🏥 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 💀 🏥 🚑 ♿ ⚠️
2828426 16 F LA 02/26/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 PVT-52N4S
PVT-9M2R7
Urticaria; Urticaria Urticaria; Urticaria
Diffuse urticaria about 1 hour post administration. Returned to clinic-received 10 mg Zyrtec orally ... Diffuse urticaria about 1 hour post administration. Returned to clinic-received 10 mg Zyrtec orally with some resolution. Denied SOB, wheezing, angioedema. Normal BP and normal pulse ox. No previous allergies More
2828427 24 F MN 02/26/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0171
EW0171
EW0183
EW0183
Diplopia, Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head... Diplopia, Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal; Multiple sclerosis, Multiple sclerosis relapse; Diplopia, Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal; Multiple sclerosis, Multiple sclerosis relapse More
I had my first Multiple Sclerosis flare in July 2021 (1.5 months after receiving vaccine). I was off... I had my first Multiple Sclerosis flare in July 2021 (1.5 months after receiving vaccine). I was officially diagnosed in April 2023. More
✓
2828428 M 02/26/2025 COVID19
 MODERNA
COVID-19 COVID-19
he has had COVID19 3 times; This spontaneous case was reported by a patient and describes the occurr... he has had COVID19 3 times; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he has had COVID19 3 times) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he has had COVID19 3 times). At the time of the report, COVID-19 (he has had COVID19 3 times) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Patient was a senior and he had every shot with Moderna vaccine for COVID and his last shot was last summer, he thought it was on 01June 2024. He had COVID19 3 times with the last case being approximately 2 months (Aug2024) after last COVID19 vaccine administration. No treatment medication was reported. This case was linked to MOD-2025-782574 (Patient Link). Reporter did not allow further contact More
2828429 1 M RI 02/26/2025 DTPPVHBHPB
DTPPVHBHPB
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
 u7921aa
u7921aa
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
CHILD CAME IN FOR HIS 1 YEAR WELL CHILD VISIT WITH HIS MOTHER. PATIENT WAS TO BE GIVEN HIS VARICELL... CHILD CAME IN FOR HIS 1 YEAR WELL CHILD VISIT WITH HIS MOTHER. PATIENT WAS TO BE GIVEN HIS VARICELLA VACCINE TODAY BUT WAS ADMINISTERED VAXELLIS IN ERROR. PROVIDER NOTICED THE ERROR WHEN REVIEWING THE PATIENTS CHART AND CALLED TO SPEAK WITH THE MOTHER IMMEDICATELY. THE PATIENT IS NOT HAVING ANY SYMPTOMS OR SIDE EFFECTS FROM THE VAXELLIS. MOTHER WILL MONITOR AND REPORT ANYTHING TO OUR OFFICE IF SOMETHING ARISES. More
2828430 2 F CA 02/26/2025 COVID19
 PFIZER\BIONTECH
 LN7305
Product preparation issue Product preparation issue
Patient was given first Covid vaccine one year prior to this one. This vaccine was the second dose f... Patient was given first Covid vaccine one year prior to this one. This vaccine was the second dose for patient, but it was given without being diluted. More
2828431 53 F MO 02/26/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Blood test, Erythema, Full blood count, Magnetic resonance imaging, Peripheral s... Blood test, Erythema, Full blood count, Magnetic resonance imaging, Peripheral swelling; Skin warm, Ultrasound scan More
SHORTLY AFTER RECEIVING THE FIRST DOSE OF SHINGRIX IN MY LEFT ARM, I EXPERIENCED ADVANCED SWELLING. ... SHORTLY AFTER RECEIVING THE FIRST DOSE OF SHINGRIX IN MY LEFT ARM, I EXPERIENCED ADVANCED SWELLING. THE SWELLING CONTINUED AND 2 DAYS AFTER RECEIVING THE INJECTION, MY ARM WAS SWOLLEN AND EXTREMELY HOT TO THE TOUCH. THE REDNESS AND SWELLING CONTINUED AND I WENT TO THE EMERGENCY ROOM 4 DAYS POST INJECTION. More
✓
2828432 81 M MI 02/26/2025 COVID19
COVID19
 MODERNA
MODERNA
 016B21A
023C21A
Back pain, Balance disorder, Gait inability, Nervous system disorder, Spinal ope... Back pain, Balance disorder, Gait inability, Nervous system disorder, Spinal operation; Back pain, Balance disorder, Gait inability, Nervous system disorder, Spinal operation More
30 days after the second vaccination I had balance problems, severe back pain, and couldn't wal... 30 days after the second vaccination I had balance problems, severe back pain, and couldn't walk. This has not gone away since. More
✓
2828433 6 F OH 02/26/2025 COVID19
 PFIZER\BIONTECH
 LM2045
Expired product administered, No adverse event Expired product administered, No adverse event
on Feb 23, 2025, 6 y/o female was given a pfizer vaccine (5y-11month )that had passed the BUD of 1/2... on Feb 23, 2025, 6 y/o female was given a pfizer vaccine (5y-11month )that had passed the BUD of 1/22/2025. Father is notified the incident on Feb 26, 2025. No side effect is notified. More
2828434 21 F NY 02/26/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 012H21B
012H21B
029L20A
029L20A
025J20A
025J20A
