ear swelling, Erythema, Pruritus, Swelling face; Ear swelling, Erythema, Pruritu... Ear swelling, Erythema, Pruritus, Swelling face; Ear swelling, Erythema, Pruritus, Swelling face More
Redness/ itching in face and ears and swelling. Administered Benadryl. Redness/ itching in face and ears and swelling. Administered Benadryl.
2863135 66 F CA 10/03/2025 PNC21
 MERCK & CO. INC.
 Z003579
Injection site rash Injection site rash
RASHES DEVELOP FROM LEFT SHOULDER DOWN TO ELBOW RASHES DEVELOP FROM LEFT SHOULDER DOWN TO ELBOW
2863137 28 F CO 10/03/2025 PNC20
 PFIZER\WYETH
 MA2505
Feeling hot, Rash, Swelling Feeling hot, Rash, Swelling
RASH, HEAT, SWELLING. RASH, HEAT, SWELLING.
2863138 5 M CO 10/03/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Vomiting Vomiting
Vomiting started two hours after vaccination. He had no nausea or vomiting prior to the vaccination ... Vomiting started two hours after vaccination. He had no nausea or vomiting prior to the vaccination and no one else at home ill. More
2863139 70 M FL 10/03/2025 COVID19
 PFIZER\BIONTECH
Injection site pain, Pain, Pyrexia Injection site pain, Pain, Pyrexia
Soreness at injection site; overall body aches; high heart rate (88-93); likely fever Soreness at injection site; overall body aches; high heart rate (88-93); likely fever
2863140 74 F WI 10/03/2025 PNC21
 MERCK & CO. INC.
 Neck:00006-4347
Injection site erythema, Injection site pruritus, Injection site warmth, Nausea Injection site erythema, Injection site pruritus, Injection site warmth, Nausea
First there were two red blotches on the upper left arm and then that turned into red, swollen, itch... First there were two red blotches on the upper left arm and then that turned into red, swollen, itchy, 4X 6 inch area and very warm to touch. I also had a temperature of 99.5 along with nausea. More
2863141 59 F AL 10/03/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 00069252810
00069252810
Asthenia, Back pain, Chest pain, Nausea, Pericarditis; Tremor Asthenia, Back pain, Chest pain, Nausea, Pericarditis; Tremor
Experienced weakness in week after Covid shot, with increasing pain on Monday and Tuesday night with... Experienced weakness in week after Covid shot, with increasing pain on Monday and Tuesday night with shakiness, nausea, and chest and back pain, then on Wednesday morning, pain was strong enough to go to emergency room More
2863142 72 F AL 10/03/2025 COVID19
 PFIZER\BIONTECH
 MY9550
Ageusia Ageusia
Loss of taste Loss of taste
2863143 59 M AL 10/03/2025 COVID19
 PFIZER\BIONTECH
 MY9550
Ageusia Ageusia
Loss of taste Loss of taste
2863144 60 F MP 10/03/2025 FLU3
 SEQIRUS, INC.
