🏥 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 💀 🏥 🚑 ♿ ⚠️
2863479 59 F VA 10/06/2025 PNC20
 PFIZER\WYETH
Injection site rash, Rash, Rash papular, Rash pruritic Injection site rash, Rash, Rash papular, Rash pruritic
6 days after receiving shot I noticed a rash approximately 3 inches below injection site. It is sli... 6 days after receiving shot I noticed a rash approximately 3 inches below injection site. It is slightly raised, painful with slight itching. Dr. prescribed Triamcinolone ointment Twice a day for 10 days. Also recommended an antihistamine. If appears to get worse to start oral steroids. More
2863481 22 F OH 10/06/2025 FLU3
 SANOFI PASTEUR
 U8790BA
Muscular weakness Muscular weakness
Employee reported feeling of weakness in left arm approximately 30 hours after flu shot administrati... Employee reported feeling of weakness in left arm approximately 30 hours after flu shot administration. Flu shot administered on 9/29/2025. She reported to the clinic on 10/02/2025 to report symptoms. Examined by the Employee Health PA-C. Noted that, Left deltoid where injection was placed has no redness, warmth, or swelling. Shoulder ROM is full. Strength is 4/5" Was prescribed a course of prednisone. Employee returned 4 days later stating no improvement in symptoms. Re-examined by Employee Health PA-C and MRI ordered as well as formal physical therapy. More
2863482 69 F 10/06/2025 COVID19
 MODERNA
Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vac... Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth More
warm and kind of hard to the touch; arm immediately had like a red; expect some soreness and that ki... warm and kind of hard to the touch; arm immediately had like a red; expect some soreness and that kind of thing; was a big red circle, the size of a tennis ball - it is circular/ it looks more like a light bulb - it has more of an elongated shape; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm and kind of hard to the touch), VACCINATION SITE ERYTHEMA (arm immediately had like a red), VACCINATION SITE PAIN (expect some soreness and that kind of thing) and VACCINATION SITE SWELLING (was a big red circle, the size of a tennis ball - it is circular/ it looks more like a light bulb - it has more of an elongated shape) in a 69-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 22-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 22-Sep-2025, the patient experienced VACCINATION SITE WARMTH (warm and kind of hard to the touch), VACCINATION SITE ERYTHEMA (arm immediately had like a red), VACCINATION SITE PAIN (expect some soreness and that kind of thing) and VACCINATION SITE SWELLING (was a big red circle, the size of a tennis ball - it is circular/ it looks more like a light bulb - it has more of an elongated shape). The patient was treated with Ibuprofen at an unspecified dose and frequency and Paracetamol (Acetaminophen) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm and kind of hard to the touch), VACCINATION SITE ERYTHEMA (arm immediately had like a red), VACCINATION SITE PAIN (expect some soreness and that kind of thing) and VACCINATION SITE SWELLING (was a big red circle, the size of a tennis ball - it is circular/ it looks more like a light bulb - it has more of an elongated shape) had not resolved. No relevant medical conditions, does not take any medication No vaccines given within the past 4 weeks. No concomitant medication was reported. It was reported that the patient had received the vaccine, and the arm was immediately had like a red. The patient did not notice it until the next day because she had the little band-aid there. It was a big red circle, the size of a tennis ball, it was circular, warm and kind of hard to the touch. These symptoms might have happened the same day, but patient did not really notice it until the next day. It was continued to be that way and on the reporting day, it was not as vibrantly red, but it looked more like a light bulb, it had more of an elongated shape. It was not as bright as what it was before but still warm to the touch. The patient had only taken Ibuprofen or Acetaminophen for it, might be once a day. The patient also takes the flu vaccine as well and would wait until October to take it. It was unknown if the patient experienced any additional symptoms or events. More
2863483 42 F NE 10/06/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 LD9Y5
Hypoaesthesia, Injected limb mobility decreased, Muscular weakness, Pain, Paraes... Hypoaesthesia, Injected limb mobility decreased, Muscular weakness, Pain, Paraesthesia More
Patient reports since receiving her influenza vaccine on 09/15/2025 she has had some numbness and ti... Patient reports since receiving her influenza vaccine on 09/15/2025 she has had some numbness and tingling down her left arm to her fingers as well as pain when she turns her wrist or shoulder. She reports feeling like her range of motion is limited, she is able to lift her arm to get shoulder but reports pain when above her shoulder in the anterior and posterior deltoid muscle. Patient reports she feels as though her left arm is not as strong as normal as well. She reports with initial injection she had some pain at the injection sight as inspected but as time has gone on she developed the numbness. She is unable to give a range of when the numbness started from when she received her shot. Patient states she does not want to see her provider yet as she would like to give it more time to see if pain improves. More
