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
2870818 21 F MI 11/05/2025 COVID19
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 80777-0400-60
58160-0912-52
Laboratory test, Polyarthritis; Laboratory test, Polyarthritis Laboratory test, Polyarthritis; Laboratory test, Polyarthritis
Polyarthritis lasting for 1 month Polyarthritis lasting for 1 month
2870819 56 F NY 11/05/2025 FLU3
 SANOFI PASTEUR
 U8864CA
Contusion Contusion
The patient came into the pharmacy on November 5th to report that she experienced extensive bruising... The patient came into the pharmacy on November 5th to report that she experienced extensive bruising after her flu shot on October 24. She said that it is not painful to the touch, but has been nearly 2 weeks, and she showed me that her arm is still very bruised. There was a bluish/purplish square shaped bruise about 2 inches by 2 inches in size. I told her that bruising can occur after any vaccination, and that, although very unfortunate, it should resolve in time. More
2870822 40 F MI 11/05/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 7345R
Injection site erythema, Injection site pruritus, Injection site urticaria Injection site erythema, Injection site pruritus, Injection site urticaria
11/5/25 Reported possible reaction to 11/3/25 Flu vaccination. Called and spoke to employee, claime... 11/5/25 Reported possible reaction to 11/3/25 Flu vaccination. Called and spoke to employee, claimed she had hives around injection 3 inches in diameter, with redness and itchiness. Denies any other symptoms, and was resolved the next day. More
2870829 5 M CA 11/05/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
Cough, Pyrexia, Wheezing Cough, Pyrexia, Wheezing
WHEEZING; FEVER; COUGH; A spontaneous report has been received from a consumer. The report concerns ... WHEEZING; FEVER; COUGH; A spontaneous report has been received from a consumer. The report concerns a male child patient of [withheld] ethnic origin born in 2019 (age 5 years, height 119 cm, weight 24.04 kg). No medical history was reported. No concomitant products were reported. The patient received Flumist, via respiratory for flu vaccine on 19-SEP-2025. The patient received 1 dose(s). No malfunction has been reported for the Accuspray Single Dose device. On 20-SEP-25, the patient experienced fever (preferred term: Pyrexia) and cough (preferred term: Cough). On 21-SEP-25, the patient experienced wheezing (preferred term: Wheezing). The outcome of the event(s) of cough and wheezing was unknown. At the time of reporting, the event fever was improving. The events were considered non-serious. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUMIST Product Role:Suspect Device Problem code:Adverse Event Without Identified Device or Use Problem Manufacturer Name:ASTRAZENECA Labeled for single use:No Non-Significant correction 15-Oct-25: Null favors for county data field was added. Non-Significant correction on 04-Nov-2025: Null flavor from the vaccine facility state removed. Narrative amended. Non-significant correction 05-NOV-2025: Null flavor removed for telephone and fax , Narrative amended More
2870830 74 F AZ 11/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Arthralgia, Incomplete course of vaccination, Inflammation, Inflammatory marker ... Arthralgia, Incomplete course of vaccination, Inflammation, Inflammatory marker increased, Magnetic resonance imaging abnormal; Pain in extremity, Polymyalgia rheumatica, Rheumatoid arthritis, Rheumatoid factor increased, Shoulder arthroplasty More
Rheumatoid arthritis/Rheumatoid Arthritis femur and seronegative; Polymyalgia rheumatica; Underdose... Rheumatoid arthritis/Rheumatoid Arthritis femur and seronegative; Polymyalgia rheumatica; Underdose; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included eye dryness and constipation. Concomitant products included ciclosporin (Restasis), tiotropium bromide monohydrate (Spiriva), salbutamol sulfate (Albuterol), linaclotide (Linzess), colecalciferol (Vitamin D3), cholesterol, menaquinone-7 (Vitamin K2), ascorbic acid (Vit C) and magnesium. On 11-JUN-2024, the patient received the 1st dose of Shingrix (left arm). On 11-JUN-2024, an unknown time after receiving Shingrix, the patient experienced underdose (Verbatim: Underdose). On 02-JUL-2024, the patient experienced rheumatoid arthritis (Verbatim: Rheumatoid arthritis/Rheumatoid Arthritis femur and seronegative) (serious criteria GSK medically significant) and polymyalgia rheumatica (Verbatim: Polymyalgia rheumatica) (serious criteria GSK medically significant). The patient was treated with oxycodone. The outcome of the rheumatoid arthritis and polymyalgia rheumatica were not resolved and the outcome of the underdose was not applicable. The reporter considered the rheumatoid arthritis and polymyalgia rheumatica to be related to Shingrix. The company considered the rheumatoid arthritis and polymyalgia rheumatica to be unrelated to Shingrix. Additional Information: GSK receipt date 21 Oct 2025 The reporter was the patient who had received a shingles vaccine in her left arm on the 11th of June 2024. The patient did not have a lot number to verify the product but had called it SHINGRIX. This vaccine had been the first in the series. The patient reported that she did not go back to receive the second dose of the vaccine series. Three weeks after receiving the vaccine, the patient had experienced pain in both shoulders, arms, and hands. She had gone to her physician and had lab tests with abnormal results, including high R Factor and high marker values. She had been diagnosed with rheumatoid arthritis, polymyalgia rheumatica. The pain had continued and had become intolerable, leading her to visit the emergency department for pain relief injections. An MRI had shown bone-on-bone, and the patient had been scheduled for a total reverse shoulder replacement. In April 2025, her doctor had reversed the diagnosis of RA and PMR due to improved lab values and her hands not being symmetrical. The patient had stated that prior to the vaccine, she had been fine, had had no shoulder issues, and had not required surgery. She had reported that the vaccine had triggered severe inflammation and bone deterioration. The patient had no wearing effect on my shoulder and it had not impacted her at all, now I am in severe pain as bones had been eaten away because after the shot she went into severe inflammation and destruction.. She had undergone outpatient surgery to replace her left shoulder and had experienced uncontrolled pain despite oxycodone. She had planned to have her right shoulder replaced once the left had healed. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: A case of Rheumatoid arthritis and Polymyalgia rheumatica, 21 days after receiving 1st dose of Shingrix, in a 74-year-old female patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought. More
2870833 OH 11/05/2025 FLU4
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
Someone took it out and put it in their home fridge; This non-serious case was reported by a pharmac... Someone took it out and put it in their home fridge; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis. On an unknown date, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: Someone took it out and put it in their home fridge). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-OCT-2025 The healthcare professional informed that a patient took a Flulaval vaccine to their home, and they put it into their home fridge, however, they may thought that the vaccines was expose to an excursion. The Healthcare professional informed that it was at room temperature for 24 hours. No prior excursions. The batch number was not provided upon follow up with the reporter. More
2870840 TN 11/05/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
patients received expired flu vaccine; This non-serious case was reported by a physician via call ce... patients received expired flu vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 4-year-old patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) for prophylaxis. On an unknown date, the patient received FluLaval 2025-2026 season. On an unknown date, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced expired vaccine used (Verbatim: patients received expired flu vaccine). 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: 17-OCT-2025 The physician wanted to know how long the patient needs to wait before coming back into receive in date flu vaccine. The batch number was not provided upon follow- up with the reporter. More
2870841 56 F VA 11/05/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 046B21A
046B21A
046B21A
046B21A
