๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

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

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2872111 46 F OR 11/11/2025 COVID19
 PFIZER\BIONTECH
 na0590
Rash, Swelling Rash, Swelling
patient initially had a rash and then significant swelling occured. her dr told her to take claritin... patient initially had a rash and then significant swelling occured. her dr told her to take claritin and apply hydrocortisone More
2872113 73 F KY 11/11/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052864
UT8781BA
Thalamic stroke; Thalamic stroke Thalamic stroke; Thalamic stroke
As per incident report received from PCP Physician: Pt suffered a R thalamic stroke 2 days after coa... As per incident report received from PCP Physician: Pt suffered a R thalamic stroke 2 days after coadministration of COVID and high dose flu. There is a slight increase risk of nonhemorrhagic stroke when high dose flu and bivalent COVID vaccines specifically are given together, but there is no specific recommendation against doing so given the increased benefit of immunization with both vaccines. Of note, the increased risk appears to come from the high dose flu, not the COVID vaccine specifically, as standard dose flu co-administered with COVID vaccine does not have this risk. Pt seen at hospital. More
โœ“
2872114 64 M MS 11/11/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 CY3MGA
Erythema, Peripheral swelling, Skin discolouration Erythema, Peripheral swelling, Skin discolouration
Patients left arm is red, swollen, discolored in the middle with red ring around the outside startin... Patients left arm is red, swollen, discolored in the middle with red ring around the outside starting on 11/4/25. More
2872118 11/11/2025 FLU3
 SANOFI PASTEUR
 TFAA2544
Limb injury Limb injury
Shoulder injury, physical therapy Shoulder injury, physical therapy
2872119 25 F VA 11/11/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 LT9HP
Limb injury Limb injury
Shoulder injury, physical therapy Shoulder injury, physical therapy
2872120 73 M TX 11/11/2025 COVID19
FLU3
PNC21
 PFIZER\BIONTECH
SANOFI PASTEUR
MERCK & CO. INC.
 na0590
u8862ca
z007870
Pruritus, Swelling; Pruritus, Swelling; Pruritus, Swelling Pruritus, Swelling; Pruritus, Swelling; Pruritus, Swelling
patient reported arm swelling and itching patient reported arm swelling and itching
2872121 45 M MO 11/11/2025 COVID19
FLU3
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS

Diarrhoea, Lip swelling, Oesophageal disorder, Urticaria; Diarrhoea, Lip swellin... Diarrhoea, Lip swelling, Oesophageal disorder, Urticaria; Diarrhoea, Lip swelling, Oesophageal disorder, Urticaria More
Recurring Hives, intermittent diahrea, intermitten swelling of lips, intermitent swelling of esophog... Recurring Hives, intermittent diahrea, intermitten swelling of lips, intermitent swelling of esophogus. More
2872124 76 F NM 11/11/2025 COVID19
 PFIZER\BIONTECH
 NA0739
Injection site pain, Injection site pruritus, Injection site swelling Injection site pain, Injection site pruritus, Injection site swelling
Swelling, pain, itch in left deltoid . patient applied Traumeel and cortisone topically. patient has... Swelling, pain, itch in left deltoid . patient applied Traumeel and cortisone topically. patient has recovered. More
2872126 75 F CO 11/11/2025 COVID19
 MODERNA
 3052732
Oral herpes, Oral pain Oral herpes, Oral pain
Arm got red and swollen for 5-6 days following the vaccine. Fever blister on lip 1 week after the v... Arm got red and swollen for 5-6 days following the vaccine. Fever blister on lip 1 week after the vaccine for 1 week. Middle of mouth was sore for a day and a half . Finally better 11/5/25 More
2872127 53 F NE 11/11/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 ES4H5
Injection site pain Injection site pain
Patient complains of pain at or near the injection site > 1 month after injection. Patient complains of pain at or near the injection site > 1 month after injection.
2872139 67 M TX 11/11/2025 COVID19
 MODERNA
COVID-19, Vaccination failure COVID-19, Vaccination failure
COVID; mNEXSPIKE 25-26 does not work; This spontaneous case was reported by a consumer and describes... COVID; mNEXSPIKE 25-26 does not work; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and VACCINATION FAILURE (mNEXSPIKE 25-26 does not work) in a 67-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 24-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 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 COVID-19 (COVID) and VACCINATION FAILURE (mNEXSPIKE 25-26 does not work). At the time of the report, COVID-19 (COVID) had not resolved and VACCINATION FAILURE (mNEXSPIKE 25-26 does not work) outcome was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as unknown. No concomitant medication was reported. It was reported that mNEXSPIKE 25-26 did not work, patient and his wife both received this vaccine and subsequently caught COVID on or around 17-Oct-2025. Two weeks later, they were still very sick and coughing up mucus. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790809 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790809:Original Case Number : MOD-2025-790809/ wife's case More
2872140 M 11/11/2025 COVID19
 MODERNA
 UNK
Malaise Malaise
he felt a little off; This spontaneous case was reported by a consumer and describes the occurrence ... he felt a little off; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (he felt a little off) in a male patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. UNK) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 31-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 31-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced MALAISE (he felt a little off). At the time of the report, MALAISE (he felt a little off) outcome was unknown. No concomitant medications provided by the reporter. It was received that the patient received updated Moderna Covid shot on 31-Oct-2025 at an unknown location. It was received that post vaccination the patient felt a little off after the vaccination. No treatment medications provided by the reporter. More
