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
2867738 1 F MI 10/23/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 9C295
Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered
gave a patient the wrong vaccine last night and it would be the fourth dose of the Pediatrics; gave ... gave a patient the wrong vaccine last night and it would be the fourth dose of the Pediatrics; gave a patient the wrong vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 1-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9C295, expiry date 02-FEB-2027) for prophylaxis. On 07-OCT-2025, the patient received the 4th dose of Pediarix. On 07-OCT-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: gave a patient the wrong vaccine last night and it would be the fourth dose of the Pediatrics) and wrong vaccine administered (Verbatim: gave a patient the wrong vaccine). The outcome of the extra dose administered and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-OCT-2025 Medical assistant reported that they were just trying to call and get information regarding complications or anything about receiving a fourth dose. More
2867739 F CT 10/23/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles after vaccination; This serious case was reported by a physi... Suspected vaccination failure; Shingles after vaccination; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles after vaccination). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix. Additional Information: GSK receipt date: 16-OCT-2025 Physician also stated that the long-term data has gone down. No further details were provided. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: A case of Vaccination failure and Herpes zoster, on an unknown time after receiving 1st dose of Shingrix and the 2nd dose of Shingrix, in a 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
2867740 10/23/2025 COVID19
 MODERNA
Near death experience Near death experience
Moderna almost killed me; This spontaneous case was reported by a consumer and describes the occurre... Moderna almost killed me; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Moderna almost killed me) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Moderna almost killed me) (seriousness criterion medically significant). At the time of the report, NEAR DEATH EXPERIENCE (Moderna almost killed me) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication was not provided. Treatment medication was not reported.; Reporter's Comments: Very little information provided at this time. The benefit-risk relationship of product is not affected by this report. More
2867741 F PA 10/23/2025 COVID19
 MODERNA
Pyrexia, Rash Pyrexia, Rash
It was a rather large rash. It covered her arm in the upper and lower areas; Slight fever; This spon... It was a rather large rash. It covered her arm in the upper and lower areas; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (It was a rather large rash. It covered her arm in the upper and lower areas) and PYREXIA (Slight fever) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (It was a rather large rash. It covered her arm in the upper and lower areas) and PYREXIA (Slight fever). At the time of the report, RASH (It was a rather large rash. It covered her arm in the upper and lower areas) and PYREXIA (Slight fever) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. Current age of patient was reported as 80-years. It was reported that post vaccination patient got a slight fever and she got a rash that was expansive on her arm. The rash went above the vaccine, it went down her arm, but it was dissipated and then each time she got a booster it got to the point where it's a circle around the vaccine, but nothing like it was the first time. The patient received total 6 Moderna vaccine. No treatment medications provided by the reporter. This case was linked to MOD-2025-790320 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2025: Live non-significant follow-up information received in which reporter details and reference numbers were added. On 16-Oct-2025: Live non-significant follow-up received, and new reference number was added. More
2867742 60 F PA 10/23/2025 COVID19
COVID19
FLUX
FLUX
RVX
RVX
 MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER





Acute disseminated encephalomyelitis, Alopecia, Blood pressure measurement, Decu... Acute disseminated encephalomyelitis, Alopecia, Blood pressure measurement, Decubitus ulcer, Septic shock; Weight, Weight decreased; Acute disseminated encephalomyelitis, Alopecia, Blood pressure measurement, Decubitus ulcer, Septic shock; Weight, Weight decreased; Acute disseminated encephalomyelitis, Alopecia, Blood pressure measurement, Decubitus ulcer, Septic shock; Weight, Weight decreased More
ADEM/paralyzed/brain, the thorax and the spine were all inflamed/couldn't speak, write, see, wa... ADEM/paralyzed/brain, the thorax and the spine were all inflamed/couldn't speak, write, see, walk/no control over their bowels or bladder/wearing a diaper/choking risk/blindness and inability to take solid food/came close to death/seizure; blood pressure was 60/40/went into septic shock; had a bed sore now for 8-9 months; Patient had lost 40 pounds; hair fell out; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM/paralyzed/brain, the thorax and the spine were all inflamed/couldn't speak, write, see, walk/no control over their bowels or bladder/wearing a diaper/choking risk/blindness and inability to take solid food/came close to death/seizure), SEPTIC SHOCK (blood pressure was 60/40/went into septic shock), DECUBITUS ULCER (had a bed sore now for 8-9 months), WEIGHT DECREASED (Patient had lost 40 pounds) and ALOPECIA (hair fell out) in a 60-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect products included non-company products RSV vaccine for an unknown indication and Influenza vaccine for an unknown indication. The patient's past medical history included Road traffic accident (had a motorcycle accident when she was 16yo that severely damaged the leg but recovered from it and was still able to walk.). Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Patient received all Moderna Covid vaccines). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included Wheelchair user. In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form, dose of RSV vaccine (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 06-Oct-2024, the patient experienced ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM/paralyzed/brain, the thorax and the spine were all inflamed/couldn't speak, write, see, walk/no control over their bowels or bladder/wearing a diaper/choking risk/blindness and inability to take solid food/came close to death/seizure) (seriousness criteria hospitalization, disability, medically significant and life threatening), SEPTIC SHOCK (blood pressure was 60/40/went into septic shock) (seriousness criteria hospitalization, disability, medically significant and life threatening), DECUBITUS ULCER (had a bed sore now for 8-9 months) (seriousness criteria hospitalization, disability, medically significant and life threatening), WEIGHT DECREASED (Patient had lost 40 pounds) (seriousness criteria hospitalization and disability) and ALOPECIA (hair fell out) (seriousness criteria hospitalization and disability). The patient was treated with Dipyridamole (Platelet) at an unspecified dose and frequency. At the time of the report, ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM/paralyzed/brain, the thorax and the spine were all inflamed/couldn't speak, write, see, walk/no control over their bowels or bladder/wearing a diaper/choking risk/blindness and inability to take solid food/came close to death/seizure), SEPTIC SHOCK (blood pressure was 60/40/went into septic shock), DECUBITUS ULCER (had a bed sore now for 8-9 months), WEIGHT DECREASED (Patient had lost 40 pounds) and ALOPECIA (hair fell out) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2024, Blood pressure measurement: 60/40. On 06-Oct-2024, Weight: lost 40 pounds. No concomitant medications were reported. The patient had gotten sick a week earlier and had received both the flu shot and the COVID shot. A week later, the patient's brain, thorax, and spine became inflamed. The patient unable to speak, write, see, or walk. The patient still had no control over their bowels or bladder. The patient was still wearing a diaper a year later. The patient had been to 7 facilities. The patient was taken by ambulance, was transported from a hospital near where she lives. The patient spent 2 weeks on a neurological CCU unit because they did not know what was wrong with the patient. They drained their blood and added platelets. Typically, it was done 3 times. They did it 5 times. The patient was on antibiotics for 8 months. Due to symptoms, the patient had to eat baby food because she was choking at risk. Patient had baby food for the first two weeks. The blindness and inability to take solid food resolved after 2 weeks. The patient went into septic shock at the first rehab and had to be transported, where the patient had a seizure. They packed the patient in ice, and the blood pressure was 60/40. It was reported that patient came close to death twice (referring to first the initial ADEM symptoms and the septic shock). Currently, the patient was in total care. Still cannot walk and she was in a nursing home, had regained the use of the arms and legs but had no feeling in the midsection. The patient was still paralyzed, still wearing a diaper, and was going to be in a wheelchair the rest of life. The patient's brain was foggy since all this happened. That was one of the residual effects because the brain was inflamed, it caused damage. The patient had a bed sore now for 8-9 months. The patient's hair fell out. Between the reporter and patient, they had lost 100 pounds. Patient had two medical professionals and told her that the reactions were caused by the COVID shot. She also added she was told that nobody in her bloodline can never have the shot again. The reporter imagined that patient had about 6 Moderna COVID-19 shots but had no further details as she did not have the vaccine card. They drained blood and added platelets. Typically, it was done 3 times, and they did it 5 times. This case was linked to US-MODERNATX, INC.-MOD-2025-790250 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2025: Live follow-up received which contains significant information, patient initial, event verbatim and start date were updated. This case was linked to US-MODERNATX, INC.-MOD-2025-790250 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2025: Live follow-up received which contains significant information, patient initial, event verbatim and start date were updated.; Reporter's Comments: Company comment: RSV vaccine was considered as a co-suspect product. Events septic shock and decubitus ulcer were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790250:Reporter's case More
โœ“ โœ“ โœ“
2867743 73 F PA 10/23/2025 COVID19
 MODERNA
Fatigue, Illness, Malignant neoplasm progression, Rash, Sepsis Fatigue, Illness, Malignant neoplasm progression, Rash, Sepsis
severe illness; sepsis; exacerbated pre-existing conditions like blood cancer; rash; fatigue; This s... severe illness; sepsis; exacerbated pre-existing conditions like blood cancer; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (severe illness), SEPSIS (sepsis) and MALIGNANT NEOPLASM PROGRESSION (exacerbated pre-existing conditions like blood cancer) in a 73-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hematological malignancy. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1 (lot: 006B21A)) on 26-Mar-2021, Moderna COVID-19 Vaccine (Dose 2) on 27-Apr-2021 and Moderna COVID-19 Vaccine (Dose 3) on 09-Nov-2021. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Hematological neoplasm (Blood cancer). On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, the patient experienced SEPSIS (sepsis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ILLNESS (severe illness) (seriousness criterion hospitalization), MALIGNANT NEOPLASM PROGRESSION (exacerbated pre-existing conditions like blood cancer) (seriousness criterion medically significant), RASH (rash) and FATIGUE (fatigue). The patient was hospitalized on sometime in 2023 due to SEPSIS, and then on 12-Oct-2025 due to ILLNESS. At the time of the report, ILLNESS (severe illness), SEPSIS (sepsis), MALIGNANT NEOPLASM PROGRESSION (exacerbated pre-existing conditions like blood cancer), RASH (rash) and FATIGUE (fatigue) had not resolved. No concomitant medications were reported. The patient experienced severe side effects after receiving the fourth Moderna booster shot. She described persistent health issues, including a rash, fatigue, and exacerbated pre-existing conditions like blood cancer, following the vaccination. In addition, she had to take a break due to severe illness and ended up in the hospital on Sunday. Despite undergoing numerous tests, the cause of her condition remained unidentified. She visited her doctor recently and needed to undergo additional tests to determine the issue. She recalled a severe episode of sepsis two years ago that left her hospitalized for seven days. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Due to lack of biological plausibility, the causality of the events sepsis and malignant neoplasm progression was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
โœ“
2867744 70 M VA 10/23/2025 COVID19
COVID19
FLUX
FLUX
 PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Chills, Hypersomnia, Myalgia, Pyrexia, Skin sensitisation; Vomiting; Chills, Hyp... Chills, Hypersomnia, Myalgia, Pyrexia, Skin sensitisation; Vomiting; Chills, Hypersomnia, Myalgia, Pyrexia, Skin sensitisation; Vomiting More
slept 18 hours straight after symptom onset; skin sensitivity; fever spiked to 103; severe muscle ac... slept 18 hours straight after symptom onset; skin sensitivity; fever spiked to 103; severe muscle aches; All-night vomiting; chills; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 16Oct2025 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 16Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCORTISONE, start date: May2025; TAMSULOSIN, start date: Aug2005. Past drug history included: Opdualag, start date: Nov2023, stop date: May2024, for Cancer. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: VOMITING (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025), described as "All-night vomiting"; CHILLS (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025); PYREXIA (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025), described as "fever spiked to 103"; MYALGIA (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025), described as "severe muscle aches"; SKIN SENSITISATION (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025), described as "skin sensitivity"; HYPERSOMNIA (non-serious) with onset 16Oct2025 at 23:30, outcome "recovered with sequelae" (Oct2025), described as "slept 18 hours straight after symptom onset". Therapeutic measures were not taken as a result of hypersomnia, skin sensitisation, pyrexia, myalgia, vomiting, chills. Additional information: The patient had no known allergies. Other vaccine in four weeks was reported as no. 12 hours after injection fever spiked to 103, severe muscle aches, all-night vomiting, chills- 36 hours later severe muscle aches, skin sensitivity, slept 18 hours straight after symptom onset. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2867745 7 M 10/23/2025 FLU3
 SANOFI PASTEUR
 U8827AA