Amnesia, Arteriogram carotid, Behaviour disorder, Blood pressure measurement, CS... Amnesia, Arteriogram carotid, Behaviour disorder, Blood pressure measurement, CSF culture; Cerebral atrophy, Cognitive disorder, Corticobasal degeneration, Gait disturbance, Laboratory test; Lumbar puncture, Magnetic resonance imaging, Magnetic resonance imaging head, Magnetic resonance imaging neck, Positron emission tomogram; Spinal osteoarthritis, Tremor, Vertebral foraminal stenosis, Vertebrobasilar insufficiency, Whole-genome sequencing More
The patient's temper changed drastically, she became very selfish and egoistic, and very agitat... The patient's temper changed drastically, she became very selfish and egoistic, and very agitated especially in the evenings, before going to bed; Vertebrobasilar insufficiency; multilevel cervical spondylosis; bilateral foraminal narrowing C5/C6; right hand sometime shaking; frontal lobe atrophy; Corticobasal degeneration/dementia; disturbances of walking abilities; cognitive functions/impacting cognitive abilities/exhibited accelerated cognitive and physical decline; The patient had a memory formation failure after mRNA vaccination/she developed an inability to form new long-term memories, while her existing memories remained intact/memory lapses; This spontaneous case was reported by an other health care professional and describes the occurrence of CORTICOBASAL DEGENERATION (Corticobasal degeneration/dementia) and CEREBRAL ATROPHY (frontal lobe atrophy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A, 014C21A and 60H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Donepezil hydrochloride (Donepezil) for Alzheimer's disease. The patient's past medical history included Numbness of head (head skin numbness) in 2019. Family history included Dementia (The patient's grandmother and great-grandmother on mother side both had dementia in their 75-80, which unfortunately made less critical to this diagnosis of Alzheimer's, which eventually turned out to be wrong) since an unknown date. Concurrent medical conditions included Sleep disorder NOS and Memory impairment (Some deterioration in patient's memory and mild impairment) since 2019. Concomitant products included Valeriana officinalis root (Valerian root) for Sleep disorder NOS, Melatonin for an unknown indication. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient started Donepezil hydrochloride (Donepezil) (unknown route) 5 milligram once a day. In September 2022, Donepezil hydrochloride (Donepezil) (unknown route) dosage was changed to 10 milligram once a day. In July 2021, the patient experienced AMNESIA (The patient had a memory formation failure after mRNA vaccination/she developed an inability to form new long-term memories, while her existing memories remained intact/memory lapses). In May 2022, the patient experienced CORTICOBASAL DEGENERATION (Corticobasal degeneration/dementia) (seriousness criterion medically significant). In 2022, the patient experienced COGNITIVE DISORDER (cognitive functions/impacting cognitive abilities/exhibited accelerated cognitive and physical decline) and GAIT DISTURBANCE (disturbances of walking abilities). In 2023, the patient experienced CEREBRAL ATROPHY (frontal lobe atrophy) (seriousness criterion medically significant). In July 2023, the patient experienced TREMOR (right hand sometime shaking). On an unknown date, the patient experienced BEHAVIOUR DISORDER (The patient's temper changed drastically, she became very selfish and egoistic, and very agitated especially in the evenings, before going to bed), VERTEBROBASILAR INSUFFICIENCY (Vertebrobasilar insufficiency), SPINAL OSTEOARTHRITIS (multilevel cervical spondylosis) and VERTEBRAL FORAMINAL STENOSIS (bilateral foraminal narrowing C5/C6). The patient was treated with Rehabilitation therapy (rehabilitation) for Cognitive disorder. In September 2023, BEHAVIOUR DISORDER (The patient's temper changed drastically, she became very selfish and egoistic, and very agitated especially in the evenings, before going to bed) had resolved. At the time of the report, CORTICOBASAL DEGENERATION (Corticobasal degeneration/dementia), CEREBRAL ATROPHY (frontal lobe atrophy), AMNESIA (The patient had a memory formation failure after mRNA vaccination/she developed an inability to form new long-term memories, while her existing memories remained intact/memory lapses), VERTEBROBASILAR INSUFFICIENCY (Vertebrobasilar insufficiency), SPINAL OSTEOARTHRITIS (multilevel cervical spondylosis) and VERTEBRAL FORAMINAL STENOSIS (bilateral foraminal narrowing C5/C6) outcome was unknown and COGNITIVE DISORDER (cognitive functions/impacting cognitive abilities/exhibited accelerated cognitive and physical decline), GAIT DISTURBANCE (disturbances of walking abilities) and TREMOR (right hand sometime shaking) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2020, Magnetic resonance imaging head: unremarkable, no brain issues were found. On 24-Feb-2020, Magnetic resonance imaging neck: MRI was performed for the neck area, which did not reveal any issues. On 11-Oct-2020, Magnetic resonance imaging neck: Unremarkable except for multilevel cervical spondylosis. There was mild resultant bilateral foraminal narrowing at C5/C6.. On 10-Nov-2020, Magnetic resonance imaging neck: Unremarkable, no issue was revealed. On 11-Jan-2022, Laboratory test: Short memory measurements based on sequence of pictures of animals. First try: 56% and 1245ms, second try: 48% and 1373ms. On 02-Feb-2022, Magnetic resonance imaging head: Unremarkable, no issues revealed. In February 2022, Magnetic resonance imaging head: Showed minimal white matter changes, related to age. In May 2022, Magnetic resonance imaging neck: MRI images unremarkable. In 2023, Lumbar puncture: Tests performed in [withheld], excluded Alzheimer's, because lumbar puncture had shown normal levels of proteins in patient's spinal fluid. In 2023, Positron emission tomogram: Further study, using PET scan, resulted in a diagnosis of Corticobasal degeneration. In September 2023, Magnetic resonance imaging: The 3 Tesla MRI scan (augmented by NeuroQuant analysis) also showed very noticeable atrophy of the frontal brain areas. Significant deterioration and atrophy.. In September 2024, Magnetic resonance imaging: A new 3Tesla MRI was arranged, and it was performed in Sep-2024, at the same location where the Sep 2023 3Tesla MRI was done. They were remarkably similar; those images did not show any significant change between Sep 2023 and Sep 2024. Moreover, the 3T MRI reports gave NeuroQuant7 determined numerical values related to brain degradation, such as, for instance, the volume of gray matter: MRI 3 Tesla, Sep 2023, gray matter: 401 cm^3; MRI 3 Tesla, Sep 2024, gray matter: 393 cm^3. These numbers were determined by NeuroQuant software version 4.1.1 for both 2023 and 2024 data. The Sep-2023 scan was analyzed by NeuroQuant version 3.1.1, giving 387 cm^3. The same as Sep-2023 MRI data, analyzed by NeuroQuant version 4.1.1, gave 401 cm^3. This difference (14 cm^3, or 3.5%) was assumed as an estimation for the error bars for all data points.. In November 2024, Whole-genome sequencing: The NIH genome results also came with a conclusion negative NIAID research whole genome sequencing result. Specifically, both 23andme and NIH genetics results showed that patient's APOE genotype (T/T for rs429358 and C/T for rs7412) corresponds to "lower risk" of Alzheimer's. Both genetics results also showed that patient did not have mutations in BChE gene. The BChE-K version (rs1803274) was explicitly linked to faster cognitive decline on Donepezil (5,6). The atypical BChE variant (rs1799807 AA), may also indicate reduced BChE ability to break down acetylcholine-like compounds, potentially amplifying Donepezil's effects. For both of these genes patient's alleles were wild-type, i.e. do not show mutations that would explain adverse reaction do Donepezil. This finding did not support our earlier hypothesis that Donepezil may explain patient's fast decline in 2022-2023. On an unknown date, Arteriogram carotid: MRA showed no blockage but revealed Vertebral basilar system was diminutive in size. The patient may had inherited Vertebral basilar system of diminutive size from grandmother. On an unknown date, Blood pressure measurement: Typical blood pressure was always low, around 110/70. On an unknown date, CSF culture: no amyloid plaques observed.