🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2867175 32 F ND 10/20/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2CA5M
Nausea, Retching, Tachycardia Nausea, Retching, Tachycardia
Extreme nausea, dry heaving, tachycardia (133 resting HR) -- remedied by Zofran Extreme nausea, dry heaving, tachycardia (133 resting HR) -- remedied by Zofran
2867176 77 F VA 10/20/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 na0589
ut8781da
Dizziness, Hyperhidrosis, Syncope, Vomiting; Dizziness, Hyperhidrosis, Syncope, ... Dizziness, Hyperhidrosis, Syncope, Vomiting; Dizziness, Hyperhidrosis, Syncope, Vomiting More
Vasovagal Syncope. Patient felt dizzy and laid on the floor. She started sweating and vomited twic... Vasovagal Syncope. Patient felt dizzy and laid on the floor. She started sweating and vomited twice. After about 6 minutes she felt better. We got her ice and offered water. she said this has happened before when getting vaccines. She refused medical treatment and left on her own. More
2867177 11 M CO 10/20/2025 COVID19
 MODERNA
 3052581
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
The Moderna Spikevax Covid vaccine indicated for age 12 years and above was INADVERTANTLY given to t... The Moderna Spikevax Covid vaccine indicated for age 12 years and above was INADVERTANTLY given to this patient at age 11 years and 10 1/2 months. Patient had no adverse reaction or symptoms. More
2867178 66 F TX 10/20/2025 FLU3
FLU3
PNC21
PNC21
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 U8875AA
U8875AA
Z009681
Z009681
Injection site erythema, Injection site pain, Injection site swelling, Periphera... Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling, Pruritus; Skin warm; Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling, Pruritus; Skin warm More
Patient presented to pharmacy today (10/20) and reports getting vaccine last Monday (10/13) and just... Patient presented to pharmacy today (10/20) and reports getting vaccine last Monday (10/13) and just having a small bump and mild pain at injection site that lasted 3 days (right arm). On Saturday (10/18) patient reports having itching, redness, warmth and swelling on right arm that was not there before. She applied Vicks VapoRub to site and next day applied hydrocortisone. Patient states seeing improvement after using hydrocortisone. Today the injection site looked mildly red and swollen and patient states not having any pain. Patient might go to the doctor to seek further evaluation. More
2867179 88 F CT 10/20/2025 FLU3
 SANOFI PASTEUR
 U8881DA
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received the Fluzone 2025/2026 vaccine (49281-0425-50) from our pharmacy on 10/16/25. On 10... Patient received the Fluzone 2025/2026 vaccine (49281-0425-50) from our pharmacy on 10/16/25. On 10/20/25, we were notified by (Activity Director) of (withheld name) Day Center in (city name withheld) that the family notified her that Patient had previously gotten the vaccine at pharmacy. Upon checking database, the pharmacist confirmed she had received the Influenza HD vaccine on 09/25/2025 at Pharmacy. No adverse events have been reported. More
2867183 42 F IL 10/20/2025 FLU3
 SEQIRUS, INC.
 AX5589A
Injected limb mobility decreased, Injection site pain Injected limb mobility decreased, Injection site pain
Severe pain upon injection now with continuous pain going on for almost 2 weeks, worsening, limited ... Severe pain upon injection now with continuous pain going on for almost 2 weeks, worsening, limited range of motion with affected arm, injection site is still painful to touch More
2867184 31 F PA 10/20/2025 COVID19
DTAP
FLU3
 MODERNA
SANOFI PASTEUR
SEQIRUS, INC.


Injection site pruritus, Injection site swelling, Neuralgia; Injection site prur... Injection site pruritus, Injection site swelling, Neuralgia; Injection site pruritus, Injection site swelling, Neuralgia; Injection site pruritus, Injection site swelling, Neuralgia More
Swelling, itching at injection site. Nerve pain in teeth on one side or mouth Swelling, itching at injection site. Nerve pain in teeth on one side or mouth
2867185 55 F FL 10/20/2025 FLU3
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2CA5M
7yd42
Injection site pain, Injection site warmth; Injection site pain, Injection site ... Injection site pain, Injection site warmth; Injection site pain, Injection site warmth More
patient describes a hot, painful site reaction that has gotten larger over the past 4 days. patient... patient describes a hot, painful site reaction that has gotten larger over the past 4 days. patient did not report reaction until today (10/20/25) More
2867188 72 F TX 10/20/2025 FLU3
 SEQIRUS, INC.
 407261
Erythema, Swelling Erythema, Swelling
she had swelling and redness about 3 inches in diameter, resolved by ice and ibuprofen she had swelling and redness about 3 inches in diameter, resolved by ice and ibuprofen
2867189 55 F CO 10/20/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SEQIRUS, INC.
SEQIRUS, INC.
