🏥 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 💀 🏥 🚑 ♿ ⚠️
2868806 63 F OR 10/27/2025 COVID19
 PFIZER\BIONTECH
 NA4459
Rash, Urticaria Rash, Urticaria
They reported rash and hives on the torso, chest, and arm following COVID and flu vaccinations on 10... They reported rash and hives on the torso, chest, and arm following COVID and flu vaccinations on 10/24/25. They noted a similar reaction last year, but this year?s rash is more severe. The reaction began on the morning of 10/26/25 and has been worsening. The employee has a history of fatigue or increased reactions (not rash) with COVID vaccines. Both COVID and flu vaccines were administered together this year, so either or both may have contributed. More
2868808 7 M VA 10/27/2025 COVID19
 PFIZER\BIONTECH
 MY9548
Wrong product administered Wrong product administered
Patient came to flu clinic with mom and sibling. I was vaccinating child with the flu vaccine per mo... Patient came to flu clinic with mom and sibling. I was vaccinating child with the flu vaccine per mom. After flu vaccination I had pt go sit down in a chair in the room to wait for his mom and sibling to be done. Mom made me aware that pt was also to receive the Covid vaccination as well. I had pt come sit back down near me. I realized I had no covid vaccines in my cooler and went over to my coworkers station to grab one of hers. I administered the vaccine to the patient before it was documented in EMR. When I went to document the Covid vaccine that was given, I realized that the wrong vaccine was administered to patient. I notified my supervisor about the medication error and I completed a report and VAERS report. My supervisor notified risk management and contacted patients pcp. Family will be notified as well. More
2868809 70 M CA 10/27/2025 FLU3
 SEQIRUS, INC.
 407243
Arthralgia, Periarthritis, X-ray limb Arthralgia, Periarthritis, X-ray limb
Pt reported shoulder pain, per MD pt has "frozen shoulder", although during assessment pat... Pt reported shoulder pain, per MD pt has "frozen shoulder", although during assessment patient lifted arm with no grimacing. He did receive PRN Tylenol, Tramadol, and Naproxen. More
2868810 69 F PA 10/27/2025 FLU3
 SANOFI PASTEUR
Ophthalmic migraine, Visual impairment Ophthalmic migraine, Visual impairment
Ocular migraine - zigzag bright line in field of vision, lasted 45 minutes. Ocular migraine - zigzag bright line in field of vision, lasted 45 minutes.
2868811 49 F IL 10/27/2025 COVID19
 MODERNA
Arthralgia, Dysstasia, Fatigue, Headache, Pain in extremity Arthralgia, Dysstasia, Fatigue, Headache, Pain in extremity
After receiving the second dose of the COVID-19 vaccine, I began to feel constant pain in my joints,... After receiving the second dose of the COVID-19 vaccine, I began to feel constant pain in my joints, head, shoulders, and legs. I also feel constant physical fatigue and cannot stand for long periods of time as I could before. Painkillers do not help me at all. More
2868812 48 F MN 10/27/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052671
407261
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Gave 48-year-old client Fluad instead of Flucelvax. Noticed right after administration - immediately... Gave 48-year-old client Fluad instead of Flucelvax. Noticed right after administration - immediately notified client of error. More
2868813 11 F NC 10/27/2025 COVID19
 PFIZER\BIONTECH
 NA4452
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
no side effects, 11 yo given 12 & up dose no side effects, 11 yo given 12 & up dose
2868814 1.25 F FL 10/27/2025 DTAPHEPBIP
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 TE499
4D255
Febrile convulsion, Pyrexia; Febrile convulsion, Pyrexia Febrile convulsion, Pyrexia; Febrile convulsion, Pyrexia
Pt went to ER for seizures: dx with Complex febrile seizure (HCC) (Primary Dx); Post-vaccination f... Pt went to ER for seizures: dx with Complex febrile seizure (HCC) (Primary Dx); Post-vaccination fever Discharge Disposition: Home or Self Care More
2868815 51 M CA 10/27/2025 FLU3
 SEQIRUS, INC.
 AS5812A
Pain in extremity, Periarthritis Pain in extremity, Periarthritis
Pt reported sore arm, MD believes this is "frozen shoulder". Pt receiving Naproxen and ace... Pt reported sore arm, MD believes this is "frozen shoulder". Pt receiving Naproxen and acetaminophen. More
2868816 43 F MN 10/27/2025 COVID19
COVID19
COVID19
COVID19
FLU3
FLU3
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
PFIZER\BIONTECH
PFIZER\BIONTECH
SEQIRUS, INC.
SEQIRUS, INC.