 AX4605A
Blood pressure increased, Dizziness, Erythema, Mobility decreased, Tinnitus Blood pressure increased, Dizziness, Erythema, Mobility decreased, Tinnitus
S: Patient reports experiencing sudden onset of ringing in the ears (tinnitus) and dizziness approx... S: Patient reports experiencing sudden onset of ringing in the ears (tinnitus) and dizziness approximately minutes after receiving the influenza vaccine. Patient stated it was hard to get up and move due to the dizziness. No chest pain, shortness of breath, rash, or swelling reported at the time of assessment. Patient stated she has a history of Vertigo and Hyper-acidity. O: Heart Rate: 83 bpm Blood Pressure: 160/80 mmHg Patient observed to be alert but visibly uncomfortable; also observed to have redness on the face. Ambulation limited due to dizziness. No visible signs of anaphylaxis (e.g., hives, swelling, respiratory distress). A: Presenting with tinnitus and dizziness, elevated BP noted. No immediate life- threatening signs, but symptoms concerning. P: Advised patient to seek immediate evaluation in the Emergency Department for further workup and monitoring. Vitals monitored during observation. Patient educated on signs and symptoms to report urgently (e.g., worsening dizziness, chest pain, difficulty breathing, loss of consciousness). Incident reported per vaccine adverse event protocol. Will follow up as needed pending ED evaluation. More
2863145 57 F TX 10/03/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 9FG5M
Injection site urticaria, Rash, Urticaria Injection site urticaria, Rash, Urticaria
I was seen in Urgent care as I began to develop hives on the evening of 2 October. I notice one spo... I was seen in Urgent care as I began to develop hives on the evening of 2 October. I notice one spot of a race on my inner arm. When I woke up on 2 October. I had hives on my upper and lower arms, the upper part of my neck and on my back. More
2863146 32 M 10/03/2025 UNK
 UNKNOWN MANUFACTURER
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
Patient had multiple medications scheduled including zofran & morphine. As pt its getting ready ... Patient had multiple medications scheduled including zofran & morphine. As pt its getting ready to go to CT scan tetanus vaccine administered via IV route instead of IM how it was ordered. Error was identify immediately after administration. Patient assessed and remained stable with no acute distress noted. Vital signs within normal limits. NP notified at this time & recommended calling poison control. Poison control was called & spoke to [withheld], per their recommendation to keep patient to be monitored 6 hours along with CBC & BMP re check at that time post Tdap IV administration. Per poison control patient to be monitored for potential adverse effects including hypersensitivity reaction, anaphylaxis reaction. NP made aware. Vitals signs were reassesses and remain stable. No complications noted at injection site, no complaints of pain, burning or swelling. More
2863303 18 M NJ 10/03/2025 HPV9
 MERCK & CO. INC.
 Y020531
No adverse event, Wrong product administered No adverse event, Wrong product administered
PATIENT WAS CALLED TO COME BACK TO OFFICE DUE TO WRONG VACCINE GIVEN. NO REACTION. NO TREATMENT. PATIENT WAS CALLED TO COME BACK TO OFFICE DUE TO WRONG VACCINE GIVEN. NO REACTION. NO TREATMENT.
2863304 11 F LA 10/03/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 Y015560
U8573AA
U8564AA
Erythema, Tenderness; Erythema, Tenderness; Erythema, Tenderness Erythema, Tenderness; Erythema, Tenderness; Erythema, Tenderness
5-6 cm of erythema to (R) deltoid tender no warmth 5-6 cm of erythema to (R) deltoid tender no warmth
2863305 80 M MN 10/03/2025 FLU3
 SEQIRUS, INC.
 407256
Injection site rash, Rash, Rash pruritic Injection site rash, Rash, Rash pruritic
patient experienced a rash around the injection site as well as on the torso of the body. Rash is sl... patient experienced a rash around the injection site as well as on the torso of the body. Rash is slightly itchy. Denies any shortness of breath, swelling, or anaphylactic symptoms. More