 3052864
3052864
948402
948402
Heart rate increased, Injection site erythema, Injection site induration, Inject... Heart rate increased, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth; Pain, Pyrexia; Heart rate increased, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth; Pain, Pyrexia More
Patient reports on the RIGHT deltoid, where covid shot was administered, injection site became red, ... Patient reports on the RIGHT deltoid, where covid shot was administered, injection site became red, raised, firm, and hot to the touch. Hours later, that evening and throughout the night, she had a rapid resting heart rate of 140, fever, body aches. Systemic symptoms resolved the following morning, skin near injection site had also improved. More
2867190 94 M 10/20/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0589
U8874CA
Injection site bruising; Injection site bruising Injection site bruising; Injection site bruising
Bruising and possible hematoma at the injection site Bruising and possible hematoma at the injection site
2867191 53 M OR 10/20/2025 FLU3
 SANOFI PASTEUR
Incorrect dose administered Incorrect dose administered
Patient was given the High Dose flu shot, when, based on their age they should have received a regul... Patient was given the High Dose flu shot, when, based on their age they should have received a regular dosed flu shot. More
2867193 19 M MD 10/20/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.

Erythema, Pain, Skin swelling, Urticaria; Erythema, Pain, Skin swelling, Urticar... Erythema, Pain, Skin swelling, Urticaria; Erythema, Pain, Skin swelling, Urticaria More
Spontaneous Urticaria covering most of body, neck, and face, lips. Severe red, raised, itchy hives (... Spontaneous Urticaria covering most of body, neck, and face, lips. Severe red, raised, itchy hives (no swelling of the mouth, throat or tongue). Seen by the school health clinic, given low dose steroid (10mg/day for 6 days). The hives persisted and worsened, with associated pain. Was seen in the local hospital at the emergency room and given: Prednisone dose pack starting at 60mg and ending at 10 mg for 6 days, Allegra 180 1/day and Pepcid AC 20mg twice per day. The hives went away after 10 days. More
2867194 54 F TX 10/20/2025 COVID19
COVID19
 MODERNA
MODERNA

Decreased appetite, Diarrhoea, Dizziness, Injection site bruising, Injection sit... Decreased appetite, Diarrhoea, Dizziness, Injection site bruising, Injection site swelling; Nausea, Skin warm, Vomiting More
nausea, vomiting, diarrhea, swelling and bruising at injection site, warm to touch. light-headedness... nausea, vomiting, diarrhea, swelling and bruising at injection site, warm to touch. light-headedness, lack of appetite. More
2867196 73 M TX 10/20/2025 FLU3
 SANOFI PASTEUR
 U8862EA
Lip swelling, Periorbital swelling, Pharyngeal swelling, Swelling face Lip swelling, Periorbital swelling, Pharyngeal swelling, Swelling face
Patient reported that he woke up the next morning post-vaccination with puffy eyes, upper lip, and s... Patient reported that he woke up the next morning post-vaccination with puffy eyes, upper lip, and swelling around face and throat (but no trouble breathing). Condition sustained for a few days, patient went to see doctor on Monday and received prescription for steroid. More
2867198 0.5 M CA 10/20/2025 DTAPHEPBIP
DTAPHEPBIP
FLU3
FLU3
HIBV
HIBV
PNC20
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
PFIZER\WYETH







Asthenia, Blood test normal, Body temperature increased, Chest X-ray abnormal, C... Asthenia, Blood test normal, Body temperature increased, Chest X-ray abnormal, Cold sweat; Cyanosis, Diarrhoea, Pallor, Vomiting; Asthenia, Blood test normal, Body temperature increased, Chest X-ray abnormal, Cold sweat; Cyanosis, Diarrhoea, Pallor, Vomiting; Asthenia, Blood test normal, Body temperature increased, Chest X-ray abnormal, Cold sweat; Cyanosis, Diarrhoea, Pallor, Vomiting; Asthenia, Blood test normal, Body temperature increased, Chest X-ray abnormal, Cold sweat; Cyanosis, Diarrhoea, Pallor, Vomiting More
Pale. Vomiting (hours). Clammy. Low temperature. Blue lips. Diarrhea. Weakness Pale. Vomiting (hours). Clammy. Low temperature. Blue lips. Diarrhea. Weakness
2867200 74 F AL 10/20/2025 COVID19
 PFIZER\BIONTECH
 NA0590
Erythema, Swelling, Urticaria Erythema, Swelling, Urticaria
Moderate swelling, erythema, redness & urticaria noted Moderate swelling, erythema, redness & urticaria noted
2867201 62 M FL 10/20/2025 FLU3
PNC21
VARZOS
 SEQIRUS, INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 407004
Z009681
C9X3R
Rhabdomyolysis; Rhabdomyolysis; Rhabdomyolysis Rhabdomyolysis; Rhabdomyolysis; Rhabdomyolysis
PATIENT REPORTS TO PHARMACY ON 10-20-2025 AND INFORMS US THAT THE VACCINES GAVE HIM RHABDOMYOLYSIS PATIENT REPORTS TO PHARMACY ON 10-20-2025 AND INFORMS US THAT THE VACCINES GAVE HIM RHABDOMYOLYSIS
2867202 18 F UT 10/20/2025 COVID19
 PFIZER\BIONTECH
 NA4457
No adverse event, Wrong product administered No adverse event, Wrong product administered
PATIENT CAME INTO THE PHARMACY LOOKING TO BE VACCINATED WITH THE NUVAXOVID COVID VACCINE AND THE COM... PATIENT CAME INTO THE PHARMACY LOOKING TO BE VACCINATED WITH THE NUVAXOVID COVID VACCINE AND THE COMIRNATY (PFIZER) VACCINE WAS ADMINISTERED IN ERROR. NO REACTIONS OR ADVERSE EVENTS HAVE OCCURED AS OF THIS WRITING. More
2867238 F NC 10/20/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946904
Musculoskeletal stiffness, Myalgia Musculoskeletal stiffness, Myalgia
