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
2866898 M NJ 10/20/2025 TDAP
GLAXOSMITHKLINE BIOLOGICALS
94kg2
Inappropriate schedule of product administration Inappropriate schedule of product administration
Administration in less than recommended intervals; This non-serious case was reported by a pharmacis... Administration in less than recommended intervals; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 94kg2, expiry date 28-NOV-2027) for prophylaxis. Previously administered products included Boostrix (received first dose on 21-MAR-2025). On 30-SEP-2025, the patient received the 2nd dose of Boostrix. On 30-SEP-2025, 193 days after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: Administration in less than recommended intervals). The outcome of the drug dose administration interval too short 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: 02-OCT-2025 The reporter reported that administration of Boostrix in intervals that are less than 10 years. The reporter mentioned that the patient received the first dose on 21st March 2025 and the second dose on 30th September 2025. The patients initials, male and 50 years of age. The vaccine dose administered in September had a lot number of 94kg2 and expiration date 28th November 2027. More
2866899 0.42 F GA 10/20/2025 DTAPIPV
GLAXOSMITHKLINE BIOLOGICALS
y49bz
Inappropriate schedule of product administration Inappropriate schedule of product administration
Administration to a less than 4 year old patient; Inappropriate schedule of vaccine administered; Th... Administration to a less than 4 year old patient; Inappropriate schedule of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number y49bz) for prophylaxis. On 16-AUG-2024, the patient received Kinrix. On 16-AUG-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to a less than 4 year old patient) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of 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 and 09-OCT-2025 The reporter called and reported that the Kinrix, Dtdap and polio, was given to someone under 4, what were the complications of that. The vaccine administration facility was the same as primary reporter. The reporter confirmed Kinrix was the patient 3rd dose of DTaP and IPV. The intention was to administer a DTaP and IPV dose. Call was placed to HCP a day before day of reporting, but MI was unsuccessful in reaching HCP at that time. More
2866900 10/20/2025 COVID19
NOVAVAX

Condition aggravated Condition aggravated
severe side effects and it feels like exacerbating; Initial information received on 09-Oct-2025 rega... severe side effects and it feels like exacerbating; Initial information received on 09-Oct-2025 regarding an unsolicited valid serious case received from a Patient. This case involves an unknown age and gender patient who reported that experienced severe side effects and it feels like exacerbating after receiving NVX-COV2373 (original) adjuvanted vaccine [Novavax COVID-19 vaccine, adjuvanted]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immune-mediated neurological disorder with from prior vaccines (diff brand). On unknown date in Oct-2025, the patient received unknown dose of suspect NVX-COV2373 (original) adjuvanted vaccine, Injection (strength, lot number and expiry date not reported) via unknown route in unknown administration site for Covid-19 vaccination. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On unknown date in Oct-2025 the patient experienced severe side effects and it feels like exacerbating (condition aggravated) (unknown latency). It was reported that "received vax last weekend myriad preexisting neuro/immune from covid and i also believe from prior vaccines (diff brand) want to tell someone there what is happening i am experiencing severe side effects and it feels like exacerbating" 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
2866901 F CT 10/20/2025 FLU3
SANOFI PASTEUR
U8440AA
Expired product administered, No adverse event Expired product administered, No adverse event
expired flublok was accidentally given, what should they do, with no reported adverse event; Initial... expired flublok was accidentally given, what should they do, with no reported adverse event; Initial information received on 13-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to this US-SA-2025SA306396 and US-SA-2025SA306750. This case involves an unknown age female patient who received expired dose of influenza trivalent recombinant vaccine [Flublok] with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, the patient received an expired 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection, lot U8440AA, expiry date:30-Apr-2025,strength: standard, frequency: once, via intramuscular route in the arm nos (not otherwise specified) for Influenza with no reported adverse event (expired product administered) (latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA306396: US-SA-2025SA306750: US-SA-2025SA305716: More
2866902 F 10/20/2025 COVID19
UNKNOWN MANUFACTURER

Faeces discoloured Faeces discoloured
made my stool turn green; Initial information received on 14-Oct-2025 regarding an unsolicited valid... made my stool turn green; Initial information received on 14-Oct-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves an unknown age female patient who reported that it made my stool turn green after receiving NVX-COV2373 (original) adjuvanted vaccine [Nuvaxovid]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, the patient received unknown dose of suspect NVX-COV2373 (original) adjuvanted vaccine, Injection (strength, lot number and expiry date: not reported) via unknown route in unknown administration site for Immunization. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On 14-Oct-2025 the patient report that it made my stool turn green (faeces discoloured) (latency: 1 day). 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 made my stool turn green. More
2866903 70 F VA 10/20/2025 FLU3
SANOFI PASTEUR
UT8437BA
Expired product administered, No adverse event Expired product administered, No adverse event
administered expired FLUZONE NP from last year with no reported adverse event; Initial information r... administered expired FLUZONE NP from last year with no reported adverse event; Initial information received on 14-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to this case US-SA-2025SA308068. This case involves a 70 years old female patient who administered an expired Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] from last year with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot UT8437BA, strength: standard, expiry date:30-Jun-2025,Frequency :once, via intramuscular route in the right deltoid for Influenza, from last year with no reported adverse event (expired product administered) (latency: same day). Reportedly,Caller states that she needs assistance with 2 things. She needs to order some high dose vaccines from Vaccine Shoppe; she states that she tried to go online, but she couldn't log in. She also needs to report that 2doses of FLUZONE NP from last year were administered to 2 patients. 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-2025SA308068:2nd Patient More