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion: temperature reached: 25.7 f degrees duration: 4 hours and 17 minutes with no ... temperature excursion: temperature reached: 25.7 f degrees duration: 4 hours and 17 minutes with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 years old male patient who was administered to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which had temperature excursion: temperature reached: 25.7 F degrees duration: 4 hours and 17 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot U8827AA, expiry date 30-Jun-2026, frequency once and strength standard) via intradermal route in the right arm for Immunisation and temperature excursion: temperature reached: 25.7 f degrees duration: 4 hours and 17 minutes with no reported adverse event (product storage error). Reportedly, temperature excursion occurred while vaccine was in storage prior to administration. The excursion was identified after the administration of the vaccine. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA304532:master case More
2867746 76 F NJ 10/23/2025 FLU3
 SANOFI PASTEUR
 U8855AA
Product storage error Product storage error
fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a ... fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a patient when the vaccines were basically considered frozen with no adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. Several cases were created from this master case. This case involves 76 years old female patient and reporter reported fridge went below the storage limit that it got to negative 11f and ended up giving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] to a patient when the vaccines were basically considered frozen with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or ''no other immunizations'': no other immunizations. On 15-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 (strength- high dose) (lot U8855AA) (unknown expiry date) via unknown route in unknown administration site for Influenza (Influenza immunization); for which fridge went below the storage limit that it got to negative 11f and ended up giving fluzone HD to a patient when the vaccines were basically considered frozen with no adverse event (poor quality product administered) (latency- same day). It was reported, ''Office manager called because their fridge went below the storage limit that it got to negative 11F. They ended up giving FLUZONE HD to 8 patients when the vaccines were basically considered frozen. She asked if the patients will experience adverse reactions. No Treatment was received''. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA311016:02691485 US-SA-2025SA311032:02691502 US-SA-2025SA310596:02691483 US-SA-2025SA311029:02691482 US-SA-2025SA311035:02691509 US-SA-2025SA311063:02691492 US-SA-2025SA311026:02691495 More
2867747 66 M NJ 10/23/2025 FLU3
 SANOFI PASTEUR
 U8855AA
No adverse event, Product storage error No adverse event, Product storage error
fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a ... fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a patient when the vaccines were basically considered frozen with no adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA311022 (master case). This case involves 66 years old male patient and reporter reported fridge went below the storage limit that it got to negative 11f and ended up giving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] to a patient when the vaccines were basically considered frozen with no 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) (Prevnar 20) for Prophylactic vaccination (Immunisation). On 15-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 (strength- high dose) (lot U8855AA) (unknown expiry date) via unknown route in unknown administration site for Influenza (Influenza immunization); for which fridge went below the storage limit that it got to negative 11f and ended up giving fluzone hd to a patient when the vaccines were basically considered frozen with no adverse event (poor quality product administered) (latency- same day). It was reported, ''Office manager called because their fridge went below the storage limit that it got to negative 11F. They ended up giving FLUZONE HD to 8 patients when the vaccines were basically considered frozen. She asked if the patients will experience adverse reactions. No Treatment was received''. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA311022:02691406 (master case) More
2867748 78 F NJ 10/23/2025 FLU3
 SANOFI PASTEUR
 U8855AA
No adverse event, Product storage error No adverse event, Product storage error
fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a ... fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a patient when the vaccines were basically considered frozen with no adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA311022 (master case). This case involves 78 years old female patient and reporter reported fridge went below the storage limit that it got to negative 11f and ended up giving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] to a patient when the vaccines were basically considered frozen with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or ''no other immunizations'': no other immunizations On 15-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 (strength- high dose) (lot U8855AA) (unknown expiry date) via unknown route in unknown administration site for Influenza (Influenza immunization); for which fridge went below the storage limit that it got to negative 11f and ended up giving fluzone HD to a patient when the vaccines were basically considered frozen with no adverse event (poor quality product administered) (latency- same day). It was reported, ''Office manager called because their fridge went below the storage limit that it got to negative 11F. They ended up giving FLUZONE HD to 8 patients when the vaccines were basically considered frozen. She asked if the patients will experience adverse reactions. No Treatment was received''. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA311022:master case More
2867749 85 F MI 10/23/2025 FLU3
 SANOFI PASTEUR
Arthralgia, Malaise, Pain in extremity Arthralgia, Malaise, Pain in extremity
pain is in her left hip; pain is in her both upper arms, and her fingers; Initial information receiv... pain is in her left hip; pain is in her both upper arms, and her fingers; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves 85 years old female patient who had pain in her left hip and pain in her both upper arms, and her fingers after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Sep-2025, the patient received a dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (once) (lot number, strength, expiry date- not reported) via unknown route in unknown administration site for Influenza (Influenza immunization). Information on the batch number was requested corresponding to the one at time of event occurrence. On 03-SEP-2025 the patient developed pain in her left hip (arthralgia) and pain is in her both upper arms, and her fingers (pain in extremity) (latency- 1 day). It was reported, ''Caller is reporting that she received a FLUZONE HD last month, but she has been really sick, next to disabled, ever since she received the vaccine. We asked for her to describe her symptoms, and she stated it was "painful". She said it looks like arthritis all over, though she did not mention any physical appearance symptoms. She said it started with pain the day after her injection and it has continued since. Caller said the pain is in her both upper arms, her left hip, and her fingers. She thought it would go away after a few days but it has stayed with her. Caller stated she wished she had never gotten the shot. We asked if she had reached out to her doctor about it, and she said yes. The provider told her she would have to get started with physical therapy. She did not say the doctor gave her any other advice or treatment''. Action taken was not applicable. It was not reported if the patient received corrective treatment for both the events. At time of reporting, the outcome was Not Recovered / Not Resolved for both the events. More