2872141 38 M NY 11/11/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA








Laboratory test, Nausea, Oropharyngeal pain, Pyrexia; Nausea, Oropharyngeal pain... Laboratory test, Nausea, Oropharyngeal pain, Pyrexia; Nausea, Oropharyngeal pain, Pyrexia, Vomiting; Diarrhoea, Nausea, Oropharyngeal pain, Pyrexia, Vomiting; Laboratory test, Nausea, Oropharyngeal pain, Pyrexia; Nausea, Oropharyngeal pain, Pyrexia, Vomiting; Diarrhoea, Nausea, Oropharyngeal pain, Pyrexia, Vomiting; Laboratory test, Nausea, Oropharyngeal pain, Pyrexia; Nausea, Oropharyngeal pain, Pyrexia, Vomiting; Diarrhoea, Nausea, Oropharyngeal pain, Pyrexia, Vomiting More
Sore throats; Fevers; Queasy; This spontaneous case was reported by a consumer and describes the occ... Sore throats; Fevers; Queasy; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throats), PYREXIA (Fevers) and NAUSEA (Queasy) in a 38-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 31-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 01-Nov-2025, the patient experienced OROPHARYNGEAL PAIN (Sore throats), PYREXIA (Fevers) and NAUSEA (Queasy). At the time of the report, OROPHARYNGEAL PAIN (Sore throats), PYREXIA (Fevers) and NAUSEA (Queasy) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2025, Laboratory test: Everything returned within normal range. No concomitant medications were provided. The patient had the vaccine and had fever, which was expected. However, the patient had sore throats, which was not expected. The patient felt queasy. It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no additional lab data/results available. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790840, US-MODERNATX, INC.-MOD-2025-790841 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790841:Child case US-MODERNATX, INC.-MOD-2025-790840:Mother case More
2872142 73 F 11/11/2025 COVID19
COVID19
 MODERNA
MODERNA

Asthenia, Chills, Discomfort, Illness, Pain; Pyrexia Asthenia, Chills, Discomfort, Illness, Pain; Pyrexia
uncomfortable; fever; shivering; pain; Absolutely no energy and no strength; I've been very sic... uncomfortable; fever; shivering; pain; Absolutely no energy and no strength; I've been very sick since I got that vaccine yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), ASTHENIA (Absolutely no energy and no strength), ILLNESS (I've been very sick since I got that vaccine yesterday), DISCOMFORT (uncomfortable) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Systemic anaphylaxis (5 times since twenties). Previously administered products included for COVID-19 prophylaxis: SPIKEVAX [ELASOMERAN] (Patient had two Moderna's) and SPIKEVAX [ELASOMERAN] (Patient had two Moderna's); for Product used for unknown indication: COMIRNATY (Patient had two Pfizer's), COMIRNATY (Patient then got a Pfizer alternating) and COMIRNATY (Patient had two Pfizer's). Past adverse reactions to the above products included No adverse effect with COMIRNATY, COMIRNATY, COMIRNATY, SPIKEVAX [ELASOMERAN] and SPIKEVAX [ELASOMERAN]. Concurrent medical conditions included Asthma and Allergy. Concomitant products included Influenza vaccine from 11-Sep-2025 to 11-Sep-2025 for an unknown indication. On 05-Nov-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 05-Nov-2025, the patient experienced PAIN (pain), ASTHENIA (Absolutely no energy and no strength), ILLNESS (I've been very sick since I got that vaccine yesterday), PYREXIA (fever) and CHILLS (shivering). On 06-Nov-2025, the patient experienced DISCOMFORT (uncomfortable). At the time of the report, PAIN (pain), ASTHENIA (Absolutely no energy and no strength), ILLNESS (I've been very sick since I got that vaccine yesterday), PYREXIA (fever) and CHILLS (shivering) had not resolved and DISCOMFORT (uncomfortable) outcome was unknown. The patient could not get COVID, as the patient had Moderna before. The patient had two Pfizer's, then had two Moderna's, then got a Pfizer alternating, and this time the patient was supposed to get the mNEXSPIKE. The patient was very sick since she got that vaccine the day before reporting. The patient had so many allergies and everything. The patient was so sick last night, all night shivering, pain, uncomfortable on the day of reporting. Patient had no energy and strength. The patient still had a fever, but it was not quite as bad. The patient was at very high risk of serious complications from COVID because patient was asthmatic, old, and had gone through systemic anaphylaxis reactions maybe 5 times since the patient was in her twenties. The patient was very upset and confused due to receiving Spikevax 2025-2026 instead of mNEXSPIKE 2025-2026. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. No causality provided. More
2872146 11/11/2025 COVID19
 PFIZER\BIONTECH
Illness Illness
it made me sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID:... it made me sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "it made me sick". Additional information: It was reported that I did not mean to put trust in, I do not trust Pfizer because I got the covid shot, a few years ago and it made me sick. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2872147 M SC 11/11/2025 COVID19
 PFIZER\BIONTECH
COVID-19 COVID-19