2866905 79 F TX 10/20/2025 FLU3
SANOFI PASTEUR
U8489BA
Expired product administered, No adverse event Expired product administered, No adverse event
pre-assessed as a medication error (unintentional)/an inappropriate use (unknown intention) due to t... pre-assessed as a medication error (unintentional)/an inappropriate use (unknown intention) due to the administration of an expired FLUZONE HD with no reported adverse event; Initial information received on 14-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 79-year-old female patient who received expired Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone HD]) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Oct-2025, the patient received a 0.5ml expired dose, of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot U8489BA, frequency-once and expired date-30-Jun-2025) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered). 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
2866907 CA 10/20/2025 FLU3
SANOFI PASTEUR

No adverse event, Product storage error No adverse event, Product storage error
products were exposed to a temperature of -0.92 degrees Celsius and were out of range for a total of... products were exposed to a temperature of -0.92 degrees Celsius and were out of range for a total of 30 minutes, due to refrigerator malfunction, these vaccines have been administered post excursion with no reported adverse event; Initial information received on 15-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to this case US-SA-2025SA309664. This case involves an unknown age and unknown gender patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] which were exposed to a temperature of -0.92 degrees Celsius and were out of range for a total of 30 minutes, due to refrigerator malfunction, these vaccines have been administered post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number, expiry date ad strength not reported) via unknown route in unknown administration site for Prophylactic vaccination [Immunisation] which were exposed with temperature of -0.92 degrees Celsius and were out of range for a total of 30 minutes, due to refrigerator malfunction, these vaccines have been administered post excursion with no reported adverse event (poor quality product administered) (latency: same day). Reportedly,human error was involved. At the beginning of the call the HCP [ Health care professional] stated these vaccines have been administered post excursion and is asking how to manage those doses. Notified the caller that the extended stability information does not cover an excursion of this length and/or temperature, and the dispensing of the products is no longer supported. 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-2025SA309664: More
2866916 60 F NY 10/20/2025 COVID19
MODERNA
007B21A
Condition aggravated, Crohn's disease, SARS-CoV-2 antibody test positive Condition aggravated, Crohn's disease, SARS-CoV-2 antibody test positive
This shot reactivated my Crohn?s disease. This shot reactivated my Crohn?s disease.
โœ“
2866917 F 10/20/2025 VARZOS
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
3k743
PEY93
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; Facial Shingles; This serious case was reported by a consumer and des... Suspected vaccination failure; Facial Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 3k743) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number PEY93) for prophylaxis. Concurrent medical conditions included heart disease, unspecified, diabetes mellitus and thyroid disorder. Concomitant products included tirzepatide (Mounjaro), metoprolol, metformin and levothyroxine sodium (Synthroid). On 01-JUL-2022, the patient received the 2nd dose of Shingrix. On 26-JAN-2022, the patient received the 1st dose of Shingrix. On 11-SEP-2025, 1168 days after receiving Shingrix and 1324 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Facial Shingles). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 23-SEP-2025 Patient could not contact to the physician and the emergency department physician misdiagnosed with cellu. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, 1324 days after receiving the first dose of Shingrix and 1168 days after receiving the second dose of Shingrix, in a 67-year-old female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2866918 10/20/2025 RVX
UNKNOWN MANUFACTURER
UNK
Cough, Dyspnoea, Respiratory syncytial virus infection, Vaccination failure Cough, Dyspnoea, Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; Respiratory syncytial virus infection; This serious case was reported... Suspected vaccination failure; Respiratory syncytial virus infection; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolving. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date:14-OCT-2025 This case was reported by a patient via interactive digital media. The patient experienced RSV (respiratory syncytial virus infection) for 5 weeks, it got better but not gone. He/she still had a cough and short of breath. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure as details of time to onset and laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving RSV vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2866919 87 F VA 10/20/2025 FLU3
SANOFI PASTEUR
UT8437BA
Expired product administered, No adverse event Expired product administered, No adverse event
report that 2 doses of FLUZONE NP from last year were administered to patient with no reported adver... report that 2 doses of FLUZONE NP from last year were administered to patient with no reported adverse event; Initial information received on 14-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 88 years old female patient who received 2 doses of expired Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] from last year no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, received expired 2 doses of 0.5ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine from last year Suspension for injection (lot UT8437BA) standard strength, frequency-once and expiry date-30-Jun-2025 via intramuscular route in the left deltoid for Influenza no reported adverse event (expired product administered) (latency-same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA309139: More
2866921 57 F IL 10/20/2025 FLU3
FLU3
SANOFI PASTEUR
SANOFI PASTEUR
U8863BA
U8889CA
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
While updating our list of employees who were vaccinated at our most recent flu vaccine clinic on 10... While updating our list of employees who were vaccinated at our most recent flu vaccine clinic on 10/15/25, I found that the employee listed in this report had previously been documented as having received their vaccine at an earlier clinic on 9/23/2025. I contacted the employee to confirm which date was correct since we had 2 completed flu consent forms that were signed and dated on both clinic days. The employee was unsure if she had previously been vaccinated and walked into the 10/15/25 clinic to verify and was told by someone that she had not been and was then handed the consent form to fill out. More
2866922 18 F VA 10/20/2025 FLU3
HPV9
SEQIRUS, INC.