Arthralgia, Injected limb mobility decreased; Arthralgia, Joint swelling, Mobili... Arthralgia, Injected limb mobility decreased; Arthralgia, Joint swelling, Mobility decreased; Arthralgia, Injected limb mobility decreased; Arthralgia, Joint swelling, Mobility decreased; Arthralgia, Injected limb mobility decreased; Arthralgia, Joint swelling, Mobility decreased More
Severe pain in upper left shoulder developed a few hours after the shots were administered. Limited ... Severe pain in upper left shoulder developed a few hours after the shots were administered. Limited mobility raising arm above the level of the shoulder. Pain has decreased some, but persists 5 days after shot administration. Range of motion has continued to increase, but is still and hinderance. More
2868817 37 F TX 10/27/2025 FLU3
 SANOFI PASTEUR
 UT8873KA
Flushing, Hypotension, Rash Flushing, Hypotension, Rash
20 minutes after receiving vaccine, patient experienced hypotension (84/48) and facial flushing. Pa... 20 minutes after receiving vaccine, patient experienced hypotension (84/48) and facial flushing. Patient also noted to have rash on bilateral cheeks, but patient stated that she was unsure if the rash was present prior to receiving vaccine. More
2868818 11 F ID 10/27/2025 FLUN3
HPV9
MNQ
 MEDIMMUNE VACCINES, INC.
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 YF3413B
Y013565
537LH
Circumstance or information capable of leading to medication error; Circumstance... Circumstance or information capable of leading to medication error; Circumstance or information capable of leading to medication error; Circumstance or information capable of leading to medication error More
When administering the tdap vaccine the pt pulled away and most of the vaccine landed on her arm. No... When administering the tdap vaccine the pt pulled away and most of the vaccine landed on her arm. No scratch or any other injury was sustained. More
2868819 62 M MN 10/27/2025 FLU3
 SEQIRUS, INC.
 407261
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Fluad vaccine given in error to 62-year-old client. Fluad vaccine given in error to 62-year-old client.
2868820 77 M AZ 10/27/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Cough, Dizziness, Dysphonia, Hyperhidrosis, Pain; Pyrexia Cough, Dizziness, Dysphonia, Hyperhidrosis, Pain; Pyrexia
rough voice, cough, fever, sweats, aches and pains, dizziness and light headedness rough voice, cough, fever, sweats, aches and pains, dizziness and light headedness
2868827 1.08 IN 10/27/2025 PNC15
 MERCK & CO. INC.
 X019197
Expired product administered, No adverse event Expired product administered, No adverse event
no symptomatic events; a VAXNEUVANCE dose that was administered to a 13 month old patient that was e... no symptomatic events; a VAXNEUVANCE dose that was administered to a 13 month old patient that was expired on 8/30/2025; This spontaneous report was received from a Physician Assistant and refers to a 13-month-old patient of unknown gender. The patient's medical history, drug history, concurrent conditions and concomitant therapies were not reported. On 06-Oct-2025, the patient was vaccinated with an expired dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE), which was the fourth dose administered to this patient, (lot #X019197, expiration date: 30-Aug-2025) (dose, route of administration and anatomical site were not provided) as prophylaxis (Expired product administered). There were no symptomatic events, no additional adverse events (No adverse event). More
2868829 10/27/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Unevaluable event Unevaluable event
put in the hospital after taking RSV; This serious case was reported by a consumer via interactive d... put in the hospital after taking RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced hospitalization (Verbatim: put in the hospital after taking RSV) (serious criteria hospitalization). The outcome of the hospitalization was not reported. It was unknown if the reporter considered the hospitalization to be related to RSV vaccine. The company considered the hospitalization to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 16-OCT-2025 This case was reported by a consumer via interactive digital media. The patient was hospitalized after taking RSV vaccine. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Hospitalization, unknown time after receiving RSV vaccine, in a patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
✓
2868831 11 F IA 10/27/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5KR3R
Wrong product administered Wrong product administered
inadvertently gave an Infanrix instead of Boostrix; This non-serious case was reported by a other he... inadvertently gave an Infanrix instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 5KR3R) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 01-OCT-2025, the patient received Infanrix. The patient did not receive Boostrix. On 01-OCT-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: inadvertently gave an Infanrix instead of Boostrix). The outcome of the wrong vaccine administered 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: 09-OCT-2025 On 9th October 2025, a CMA called and reported that an 11-year-old had come through, and they had inadvertently administered Infanrix instead of Boostrix. More
2868833 41 M 10/27/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Essential tremor Essential tremor
essential tremors; This non-serious case was reported by a consumer via call center representative a... essential tremors; This non-serious case was reported by a consumer via call center representative and described the occurrence of essential tremor in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. In MAR-2009, the patient received the 1st dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced essential tremor (Verbatim: essential tremors). The outcome of the essential tremor was unknown. It was unknown if the reporter considered the essential tremor to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the essential tremor to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2025125448 Additional Information: GSK Receipt Date: 30-SEP-2025 The reporter described that having a diagnosis of essential tremors in 2009 that he believes is considered a neurological disorder, so was thought he was not supposed to receive the TDaP (claiming that the pertussis immunization caused the side effects).; Sender's Comments: GSK-US2025125448:Same patient/Different dose More