Covid after Pfizer Covid Booster; This is a spontaneous report received from a Consumer or other non... Covid after Pfizer Covid Booster; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 64-year-old male 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "Covid after Pfizer Covid Booster". Additional Information: During an inbound call for financial assistance, the patient, stated, he was prescribed paxlovid today he was wondering if he qualify for any of these programs. he know he have a limited window where he can start this medication. When advised that he did not qualify because his income exceeded the program eligibility, This was his first experience with it, and the doctor, she may not have known and, you know, prescribed to her local pharmacy. He was sort of scrambling to figure out what he need to do today being day two. After advising him to reach out to his healthcare provider, Patient stated, he was waiting for her to write him back. We got a Pfizer booster, COVID boosters on Wednesday. And ironically, the day after, he came up with symptoms. And he tested positive today for COVID. And we were at a wedding over the weekend. So, we stuck with Pfizer. He thought that you may be able to pull a rabbit out of your hat, but not this time. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2872149 52 F KY 11/11/2025 UNK
 UNKNOWN MANUFACTURER
Headache, Malaise, Myalgia Headache, Malaise, Myalgia
mild myalgia; mild headache; general feeling of being unwell for about 24 hours; Initial information... mild myalgia; mild headache; general feeling of being unwell for about 24 hours; Initial information received on 05-Nov-2025 regarding an unsolicited valid non-serious case received from patient. This case involves a 52 years old female patient who had mild myalgia, mild headache and general feeling of being unwell for about 24 hours after receiving influenza trivalent recombinant vaccine [Flublok TIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Nov-2025, the patient received 0.5 ml of suspect influenza trivalent recombinant vaccine Solution for injection of standard strength, frequency once (Unknown lot and expiry date) via intramuscular route in the right arm for Influenza (Influenza immunisation). On 04-Nov-2025 the patient developed mild myalgia (myalgia), mild headache (headache) and general feeling of being unwell for about 24 hours (malaise) (latency same day) following the administration of influenza trivalent recombinant vaccine. Action taken was not applicable. The patient was treated with paracetamol (Tylenol) for Myalgia, Headache and Malaise. At time of reporting, the outcome was Recovered / Resolved on 05-Nov-2025 for all the events. More
2872150 KY 11/11/2025 FLU3
 SANOFI PASTEUR
Extra dose administered, No adverse event Extra dose administered, No adverse event
mentioned that they gave a fluzone hd today and after administration, they realized that the patient... mentioned that they gave a fluzone hd today and after administration, they realized that the patient already had that vaccine a month ago with no reported ae; Initial information received on 05-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient reporter mentioned that they gave a INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] today and after administration, they realized that the patient already had that vaccine a month ago with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2025, the patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Influenza (Influenza immunisation). On 05-Nov-2025 patient also received another dose of same vaccine with an unknown batch number via unknown route in unknown administration site for Influenza (Influenza immunisation) after administration, they realized that the patient already had that vaccine a month ago with no reported ae (extra dose administered) (latency same day). Information on batch number and expiry date corresponding to the one at time of event occurrence could not be requested Action taken- not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2872151 5 M NC 11/11/2025 UNK
 UNKNOWN MANUFACTURER
 409608
Injection site rash Injection site rash
Rash like reaction on his upper left arm while still local to the injection site; This spontaneous c... Rash like reaction on his upper left arm while still local to the injection site; This spontaneous case, initially received on 20-Oct-2025, (Including additional information received on 06-Nov-2025) was reported by a non-health professional and concerns a child male patient. Drug history included flu vaccine. The concomitant medication and medical history were reported as unknown. Administration of company suspect drug: On 18-Oct-2025, the patient received Flucelvax (TIV) for Unknown indication, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Left Deltoid (upper left arm), Lot number: 409608, Expiry date: 30-Jun-2026. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-Oct-2025, the patient experienced Rash like reaction on his upper left arm while still local to the injection site (outcome: Unknown). On 19-Oct-2025, the patient's family member saw noticeably large rash like reaction on his upper left arm while local to the injection site. It might be 3-5 inches in diameter. He had not mentioned any itching, pain or discomfort of any sort up to that point. When asked, he told the reporter that it did not hurt or itch and he felt fine. His temperature was normal the forehead thermometer used. The reporter known those were not very accurate. The patient's father took pictures of his arm for documentation and mentioned he had no history of reaction to an injection of any type, including prior vaccination and specifically flu vaccine. He had previously gotten vaccine at family clinic as well as other locations from other manufacturer. Outcome of event: Unknown Treatment measure associated with event: Unknown Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide seriousness and causality assessment.; Reporter's Comments: The event is related due to spontaneous nature of event More
2872152 11/11/2025 UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 No batch number
No batch number