2867750 45 M 10/23/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Pain in extremity Pain in extremity
Experienced some very mild soreness in the arm; This spontaneous case, initially received on 09-Oct-... Experienced some very mild soreness in the arm; This spontaneous case, initially received on 09-Oct-2025, was reported by a health professional and concerns an adult male patient. Relevant medical history and concomitant medication was unknown. Administration of company suspect drug: On 08-Oct-2025, the patient received Flucelvax (TIV) for Indication: Unknown, Dose regimen: not reported, Route of administration: not reported; Anatomical Location: Arm, Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On Oct-2025, the patient Experienced some very mild soreness in the arm (outcome: Unknown). On 08-Oct-2025, the patient received his annual immunization of the 25-26 Flucelvax vaccine via Health Services. The patient had experienced some very mild soreness in the arm in which the vaccine was administered. There were no other issues or symptoms to report at the time of reporting. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter reported event seriousness as unknown and causality assessment was not reported.; Reporter's Comments: Due to the spontaneous nature of the case, the event is considered related for reporting purposes More
2867751 3 M NC 10/23/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Pain in extremity, Sleep disorder Pain in extremity, Sleep disorder
Patient was saying his leg hurt; Trouble sleeping; This spontaneous case, initially received on 08-... Patient was saying his leg hurt; Trouble sleeping; This spontaneous case, initially received on 08-Oct-2025, was reported by a health professional and concerns a child male patient. Administration of company suspect drug: On 06-Oct-2025, the patient received Flucelvax (TIV) for Indication not reported, dose: not reported, route of administration: not reported, anatomical location: not reported. Lot number: No batch number available and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Patient was saying his leg hurt (outcome: Unknown), Trouble sleeping (outcome: Unknown). Two of her sons, received their flu shots (Flucelvax) on 06-Oct-2025. Both had the vaccine administered by their pediatrician in their thigh. For her younger son, he was saying his leg hurt for most of the night to the point where he had trouble sleeping. For her older son, his leg also hurt and the next day (07-Oct-25) the leg where he got the flu shot was hurting and the area just above his knee was also swollen. She was making him an appointment with his pediatrician on 08-Oct-25 to have his leg checked. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality for Patient was saying his leg hurt, Trouble sleeping.; Reporter's Comments: Due to the spontaneous nature of the case, events are considered related for reporting purposes. More
2867752 78 F 10/23/2025 UNK
 UNKNOWN MANUFACTURER
 UNK
Atrial flutter Atrial flutter
Atrial Flutter; This 79-year-old female subject was enrolled in an open label study titled A phase 3... Atrial Flutter; This 79-year-old female subject was enrolled in an open label study titled A phase 3b, randomized, open label, multi-country, multi-center, extension and crossover vaccination study to evaluate the immunogenicity and safety of different revaccination schedules and persistence of a single dose of the RSVPreF3 OA vaccine in adults aged 60 years and above who participated in the RSV OA=ADJ-006 study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) 120 ๏ฟฝg on 07-APR-2025, for prophylaxis. In AUG-2025, between 3 and 5 months after receiving RSVPreF3 vaccine + AS01E, the subject developed moderate - grade 2 atrial flutter (Verbatim: Atrial Flutter). Serious criteria included hospitalization. The subject was treated with apixaban (Eliquis) and metoprolol tartrate. The outcome of atrial flutter was unknown. The investigator considered that there was no reasonable possibility that the atrial flutter may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial flutter may have been caused by RSVPreF3 vaccine + AS01E. GSK Receipt Date: 17-OCT-2025 Participant reported hospitalization sometime in early August 2025 for Atrial Flutter. Participant reported that she was discharged after a one day. Follow up PCP (Primary care physician) appointment on 23 AUG 2025 where subject was prescribed Eliquis 5 mg BID and Metoprolol tartrate 25 mg BID. Participant would follow up with cardiology this month. Admitted to Medical center - records were requested to determine if any further reporting was required. AE (adverse event) was not related to study treatment. Hospital Admission date of AE: UNK-AUG-2025 Hospital Discharge date of AE: UNK-AUG-2025 SAE was not Related to Study Participation Activities other than Study Treatment. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). This was a new disease and not exacerbation of an existing disease. Date event became serious: UNK-AUG-2025; Sender's Comments: A case of Atrial flutter, between 3 and 5 months after receiving 1st dose of RSVPreF3 vaccine + AS01E, in 79-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset. More
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2867762 14 F WA 10/23/2025 FLU3
FLU3
FLU3
FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8854AA
U8854AA
U8854AA
U8854AA
U8854AA
Anaemia, Anxiety, Arthralgia, Asthenia, Blood fibrinogen increased; C-reactive p... Anaemia, Anxiety, Arthralgia, Asthenia, Blood fibrinogen increased; C-reactive protein increased, Chest pain, Computerised tomogram normal, Computerised tomogram thorax, Condition aggravated; Dyspnoea, Electrocardiogram normal, Fatigue, Fibrin D dimer increased, Full blood count abnormal; Lymphadenopathy, Malaise, Metabolic function test normal, Pain in extremity, Pleuritic pain; Red blood cell sedimentation rate increased, Ultrasound Doppler normal More
Within minutes of vaccination, patient reported pleuritic chest pain and left shoulder pain that pro... Within minutes of vaccination, patient reported pleuritic chest pain and left shoulder pain that prompted evaluation in the ER. Initial diagnosis of anxiety and discharged, pain persisted and she also developed some shortness of breath and subjective weakness/fatigue/general malaise. She was reevaluated in the ER the following day and labs were notable for an elevated D-dimer, normal EKG, and CT angio negative for pulmonary embolism but notable for some left axillary adenopathy. I evaluated her 3 days later and chest pain was improving though not resolved but she continued to report fatigue and then endorsed some posterior right leg pain. I repeated labs and notable for now normal d-dimer, elevated fibrinogen, elevated ESR/CRP, normal CMP and CBC with only mild anemia. Doppler US negative for DVT. At the time of writing this, she had additional evaluation completed at another clinic and was not yet fully returned to baseline. More
2867763 8 F WA 10/23/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Angiogram pulmonary normal, Electrocardiogram ST segment abnormal, Eye movement ... Angiogram pulmonary normal, Electrocardiogram ST segment abnormal, Eye movement disorder, Fibrin D dimer increased, Loss of consciousness; Malaise, Syncope, Tremor, Troponin normal More
I am NOT certain of the exact brand of influenza vaccine received - this was not given at my clinic... I am NOT certain of the exact brand of influenza vaccine received - this was not given at my clinic. 12 days after receiving flu vaccine, she had an episode of LOC (described by the ER as syncopal episode with shaking, eyes rolled back) immediately after reporting feeling unwell. In the ER, d-dimer was elevated with normal troponin and this prompted a CT angio to eval pulmonary embolism which was normal. I am submitting this case because it is the second patient of mine this week to have an elevated d-dimer in the ER and undergo an eval for PE and I have never had a pediatric patient with these labs/evaluations before. EKG showed a left axis and nonspecific ST abnormalities and she was referred to cardiology. More