2863484 81 F MI 10/06/2025 FLU3
 SANOFI PASTEUR
 U8847AA
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adverse reaction. Given two high doses within a month No adverse reaction. Given two high doses within a month
2863485 1 F ID 10/06/2025 FLU3
HEPA
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 FH4YR
Y018512
Y019930
Z008082
Injection site induration, Injection site irritation, Injection site pain, Injec... Injection site induration, Injection site irritation, Injection site pain, Injection site swelling, Injection site ulcer; Injection site induration, Injection site irritation, Injection site pain, Injection site swelling, Injection site ulcer; Injection site induration, Injection site irritation, Injection site pain, Injection site swelling, Injection site ulcer; Injection site induration, Injection site irritation, Injection site pain, Injection site swelling, Injection site ulcer More
Patient woke up 2 days post vaccination with irritation to the L thigh. Today, 11 days post vaccinat... Patient woke up 2 days post vaccination with irritation to the L thigh. Today, 11 days post vaccination the patient came in with a half dollar size, raised, indurated sore on L thigh. It is tender, not hot, but has not prevented child from moving and acting normally. More
2863486 63 F NY 10/06/2025 COVID19
 MODERNA
 3052549
Injection site bruising, Injection site pain Injection site bruising, Injection site pain
soreness and bruising around injection site for more than 1 week soreness and bruising around injection site for more than 1 week
2863487 36 M TX 10/06/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052581
UT8858NA
Immediate post-injection reaction, Presyncope; Immediate post-injection reaction... Immediate post-injection reaction, Presyncope; Immediate post-injection reaction, Presyncope More
Patient had vasovagal response lasting around 10 minutes. Onset was immediately following COVID-19 v... Patient had vasovagal response lasting around 10 minutes. Onset was immediately following COVID-19 vaccination. Warned staff prior to vaccination - we elevated his legs temporarily before transitioning him to laying flat on the floor and applied ice packs to neck and arm. Flu shot was administered during this time with no additional vasovagal response noted. Waited with patient 30 minutes post vaccines before he was stable and felt comfortable walking again. Patient's partner said they would take over driving when they left. More
2863488 64 F FL 10/06/2025 PNC21
 MERCK & CO. INC.
 z006889
Diarrhoea, Mobility decreased, Pain, Pyrexia, Vomiting Diarrhoea, Mobility decreased, Pain, Pyrexia, Vomiting
Patient started having diarrhea about 4 times and vomiting along with each diarrhea at 10 pm on 10... Patient started having diarrhea about 4 times and vomiting along with each diarrhea at 10 pm on 10-5-25. She also complained of fever and painful, unable to lift her arm. However today 10-6-25 her diarrhea and vomiting have stopped. More
2863490 48 M NH 10/06/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 Lot Number: 305
u8881ca
Injection site pain, Pain, Wrong technique in product usage process; Injection s... Injection site pain, Pain, Wrong technique in product usage process; Injection site pain, Pain, Wrong technique in product usage process More
He reports the first vaccine caused him so much pain that radiated from his shoulder down to his fin... He reports the first vaccine caused him so much pain that radiated from his shoulder down to his fingers that he jumped and verbalized it to the RN administering it. He reports the injection "came from high up with a downward angle" to his right upper shoulder. He reports he has never felt similar pain in the past with vaccine administration. He reports he felt no pain with the second vaccine. More
2863491 59 F TX 10/06/2025 FLU3
FLU3
PNC20
PNC20
 SEQIRUS, INC.
SEQIRUS, INC.
PFIZER\WYETH
PFIZER\WYETH
 948406
948406
MA2502
MA2502
Bone pain, Chills, Decreased appetite, Erythema, Fatigue; Headache, Inflammation... Bone pain, Chills, Decreased appetite, Erythema, Fatigue; Headache, Inflammation, Oedema peripheral, Pyrexia, Urticaria; Bone pain, Chills, Decreased appetite, Erythema, Fatigue; Headache, Inflammation, Oedema peripheral, Pyrexia, Urticaria More
Patient claims later the night of receiving her vaccines she experienced Fatigue, bone pain, fever, ... Patient claims later the night of receiving her vaccines she experienced Fatigue, bone pain, fever, armpit swollen, Shivering, headache, arm inflammation, a Red welt on her left arm, and loss of appetite. More
2863493 75 F 10/06/2025 FLU3
 SANOFI PASTEUR
 U8847BA
Diarrhoea, Nausea, Pyrexia, Rash, Vomiting Diarrhoea, Nausea, Pyrexia, Rash, Vomiting
5 days of low grade fever, severe nausea, vomitting, and diarrhea. facial rash 5 days of low grade fever, severe nausea, vomitting, and diarrhea. facial rash
2863494 22 F WY 10/06/2025 FLU3
 SEQIRUS, INC.