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CORTICOBASAL DEGENERATION (Corticobasal degeneration/dementia), CEREBRAL ATROPHY (frontal lobe atrophy), COGNITIVE DISORDER (cognitive functions/impacting cognitive abilities/exhibited accelerated cognitive and physical decline), AMNESIA (The patient had a memory formation failure after mRNA vaccination/she developed an inability to form new long-term memories, while her existing memories remained intact/memory lapses), GAIT DISTURBANCE (disturbances of walking abilities), TREMOR (right hand sometime shaking), BEHAVIOUR DISORDER (The patient's temper changed drastically, she became very selfish and egoistic, and very agitated especially in the evenings, before going to bed) and VERTEBROBASILAR INSUFFICIENCY (Vertebrobasilar insufficiency) to be related. No further causality assessments were provided for SPINAL OSTEOARTHRITIS (multilevel cervical spondylosis) and VERTEBRAL FORAMINAL STENOSIS (bilateral foraminal narrowing C5/C6). The patient had experienced a rare and profound neurological condition following mRNA COVID-19 vaccination. Within weeks of receiving two vaccine doses, she developed an inability to form new long-term memories, while her existing memories remained intact. The sudden onset, in the absence of structural brain damage on initial imaging, closely paralleled the clinical profile of patient [withheld], albeit with a non-surgical etiology. In 2022, the patient was misdiagnosed with Alzheimer's disease and treated Donepezil for over a year, during which she exhibited accelerated cognitive and physical decline, as well as frontal lobe atrophy confirmed by 3T MRI in 2023. Treatment was discontinued that year, and by 2024, partial cognitive recovery and stabilization in gray matter volume were documented. The initial hypotheses were that the patient was homozygous TT at rs1799807 in the BCHE gene-a rare variant associated with reduced butyrylcholinesterase activity and possible Donepezil toxicity. However, full genome analysis did not confirm this. BCHE genotypes, especially for patients with atypical clinical response, prompt the need of further studies toward genetical pharmacogenetic screening practices in dementia therapy. The patient had two neurological injuries, and the patient sustained arose from distinct mechanisms, the first, a functional shutdown of memory encoding potentially triggered by vaccine-induced immune or molecular mechanism interference: the second, a pharmacogenetic injury likely caused by a neuroimmune reaction. Using a coincidence-based statistical framework, the likelihood that the initial memory shutdown was caused by the vaccine was estimated at over 99.998%. The patient's condition reflected a selective disruption of memory encoding processes, involving pathways such as PKM-KIBRA signaling, CREB-mediated transcription, and dendritic translation. Around 2019, when a patient was 55 years old, she started to complain about head skin numbness. Some deterioration in patient's memory was observed in 2019 and 2020, but it was very mild impairment. For example, she would forget some names, which would be typical of any normal person. The main reason to see the doctors in [withheld name] Multispecialty Group in 2019 was the numbness of her scalp 5, which patient had complained about. In 2019 and 2020, she did a lot of reading and driving (including to physical therapy and acupuncture appointments, which tried to help with the numbness). The patient had not been sick with Covid all that time. At the end of 2020, she was almost in completely perfect shape. In October 2020, she went horseback riding. The patient did horse riding as a child. Another example was in December 2020, the patient took photos and videos on her phone without any problems. But in the summer of 2021, memory loss accelerated greatly and even began to become dangerous. In 26-Jun-2021, she was unable to turn on TV programs (social media alike) on a computer. In October to December 2021, memory problems grew like a snowball. On 11-Oct-2021, she forgot that she had already received the parcel and was still waiting for it. From July to September 2021, the patient had some memory lapses. On 07-Oct-2021, the patient lost her tights in the morning, and was looking for them on the second floor, while they were in the drawer downstairs. In the evening the patient took out baked fish but forgot to turn off the oven. On 29-Oct-2021, the patient was forgetting and waiting for who had already come home. On 18-Nov-2021, the patient in the middle of the night saw that the branches were swaying and covering the streetlamp. At this moment, the patient recalled that the electrician had come yesterday and changed the electric meter, and the patient had not even remembered about it the evening before. On 21-Nov-2021, the patient was going to [withheld state] to see friends, since the friends had a newborn son. On 29-Dec-2021, the patient forgot that they all had come together. On 02-Jan-2022, the patient lost on the airport. From January to February 2022, the patient went to a neurologist to study her conditions. On 03-May-2022, the patient [withheld name] neurology doctor gave an assessment of Alzheimer's disease, unspecified and prescribed Donepezil 5mg/day based on cognitive evaluation. From these observations, it appeared possible that the patient's memory mechanism damage might be caused by or memory mechanism was switched off by mRNA vaccination in April and May of 2021. But it also could have been a coincidence. Come up with a more definite conclusion about mRNA as the cause only in late 2023, after the initial wrong diagnosis of Alzheimer's was excluded, and after coincidence analysis with health impacts of another person was performed. In early 2022, the patient went to see [withheld name] neurologists and after another MRI scan (which again was unremarkable), the patient was diagnosed with Alzheimer's disease, unspecified. The patient was diagnosed with Alzheimer's Disease in May-2022 based on cognitive evaluations, while MRI images were unremarkable, and treatment with Donepezil started (5mg/day since May-2022, doubled to 10mg/day from Sep-2022). The patient's condition was deteriorating very fast in the second half of 2022, impacting cognitive abilities. Moreover, disturbances of walking abilities started to appear, which were now very severe. It was decided to stop Donepezil treatment in Sep 2023, based on vascular insufficiency hypothesis. It was reported that the patient's brain atrophy may have been caused by Donepezil, and not by natural progression of her disease. The doctors typically believed that Donepezil cannot cause long-term brain degradation. The MRI was used to measurements to determine if Donepezil was an issue. The standard MRI performed in February 2022 was unremarkable, no brain issues were found. From May-2022 till Sep-2023 the patient was taking Donepezil. For MRI-based measurements of gray matter volume also showed, as a shaded area, the time when patient was treated by Donepezil (5mg/day between May-2022 and Sep-2022, and 10mg/day between after Sep-2022 and Sep-2023). One can see that significant degradation coincided with the application of Donepezil. Moreover, after Donepezil treatment stopped, the degradation of gray matter volume stopped as well, and stabilization was observed. This, and especially stabilization, supported the hypothesis that patient's fast brain degeneration between May-2022 and Sep-2023 was caused by Donepezil itself, however this may also be a coincidence, due to progression of neuroinflammation response. She was a very active buyer, but starting in Summer 2022 reduced to a third of normal, and by Dec-2022 the activity was stopped completely, the patient had lost computer abilities. Starting around January to February 2023, the patient was not reading any more. In late 2022, early 2023, the patient's temper changed drastically, she became very selfish and egoistic, and very agitated especially in the evenings, before going to bed, so that every evening became a nightmare. Starting from around Apr-2023, when the patient stand up and started to walk, the first several steps were very small, about 5cm in length. Gait significantly deteriorated by that time. Starting from around July-2023, the patient's right hand sometime shaking, when she was sitting calmly, and watching TV. By around early 2023, the patient was not engaging in conversation. When the patient stopped taking Donepezil in Sep-2023, some improvements were observed in conversation, cognitive functions and walking, and since then it was observed slowing down of degradation of cognitive function, and even some modest improvements, involuntary shaking of hands was gone. The patient was now much more engaged in conversations. The patient's temper and character returned to normal, she was not selfish and egoistic anymore, there was no agitation, she was nice and kind, and even in the evenings at bedtime and could have normal conversation and could make jokes. The patient's computer skills were coming back. The patient's behavior prior to the 2022/2023 new year party versus her behavior prior to the 2023/2024 new year's party (when she was no longer taking the medicine) was much better and more manageable. The