🏥 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 💀 🏥 🚑 ♿ ⚠️
2869178 F OH 10/28/2025 COVID19
 PFIZER\BIONTECH
Tinnitus Tinnitus
got tinnitus in my left ear; This is a spontaneous report received from a Consumer or other non HCP,... got tinnitus in my left ear; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 68-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, On Left Arm), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1 (BOOSTER), SINGLE, On Left Arm), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2 (BOOSTER), SINGLE, On Left Arm), for Covid-19 immunisation. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "got tinnitus in my left ear". Additional information: The patient was a 68-year-old female in good health. Approximately 10 days after receiving her third (and final) Pfizer booster vaccination, with all five doses administered in the same left arm, she developed tinnitus in the left ear. The tinnitus persisted and did not occur in the right ear. It was described as a swishing air noise and occasionally the cricket legs rubbing noise at the same time. The patient became used to it and did not let it bother her. The noise had not changed or gotten any louder. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2869179 10/28/2025 COVID19
 UNKNOWN MANUFACTURER
Aortic dilatation, Cardiac failure, Inflammation, Refraction disorder Aortic dilatation, Cardiac failure, Inflammation, Refraction disorder
heart failure; reduced refraction; enlarged aorta; inflammation; Initial information received on 21-... heart failure; reduced refraction; enlarged aorta; inflammation; Initial information received on 21-Oct-2025 regarding an unsolicited valid serious case received from a Patient. This case involves an unknown age and unknown gender patient who experienced heart failure, reduced refraction, enlarged aorta and inflammation after receiving NVX-COV2705 (OMICRON JN.1) adjuvanted vaccine [Novavax Covid-19 Vaccine, Adjuvanted (2024-2025 Formula)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose 4 (unknown dose) of suspect NVX-COV2705 (OMICRON JN.1) adjuvanted vaccine, Injection (strength, lot number and expiry date not reported) via unknown route in unknown administration site and 3 other doses were administered on unknown dates for same vaccine for prophylactic vaccination. On an unknown date the patient developed heart failure (cardiac failure), reduced refraction (refraction disorder), enlarged aorta (aortic dilatation) and inflammation (unknown latency). Patient had 4 novavax vaccines and a single mrna in the beginning, wanted to understand the percentage of people with this side affect as compared to the mrna vaccine. trying to decide if he should get the latest shot Action taken: Not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events. Seriousness criteria: Medically significant for cardiac failure.; Sender's Comments: Sanofi Company Comment dated 28-OCT-2025: This case involves an unknown age and unknown gender patient who experienced heart failure, reduced refraction, enlarged aorta and inflammation after receiving NVX-COV2705 (OMICRON JN.1) adjuvanted vaccine [Novavax Covid-19 Vaccine, Adjuvanted (2024-2025 Formula)]. Further information regarding medical history, concomitant medications and tolerance, clinical course, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
2869180 F NY 10/28/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Burning sensation, Chest pain, Neuralgia, Paraesthesia Burning sensation, Chest pain, Neuralgia, Paraesthesia
Neuropathic pain; Tingling; Burning sensation goes through both arms, chest and back; This spontaneo... Neuropathic pain; Tingling; Burning sensation goes through both arms, chest and back; This spontaneous case, initially received on 14-Oct-2025, was reported by a non health professional and concerns an elderly female patient. Administration of company suspect drug: On 10-Oct-2025, the patient received Fluad (TIV) for Unknown, dose: unknown, route of administration: not reported, anatomical location: not reported, Lot number: No batch number available and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Oct-2025, the patient experienced Neuropathic pain (outcome: Unknown), Tingling (outcome: Unknown), Burning sensation goes through both arms, chest and back (outcome: Unknown). Consumer stated that she took the senior flu shot (Fluad) last week, and was experiencing a kind of neuropathic pain, with tingling and burning sensation. Referred that it went through both arms, chest and back. Inquired if this had been reported and how long it could last. Treatment measures associated with event unknown. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, events are considered related for reporting purposes. More
2869181 15 M UT 10/28/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052995
407003
Underdose; Underdose Underdose; Underdose
PEDS COVID-19 DOSE 0.26 ML GIVEN TO 15 YEAR OLD IN ERROR PEDS COVID-19 DOSE 0.26 ML GIVEN TO 15 YEAR OLD IN ERROR
2869182 11 M PA 10/28/2025 FLU3
 SEQIRUS, INC.