2867769 NJ 10/23/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
PFIZER\WYETH

Interchange of vaccine products; Interchange of vaccine products Interchange of vaccine products; Interchange of vaccine products
Patient received 1 dose of Trumenba in October 2023. Patient received 1 dose of Bexsero in October 2... Patient received 1 dose of Trumenba in October 2023. Patient received 1 dose of Bexsero in October 2025.; This non-serious case was reported by a physician via call center representative and described the occurrence of interchange of vaccine products in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis. In OCT-2025, the patient received the 1st dose of Bexsero. In OCT-2023, the patient received the 1st dose of Trumenba. In OCT-2025, an unknown time after receiving Bexsero and an unknown time after receiving Trumenba, the patient experienced interchange of vaccine products (Verbatim: Patient received 1 dose of Trumenba in October 2023. Patient received 1 dose of Bexsero in October 2025.). The outcome of the interchange of vaccine products 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: 06-OCT-2025 The patient received 1 dose of Trumenba and 1 dose of Bexsero. The reporter asked was a second dose of Bexsero required. The batch number was not provided upon follow up with the reporter. More
2867770 15 F 10/23/2025 FLUX
 UNKNOWN MANUFACTURER
 U8827AA
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion occurred while vaccine was in storage prior to administartion, temperature r... temperature excursion occurred while vaccine was in storage prior to administartion, temperature reached 25.7 f degrees duration: 4 hours and 17minutes with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 years old female patient (160 cm and 53.97 kg) who was to receive Influenza USP Trival A-B Subvirion No Preservative Vaccine that had temperature excursion occurred while it was in storage prior to administartion, temperature reached 25.7 f degrees duration: 4 hours and 17minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, a dose of 0.5ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot U8827AA and expiry date-30-Jun-2026) (strength-unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) had temperature excursion occurred while it was in storage prior to administartion, temperature reached 25.7 f degrees duration: 4 hours and 17minutes with no reported adverse event (product storage error) (unknown latency). 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
2867771 0.33 MI 10/23/2025 FLU3
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
4- month-old patient received Fluzone NP in error with no reported adverse event; Initial informatio... 4- month-old patient received Fluzone NP in error with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old and unknown gender patient who received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] in error 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, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel), Pneumococcal vaccine conj 7v (CRM197) (Prevnar); and Rotavirus vaccine for Immunisation. On an unknown date, 4- month-old patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Strength = standard) dose 0. 5ml 1x(once) Suspension for injection (batch and expiry date unknown) via intramuscular route in the left thigh for Immunization, in error with no reported adverse event (wrong product administered) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Action taken- not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2867774 61 M VA 10/23/2025 COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 NA0739
NA0739
NA0739
U8823BA
U8823BA
U8823BA
Blood sodium decreased, Blood test, Chest pain, Dyspnoea, Dysstasia; Gait inabil... Blood sodium decreased, Blood test, Chest pain, Dyspnoea, Dysstasia; Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Monoplegia; Muscle spasms; Blood sodium decreased, Blood test, Chest pain, Dyspnoea, Dysstasia; Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Monoplegia; Muscle spasms More
Shortness of breath and chest pain middle of the night following his having the flu and covid booste... Shortness of breath and chest pain middle of the night following his having the flu and covid booster on 10/07/2025. Called 911 on 10/08/25 and went to urgent care who misdiagnosed him as having pneumonia. Continued to feel worse with increasing pain from muscle cramping it seemed. Saturday 10/11/25 went to ER. They diagnosed low sodium disputed the pneumonia diagnosis but did not recommend hospital admission and sent him home to get a follow up lab for sodium with his PCP. He got the new level at his PCP on 10/14/25. PCP recommended immediately to go to the Hospital ER on 10/15/2025. He was tested for low sodium there and they found he needed admission to the hospital. He was unable to get out of the bed at the time and walk. The next morning the PT came to help him get up but he was unable to push himself up to stand. The hospital Doctor examined him and determined need for a neurology consult. Neurologist examined him and came back to the room to ask him if he had had any infections and/or vaccinations which is when they heard the vaccination was the previous Tuesday. The Neurologist immediately decided he has Gilliam Barre Syndrome. The treatment was started right away, Immunoglobulin IV was started on 10/17/2025. So far as of today 10/22/2025 he has completed a course of the IV treatment. He has been receiving PT and started to be able to stand with assistance and walk with assistance to a toilet but this is very difficult and he has paralysis type of problem with his right arm hand and his right leg. He is being recommended to go from the hospital to an acute rehab facility for intensive PT for the time it take him to be well enough to come home. An important not here is that his health insurance company had called and asked him if he had gotten his covid and flu vaccination yet and told him to go and get these vaccinations. He was following the order of his insurance company when he went ot have the vaccines. More
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2867775 11 F NC 10/23/2025 FLU3
FLU3
MNQ
MNQ
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8827AA
U8827AA
U8509AA
U8509AA
U8353AA
U8353AA
Blood glucose, Dizziness, Electrocardiogram, Generalised tonic-clonic seizure, P... Blood glucose, Dizziness, Electrocardiogram, Generalised tonic-clonic seizure, Pallor; Partial seizures, Presyncope; Blood glucose, Dizziness, Electrocardiogram, Generalised tonic-clonic seizure, Pallor; Partial seizures, Presyncope; Blood glucose, Dizziness, Electrocardiogram, Generalised tonic-clonic seizure, Pallor; Partial seizures, Presyncope More
Patient received Tdap, Meningococcal & Flu vaccines as well as CBC. She had an apparent vasovaga... Patient received Tdap, Meningococcal & Flu vaccines as well as CBC. She had an apparent vasovagal reaction - turned pale, felt dizzy. She was then helped to exam table and had a generalized tonic-clonic seizure 5+ minutes followed by a prolonged partial seizure More
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2867845 55 F CT 10/23/2025 UNK
 UNKNOWN MANUFACTURER
Arthralgia, Dizziness, Joint swelling Arthralgia, Dizziness, Joint swelling
sever arthralgia , joint swelling & dizziness remain , reported to pharmacist who administered... sever arthralgia , joint swelling & dizziness remain , reported to pharmacist who administered at pharmacy More
2867847 4 M DC 10/23/2025 UNK
 UNKNOWN MANUFACTURER
 NA0846
Wrong product administered Wrong product administered
Wrong Formulation administered. Wrong Formulation administered.