patient's behavior improved after stopping donepezil medication. The patient's typical blood pressure was always low, around 110/70, and she was always drinking coffee, but around 2015 stopped drinking coffee. It was reported that it caused a reduction of the average blood pressure that may have contributed to developing the symptoms. This led to the hypothesis of Vertebrobasilar insufficiency due to hypotension in her case. It was suggested that it was not Alzheimer's, and not vascular dementia, and suggested that it was Vertebrobasilar insufficiency, which had all symptoms. Very early onset for patient may be caused by stopping drinking coffee around 2015, and by transitioning to a much less active lifestyle when she stopped working in 2019. Based on the Vertebrobasilar insufficiency diagnosis hypothesis, it was suggested that there will be no amyloid plaques observed (which was later confirmed by spinal fluid test) and decided to stop donepezil treatment in Sep 2023. Also, from Jun-2023 the patient resumed drinking coffee for breakfast and lunch. From June to the end of Aug-2023 the patient was going swimming pool several times per week. All this seemed to help with speech, reasoning, crosswords skills, etc. The patient for years was taking double doses of Valerian root calming herbal pills for sleep. It was found that Benzodiazepines cause memory loss, and they have similar actions as Valerian root. This may have contributed to the development of patient's memory issues. In August to Sep-2023 it was reduced and then stopped taking valerian root for patient, replacing it with melatonin. In Jul-2024 the patient went through a clinical trial (which was real stimulation, not placebo). This stimulation helped to improve patient's conditions and possibly restored some skills. The NIH genome result also came with a negative conclusion. In Jul-2024, the patient was receiving transcranial current stimulation, and the walking abilities were improved. The patient was a good painter from childhood. The patient's painting skills were restored from 05-Aug-2024 to 09-Aug-2024. Since patient's vaccination happened during the specified window, it was concluded that with probability 93% (which was 100%-7%) her dementia may have been caused by vaccination. Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2025: Live follow up received which contains no new information.; Reporter's Comments: Company Comment: The medical history of memory impairment, family history of dementia, and co ๏ฟฝ suspect product Donepezil remains as contributor factors for the event corticobasal degeneration. The event Spinal osteoarthritis and Vertebral foraminal stenosis were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of the product is not affected by this report. More
2870842 40 F 11/05/2025 COVID19
 MODERNA
Blindness unilateral, Cerebrovascular accident, Urticaria Blindness unilateral, Cerebrovascular accident, Urticaria
After the second dose she was blind in one eye, covered with hives and had a stroke; After the secon... After the second dose she was blind in one eye, covered with hives and had a stroke; After the second dose she was blind in one eye, covered with hives and had a stroke; After the second dose she was blind in one eye, covered with hives and had a stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (After the second dose she was blind in one eye, covered with hives and had a stroke), BLINDNESS UNILATERAL (After the second dose she was blind in one eye, covered with hives and had a stroke) and URTICARIA (After the second dose she was blind in one eye, covered with hives and had a stroke) in a 40-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (After the second dose she was blind in one eye, covered with hives and had a stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS UNILATERAL (After the second dose she was blind in one eye, covered with hives and had a stroke) (seriousness criteria hospitalization and medically significant) and URTICARIA (After the second dose she was blind in one eye, covered with hives and had a stroke) (seriousness criterion hospitalization). The patient was hospitalized for 14 days due to BLINDNESS UNILATERAL, CEREBROVASCULAR ACCIDENT and URTICARIA. At the time of the report, CEREBROVASCULAR ACCIDENT (After the second dose she was blind in one eye, covered with hives and had a stroke), BLINDNESS UNILATERAL (After the second dose she was blind in one eye, covered with hives and had a stroke) and URTICARIA (After the second dose she was blind in one eye, covered with hives and had a stroke) had resolved. Concomitant medication was not provided. It was reported that the patient had received two doses of the COVID-19 vaccine. It was explained that after the second dose, the patient had gone blind in one eye, had developed hives, and had suffered a stroke. She had been hospitalized for approximately two weeks. The patient was young and strong and had fully recovered. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
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2870843 5 MD 11/05/2025 COVID19
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UNKNOWN MANUFACTURER

Hypotonic-hyporesponsive episode; Hypotonic-hyporesponsive episode Hypotonic-hyporesponsive episode; Hypotonic-hyporesponsive episode
Hypotonic Hypo-responsiveness reaction/Unresponsive; This spontaneous case was reported by a pharmac... Hypotonic Hypo-responsiveness reaction/Unresponsive; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic Hypo-responsiveness reaction/Unresponsive) in a 5-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic Hypo-responsiveness reaction/Unresponsive) (seriousness criterion medically significant). At the time of the report, HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic Hypo-responsiveness reaction/Unresponsive) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. The reporter had incident where the patient getting concomitant flu and Covid vaccines was going unresponsive (Hypotonic Hypo-responsiveness reaction). They were looking into lots of medication. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790768 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2025: Live follow-up received and non-significant information includes reporter contact details updated.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790768:Master case (Same reporter for different patient) More
2870844 29 F MA 11/05/2025 COVID19
COVID19
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UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Headache, Insomnia, Musculoskeletal chest pain, Pain, Pain in extremity; Palpita... Headache, Insomnia, Musculoskeletal chest pain, Pain, Pain in extremity; Palpitations; Headache, Insomnia, Musculoskeletal chest pain, Pain, Pain in extremity; Palpitations More
Intense soreness that increased at night; Insomnia; Palpitations; Ribs were catching; hurts to move ... Intense soreness that increased at night; Insomnia; Palpitations; Ribs were catching; hurts to move arm (worse than normal); Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Intense soreness that increased at night), INSOMNIA (Insomnia), PALPITATIONS (Palpitations), MUSCULOSKELETAL CHEST PAIN (Ribs were catching) and PAIN IN EXTREMITY (hurts to move arm (worse than normal)) in a 29-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. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. Previously administered products included for Product used for unknown indication: Hepatitis b. Past adverse reactions to the above products included No adverse effect with Hepatitis b. On 24-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 24-Oct-2025, the patient experienced PAIN (Intense soreness that increased at night), INSOMNIA (Insomnia), PALPITATIONS (Palpitations), MUSCULOSKELETAL CHEST PAIN (Ribs were catching), PAIN IN EXTREMITY (hurts to move arm (worse than normal)) and HEADACHE (Pounding headache). At the time of the report, PAIN (Intense soreness that increased at night), INSOMNIA (Insomnia), PALPITATIONS (Palpitations), MUSCULOSKELETAL CHEST PAIN (Ribs were catching), PAIN IN EXTREMITY (hurts to move arm (worse than normal)) and HEADACHE (Pounding headache) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. It was reported that patient had intense soreness that increased at night, insomnia, pounding headache, palpitations, the ribs were catching, and it was hurting to move arm (worse than normal). 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 lab data/results available. Treatment information was not reported. More
2870846 11/05/2025 COVID19