 406986
Anaphylaxis treatment, Syncope, Unresponsive to stimuli Anaphylaxis treatment, Syncope, Unresponsive to stimuli
Fainted after immunization, given Epipen and became responsive Fainted after immunization, given Epipen and became responsive
2863495 11 M NH 10/06/2025 FLU3
FLU3
HPV9
HPV9
MNQ
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 9JC49
9JC49
Y018416
Y018416
U8574AA
U8574AA
Dizziness, Fall, Head injury, Hyperhidrosis, Muscular weakness; Pallor; Dizzines... Dizziness, Fall, Head injury, Hyperhidrosis, Muscular weakness; Pallor; Dizziness, Fall, Head injury, Hyperhidrosis, Muscular weakness; Pallor; Dizziness, Fall, Head injury, Hyperhidrosis, Muscular weakness; Pallor More
Patient had vaccines administered, sat with medical assistant for about 5 minutes. Shortly after wa... Patient had vaccines administered, sat with medical assistant for about 5 minutes. Shortly after walking out of the room and was headed to check out, patient became weak in the knees and started to lean against the wall while walking. Roughly 2 minutes he fell forward, hit the right side of his head on the corner of the window and landed on the floor. Patient was unaware of surroundings at the time he came too. Patient was very sweaty and pale in the face, at the time patient stated he was dizzy while sitting on the floor. After 5 minutes on the floor we were able to move him to a room and have him lie down with his knees bent. Applied cool packs to his neck and head. After about 10 minutes of lying on the table was able to sit up without any concerns, then about 5 minutes after sitting he was able to safely walk out of the office. More
2863496 1.67 M IL 10/06/2025 DTAPIPVHIB
HEP
PNC20
 SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
 uk353aa
y019252
lx2498
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Pt inadvertently received additional dose of Hep B. No adverse side effects noted. Pt inadvertently received additional dose of Hep B. No adverse side effects noted.
2863497 71 M SC 10/06/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 ut8829ba
z006073
Injection site pain; Injection site pain Injection site pain; Injection site pain
patient reported pain at site patient reported pain at site
2863499 53 F CA 10/06/2025 PNC20
 PFIZER\WYETH
 MA2523
Blister rupture, Injection site erythema, Injection site warmth, Pyrexia, Rash p... Blister rupture, Injection site erythema, Injection site warmth, Pyrexia, Rash pruritic More
Developed redness to right upper arm and warm feeling the evening after the vaccine was administered... Developed redness to right upper arm and warm feeling the evening after the vaccine was administered. On the third day the affected area developed blisters which subsequently popped on their own. Reports associated symptoms of low-grade fever, which is now resolved. The rash is associated with itching. More
2863500 84 M 10/06/2025 FLU3
 SEQIRUS, INC.
 407259
Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered
Patient wife came in with husband for walk in vaccines, she asked to have a influenza vaccine for hi... Patient wife came in with husband for walk in vaccines, she asked to have a influenza vaccine for him. After processing the vaccine, I went out to give the patient the vaccine, confirming his name and DOB and which vaccine he was receiving, he then confirmed the vaccine, and it was given. After giving the patient asked if it was Pfizer, to which I clarified it is an influenza vaccine and he told me that he wanted a COVID vaccine not influenza and he had already previously received an influenza vaccine with his doctor last month (we called the doctor and confirmed it was given on 9/11/2025). Wife confirmed it was her mistake and that they will be back next week for a COVID vaccine. More
2863501 39 F PA 10/06/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 LD9Y5
Syncope Syncope
Patient fainted. gave cold water and allowed her to come to her feet slowly Patient fainted. gave cold water and allowed her to come to her feet slowly
2863502 62 F IL 10/06/2025 UNK
 UNKNOWN MANUFACTURER
 ZE423
Chills, Productive cough, Pruritus, Sneezing Chills, Productive cough, Pruritus, Sneezing
Teammate stated she had flu shot at (withheld name) Hospital at flu clinic on 10/3/25. Teammate stat... Teammate stated she had flu shot at (withheld name) Hospital at flu clinic on 10/3/25. Teammate stated that night, 10/3/25, she started having chills, sneezing and was coughing up phlegm and on Saturday afternoon, 10/4/25, Teammate stated she started to have itching to back of neck. Teammate stated she is still having itching to back of neck and is still coughing and bringing up phlegm. Treatment options reviewed with teammate if needed. Teammate stated not having any difficulty breathing. Teammate will go to Occupational Health to seek treatment. More
2863503 66 F MN 10/06/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052741
U8847BA
Injection site erythema, Injection site pruritus; Injection site erythema, Injec... Injection site erythema, Injection site pruritus; Injection site erythema, Injection site pruritus More
The evening following vaccine patient developed redness, itching at injection site of left upper arm... The evening following vaccine patient developed redness, itching at injection site of left upper arm. Redness continued to spread over the upcoming days resulting in a follow-up visit in clinic on 10/6/25. More
2863504 94 F OH 10/06/2025 FLU3
 SEQIRUS, INC.