2863309 36 F 10/03/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 NA0738
948402
Chest pain, Dyspnoea, Nocturnal dyspnoea; Chest pain, Dyspnoea, Nocturnal dyspno... Chest pain, Dyspnoea, Nocturnal dyspnoea; Chest pain, Dyspnoea, Nocturnal dyspnoea More
Chest pain, SOB, Nocturnal dyspnea Chest pain, SOB, Nocturnal dyspnea
2862680 81 F FL 10/02/2025 COVID19
 MODERNA
 3052154
No adverse event, Wrong patient No adverse event, Wrong patient
For Reference Couple A is identified Couple B is identified Narrative: Couple A came arrived at phar... For Reference Couple A is identified Couple B is identified Narrative: Couple A came arrived at pharmacy for Shingles vaccination. Couple B came to pharmacy for completion steps in the immunization portal and database, the assigned immunizer grabbed the vaccines. She exited the pharmacy and loudly called for the names of Couple B. However, after doing so, Couple A rogered up to the call. Immunizer proceeded to vaccinate Couple A with the vaccines for Couple B. No adverse events/side effects to report More
2862681 82 M FL 10/02/2025 COVID19
 MODERNA
 3052583
No adverse event, Wrong product administered No adverse event, Wrong product administered
For Reference Couple A is identified Couple B is identified Narrative: Couple A came arrived at phar... For Reference Couple A is identified Couple B is identified Narrative: Couple A came arrived at pharmacy for Shingles vaccination. Couple B came to pharmacy for COVID vaccination. Couple B arrived first and their vaccines were made to be prepared. After completion steps in the immunization portal and database, the assigned immunizer grabbed the vaccines. She exited the pharmacy and loudly called for the names of Couple B. However, after doing so, Couple A rogered up to the call. Immunizer proceeded to vaccinate Couple A with the vaccines for Couple B. No adverse events/side effects to report. More
2862682 80 F CA 10/02/2025 FLUX
 UNKNOWN MANUFACTURER
Diarrhoea, Haematemesis, Night sweats Diarrhoea, Haematemesis, Night sweats
1) Vomiting / Diarrhea - very bad 2) Night sweats 1) Vomiting / Diarrhea - very bad 2) Night sweats
2862683 55 F MI 10/02/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 ER2613
N/A
Death, Sudden death, Syncope; Death, Sudden death, Syncope Death, Sudden death, Syncope; Death, Sudden death, Syncope
Online report of sudden death, 60-year old female lawyer and marathon runner. Despite on-site emerge... Online report of sudden death, 60-year old female lawyer and marathon runner. Despite on-site emergency care victim was declared dead at 10:27am Witness said she collapsed durr. DOSE1 date 03/18/21 LOT#ER2613 subsequent dose info unknown. Victim traveled in Aug 21, therefore met "fully vaxxed" criteria More
โœ“
2862684 51 M NY 10/02/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8732
N/A
Death; Death Death; Death
Online report of "peaceful death" of 55-year old male inoculated at age 51. DOSE1 date 03/... Online report of "peaceful death" of 55-year old male inoculated at age 51. DOSE1 date 03/24/21 LOT#ER8732 DOSE2 date 04/15/21 LOT# UNK. Victim was a well known public figure. Onset date estimated based off online reports. More
โœ“ โœ“ โœ“
2862685 59 F CT 10/02/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EL0140
EL0140
EL3202
EL3202
Blood donor, Central venous catheterisation, Death, SARS-CoV-2 test, Tachycardia... Blood donor, Central venous catheterisation, Death, SARS-CoV-2 test, Tachycardia; Transfusion, Uterine cancer; Blood donor, Central venous catheterisation, Death, SARS-CoV-2 test, Tachycardia; Transfusion, Uterine cancer More
Online report of A+ blood type female healthcare-social worker death after uterine cancer. Dose1 dat... Online report of A+ blood type female healthcare-social worker death after uterine cancer. Dose1 date 12/23/20 LOT# EL0140 Dose2 date 01/13/21 LOT# EL3202 On social media, victim stated her 65th COVID test was on 10/19/21. Onset date may be 09/12/24 based on 11/12/24 post. Victim donated blood in 03/21 to hospital. Received blood donation twice after onset before death. Posts a valuable source. More
โœ“ โœ“ โœ“
2862734 F WA 10/02/2025 MMRV
 MERCK & CO. INC.