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 PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Cough, Eye pruritus, Throat irritation, Vision blurred; Cough, Eye pruritus, Thr... Cough, Eye pruritus, Throat irritation, Vision blurred; Cough, Eye pruritus, Throat irritation, Vision blurred; Cough, Eye pruritus, Throat irritation, Vision blurred More
eyes are blurry they feel like they're itching; eyes are blurry they feel like they're itc... eyes are blurry they feel like they're itching; eyes are blurry they feel like they're itching; minor scratchy throat; cough; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), in Oct2025 as dose number uknown, single for immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), in Oct2025 as dose 2, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Shingles vaccine (DOSE 1), for Immunisation. The following information was reported: COUGH (non-serious) with onset Oct2025, outcome "not recovered"; VISION BLURRED (non-serious), EYE PRURITUS (non-serious) all with onset Oct2025, outcome "not recovered" and all described as "eyes are blurry they feel like they're itching"; THROAT IRRITATION (non-serious) with onset Oct2025, outcome "not recovered", described as "minor scratchy throat". Additional information: In Oct2025 (reported as "two weeks ago"), the patient had 3 vaccines (COVID-19 update, flu vaccine and the second shingles vaccine). Two days after getting the vaccines, the patient had a minor scratchy throat. At the time of the report, the patient still has the scratchy throat. The patient had a constant cough that doesn't go away. The patient's eyes are blurry, and they feel like they're itching and b (as reported). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2870847 11/05/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
took Paxlovid previously when patient had COVID; took Paxlovid previously when patient had COVID; Th... took Paxlovid previously when patient had COVID; took Paxlovid previously when patient had COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "took Paxlovid previously when patient had COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Pfizer COVID vaccine for Covid. It was reported that the patient took Paxlovid previously when the patient had COVID. It was unknown if the patient having COVID was before or after having Pfizer COVID vaccine. The patient also wanted to confirm if the Pfizer COVID vaccine and Johnson and Johnson COVID vaccine were the same kind of vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2870848 11/05/2025 COVID19
 PFIZER\BIONTECH
Headache, Influenza, Myalgia, Somnolence Headache, Influenza, Myalgia, Somnolence
flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or ot... flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790487 (Moderna). A 69-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 5, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 Immunization; Comirnaty (DOSE 2, SINGLE), for COVID-19 Immunization; Comirnaty (DOSE 3(BOOSTER), SINGLE), for COVID-19 Immunization; Comirnaty (DOSE 4(BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; HEADACHE (non-serious), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness". Additional information: The reporter stated that patient has received 6 doses of the Pfizer COVID vaccine and had a reaction every time. The reporter states that patient would be sick for a day or two and it felt like the flu with muscle aches, headache, sleepiness and everything. The reporter states that patient is not looking forward to getting the vaccine, but on the flip side has never had COVID. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2870849 11/05/2025 COVID19
 PFIZER\BIONTECH
Headache, Influenza, Myalgia, Somnolence Headache, Influenza, Myalgia, Somnolence
flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or ot... flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790487 (Moderna). A 69-year-old patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), for COVID-19 immunization; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Comirnaty (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Comirnaty (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; HEADACHE (non-serious), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness". Additional information: The reporter stated that patient has received 6 doses of the Pfizer COVID vaccine and had a reaction every time. The reporter states that patient would be sick for a day or two and it felt like the flu with muscle aches, headache, sleepiness and everything. The reporter states that patient is not looking forward to getting the vaccine, but on the flip side has never had COVID. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2870850 F 11/05/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
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Diarrhoea, Fatigue; Fatigue; Asthenia, Diarrhoea, Fatigue; Asthenia, Diarrhoea, ... Diarrhoea, Fatigue; Fatigue; Asthenia, Diarrhoea, Fatigue; Asthenia, Diarrhoea, Fatigue; Pain in extremity; Diarrhoea, Fatigue; Fatigue; Asthenia, Diarrhoea, Fatigue; Asthenia, Diarrhoea, Fatigue; Pain in extremity; Diarrhoea, Fatigue; Fatigue; Asthenia, Diarrhoea, Fatigue; Asthenia, Diarrhoea, Fatigue; Pain in extremity; Diarrhoea, Fatigue; Fatigue; Asthenia, Diarrhoea, Fatigue; Asthenia, Diarrhoea, Fatigue; Pain in extremity; Diarrhoea, Fatigue; Fatigue; Asthenia, Diarrhoea, Fatigue; Asthenia, Diarrhoea, Fatigue; Pain in extremity More
feeling kind of drained/fatigue/really tired; Diarrhea; This is a spontaneous report received from a... feeling kind of drained/fatigue/really tired; Diarrhea; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 78-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 31Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization; Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), administration date: 2024, for COVID-19 immunization, reaction(s): "fatigue/drained but it's like fatigue". The following information was reported: DIARRHOEA (non-serious) with onset 2025, outcome "recovering", described as "Diarrhea"; FATIGUE (non-serious) with onset 2025, outcome "recovering", described as "feeling kind of drained/fatigue/really tired". Additional information: Caller was calling about the Pfizer covid vaccine. She was asking if the symptoms she experienced were considered normal. She mentioned feeling kind of drained, diarrhea, fatigue, and really tired. Caller confirmed the information. She stated she does not know which formula she got and she cannot confirm since they did not show it to her. She also took the covid vaccine last year, got it in 2024 and this year on 31st, last Friday. Caller stated she felt better today. Caller added that when she first got it in 2021, she did not had any side effects. It just started back in 2024 when she had fatigue and she would say drained but it was like fatigue. She was just checking to make sure since she talked to a couple of people who did not have the effects so she was thinking it does not like her body or something. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2870852 M 11/05/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Chills, Diarrhoea, Eye irritation, Fatigue, Lacrimation increased; Nausea, Rhino... Chills, Diarrhoea, Eye irritation, Fatigue, Lacrimation increased; Nausea, Rhinorrhoea, Vaccination site pain More
runny nose; tearing of the eye; burning of eye; diarrhea; fatigue; pain at the injection site; chill... runny nose; tearing of the eye; burning of eye; diarrhea; fatigue; pain at the injection site; chills; nausea; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 82-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 included: "Covid-19", start date: 2020 (unspecified if ongoing); "Covid-19", start date: 2022 (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine, for Covid-19 Immunization. The following information was reported: RHINORRHOEA (non-serious), outcome "not recovered", described as "runny nose"; LACRIMATION INCREASED (non-serious), outcome "not recovered", described as "tearing of the eye"; EYE IRRITATION (non-serious), outcome "not recovered", described as "burning of eye"; DIARRHOEA (non-serious), outcome "not recovered", described as "diarrhea"; FATIGUE (non-serious), outcome "not recovered"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain at the injection site"; CHILLS (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered". Additional information: Question: Caller, Patient, was asking if diarrhea was a side effect of Comirnaty? Caller provided that he received the 2025/2026 Comirnaty vaccine on Saturday in which he was experiencing diarrhea, fatigue, pain at the injection site, runny nose, burning/tearing of the eye, chills and nausea. Caller stated that he has experienced nausea since Saturday. Caller provided that he had IBS and previously always took Moderna vaccines. Caller asked how long the side effects can last? When did they come on for other participants and what should he do about them? Caller provided that he never had a side effect of diarrhea with the Moderna vaccine. Caller stated that he took the vaccine all along and had covid twice, once in 2020 and once in 2022. Caller confirmed the covid diagnoses were after taking the Moderna vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2870853 F 11/05/2025 COVID19