No batch number
Arthralgia, Asthenia, Chills, Cough, Dizziness; Fatigue, Injection site pain, Or... Arthralgia, Asthenia, Chills, Cough, Dizziness; Fatigue, Injection site pain, Oropharyngeal pain, Productive cough, Pruritus; Pyrexia, Rash, Rash erythematous, Rhinorrhoea, Sneezing More
Sore throat; Productive coughing with mucus; Runny nose; 101.4 F fever; Runny nose; Dry cough; Sever... Sore throat; Productive coughing with mucus; Runny nose; 101.4 F fever; Runny nose; Dry cough; Severe joint pain; Sneezing; Weakness; Injection site soreness; Tired; Getting chills; Feeling dizzy; Red skin rash; Skin itching; This spontaneous case, initially received on 23-Oct-2025, was reported by a non health professional and concerns a patient of unknown age/gender. Medical history and concomitant medication were reported as unknown. Administration of company suspect drug: On 17-Oct-2025, the patient received Fluad (TIV) for Indication not reported, dose regimen: not reported, route of administration: not reported, anatomical location: not reported. Lot number: No batch number available and requested upon follow-up. Adverse reactions/events and outcomes: On 18-Oct-2025, the patient experienced 101.4 F fever (outcome: Recovering / Resolving), Runny nose (outcome: Unknown), Dry cough (outcome: Unknown), Severe joint pain (outcome: Unknown), Sneezing (outcome: Unknown), Weakness (outcome: Unknown). On 19-Oct-2025, the patient experienced Productive coughing with mucus (outcome: Unknown), Runny nose (outcome: Unknown). On 21-Oct-2025, the patient experienced Sore throat (outcome: Unknown). On Oct-2025, the patient experienced Injection site soreness (outcome: Unknown), Tired (outcome: Unknown), Getting chills (outcome: Unknown), Feeling dizzy (outcome: Unknown), Red skin rash (outcome: Unknown), Skin itching (outcome: Unknown). On 17-Oct-2025, reporter was given an injection of the Fluad 65+ vaccine at reporter's local pharmacy. Within 7 hours of receiving the vaccination, reporter had the usual injection site soreness and was tired. During this time, reporter also started getting chills, feeling dizzy and developed a 1 1/2 red skin rash on reporter's opposite arm. By the next morning, reporter was running a 101.4๏ฟฝF fever, had a runny nose and a dry cough, severe joint pain, sneezing and weakness. It took several days for reporter's fever to subside. Reporter was taking ibuprofen and cetirizine hydrochloride to control the skin itching/rash and fever/joint pain. At days 3๏ฟฝ4, reporter had productive coughing with mucus and runny nose. At day 5, reporter had a sore throat that only subsided that night. Reporter reported these symptoms to reporter's doctors and filed a report with VAERS. Note: Reporter had had other flu vaccines for seniors over the past seven years and none of them gave such an extreme reaction other than 2 days of tiredness and a sore arm at the injection site. Reporter suspected that the adjuvant used in this vaccine was responsible for this extreme reaction. Fluad (TIV) action taken: Not Applicable Treatment medication: Cetirizine dihydrochloride , Ibuprofen Reporter's assessment: The reporter assessed serioussness as unknown for events and causality was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, events are considered related for reporting purposes More
2872154 77 M GA 11/11/2025 COVID19
 MODERNA
 3052671
Aphasia, Mobility decreased, Unresponsive to stimuli Aphasia, Mobility decreased, Unresponsive to stimuli
Patient received vaccine on 11/10/25 with no adverse reactions during that day. The patient's s... Patient received vaccine on 11/10/25 with no adverse reactions during that day. The patient's spouse contacted the pharmacy on 11/11/25 at around 3:30pm and stated that patient had an episode of non-responsiveness in the morning for about an hour and a half. She said he was still breathing during the episode, but he was non-verbal and could not move his arms or mouth. She said a visitation angel was there as well and his blood pressure was in normal range and his pupils were reactive to light. She said he had this reaction to a muscle relaxer a while back as well. She said he was "zoned out" for a while today until they crushed his carbidopa/levodopa pills to give to him, and then he was responsive once those took effect. We asked if she had contacted emergency 911 and she said no, but they were monitoring him. She said he has been ok the rest of the day but is just a little slow moving around. She said some days he is slower than others due to dementia and the Parkinson's disease. She said that if he shows any other signs again of this, she will take him to get seen. More
2872155 31 F WA 11/11/2025 FLU3
 SEQIRUS, INC.
 409411
Blood glucose normal, Dizziness, Hyperhidrosis, Pruritus, Rash Blood glucose normal, Dizziness, Hyperhidrosis, Pruritus, Rash
Rash, itching, sweating and dizziness approx. i hour after vaccination, denies SOB or trouble breath... Rash, itching, sweating and dizziness approx. i hour after vaccination, denies SOB or trouble breathing. No previous allergic reaction to vaccine. Treatment: Decadron injection, pepcid IV, CMP, More
2872156 75 F NY 11/11/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 MY9550
409166
Asthenia, Malaise, Urinary tract infection; Asthenia, Malaise, Urinary tract inf... Asthenia, Malaise, Urinary tract infection; Asthenia, Malaise, Urinary tract infection More
PT RECEIVED VACCINES AROUNF 9;20 PM AND WAS SITTING IN THE PHARMACY. AROUND 10;45, WHILE THE PT WAS ... PT RECEIVED VACCINES AROUNF 9;20 PM AND WAS SITTING IN THE PHARMACY. AROUND 10;45, WHILE THE PT WAS LEAVING SHE WASNT FEELING GOOD, SHE FELT WEAK AND ILL AND THE ABULNACE WAS CALLED. AT THE HOSPITAL PT WAS DIAGNES WIHT A UTI More
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2872178 62 F ID 11/11/2025 FLU3
 SEQIRUS, INC.