MERCK & CO. INC.
406985
y015599
Injection site mass, Ultrasound scan; Injection site mass, Ultrasound scan Injection site mass, Ultrasound scan; Injection site mass, Ultrasound scan
Pt has mass at injection site. Treated with antibiotic Pt has mass at injection site. Treated with antibiotic
โœ“
2866943 15 F PA 10/20/2025 FLU3
SANOFI PASTEUR
U8889CA
Burning sensation Burning sensation
Approximately ten minutes after administration the patient came back to the pharmacy and stated that... Approximately ten minutes after administration the patient came back to the pharmacy and stated that her arm was burning More
2866944 4 M KY 10/20/2025 FLU3
SANOFI PASTEUR
UT8826KA
Injection site erythema, Injection site inflammation, Injection site pain, Injec... Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth More
0317PM 10/18/2025 Arm was inflamed, hot, and painful to touch next day 10/19/2025 0836pm redness spr... 0317PM 10/18/2025 Arm was inflamed, hot, and painful to touch next day 10/19/2025 0836pm redness spread down arm towards elbow, area is much larger. Gave ibuprofen on 10/18/25 0324PM. More
2866945 47 F FL 10/20/2025 FLU3
FLU3
SEQIRUS, INC.
SEQIRUS, INC.


Chills, Erythema, Fatigue, Influenza virus test negative, Pain; Pyrexia, SARS-Co... Chills, Erythema, Fatigue, Influenza virus test negative, Pain; Pyrexia, SARS-CoV-2 test negative, Swelling More
Left arm shoulder area was red and swollen, fever, body aches and chills, fatigue Left arm shoulder area was red and swollen, fever, body aches and chills, fatigue
2866946 20 M PA 10/20/2025 COVID19
FLU3
MODERNA
SEQIRUS, INC.
3053648
948418
Anaphylactic reaction; Anaphylactic reaction Anaphylactic reaction; Anaphylactic reaction
Patient had an anaphylactic reaction; pharmacy staff administered epinephrine injection and called 9... Patient had an anaphylactic reaction; pharmacy staff administered epinephrine injection and called 911 for paramedics. More
2866947 17 M PA 10/20/2025 COVID19
COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
FE3590
FE3590
FE3590
Brain fog, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram ambulatory; F... Brain fog, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram ambulatory; Fatigue, Laboratory test abnormal, Pericarditis, Tonsillectomy, Ultrasound scan; X-ray More
Heart issues (presumed pericarditis per Cardiologist, Hospital), extreme fatigue, brain fog. Heart issues (presumed pericarditis per Cardiologist, Hospital), extreme fatigue, brain fog.
โœ“ โœ“
2866948 6 M MI 10/20/2025 FLU3
SANOFI PASTEUR
UT8770MA
Erythema, Peripheral swelling, Skin warm Erythema, Peripheral swelling, Skin warm
swelling , redness, warmth from elbow to top of shoulder. Was put on antibiotics and steroids. swelling , redness, warmth from elbow to top of shoulder. Was put on antibiotics and steroids.
2866949 12 F PA 10/20/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
MODERNA
MODERNA
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


30135BA
30135BA
FE3590
FE3590
FJ4989
FJ4989
Heart rate abnormal, Hypotension, Laboratory test, Orthostatic hypotension, Post... Heart rate abnormal, Hypotension, Laboratory test, Orthostatic hypotension, Postural orthostatic tachycardia syndrome; Tilt table test; Heart rate abnormal, Hypotension, Laboratory test, Orthostatic hypotension, Postural orthostatic tachycardia syndrome; Tilt table test; Heart rate abnormal, Hypotension, Laboratory test, Orthostatic hypotension, Postural orthostatic tachycardia syndrome; Tilt table test; Heart rate abnormal, Hypotension, Laboratory test, Orthostatic hypotension, Postural orthostatic tachycardia syndrome; Tilt table test More
low blood pressure. heart rate issues. orthostatic hypotension. POTS. low blood pressure. heart rate issues. orthostatic hypotension. POTS.
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2866950 16 F VA 10/20/2025 MNQ
SANOFI PASTEUR
U8574AA
Erythema, Peripheral swelling, Skin warm Erythema, Peripheral swelling, Skin warm
Left arm is swollen, red and warm to the touch. Left arm is swollen, red and warm to the touch.