Muscle Stiffness; Held Her Second Dose; Muscle Pain; Initial report received on 15-Sep-2025. A phar... Muscle Stiffness; Held Her Second Dose; Muscle Pain; Initial report received on 15-Sep-2025. A pharmacist reported that a 38-year-old female received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but did not receive the second dose yetand developed muscle stiffness and muscle pain. No medical history or concomitant medications were reported. On 11-Aug-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 946904; expiration date 17-Oct-2027, NDC number not available)] intramuscularly in the left deltoid. Concomitant vaccines administered included an influenza vaccine (lot # and route not provided) in the right deltoid. On 11-Aug-2025, after receiving HEPLISAV-B, the patient experienced muscle stiffness. The patient also has muscle pain when she raises her arm up and down. On 14-Sep-2025, 35 days after receiving the first dose of HEPLISAV-B, the patient presented to the pharmacy to receive the second dose. After the patient reported the muscle stiffness and muscle pain, the second dose was held and not administered. The pharmacist inquired if the patient can receive the second dose of HEPLISAV-B. No other information was available. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2867239 F PA 10/20/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946064
Interchange of vaccine products, No adverse event Interchange of vaccine products, No adverse event
Had a Dose of Recombivax then a Dose of HEPLISAV-B; Initial report received on 15-Sep-2025. A pharm... Had a Dose of Recombivax then a Dose of HEPLISAV-B; Initial report received on 15-Sep-2025. A pharmacist reported that a 40-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after receiving RECOMBIVAX previously. Medical history included a sulfa allergy. No concomitant medications were reported. On 19-Jun-2025, the patient received dose 1 of a hepatitis B vaccine [RECOMBIVAX HB (lot number not available)]. On 19-Jul-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 946064, expiration date 31-Aug-2027, and NDC number 43528-003-05; site not available)] intramuscularly. No other side effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2867241 31 F 10/20/2025 FLUX
FLUX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 7fqy52
7fqy52
Dizziness, Headache, Nausea, Rash, Swelling; Swollen tongue Dizziness, Headache, Nausea, Rash, Swelling; Swollen tongue
Swelling,; rash; severe nausea,; headache,; dizziness/lightheaded; swollen tongue; This non-serious ... Swelling,; rash; severe nausea,; headache,; dizziness/lightheaded; swollen tongue; This non-serious case was reported by a consumer and described the occurrence of swelling in a 31-year-old female patient who received Flu unspecified (Influenza vaccine) (batch number 7fqy52) for prophylaxis. Concomitant products included methotrexate sodium (Methotrexate), belimumab (Benlysta), hydroxychloroquine phosphate (Plaquenil), methylphenidate hydrochloride (Concerta) and propranolol (Propanolol). On 07-OCT-2025, the patient received Influenza vaccine. On 07-OCT-2025, less than a day after receiving Influenza vaccine, the patient experienced swelling (Verbatim: Swelling,), rash (Verbatim: rash), nausea (Verbatim: severe nausea,), headache (Verbatim: headache,), dizziness (Verbatim: dizziness/lightheaded) and swollen tongue (Verbatim: swollen tongue). The outcome of the swelling, rash, nausea, headache, dizziness and swollen tongue were unknown. It was unknown if the reporter considered the swelling, rash, nausea, headache, dizziness and swollen tongue to be related to Influenza vaccine. It was unknown if the company considered the swelling, rash, nausea, headache, dizziness and swollen tongue to be related to Influenza vaccine. Additional Information: GSK Receipt Date: 07-OCT-2025 The reporter reported that the patient received Flu shot and had swelling, rash, severe nausea, headache, dizziness, lightheaded, swollen tongue. More
2867242 10/20/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incorrect route of product administration Incorrect route of product administration
Possible given SQ instead of IM; This non-serious case was reported by a nurse via sales rep and des... Possible given SQ instead of IM; This non-serious case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a patient who received Flu Seasonal TIV Quebec (FluLaval 2025-2026 season) for prophylaxis. On 09-OCT-2025, the patient received the 1st dose of FluLaval 2025-2026 season. On 09-OCT-2025, an unknown time after receiving FluLaval 2025-2026 season, the patient experienced intramuscular formulation administered by other route (Verbatim: Possible given SQ instead of IM). The outcome of the intramuscular formulation administered by other route 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: 09-OCT-2025 The nurse called to understand if they needed to readminister Flulaval to 60 employees since a 5/8 inch needle was provided for administration instead of a 1 inch needle. She was unsure how many employees may need to be revaccinated due to their size and the needle side used. Possibly Flulaval given subcutaneous instead of intramuscular route. More
2867243 M TX 10/20/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
Suspected vaccination failure; had shingles on leg near groin moving towards the back of his leg and... Suspected vaccination failure; had shingles on leg near groin moving towards the back of his leg and was painful; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a elderly male 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 07-OCT-2025, 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: had shingles on leg near groin moving towards the back of his leg and was painful). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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 to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 14-OCT-2025 The reporter reported that the patient received both doses of Shingrix a while ago and shingles developed even after patient got previous vaccine. The patient had shingles on leg near groin moving towards the back of his leg and was painful. It was asked if patient had received Shingrix vs Zostavax then asked if patient received both doses. As far as they were told patient received both doses of Shingrix a while ago. The patient on antibiotics for symptoms but not sure about other medications patients may be on for other conditions. The batch number was not provided and a request for this information has been made. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: A case of Vaccination failure, unknown time after receiving 2nd dose of Shingrix and the 1st dose of Shingrix, in a elderly male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2867252 0.33 F SC 10/20/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