 408924
Wrong product administered Wrong product administered
Patient requested Covid vaccine and was given Fluad 11/10/2025. Patient had Flucelvax administered 9... Patient requested Covid vaccine and was given Fluad 11/10/2025. Patient had Flucelvax administered 9/19/2025. More
2872180 76 M PA 11/11/2025 FLU3
 SANOFI PASTEUR
 u8859ca
Rash Rash
rash on chest, back and arms rash on chest, back and arms
2872182 28 M LA 11/11/2025 FLU3
HEP
TDAP
 SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
 u8863ca
947931
94kg2
Fall, Loss of consciousness, Tremor; Fall, Loss of consciousness, Tremor; Fall, ... Fall, Loss of consciousness, Tremor; Fall, Loss of consciousness, Tremor; Fall, Loss of consciousness, Tremor More
Administered the three vaccinations, and patient began to tremor. As I was getting help patient fell... Administered the three vaccinations, and patient began to tremor. As I was getting help patient fell from Chair to Floor and passed out. Patient was able to quickly become responsive and I helped him back in his seat. Patient again began tremoring where this time I held him up from falling. We then called EMS and waited for their assistance until they arrived. More
2872183 4 M WA 11/11/2025 COVID19
 PFIZER\BIONTECH
 na0846
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
I asked a co-worker which Covid vaccine he would need. She misunderstood the age that I told her tha... I asked a co-worker which Covid vaccine he would need. She misunderstood the age that I told her that he was and we chose the wrong covid product for his age. More
2872184 53 F MO 11/11/2025 FLU3
FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 3F7A5
3F7A5
3F7A5
Gait disturbance, Hypoaesthesia, Laboratory test normal, Limb discomfort, Lumbar... Gait disturbance, Hypoaesthesia, Laboratory test normal, Limb discomfort, Lumbar puncture normal; Magnetic resonance imaging head normal, Magnetic resonance imaging neck normal, Magnetic resonance imaging spinal normal, Magnetic resonance imaging thoracic normal, Muscular weakness; Paraesthesia More
I received the vaccine on 8/31/25. On 9/14/25, I developed leg weakness and heaviness. I had a hard ... I received the vaccine on 8/31/25. On 9/14/25, I developed leg weakness and heaviness. I had a hard time walking up stairs. My arms and hands developed numbness and tingling. This progressively got worse and I was seen 3 times in the Emergency room and was finally admitted to the hospital for a few days for testing and treatment. All tests have come back normal. More
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2872186 71 M TX 11/11/2025 COVID19
 MODERNA
 3052733
Pruritus Pruritus
patient has experience itchiness on the right arm and it about 2 by 3 inches area patient has experience itchiness on the right arm and it about 2 by 3 inches area
2872187 94 F CA 11/11/2025 FLU3
FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
 407272
407272
407272
Aphasia, Asthenia, Blood magnesium, Computerised tomogram head, Electrocardiogra... Aphasia, Asthenia, Blood magnesium, Computerised tomogram head, Electrocardiogram; Full blood count, Influenza virus test, Magnetic resonance imaging head, Malaise, Pain; Somnolence, Urine analysis, Vitamin B12 More
She is weak, achy, feeling unwell. Daughter reports patient can't think of words, or put sente... She is weak, achy, feeling unwell. Daughter reports patient can't think of words, or put sentences together Forgetful of her surroundings. Very groggy and just wants to sleep. This has been going on for 2.5 weeks More
2872190 27 F CA 11/11/2025 COVID19
 NOVAVAX
Blood test, Chest X-ray, Electrocardiogram, Palpitations Blood test, Chest X-ray, Electrocardiogram, Palpitations
Heart pounding , will need to follow up with PCP for further evaluation and monitoring as recommende... Heart pounding , will need to follow up with PCP for further evaluation and monitoring as recommended by ER doctor. More
2872191 46 F AZ 11/11/2025 FLU3
 SANOFI PASTEUR
 UT8802NA
Injection site erythema, Injection site induration, Insomnia Injection site erythema, Injection site induration, Insomnia
3 hrs after vaccine I noticed an 1-2? induration at the injection site surrounded by redness the ne... 3 hrs after vaccine I noticed an 1-2? induration at the injection site surrounded by redness the next day it quadrupled in size. Never had this kind of reaction despite getting flu shot every single year. Skin reaction resolved but also started experiencing insomnia night after injection and persisting to this day. (No history of insomnia or other probable causes) More
2872193 38 F IL 11/11/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.

Balance disorder, Chest X-ray, Dizziness, Electrocardiogram, Fibrin D dimer; Ful... Balance disorder, Chest X-ray, Dizziness, Electrocardiogram, Fibrin D dimer; Full blood count, Magnetic resonance imaging, Metabolic function test, Vertigo More
Experienced loss of balance in the bathroom in the early morning hours on 11/1. Went back to sleep, ... Experienced loss of balance in the bathroom in the early morning hours on 11/1. Went back to sleep, woke up feeling fine. Drove and began experiencing dizziness/lightheadedness while driving and had more issues with my balance while walking. At one point, felt like I was going to pass out at a stop light. These symptoms continued on and off the rest of the day. My dad brought some OTC bonine to try. Took 1 tab and fell asleep on the couch. An hour or two later, I woke up and experienced severe vertigo. Had to have help getting to bathroom and to bed. The following morning, it was back to the previous feelings of dizziness/lightheadedness. Since I have a history of MS, my husband insisted on taking to Clinic for a thorough work up. More
2868596 62 F FL 11/10/2025 FLUC4
 SEQIRUS, INC.