 Y018157
No adverse event, Product storage error No adverse event, Product storage error
PROQUAD was administered after having experienced two TE; No other AE; This spontaneous report was r... PROQUAD was administered after having experienced two TE; No other AE; This spontaneous report was received from a medical assistant and refers to a 5-year-old female patient. The patients' pertinent medical histories, concurrent conditions, previous drugs reactions or allergies and concomitant medications were not reported. On an unspecified day of 2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), lot #Y018157 has been verified to be a valid lot number, expiration date: 29-Apr-2026, administered at a dose of 0.5 mL for prophylaxis (route of administration and anatomical site of injection were not provided). The vaccine administered experienced two temperature exposures (reported as on 11-Apr-2025 and 12-Apr-2025) at a temperature of 14.85๏ฟฝC for a time frame of 0 hours, 30 minutes and 0 seconds and at a temperature of 14.08๏ฟฝC for 0 hours, 5 minutes and 0 seconds (Product storage error). Additionally, it was stated that on 07-Jul-2025, the patient received the varicella virus vaccine (Oka๏ฟฝMerck), lot number Y013348 (expiration date: 02-Aug-2026), administered subcutaneously in the right rectus femoris. No further information was provided, and no additional adverse event was reported (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : [withheld]@merck.com , Index date : 2025-09-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : caso_Part5 , Central date : 2025-09-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2862735 M 10/02/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered at inappropriate site No adverse event, Product administered at inappropriate site
He said his son got the vaccine recently but he thinks they injected the vaccine too low. He said th... He said his son got the vaccine recently but he thinks they injected the vaccine too low. He said the nurse injected below his armpit.; No additional AE; This spontaneous report was received from a consumer regarding a 10-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered below the armpit for prophylaxis (strength, dose, vaccination scheme, route of administration, lot number, and expiration date were not reported). The reporter said that he thought they injected the vaccine too low (Product administered at inappropriate site). No additional adverse event was reported. Additional information is not expected. More
2862736 7 F MD 10/02/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Inbound call from FBE who reports she received an email from a nurse reporting administration of GAR... Inbound call from FBE who reports she received an email from a nurse reporting administration of GARDASIL 9 to a 7 year old child.; No additional AE; This spontaneous report was received from a Nurse Practitioner and refers to a 7-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (lot #, expiration date, strength, dose number, route of administration, anatomical location not provided) as prophylaxis, at the age of 7 years old (inappropriate age at vaccine administration). No additional adverse events were reported. More
2862737 KS 10/02/2025 PNC21
 MERCK & CO. INC.
 Z004302
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Nurse calling to report administering a dose of CAPVAXIVE after experiencing a tem... No additional AE; Nurse calling to report administering a dose of CAPVAXIVE after experiencing a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-Sep-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection 168 mcg/ml (lot #Z004302 with expiration date reported as and confirmed to be 04-Sep-2026) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. The dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was administered after experiencing a temperature excursion (TE) (temperature: 50.3F; time frame: 154 hours 0 minutes 0 seconds; previous temperature excursion: no) (product storage error). The TE assessment was not supported. No additional information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported (no adverse event). More
2862742 F 10/02/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
G2HA7
G2HA7
G2HA7
G2HA7
Arthralgia, Chills, Fatigue, Myalgia, Nausea; Pyrexia, Rash; Arthralgia, Dry ski... Arthralgia, Chills, Fatigue, Myalgia, Nausea; Pyrexia, Rash; Arthralgia, Dry skin, Face oedema, Injection site reaction, Myalgia; Pruritus, Pyrexia, Rash, Rash erythematous, Rash papular; Arthralgia, Chills, Fatigue, Myalgia, Nausea; Pyrexia, Rash; Arthralgia, Dry skin, Face oedema, Injection site reaction, Myalgia; Pruritus, Pyrexia, Rash, Rash erythematous, Rash papular More