 PFIZER\BIONTECH
Headache Headache
headache off and on; This is a spontaneous report received from a Consumer or other non HCP. An 82-... headache off and on; This is a spontaneous report received from a Consumer or other non HCP. An 82-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 31Oct2025 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: HEADACHE (non-serious) with onset 2025, outcome "not recovered", described as "headache off and on". No follow-up attempts are possible. Additional information: Reporter stated, reporter had a 82 year old mother that on Friday had the COVID booster shot (Clarified as Pfizer COVID-19 Vaccine) and she had been experiencing a headache off and on ever since she took the booster on Friday so reporter is calling to find out if that was a side effect and what the reporter need to know. Batch/lot number is not provided, and it cannot be obtained. More
2870854 11/05/2025 COVID19
 PFIZER\BIONTECH
Headache, Influenza, Myalgia, Somnolence Headache, Influenza, Myalgia, Somnolence
flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or ot... flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790487 (Moderna). A 69-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; HEADACHE (non-serious), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness". Additional information: The reporter stated that patient has received 6 doses of the Pfizer COVID vaccine and had a reaction every time. The reporter states that patient would be sick for a day or two and it felt like the flu with muscle aches, headache, sleepiness and everything. The reporter states that patient is not looking forward to getting the vaccine, but on the flip side has never had COVID. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2870855 11/05/2025 COVID19
 PFIZER\BIONTECH
Therapeutic response unexpected Therapeutic response unexpected
when she took the Pfizer covid 19 vaccine her arthritis was gone; This is a spontaneous report rece... when she took the Pfizer covid 19 vaccine her arthritis was gone; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "when she took the Pfizer covid 19 vaccine her arthritis was gone". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2870860 18 M CA 11/05/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0590
U8864AA
Confusional state, Dizziness; Confusional state, Dizziness Confusional state, Dizziness; Confusional state, Dizziness
Patient received the vaccine at 1:15pm and at about 1:16pm he fainted, at 1:17pm he awoke feeling co... Patient received the vaccine at 1:15pm and at about 1:16pm he fainted, at 1:17pm he awoke feeling confused. I offered him water and a snack. He was feeling lightheaded so I directed him to sit on a couch near by and lift his feet. I offered to call someone for him, however, he declined stating he was feeling better. After about 10 minutes he was feeling much better. He stayed seated for a while and then proceeded to leave stating he felt much better. More
2870862 76 M OH 11/05/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8800AA
u8800aa
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
No adverse event. reporting 2 fluzone HD doses given on same day No adverse event. reporting 2 fluzone HD doses given on same day
2870863 57 F CO 11/05/2025 FLU3
 SANOFI PASTEUR
 UT8836NA
Injection site pain, Musculoskeletal pain, Neck pain, Pain, Swelling Injection site pain, Musculoskeletal pain, Neck pain, Pain, Swelling
Sharp and throbbing injection site pain. "Cannot lay on that side", shooting pain down arm... Sharp and throbbing injection site pain. "Cannot lay on that side", shooting pain down arm, then across shoulder blades then moved up to the neck. Took Tylenol arthritis the same night and it relieved some of the pain. Went to the chiropractor 10/22 and 10/27, some immediate pain relief but pain returned after a few hours. Chiropractor noted continued swelling between shoulder blades and neck. Also used LED light therapy and TENS unit at night around 1700 for short term relief but pain will return by 0200. Takes motrin for some short term relief. Currently, pain rated at 4/10. At the worst pain was rated at 10/10. More
2870875 22 F AL 11/05/2025 COVID19
 UNKNOWN MANUFACTURER
 042A21A
Computerised tomogram, Deep vein thrombosis, Pulmonary embolism, Thrombectomy, U... Computerised tomogram, Deep vein thrombosis, Pulmonary embolism, Thrombectomy, Ultrasound scan More
Pulmonary embolism (PE) (bilateral) requiring hospitalization, deep vein thrombosis (DVT) (right) r... Pulmonary embolism (PE) (bilateral) requiring hospitalization, deep vein thrombosis (DVT) (right) requiring two surgeries. More
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2870877 64 F NC 11/05/2025 FLU3
 SANOFI PASTEUR
 tfaa2536
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
Pain in the upper arm/shoulder area Pain in the upper arm/shoulder area
2870879 68 F AZ 11/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 4AB32
4AB32
Asthenia, Chills, Dehydration, Diarrhoea, Immediate post-injection reaction; Inj... Asthenia, Chills, Dehydration, Diarrhoea, Immediate post-injection reaction; Injection site mass, Injection site pain, Nausea, Vomiting More
Painful injection. A large knot in injection site immediately. Terrible chills from 9:00 PM (10/27)... Painful injection. A large knot in injection site immediately. Terrible chills from 9:00 PM (10/27) until 1:00 AM (10/28). Terrible violent vomiting starting at 3:00 AM (10/28) until 2:00 PM with violate Diarrhea. I became dehydrated. Saw PA in my PCP office. She dispensed an anti nausea tablet. The patient is still weak and nauseated. More
2870882 65 F 11/05/2025 FLU3
 SEQIRUS, INC.
Incorrect route of product administration Incorrect route of product administration
Vaccine administered IV instead of IM Vaccine administered IV instead of IM
2870883 1.08 M ID 11/05/2025 FLU3
HIBV
MMRV
PNC20
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 5EF45
X022982
Y019464
MA2483
Y013073
Rhinorrhoea; Rhinorrhoea; Rhinorrhoea; Rhinorrhoea; Rhinorrhoea Rhinorrhoea; Rhinorrhoea; Rhinorrhoea; Rhinorrhoea; Rhinorrhoea
Per MOP, states patient only had runny nose over the weekend which resolved on its own. Per MOP, states patient only had runny nose over the weekend which resolved on its own.
2870886 28 M OK 11/05/2025 COVID19
 MODERNA
Headache, Hypoaesthesia Headache, Hypoaesthesia
Heart hurts when I run long distances and my limbs go numb very easily Heart hurts when I run long distances and my limbs go numb very easily
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2870888 82 F CO 11/05/2025 COVID19
PNC20
 MODERNA
PFIZER\WYETH

Injection site reaction, Pruritus, Rash erythematous, Rash papular; Injection si... Injection site reaction, Pruritus, Rash erythematous, Rash papular; Injection site reaction, Pruritus, Rash erythematous, Rash papular More
Pt developed a raised red rash at the injection site on her right arm that was very itchy. It took t... Pt developed a raised red rash at the injection site on her right arm that was very itchy. It took two weeks to heal and patient did take oral Benadryl and hydrocortisone cream to treat it. More
2870889 39 F AK 11/05/2025 FLU3
 SANOFI PASTEUR
Injected limb mobility decreased, Pain in extremity, Shoulder injury related to ... Injected limb mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration More
The patient had severe pain in the L arm 2 days after the vaccine that has persisted, with reduced R... The patient had severe pain in the L arm 2 days after the vaccine that has persisted, with reduced ROM due to pain in the L arm and shoulder. Suspect shoulder injury related to vaccine administration vs. severe localized vaccine reaction. More
2870890 70 F TX 11/05/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 U8874CA
Z007870
Injection site bruising, Injection site pain; Injection site bruising, Injection... Injection site bruising, Injection site pain; Injection site bruising, Injection site pain More
Patient reported that following the day of vaccination she started developing a large bruise where s... Patient reported that following the day of vaccination she started developing a large bruise where she got her pneumonia vaccine and had a lot of pain, the bruise started to spread and so she went to see her doctor. More
2870892 78 M NJ 11/05/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.