 948415
Dizziness, Pallor Dizziness, Pallor
About 5-10 minutes after he received the vaccination, he began to feel dizzy. He looked pale and sai... About 5-10 minutes after he received the vaccination, he began to feel dizzy. He looked pale and said he was lightheaded. We offered him anything while observing. His father wanted him to have a soda so possibly the sugar will help him. He sat for about 15-20 more minutes and started feeling a lot better. His father said he was good to leave and he and his wife would keep an eye on him. I called to see how he was doing the following day and his father said that he was fine once he got home. More
2869183 19 F WA 10/28/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
 3052733
3052733
TFAA2503
TFAA2503
Blood test normal, Feeling abnormal, Headache, Nausea, Pyrexia; Syncope, Urine a... Blood test normal, Feeling abnormal, Headache, Nausea, Pyrexia; Syncope, Urine analysis normal; Blood test normal, Feeling abnormal, Headache, Nausea, Pyrexia; Syncope, Urine analysis normal More
10/22/25 - 10/23/25 - Fever, took Advil, 10/23 Fainted, went to the ER (withheld name, city, state),... 10/22/25 - 10/23/25 - Fever, took Advil, 10/23 Fainted, went to the ER (withheld name, city, state), 10/23-10/24 Felt dazed all day. Currently feels dazed off and on. 10/24 to today - Headache with Nausea. Was 6-7/10, currently 4-5/10. Headache is worse with movement, especially with changing position up and down. More
2869184 0.33 M AZ 10/28/2025 DTAPIPVHIB
PNC20
RV1
 SANOFI PASTEUR
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 UK343AA
MG7421
94A7Z
Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered
RSV vaccine given in June 2025. Second RSV vaccine administered 10/28/25. Vaccine Error. Contacted M... RSV vaccine given in June 2025. Second RSV vaccine administered 10/28/25. Vaccine Error. Contacted Medical Director Dr. [withheld] and he stated no harm to infant with second dose. This vaccine weans off after 4-6 weeks and now the baby has extra protection, less immunologic reaction. One dose is recommended for the vaccine schedule. Parent to be aware of common vaccine adverse reactions (fever, etc.). Contacted Dr. [wihtheld] and explained there should be no problems. Baby will have a better response due to months in between vaccines and higher antibody level. Contacted parent and shared all information from providers and also explained the first dose of RSV vaccine was given outside of recommendations also (Oct-March). Parent understood and will watch for any adverse reactions. Will contact EMS or provider if needed. More
2869185 13 M UT 10/28/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052995
407003
Underdose; Underdose Underdose; Underdose
PEDS COVID-19 0.25 ML GIVEN IN ERROR TO 13 YEAR OLD PEDS COVID-19 0.25 ML GIVEN IN ERROR TO 13 YEAR OLD
2869186 16 M TX 10/28/2025 UNK
 UNKNOWN MANUFACTURER
 LX5014
Unevaluable event Unevaluable event
SEE ATTACHED DOCUMENTS SEE ATTACHED DOCUMENTS
2869187 48 M KY 10/28/2025 FLU3
 SANOFI PASTEUR
 u8823ca
Dysgeusia, Joint swelling, Pain in extremity, Swelling Dysgeusia, Joint swelling, Pain in extremity, Swelling
Patient experienced bad taste in mouth, swelling in arm and shoulder, and arm pain. Patient experienced bad taste in mouth, swelling in arm and shoulder, and arm pain.
2869188 3 F WA 10/28/2025 COVID19
 MODERNA
 3052668
Product lot number issue, Wrong product administered Product lot number issue, Wrong product administered
pt came into the office to recive their covid vaccine, when vaccine was pulled the lot number did no... pt came into the office to recive their covid vaccine, when vaccine was pulled the lot number did not match the system. vaccine was brought to LEAD staff, medication program coordinator and backup vaccine coordinator who reviewed the preflled syrigne and confirmed the vaccine was the correct one but that the lot may have been enetered incorrectly. lot was changed by them and i confired after entering lot number i was okay to amndinister to which the ressured me that i was okay. i return to the pt room with the vaccine, confirmed with mother pt information and vaccine and adminitered. shortly after administering medication program coordinator entered the room and informed me that the vaccine was inccorect, however vaccine had already been administrerd. pt mother spoke to individual one on one in regards to event. More
2869189 80 M MN 10/28/2025 COVID19
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Rash; Rash Rash; Rash
Rash on abdomen and groin area Rash on abdomen and groin area
2869190 35 F WI 10/28/2025 COVID19
 PFIZER\BIONTECH
 NA0738
Blindness, Headache Blindness, Headache
Patient reported short drive home (approximately 5 minutes), then sudden onset of severe headache an... Patient reported short drive home (approximately 5 minutes), then sudden onset of severe headache and vision loss approximately 5 minutes after arriving home. Patient had not waited at the pharmacy following the reaction due to previous vaccines with no issues. Vision loss resolved gradually over the course of several hours, and the headache resolved sometime the next day. Patient did NOT seek medical care, and did not report to pharmacy until 10/28/2025 More
2869191 F MI 10/28/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Supraventricular tachycardia Supraventricular tachycardia
Went into SVT nothing wrong with heart Went into SVT nothing wrong with heart
✓ ✓
2869196 12 M CO 10/28/2025 COVID19
 MODERNA
 3053482
No adverse event, Underdose No adverse event, Underdose
Error in vaccine given: given the 6m-11yr Moderna 2025-26 COVID vaccine, no adverse outcome. Error in vaccine given: given the 6m-11yr Moderna 2025-26 COVID vaccine, no adverse outcome.