Fever over 102; chills; myalgia; arthralgia; rash; nausea; Fatigue; This non-serious case was report... Fever over 102; chills; myalgia; arthralgia; rash; nausea; Fatigue; This non-serious case was reported by a consumer and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 16-SEP-2025, the patient received Shingrix. In SEP-2025, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever over 102), chills (Verbatim: chills), myalgia (Verbatim: myalgia), arthralgia (Verbatim: arthralgia), rash (Verbatim: rash), nausea (Verbatim: nausea) and fatigue (Verbatim: Fatigue). The outcome of the fever, chills, myalgia, arthralgia, rash, nausea and fatigue were not resolved. It was unknown if the reporter considered the fever, chills, myalgia, arthralgia, rash, nausea and fatigue to be related to Shingrix. It was unknown if the company considered the fever, chills, myalgia, arthralgia, rash, nausea and fatigue to be related to Shingrix. Additional Information: GSK Receipt Date: 17-SEP-2025 The patient who experienced fever over 102, chills, myalgia, arthralgia, rash, nausea, fatigue and the symptoms were treated. The symptomatic treatment was provided. The patient was on long list of concomitant medication. More
2862743 F 10/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2M7GR
Injection site rash, Pyrexia Injection site rash, Pyrexia
rash injection site; fever chills; This non-serious case was reported by a consumer and described th... rash injection site; fever chills; This non-serious case was reported by a consumer and described the occurrence of injection site rash in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 2M7GR) for prophylaxis. On 09-SEP-2025, the patient received Shingrix. On 10-SEP-2025, 1 days after receiving Shingrix, the patient experienced injection site rash (Verbatim: rash injection site) and fever chills (Verbatim: fever chills). On 13-SEP-2025, the outcome of the fever chills was resolved (duration 3 days). On 14-SEP-2025, the outcome of the injection site rash was resolved (duration 4 days). It was unknown if the reporter considered the injection site rash and fever chills to be related to Shingrix. It was unknown if the company considered the injection site rash and fever chills to be related to Shingrix. Additional Information: GSK Receipt Date: 17-SEP-2025 The reporter stated that, A 60-year-old female was received Shingrix on 09-SEP-2025, patient experienced rash injection site and fever chills on 10-SEP-2025. The symptoms of ash injection site and fever chill were not treated. Fever chills resolved on 13-SEP-2025 and injection site rash was resolved on 14-SEP-2025. Patient was not pregnant. The expiry date of Shingrix was reported as unknown and no other products reported. More
2862744 VA 10/02/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Wrong technique in product usage process Wrong technique in product usage process
Boostrix - needle size, used the 5/8 inch needle instead of the 1 inch needle; This non-serious case... Boostrix - needle size, used the 5/8 inch needle instead of the 1 inch needle; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect vaccine administration technique in a 65-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 07-SEP-2025, the patient received Boostrix (intramuscular, unknown deltoid). On 07-SEP-2025, an unknown time after receiving Boostrix, the patient experienced incorrect vaccine administration technique (Verbatim: Boostrix - needle size, used the 5/8 inch needle instead of the 1 inch needle). The outcome of the incorrect vaccine administration technique was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-Sep-2025 A pharmacist reported that yesterday a patient received a Boostrix dose. The dose was administered in the deltoid muscle but they used the 5/8 inch needle instead of the 1 inch needle. The HCP asked if the patient should be revaccinated and what would be the adverse reactions if the patient receive and extra dose. More
2862745 VA 10/02/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
patient received doses of Boostrix vaccine after a temperature excursion; This non-serious case was ... patient received doses of Boostrix vaccine after a temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: patient received doses of Boostrix vaccine after a temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-SEP-2025 Chief of pharmacy called to report that they had a temperature excursion and asked about the stability of Boostrix and Shingrix after a temperature excursion of 32.8 degree C for 93 hours. No prior excursion. HCP (health care professional) mentioned they administered 6 doses of Boostrix and 4 doses of Shingrix after this temperature excursion to 10 different patients and wanted to know do they need to revaccinate them. HCP only mentioned the initials of the patients who received the doses but did not provide further information about gender, age, lot number or expiration date. The batch number was not provided upon follow- up with the reporter. This was 1 of 10 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025117354:same reporter, Different patient US-GSK-US2025117352:same reporter, Different patient US-GSK-US2025117369:same reporter, Different patient US-GSK-US2025117362:same reporter, Different patient US-GSK-US2025117349:same reporter, Different patient US-GSK-US2025117361:same reporter, Different patient US-GSK-US2025117367:same reporter, Different patient US-GSK-US2025117358:same reporter, Different patient US-GSK-US2025117365:same reporter, Different patient More