2868838 10/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster oticus, Pain, Vaccination failure Herpes zoster oticus, Pain, Vaccination failure
Suspected vaccination failure; Got my shingles a shot then got the weirdest form of shingles ever. I... Suspected vaccination failure; Got my shingles a shot then got the weirdest form of shingles ever. It's in my ear canal; 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. The patient's past medical history included chickenpox (the poor child that got three chicken pox). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster oticus (Verbatim: Got my shingles a shot then got the weirdest form of shingles ever. It's in my ear canal) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster oticus was resolved. It was unknown if the reporter considered the vaccination failure and herpes zoster oticus to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster oticus to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 18-OCT-2025 Patient got shingles shot then got the weirdest form of shingles ever and it was in ear canal. It was the most unimaginable pain but patient keep getting shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Herpes zoster oticus, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2868839 10/27/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Ophthalmic herpes zoster, Vaccination failure; Ophthalmic herpes zoster, Vaccina... Ophthalmic herpes zoster, Vaccination failure; Ophthalmic herpes zoster, Vaccination failure More
Got shingles in eye/suspected vaccination failure; Got shingles in eye; This serious case was report... Got shingles in eye/suspected vaccination failure; Got shingles in eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 92-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles in eye/suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: Got shingles in eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date:21 Oct 2025 This case was reported by a consumer via interactive digital media. This case was reported as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not provided at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and ophthalmic herpes zoster , unknown time after receiving Shingles vaccine(1st and 2nd dose ), in a 92-year-old patient. Based on the available information a? possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2868841 62 F CT 10/27/2025 UNK
 UNKNOWN MANUFACTURER
Incorrect route of product administration Incorrect route of product administration
Intravascular administration of Fluarix instead of the Intramuscular route; This non-serious case wa... Intravascular administration of Fluarix instead of the Intramuscular route; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 62-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) for prophylaxis. On 03-OCT-2025, the patient received the 1st dose of Fluarix 2025-2026 season. On 03-OCT-2025, an unknown time after receiving Fluarix 2025-2026 season, the patient experienced intramuscular formulation administered by other route (Verbatim: Intravascular administration of Fluarix instead of the Intramuscular route). The outcome of the intramuscular formulation administered by other route 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: 03-OCT-2025 The nurse reported that the Intravascular administration of Fluarix instead of the Intramuscular route to the patient. She called to know if there were safety concerns to take care of with the patient and to know if a new dose should be administered. The batch number was not provided upon follow up with the reporter. More
2868844 F 10/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Hemiplegia Hemiplegia
Paralysis (on one side) after vaccination; This serious case was reported by a consumer via call cen... Paralysis (on one side) after vaccination; This serious case was reported by a consumer via call center representative and described the occurrence of paralysis one side of body in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced paralysis one side of body (Verbatim: Paralysis (on one side) after vaccination) (serious criteria GSK medically significant). The outcome of the paralysis one side of body was unknown. It was unknown if the reporter considered the paralysis one side of body to be related to Shingrix. The company considered the paralysis one side of body to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 14-OCT-2025 The counselor reported that a patient received Shingrix, and got injured, the caller informed that the patient got paralysis in one side. The batch number was not provided and a request for this information had been made.; Sender's Comments: A case of Hemiplegia, on an unknown date, an unknown time after receiving Shingrix, in a female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2868846 F RI 10/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Chemotherapy, Lymphoma Chemotherapy, Lymphoma
lymphoma; This serious case was reported by a consumer via call center representative and described ... lymphoma; This serious case was reported by a consumer via call center representative and described the occurrence of lymphoma in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced lymphoma (Verbatim: lymphoma) (serious criteria GSK medically significant). The outcome of the lymphoma was unknown. It was unknown if the reporter considered the lymphoma to be related to Shingrix. The company considered the lymphoma to be unrelated to Shingrix. Additional Information: GSK receipt date: 16-OCT-2025 The patient received both doses of Shingrix for shingles in 2021 for shingles subsequently to that the patient had to undergo chemotherapy for lymphoma. It had been a couple of years patient's immune system was back and wanted to know if she needed to do the 2 doses again. The reporter did not know if it would be still effective after chemotherapy. Chemotherapy for lymphoma started in winter of 2021 till spring March of 2022. Date of Shingrix vaccine was unknown. The chemotherapy was hopefully done for done. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: A case of Lymphoma, less than 2 years after receiving Shingrix, in an elderly female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2868847 75 F 10/27/2025 COVID19