2869197 60 F CA 10/28/2025 FLU3
 SEQIRUS, INC.
 407266
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient checked in to our intake window inquiring for a high-dose flu vaccine. Fluad was typed up. ... Patient checked in to our intake window inquiring for a high-dose flu vaccine. Fluad was typed up. Pharmacist failed to recognize patient was not 65 years old. Patient's date of birth was xx-xx-xxxx and the pharmacist mistakenly mixed up the age and the year of birth. Fluad was given to patient. Patient did not have any reaction after the vaccine was given. Patient was apologetic to us but I reassured her the mishap was on our end. More
2869199 85 F UT 10/28/2025 COVID19
DF
PNC20
 MODERNA
SANOFI PASTEUR
PFIZER\WYETH
 3052581
407981
ma2488
Dehydration, Posture abnormal, Presyncope, Pulse abnormal, Urinary tract infecti... Dehydration, Posture abnormal, Presyncope, Pulse abnormal, Urinary tract infection; Dehydration, Posture abnormal, Presyncope, Pulse abnormal, Urinary tract infection; Dehydration, Posture abnormal, Presyncope, Pulse abnormal, Urinary tract infection More
After giving the vaccines and patient left the area with her husband, she was found by assisted livi... After giving the vaccines and patient left the area with her husband, she was found by assisted living staff slumped in her wheelchair with a very weak pulse. EMS called and transported to hospital, kept overnight for observation and determined to have UTI and dehydration. Most likely vasal vagal response to the 3 injections. Discharged following day and staff reported she was doing well. More
✓
2869202 21 F WA 10/28/2025 FLU3
 SANOFI PASTEUR
 UT8804CA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Inadvertently gave high dose flu to a 21 year old pt. Called pt to inform of error. Pt reported no ... Inadvertently gave high dose flu to a 21 year old pt. Called pt to inform of error. Pt reported no ill effects. More
2869203 10 M UT 10/28/2025 COVID19
 MODERNA
 3052784
Incorrect dose administered Incorrect dose administered
MODERNA SPIKEVAX FOR 12+ GIVEN TO 10 YEAR OLD IN ERROR MODERNA SPIKEVAX FOR 12+ GIVEN TO 10 YEAR OLD IN ERROR
2869204 34 F PA 10/28/2025 FLU3
 SANOFI PASTEUR
 FLUBLOCK
Oral pruritus Oral pruritus
patient reported itchy mouth patient reported itchy mouth
2869205 79 M CA 10/28/2025 COVID19
 MODERNA
 3052669
Fatigue, Headache, Myalgia, Pain Fatigue, Headache, Myalgia, Pain
Patient received a Vaccine injection (Spikevax) on 10/10/25. On 10/13/25, patient called reported... Patient received a Vaccine injection (Spikevax) on 10/10/25. On 10/13/25, patient called reported that he had side effects - fatigues, Headache, muscle aches and pains, total body aches??, no fever, dizziness? plus some uncommon SEs (patient did not elaborate)" Pharmacist assessed his SEs, told him some patients have experienced the same SEs, as well as uncommon SEs but they're doing ok. Patient responded - so maybe the SEs are from his previous procedure (patient did not disclose what procedure). More
2869206 57 F UT 10/28/2025 FLU3
 SEQIRUS, INC.
 407273
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Senior Dose vaccine given to age 57 in error Senior Dose vaccine given to age 57 in error
2869207 78 M FL 10/28/2025 FLU3
 SANOFI PASTEUR
 u8859da
Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered
Patient was provided with incorrect vaccination leading to duplication of vaccination of Fluzone HD. Patient was provided with incorrect vaccination leading to duplication of vaccination of Fluzone HD.
2869208 51 F UT 10/28/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052860
407003
Underdose; Underdose Underdose; Underdose
PEDS DOSE 0.25 ML GIVEN IN ERROR TO 51 YEAR OLD PEDS DOSE 0.25 ML GIVEN IN ERROR TO 51 YEAR OLD
2869209 2 M CA 10/28/2025 COVID19
 UNKNOWN MANUFACTURER
Dysstasia, Gait disturbance, Injection site pain, Injection site swelling, Weigh... Dysstasia, Gait disturbance, Injection site pain, Injection site swelling, Weight bearing difficulty More
Swollen leg. The leg is so tender and painful that the child is not able to stand, out weight on it ... Swollen leg. The leg is so tender and painful that the child is not able to stand, out weight on it or walk More
2869210 19 F 10/28/2025 FLU3
 SEQIRUS, INC.