2867848 46 F KS 10/23/2025 FLU3
 SANOFI PASTEUR
 U8863DA
Injection site erythema, Injection site pain, Injection site swelling, Product a... Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site More
Redness, slight swelling, and pain to upper back of rt arm. Vaccination was given more in fatty tiss... Redness, slight swelling, and pain to upper back of rt arm. Vaccination was given more in fatty tissue than muscle. Advised to use ice ,Tylenol, ibuprofen and Benadryl for discomfort and pain. Given another flu shot to left deltoid More
2867851 72 M ME 10/23/2025 COVID19
 MODERNA
 3052583
Arthropathy, Mobility decreased, Pain Arthropathy, Mobility decreased, Pain
Pt reported that he had significant pain and limited range of motion shortly after receiving the sho... Pt reported that he had significant pain and limited range of motion shortly after receiving the shot. While the pt has recovered most of the range of motion by today he is still experiencing pain to the point he needs to take Tylenol for relief (unable to do NSAIDs due to other health issues). The pain has gotten just slightly better since receiving the shot. They also report feeling like something is in their joint which wasn't there before. More
2867852 71 F 10/23/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0169
EW0169
EW0169
EW0169
EW0179
EW0179
EW0179
EW0179
Acute kidney injury, Antinuclear antibody increased, Antinuclear antibody negati... Acute kidney injury, Antinuclear antibody increased, Antinuclear antibody negative, Antinuclear antibody positive, Antiphospholipid antibodies positive; Arthralgia, Beta-2 glycoprotein antibody negative, Biopsy kidney normal, Blood creatinine increased, C-reactive protein increased; Cardiolipin antibody negative, Computerised tomogram thorax, Deep vein thrombosis, Electrophoresis protein abnormal, Fatigue; Hypophagia, Myalgia, Pulmonary embolism, Ultrasound scan; Acute kidney injury, Antinuclear antibody increased, Antinuclear antibody negative, Antinuclear antibody positive, Antiphospholipid antibodies positive; Arthralgia, Beta-2 glycoprotein antibody negative, Biopsy kidney normal, Blood creatinine increased, C-reactive protein increased; Cardiolipin antibody negative, Computerised tomogram thorax, Deep vein thrombosis, Electrophoresis protein abnormal, Fatigue; Hypophagia, Myalgia, Pulmonary embolism, Ultrasound scan; Acute kidney injury, Antinuclear antibody increased, Antinuclear antibody negative, Antinuclear antibody positive, Antiphospholipid antibodies positive; Arthralgia, Beta-2 glycoprotein antibody negative, Biopsy kidney normal, Blood creatinine increased, C-reactive protein increased; Cardiolipin antibody negative, Computerised tomogram thorax, Deep vein thrombosis, Electrophoresis protein abnormal, Fatigue; Hypophagia, Myalgia, Pulmonary embolism, Ultrasound scan More
Pulmonary embolisms (bilateral), DVTs, triple positive antiphospholipid antibodies, elevated ANA (pr... Pulmonary embolisms (bilateral), DVTs, triple positive antiphospholipid antibodies, elevated ANA (previously normal), acute kidney injury. Prior to hospitalization she had 1 month of progressive myalgias, arthralgias, fatigue, poor oral intake. She had AKI on admission to hospital and concern for autoimmune cause. More
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2867858 69 M MI 10/23/2025 FLU3
 SANOFI PASTEUR
 U8862CA
Extra dose administered Extra dose administered
Patient had 2 Fluzone High-Dose flu shots in the same day. The first was administered at the doctor&... Patient had 2 Fluzone High-Dose flu shots in the same day. The first was administered at the doctor's office, and the second was administered at pharmacy after being requested by the patient. More
2867859 68 F NJ 10/23/2025 FLU3
 SEQIRUS, INC.