Abdominal pain, Computerised tomogram, Constipation, Henoch-Schonlein purpura, L... Abdominal pain, Computerised tomogram, Constipation, Henoch-Schonlein purpura, Laboratory test; Nausea, Rash, Rash pruritic; Abdominal pain, Computerised tomogram, Constipation, Henoch-Schonlein purpura, Laboratory test; Nausea, Rash, Rash pruritic; Abdominal pain, Computerised tomogram, Constipation, Henoch-Schonlein purpura, Laboratory test; Nausea, Rash, Rash pruritic; Abdominal pain, Computerised tomogram, Constipation, Henoch-Schonlein purpura, Laboratory test; Nausea, Rash, Rash pruritic More
For about two months I suffered with severe nausea, abdominal pain, rashes (painful and itching), co... For about two months I suffered with severe nausea, abdominal pain, rashes (painful and itching), constipation. Diagnosed w/ IgA vasculitis. More
2828435 56 F MI 02/26/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 J4349
Syringe issue Syringe issue
While giving the patient her influenza vaccine, the vaccine fluid sprayed out of the side of the hub... While giving the patient her influenza vaccine, the vaccine fluid sprayed out of the side of the hub of the pre-filled syringe Upon noticing this occurring, the vaccine was stopped. Patient reported not having felt any vaccine going into her arm. Another influenza vaccine was attempted and was able to be administered without incident. Upon closer inspection of the failed vaccine pre-filled syringe, there appears to be a small hole on the side of the hub. More
2828436 15 F AL 02/26/2025 HPV9
 MERCK & CO. INC.
 Y010466
Injection site pruritus, Injection site rash, Injection site swelling Injection site pruritus, Injection site rash, Injection site swelling
rash, swelling and itching at injection site rash, swelling and itching at injection site
2828437 1.5 F OR 02/26/2025 DTAPIPV
 SANOFI PASTEUR
 U7838AA
Wrong product administered Wrong product administered
She was just due for DTaP and was given DTaP/IPV combo. She was just due for DTaP and was given DTaP/IPV combo.
2828438 35 F VA 02/26/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00553
Rash Rash
Rash to chest, upper back, neck and jawline. Treated with IM benadryl with onset of symptoms, but h... Rash to chest, upper back, neck and jawline. Treated with IM benadryl with onset of symptoms, but had po benadryl prior to vaccine due to unreported/unseen rash from first dose on chest per patient. No respiratory symptoms, no hypotension. More
2828439 12 M CA 02/26/2025 HPV9
 MERCK & CO. INC.
 X024650
Dizziness, Nausea Dizziness, Nausea
Dizziness and nausea, within 15 minutes after administration Dizziness and nausea, within 15 minutes after administration
2828440 40 F NJ 02/26/2025 COVID19
COVID19
 MODERNA
MODERNA

Asthma, Autoimmune disorder, Feeling cold, Influenza like illness, Malaise; Musc... Asthma, Autoimmune disorder, Feeling cold, Influenza like illness, Malaise; Muscle rigidity, Musculoskeletal stiffness, Pain, Pyrexia, Sleep disorder More
Event occurred approximately 8 hours after receiving my 3rd Moderna (booster) shot. A few hours aft... Event occurred approximately 8 hours after receiving my 3rd Moderna (booster) shot. A few hours after receiving the shot I started feeling unwell like I was coming down with the flu, then by 8:00 PM that same day I felt like I was freezing cold and sweating in bed, developed a fever of 102, every muscle in my body was tense and was rigid like I had tetanus, and the body pain was so intense that I did not sleep for 24 hours. These symptoms subsided after 48 hours, but my entire body was sore for days afterwards from the severe muscle rigidity. I was also diagnosed with asthma and an autoimmune disorder later but I am unsure if this is a delayed side-affect of the Covid booster or not. More
2828441 82 F MI 02/26/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 zd3gz
Injection site pruritus, Injection site reaction, Injection site swelling Injection site pruritus, Injection site reaction, Injection site swelling
Itchy, red and raised area of injection site after 1 week Itchy, red and raised area of injection site after 1 week
2828442 27 M KS 02/26/2025 SMALLMNK
 BAVARIAN NORDIC
 96867
Discomfort, Immediate post-injection reaction, Local reaction, Rash, Skin lesion Discomfort, Immediate post-injection reaction, Local reaction, Rash, Skin lesion
Pt presented on 2/24/25 stating that he has had a painful rash, MPOX lesions, to the bilateral palms... Pt presented on 2/24/25 stating that he has had a painful rash, MPOX lesions, to the bilateral palms of his hands. He said it started right after the first vaccine. We proceeded with 2nd vaccination on 2/24/25. He presents today 2/26/25 with a local reaction to the RUA. Given steroid shot and instructed to take antihistamines. Spoke to epidemiologist and was told it was a vaccine reaction. Lidocaine applied to lesions and he states that did help with discomfort More
2828443 27 M CA 02/26/2025 COVID19
 PFIZER\BIONTECH
 EW0175
Testicular pain Testicular pain
Acute pain in one side of testicle Acute pain in one side of testicle
2828444 4 F NH 02/26/2025 MMRV
 MERCK & CO. INC.