Loss of consciousness Loss of consciousness
Patient passed out but remained sitting in the chair. Patient stayed for about 30 minutes until she ... Patient passed out but remained sitting in the chair. Patient stayed for about 30 minutes until she felt comfortable to leave. More
2869211 60 F MI 10/28/2025 COVID19
FLU3
PNC20
VARZOS
 MODERNA
SEQIRUS, INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 8146670
409415
MA2506
7YD42
Pain, Pyrexia, Urinary incontinence; Pain, Pyrexia, Urinary incontinence; Pain, ... Pain, Pyrexia, Urinary incontinence; Pain, Pyrexia, Urinary incontinence; Pain, Pyrexia, Urinary incontinence; Pain, Pyrexia, Urinary incontinence More
Patient called to ask what vaccines she received in the left arm (covid and flu) because she develop... Patient called to ask what vaccines she received in the left arm (covid and flu) because she developed a red circular rash that is not hard and not soft, painful and itchy that she noticed today 10/28. She was counseled on self care and to follow up with primary care provider. She also reported that she went to the ER on Saturday 10/25 due to fever of 102 F, body aches and could not get to the bathroom she peed herself per self report. Patient stated that she got scared and went to the ER because she does have chronic kidney disease. Per patient, per ER they attributed the symptoms to the side effects of receiving vaccinations. They provided her follow up instructions of taking fluids, tylenol and advil. More
2869213 33 F WA 10/28/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052671
948410
Syncope; Syncope Syncope; Syncope
Vasovagal syncope Vasovagal syncope
2869214 74 F TX 10/28/2025 COVID19
 MODERNA
 025620A
Amyotrophic lateral sclerosis, Bulbar palsy, Dysphagia, Speech disorder, Throat ... Amyotrophic lateral sclerosis, Bulbar palsy, Dysphagia, Speech disorder, Throat tightness More
Patient had the first vaccination on 1/4/21. Approximately ten days later her throat constricted ca... Patient had the first vaccination on 1/4/21. Approximately ten days later her throat constricted causing her difficulty. A episode pen was administered and may have helped. Patient took the second Moderna shot on 1/29/21 and a booster on 8/16/21. In November of 2021 she was still having some difficulty swallowing and speaking and she was diagnosed with bulbar palsy ALS. This was confirmed at (withheld) in May of 2022. More
✓ ✓
2869215 49 M WA 10/28/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 948401
948401
Angiogram, Angiogram abnormal, Bursitis infective, Cellulitis, Debridement; Inci... Angiogram, Angiogram abnormal, Bursitis infective, Cellulitis, Debridement; Incisional drainage, Inflammation, Joint swelling, Peripheral swelling, Rash More
received annual flu shot at my employment, upper arm had large amount of swelling for a week after f... received annual flu shot at my employment, upper arm had large amount of swelling for a week after flu shot, more so then in previous years, a week after upper arm swelling improved my elbow had significant swelling causing severe bursitis and cellulitis tracking from my wrist all the way up my arm to arm pit, with septic bursitis forming requiring ER visit, inpatient hospitalization and eventually surgical debridemnet of septic bursitis with drainage of fluid and IV antibiotics for two weeks. More
✓
2869216 66 M FL 10/28/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 ut8781da
LX4482
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
N/A - Duplicate Prevnar 20 given. First on 10/25/24 and second dose given on 10/11/25. No adverse re... N/A - Duplicate Prevnar 20 given. First on 10/25/24 and second dose given on 10/11/25. No adverse reactions reported More
2869217 25 M WI 10/28/2025 COVID19
COVID19
FLU3
FLU3
TDAP
TDAP
 PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 MY9548
MY9548
TFAA2546
TFAA2546
292H2
292H2
Eye movement disorder, Fall, Head injury, Hyperhidrosis, Muscle twitching; Pallo... Eye movement disorder, Fall, Head injury, Hyperhidrosis, Muscle twitching; Pallor; Eye movement disorder, Fall, Head injury, Hyperhidrosis, Muscle twitching; Pallor; Eye movement disorder, Fall, Head injury, Hyperhidrosis, Muscle twitching; Pallor More
Pt received 3 vaccines and remained seated while family members received their vaccines. Within 5 mi... Pt received 3 vaccines and remained seated while family members received their vaccines. Within 5 minutes post-vaccination, patient fell forward onto the floor, hitting his forehead. Patient was helped back into the chair where he remained conscious and alert but sweating profusely and because very pale. Patient's body twitched and his eyes rolled to the back of his head. EMS was called, responded, and transported patient to the hospital for further examination. More
2869218 60 F FL 10/28/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 U8832CA
LX4482
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
N/A - Duplicate Prevnar 20 given. First on 10/25/24 and second dose given on 10/11/25. No adverse re... N/A - Duplicate Prevnar 20 given. First on 10/25/24 and second dose given on 10/11/25. No adverse reactions reported More
2869219 28 F CA 10/28/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 NA0739
AX4142A
Asthenia, Dizziness, Nausea, Paraesthesia; Asthenia, Dizziness, Nausea, Paraesth... Asthenia, Dizziness, Nausea, Paraesthesia; Asthenia, Dizziness, Nausea, Paraesthesia More
at clinic Patient got Afluria and comrnaty in the left arm patient was ok with afluria vaccine but o... at clinic Patient got Afluria and comrnaty in the left arm patient was ok with afluria vaccine but once comirnaty injection was administered patient started feeling not pain but moreso radiation, then nausea, then finger tingling and felt faint so sat down. I let patient stay and provided her water and food to feel energy from feeling weakness and let her stay at the clinci botth for half an hour and sit down and had her get up slowly when she ewas ready. I had someone from corporate assess her, seemed like vaccine administration was done fine and oth in left arm, we assessed patient proably felt more anxiety from getting the pfizer vaccine. Patient needed some time to rest and asess but ultimately patient was ok and we had security monitor her with her consent (not closely per patient request but moreso just check in on her) in case there were any issues to call the emergency department or medical aid More