 407271
Arthralgia Arthralgia
Patient experienced pain on both knees in the evening after receiving the fluad shot in the morning ... Patient experienced pain on both knees in the evening after receiving the fluad shot in the morning on 10/17/25. Patient took tylenol 500 mg the next day (10/18/25) and started feeling better from 48 hours. Patient reported adverse reaction on 10/22/25. Advised patient to take 650 mg tylenol arthritis and follow up with primary doctor to have it evaluated. As of 10/23/25 followed up with patient much better with little pain on right knee and stopped tylenol and will follow up with md if pain comes back. More
2867862 68 F TX 10/23/2025 FLU3
 SANOFI PASTEUR
 U8862CA
Electrocardiogram, Palpitations Electrocardiogram, Palpitations
Palpitations Palpitations
2867863 9 F ME 10/23/2025 COVID19
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 8146670
5EF45
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
No adverse effect yet, just wanted to report this error No adverse effect yet, just wanted to report this error
2867867 36 F MO 10/23/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 9CC9K
Lip swelling, Pharyngeal swelling, Urticaria Lip swelling, Pharyngeal swelling, Urticaria
Caregiver reported that she developed hives approx 3 hours after administration of the vaccine. Prog... Caregiver reported that she developed hives approx 3 hours after administration of the vaccine. Progressed to lip swelling and throat swelling several hours later. More
2867869 94 F PA 10/23/2025 COVID19
 MODERNA
 3044069
Expired product administered Expired product administered
RESIDENT RCVD EXPIRED VACCINE (6/14/25) RESIDENT RCVD EXPIRED VACCINE (6/14/25)
2867870 91 F PA 10/23/2025 COVID19
 MODERNA
 3044069
Expired product administered Expired product administered
RESIDENT RCVD EXPIRED VACCINE (6/14/25) RESIDENT RCVD EXPIRED VACCINE (6/14/25)
2867872 84 F PA 10/23/2025 COVID19
 MODERNA
 3044069
Expired product administered Expired product administered
RESIDENT RCVD EXPIRED VACCINE (6/14/25) RESIDENT RCVD EXPIRED VACCINE (6/14/25)
2867873 86 F PA 10/23/2025 COVID19
 MODERNA
 3044069
Expired product administered Expired product administered
RESIDENT RCVD EXPIRED VACCINE (6/14/25) RESIDENT RCVD EXPIRED VACCINE (6/14/25)
2867874 68 F CT 10/23/2025 FLU3
 SANOFI PASTEUR
 U8830BA
Limb injury, Product administered at inappropriate site Limb injury, Product administered at inappropriate site
Patient reported to facility at 11:30 on 10/23/2025. Patient states that she believes the vaccine wa... Patient reported to facility at 11:30 on 10/23/2025. Patient states that she believes the vaccine was given too high on her arm when she got it on 09/13/2025. She reports that she now has a shoulder injury that she will be following up with an orthopedic doctor for. More
2867875 39 M TX 10/23/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 031A21A
031A21A
031A21A
031A21A
031A21A
031A21A
044B21A
044B21A
044B21A
044B21A
044B21A
044B21A
Abdominal pain, Antibody test positive, Biopsy colon normal, Blood electrolytes ... Abdominal pain, Antibody test positive, Biopsy colon normal, Blood electrolytes normal, Colitis; Colonoscopy normal, Computerised tomogram abdomen abnormal, Computerised tomogram head normal, Diarrhoea, Exudative retinopathy; Fatigue, Glomerular filtration rate normal, Glycosylated haemoglobin normal, Haematocrit increased, Haemoglobin increased; Headache, High density lipoprotein normal, Immediate post-injection reaction, Inflammation, Low density lipoprotein increased; Malaise, Mobility decreased, Oropharyngeal pain, Pain, Platelet count decreased; Retinal injury, Visual impairment, Vitamin D; Abdominal pain, Antibody test positive, Biopsy colon normal, Blood electrolytes normal, Colitis; Colonoscopy normal, Computerised tomogram abdomen abnormal, Computerised tomogram head normal, Diarrhoea, Exudative retinopathy; Fatigue, Glomerular filtration rate normal, Glycosylated haemoglobin normal, Haematocrit increased, Haemoglobin increased; Headache, High density lipoprotein normal, Immediate post-injection reaction, Inflammation, Low density lipoprotein increased; Malaise, Mobility decreased, Oropharyngeal pain, Pain, Platelet count decreased; Retinal injury, Visual impairment, Vitamin D More
Vaccine: Moderna COVID-19 mRNA-1273 (lots 031A21A and 044B21A, given March and April 2021). Immediat... Vaccine: Moderna COVID-19 mRNA-1273 (lots 031A21A and 044B21A, given March and April 2021). Immediately after each vaccination the patient experienced intense fatigue, body aches, and malaise, remaining in bed and largely unable to move for approximately 24?36 hours after each dose. No hospitalization at that time; symptoms resolved over two days. He remained well until November 2022 when he contracted COVID-19. About one month later, on 12/17/2022, he presented to ER with severe abdominal pain and diarrhea. CT abdomen/pelvis showed acute colitis extending from the cecum to mid-transverse colon with possible terminal ileitis. He was treated with Augmentin and prednisone and referred to gastroenterology. On 02/07/2023 colonoscopy by revealed visually normal mucosa; biopsies were taken. On 02/17/2023 he returned to the ER for headache and sore throat; strep testing was positive and CT head was performed (no acute intracranial findings). By mid-2023 he developed progressive visual changes and was diagnosed with Coats disease (retinal vascular injury described as an ?eye stroke?). He experienced two additional COVID-19 reinfections after the November 2022 episode (between 2023 and 2025), each followed by temporary fatigue and worsening of inflammatory symptoms. Through 2024 he underwent testing showing microclot formation and began a spike-clearance protocol including Neprinol (fibrinolytic enzyme), low-dose naltrexone, N-acetyl-L-cysteine, melatonin, vitamin D, and other mitochondrial-support supplements. Spike-antibody titers have remained at or above the laboratory upper limit (>10 000 U/mL) on multiple occasions between 2021 and 2025 despite no additional vaccination. These persistently elevated levels were noted by clinicians during evaluation for inflammatory and microclotting symptoms. Overall course: early post-vaccination systemic reactions with prolonged bed rest, followed nearly 20 months later by gastrointestinal inflammation, recurrent infections, retinal vascular disease, and subsequent reinfections associated with ongoing fatigue and inflammation. The patient continues follow-up with gastroenterology, hematology, and integrative-medicine providers for ongoing vascular and inflammatory evaluation. Current status: improved but not fully resolved. More
2867879 65 F OH 10/23/2025 FLU3
 SANOFI PASTEUR
 U8862CA
Dysphagia, Injection site inflammation, Injection site pain, Lymphadenopathy Dysphagia, Injection site inflammation, Injection site pain, Lymphadenopathy
Lymph node swelling ("3x normal size"), difficulty swallowing, inflammation and pain at in... Lymph node swelling ("3x normal size"), difficulty swallowing, inflammation and pain at injection site More
2867880 73 F NY 10/23/2025 FLU3
 SANOFI PASTEUR
 U8874AA
Injection site bruising, Injection site discolouration Injection site bruising, Injection site discolouration
The patient's arm had significant bruising following vaccine administration. Her arm was very b... The patient's arm had significant bruising following vaccine administration. Her arm was very black and blue in addition to bruising around the vaccine administration site. This bruising was still evident 1 week after vaccine administration. She noted that her arm is starting to turn yellow, and the arm seems to be healing. More
2867881 35 F WI 10/23/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SEQIRUS, INC.