2862746 57 M CA 10/02/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 342XP
Inappropriate schedule of product administration, Underdose Inappropriate schedule of product administration, Underdose
the majority of the 0.5 milliliters tribble down to his arm; dose just tribble down on his arm; dose... the majority of the 0.5 milliliters tribble down to his arm; dose just tribble down on his arm; dose just tribble down on his arm; he was getting the Second dose, 2 years later; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 342XP, expiry date 28-APR-2027) for prophylaxis. Previously administered products included Shingrix (received first dose in 2023). On 11-SEP-2025, the patient received the 2nd dose of Shingrix. On 11-SEP-2025, an unknown time after receiving Shingrix, the patient experienced underdose (Verbatim: the majority of the 0.5 milliliters tribble down to his arm), exposure via skin contact (Verbatim: dose just tribble down on his arm), inadvertent exposure to vaccine (Verbatim: dose just tribble down on his arm) and drug dose administration interval too long (Verbatim: he was getting the Second dose, 2 years later). The outcome of the underdose, exposure via skin contact, inadvertent exposure to vaccine and drug dose administration interval too long were not applicable. Additional Information: GSK receipt date: 12-SEP-2025, 15-SEP-2025 The pharmacist administered a Shingrix vaccination using a Vanish Point needle, but the needle retracted prematurely, causing the dose to spill down the patient's arm. The patient was receiving their second dose of Shingrix, two years after the first dose, which was already outside the recommended dosing schedule. Due to the premature retraction, it appeared that the majority of the 0.5 milliliters of the vaccine did not enter the patient's body. The healthcare professional questioned whether it would be appropriate to administer another dose, considering that the patient may not have been administered sufficient amount. More
2862747 62 F MO 10/02/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 MA2523
MA2523
Erythema, Nodule, Pain, Pain in extremity, Pyrexia; Skin warm Erythema, Nodule, Pain, Pain in extremity, Pyrexia; Skin warm
huge red-hot knot in the arm spreading around and down arm; was just having pain in the arm; aching ... huge red-hot knot in the arm spreading around and down arm; was just having pain in the arm; aching all over; fever; This is a spontaneous report received from a Nurse from medical information team. A 62-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 05Sep2025 as dose number unknown, single (Lot number: MA2523, Expiration Date: 30Sep2026) at the age of 62 years, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "huge red-hot knot in the arm spreading around and down arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "was just having pain in the arm"; PAIN (non-serious), outcome "unknown", described as "aching all over"; PYREXIA (non-serious), outcome "unknown", described as "fever". The reporter stated that she has already spoken to Pfizer Safety to report that 2 adult patients were administered Prevnar-20 and both had reactions. One patient was administered the vaccine on 05Sep2025 and the other on 08Sep2025. She wanted to find out if Pfizer had identified any current issues with a LOT of the vaccine. More
2862748 10/02/2025 COVID19
 PFIZER\BIONTECH
Anaphylactic reaction Anaphylactic reaction
got an anaphylactic reaction to this initial MRNA vaccine; This is a spontaneous report received fro... got an anaphylactic reaction to this initial MRNA vaccine; This is a spontaneous report received from a Physician. Other Case identifier(s): NOV25-00837 (NOVAVAX). An adult patient received BNT162b2 (BNT162B2), as dose 2, 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, SINGLE), for COVID-19 Immunization, reaction(s): "got an anaphylactic reaction to this initial MRNA vaccine". The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "got an anaphylactic reaction to this initial MRNA vaccine". Clinical course: It was reported that when the Pfizer vaccine first came out for Covid-19 and it received emergency authorization, the patient received two doses. The patient got an anaphylactic reaction to this initial MRNA vaccine. After the first dose, the reaction was somewhat mild. With the second dose, the reaction was quite stronger. The patient was told by Pfizer and the CDC that patient should not have another MRNA based vaccination. The patient had never had a reaction to any other vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is a reasonable possibility that the event anaphylactic reaction was related to BNT162b2 based on known drug safety profile.,Linked Report(s) : US-PFIZER INC-PV202500115715 same reporter/patient/AE, different doses; More
2862749 73 F MD 10/02/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Headache; Headache Headache; Headache