 406981
Injection site bruising, Injection site erythema, Injection site pain, Injection... Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Joint injury More
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injec... Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe More
2871598 F 11/10/2025 FLUX
 UNKNOWN MANUFACTURER
 247L3
Chills, Hepatic enzyme increased, Pyrexia Chills, Hepatic enzyme increased, Pyrexia
Fever; elevated liver enzymes; chills; This non-serious case was reported by a consumer and describe... Fever; elevated liver enzymes; chills; This non-serious case was reported by a consumer and described the occurrence of fever in a 60-year-old female patient who received Flu unspecified (Flu vaccine) (batch number 247L3, expiry date 30-JUN-2026) for prophylaxis. Concurrent medical conditions included diabetes, medullary sponge kidney, triglycerides high and anxiety. Concomitant products included semaglutide (Ozempic), hydrochlorothiazide;triamterene (Maxide), fenofibrate and bupropion. On 22-OCT-2025, the patient received Flu vaccine .5 ml. On 23-OCT-2025, 1 days after receiving Flu vaccine, the patient experienced fever (Verbatim: Fever), elevated liver enzymes (Verbatim: elevated liver enzymes) and chills (Verbatim: chills). The outcome of the fever, elevated liver enzymes and chills were resolving. It was unknown if the reporter considered the fever, elevated liver enzymes and chills to be related to Flu vaccine. It was unknown if the company considered the fever, elevated liver enzymes and chills to be related to Flu vaccine. Additional Information: GSK receipt date: 24-OCT-2025 The reporter mentioned after vaccine patient experienced fever 105, chills, elevated liver enzyme. More
2871603 51 F PA 11/10/2025 UNK
 UNKNOWN MANUFACTURER
 2NG23
Dizziness, Tremor Dizziness, Tremor
Dizziness; Shakiness; This non-serious case was reported by a consumer via call center representativ... Dizziness; Shakiness; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 51-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number 2NG23, expiry date JUN-2026) for prophylaxis. On 06-NOV-2025, the patient received Fluarix 2025-2026 season. On 06-NOV-2025, less than a day after receiving Fluarix 2025-2026 season, the patient experienced dizziness (Verbatim: Dizziness) and tremor (Verbatim: Shakiness). The outcome of the dizziness and tremor were not resolved. It was unknown if the reporter considered the dizziness and tremor to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the dizziness and tremor to be related to Fluarix 2025-2026 season and Fluarix 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. Additional Information: GSK Receipt Date: 06-NOV-2025 The patient self-reported this case for herself. The patient did not have any other conditions and did not receive any other products. More
2871611 F AL 11/10/2025 FLUX
 UNKNOWN MANUFACTURER
 UNK
Allergy to vaccine Allergy to vaccine
Allergic; This non-serious case was reported by a consumer via other manufacturer and described the ... Allergic; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of allergy to vaccine in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced allergy to vaccine (Verbatim: Allergic). The outcome of the allergy to vaccine was not reported. It was unknown if the reporter considered the allergy to vaccine to be related to Flu vaccine. It was unknown if the company considered the allergy to vaccine to be related to Flu vaccine. Additional Information: GSK Receipt Date: 23-OCT-2025 The patient self-reported this case for himself. Patient reported i was allergic to the flu and hepatitis vaccines, probably due to the preservatives. The batch number was not provided, and we are unable to contact the reporter. More
2871612 11/10/2025 FLUX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Malaise; Malaise Malaise; Malaise
took a Flu Shot patient was sick for 2 to 3 weeks; This non-serious case was reported by a consumer ... took a Flu Shot patient was sick for 2 to 3 weeks; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine and Flu vaccine. On an unknown date, an unknown time after receiving RSV vaccine and Flu vaccine, the patient experienced sickness (Verbatim: took a Flu Shot patient was sick for 2 to 3 weeks). The outcome of the sickness was resolved. It was unknown if the reporter considered the sickness to be related to RSV vaccine and Flu vaccine. It was unknown if the company considered the sickness to be related to RSV vaccine and Flu vaccine. Additional Information: GSK Receipt Date: 25-OCT-2025 This case was reported by a patient via interactive digital media. The patient reported discontinuing government-administered vaccines approximately 40 years ago. The patient stated that prior to discontinuation, each influenza vaccination resulted in illness lasting 2 to 3 weeks. The batch number was not provided, and we are unable to contact the reporter. More
2871626 M MO 11/10/2025 FLU3
FLUX
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 B59DH
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
overdose; This non-serious case was reported by a other health professional via call center represe... overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number B59DH, expiry date 30-JUN-2026) for prophylaxis. Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Fluarix 2024-2025 season and Influenza vaccine. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season and Influenza vaccine, the patient experienced accidental overdose (Verbatim: overdose). The outcome of the accidental overdose 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:24-OCT-2025 The Department of Health administrator reports a patient received a high dose of flu vaccine and Fluarix at a flu clinic. He was supposed to get a covid vaccine and Fluarix but got a high dose of flu vaccine and Fluarix in error. The reporter consented to follow up. More
2871647 F 11/10/2025 COVID19
 UNKNOWN MANUFACTURER
Bradycardia, Echocardiogram, Heart rate, Hypovolaemia, Supraventricular tachycar... Bradycardia, Echocardiogram, Heart rate, Hypovolaemia, Supraventricular tachycardia More