Blood pressure abnormal, Condition aggravated; Blood pressure abnormal, Conditio... Blood pressure abnormal, Condition aggravated; Blood pressure abnormal, Condition aggravated More
Higher blood pressure than usual, Lisinopril not effective as it usually was. Discussed with doctor ... Higher blood pressure than usual, Lisinopril not effective as it usually was. Discussed with doctor and scheduled office visit to review. No limitations on routine activities. More
2870893 28 F IL 11/05/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 948405
948405
Anaphylaxis treatment, Blood test, Chest discomfort, Flushing, Hypoaesthesia; Hy... Anaphylaxis treatment, Blood test, Chest discomfort, Flushing, Hypoaesthesia; Hypoaesthesia oral, Lip swelling, Swelling face, Throat tightness, Urticaria More
Oct 29th swollen and numb upper lip/face given iv benadryl and steroids at ER and prescription for p... Oct 29th swollen and numb upper lip/face given iv benadryl and steroids at ER and prescription for prednisone, claritin,and epipen. Night of oct 30th hives all over body with flushed face. Given epi injection via ER staff. Morning of Oct 31 full body severe hives, primary dr visit referred to allergist with continued prednisone and claritin. Night of Oct 31 face fully swelled and flushed with back of throat and chest tight, epipen administered via patient. Monitored at hospital, given oral benadryl, and sent home. Morning of Nov 1st woke up with severe face swelling. And admitted to hospital. More
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2870894 55 F OR 11/05/2025 FLU3
FLU3
FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
 948402
948402
948402
948402
Blood thyroid stimulating hormone decreased, C-reactive protein, Chills, Diarrho... Blood thyroid stimulating hormone decreased, C-reactive protein, Chills, Diarrhoea, Full blood count; Headache, Heart rate increased, Influenza virus test, Laryngoscopy normal, Mononucleosis heterophile test negative; Odynophagia, Oropharyngeal pain, Pyrexia, Red blood cell sedimentation rate, SARS-CoV-2 test; Streptococcus test, Tenderness, Thyroid stimulating immunoglobulin, Thyroiditis subacute, Thyroxine increased More
Normally my arm is sore after vaccine- with this one, zero soreness however a few days after vaccine... Normally my arm is sore after vaccine- with this one, zero soreness however a few days after vaccine, I developed pain in my lower throat on one side with swallowing. One week later, developed had headache after eating Japanese Natto ( fermented soybeans) then the next day had fever, chills and diarrhea. This resolved after 24 hours. Closer to week 2 post vaccine, developed fever , chills, headache and throat pain with swallowing, tenderness upon palpation on thyroid. Fevers lasted 4 days with chills and elevated heart rate. Saw PCP, ordered blood tests to include TSH and Free T4. Saw ENT , had laryngoscopy which looked good. ENT ordered thyroid ultrasound. So far, as of today, blood work came back low TSH and elevated T4. Diagnosed thus far with subacute thyroiditis. More thyroid labs are being added on and ultrasound is in 3 days. More
2870895 68 M NY 11/05/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR

Pyrexia; Pyrexia Pyrexia; Pyrexia
Low grade fever 99.5 Low grade fever 99.5
2870403 F NE 11/04/2025 UNK
 UNKNOWN MANUFACTURER
Pain Pain
little soreness last night; Initial information received on 23-Oct-2025 regarding an unsolicited val... little soreness last night; Initial information received on 23-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional. This case involves an unknown age female patient who had little soreness last night after receiving Influenza Trivalent Recombinant Vaccine [FlublokTIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Oct-2025, the patient received Influenza Trivalent Recombinant Vaccine Solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). Information on batch number and expiry date corresponding to the one at time of event occurrence could not be requested On 22-OCT-2025 the patient had little soreness last night (pain)(latency same day). It was reported "little soreness last night but no side effects." Action taken-not applicable. It was not reported if the patient received a corrective treatment for the event At time of reporting, the outcome was Unknown for the event More
2870405 50 F CA 11/04/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
administration of fluzone hd to a patient whose age is not approved for the vaccine, with no reporte... administration of fluzone hd to a patient whose age is not approved for the vaccine, with no reported adverse event; needed the regular dose of FLUZONE 0.5 mg but were administered FLUZONE HD with no reported ae; Initial information received on 23-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 50 years old female patient who was administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] instead of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which is not approved for the patient age group, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Oct-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (once), Strength Standard (unknown expiry date) lot number not reported via unknown route in unknown administration site for influenza immunisation instead of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], whose age is not approved for the vaccine, with no reported adverse event (product administered to patient of inappropriate age) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2870406 55 F MO 11/04/2025 FLU3
 SANOFI PASTEUR
 UT88220AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
inadvertently administered a FLUZONE HD with no AE; Initial information received on 24-Oct-2025 reg... inadvertently administered a FLUZONE HD with no AE; Initial information received on 24-Oct-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 55 years old female patient who was inadvertently administered Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD]with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine Inact Split 3v (Fluarix); And Covid-19 Vaccine (Covid-19 Vaccine) both for Immunisation. On 24-Oct-2025, the patient inadvertently received 0.5mL dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (once), Suspension for injection in pre-filled syringe, lot UT88220AA and expiry date 30-Jun-2026 via intramuscular route in the left deltoid for influenza immunisation, with no reported adverse event (wrong product administered) (Latency Same day). Reportedly, they intended to administer Fluarix and a Covid-19 Vaccine. Fluzone HD is the medication given in error. 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
2870407 35 M MO 11/04/2025 FLU3
 SANOFI PASTEUR
 UT88220AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
clinic inadvertently administered a FLUZONE HD with no AE; Initial information received on 24-Oct-2... clinic inadvertently administered a FLUZONE HD with no AE; Initial information received on 24-Oct-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 35 years old male patient who was inadvertently administered Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD]with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine Inact Split 3v (Fluarix); And Covid-19 Vaccine (Covid-19 Vaccine) both for Immunisation. On 24-Oct-2025, the patient inadvertently received 0.5mL dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (once), Suspension for injection in pre-filled syringe, lot UT88220AA and expiry date 30-Jun-2026 via intramuscular route in the left deltoid for influenza immunisation, with no reported adverse event (wrong product administered) (Latency Same day). Reportedly, they intended to administer Fluarix and a Covid-19 Vaccine. Fluzone HD is the medication given in error. 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
2870408 43 M MO 11/04/2025 FLU3
 SANOFI PASTEUR
 UT88220AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
inadvertently administered a FLUZONE HD with no AE; Initial information received on 24-Oct-2025 rega... inadvertently administered a FLUZONE HD with no AE; Initial information received on 24-Oct-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 43 years old male patient who was inadvertently administered Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine Inact Split 3v (Fluarix); And Covid-19 Vaccine (Covid-19 Vaccine) both for Immunisation. On 24-Oct-2025, the patient inadvertently received 0.5mL dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (once), Suspension for injection in pre-filled syringe, Strength high dose, lot UT88220AA and expiry date 30-Jun-2026 via intramuscular route in the left deltoid for influenza immunisation, with no reported adverse event (wrong product administered) (Latency Same day). Reportedly, they intended to administer Fluarix and a Covid-19 Vaccine. Fluzone HD is the medication given in error. 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
2870409 65 F NY 11/04/2025 FLU3
 SANOFI PASTEUR
 U8837BA
Circumstance or information capable of leading to medication error, No adverse e... Circumstance or information capable of leading to medication error, No adverse event, Underdose More
patient was "moving their arm" during administration/vaccine administered at less than the... patient was "moving their arm" during administration/vaccine administered at less than the approved dose with no AE; Initial information received on 24-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 years old female patient who moved his arm during administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] and less than the approved dose was administered at with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Oct-2025, the patient while receiving 0.5ml dose 1 of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8837BA and expiry date 30-Jun-2026 via intramuscular route in the left deltoid for Immunization moved his arm and less than the approved dose was administered at with no reported adverse event (incorrect dose administered) (latency Same day). Reportedly, the patient was "moving their arm" during administration and confirmed that the prefilled syringe was not damaged. 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
2870411 F GA 11/04/2025 UNK
 UNKNOWN MANUFACTURER
Loss of personal independence in daily activities, Rash Loss of personal independence in daily activities, Rash