2866951 21 F TX 10/20/2025 FLU3
FLU3
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
73BN2
73BN2
Dyspnoea, Injection site cellulitis, Injection site erythema, Injection site pai... Dyspnoea, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling; Injection site warmth, Tachycardia More
The employee reports she woke up on 10/16/2025 with worsening swelling, pain and redness to the left... The employee reports she woke up on 10/16/2025 with worsening swelling, pain and redness to the left bicep. She reports redness, swelling and hot to touch left arm from shoulder to left elbow, tachycardia, SOB that required her to "concentrate on breathing". She went to an Urgent care and was diagnosed with cellulitis to her left arm. Notes from visit state VS 140/90-130-temp 98.9. Note states she was given Decadron - no dose or route noted. More
2866952 92 M IA 10/20/2025 COVID19
MODERNA
3052671
Death Death
Resident passed away Resident passed away
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2866953 77 F MI 10/20/2025 COVID19
FLU3
MODERNA
SANOFI PASTEUR
8146545
U8862EA
Erythema, Inflammation, Pruritus, Skin warm; Erythema, Inflammation, Pruritus, S... Erythema, Inflammation, Pruritus, Skin warm; Erythema, Inflammation, Pruritus, Skin warm More
Patient presented to the pharmacy asking about the normalcy of getting a reaction on her arm 2 days ... Patient presented to the pharmacy asking about the normalcy of getting a reaction on her arm 2 days after the vaccinations. She said it was warm, red, inflamed, and a little itchy. This started on the second day after getting her flu and covid vaccination. She did say she has not had a reaction like this before and wanted to just gather some information. She said it really was not bothersome. I thanked her for reporting this and told her I was also going to report this to VAERS. I did instruct her that injection site reactions can happen and that it should not alarm her. I also then instructed her to utilize OTC medications for any irritation. I told her I would follow up with her again soon and to also call or stop by if condition worsens or seek medical care/PCP if she felt the need. More
2866954 39 M AR 10/20/2025 TD
TD
SANOFI PASTEUR
SANOFI PASTEUR
U8491AA
U8491AA
Chest pain, Decreased appetite, Dyspnoea, Injection site pain, Laboratory test n... Chest pain, Decreased appetite, Dyspnoea, Injection site pain, Laboratory test normal; Nausea, Pyrexia, X-ray normal More
Donor received the fourth dose of the Tenivac vaccine on September 22, 2025. The donor stated that t... Donor received the fourth dose of the Tenivac vaccine on September 22, 2025. The donor stated that the following day, September 23, 3035, he began having a burning sensation in his lungs and was having a hard time breathing. Donor was evaluated by an EMT and was told that he had a slight fever. Donor could not eat for a few days due to nausea. Donor is a smoker and stated he felt fine within a few days and only had mild tenderness at the injection site. More
2866955 30 F ME 10/20/2025 FLU3
SEQIRUS, INC.
406995
Brain fog, Flushing, Headache, Neck pain, Pruritus Brain fog, Flushing, Headache, Neck pain, Pruritus
8:30 AM injection given. 2:30 PM individual felt flush, foggy with thoughts, itchy forehead. 6:00PM... 8:30 AM injection given. 2:30 PM individual felt flush, foggy with thoughts, itchy forehead. 6:00PM headache, sore neck which continued for 24hours. More
2866957 28 F IL 10/20/2025 COVID19
MODERNA

Myalgia, Swelling Myalgia, Swelling
Significant deltoid pain, supraclavicular pain and swelling, no palpable lymph nodes Significant deltoid pain, supraclavicular pain and swelling, no palpable lymph nodes
2866958 12 F NY 10/20/2025 MNQ
SANOFI PASTEUR
U8599AA
Asthenia, Dizziness, Dyspnoea, Nausea Asthenia, Dizziness, Dyspnoea, Nausea
On August 25, she began experiencing symptoms including nausea, dizziness, shortness of breath, and ... On August 25, she began experiencing symptoms including nausea, dizziness, shortness of breath, and general weakness. These symptoms persisted daily. On August 29, was brought to PCP office for evaluation and was believed to be viral. Symptoms continued and escalated, eventually leading to anxiety attacks that developed into full panic attacks and hyperventilating. On one occasion the attack led to EMS being called and administering oxygen. Parents also noticed increasing forgetfulness in patient? she began having difficulty remembering events at school and at home. More
2866959 91 M FL 10/20/2025 FLU3
SEQIRUS, INC.