 407246
Extra dose administered Extra dose administered
patient received a second dose of flu vaccine this year patient received a second dose of flu vaccine this year
2863505 77 F SC 10/06/2025 FLU3
RSV
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 UT8829BA
5F5XK
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling More
PATIENT REPORTED REDNESS, SORENESS, ITCHINESS, AND SWELLING AT THE SITE OF INJECTION PATIENT REPORTED REDNESS, SORENESS, ITCHINESS, AND SWELLING AT THE SITE OF INJECTION
2863506 57 F GA 10/06/2025 HEPAB
PNC21
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS


Dizziness, Syncope; Dizziness, Syncope; Dizziness, Syncope Dizziness, Syncope; Dizziness, Syncope; Dizziness, Syncope
Patient had a fainting incidence in which she felt dizzy. Stated she has a strong vaso-vagal respons... Patient had a fainting incidence in which she felt dizzy. Stated she has a strong vaso-vagal response and had experienced this before More
2863507 76 M FL 10/06/2025 UNK
 UNKNOWN MANUFACTURER
Chills, Fatigue Chills, Fatigue
Chills, Fatigue Chills, Fatigue
2863508 50 F FL 10/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7523J
Eye swelling Eye swelling
Eye swelling Eye swelling
2863509 1.17 M MN 10/06/2025 COVID19
 MODERNA
 3052586
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Higher dose of COVID vaccine Spikevax 50 mcg IM was given instead of the age appropriate dose of Spi... Higher dose of COVID vaccine Spikevax 50 mcg IM was given instead of the age appropriate dose of Spikevax 25 mcg IM. Parent reports no adverse reactions. Patient had normal side effect fussiness. More
2863510 44 F FL 10/06/2025 UNK
 UNKNOWN MANUFACTURER
Lip swelling, Urticaria Lip swelling, Urticaria
I had hives all over body and my lips and eye swelled. Hospital gave me Benadryl pep in and steroid ... I had hives all over body and my lips and eye swelled. Hospital gave me Benadryl pep in and steroid by IV and prescribed to keep drinking Benadryl More
2863511 15 M AZ 10/06/2025 FLU3
 SANOFI PASTEUR
 u8832da
Head injury, Pallor, Syncope Head injury, Pallor, Syncope
Patient received the flu and covid vaccine. Patient stood up after receiving the vaccines to let mo... Patient received the flu and covid vaccine. Patient stood up after receiving the vaccines to let mom sit to get her vaccine. While standing patient fainted and hit head on door. Patient was asked to stay seated on the floor. Got a cold pack to apply to head and neck as well as got patient a water and candy to help. Patient stayed seated for a few minutes then moved to chair in vaccine room and stayed seated for about 10 minutes. Patient was pale in color for a few minutes. Once color returned patient moved to chairs outside of pharmacy in "waiting" area and stayed seated there for another 10 minutes. Mom and him said he was feeling better and left. Patient and Mom were asked several times if EMS needed to be called. Patient and mom both declined. More
2863512 94 F AL 10/06/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 na4452
ut8781da
Injection site haemorrhage, Loss of consciousness; Injection site haemorrhage, L... Injection site haemorrhage, Loss of consciousness; Injection site haemorrhage, Loss of consciousness More
patient received both vaccines. after covid vaccine patient's arm did bleed significantly. pati... patient received both vaccines. after covid vaccine patient's arm did bleed significantly. patient then passed out after exiting the pharmacy and ems was contacted thru the front store. More
2863513 M NY 10/06/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Illness; Illness Illness; Illness
Without exception I was always ill for 24 hours +/- starting about 12 hours after the vaccination wa... Without exception I was always ill for 24 hours +/- starting about 12 hours after the vaccination was given; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Without exception I was always ill for 24 hours +/- starting about 12 hours after the vaccination was given) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. The patient's past medical history included COVID-19 (fairly ill for two weeks) from March 2020 to 2020. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Without exception I was always ill for 24 hours +/- starting about 12 hours after the vaccination was given). At the time of the report, ILLNESS (Without exception I was always ill for 24 hours +/- starting about 12 hours after the vaccination was given) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medications were not reported. Patient had received the 8th Covid vaccine on 27-Sep-2025, almost 36 hours ago, along with the flu vaccine. Patient have been vaccinated since December 2020, had contracted Covid in March 2020. Patient was fairly ill for two weeks. Ever since then patient had have received the vaccines of Moderna or Pfizer. It was reported that without exception patient was always ill for 24 hours +/- starting about 12 hours after the vaccination was administered. Patient was not able believe that how he was able to tolerate the Moderna's newest vaccination. Treatment information was not reported. More
2863514 67 M MA 10/06/2025 COVID19
 MODERNA
 3052734
Vaccination site pain Vaccination site pain
Injection site soreness; This spontaneous case was reported by a consumer and describes the occurren... Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 67-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052734) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2024-2025 PFS (Dose 7) in December 2024; for Product used for unknown indication: COMIRNATY (6 Pfizer vaccines). Past adverse reactions to the above products included No adverse effect with COMIRNATY; and Vaccination site pain with SPIKEVAX 2024-2025 PFS. On 25-Sep-2025, the patient received eighth dose of mRNA-1283 (MNEXSPIKE PFS) (unknown route) .2 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) had resolved. No concomitant medication was reported. It was reported that patient had received 8 doses of covid-19 vaccine since 2020 , 6 Pfizer doses and 7th dose of Moderna was in Dec 2024. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-789741 (Patient Link). More
2863515 66 M 10/06/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Fatigue, Somnolence; Fatigue, Somnolence Fatigue, Somnolence; Fatigue, Somnolence