Bad headache began within 12 hours of injection; This is a spontaneous report received from a Consum... Bad headache began within 12 hours of injection; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19Sep2025 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Sep2025 at 15:45 as dose 1, single, in right arm for influenza immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Nonone. Concomitant medication included: GABAPENTIN, start date: 30Jun2025. The following information was reported: HEADACHE (non-serious) with onset 19Sep2025 at 22:00, outcome "not recovered", described as "Bad headache began within 12 hours of injection". Therapeutic measures were taken as a result of headache. Additional information: The patient experienced a bad headache that began within 12 hours of injection, and it was ongoing at the time of the report. No over-the-counter medications reduced the pain. The vaccine was administered at a pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior the Pfizer vaccine. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2862750 10/02/2025 COVID19
 PFIZER\BIONTECH
 NA0590
Axillary pain, Vaccination site pain Axillary pain, Vaccination site pain
Sore arm around injected area, and sore underarm; Sore arm around injected area, and sore underarm; ... Sore arm around injected area, and sore underarm; Sore arm around injected area, and sore underarm; This is a spontaneous report received from an Other HCP. An adult patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 26Sep2025 as dose 1, single (Lot number: NA0590) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 06Sep2025. The following information was reported: VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 26Sep2025, outcome "recovering" and all described as "Sore arm around injected area, and sore underarm". Therapeutic measures were not taken as a result of vaccination site pain, axillary pain. More
2862751 72 F 10/02/2025 COVID19
 PFIZER\BIONTECH
Chills, Fatigue, Pain, Tremor Chills, Fatigue, Pain, Tremor
Shaking; Chills; Body aches; Extreme exhaustion; This is a spontaneous report received from a Pharma... Shaking; Chills; Body aches; Extreme exhaustion; This is a spontaneous report received from a Pharmacist. A 72-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 27Sep2025 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left deltoid for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 26Sep2025 as dose number unknown, single, in right arm. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Peanut allergy" (unspecified if ongoing); "Soy allergy" (unspecified if ongoing). Concomitant medications included: CRANBERRY; ESTRADIOL; GABAPENTIN; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]; LISINOPRIL HCTZ; PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]; SIMVASTATIN; TURMERIC [CURCUMA LONGA RHIZOME]. The following information was reported: PAIN (non-serious) with onset 27Sep2025 at 19:00, outcome "not recovered", described as "Body aches"; CHILLS (non-serious) with onset 27Sep2025 at 19:00, outcome "not recovered"; FATIGUE (non-serious) with onset 27Sep2025 at 19:00, outcome "not recovered", described as "Extreme exhaustion"; TREMOR (non-serious) with onset 27Sep2025 at 19:00, outcome "not recovered", described as "Shaking". Therapeutic measures were not taken as a result of tremor, chills, pain, fatigue. Additional information: The vaccine was administered at a pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior the Pfizer vaccine. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2862752 20 10/02/2025 RSV
TDAP
 PFIZER\WYETH
UNKNOWN MANUFACTURER

Injection site pruritus; Injection site pruritus Injection site pruritus; Injection site pruritus
Itchy at injection site; possible infection at injection site; This is a spontaneous report received... Itchy at injection site; possible infection at injection site; This is a spontaneous report received from a Nurse from a sales representative. A 20-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 17Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 20 years, in left arm for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 17Sep2025 as unk, single, in right arm. The patient's relevant medical history included: "AdHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Sulfa antibiotics Allergy" (unspecified if ongoing). Concomitant medication(s) included: PRE NATAL FORMULA. The following information was reported: VACCINATION SITE PRURITUS (medically significant) with onset 19Sep2025, outcome "recovered" (22Sep2025), described as "Itchy at injection site"; VACCINATION SITE INFECTION (medically significant) with onset 19Sep2025, outcome "recovered" (22Sep2025), described as "possible infection at injection site". The events "itchy at injection site" and "possible infection at injection site" required emergency room visit. Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site infection. Clinical course: Itchy at injection site to the point of going to the ER. Doctor gave antibiotic due to possible infection at injection site. The patient received treatment for the adverse event with Keflex. Causality for "itchy at injection site" and "possible infection at injection site" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The event vaccination site pruritus, and vaccination site infection are conservatively assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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