SEQIRUS, INC.



Anaphylactic reaction, Dysphonia, Nasal congestion, Peripheral swelling, Pharyng... Anaphylactic reaction, Dysphonia, Nasal congestion, Peripheral swelling, Pharyngeal swelling; Pruritus, Swelling face, Urticaria; Anaphylactic reaction, Dysphonia, Nasal congestion, Peripheral swelling, Pharyngeal swelling; Pruritus, Swelling face, Urticaria More
Anaphylaxis - full-body hives, throat swelling, face and lips swelling, muffled voice, itching every... Anaphylaxis - full-body hives, throat swelling, face and lips swelling, muffled voice, itching everywhere (began suddenly on hands and feet--my first indication that something weird was happening!), swollen hands, plugged nose More
2867882 F 10/23/2025 COVID19
 MODERNA
No adverse event, Product administered to patient of inappropriate age, Product ... No adverse event, Product administered to patient of inappropriate age, Product prescribing error More
Wrong vaccination type was ordered (ordered 12y+ vaccine Moderna when should have ordered Pfizer 6m-... Wrong vaccination type was ordered (ordered 12y+ vaccine Moderna when should have ordered Pfizer 6m-11y vaccine), 3 year old patient received vaccination before error was determined. Patient had no immediate signs or symptoms of adverse reaction and was monitored for 15 minutes. Discussed error with family and reviewed possible adverse effects of this. Reviewed when to seek care in Emergency Department versus when to call our office. More
2867884 28 F 10/23/2025 FLU3
FLU3
FLU3
FLU3
FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR


U8863EA
U8863EA
U8863EA
Shoulder injury related to vaccine administration; Discomfort, Immediate post-in... Shoulder injury related to vaccine administration; Discomfort, Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Pain; Product administered at inappropriate site, Tenderness; Shoulder injury related to vaccine administration; Discomfort, Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Pain; Product administered at inappropriate site, Tenderness More
serva, left shoulder injury serva, left shoulder injury
2867886 84 F SC 10/23/2025 FLU3
 SEQIRUS, INC.
 407249
Local reaction Local reaction
local reaction local reaction
2867887 70 M IA 10/23/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 NA4452
407252
Angina pectoris, Cardiac monitoring normal, Condition aggravated, Depressed leve... Angina pectoris, Cardiac monitoring normal, Condition aggravated, Depressed level of consciousness; Angina pectoris, Cardiac monitoring normal, Condition aggravated, Depressed level of consciousness More
Pt received vaccines. He had angina shortly after. Pt was barely conscious. We called an ambulance f... Pt received vaccines. He had angina shortly after. Pt was barely conscious. We called an ambulance for patient. More
2867888 69 F WI 10/23/2025 FLU3
FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
 407242
407242
407242
Burning sensation, CSF cell count decreased, CSF protein normal, Cervical spinal... Burning sensation, CSF cell count decreased, CSF protein normal, Cervical spinal stenosis, Dysphonia; Gait disturbance, Lumbar spinal stenosis, Magnetic resonance imaging normal, Muscular weakness, Neuropathy peripheral; Oropharyngeal pain, Polyneuropathy More
Diagnosed with polyneuritis: She had the flu vaccine on 10/1 and the following day she developed a ... Diagnosed with polyneuritis: She had the flu vaccine on 10/1 and the following day she developed a burning sensation in her feet. Then, it started occurring in her hand as well. She then has noted weakness in her legs and is having a tough time walking and doing stairs. She also has noted a change in her voice which sounds more hoarse along with throat pain. No issues with eating or blurry vision or bowel/bladder issues. More
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2867889 6 M OR 10/23/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 YF3413
Cough, Device use issue, Rhinorrhoea Cough, Device use issue, Rhinorrhoea
Patient was seen in transplant clinic on 10/14/25 for routine visit and had no signed of adverse rea... Patient was seen in transplant clinic on 10/14/25 for routine visit and had no signed of adverse reactions, but clinic advised patient and patient mother live virus should not have been given to transplant patient. Patient mom advised clinic that patient had running nose and cough after the vaccine was administered (dates not given/known) More
2867890 41 F TX 10/23/2025 FLU3
 SEQIRUS, INC.
Condition aggravated, Headache, Hypertension, Nausea Condition aggravated, Headache, Hypertension, Nausea
headache, nausea, high blood pressure headache, nausea, high blood pressure
2867891 82 M 10/23/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 MY9550
U8830CA
Pain in extremity; Pain in extremity Pain in extremity; Pain in extremity
ARM PAIN STILL SINCE 9/17 ARM PAIN STILL SINCE 9/17
2867892 50 M IL 10/23/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
 8146545
8146545
Ut8770ma
Ut8770ma
Asthenia, Chest pain, Decreased appetite, Dizziness, Fatigue; Headache, Injectio... Asthenia, Chest pain, Decreased appetite, Dizziness, Fatigue; Headache, Injection site pain, Musculoskeletal stiffness, Myalgia, Pyrexia; Asthenia, Chest pain, Decreased appetite, Dizziness, Fatigue; Headache, Injection site pain, Musculoskeletal stiffness, Myalgia, Pyrexia More
Per employee report: "Received both the Fluzone and COVID vaccination. Starting in the morning... Per employee report: "Received both the Fluzone and COVID vaccination. Starting in the morning the following day, I began experiencing progressive fatigue, myalgias, back stiffness, dizziness, and weakness. Noted headache, mild to moderate fever, and mild headache, in addition to injection site soreness (L shoulder)" . He states he also had some chest pain, pleurisy like sensation and low appetite. He communicated to his PCP regarding symptoms but never went to see PCP for a visit. He also declined evaluation from Employee Health clinic. His symptoms resolved after 36 hours post vaccination. More
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