I feel a little groggy/feel there's something in my system that's making me, want to just ... I feel a little groggy/feel there's something in my system that's making me, want to just kind of relax/you might fall asleep for a little bit; kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I feel a little groggy/feel there's something in my system that's making me, want to just kind of relax/you might fall asleep for a little bit) and FATIGUE (kind of tired) in a 66-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS. Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. In October 2024, the patient experienced SOMNOLENCE (I feel a little groggy/feel there's something in my system that's making me, want to just kind of relax/you might fall asleep for a little bit) and FATIGUE (kind of tired). In October 2024, SOMNOLENCE (I feel a little groggy/feel there's something in my system that's making me, want to just kind of relax/you might fall asleep for a little bit) and FATIGUE (kind of tired) had resolved with sequelae. It was reported that patient did not have relevant medical history (vaccines within the past 4 weeks, medical conditions), he was very healthy and athletic. Concomitant medications details were not reported by the reporter. He had every Moderna shot and booster since the start of Covid. He had never contracted Covid. Patient reported that afterwards, he felt a little groggy, he got it on a day when he was not doing weight training, so he doesn't have to, cause it's kind of hard to lift weights when got shots in arms, and kind of tired. Patient also reported that put all that into the body it was temporary, it was just a good excuse to have a short nap. He usually just felt there was something in his system that's making him, wanted to just kind of relax, and usually just put head back and, and then relax and suddenly might fall asleep for a little bit. He also stated he has done that with just regular flu shots even prior to COVID, he also stated that just get jabbed and don't have the, from the energy standpoint, 12 to 24 hours for it to kind of let you get back to that full speed. Patient also stated some people say they get a discomfort in the arms. He had never really experienced that. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789787 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2025: Live non-significant information received, Reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789787:Master case (same reporter) More
2863516 F 10/06/2025 COVID19
 MODERNA
Delusion of parasitosis Delusion of parasitosis
has had serious side effects/called Morgellons; This spontaneous case was reported by a consumer and... has had serious side effects/called Morgellons; This spontaneous case was reported by a consumer and describes the occurrence of DELUSION OF PARASITOSIS (has had serious side effects/called Morgellons) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DELUSION OF PARASITOSIS (has had serious side effects/called Morgellons) (seriousness criterion medically significant). At the time of the report, DELUSION OF PARASITOSIS (has had serious side effects/called Morgellons) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter considered DELUSION OF PARASITOSIS (has had serious side effects/called Morgellons) to be related. Concomitant medication was not reported. Patient did not receive any vaccines 4 weeks prior to the ones received in 2021. It was reported that patient had a lot of numbers and dates of administration but will not talk about it until she talks to her attorney. In 2021, she took the Modern shot that was the two-series shot and ever since then she had serious side effects that are not recognized by the CDC called Morgellons. It was stated that she did know that the nanotechnology that was inside of the vaccine was off of the patent number (withheld). She had been pulling out the nanotechnology out of her system for some time. She had collected quite a bit of it for her own records and stuff. The nanotechnology that was inside of her was not revealed or disclosed to the public. She had nothing but adverse side effects that the CDC didn't recognize. She had collected all the nanotechnology for the last 3 years. She had detoxed for the last 3 years, pretty well, but it was not completely out. She will never get another vaccine again and supposedly the lot number she got was one of the kill switches, what they call the death shots. There were so many lot numbers that were given out that were supposed to have had a direct effect on that person, that was supposed to be like more, she didn't know, that's not even been proven yet, like the other point, well, it had been proven. She had the stuff that she was pulling out of her skin. It was not like it was not there because she had not had it prior to all of that. Later on in the call that she would like to know the ingredients of the vaccine because it could be her body not responding well or something. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Company comment: Causality is assessed as not related considering psychiatric nature of the condition and lack of biological plausibility for causality. The benefit-risk relationship of product is not affected by this report. More
2863517 M 10/06/2025 COVID19
 MODERNA
COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test
mild case of Covid; This spontaneous case was reported by a consumer and describes the occurrence of... mild case of Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (mild case of Covid) in a male 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (mild case of Covid). At the time of the report, COVID-19 (mild case of Covid) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. Concomitant medications details were not reported by the reporter. Patient reported that he and his wife got a mild case of Covid after previous vaccines They had body aches but not as bad as the flu, but they were not feeling right. Patient bought OTC test and tested positive for Covid. Patient said they got the virus 6 to 7 months after the vaccines. It was unknown if the patient experienced any additional symptoms/events. Treatment details were not reported by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789804 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789804:Wife case More
2863518 73 M FL 10/06/2025 COVID19
 MODERNA
CD4 lymphocytes, COVID-19 CD4 lymphocytes, COVID-19