Decreased appetite Decreased appetite
wrong age /dose of Kinrix was administered to a 4 month old baby; This non-serious case was reported... wrong age /dose of Kinrix was administered to a 4 month old baby; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis. Previously administered products included Dtap vaccine (received first dose in JUN-2025). Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap). On 05-AUG-2025, the patient received the 2nd dose of Kinrix. On 05-AUG-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: wrong age /dose of Kinrix was administered to a 4 month old baby). The outcome of the inappropriate age at vaccine administration 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: 26-SEP-2025 and 27-SEP-2025 A nurse reported that a dose of Kinrix was administered to a 4 month old baby. The patient was supposed to get Infanrix and IPV separately. The patient has received a Dtap dose back on Jun 2025, so this Kinrix shot corresponded to 2nd Dtap in the primary series. More
2867258 MA 10/20/2025 COVID19
 MODERNA
Embolism, Fatigue, Feeling abnormal Embolism, Fatigue, Feeling abnormal
Embolism; Felt weird; felt very tired/ could not step up and could not stand; This spontaneous case ... Embolism; Felt weird; felt very tired/ could not step up and could not stand; This spontaneous case was reported by a consumer and describes the occurrence of EMBOLISM (Embolism) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMBOLISM (Embolism) (seriousness criterion medically significant), FEELING ABNORMAL (Felt weird) and FATIGUE (felt very tired/ could not step up and could not stand). At the time of the report, EMBOLISM (Embolism), FEELING ABNORMAL (Felt weird) and FATIGUE (felt very tired/ could not step up and could not stand) outcome was unknown. No concomitant medication was reported. It was reported that patient had the same side effects as with the reporter. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790018 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790018:Reporter case More
2867259 F 10/20/2025 COVID19
 MODERNA
Illness Illness
ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) ... ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) in a female patient of an unknown age 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 ILLNESS (ill). At the time of the report, ILLNESS (ill) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The reporter assumed that the patient became ill due to the vaccine. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789929 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789929:Same reporter/ Different patient More
2867260 10/20/2025 COVID19
 MODERNA
COVID-19 COVID-19
got the shots and got COVID twice; This spontaneous case was reported by a consumer and describes th... got the shots and got COVID twice; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got the shots and got COVID twice) 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 first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (got the shots and got COVID twice). At the time of the report, COVID-19 (got the shots and got COVID twice) outcome was unknown. No concomitant medications were reported. The patient received 2 covid vaccines. The patient got COVID twice after taking the shots before they got sick. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790306 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2025: Live follow-up received contains non-significant information included reference numbers were added. On 15-Oct-2025: Live follow-up received contains non-significant information included reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790306:Reporter's case More
2867261 74 F CT 10/20/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052669
3052669
Aphasia, Chills, Headache, Incontinence, Moaning; Pyrexia, Vomiting Aphasia, Chills, Headache, Incontinence, Moaning; Pyrexia, Vomiting
inability to speak coherently; incontinence; involuntary groaning; chills; headache; vomiting; 6-8 h... inability to speak coherently; incontinence; involuntary groaning; chills; headache; vomiting; 6-8 hours of fever; This spontaneous case was reported by a consumer and describes the occurrence of APHASIA (inability to speak coherently), INCONTINENCE (incontinence), MOANING (involuntary groaning), CHILLS (chills) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052669) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. In October 2025, the patient experienced APHASIA (inability to speak coherently), INCONTINENCE (incontinence), MOANING (involuntary groaning), CHILLS (chills), HEADACHE (headache), VOMITING (vomiting) and PYREXIA (6-8 hours of fever). The patient was treated with Paracetamol (Tylenol) in October 2025 for Headache, at an unspecified dose and frequency. In October 2025, PYREXIA (6-8 hours of fever) had resolved. At the time of the report, APHASIA (inability to speak coherently), INCONTINENCE (incontinence), MOANING (involuntary groaning), CHILLS (chills), HEADACHE (headache) and VOMITING (vomiting) had resolved. No Concomitant medications were reported. Patient experienced symptoms about 12 hours later, including 6-8 hours of fever, chills, vomiting, incontinence, headache, incoherent speech, and involuntary groaning. The episode was described as the worst in their life. There was a concern about possible neurological side effects. Tylenol was taken on the second day, followed by vomiting. The patient had no medical history or risk factors, and no lab results were available.; Reporter's Comments: Due to lack of biological plausibility, Incontinence and moaning events were assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
2867262 72 F 10/20/2025 COVID19
 MODERNA
Asthenia, Fatigue Asthenia, Fatigue