COVID19
 MODERNA
MODERNA

COVID-19, Chills, Pyrexia, SARS-CoV-2 test, Vaccination site erythema; Vaccinati... COVID-19, Chills, Pyrexia, SARS-CoV-2 test, Vaccination site erythema; Vaccination site pruritus More
I got COVID when I had had a shot; my shoulder to my elbow turned beet red and itched; my shoulder t... I got COVID when I had had a shot; my shoulder to my elbow turned beet red and itched; my shoulder to my elbow turned beet red and itched; Shaking/chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got COVID when I had had a shot.), VACCINATION SITE PRURITUS (my shoulder to my elbow turned beet red and itched), VACCINATION SITE ERYTHEMA (my shoulder to my elbow turned beet red and itched), CHILLS (Shaking/chills) and PYREXIA (fever) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. No Medical History information was reported. On 11-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced CHILLS (Shaking/chills) and PYREXIA (fever). On 18-Sep-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PRURITUS (my shoulder to my elbow turned beet red and itched) and VACCINATION SITE ERYTHEMA (my shoulder to my elbow turned beet red and itched). On an unknown date, the patient experienced COVID-19 (I got COVID when I had had a shot.). In September 2023, VACCINATION SITE PRURITUS (my shoulder to my elbow turned beet red and itched), VACCINATION SITE ERYTHEMA (my shoulder to my elbow turned beet red and itched), CHILLS (Shaking/chills) and PYREXIA (fever) had resolved. At the time of the report, COVID-19 (I got COVID when I had had a shot.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. No concomitant medications provided by the reporter. Patient past vaccination included Moderna-Covid-19 vaccine. It was reported that 5th vaccination the patient experienced the normal reaction. A week later, the patient experienced that her shoulder to her elbow turned beet red and itched. And for the next week, every day that area would get slightly smaller, slightly smaller till it eventually went away. And it took at least 1 week or 8 days for it to go away for the patient. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-320123 (Patient Link). More
2868848 75 M 10/27/2025 COVID19
 MODERNA
COVID-19 COVID-19
Got COVID for the very first time; This spontaneous case was reported by a consumer and describes th... Got COVID for the very first time; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID for the very first time) in a 75-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In September 2024, the patient experienced COVID-19 (Got COVID for the very first time). At the time of the report, COVID-19 (Got COVID for the very first time) outcome was unknown. No concomitant medications provided by the reporter. At the time of the vaccination the patient was 73-year-old. The reported stated that the date of suspect vaccine administration was incorrect even if it was documented. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-790491 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790491:Wife case More
2868849 78 F 10/27/2025 COVID19
 MODERNA
Respiratory syncytial virus infection Respiratory syncytial virus infection
She had the RSV; This spontaneous case was reported by a consumer and describes the occurrence of RE... She had the RSV; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYNCYTIAL VIRUS INFECTION (She had the RSV) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (She had the RSV). At the time of the report, RESPIRATORY SYNCYTIAL VIRUS INFECTION (She had the RSV) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient had received the Moderna vaccination. When she went to the pharmacy, they had done her vaccinations. They said things have changed now and she needed a prescription from her doctor to get a vaccination for COVID. She wanted to know if that was true. Among the boosters, people said she could get either one, Pfizer or Moderna. She always wanted to get the Moderna vaccine. She had the RSV. She was working with the equipment manager of an equipment company, and so they were exposed to a lot of different things. She kept up with all her vaccines and never ever needed a prescription to get a vaccine. She always had Moderna vaccine because of COVID. She did not want to get COVID because of her age. Moderna and her subsequent vaccinations caused her to be very faithful about getting them routinely, so she did not get COVID. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. More
2868850 26 F CA 10/27/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER
 3052741
Urticaria; Urticaria Urticaria; Urticaria
full body intense hives; This spontaneous case was reported by a consumer and describes the occurren... full body intense hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (full body intense hives) in a 26-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3052741) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052741) for COVID-19 prophylaxis and non-company product included Influenza vaccine (Flu) for an unknown indication. Psoriasis. Concurrent medical conditions included Psoriasis. On 14-Oct-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 17-Oct-2025, the patient experienced URTICARIA (full body intense hives). The patient was treated with Prednisone for Hives, at a dose of 20 milligram once a day; Diphenhydramine hydrochloride (Benadryl) for Hives, at an unspecified dose and frequency and Cetirizine hydrochloride (Zyrtec) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (full body intense hives) had not resolved. No concomitant medications were provided. The patient got full body intense hives on 17-Oct-2025, (Friday night) that still had not gone away, even after urgent care visit. It was unknown if the patient experienced any additional symptoms/events. The patient did not have any additional medical history, concomitant disease or risk factor. There were no lab data/results available. More