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (CO... COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 73-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Walking pneumonia (a year ago) in 2024 and Respiratory infection (then a month later (February) had a respiratory infection) in 2024. Concurrent medical conditions included HIV positive ((undetachable) with a recent drop in the his CD4 almost a 1/3rd, from over 900 to 640). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CD4 lymphocytes: recent drop in the his CD4 almost a 1/3rd, from over 900 to 640. No concomitant medication was reported. Patient had COVID 6 months later after the first 2 vaccines Moderna made. Patient was HIV positive undetectable) with a recent drop in his CD4 almost a 1/3rd, from over 900 to 640 and a history of walking pneumonia a year ago then a month later (February) had a respiratory infection It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789843 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789843:Case for multiple patient More
2863519 75 F 10/06/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Arthralgia, COVID-19, Chills, Headache, Muscular weakness; Arthralgia, COVID-19,... Arthralgia, COVID-19, Chills, Headache, Muscular weakness; Arthralgia, COVID-19, Chills, Headache, Muscular weakness More
Covid-19 symptoms; weakness in their legs; chills; headache; joint pain; This spontaneous case was r... Covid-19 symptoms; weakness in their legs; chills; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 symptoms), MUSCULAR WEAKNESS (weakness in their legs), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 75-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. On 27-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In 2025, the patient experienced COVID-19 (Covid-19 symptoms), MUSCULAR WEAKNESS (weakness in their legs), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, COVID-19 (Covid-19 symptoms), MUSCULAR WEAKNESS (weakness in their legs), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pain) was resolving. The concomitant medication was not reported by the reporter. The patient experienced COVID-19 symptoms for the third time. She described symptoms including chills, headache, joint pain, and weakness in her legs, which resulted in needing assistance to get out of the shower. She was uncertain whether she should contact her doctor about her leg and back issues. She mentioned that she took a COVID-19 vaccine on 27-Sep-2025 and received both the COVID-19 vaccine and the flu shot around two weeks. She was advised against taking both shots simultaneously, as it might have affected her immunity. The patient confirmed that she felt better but was still concerned about her legs giving out. She indicated that she had no other concerns. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2863520 F 10/06/2025 COVID19
 PFIZER\BIONTECH
Blood pressure measurement, COVID-19, Drug ineffective Blood pressure measurement, COVID-19, Drug ineffective
did get a mild case of COVID and took Paxlovid; did get a mild case of COVID and took Paxlovid; This... did get a mild case of COVID and took Paxlovid; did get a mild case of COVID and took Paxlovid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. An 88-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic", start date: 2001 (ongoing), notes: for about 24 years. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did get a mild case of COVID and took Paxlovid". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 130/75-80, notes: usual blood pressure. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient stated that she is in her late eighties and she just wanted to make sure. Her husband and she had taken 5 of [the COVID-19 vaccines] and have had no problem with them. She did get a mild case of COVID and took PAXLOVID. It was a very mild case. Her husband and she had never had any reaction to the COVID-19 vaccine. She is glad she took it; it helped her. She is diabetic. She made the right decision. Patient also mentioned that her husband does not have the health conditions she has. Caller described that she has been diabetic for "about 24 years" and that her usual blood pressure is 130/75-80. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2863521 F 10/06/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Chills, Feeling hot, Headache, Lethargy, Myalgia; Pain in extremity Chills, Feeling hot, Headache, Lethargy, Myalgia; Pain in extremity
Sore and warm to touch left arm; muscle aches; chills; headache; lethargy; warm to touch left arm; T... Sore and warm to touch left arm; muscle aches; chills; headache; lethargy; warm to touch left arm; This is a spontaneous report received from a Consumer or other non HCP. An adult female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Sep2025 at 09:30 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE, start date: 17Sep2025. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Sep2025, outcome "recovering", described as "Sore and warm to touch left arm"; CHILLS (non-serious) with onset 29Sep2025, outcome "recovering"; HEADACHE (non-serious) with onset 29Sep2025, outcome "recovering"; LETHARGY (non-serious) with onset 29Sep2025, outcome "recovering"; MYALGIA (non-serious) with onset 29Sep2025, outcome "recovering", described as "muscle aches"; FEELING HOT (non-serious) with onset 29Sep2025, outcome "recovering", described as "warm to touch left arm". Therapeutic measures were not taken as a result of pain in extremity, myalgia, chills, headache, lethargy, feeling hot. Additional Information: No Known allergy. Yes, the patient taken any other medications within 2 weeks of the event starting. No, the did not patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reported. No, the patient receive any other vaccines on the same date as the vaccine(s) for which you are reporting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2863522 67 NC 10/06/2025 COVID19
 PFIZER\BIONTECH
Chills, Influenza like illness Chills, Influenza like illness
Flu-like soreness and chills; Flu-like soreness and chills; This is a spontaneous report received fr... Flu-like soreness and chills; Flu-like soreness and chills; This is a spontaneous report received from a Consumer or other non HCP. A 67-year-old patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Contrast material used for CTs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), CHILLS (non-serious) all with onset 30Sep2025, outcome "not recovered" and all described as "Flu-like soreness and chills". Therapeutic measures were not taken as a result of influenza like illness, chills. Additional information: Patient did not receive any other vaccines on the same date as the vaccine for which they were reporting. Patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which they were reporting. Patient was not taking any other medications within 2 weeks of the event starting. No hospitalization/prolonged hospitalization for any event. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2863523 48 M NJ 10/06/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Chills, Mobility decreased, Pyrexia; Chills, Mobility decreased, Pyrexia Chills, Mobility decreased, Pyrexia; Chills, Mobility decreased, Pyrexia