weakness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ... weakness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and FATIGUE (fatigue) in a 72-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The patient's past medical history included Pregnancy (only two childbirths) and Tonsillectomy. Concurrent medical conditions included Bone spur (went to the chiropractor for ultrasonic heat therapy for a bone spur in her arm and back but stated that she was born with a "bad arm and spine"), Colitis, Arm discomfort (born with a "bad arm and spine") and Spinal disorder NOS (born with a "bad arm and spine"). Concomitant products included Influenza vaccine (Flu) from 2025 to an unknown date for an unknown indication. On 10-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. In October 2025, the patient experienced ASTHENIA (weakness) and FATIGUE (fatigue). The patient was treated with Paracetamol (Tylenol) in October 2025 at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness) and FATIGUE (fatigue) outcome was unknown. The patient had flu shot 10 days prior to the COVID-19 vaccine. The patient was expecting to take the mNEXSPIKE vaccine but discovered later by looking at the receipt that she received Spikevax. She experienced significant fatigue and weakness after receiving the Spikevax COVID-19 vaccine. The reaction as worse (really crappy) than previous Moderna vaccinations. She took Tylenol to manage her symptoms. She had no family history of colitis and had been generally healthy. The patient went to the chiropractor for ultrasonic heat therapy for a bone spur in her arm and back but stated that she was born with a bad arm and spine. It was unknown if the patient experienced any additional symptoms/events. This case was linked to US-MODERNATX, INC.-MOD-2025-790276 (E2B Linked Report). This case was linked to MOD-2025-790275 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790276:Son's case More
2867263 9 M PA 10/20/2025 COVID19
 MODERNA
 3053253
Eye movement disorder, Seizure, Syncope, Vision blurred Eye movement disorder, Seizure, Syncope, Vision blurred
fainted; convulsions; blurry vision; eyes rolled back in head; This spontaneous case was reported by... fainted; convulsions; blurry vision; eyes rolled back in head; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) and SEIZURE (convulsions) in a 9-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3053253) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 06-Oct-2025, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), SEIZURE (convulsions) (seriousness criterion medically significant), VISION BLURRED (blurry vision) and EYE MOVEMENT DISORDER (eyes rolled back in head). On 06-Oct-2025, SYNCOPE (fainted), SEIZURE (convulsions), VISION BLURRED (blurry vision) and EYE MOVEMENT DISORDER (eyes rolled back in head) had resolved. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2867264 20 F 10/20/2025 COVID19
 PFIZER\BIONTECH
Arrhythmia Arrhythmia
arrhythmia; This is a spontaneous report received from a Consumer or other non HCP from a sales repr... arrhythmia; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. A 20-year-old female patient received BNT162b2 (BNT162B2), on 23Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 20 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Peanut allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE , UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: ARRHYTHMIA (medically significant) with onset Oct2021, outcome "recovered" (Feb2022). Therapeutic measures were taken as a result of arrhythmia. Clinical course: Vaccine lot number provided as 301258A. Unknown if other vaccine same date, other vaccine in four weeks, other medications in two weeks. Patient stated that almost immediately after receiving the second dose she developed an arrhythmia. She had the arrhythmia for four months. She had to take a beta blocker and it eventually resolved. Treatment: Beta blocker. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2867265 F MD 10/20/2025 COVID19
 PFIZER\BIONTECH
 LN0590
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
caught the Covid; caught the Covid; This is a spontaneous report received from a Consumer or other n... caught the Covid; caught the Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. An 84-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Mar2025 as dose 2, 0.3 ml single (Lot number: LN0590, Expiration Date: 07May2025) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (ongoing), notes: taking a little cancer pill. The patient took concomitant medications. Vaccination history included: BNT162b2 omicron (kp.2) (DOSE 5, SINGLE (also reported as dose 1); lot: LN0590, expiry: 07May2025), administration date: 17Oct2024, when the patient was 83-year-old, for Covid-19 immunization, reaction(s): "covid-19"; Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, when the patient was 81 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, when the patient was 81 years old, for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 2021, when the patient was 81 years old, for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 2022, when the patient was 82 years old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2025, outcome "recovering" and all described as "caught the Covid". The event "caught the covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Sep2025) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient has reported needing Paxlovid. Patient had COVID after COVID vaccine shots. The patient confirmed that she never had COVID before. What actually happened was her husband was in the hospital, and he came home and then he went to see his primary care doctor on 09Sep but while he was in the hospital, the hospital was very cold, and he caught a cold. So, when he came home and he went to see his primary care doctor, they did not do anything about it, he was coughing but he was not coughing real bad but that last Wednesday he started coughing really bad. So, the patient called his doctor, and they told her to give him some cough medicine and then she (the patient) started coughing too. The patient caught