 Y014437
Injection site erythema, Injection site swelling, Injection site warmth Injection site erythema, Injection site swelling, Injection site warmth
Redness, warm, swelling to injection site. Redness, warm, swelling to injection site.
2828445 44 F CA 02/26/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8230
ER8230
EW0153
EW0153
Abdominal pain upper, Asthenia, Headache, Heavy menstrual bleeding, Loss of pers... Abdominal pain upper, Asthenia, Headache, Heavy menstrual bleeding, Loss of personal independence in daily activities; Menstrual discomfort, Menstruation irregular, Muscle spasms, Premenstrual dysphoric disorder, Stress; Abdominal pain upper, Asthenia, Headache, Heavy menstrual bleeding, Loss of personal independence in daily activities; Menstrual discomfort, Menstruation irregular, Muscle spasms, Premenstrual dysphoric disorder, Stress More
My menstrual cycle, which was always very regular, became completely unpredictable in the months fol... My menstrual cycle, which was always very regular, became completely unpredictable in the months following the Covid vaccine. It became some burdensome, that I was unable to prepare for the start and stop of it the menstruation. Additionally, I never suffered from PMS prior to the vaccine. Now, I suffer from debilitating cramps, headache, and stomach pain prior to and during menstruation. My periods are extremely heavy - which was not the case prior to the vaccine. I have never had a regular period since June of 2021. This is a direct result of the Covid Vaccine that I was forced to take. I am unable to participate in the physical activities I once enjoyed due to the pain, embarrassment, and discomfort of irregular periods, heavy periods, and constant stress of bleeding. More
✓
2828446 8 M TX 02/26/2025 DTAP
IPV
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
 3CA11C1
X1C891M
X006983
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Dtap inadvertently given instead of tdap, no symptoms, just wrong vax administered Dtap inadvertently given instead of tdap, no symptoms, just wrong vax administered
2828447 61 F MN 02/26/2025 COVID19
 MODERNA
 007B21A
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
✓
2828448 57 F NC 02/26/2025 PNC21
PNC21
TDAP
TDAP
VARZOS
VARZOS
UNK
UNK
UNK
UNK
VARZOS
VARZOS
 MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 013009
013009
U8115AA
U8115AA
4H79Y
4H79Y
013009
013009
U8115AA
U8115AA
4H79Y
4H79Y
Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope; Incoherent, Synco... Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope; Incoherent, Syncope More
After the 3rd vaccine (order was shingrix, capvaxive, adacel) patient incoherent then fainted. I ad... After the 3rd vaccine (order was shingrix, capvaxive, adacel) patient incoherent then fainted. I administered one dose of epinephrine 0.3mg. More
2828449 38 F IL 02/26/2025 TD
 SANOFI PASTEUR
 u8021BA
Muscular weakness, Pain in extremity, Restlessness Muscular weakness, Pain in extremity, Restlessness
Arm is weak and restless. Pt denies redness or swelling at the injection site. Pt does have pain in ... Arm is weak and restless. Pt denies redness or swelling at the injection site. Pt does have pain in the arm. More
2828450 73 F MN 02/26/2025 COVID19
 JANSSEN
 003A21A
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
✓
2828451 18 F NY 02/26/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 3L339
Dizziness, Pallor, Vomiting Dizziness, Pallor, Vomiting
Patient was very anxious prior to vaccination. 5 minutes after Men B vaccine patient felt dizzy and ... Patient was very anxious prior to vaccination. 5 minutes after Men B vaccine patient felt dizzy and lightheaded. She ended up vomiting. She was sat in a chair. She was pale. given Juice. Vital signs stable. Patient monitored for 15 min. Discussed with Provider. Patient felt better deemed could leave office with ride. Had similar episode with 1st HPV and worse episodes with blood work. Known needle phobia. More
2828452 78 F 02/26/2025 COVID19
 MODERNA
Fatigue, Hypokinesia, Impaired work ability, Therapeutic response unexpected Fatigue, Hypokinesia, Impaired work ability, Therapeutic response unexpected