2868851 10/27/2025 RSV
 PFIZER\WYETH
 LL8391
Syringe issue Syringe issue
the lure lock broke on the syringe containing the sterile water; This is a spontaneous report receiv... the lure lock broke on the syringe containing the sterile water; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: LL8391, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the lure lock broke on the syringe containing the sterile water". Causality for "the lure lock broke on the syringe containing the sterile water" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: Reporter stated, "I was preparing an Abrysvo to administer to a patient and I guess the lure lock broke on the syringe containing the sterile water so, I could not use it. I have to tell the patient to come back. Is there someway, I could get a replacement". No follow-up attempts are possible. More
2868852 MN 10/27/2025 COVID19
 PFIZER\BIONTECH
 NA4457
Device breakage Device breakage
syringe break when putting needle on it; This is a spontaneous report received from a Pharmacist and... syringe break when putting needle on it; This is a spontaneous report received from a Pharmacist and an Other HCP from product quality group. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Lot number: NA4457, Expiration Date: 23Jul2026) for covid-19 immunisation, Device Lot Number: NA4457, Device Expiration Date: 23Jul2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "syringe break when putting needle on it". Causality for "syringe break when putting needle on it" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction). Additional information: There was a syringe break when putting needle on it, it snapped off. NDC Number was 0069252801. More
2868853 33 F CA 10/27/2025 COVID19
 PFIZER\BIONTECH
 NA0739
Device mechanical issue, Device occlusion, Incorrect dose administered by device... Device mechanical issue, Device occlusion, Incorrect dose administered by device, Vaccination site pain More
patient felt pain; Patient did not get full dose; Plunger was hard as a rock at the last 1/3 of inje... patient felt pain; Patient did not get full dose; Plunger was hard as a rock at the last 1/3 of injection; plunger failed approximately 2/3rds of the way through; This is a spontaneous report received from an Other HCP from medical information team. A 33-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 20Oct2025 as dose 1, single (Lot number: NA0739, Expiration Date: 02Jul2026) at the age of 33 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED BY DEVICE (non-serious) with onset 20Oct2025, outcome "unknown", described as "Patient did not get full dose"; DEVICE MECHANICAL ISSUE (non-serious) with onset 20Oct2025, outcome "unknown", described as "Plunger was hard as a rock at the last 1/3 of injection"; VACCINATION SITE PAIN (non-serious) with onset 20Oct2025, outcome "unknown", described as "patient felt pain"; DEVICE OCCLUSION (non-serious) with onset 20Oct2025, outcome "unknown", described as "plunger failed approximately 2/3rds of the way through". Causality for "patient did not get full dose", "plunger was hard as a rock at the last 1/3 of injection" and "plunger failed approximately 2/3rds of the way through" was determined associated to device constituent of BNT162b2 omicron (lp.8.1). Additional information: Pharmacy technician queried asking "Is 2/3 dose enough for coverage or need to give her another one. Reporter was administering the Comirnaty covid shot to a patient but the plunger failed approximately 2/3rds of the way through and was hard as a rock. The patient did not get a full dose; she got just about 2/3rds of dose into her body. Around 2/3s of the dose, the plunger hardened to like a rock, like pressing a rock on it, and the lady felt pain. They removed the syringe from the patient. When took it out, pressed the plunger harder and had to put full force and the last third of the injection was wasted in the waste bin. Caller has done a couple of hundred shots so far, and these were the only ones that had this issue, so caller got weirded out. First time going through something like that. Caller was the injecting immunization technician, caller was the one doing the plunger. More
2868854 F 10/27/2025 COVID19
 PFIZER\BIONTECH
Allergy to vaccine, Fear, Throat tightness Allergy to vaccine, Fear, Throat tightness
allergic to this LP.8.1. protein; throat tightened; it was scary/it was pretty frightening; This is ... allergic to this LP.8.1. protein; throat tightened; it was scary/it was pretty frightening; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient 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. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset 2025, outcome "unknown", described as "allergic to this LP.8.1. protein"; FEAR (non-serious) with onset 2025, outcome "unknown", described as "it was scary/it was pretty frightening"; THROAT TIGHTNESS (non-serious) with onset 2025, outcome "unknown", described as "throat tightened". Additional information: The patient received the new Pfizer COVID vaccine (2025-2026) a month ago and she just wanted to confirm what the difference between the new and the previous formulation is. The patient mentioned that apparently she was allergic to this LP.8.1. protein. She has had a number of COVID shots but this was the first time she had a severe reaction after vaccination. The patient stated she had a reaction to the new covid shot, her throat tightened. She did not go to the hospital, but it was scary. So, for her to get more shots next year, she wanted to know what is different, what ingredients was different with the new covid shot, so that she can check before she gets it again because it was pretty frightening. She never had the reaction before and she has had five to six covid shots over the years starting with the epidemic of covid and she never had that reaction. She wanted to know what is the new ingredient, so that she can make sure that it does not happen again. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2868855 F 10/27/2025 RSV