his cold, so she called her doctor yesterday morning and was told to come to the office and she will be evaluated. When she went to her doctor, she gave her a test, and confirmed she had COVID. The patient was prescribed medication for COVID and took the medicine (name unspecified). Other than that, she had only taken cough medicine because she did not know any better. She took the cough medicine because she thought it was a cold and had coughing and runny nose. The patient was upset about it because every time it was time for her to get her covid shot, she got it and last shot was in Mar this year. She was angry about that and a little disappointed because every time she was supposed to get the covid, she went to the pharmacy, and she got the covid shot every time. She was so hurt and so angry, because she did everything she was supposed to. The patient is feeling better now. No follow-up attempts are possible. More
2867266 M NY 10/20/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 MY9547
MY9547
Chills, Fatigue, Gait disturbance, Malaise, Muscular weakness; Myalgia, Pain, Re... Chills, Fatigue, Gait disturbance, Malaise, Muscular weakness; Myalgia, Pain, Retching, Temperature intolerance, Vomiting More
severe chills /he was awakened at 5 AM due to chills; where if he let cool air under the blanket the... severe chills /he was awakened at 5 AM due to chills; where if he let cool air under the blanket then he would get a chill; he had weakness in his legs; pain in his leg muscles; feeling wobbly; threw up; dry heaving; Feels very tired; body aches; feels general malaise; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 66-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 15Oct2025 as dose 1, 0.3 ml single (Lot number: MY9547, Expiration Date: 15Jun2026), in left arm for covid-19 immunisation, Device Lot Number: MY9547, Device Expiration Date: 15Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 16Oct2025, outcome "unknown", described as "Feels very tired"; PAIN (non-serious) with onset 16Oct2025, outcome "not recovered", described as "body aches"; RETCHING (non-serious) with onset 16Oct2025, outcome "unknown", described as "dry heaving"; GAIT DISTURBANCE (non-serious) with onset 16Oct2025, outcome "unknown", described as "feeling wobbly"; MALAISE (non-serious) with onset 16Oct2025, outcome "not recovered", described as "feels general malaise"; MUSCULAR WEAKNESS (non-serious) with onset 16Oct2025, outcome "recovered" (16Oct2025), described as "he had weakness in his legs"; MYALGIA (non-serious) with onset 16Oct2025, outcome "recovered" (16Oct2025), described as "pain in his leg muscles"; CHILLS (non-serious) with onset 16Oct2025, outcome "recovered" (16Oct2025), described as "severe chills /he was awakened at 5 AM due to chills"; VOMITING (non-serious) with onset 16Oct2025, outcome "unknown", described as "threw up"; TEMPERATURE INTOLERANCE (non-serious) with onset 16Oct2025, outcome "unknown", described as "where if he let cool air under the blanket then he would get a chill". Therapeutic measures were not taken as a result of chills, temperature intolerance, muscular weakness, myalgia, gait disturbance, vomiting, retching, fatigue, pain, malaise. Additional information: The patient is calling about Comirnaty. He got the shot yesterday at pharmacy. He had no issues at the time but last night he was awakened at 5am with severe chills, could not go back to sleep. Getting up this morning he had weakness in his legs and pain in his leg muscles. He was feeling wobbly and had one cup of tea with just milk in it and about 20 minutes later he threw that up and went on to dry heaving. States he has never had a reaction before. He states he does not have chills anymore but does have body aches and feels general malaise, he is tired. He lives in PRIVACY and it's getting cold and he did not have the heat on last night and had to bundle under the covers to stay warm. It was a situation where if he let cool air under the blanket then he would get a chill. The weakness in his legs and pain in leg muscles he is not experiencing as of now but he has not been walking around much since he felt poor. When he exercises the legs and chooses to move from one side of the house to the other that's where he feels the tiredness. The worst part was the throwing up and the dry heaves which he has not had recently since he has not put anything in his stomach. But he just ate a whole bowl of cheerios with milk. He is hoping that stays down. He does not feel nauseous right now but there is a chance he could. Treatment was reported as declines any. He is in general good health and does not have any sort of cancers or diabetes or any of the popular conditions. He wants to know if there is any sort of idea whether this is going to go away magically. More
2867267 68 F PA 10/20/2025 COVID19
 PFIZER\BIONTECH
 NA0739
Arthralgia, Fatigue, Night sweats Arthralgia, Fatigue, Night sweats
fatigue followed by bilateral arthritic pain in wrists, hands, fingers, knees, shins, feet, toes. Pr... fatigue followed by bilateral arthritic pain in wrists, hands, fingers, knees, shins, feet, toes. Profuse night sweats. Lasting 15 days; fatigue followed by bilateral arthritic pain in wrists, hands, fingers, knees, shins, feet, toes. Profuse night sweats. Lasting 15 days; fatigue followed by bilateral arthritic pain in wrists, hands, fingers, knees, shins, feet, toes. Profuse night sweats. Lasting 15 days; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 30Sep2025 as dose number unknown, single (Lot number: NA0739) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Von Willebrand" (unspecified if ongoing); "HBP" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "gout" (unspecified if ongoing); "liver fibrosis" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL, start date: Aug1995; ALLOPURINOL, start date: Apr2020; JARDIANCE, start date: Sep2024; LANTUS, start date: Sep2024; METFORMIN, start date: Sep2023; VITAMIN D [VITAMIN D NOS], start date: Jul2024; FLU VACCINE VII, start date: 10Sep2025, stop date: 10Sep2025. Past drug history included: Ceclor, reaction(s): "Drug Hypersensitivity"; Clindamycin, reaction(s): "Drug Hypersensitivity". The following information was reported: FATIGUE (non-serious), NIGHT SWEATS (non-serious), ARTHRALGIA (non-serious) all with onset 01Oct2025, outcome "recovering" and all described as "fatigue followed by bilateral arthritic pain in wrists, hands, fingers, knees, shins, feet, toes. Profuse night sweats. Lasting 15 days". Therapeutic measures were not taken as a result of fatigue. More