407259
Full blood count, Platelet count decreased, Thrombocytopenia Full blood count, Platelet count decreased, Thrombocytopenia
Thrombocytopenia, Vaccine given 10/23/25, platelet level consistently over 200 (most of time, closer... Thrombocytopenia, Vaccine given 10/23/25, platelet level consistently over 200 (most of time, closer to 300) over the past 15yrs. Three days after immunization, with routine lab check, Plt count dropped to 34 with repeat @ 29. Patient was monitored and rechecked one week later with repeat Plt level after one week @ 234. More
2866960 34 M UT 10/20/2025 FLU3
SANOFI PASTEUR
u8848AA
Arthralgia, Joint range of motion decreased Arthralgia, Joint range of motion decreased
Severe shoulder pain which got progressively worse and started to restrict range of motion by day 2.... Severe shoulder pain which got progressively worse and started to restrict range of motion by day 2., particularly in external rotation and flexion. The pain persists despite Naproxen 500 mg BID. More
2866961 30 F WI 10/20/2025 FLU3
FLU3
SANOFI PASTEUR
SANOFI PASTEUR
U8830BA
U8830BA
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling; Injection site warmth, Urticaria More
I received the shot on Sunday 10/12 around 1730. The following morning 10/13 I had a pink, warm welt... I received the shot on Sunday 10/12 around 1730. The following morning 10/13 I had a pink, warm welt, It was painful and itchy. Tues 10/14 it was very red, defined border, raised and hot to touch. Remained painful and itchy. It was the same on Wednesday when I showed the reaction to my supervision. Treatment was just ice to site. By thursday it was a lighter pink, warm not hot. And by friday it had resolved. More
2866962 91 M TN 10/20/2025 FLU3
SANOFI PASTEUR
UT8804AA
Discomfort, Injection site pain, Myalgia, Sleep disorder Discomfort, Injection site pain, Myalgia, Sleep disorder
Patient began to experience terrible pain at injection site and in muscle around injection site star... Patient began to experience terrible pain at injection site and in muscle around injection site starting at approximately 11 pm on 10/16/2025. He was unable to get comfortable, unable to sleep as the pain became "excruciating" and he finally decided to get up at approximately 0200 on 10/17/2025 to apply heating pad. He states that the heating pad "helped" but pain seems to not only be in muscle of injection site but also in the breast muscle. Encouraged patient and patient's wife to seek care at his Primary Care Provider's office to ensure no further recommendation or course of action necessary. More
2866963 67 M 10/20/2025 FLU3
GLAXOSMITHKLINE BIOLOGICALS
4D255
Unevaluable event Unevaluable event
None noted. None noted.
2866965 12 F MA 10/20/2025 FLU3
GLAXOSMITHKLINE BIOLOGICALS
N9CS2
Unevaluable event Unevaluable event
N/A N/A
2866966 7 F VA 10/20/2025 FLUN3
FLUN3
MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
BK2021
BK2021
Decreased appetite, Dyspnoea, Fatigue, Myalgia, Nausea; Pyrexia, Urticaria Decreased appetite, Dyspnoea, Fatigue, Myalgia, Nausea; Pyrexia, Urticaria
Within hours of receiving the flu shot she developed a fever 103F, severe fatigue, hives on neck, sh... Within hours of receiving the flu shot she developed a fever 103F, severe fatigue, hives on neck, shortness of breath, nausea, loss of appetite and diffuse muscle aches. Symptoms lasted four days. More
2866967 72 F 10/20/2025 COVID19
COVID19
MODERNA
MODERNA
3052087
3052087
Pain in extremity, Wrong technique in product usage process; Pain in extremity, ... Pain in extremity, Wrong technique in product usage process; Pain in extremity, Wrong technique in product usage process More
The vaccine is kept frozen, but the immunizing person did not realize it wasn't thawed. The vac... The vaccine is kept frozen, but the immunizing person did not realize it wasn't thawed. The vaccine was attempted to be administered, but the needle became bent and the vaccine was unable to be given. The immunizer thought there was something wrong with that specific vaccine and attempted to administer a second vaccine from the same box. The same result ensued and that vaccine was unable to be administered. The patient reported a sore arm, but otherwise no other symptoms. The patient returned at a later date and was able to receive the vaccine. More
2866969 36 F WI 10/20/2025 FLU3
GLAXOSMITHKLINE BIOLOGICALS

Mobility decreased, Pain in extremity Mobility decreased, Pain in extremity
Arm pain, decreased ROM. Arm pain, decreased ROM.
2866970 49 F MD 10/20/2025 FLU3
GLAXOSMITHKLINE BIOLOGICALS
7nt95
Arthralgia, Back pain, Pain Arthralgia, Back pain, Pain
Severe mid upper back pain radiation to shoulder on 10/15/25 and continued left shoulder pain as of ... Severe mid upper back pain radiation to shoulder on 10/15/25 and continued left shoulder pain as of today 10/20/25 More
2866971 69 F UT 10/20/2025 FLU3
HEPAB
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
U8800BA
AZ2A3
Injection site bruising, Injection site scar; Injection site bruising, Injection... Injection site bruising, Injection site scar; Injection site bruising, Injection site scar More
Patient complained of bruising at the injection site about 11 days (9/13/2025) after getting the vac... Patient complained of bruising at the injection site about 11 days (9/13/2025) after getting the vaccination. And on 10/16/25, patient states that the injection site had scarred. More