 PFIZER\WYETH
Exposure during pregnancy, Premature delivery Exposure during pregnancy, Premature delivery
The vaccine was administered to a pregnant patient who delivered the baby earlier than expected.; Th... The vaccine was administered to a pregnant patient who delivered the baby earlier than expected.; This is a spontaneous report received from a Nurse from medical information team. A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Oct2025 as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient was 32 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 33 weeks pregnant at the event onset. The patient is expected to deliver one baby(s). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE DELIVERY (medically significant), outcome "unknown", described as "The vaccine was administered to a pregnant patient who delivered the baby earlier than expected.". The baby was delivered. Nurse has some questions about Abrysvo. The vaccine was administered to a pregnant patient who delivered the baby earlier than expected. The nurse reviewed information from the CDC, which states that for antibodies to form in the baby, the vaccine should be administered at least two weeks before delivery. She is wondering if the baby now needs Beyfortus (Nirsevimab) to be fully protected. When asked if the vaccine was administered between 32-36 weeks of gestation, the nurse confirmed that it was given on October 8th, 2025, at 32 weeks and 3 days of gestational age. The baby was born, so maybe the full immune protection did not have time to develop. Nurse ruled out any adverse event from the patients. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event premature delivery most likely due to patient underlying contributory factors. 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
2868856 10/27/2025 COVID19
 PFIZER\BIONTECH
Viral infection, Vomiting Viral infection, Vomiting
virus; I was up so sick, vomiting at least 24 hours, it was awful; This is a spontaneous report rece... virus; I was up so sick, vomiting at least 24 hours, it was awful; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization; Bnt162b2 (Dose 2, single), for Covid-19 immunization; Bnt162b2 (Dose 3 (booster), single), for Covid-19 immunization. The following information was reported: VOMITING (non-serious) with onset 2025, outcome "recovered" (2025), described as "I was up so sick, vomiting at least 24 hours, it was awful"; VIRAL INFECTION (non-serious) with onset 2025, outcome "recovered", described as "virus". The events "virus" and "i was up so sick, vomiting at least 24 hours, it was awful" required physician office visit. Therapeutic measures were taken as a result of viral infection, vomiting. Additional information: Consumer stated, patient just wanted to call an adverse reaction to Pfizer vaccine that patient had in June. Patient mean patient was not having a reaction now. Patient had it then but patient just have not had a chance to get to it, so patient was sick and patient do not have time to do this. Now this was going to take a while. Consumer stated, got the Pfizer COVID Vaccine in June to patient's pharmacy at grocery store. Patient doesn't know the LOT number or any of that (clarified as Pfizer COVID-19 Vaccine). Consumer stated, got the virus at 05:30 at night quarter to 6 and at 03:00 in the morning patient was up so sick, vomiting at least 24 hours before patient call the doctor. She put patient on a med and so patient survived obviously but it was awful. She said you should have called her yesterday. You are having an adverse event to this vaccine, as patent did not call but now patient just wondered if there were any long-term effects because patient have just had lately and it has been going on for 3 weeks, and nothing seems to be wrong but asked if a possible side effect. Consumer stated, "It was patient's 4th Pfizer injection. Patient did not even think twice about getting it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2868857 54 M TX 10/27/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EP6955
EP6955
Alanine aminotransferase abnormal, Aspartate aminotransferase abnormal, Fibrin D... Alanine aminotransferase abnormal, Aspartate aminotransferase abnormal, Fibrin D dimer increased, Illness, Lymphocyte count abnormal; Monocyte count abnormal, Neutrophil count abnormal More
Got sick after the first 2 shots; affected his neutrophils, lymphocytes, and monocytes; affected his... Got sick after the first 2 shots; affected his neutrophils, lymphocytes, and monocytes; affected his neutrophils, lymphocytes, and monocytes; affected his neutrophils, lymphocytes, and monocytes; affected his ALT and AST; affected his ALT and AST; he had failing D dimers; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 54-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: EP6955) at the age of 54 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; LOT#: EN6205; Intramuscular, Right deltoid), administration date: 02Mar2021, when the patient was 54-year-old, for COVID-19 immunization, reaction(s): "Got sick", "affected his neutrophils, lymphocytes, and monocytes", "affected his neutrophils, lymphocytes, and monocytes", "affected his neutrophils, lymphocytes, and monocytes", "affected his ALT and AST", "affected his ALT and AST", "he had failing D dimers". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got sick after the first 2 shots"; NEUTROPHIL COUNT ABNORMAL (non-serious), LYMPHOCYTE COUNT ABNORMAL (non-serious), MONOCYTE COUNT ABNORMAL (non-serious), outcome "unknown" and all described as "affected his neutrophils, lymphocytes, and monocytes"; ALANINE AMINOTRANSFERASE ABNORMAL (non-serious), ASPARTATE AMINOTRANSFERASE ABNORMAL (non-serious), outcome "unknown" and all described as "affected his ALT and AST"; FIBRIN D DIMER INCREASED (non-serious), outcome "unknown", described as "he had failing D dimers". Additional information: The patient took E series of the Covid-19 vaccine in Mar2021 and it affected his neutrophils, lymphocytes, and monocytes, and he immediately got sick. It affected his ALT and AST and he had failing D dimers. More