2867268 48 M 10/20/2025 COVID19
FLU3
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 00069-2528-10
58160-0912-52
Headache, Insomnia, Pain, Palpitations; Headache, Insomnia, Pain, Palpitations Headache, Insomnia, Pain, Palpitations; Headache, Insomnia, Pain, Palpitations
Heart racing; hard to sleep; headache; body aches; This is a spontaneous report received from a Cons... Heart racing; hard to sleep; headache; body aches; This is a spontaneous report received from a Consumer or other non HCP. A 48-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 18Oct2025 at 15:30 as dose 1, single (Lot number: 00069-2528-10) at the age of 48 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 18Oct2025 as dose number unknown, single (Lot number: 58160-0912-52), in left arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: HEPATITIS B VACCINE taken for immunisation, on 30Sep2025 as dose number unknown, single. The following information was reported: PALPITATIONS (non-serious) with onset 18Oct2025 at 22:00, outcome "recovering", described as "Heart racing"; PAIN (non-serious) with onset 18Oct2025 at 22:00, outcome "recovering", described as "body aches"; INSOMNIA (non-serious) with onset 18Oct2025 at 22:00, outcome "recovering", described as "hard to sleep"; HEADACHE (non-serious) with onset 18Oct2025 at 22:00, outcome "recovering". Therapeutic measures were not taken as a result of palpitations, insomnia, headache, pain. Additional information: The patient had no known allergies. The patient was not taking any other medications within 2 weeks of the event starting. More
2867269 81 M 10/20/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052732
407267
Chills; Chills Chills; Chills
Patient reports severe chills with co-administration this season. Patient reports severe chills with co-administration this season.
2867270 71 F 10/20/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052732
407267
Chills, Impaired work ability; Chills, Impaired work ability Chills, Impaired work ability; Chills, Impaired work ability
Patient reports severe chills this year after co-administration - had to leave work early today with... Patient reports severe chills this year after co-administration - had to leave work early today with how they were feeling. More
2867271 59 F CO 10/20/2025 FLU3
 SANOFI PASTEUR
 U8823DA
Injection site pain, Injection site scab, Pain, Product administered at inapprop... Injection site pain, Injection site scab, Pain, Product administered at inappropriate site More
Patient reported back to the pharmacy stating that the vaccination had been given too high and was v... Patient reported back to the pharmacy stating that the vaccination had been given too high and was very painful both at the time of the injection and still when she presented, which was 7 days later. Patient still had a scab from the injection site and it was less than an inch from the shoulder joint. More
2867272 73 F WA 10/20/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052835
407266
Immediate post-injection reaction, Pain, Product administered at inappropriate s... Immediate post-injection reaction, Pain, Product administered at inappropriate site, Sleep disorder; Immediate post-injection reaction, Pain, Product administered at inappropriate site, Sleep disorder More
The patient reported this on 10/10/25 at 10:02am and showed pictures of the vaccine placement. Both ... The patient reported this on 10/10/25 at 10:02am and showed pictures of the vaccine placement. Both vaccines were administered quite high (almost into the shoulder). I spoke to the patient on the phone today, 10/20/25, and she shared that she noticed the pain/soreness/discomfort immediately as soon as the vaccines were administered, she was unable to roll over during sleep, the soreness/achiness lasted about 3-3.5 days, and patient shares she was wearing a sleeveless top with jacket on top (so no sweater to obstruct access or view), and she took 2 doses of her migraine medication (Fioricet with codeine - one immediately upon getting home, and another dose the following evening). Patient shared that she used to work in the ED and has administered many shots. More
2867275 85 F MO 10/20/2025 FLU3
 SANOFI PASTEUR
 UT8820AA
Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth More
Patient received Fluzone HD on Friday 10/17 but reports that on Sunday 10/19 her left arm became war... Patient received Fluzone HD on Friday 10/17 but reports that on Sunday 10/19 her left arm became warm to the touch, red in appearance to the elbow and encircling the upper arm, swollen and itchy. She denies symptoms of anaphylaxis and reports these symptoms originated Sunday evening. More
2867276 67 F CT 10/20/2025 COVID19
 MODERNA
Wrong product administered Wrong product administered
I called this morning to verify they had Moderna Mnexspike in stock. When I registered at the count... I called this morning to verify they had Moderna Mnexspike in stock. When I registered at the counter, I specifically noted I wanted the lower dose Moderna twice. Before the shot was administered, I mentioned again that I wanted the lower dose Moderna vaccine. I discovered they had given me the Moderna Spikevax instead when I looked at the post-visit paperwork, and immediately informed the pharmacist via phone call. More
2867277 0.75 M PA 10/20/2025 FLU3
 SANOFI PASTEUR
 U8889D
Urticaria Urticaria
diffuse urticaria a few hours after administration of vaccine diffuse urticaria a few hours after administration of vaccine
2867278 82 F MI 10/20/2025 PNC21
 MERCK & CO. INC.