2866972 79 M IN 10/20/2025 FLU3
SANOFI PASTEUR

Pruritus Pruritus
itching began 5-6 hours after vaccination. whole body itching at first then subsided to hands and fe... itching began 5-6 hours after vaccination. whole body itching at first then subsided to hands and feet only. patient is still experiencing hands and feet itch More
2866973 78 M MI 10/20/2025 COVID19
COVID19
COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
FLU3
FLU3
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
3052133
3052133
3052133
3052133
3052133
407257
407257
407257
407257
407257
Albumin CSF decreased, Areflexia, Balance disorder, Burning sensation, CSF gluco... Albumin CSF decreased, Areflexia, Balance disorder, Burning sensation, CSF glucose increased; CSF immunoglobulin increased, CSF lymphocyte count normal, CSF neutrophil count negative, CSF protein normal, Chills; Computerised tomogram spine normal, Decreased vibratory sense, Electromyogram abnormal, Feeling hot, Hypoaesthesia; Loss of personal independence in daily activities, Magnetic resonance imaging spinal abnormal, Mononeuropathy, Muscular weakness, Pain; Paraesthesia, Pyrexia, Spinal osteoarthritis; Albumin CSF decreased, Areflexia, Balance disorder, Burning sensation, CSF glucose increased; CSF immunoglobulin increased, CSF lymphocyte count normal, CSF neutrophil count negative, CSF protein normal, Chills; Computerised tomogram spine normal, Decreased vibratory sense, Electromyogram abnormal, Feeling hot, Hypoaesthesia; Loss of personal independence in daily activities, Magnetic resonance imaging spinal abnormal, Mononeuropathy, Muscular weakness, Pain; Paraesthesia, Pyrexia, Spinal osteoarthritis More
09/16/25 Provider Encounter Note. Patient presents today for evaluation of a recent 3 day history of... 09/16/25 Provider Encounter Note. Patient presents today for evaluation of a recent 3 day history of paresthesia complaints. Patient reports that he received his influenza and COVID immunizations one-week ago. Following his immunization, he did feel achy and feverish. He is unsure if these are the symptoms to better explain his below paresthesia symptoms. 09/19/25 Presented in the Emergency Department. The patient reports that he got his Influenza and COVID vaccinations last week, specifically on 09/10/2025. The next day (09/11), the patient states that he noticed some tingling all over his body. He states it was most prominent to his lateral hips, lateral bilateral ribs, and lateral shoulders. Patient states the pain started as "dull and achy" but then progressed to feeling "like my body was on fire." He was taking ibuprofen and aspirin which was helping his symptoms and after several days, he states that his symptoms resolved. During this time, he also felt unsteady. He states that he typically walks approximately 3 miles per day. He was unable to complete his morning walks secondary to feeling of instability. He denies any falls, syncopal episodes, or injuries. Patient made an appointment with his outpatient PCP who saw him on 09/16. Patient had a thorough laboratory workup performed which was largely noncontributory. After shared decision-making, spinal imaging and EMG was deferred. Patient states that 2 days ago, he was restraining his deck and yesterday he stood for a long period of time. By yesterday evening, patient states that his pain and numbness returned. He called his outpatient PCP back to let him know that his symptoms had again worsened and was advised to present to the ED for further evaluation and management of his symptoms. Patient denies speech changes, trouble swallowing, or breathing. Upon ROS, he states that yesterday he felt feverish and had chills but denies having a temperature per his thermometer reading. He denies headaches, changes in vision or hearing, sore throat, congestion, rhinorrhea, chest pain, shortness of breath, abdominal pain, nausea, vomiting, changes in bowel movements, and urinary symptoms. No urinary or bowel incontinence. No known sick contacts. No recent travel. 10/03/25 Provider Office Visit. 10/10/25 Presented to ED and admitted. Discharged 10/18/25 to in-patient rehab. More
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2866976 20 F CA 10/20/2025 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UK223AA
UK223AA
UK223AA
UK223AA
UK223AA
UK223AA
UK223AA
X1A261M
X1A261M
X1A261M
X1A261M
X1A261M
X1A261M
X1A261M
4BX39
4BX39
4BX39
4BX39
4BX39
4BX39
4BX39
Activated partial thromboplastin time normal, Analgesic drug level therapeutic, ... Activated partial thromboplastin time normal, Analgesic drug level therapeutic, Anaphylactic reaction, Anaphylaxis treatment, Angioedema; Blood alcohol normal, Blood creatine phosphokinase normal, Blood gases normal, Blood glucose normal, Blood immunoglobulin E increased; Blood ketone body, Blood lactic acid increased, Blood magnesium normal, Blood phosphorus normal, Blood potassium decreased; Chest discomfort, Dysphagia, Dyspnoea, Electrocardiogram normal, Eye pruritus; Eye swelling, Full blood count normal, Hyperhidrosis, Intensive care, International normalised ratio normal; Lip swelling, Metabolic acidosis, Periorbital oedema, Positive airway pressure therapy, Prothrombin time normal; Pruritus, Swelling face, Swelling of eyelid, Urticaria, Wheezing; Activated partial thromboplastin time normal, Analgesic drug level