2868858 F CA 10/27/2025 RSV
 PFIZER\WYETH
Erythema, Exposure during pregnancy, Pain in extremity, Peripheral swelling Erythema, Exposure during pregnancy, Pain in extremity, Peripheral swelling
Arm swelled up quite a bit; Arm was red; arm was painful; This is a spontaneous report received from... Arm swelled up quite a bit; Arm was red; arm was painful; This is a spontaneous report received from an Other HCP from a sales representative. An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient was 36 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 36 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "recovering", described as "Arm swelled up quite a bit"; VACCINATION SITE ERYTHEMA (non-serious), outcome "recovering", described as "Arm was red"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "arm was painful". It was unknown if therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pain. Additional information: Patient in 36th week of pregnancy received 1 shot Abrysvo. Arm swelled up quite a bit, was red and painful for over a week. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2868860 NY 10/27/2025 RSV
 PFIZER\WYETH
Syringe issue Syringe issue
one of it during giving out a shot, it broke when twisting and thinks it may be defective piece as t... one of it during giving out a shot, it broke when twisting and thinks it may be defective piece as there's probably an issue with the vial; This is a spontaneous report received from an Other HCP from product quality group, Program ID. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "one of it during giving out a shot, it broke when twisting and thinks it may be defective piece as there's probably an issue with the vial". Additional information: The caller is a pharmacy tech, calling in as they use the Abrysvo for vaccination and one of it during giving out a shot, it broke when twisting and thinks it may be defective piece as there's probably an issue with the vial. Reporter is asking for replacement. There were no glass shards the container did not break. He had the vial packed up in the mailer so he could not give the lot number. Causality for "one of it during giving out a shot, it broke when twisting and thinks it may be defective piece as there's probably an issue with the vial" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2868861 F 10/27/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a Consumer or... diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid". Clinical course: Caller mentioned that she is having her Pfizer covid 19 vaccines but she got diagnosed with Covid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2868862 F 10/27/2025 COVID19
 PFIZER\BIONTECH
Plasma cell myeloma Plasma cell myeloma
multiple myeloma; This is a spontaneous report received from a Consumer or other non HCP, Program ID... multiple myeloma; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLASMA CELL MYELOMA (medically significant), outcome "unknown", described as "multiple myeloma". Therapeutic measures were taken as a result of plasma cell myeloma. The caller mentioned that she received all of her Covid vaccines since Covid and gotten every single covid vaccines and then she developed multiple myeloma and she had stem cell transplant which reset her entire immune system. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2868865 TX 10/27/2025 FLU3
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
a patient under 65 years old was administered with FLUZONE HD with no reported adverse event; Initia... a patient under 65 years old was administered with FLUZONE HD with no reported adverse event; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult and unknown gender patient under 65 years old and was administered with influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] 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 under the age of 65 years old received influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Influenza (Influenza immunization) with no reported adverse event (product administered to patient of inappropriate age) (same day latency). It was reported that, nurse declined to provide information since she does not know if they are allowed to give out patient information. Nurse also mentioned that they called the patient, who then reported that they are fine. Information on the batch number could not be requested corresponding to the one at time of event occurrence Action taken was not applicable. No additional information available at time of call; caller declined to respond to questions and refuses future follow-up. 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
2868868 77 F IL 10/27/2025 FLU3
 SANOFI PASTEUR
 U8862BA
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient received two doses of fluzone hd with no reported adverse event; Initial information receive... patient received two doses of fluzone hd with no reported adverse event; Initial information received on 21-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 77 years old female patient who received two doses of influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included covid-19 vaccine for Immunisation. On 21-Oct-2025, the patient received extra dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength), frequency: once with lot U8862BA and expiry date 30-JUN-2026 via unknown route in the left arm for Influenza immunization with no reported adverse event (extra dose administered) (Latency same day). 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
2868869 3 M ID 10/27/2025 FLU3
FLUN3
 GLAXOSMITHKLINE BIOLOGICALS
MEDIMMUNE VACCINES, INC.