BRADYCARDIA; SUPRAVENTRICULAR TACHYCARDIA (SVT); HYPOVOLEMIA; Initial information received on 27-Oct... BRADYCARDIA; SUPRAVENTRICULAR TACHYCARDIA (SVT); HYPOVOLEMIA; Initial information received on 27-Oct-2025 and 30-Oct-2025 (all processed together) regarding a solicited valid serious case received from a physician, in the scope of company sponsored study. This case involves a 50-year-old female subject who experienced bradycardia, hypovolemia and supraventricular tachycardia (SVT), during the study participation. The subject's past vaccination(s) included covid-19 vaccine on 06-Mar-2021 and 25-Mar-2021 (variant: Wuhan) and covid-19 vaccine on 30-Sep-2021 (variant: unknown); all via intramuscular route as Immunisation. The subject's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the subject had ongoing Irritable bowel syndrome since 1995, Drug hypersensitivity since 2004, Major depression and Migraine with aura both since 01-May-2013, Sjogren's syndrome and Gilbert's syndrome both since 28-Dec-2020, Postmenopause since Nov-2023, Generalised anxiety disorder and Hyperlipidaemia both since 02-Jul-2024. Concomitant medications included venlafaxine hydrochloride (effexor) for generalised anxiety disorder; sumatriptan succinate for migraine with aura; estradiol, norethisterone acetate for postmenopause; paracetamol (tylenol extra strength) for headache; ondansetron and loperamide both for gastrointestinal disorder; potassium for hypokalaemia; and magnesium sulfate for hypomagnesaemia. On 14-Oct-2025, the screening/ visit 1 was performed. At 12:44, the subject received a dose 01 of suspect investigational NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE, Solution for injection in pre-filled syringe at an unknown dose via unknown route in the left deltoid muscle as prophylactic vaccination. On 24-Oct-2025, 9 days 11 hrs 16 min following the administration of first dose NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE, the subject was admitted to the hospital and stated that they gave her intravenous (iv) hydration and iv ondansetron. They were going to discharge (DC) her home, but her heart rate was noted to be bradycardic in the 30s-40s. The subject was diagnosed with bradycardia (intensity: severe). She was admitted with continuous telemetry. Subject stated that they corrected her potassium and magnesium levels with iv potassium (K) and magnesium (Mg). The subject also had hypovolemia (hypovolaemia; intensity: severe) due to vomiting, diarrhea, and bradycardia as per DC record. The event of hypovolemia was assessed as medically significant. On 25-Oct-2025, the subject recovered from the event bradycardia. On same day, 10 days 11 hrs 16 min following the administration of NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE, the subject was going to be discharged on saturday but was then noted to have a run of supraventricular tachycardia (SVT) (supraventricular tachycardia; intensity: moderate). Subject was given flecainide for the arrythmta. Subject stated that she had 2 echocardiograms that were normal. She did not have any further runs of SVT and has a normal heart rate (HR) at this time. All the events were assessed as a medically attended adverse event (MAAE) but not an Adverse Event of Special Interest (AESI). Healthcare encounter was required for all the events. Specialist consultation was performed for bradycardia and supraventricular tachycardia (SVT). Action taken with SARS-COV-2 (OMICRON JN.1) RECOMBINANT SPIKE PROTEIN was not applicable for all the events. On 27-Oct-2025, it was planned to discharge the subject with a holter monitor and she was going to follow-up after a week of wearing the monitor. It was reported that the subject was in for unscheduled visit after hospitalization. Subject brought DC records. Diagnosis (DX) per record was hypovolemia which was due to vomiting, diarrhea, and bradycardia. On 28-Oct-2025, the subject recovered from the event hypovolemia. At time of reporting, the outcome was Recovering / Resolving for the event supraventricular tachycardia (SVT). All the events did not cause discontinuation of the subject from the study. Bradycardia, Hypovolemia and Supraventricular Tachycardia (SVT) were considered to be not related to NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE by the reporter and not reportable by the company based on company causality assessment. Rationale for Investigator Causality Assessment (Bradycardia): Awaiting medical records, but bradycardia might have been caused by gastrointeshnal illness electrolyte imbalance Relationship between bradycardia, hypovolemia and supraventricular tachycardia (SVT) and the study procedure was not related by the reporter and not reportable by the company based on company causality assessment.; Sender's Comments: Sanofi Company Comment dated 06-Nov-2025: This case involves a 50-year-old female subject who was diagnosed with bradycardia, hypovolemia and supraventricular tachycardia (SVT) following the study vaccine. Considering the use of concomitant medications, ongoing medical histories and nature of the event, the Sponsor considers, all the event as not related to the study vaccine, in agreement with the Investigator. Additionally, due to lack of information regarding subject family history, concurrent illness and risk factors, the case will be re-evaluated post further update. More
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2871648 10 F 11/10/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Chills, Tremor, Vomiting Chills, Tremor, Vomiting
Vomiting; Shivering; Shaking; This spontaneous case, initially received on 23-Oct-2025, was reported... Vomiting; Shivering; Shaking; This spontaneous case, initially received on 23-Oct-2025, was reported by a Non-Health Professional and concerns a child female patient. Weight: 35.28 kg; Height: 142.2 cm Administration of company suspect drug: On 22-Oct-2025 17:30, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: Not reported, Route of Administration: Not Reported, Anatomical location: Not reported, Lot number: No batch number available will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 23-Oct-2025 04:30, the patient experienced Vomiting (outcome: Recovered / Resolved, stop date: 23-Oct-2025 06:30), Shivering (outcome: Recovered / Resolved, stop date: 23-Oct-2025 06:30), Shaking (outcome: Recovered / Resolved, stop date: 23-Oct-2025 06:30). Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter considered the events Shaking, Shivering, Vomiting related to the administration of Flucelvax (TIV) and seriousness reported as non-serious; Reporter's Comments: Due to the spontaneous nature of the case, events Vomiting, Shivering and Shaking were considered related for reporting purposes More
2871649 F WA 11/10/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Needle issue, Underdose Needle issue, Underdose