Chills; fever; unable to get out of bed or move; This is a spontaneous report received from a Consum... Chills; fever; unable to get out of bed or move; 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 30Sep2025 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 30Sep2025 as dose number unknown, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; CRESTOR taken for lipid management. The following information was reported: CHILLS (non-serious) with onset 01Oct2025, outcome "recovered"; PYREXIA (non-serious) with onset 01Oct2025, outcome "recovered", described as "fever"; MOBILITY DECREASED (non-serious) with onset 01Oct2025, outcome "recovered", described as "unable to get out of bed or move". Therapeutic measures were taken as a result of chills, pyrexia, mobility decreased. Additional information: Patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting, the patient received other medications within 2 weeks of the event starting. Patient received treatment for the adverse event with Advil. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2863524 61 F NY 10/06/2025 COVID19
 PFIZER\BIONTECH
Glossodynia, Injection site pain Glossodynia, Injection site pain
Sore tongue - back right side; Sore injection site - right upper arm; This is a spontaneous report r... Sore tongue - back right side; Sore injection site - right upper arm; This is a spontaneous report received from a Consumer or other non HCP. A 61-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Oct2025 at 09:30 as dose 1, single (right arm/shoulder) (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Allergy: latex" (unspecified if ongoing); "Allergy: penicillin" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN, start date: 01Sep2023; METOPROLOL TARTRATE, start date: 01Jun2022; PEPCID [FAMOTIDINE], start date: 01Jan2023. Past drug history included: Monostat, reaction(s): "Allergy: monostat". The following information was reported: INJECTION SITE PAIN (non-serious) with onset 01Oct2025, outcome "not recovered", described as "Sore injection site - right upper arm"; GLOSSODYNIA (non-serious) with onset 01Oct2025, outcome "not recovered", described as "Sore tongue - back right side". Therapeutic measures were not taken as a result of glossodynia, injection site pain. Additional information: Patient didn't received any other vaccines on the same date as the vaccination. Patient didn't received any other vaccines within 4 weeks prior to the vaccination. Patient took other medications within 2 weeks of the event started. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2863525 F MA 10/06/2025 COVID19
 PFIZER\BIONTECH
Syncope Syncope
fainted; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old fema... fainted; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 immunization. The following information was reported: SYNCOPE (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "fainted". Clinical course: The patient had 4 Pfizer vaccinations and fainted day after 2nd shot. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2863526 F CA 10/06/2025 COVID19
 PFIZER\BIONTECH
Asthenia, Smear cervix Asthenia, Smear cervix
getting weak; This is a spontaneous report received from a Nurse. A female patient received BNT162b... getting weak; This is a spontaneous report received from a Nurse. A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cervical cancer", start date: Feb2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "getting weak". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: While querying concomitant medication caller states in 2021 she lost her mom. Lost mom to stage 4 cancer. States her mom had the Pfizer Covid vaccine and started getting weak and after the 2nd Pfizer Covid vaccine she felt more weak. That is what took her out. It ended her. She died in 2021. Cancer was diagnosed before she received the Covid vaccine. Caller went into her room to see her. It was after she got the vaccine she would at least get up. Her mom found out she had cancer in Feb2021. She had pap smear and told has cancer. Cervical cancer. States for her mom, when she got diagnosed every once in a while, she would have to go to the hospital. She was admitted once with symptoms she was having. Caller went to her room and very unexpected she wasn't, she was alert, she doesn't know if oriented maybe to place, she doesn't know. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2863527 82 M FL 10/06/2025 COVID19
 PFIZER\BIONTECH
 EK9231
Platelet count, Platelet count increased, Therapeutic response unexpected Platelet count, Platelet count increased, Therapeutic response unexpected
Platelet count rose to 70/75 K/uL; increased platelet positive effect; Platelet count rose to 70/75 ... Platelet count rose to 70/75 K/uL; increased platelet positive effect; Platelet count rose to 70/75 K/uL; increased platelet positive effect; This is a spontaneous report received from a consumer. An 82-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EK9231) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PLATELET COUNT INCREASED (non-serious) all with onset 2021, outcome "unknown" and all described as "Platelet count rose to 70/75 K/uL; increased platelet positive effect". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: As a recipient of four Pfizer COVID-19 Vaccinations, the patient would like to share details with the company as a medical researcher regarding his platelet function during the vaccine period. For over 20 years, the patient's platelet count has been in the 50 to 60 K/uL range. During the Pfizer vaccines injections (2021 to 2023), his platelet count rose to 70/75 K/uL and then dropped back to 50/60 K/uL. The patient was asking the company to review the COVID-19 vaccines content to determine what products were included that might cause the platelet count to rise 50% from the 50 K/uL to 75 K/uL each time he was vaccinated. This increased platelet positive effect might be a secondary or tertiary effect but would be beneficial for platelet treatment rather the normal drugs. The patient thinks this increased platelet phenomenon could spotlight another way to increase platelet product for patients with MDS without the serious side effects associated with INCQOVI.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500116863 Same patient; different dose and event; More