2862754 76 F AZ 10/02/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Asthenia, Blood pressure measurement, Body temperature, Dehydration, Dizziness; ... Asthenia, Blood pressure measurement, Body temperature, Dehydration, Dizziness; Erythema, Fatigue, Feeling hot, Hyperhidrosis, Nausea; Palpitations, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Vomiting More
Arm enlarged; red, swollen hot; Arm enlarged; red, swollen hot; Arm enlarged; red, swollen hot; Fati... Arm enlarged; red, swollen hot; Arm enlarged; red, swollen hot; Arm enlarged; red, swollen hot; Fatigue; Nausea; Vomiting; Dizziness; Weakness; Fever; Heart palpitations; Sweating; Dehydrated; This is a spontaneous report received from a Consumer or other non HCP. A 76-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Heart palpitations" (unspecified if ongoing); "Apnea" (unspecified if ongoing); "COVID", start date: Nov2024 (unspecified if ongoing). Concomitant medications included: VIT D [VITAMIN D NOS], start date: 03Sep2025, stop date: 26Sep2025; METOPROLOL, start date: 03Sep2025, stop date: 26Sep2025. The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 15Sep2025, outcome "not recovered" and all described as "Arm enlarged; red, swollen hot"; DEHYDRATION (non-serious) with onset 15Sep2025, outcome "not recovered", described as "Dehydrated"; DIZZINESS (non-serious) with onset 15Sep2025, outcome "not recovered"; FATIGUE (non-serious) with onset 15Sep2025, outcome "not recovered"; PYREXIA (non-serious) with onset 15Sep2025, outcome "not recovered", described as "Fever"; PALPITATIONS (non-serious) with onset 15Sep2025, outcome "not recovered", described as "Heart palpitations"; NAUSEA (non-serious) with onset 15Sep2025, outcome "not recovered"; HYPERHIDROSIS (non-serious) with onset 15Sep2025, outcome "not recovered", described as "Sweating"; VOMITING (non-serious) with onset 15Sep2025, outcome "not recovered"; ASTHENIA (non-serious) with onset 15Sep2025, outcome "not recovered", described as "Weakness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, erythema, feeling hot, fatigue, nausea, vomiting, dizziness, asthenia, pyrexia, palpitations, hyperhidrosis, dehydration. Additional information: The vaccine was administered at a pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior the Pfizer vaccine. The patient reported her arm was enlarged; red and swollen hot. Then fatigue set in; nausea, vomiting, dizziness, weakness, fever, heart palpitations, sweating, dehydrated, and she was bedridden. The symptoms were still ongoing at the time of the report which was going on for about 12 days. Onset was on 15Sep2025. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2862755 58 F MA 10/02/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR

Dyspepsia, Gastrooesophageal reflux disease; Dyspepsia, Gastrooesophageal reflux... Dyspepsia, Gastrooesophageal reflux disease; Dyspepsia, Gastrooesophageal reflux disease More
Chronic heartburn; chronic acid reflux; This is a spontaneous report received from a Consumer or oth... Chronic heartburn; chronic acid reflux; This is a spontaneous report received from a Consumer or other non HCP. A 58-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 22Sep2025 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 22Sep2025 as dose 1, single, in right arm. The patient had no relevant medical history. Concomitant medication(s) included: NITROFURANTOIN, start date: 02Sep2025, stop date: 09Sep2025. The following information was reported: DYSPEPSIA (non-serious) with onset 23Sep2025, outcome "not recovered", described as "Chronic heartburn"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 23Sep2025, outcome "not recovered", described as "chronic acid reflux". Therapeutic measures were not taken as a result of dyspepsia, gastrooesophageal reflux disease. Additional information: Started the day after the vaccinations and progressively got worse. 1 week later, still had symptoms. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2862756 10/02/2025 COVID19
 PFIZER\BIONTECH
Fatigue, Heart rate Fatigue, Heart rate
tiredness; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A p... tiredness; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Sep2025, outcome "unknown", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter asked what could be causing rapid heartbeat and tiredness. Normal hbm was 80 but its 90 now, asked can the covid vaccines affect it from 2 weeks ago. Reporter asked can the raised heart rate create blood sugar issues. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
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