 z007870
Anxiety, Disorientation, Dizziness Anxiety, Disorientation, Dizziness
dizziness, disoriented, felt woozy. Patient went to the hospital on 10/7/25 at 3am and was discharge... dizziness, disoriented, felt woozy. Patient went to the hospital on 10/7/25 at 3am and was discharged at 3pm due to her feeling uneasy. More
✓
2867280 57 F GA 10/20/2025 FLU3
 SANOFI PASTEUR
 TFAA2540
Extra dose administered Extra dose administered
Patient was administered an additional influenza vaccine (Flublok) today in error. Previous dose was... Patient was administered an additional influenza vaccine (Flublok) today in error. Previous dose was given on 9/11/2025. More
2867282 M OR 10/20/2025 COVID19
 PFIZER\BIONTECH
 ME6072
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
positive with COVID; positive with COVID; This is a spontaneous report received from a Consumer or o... positive with COVID; positive with COVID; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Aug2025 as dose 1, single (Lot number: ME6072), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The reporter's husband (patient) also was positive with COVID and received the same vaccination on the same date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500106736 Same reporter/drug/event; different patient; More
2867283 FL 10/20/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Coeliac disease, Fatigue, Heart rate, Heart rate increased, Illness; Temperature... Coeliac disease, Fatigue, Heart rate, Heart rate increased, Illness; Temperature intolerance More
sick; celiac disease; high heart rate; heat sensitivity; fatigue; This is a spontaneous report recei... sick; celiac disease; high heart rate; heat sensitivity; fatigue; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered"; TEMPERATURE INTOLERANCE (non-serious) with onset 2021, outcome "not recovered", described as "heat sensitivity"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "not recovered", described as "high heart rate"; COELIAC DISEASE (medically significant) with onset Sep2025, outcome "unknown", described as "celiac disease"; ILLNESS (non-serious), outcome "not recovered", described as "sick". The patient underwent the following laboratory tests and procedures: Heart rate: (2021) high. Additional information: It was reported that the patient got the vaccine a few years ago and since, the patient has been sick, and then last September (Sep2025) got diagnosed with celiac disease. The patient hasn't once had in his/her life before. The patient also had high heart rate, heat sensitivity and fatigue since 2021 after the vaccination. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2867284 67 F KY 10/20/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
I had tested positive for COVID; I had tested positive for COVID; This is a spontaneous report recei... I had tested positive for COVID; I had tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 67-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2025, outcome "unknown" and all described as "I had tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2025) Positive. Clinical course: On 11Sep of this year (2025), the patient's husband and the patient herself went and had the COVID vaccine, Pfizer COVID vaccine at their local (Withheld) drug store. The patient went to the doctor on Saturday, saying she had tested positive for COVID. The patient was prescribed a five-day, ten-pill prescription. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2867285 CA 10/20/2025 COVID19
 PFIZER\BIONTECH
Feeling cold, Tremor Feeling cold, Tremor
experienced very bad symptoms like shaking and being cold when it was very hot.; experienced very ba... experienced very bad symptoms like shaking and being cold when it was very hot.; experienced very bad symptoms like shaking and being cold when it was very hot.; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 15Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), FEELING COLD (non-serious) all with onset Oct2025, outcome "unknown" and all described as "experienced very bad symptoms like shaking and being cold when it was very hot.". Additional information: It was reported that patient took the newest Covid shot yesterday 15Oct2025 from this company and experienced very bad symptoms like shaking and being cold when it was very hot. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2867286 10/20/2025 COVID19
 PFIZER\BIONTECH
Fatigue, Headache, Influenza, Lacrimation increased, Oropharyngeal pain Fatigue, Headache, Influenza, Lacrimation increased, Oropharyngeal pain
I am still having flu symptoms; slept all day fatigue/tired; watery eyes; sore throat; headache; Thi... I am still having flu symptoms; slept all day fatigue/tired; watery eyes; sore throat; headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset Oct2025, outcome "not recovered", described as "I am still having flu symptoms"; HEADACHE (non-serious) with onset Oct2025, outcome "unknown"; FATIGUE (non-serious) with onset Oct2025, outcome "unknown", described as "slept all day fatigue/tired"; OROPHARYNGEAL PAIN (non-serious) with onset Oct2025, outcome "unknown", described as "sore throat"; LACRIMATION INCREASED (non-serious) with onset Oct2025, outcome "unknown", described as "watery eyes". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
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