2863528 F 10/06/2025 COVID19
 PFIZER\BIONTECH
Autoimmune disorder Autoimmune disorder
autoimmune disease; This is a spontaneous report received from a Consumer or other non HCP, Program ... autoimmune disease; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "autoimmune disease". Clinical course: Patient inquired about the appropriate waiting period before receiving the 2025/2026 COVID-19 vaccine after having received the 2024/2025 dose on 12Aug (year unspecified), patient has autoimmune disease, and her doctor is recommending she get the new one. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2863529 F MA 10/06/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19; COVID-19; This is a spontaneous report received from a consumer. A 62-year-old female pat... COVID-19; COVID-19; This is a spontaneous report received from a consumer. A 62-year-old female patient received BNT162b2 Omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Allergic to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1), for COVID-19 immunization; Pfizer covid-19 vaccine (DOSE 2), for COVID-19 immunization; Pfizer covid-19 vaccine (DOSE 3 (BOOSTER)), for COVID-19 immunization. The patient had 4 Pfizer vaccinations. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2025, outcome "recovered with sequelae" (10Aug2025) and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ritonavir (PAXLOVID), first dose on 04Aug2025. COVID-19 was negative and patient was symptom-free on the morning of 10Aug2025. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500196265 Same patient and drug; different event and dose; More
2863530 77 F MA 10/06/2025 FLUX
 UNKNOWN MANUFACTURER
Influenza A virus test negative, Influenza B virus test negative, Injection site... Influenza A virus test negative, Influenza B virus test negative, Injection site pain, Pain, Viral infection More
still got very sick from your high valent vaccine with some kind of virus; my arm at injection site ... still got very sick from your high valent vaccine with some kind of virus; my arm at injection site was very sore; my arm at injection site was very sore and I ached all over; Initial information received on 27-Sep-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 77 years old female patient who got very sick with some kind of virus, her arm at injection site was very sore and ached all over after receiving influenza vaccine. 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 Neoplasm malignant and Immune system disorder. On 17-Sep-2025, the patient received an unknown dose of influenza vaccine produced by unknown manufacturer Concentrate and diluent for solution for Injection (strength, expiry date and lot number not reported) via intramuscular route in the arm NOS (not otherwise specified) for Influenzas immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date in SEP-2025 the patient got very sick from your high valent vaccine with some kind of virus (illness), arm at injection site was very sore (vaccination site pain) (unknown latency) and ached all over (pain) (latency- approximately few days). Relevant laboratory test results included: Influenza A virus test - In September 2025: Negative Influenza B virus test - In September 2025: Negative Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. More
2863531 CA 10/06/2025 FLU3
 SANOFI PASTEUR
 UT8770KA
No adverse event, Product storage error No adverse event, Product storage error
product used sent to PV as unsuitable product administered with no reported adverse event; Lowest of... product used sent to PV as unsuitable product administered with no reported adverse event; Lowest of 1 Celsius and the highest of 45.2 Celsius Duration: Over the course of 13 days but it was a total duration of 94 minutes with no reported adverse event; Initial information received on 30-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Infant and unknown gender patient who had Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which went under temperature excursion: negative disposition: lowest of 1 celsius and the highest of 45.2 celsius duration: over the course of 13 days but it was a total duration of 94 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot UT8770KA, expiry date and strength not reported) via unknown route in unknown administration site for Influenza and sent to pv as unsuitable product administered with no reported adverse event (poor quality product administered), lowest of 1 celsius and the highest of 45.2 celsius duration: over the course of 13 days but it was a total duration of 94 minutes (product storage error) (latency same day). Reportedly, the data reader is broken. The extended stability data did not cover the excursion. 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
2863534 73 F NY 10/06/2025 FLU3
 SANOFI PASTEUR
 U8135DA
Chills, Hyperhidrosis, Malaise Chills, Hyperhidrosis, Malaise
was sweating; said that just 2 minutes after getting the shot, she felt unwell; had chills; Initial ... was sweating; said that just 2 minutes after getting the shot, she felt unwell; had chills; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 75 years old female patient who was sweating, said that just 2 minutes after getting the shot, she felt unwell and had chills after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in OCT- 2023, 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 U8135DA, frequency once, expiry date and strength not reported) via intramuscular route in the left arm for Influenza (Influenza immunization). On an unknown date in OCT- 2023, the patient was sweating (hyperhidrosis), said that just 2 minutes after getting the shot, she felt unwell (malaise) and had chills (chills) (latency 2 min) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. Reportedly, the pharmacy offered to call for an ambulance but she declined as after about 30 minutes: she started feeling well enough to drive her car. She wanted know if others reported the same reaction. She advised that she didn't get her flu shots last year (2024) because of this experience but she was thinking about getting a flu shot this year (2025). Patient mentioned that she had been getting FLUZONE HD every year for 7 years prior to the reaction. Patient also wanted know if there are other flu vaccines for patients less than 65 years old. Patient thought it might have a lesser reaction. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date in October 2023 for all the events. More
📋 Privacy Policy & Data Disclaimer