almost unable to work, and was looking at a job as well as farming; she couldn't lift anything ... almost unable to work, and was looking at a job as well as farming; she couldn't lift anything anymore and had to practically crawl to get to the barn; she was tired all the time/had constant fatigue; Therapeutic response unexpected; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (almost unable to work, and was looking at a job as well as farming) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 31-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (almost unable to work, and was looking at a job as well as farming) (seriousness criterion disability), HYPOKINESIA (she couldn't lift anything anymore and had to practically crawl to get to the barn), FATIGUE (she was tired all the time/had constant fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Therapeutic response unexpected). At the time of the report, IMPAIRED WORK ABILITY (almost unable to work, and was looking at a job as well as farming), HYPOKINESIA (she couldn't lift anything anymore and had to practically crawl to get to the barn) and FATIGUE (she was tired all the time/had constant fatigue) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (Therapeutic response unexpected) outcome was unknown. No concomitant medications were reported. The patient was a farmer, and it was hard for her to do anything after that, she couldn't lift anything anymore and had to practically crawl to get to the barn, she could previously pick up a 50-pound bale of hay or 50-pound bag of grain, but now she was tired all the time and had constant fatigue. For the whole winter the patient was almost unable to work, and was looking at a job as well as farming, so it was really, really hard for her. Almost immediately she improved and was back to almost normal. No treatment medications were reported.; Reporter's Comments: The events were assessed as not related to the vaccine due to the absence of temporal relationship; they occurred before mRNA-1273 doses; only therapeutic response unexpected occurred after moderna vaccine. The benefit -risk relationship of product is not affected by this report. More
✓
2828453 58 M TX 02/26/2025 FLU3
 SEQIRUS, INC.
 AW1608C
Pain in extremity, Skin discolouration Pain in extremity, Skin discolouration
PT RECEIVED AFLURIA VACCINE ON 2/17/25 AT PHARMACY. PT THEN CALLED PHARMACY ON 2/22/25 SAYING SHE WA... PT RECEIVED AFLURIA VACCINE ON 2/17/25 AT PHARMACY. PT THEN CALLED PHARMACY ON 2/22/25 SAYING SHE WAS GOING TO THE HOSPITAL BECAUSE FER LEFT FINGER WAS IN ALOT OF PAIN AND HAD TURNED PURPLE. HOS[PITAL DR PRESCRIBED NITRO OINTMENT AND NIFEDIPINE TO HELP WITH CIRCULATION More
2828454 71 F GA 02/26/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 388461
388461
Arthralgia, Injected limb mobility decreased, Pain, Pain in extremity, Periarthr... Arthralgia, Injected limb mobility decreased, Pain, Pain in extremity, Periarthritis; Shoulder injury related to vaccine administration, X-ray limb More
Left arm sore, aching. Did not subside and worsened over time to painful deltoid area and joint, lo... Left arm sore, aching. Did not subside and worsened over time to painful deltoid area and joint, loss of ROM. Saw , NP 12/17/24 who directed me to see Orthopedist. Earliest appointment 01/28/2025 obtained and saw Dr . XRays taken w/ no Bone abnormalities found. Six weeks PT ordered and started Feb 4, 2025. Pain now radiating into upper left arm down to elbow, sometimes to left hand or to left clavicle w/ radiation into neck. Ortho dx: Shoulder injury r/t vaccine administration (SIRVA) (S49.80XA, T50.Z95A), Adhesive Capsulitis with ROM loss. More
2828455 1.33 M CA 02/26/2025 DTAP
HEPA
HIBV
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 9KB9G
C24B9
UK168AC
Y000224
Y010184
Erythema, Pruritus, Pustule; Erythema, Pruritus, Pustule; Erythema, Pruritus, Pu... Erythema, Pruritus, Pustule; Erythema, Pruritus, Pustule; Erythema, Pruritus, Pustule; Erythema, Pruritus, Pustule; Erythema, Pruritus, Pustule More
Day 4 following immunizations patient had small red pustules on left wrist, left ankle, and two on l... Day 4 following immunizations patient had small red pustules on left wrist, left ankle, and two on left cheek. Mom reports itching, no evidence of pain or infection. Patient is alert, pleasant, and active More
2828456 22 F CA 02/26/2025 MENB
MNQ
VARCEL
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
MERCK & CO. INC.