YF3413B
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Giving vaccines at school. Parents marked no to vaccine questionaire, if patient had received vaccin... Giving vaccines at school. Parents marked no to vaccine questionaire, if patient had received vaccine in the past 4 weeks. Proceeded to giving vaccine. Contacted CDC who states no serious problems can occur if two doses of vaccines are received. More
2868870 35 F UT 10/27/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052995
407003
Underdose; Underdose Underdose; Underdose
Moderna pediatric COVID dose (0.25 mL) given in error to an adult. Moderna pediatric COVID dose (0.25 mL) given in error to an adult.
2868871 15 M MN 10/27/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052859
409413
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Gave wrong age covid vaccine - moderna 6m-11y instead of moderna 12+ to 15-year-old client. Gave wrong age covid vaccine - moderna 6m-11y instead of moderna 12+ to 15-year-old client.
2868872 4 F ID 10/27/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 YF3413B
Extra dose administered Extra dose administered
Giving flu mist vaccines in school. Parent marked no on vaccine questionaire if patient had received... Giving flu mist vaccines in school. Parent marked no on vaccine questionaire if patient had received vaccines in the past 4 weeks. Proceeded with giving vaccine to patient. Per CDC and provider no serious problems can occur from receving two flu vaccines. More
2868873 53 F CT 10/27/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 p394k
Dizziness, Vomiting Dizziness, Vomiting
patient states she feels dizzy and is vomiting . she did telehealth. telehealth md told her it may... patient states she feels dizzy and is vomiting . she did telehealth. telehealth md told her it maybe or may not be from the shot More
2868874 65 M ME 10/27/2025 FLU3
FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
 407245
407245
407245
Body temperature decreased, Chills, Coordination abnormal, Cough, Eye discharge;... Body temperature decreased, Chills, Coordination abnormal, Cough, Eye discharge; Fatigue, Fumbling, Influenza like illness, Loss of personal independence in daily activities, Malaise; Paranasal sinus hypersecretion, Respiratory tract congestion, Sneezing More
Day two noticeably minor loss of both fine and gross motor coordination. Fumbling and dropping small... Day two noticeably minor loss of both fine and gross motor coordination. Fumbling and dropping small objects. Bumping into obstacles while walking. Difficulty performing simple tasks requiring normal dexterity. Day three to present day six experiencing debilitating flu like symptoms, e.g., Chills, low body temp 85degrees while in bed 95 degrees upon standing, extreme sinus and eye drainage, throat and chest congestion, sinus congestion, sneezing, coughing, extremely tired requiring prolonged bed rest. Still feeling sickly at present time. More
2868875 71 F CA 10/27/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Dizziness, Feeling abnormal, Mobility decreased, Musculoskeletal stiffness, Myal... Dizziness, Feeling abnormal, Mobility decreased, Musculoskeletal stiffness, Myalgia; Neuralgia, Rash More
Third day increasing nerve and muscle pain and stiffness all over. Mild dizziness or dazed feeilng. ... Third day increasing nerve and muscle pain and stiffness all over. Mild dizziness or dazed feeilng. Ongoing for 10 days, treating with advil, chiropractic, rest. Difficulty bending, kneeling, doing routine moves that had been fairly easy or at least not so painful before vaccine. Also, rash on left forearm. Not yet resolved. More
2868876 38 M UT 10/27/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052995
407003
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
none known none known
2868878 65 F 10/27/2025 FLU3
 SANOFI PASTEUR
 u48859BA
Pain in extremity Pain in extremity
patient reported pain in her legs after getting vaccine and sore arm patient reported pain in her legs after getting vaccine and sore arm
2868879 86 F OH 10/27/2025 COVID19
 MODERNA
 3052732
Feeling abnormal, Lymphadenopathy, Pain in extremity, Peripheral swelling Feeling abnormal, Lymphadenopathy, Pain in extremity, Peripheral swelling
Arm hurt, swelled up, swollen lymph nodes in armpit, felt bad, painful, started within hours after a... Arm hurt, swelled up, swollen lymph nodes in armpit, felt bad, painful, started within hours after and continued for about 1 week then tapered off symptom-wise over the next week. She sought no medical treatment, but in hindsight, wished she would have. Patient wanted us to report this on her behalf, she was told that we have to and will do so. More
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