2869223 6 M NJ 10/28/2025 FLU3
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 FH4YR
EB499
Circumstance or information capable of leading to medication error, Extra dose a... Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event; Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event More
No adverse event occurred with patient vaccine given in error-TDAP vaccine administered in error-@cl... No adverse event occurred with patient vaccine given in error-TDAP vaccine administered in error-@clinic for flu vaccine. Difficult child-non-compliant Once error discovered-mother made aware of error through interpreter-expressed understanding. Child received 4 DTAP vaccines-last one 9/24/24. Child with no reaction-afebrile-playing. Child administered flu vaccine in (RA) with no suction. More
2868408 1 M KS 10/27/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 F7X23
Expired product administered Expired product administered
patients received a Hepatitis A that have been expired; This non-serious case was reported by a nurs... patients received a Hepatitis A that have been expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received HAV (Havrix) (batch number F7X23, expiry date 25-MAY-2023) for prophylaxis. On 06-JUN-2023, the patient received the 1st dose of Havrix. On 06-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patients received a Hepatitis A that have been expired). The outcome of the expired vaccine used 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: 13-OCT-2025 The reporter was just calling wanted to see per manufacture if there were any recommendations or confirmed regarding that. More
2868409 30 F MA 10/27/2025 COVID19
FLUX
TDAP
 MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Brain fog, Chills, Vaccination site pain; Brain fog, Chills, Vaccination site pa... Brain fog, Chills, Vaccination site pain; Brain fog, Chills, Vaccination site pain; Brain fog, Chills, Vaccination site pain More
fogginess; chills; injection site pain; This spontaneous case was reported by a pharmacist and descr... fogginess; chills; injection site pain; This spontaneous case was reported by a pharmacist and describes the occurrence of BRAIN FOG (fogginess), CHILLS (chills) and VACCINATION SITE PAIN (injection site pain) in a 30-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect products included non-company products Influenza vaccine for an unknown indication and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for an unknown indication. Concurrent medical conditions included Migraine. On 16-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form, dose of Influenza vaccine (unknown route) 1 dosage form and dose of Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) (unknown route) 1 dosage form. On 17-Oct-2025, the patient experienced BRAIN FOG (fogginess), CHILLS (chills) and VACCINATION SITE PAIN (injection site pain). At the time of the report, BRAIN FOG (fogginess), CHILLS (chills) and VACCINATION SITE PAIN (injection site pain) outcome was unknown. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. It was unknown if the patient experienced any additional symptoms or events. There were no lab data or results available. Treatment medication was not reported. The reporter causality was not reported. Reporter did not allow further contact More
2868410 8 M 10/27/2025 FLU3
 SANOFI PASTEUR
 U8827AA
Product storage error Product storage error
Temperature excursion as temperature reached 25.7�F for a duration of 4 hours and 17 minutes and v... Temperature excursion as temperature reached 25.7�F for a duration of 4 hours and 17 minutes and vaccine was administered post excursion with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA304532 (master case). This case involves 8 years old male patient and reporter reported temperature excursion as temperature reached 25.7�f for a duration of 4 hours and 17 minutes and INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] was administered post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received a dose of 0.5 ml of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (frequency-once, Strength: standard) (lot U8827AA, expiry date- 30-JUN-2026) via intramuscular route in left arm for Influenza prophylaxis (Influenza immunization), which had temperature excursion as temperature reached 25.7�f for a duration of 4 hours and 17 minutes and vaccine was administered post excursion with no reported adverse event (product storage error). It was reported, ''Temperature excursion occurred while vaccine was in storage prior to administration. The excursion was identified after administration of the vaccine. The temperature reached 25.7�F for a duration of 4 hours and 17 minutes. The routine temperature check at 07:30 showed temperatures were within normal limits; temperatures were not rechecked prior to pulling the vaccine for administration at 13:30. Additionally, the temperature alarm was not alarming at the time staff pulled the vaccine from the storage unit.This incident could have been avoided by: Verifying storage temperatures prior to gathering the vaccine. Having an additional monitor that would alert staff directly if the temperature was out of range (e.g., Temp Stick). No adverse event occurred after administration.''. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA304532: More
2868411 3 M 10/27/2025 FLUX
 UNKNOWN MANUFACTURER
 U8827AA
No adverse event, Product storage error No adverse event, Product storage error