When injecting the Fluad there was a needle error, she got some of it; some leaked but it was not wh... When injecting the Fluad there was a needle error, she got some of it; some leaked but it was not where the needle hooks; This spontaneous case, initially received on 24-Oct-2025, was reported by a health professional and concerns an female patient. Administration of company suspect drug: On 09-Oct-2025, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: Not reported, Lot numbers: not reported and will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 09-Oct-2025, the patient experienced When injecting the Fluad there was a needle error, she got some of it (outcome: Not Reported), some leaked but it was not where the needle hooks (outcome: Not Reported). The registered pharmacist (RPh) stated that when they were injecting the Fluad, there had been a needle error. They mentioned that the patient received some of the dose, but it was unclear how much, and they were trying to determine whether the patient needed to be revaccinated. The Registered Pharmacist (RPh) clarified that it was a needle error and not related to the company or the product itself, noting that the Fluad had worked well. They added that some of the vaccine had leaked, but not from where the needle connects, and asked whether it was recommended to administer a second shot. Fluad (TIV) action taken: Not applicable. Reporter's assessment: The reporter considered the events as non-serious and did not provide causality assessment.; Reporter's Comments: The events were considered as not related due to nature of event (special situation). More
2871672 69 F TN 11/10/2025 FLU3
 SANOFI PASTEUR
 U8859CA
Back pain, Dysstasia, Fall, X-ray Back pain, Dysstasia, Fall, X-ray
I fell backwards landing on my behind. Tried for several hours to get up my lower back is painful an... I fell backwards landing on my behind. Tried for several hours to get up my lower back is painful and family Dr injected steroids, gave written order for x-rays, now wants me to see orthopedic. Results of x-ray inconclusive. Still waiting for orthopedic appointment. More
2871673 77 F KY 11/10/2025 COVID19
 UNKNOWN MANUFACTURER
Erythema, Pruritus, Rash Erythema, Pruritus, Rash
Skin erythema, itching, rash, (R) arm (upper) Skin erythema, itching, rash, (R) arm (upper)
2871737 32 F NH 11/10/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Injection site pain, Pain, Pain in extremity, Shoulder injury related to vaccine... Injection site pain, Pain, Pain in extremity, Shoulder injury related to vaccine administration More
Shoulder injury related to vaccine administration. ... Shoulder injury related to vaccine administration. Left arm pain - Reports worsening left arm pain for the past month, which began the night of receiving a flu vaccine on 10/03/2025. The pain is located in the left bicep tendon area. - Movement aggravates the pain. It can be a sudden, surprising pain with certain movements. Alternating ice and heat provides some relief. - The pain has been progressively worsening since the vaccination. - Denies any other injury or specific activity that could have caused the pain. - Associated symptoms: Denies numbness, tingling, or weakness. Reports the arm hurts to use. More
2871739 9 M 11/10/2025 COVID19
 PFIZER\BIONTECH
 na0589
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
regular comirnaty to 9 year old. No adverse event. wrong dose regular comirnaty to 9 year old. No adverse event. wrong dose
2871740 51 M KY 11/10/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Angiogram, Cardiac failure congestive, Computerised tomogram, Dyspnoea, Magnetic... Angiogram, Cardiac failure congestive, Computerised tomogram, Dyspnoea, Magnetic resonance imaging; Myocarditis, Ultrasound scan More
Myocardidtis.-congestive heart failure. The symptom that put me in the er and cardiac unit was seve... Myocardidtis.-congestive heart failure. The symptom that put me in the er and cardiac unit was severe shortness of breath. More
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2871741 50 F OH 11/10/2025 COVID19
COVID19
VARZOS
VARZOS
 MODERNA
MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 3052834
3052834
94J5E
94J5E
Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site pain; In... Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Nausea, Pyrexia; Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Nausea, Pyrexia More
Injection site: severe swelling from shoulder to elbow focused on the Shingrix injection site (lower... Injection site: severe swelling from shoulder to elbow focused on the Shingrix injection site (lower of the two vaccines), redness, pain, itching. Began one day post vaccination and is still present but lessening on Day 4. Systemic: fever, chills, sweating, fatigue, and nausea from Day 1 to Day 3 post-vaccination. More
2871742 27 F PA 11/10/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 406995
406995
Arthralgia, Electromyogram, Hypoaesthesia, Muscle spasms, Muscular weakness; Nec... Arthralgia, Electromyogram, Hypoaesthesia, Muscle spasms, Muscular weakness; Neck pain, Pain, Pain in extremity, Paraesthesia, Spinal X-ray More
Symptoms started 10/8 with left arm and shoulder aching and dull pain. 10/9- worsening symptoms and ... Symptoms started 10/8 with left arm and shoulder aching and dull pain. 10/9- worsening symptoms and recurrent frequent muscle spasms throughout left arm, left arm weakness, neck pain. 10/10- developed numbness and tingling of 1st-3rd fingers, continued previous symptoms. 10/13 - 10/14- worsening symptoms, saw Dr. in his office on 10/14. He started on high-dose steroid pack and muscle relaxers and ordered physical therapy. 10/21- last dose of steroid, continued symptoms but less severe. 10/22 present continued symptoms, less severe. 1st finger and tip of 2nd finger continues to have numbness and tingling. 10/30- follow up with Dr. - ordered another steroid pack since symptoms continue and last resulted in some relief More
2871743 40 F IN 11/10/2025 FLU3
 SANOFI PASTEUR
 68919AA
Arthralgia, Injected limb mobility decreased, Muscular weakness, Paraesthesia, P... Arthralgia, Injected limb mobility decreased, Muscular weakness, Paraesthesia, Product administered at inappropriate site More
Injection was given too high, into the R shoulder joint. Injection spot was noticed when I got home... Injection was given too high, into the R shoulder joint. Injection spot was noticed when I got home. Pain began that evening in R shoulder joint only. R deltoid was never sore. Pain continues x 2+ weeks and is increasing. Pain, limited range of motion, some weakness/tingling in R hand. Saw PCP 10/5/25 who recommended steroid injection into joint or PT if continues to worsen. More
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