rash on her knee, neck, and thigh, which persisted for more than a week/spread from her neck to her ... rash on her knee, neck, and thigh, which persisted for more than a week/spread from her neck to her forearms, significantly disturbing her daily life; Initial information received on 24-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves an unknown age female patient who had rash on her knee, neck, and thigh, which persisted for more than a week and spread from her forearms, significantly disturbing her daily life after receiving Influenza Trivalent Recombinant Vaccine [Flublok]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Sep-2025, the patient received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation). Information regarding batch number corresponding to the one at time of event occurrence is requested. On an unknown date in Sep-2025, the patient developed rash on her knee, neck, and thigh, which persisted for more than a week/spread from her neck to her forearms, significantly disturbing her daily life (rash) (latency3 weeks). It was reported, "patient did not receive any other vaccine" Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Not Recovered / Not Resolved for the event. More
2870412 65 F MD 11/04/2025 FLU3
 SANOFI PASTEUR
 U8864AA
No adverse event, Syringe issue, Underdose No adverse event, Syringe issue, Underdose
administration of a minuscule amount of FLUBLOK to a patient resulting from a defective syringe flan... administration of a minuscule amount of FLUBLOK to a patient resulting from a defective syringe flange with no reported adverse event; Initial information received on 24-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old female patient who was administered a minuscule amount of Influenza Trivalent Recombinant Vaccine [Flublok] resulting from a defective syringe flange with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Oct-2025, the patient received a minuscule amount of Influenza Trivalent Recombinant Vaccine Solution for injection (unknown strength) lot U8864AA and expiry date 30-Jun-2026 via intramuscular route in the left arm for resulting from a defective syringe flange with no reported adverse event (incorrect dose administered) (Latency Same day). Reportedly, The syringe's flange (referred to by the caller as the "glass at the bottom") shattered and partially detached (or remained "hanging") during administration. The dose remained mostly full, although the caller stated that a minuscule portion may have been administered to the patient. 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
2870413 67 F KS 11/04/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
U8827AA
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
administration of fluzone np to a patient who was intended to receive fluzone hd, with no reported a... administration of fluzone np to a patient who was intended to receive fluzone hd, with no reported adverse event; Initial information received on 24-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 67 years old female patient who had administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] and was intended to receive INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) for Immunisation. On 24-Oct-2025, the patient received a Dose 1 (0.5 ml) of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (Strength: Standard, Frequency: Once) (lot U8827AA, expiry date: 30-JUN-2026) via intramuscular route in the left arm for Immunization; but was intended to receive INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, with no reported adverse event (wrong product administered) (latency- same day). It was reported, ''Nurse practitioner called to seek recommendations following the administration of FLUZONE NP to a 67- year-old patient who was intended to receive FLUZONE HD. 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. More
2870414 M IA 11/04/2025 FLU3
 SANOFI PASTEUR
 U8875BA
No adverse event, Syringe issue No adverse event, Syringe issue
when she pushed the retraction button, the retraction mechanism broke, the little bit that was left ... when she pushed the retraction button, the retraction mechanism broke, the little bit that was left sprayed out, and got on the patient's skin with no adverse event; when she pushed the retraction button, the retraction mechanism broke, the little bit that was left sprayed out, and got on the patient's skin with no adverse event; Initial information received on 27-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age male patient who was administered INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and when administering physician pushed the retraction button, the retraction mechanism broke, the little bit that was left sprayed out, and got on the patient's skin with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other immunizations. On 20-Oct-2025, the patient received a dose of 0.5 ml once of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Suspension for injection in pre-filled syringe) (lot: U8875BA; expiry date: 30-Jun-2026; strength: high dose) via intramuscular route in the right arm for Immunization and when administering physician pushed the retraction button, the retraction mechanism broke, the little bit that was left sprayed out, and got on the patient's skin with no adverse event (exposure via skin contact) (accidental exposure to product) (latency: same day). It was reported, "The patient is concerned that he did not get the full dose, though the administering technician believes she did. Caller states there is always a little bit left in the hub and needle, and believes that was all that had sprayed out, as the needle was fully in the patient's arm for the administration of the dose. The retraction button broke after the dose was given. 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
2870416 67 M MS 11/04/2025 FLU3
 SANOFI PASTEUR
 U8862EA
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
subcutaneous administration of fluzone hd with no reported ae; Initial information received on 28-Oc... subcutaneous administration of fluzone hd with no reported ae; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 67 years old male patient who received Influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] via subcutaneous route with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix) for Immunisation. On 27-Oct-2025, the patient received 0.5 ml of dose 1 of Influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- high dose, expiry date- 30-JUN-2026 and lot U8862EA) once via subcutaneous route in the left deltoid for Immunization with no reported ae (incorrect route of product administration) (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
2870435 M CA 11/04/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pulse abnormal, Respiratory rate decreased, Syncope Pulse abnormal, Respiratory rate decreased, Syncope
Fainted; barely breathing; weak pulse; This serious case was reported by a consumer via call center ... Fainted; barely breathing; weak pulse; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included parkinson's disease and hypertension. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 hr 15 min after receiving Shingrix, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant), difficulty breathing (Verbatim: barely breathing) and pulse weak (Verbatim: weak pulse). The outcome of the fainting was unknown and the outcome of the difficulty breathing and pulse weak were not reported. It was unknown if the reporter considered the fainting, difficulty breathing and pulse weak to be related to Shingrix. The company considered the fainting to be unrelated to Shingrix. It was unknown if the company considered the difficulty breathing and pulse weak to be related to Shingrix. Additional Information: GSK Receipt Date: 20-OCT-2025 The caregiver reported the case on behalf of consumer (patient) stated that consumer had his first dose of Shingrix administered and they were not allowed to wait in the hospital for 15 minutes to ensure the consumer did not have an allergic reaction. The caregiver further stated the physician administering the vaccine was going to lunch and told the patient they needed to leave the office. The consumer had the dose administered then one hour and 15 minutes later he fainted. The patient was barely breathing, and he had a weak pulse. He was at a store when he fainted. Paramedics were called. The patient was treated at the store and released. The caregiver stated the paramedics administered some type of injection to the consumer after being informed the consumer had received a dose of Shingrix. The caregiver stated the physician was trying to kill the patient. Stated the report from the paramedics had been redacted with crucial information deleted concerning care of the consumer. No other products were received by the patient. No further information was provided or obtained. The batch number was not provided and a request for this information had been made.; Sender's Comments: A case of Syncope, 1 hr 15 min after receiving Shingrix, in a 74-year-old male patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2870440 64 M 11/04/2025 COVID19
 MODERNA
Fatigue, Immunisation reaction, Myalgia Fatigue, Immunisation reaction, Myalgia
few other things / stuff like that; muscle ache; general tiredness; This spontaneous case was report... few other things / stuff like that; muscle ache; general tiredness; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (few other things / stuff like that), MYALGIA (muscle ache) and FATIGUE (general tiredness) in a 64-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 24-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. In October 2025, the patient experienced IMMUNISATION REACTION (few other things / stuff like that), MYALGIA (muscle ache) and FATIGUE (general tiredness). At the time of the report, IMMUNISATION REACTION (few other things / stuff like that), MYALGIA (muscle ache) and FATIGUE (general tiredness) outcome was unknown. No concomitant medications provided by the reporter. Patient had a little bit of what call side effects, muscle ache and a few other things. Patient thought that pretty much the basic stuff, the general tiredness and stuff like that. No treatment medications provided by the reporter. This case was linked to MOD-2025-790652 (Patient Link). More
2870443 5 M CO 11/04/2025 DTAPIPV
FLU3
MMRV
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
 U7908AA
U8863AA
Z008224
Expired product administered; Expired product administered; Expired product admi... Expired product administered; Expired product administered; Expired product administered More
I was performing immunization administration and I accidentally gave the patient an expired vaccine. I was performing immunization administration and I accidentally gave the patient an expired vaccine.
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