fluzone trivalent(unopened) refrigerator temperature knob was accidentality turned down/ max tempera... fluzone trivalent(unopened) refrigerator temperature knob was accidentality turned down/ max temperature reached: 25.7f degrees for 4 hours and 17 minutes, with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to this case US-SA-2025SA303262. This case involves a 3 years old male patient (107.2 cm and 17.69 kg) who was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], post excursion with maximum temperature reached: 25.7 Fahrenheit degrees for 4 hours and 17 minutes, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot U8827AA, expiry date:30-Jun-2026, frequency: once, strength :standard via unknown route in the left arm for Immunization, post excursion were exposed with maximum temperature reached: 25.7 Fahrenheit degrees for 4 hours and 17 minutes, with no reported adverse event (product storage error). Reportedly, there was no previous excursion. Human error was involved. The product was administered post-excursion. The extended stability data did not cover the excursion. Temperature excursion during vaccine storage. The excursion was identified after the vaccine had already been administered. Routine temperature check at 07:30 showed normal limits. Vaccine was pulled for administration at 13:30, but temperatures were not rechecked. Temperature alarm was not alarming when the vaccine was retrieved. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA303262: More
2868412 8 F 10/27/2025 FLU3
 SANOFI PASTEUR
 U8827AA
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion occurred while vaccine was in storage prior to administartion, temperature r... temperature excursion occurred while vaccine was in storage prior to administartion, temperature reached 25.7 f degrees duration: 4 hours and 17minutes with no reported adverse event; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA303262. This case involves a 8 years old female patient (136.39 cm and 33.11 kg) who was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], post excursion with maximum temperature reached: 25.7 degrees Fahrenheit for 4 hours and 17 minutes, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot U8827AA, expiry date:30-Jun-2026, frequency: once, strength :standard via unknown route in the left arm for Influenza prophylaxis (influenza Immunization), post excursion which was exposed to maximum temperature reached 25.7 Fahrenheit degrees for 4 hours and 17 minutes, with no reported adverse event (product storage error). Reportedly, human error was involved: reason for excursion refrigerator temperature knob was accidentality turned down. The extended stability data didn't cover the excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA303262: More
2868413 9 M 10/27/2025 FLU3
 SANOFI PASTEUR
 U8827AA
No adverse event, Product storage error No adverse event, Product storage error
patient received Fluzone post temperature excursion; Max temperature reached: 25.7F DEGREES; Duratio... patient received Fluzone post temperature excursion; Max temperature reached: 25.7F DEGREES; Duration: 4 hours and 17 minutes with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with US-SA-2025SA304532 (master case). This case involves a 9 years old male patient (140.97 cm and 38.55 kg) who received influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] post temperature excursion where max temperature reached: 25.7f degrees for the duration: 4 hours and 17 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- unknown, expiry date- 30-JUN-2026 and lot U8827AA) once via intramuscular route in unknown administration site for influenza prophylaxis (Influenza immunization) post temperature excursion where max temperature reached: 25.7f degrees for the duration: 4 hours and 17 minutes with no reported adverse event (product storage error). It was reported that, Temperature excursion occurred while vaccine was in storage prior to administration. The excursion was identified after administration of the vaccine. The temperature reached 25.7 f degrees duration: 4 hours and 17 minutes. The routine temperature check at 07:30 showed temps were within normal limits; temperatures were not rechecked prior to pulling the vaccine for administration at 13:30. Additionally, the temperature alarm was not alarming at the time staff pulled the vaccine from the storage unit. This incident could have been avoided by verifying storage temperatures prior to gathering the vaccine, and by having an additional monitor that would alert staff directly if the temperature was out of range ie. Temp stick. Reason: refrigerator temperature knob was accidentality turned down. There was no Previous Excursion. Human error was involved. The extended stability data did not cover the excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA304532: More
2868414 6 M 10/27/2025 FLU3
 SANOFI PASTEUR
 U8827AA
No adverse event, Product storage error No adverse event, Product storage error
Temperature excursion as temperature reached 25.7�F for a duration of 4 hours and 17 minutes and v... Temperature excursion as temperature reached 25.7�F for a duration of 4 hours and 17 minutes and vaccine was administered post excursion with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA304532 (master case). This case involves 6 years old male patient (109 cm and 16.7 kg) and reporter reported temperature excursion as temperature reached 25.7�f for a duration of 4 hours and 17 minutes and INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] was administered post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received a dose of 0.5 ml of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (frequency-once, Strength: standard) (lot U8827AA, expiry date- 30-JUN-2026) via intramuscular route in right arm for Influenza prophylaxis (Influenza immunization), which had temperature excursion as temperature reached 25.7�f for a duration of 4 hours and 17 minutes and vaccine was administered post excursion with no reported adverse event (product storage error). It was reported, ''Temperature excursion occurred while vaccine was in storage prior to administration. The excursion was identified after administration of the vaccine. The temperature reached 25.7�F for a duration of 4 hours and 17 minutes. The routine temperature check at 07:30 showed temperatures were within normal limits; temperatures were not rechecked prior to pulling the vaccine for administration at 13:30. Additionally, the temperature alarm was not alarming at the time staff pulled the vaccine from the storage unit.This incident could have been avoided by: Verifying storage temperatures prior to gathering the vaccine. Having an additional monitor that would alert staff directly if the temperature was out of range (e.g., Temp Stick). No adverse event occurred after administration.''. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA304532:master case More
2868415 0.58 M 10/27/2025 FLU3
 SANOFI PASTEUR
 U8827AA
No adverse event, Product storage error No adverse event, Product storage error
fluzone trivalent(unopened) refrigerator temperature knob was accidentality turned down/ max tempera... fluzone trivalent(unopened) refrigerator temperature knob was accidentality turned down/ max temperature reached: 25.7f degrees for 4 hours and 17 minutes, with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old male patient (58.42 cm and 5.44 kg) who received influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] (unopened) post temperature excursion; the temperature excursion was due to refrigerator temperature knob was accidentality turned down where max temperature reached: 25.7 Fahrenheit degrees for the duration: 4 hours and 17 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection, expiry date: 30-Jun-2026 and lot U8827AA, frequency: once, via intramuscular route in unknown administrative site for influenza prophylaxis (Immunisation) post temperature excursion and the temperature excursion was due to refrigerator temperature knob was accidentality turned down where max temperature reached: 25.7f degrees for the duration: 4 hours and 17 minutes with no reported adverse event (product storage error) (unknown latency). Reportedly, there was no previous excursion. Human error was involved. The product was administered post-excursion. The extended stability data did not cover the excursion. Temperature excursion during vaccine storage. The excursion was identified after the vaccine had already been administered. Routine temperature check at 07:30 showed normal limits. Vaccine was pulled for administration at 13:30, but temperatures were not rechecked. Temperature alarm was not alarming when the vaccine was retrieved. 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
2868416 4 M 10/27/2025 FLU3
 SANOFI PASTEUR
 U8827AA
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion occurred while vaccine was in storage prior to administartion, temperature r... temperature excursion occurred while vaccine was in storage prior to administartion, temperature reached 25.7 f degrees duration: 4 hours and 17minutes with no reported adverse event; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA303262. This case involves a 4 years old male patient (104.14 cm and 20 kg) who was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], post excursion with maximum temperature reached: 25.7 degrees Fahrenheit for 4 hours and 17 minutes, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot U8827AA, expiry date:30-Jun-2026, frequency: once, strength :standard via unknown route in the left arm for Influenza prophylaxis (influenza Immunization), post excursion which was exposed to maximum temperature reached 25.7 Fahrenheit degrees for 4 hours and 17 minutes, with no reported adverse event (product storage error). Reportedly, human error was involved: reason for excursion refrigerator temperature knob was accidentality turned down. The extended stability data didn't cover the excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA303262: More
2868418 10/27/2025 FLU3
 SANOFI PASTEUR
Cough, Visual impairment Cough, Visual impairment
coughing; some vision issues; Initial information received on 15-Oct-2025 regarding an unsolicited v... coughing; some vision issues; Initial information received on 15-Oct-2025 regarding an unsolicited valid non-serious case received from Patient. This case involves an unknown age/gender patient who experienced coughing and some vision issues after receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2024, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE, Suspension for injection (dose, strength, lot, expiry, route and administration site: unknown) for prophylactic vaccination (immunization). On an unknown date in 2024, the patient developed a non-serious coughing (cough) and some vision issues (visual impairment) (unknown latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (coughing, some vision issues). At time of reporting, the outcome was Unknown for the events (coughing, some vision issues). More
2868419 82 F OH 10/27/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
U87678A
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
got the FLUZONE NP in error instead the prescribed FLUZONE HD with no reported adverse event; Initia... got the FLUZONE NP in error instead the prescribed FLUZONE HD with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 82 years old female patient who got the influenza USP trival A-B subvirion no preservative vaccine [Fluzone] in error instead the prescribed influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immunodeficiency. On 20-Sep-2025, the patient received a dose of 0.5 ml once of suspect influenza USP trival A-B subvirion no preservative vaccine (Suspension for injection) (lot: U87678A; strength: standard) (expiry date: unknown) via unknown route in unknown administration site for Immunization instead of the prescribed influenza USP trival A-B high dose subvirion vaccine (Suspension for injection in pre-filled syringe) with no reported adverse event (wrong product 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