therapeutic, Anaphylactic reaction, Anaphylaxis treatment, Angioedema; Blood alcohol normal, Blood creatine phosphokinase normal, Blood gases normal, Blood glucose normal, Blood immunoglobulin E increased; Blood ketone body, Blood lactic acid increased, Blood magnesium normal, Blood phosphorus normal, Blood potassium decreased; Chest discomfort, Dysphagia, Dyspnoea, Electrocardiogram normal, Eye pruritus; Eye swelling, Full blood count normal, Hyperhidrosis, Intensive care, International normalised ratio normal; Lip swelling, Metabolic acidosis, Periorbital oedema, Positive airway pressure therapy, Prothrombin time normal; Pruritus, Swelling face, Swelling of eyelid, Urticaria, Wheezing; Activated partial thromboplastin time normal, Analgesic drug level therapeutic, Anaphylactic reaction, Anaphylaxis treatment, Angioedema; Blood alcohol normal, Blood creatine phosphokinase normal, Blood gases normal, Blood glucose normal, Blood immunoglobulin E increased; Blood ketone body, Blood lactic acid increased, Blood magnesium normal, Blood phosphorus normal, Blood potassium decreased; Chest discomfort, Dysphagia, Dyspnoea, Electrocardiogram normal, Eye pruritus; Eye swelling, Full blood count normal, Hyperhidrosis, Intensive care, International normalised ratio normal; Lip swelling, Metabolic acidosis, Periorbital oedema, Positive airway pressure therapy, Prothrombin time normal; Pruritus, Swelling face, Swelling of eyelid, Urticaria, Wheezing More
F/U VAERS filed: unknown if Site RNs filed: 8/29/2025 12:56pm: call received from (withheld site nam... F/U VAERS filed: unknown if Site RNs filed: 8/29/2025 12:56pm: call received from (withheld site name) LPN (withheld employee name) to discuss concerns for ADSM who developed anaphylactic rx following recent vaccines given on 8/27/2025 (given first YF, first typhoid, and 3rd HepB). Vaccine given 8/27/25 0834am Later that day 1020am taken by EMS to ER 1020 and admitted ICU on epi drip for bilateral eye/facial swelling, SOB, difficulty swallowing .... Released 8/29/2025 s/s resolved. (See below notes) As of 9/30/2025 assumed doing well...no f/u with HCP. Assigned (withheld number) 8/29/2025 12:56pm: call received from (withheld site name) LPN (withheld employee name) to discuss concerns for ADSM who developed anaphylactic rx following recent vaccines given on 8/27/2025 (given first YF, first typhoid, and 3rd HepB). PSR was completed which triggered this consult. Caller advised (withheld) completed screening form with no allergies or medical history reported. 3 vaccines administered and (withheld) waited in room with this nurse while she completed documentation of vaccines and CDC (withheld) card to provide to (withheld). Pt left w/o reporting any adverse reactions 15 min later. However PSR report states 15 min after receipt of vaccines she began to c/o itching to left eye that spread across entire face with chest tightness, lip swelling and difficulty swallowing. Left eyelid swelling greater than right. She had urticaria and went to ER at (withheld name) General where treated with epi injection x3 then epi drip, famotidine, benadryl, solumedrol, and admitted to ICU 8/27/2025. Meds continued with addition of albuterol neb treatments. Epi drip stopped 5am next day and within 2 hours pt c/o left eyelid swelling and given another dose epi IM w/full resolution and no return of symptoms - started or 40 mg oral prednisone daily. Labs drawn included IgE total 250 (0-114), CBC, Mag, Phos, and CPK 60 (30-165) all normal. Chem had low K at 3.0 and elev gluc at 163 (ate cinnamon Belvita crackers after vaccines given). ABG's were normal but pt put on BPAP while in ICU due to hx of childhood asthma that persists into adulthood well controlled. Lactic acid was elevated at 10.3 (0.5-2.0) and lactic acid plasma elevated 4.7 HAGMA. Acetaminophen, Beta Hydroxy, APTT, PT, INR all normal with neg ETOH. EKG NSR. ---- (withheld) denied any recent viral infection. VSS. ER admission 8/27/2025 - 1014am Arrived EMS from ship - given 2 rounds epi by EMS for facial swelling, SOB. 08/27/25 1016 -- -- HR 107 RR22 BP138/75 86 MM HG 100 % NRB Pt A/Ox4 General: She is in acute distress. Appearance: She is ill-appearing, toxic-appearing and diaphoretic... ED Course Acutely distressed, ill-appearing 20-year-old female who presents after an anaphylactic reaction to the first dose of the yellow fever vaccine. Patient arrived with paramedics, he is already given 2 rounds of epinephrine, the first 1 was via epinephrine pen. Patient received a DuoNeb treatment, Solu-Medrol 125 20 minutes prior to arrival. Per EMS, she had diffuse wheezing, significant urticaria and angioedema specifically in the periorbital regions bilaterally. Respiratory at bedside, will start patient on BiPAP given her resistance to initial rounds of epinephrine and still active wheezing. Patient still had wheezing appreciated on the lower lung fields on arrival despite 2 rounds of epinephrine. Immediately gave 0.3 of epinephrine on arrival 1020am. Gave 50 of Benadryl and Pepcid. Patient already received Solu-Medrol prior to arrival, will hold on that for now, will reevaluate due to longer onset. Additionally will start magnesium. Patient did not have immediate symptomatic relief with the third round of epinephrine, believe it is appropriate to start epinephrine drip at this time (1024am). Will start at 5, as it is for symptomatic relief. Patient is hemodynamically stable otherwise. Patient continues to improve with wheezing but continues to have persistent angioedema and periorbital edema. Will titrate epinephrine to 7. Consulted ICU for admission. PMHx of exercise-induced asthma (she used inhalers until age 9) ...... 