2868420 4 F NY 10/27/2025 UNK
 UNKNOWN MANUFACTURER
 U8832BA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
administration of flublok to a 4-year-old patient with no reported adverse event; Initial informatio... administration of flublok to a 4-year-old patient with no reported adverse event; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old female patient who had administration of influenza trivalent recombinant vaccine [Flublok TIV] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Oct-2025, a 4-year-old patient received a dose 1 of 0.5 ml once of suspect Influenza Trivalent Recombinant Vaccine (Solution for Injection) (lot: U8832BA; expiry date: 31-May-2026) (strength: standard) via intramuscular route in the left thigh for Immunization with no reported adverse event (product administered to patient of inappropriate age) (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
2868421 67 M OR 10/27/2025 FLU3
 SANOFI PASTEUR
 U8855DA
No adverse event, Product storage error No adverse event, Product storage error
Max/low temperature reached: negative 7 �C to 5 �C for 4 hours and 30 minutes with no reported a... Max/low temperature reached: negative 7 �C to 5 �C for 4 hours and 30 minutes with no reported adverse events; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from other health professional. This case was linked with other cases US-SA-2025SA311838 and US-SA-2025SA311712. This case involves a 67 years old male patient who received influenza USP trival A-B high dose subvirion vaccine [fluzone HD] that was exposed to max/low temperature reached: negative 7 �c to 5 �c for 4 hours and 30 minutes with no reported adverse events. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-OCT-2025, the patient received 0.5 ml of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of strength: high dose, frequency: once with lot U8855DA and expiry date 30-JUN-2026 via intramuscular route in the right deltoid for Influenza immunization. On an unknown date, the suspect influenza USP trival A-B high dose subvirion vaccine was exposed to max/low temperature reached: negative 7 �c to 5 �c for 4 hours and 30 minutes with no reported adverse events (product storage error). It was reported, "Previous excursion: No. Human error involved. Product was administered. extended stability data did not cover the excursion" Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA311838:02693084 US-SA-2025SA311712:02693089 US-SA-2025SA311712:master case More
2868423 88 F OR 10/27/2025 FLU3
 SANOFI PASTEUR
 UT8781CA
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
temperature excursion as max/low temperature reached: negative 7 �c to 5 �c for 4 hours and 30 m... temperature excursion as max/low temperature reached: negative 7 �c to 5 �c for 4 hours and 30 minutes and product was administered after excursion with no adverse event; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional (Nursing supervisor). This case is linked to US-SA-2025SA311712 and US-SA-2025SA312041 This case involves 88 years old female patient and reporter reported temperature excursion as max/low temperature reached: negative 7 �c to 5 �c for 4 hours and 30 minutes and influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] was administered after excursion with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List of concomitant vaccines: No other vaccines On 15-Oct-2025, the patient received a dose of 0.5 ml of suspect influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot UT8781CA, expiry date- 30-JUN-2026) (Strength: High dose; Frequency: Once) via intramuscular route in the left deltoid for Influenza (Influenza immunization); which had temperature excursion as max/low temperature reached: negative 7 �c to 5 �c for 4 hours and 30 minutes and product was administered after excursion with no adverse event (product storage error). It was reported, ''Nursing supervisor called to report a temperature excursion and wanted stability information. Previous excursion: No. Human error involved. Product was administered. extended stability data did not cover the excursion. They said that the product was administered to three patients; Treatment: None ''. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA311712:02693089 US-SA-2025SA312041: More
2868424 86 F OR 10/27/2025 FLU3
 SANOFI PASTEUR
 U8855DA
No adverse event, Product storage error No adverse event, Product storage error
Fluzone HD exposed to temperature excursion; Max/low temperature reached: negative 7 �C to 5 � C... Fluzone HD exposed to temperature excursion; Max/low temperature reached: negative 7 �C to 5 � C, Duration: 4 hours and 30 minutes with no reported adverse event; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with US-SA-2025SA312041 (master case). This case involves a 86 years old female patient who received influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] was exposed to temperature excursion where max/low temperature reached: negative 7 �c to 5 � c for the duration: 4 hours and 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List of concomitant vaccines: No other vaccines On 15-Oct-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with strength- high dose (expiry date- 30-JUN-2026 and lot U8855DA) once via intramuscular route in the left deltoid for Influenza (influenza immunization) post excursion where max/low temperature reached: negative 7 �c to 5 � c, duration: 4 hours and 30 minutes with no reported adverse event (product storage error). It was reported, "Previous Excursion: None. Human error was involved. The extended stability data cover the excursion: No" Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA312041:master case US-SA-2025SA311838:02693089 US-SA-2025SA312041:02693089 More
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