8/28/2025 Symptoms of wheezing, urticaria, pruritus have resolved. Was on epinephrine drip overnight, but that was stopped this morning. Report of some left eye lid swelling present at around 7 AM, denies throat swelling, chest tightness, SOB, VSS, -she received epinephrine 0.3 mg IM and continued with famotidine, and that has been stable for several hours. .... 8/29/2025 Hospital Course: 20 y.o. female with primary admission diagnosis of anaphylaxis/angioedema after receiving a yellow fever vaccination required for the work. Required epinephrine gtt. After discontinuation required a one time dose of IM epinephrine for left eyelid swelling. Additional treated with steroid therapy. Felt back to her baseline midday on 8/28. Asymptomatic PM 8/28 into today. Discharging after one additional dose of prednisone. Labs drawn included IgE total 250 (0-114), CBC, Mag, Phos, and CPK 60 (30-165) all normal. Chem had low K at 3.0 and elev gluc at 163 (ate cinnamon Belvita crackers after vaccines given). ABG's were normal but pt put on BPAP while in ICU due to hx of childhood asthma that persists into adulthood well controlled. and mild wheezing in ER Lactic acid was elevated at 10.3 (0.5-2.0) and lactic acid plasma elevated 4.7 HAGMA. Acetaminophen, Beta Hydroxy, APTT, PT, INR all normal with neg ETOH. EKG NSR. ---- (wtihheld) denied any recent viral infection. VSS. More
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2866977 59 F MI 10/20/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
93n4j
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient had no symptoms at this time patient had no symptoms at this time
2866978 67 F AZ 10/20/2025 COVID19
MODERNA
3052835
Extra dose administered, No adverse event Extra dose administered, No adverse event
Adverse Event - patient received 2 doses of the Moderna Spikevax vaccine at the same appointment. Tr... Adverse Event - patient received 2 doses of the Moderna Spikevax vaccine at the same appointment. Treatment - patient was advised on potential side effects/health risks, monitored for a short period of time and was called later in the day to verify no symptoms or adverse reactions. Outcomes - patient has not experienced any adverse reactions and was provided with info given to me by Moderna and CDC guidlelines. More
2866981 84 M MI 10/20/2025 FLU3
SANOFI PASTEUR
U8859DA
Extra dose administered Extra dose administered
Patient drove into our Flu Clinic without an appointment and asked to be added on. Signs posted in r... Patient drove into our Flu Clinic without an appointment and asked to be added on. Signs posted in roped off drive thru flu clinic noted it was a flu clinic and he was asked if he was there for his flu shot. He said he didn't have an appointment but would like one so he was added on. After the MA gave him the High Dose Flu shot he made a comment about being glad he finally got his COVID shot and the MA reminded him he received the Flu shot, and he said why would I want that I just had one a couple weeks ago. Patient was explained it was a flu clinic where we are only giving flu and that was what he was told he was being scheduled for. The patient was told to call if he had any reactions, staff put in a patient safety report, and the health department was notified today. The patient had an unrelated visit in the office today as well and had no issues or concerns. More
2866982 85 F FL 10/20/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
f4ac3
Extra dose administered Extra dose administered
Patient received additional RSV vaccine that is not currently indicated or recommended by CDC/ACIP Patient received additional RSV vaccine that is not currently indicated or recommended by CDC/ACIP
2866985 85 M MN 10/20/2025 FLU4
SANOFI PASTEUR
US8837DA
Extra dose administered, Injection site pain Extra dose administered, Injection site pain
Site: Pain at Injection Site-Mild, Additional Details: PT WAS ADMINISTERED 2 DOSES OF FLUZONE HIGH D... Site: Pain at Injection Site-Mild, Additional Details: PT WAS ADMINISTERED 2 DOSES OF FLUZONE HIGH DOSE IN THE LEFT ARM ON 10/9/25. PT WAS INFORMED OF THE ERROR RIGHT AFTER ADMINSITRATION OF THE SECOND DOSE OF VACCINE. PT WAS CONTACTED BY PHARMACIST, (NAME WITHHELD) ON 10/10/25 @ 10 AM. PT HAS REPORTED FEELING NORMAL ,NO VISIBLE REDNESS, SWELLING OR ITCHING ON SITE OF INJECTION YET. PT HAS NOT REPORTED ANY FEVER, SHOUDLER ACHE OR NAUSEA/ STOMACH UPSET YET. , Other Vaccines: VaccineTypeBrand: COMIRNATY; Manufacturer: PFIZER; LotNumber: ; Route: IM; BodySite: RIGHT ARM; Dose: 1; VaxDate: 10/09/2025 More
2866986 59 F GA 10/20/2025 PNC20
PFIZER\WYETH
MA2505
Injection site pain, Injection site swelling Injection site pain, Injection site swelling
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Other Vaccines: Vaccine... Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: flucelvax; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN More
2866987 71 M IN 10/20/2025 COVID19
UNKNOWN MANUFACTURER
3052733
Injection site pain Injection site pain
Site: Pain at Injection Site-Mild Site: Pain at Injection Site-Mild