 DD72H
Z92L4
Y005919
Erythema, Peripheral swelling, Pruritus, Skin warm; Erythema, Peripheral swellin... Erythema, Peripheral swelling, Pruritus, Skin warm; Erythema, Peripheral swelling, Pruritus, Skin warm; Erythema, Peripheral swelling, Pruritus, Skin warm More
The patient reported to the clinic with a chief complaint of redness on her right arm. She reported ... The patient reported to the clinic with a chief complaint of redness on her right arm. She reported that her arm had been bothering her and was swollen, red, itchy and warm. Upon examination her symptoms were verified. The patient was instructed to take benadryl and report back to the clinic on 2/24/25 if there was no improvement. More
2828457 59 M ND 02/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 XZ7CB
Bell's palsy Bell's palsy
Bell's Palsy Bell's Palsy
2828458 21 M CT 02/26/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 2a755
Fall Fall
Patient was fasting before vaccine. I administered the vaccine and shortly after the patient had fal... Patient was fasting before vaccine. I administered the vaccine and shortly after the patient had fallen to the floor. We sat the patient back on the chair and gave him water, pretzels, and a lollipop and had him wait there until he was feeling better. We offered to call 911 but the patient declined. More
2828459 22 F CA 02/26/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Erythema, Injection site warmth, Pain in extremity, Peripheral swelling Erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Patient presents to clinic with the complaint of warmth at the injection site, swelling, pain and re... Patient presents to clinic with the complaint of warmth at the injection site, swelling, pain and redness to a large portion of her arm, concern for allergic reaction vs cellulitis More
2828460 0.17 M ID 02/26/2025 HIBV
 MERCK & CO. INC.
 x028614
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient was given a pedvax hib a vaxelis and a rota. Patient should have received a prevnar, vaxeli... Patient was given a pedvax hib a vaxelis and a rota. Patient should have received a prevnar, vaxelis and a rota. This was immediately reported to Dr and team lead nurse. An incident report was filed. Parent was notified. No adverse effects reported. More
2828461 42 F CA 02/26/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LJ5284
ak334
Dermatitis, Pruritus; Dermatitis, Pruritus Dermatitis, Pruritus; Dermatitis, Pruritus
15 min after admin, pt had skin inflammation and itchiness on neck, forehead, and chest. Gave pt 50m... 15 min after admin, pt had skin inflammation and itchiness on neck, forehead, and chest. Gave pt 50mg diphenhydramine. pt had her own epipen with her but she stated that she did not have difficulty breathing at the time. More
2828462 52 F GA 02/26/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 TFAA2410
Y011819
Lethargy, Mobility decreased, Peripheral swelling, Rash, Skin warm; Lethargy, Mo... Lethargy, Mobility decreased, Peripheral swelling, Rash, Skin warm; Lethargy, Mobility decreased, Peripheral swelling, Rash, Skin warm More
PATIENTS ARM WAS SEVERELY SWOLLEN AND BROKE OUT IN SEVERE RASH WITH HIGH FEVER IN ARM. PATIENT COMPL... PATIENTS ARM WAS SEVERELY SWOLLEN AND BROKE OUT IN SEVERE RASH WITH HIGH FEVER IN ARM. PATIENT COMPLAINED OF NOT BEING ABLE TO LIFT ARM APPROPRIATELY, LETHARGY More
2828463 M 02/26/2025 COVID19
 MODERNA
COVID-19 COVID-19
he had COVID19 3 times; This spontaneous case was reported by a patient and describes the occurrence... he had COVID19 3 times; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he had COVID19 3 times) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Jun-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In August 2024, the patient experienced COVID-19 (he had COVID19 3 times). At the time of the report, COVID-19 (he had COVID19 3 times) outcome was unknown. No concomitant medications were provided. Patient was senior and that in the past he had every shot with Moderna for COVID and his last shot was last summer, he thought it was 01-Jun-2024. He had COVID19, 3 times with the last case being approximately 2 months (Aug2024) after last COVID19 vaccine administration. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided. Reporter causality was not reported. This case was linked to MOD-2025-782733 (Patient Link). Reporter did not allow further contact More
2828464 91 M 02/26/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

COVID-19; COVID-19 COVID-19; COVID-19
has tested positive for Covid/he caught a COVID-19 infection; This spontaneous case was reported by ... has tested positive for Covid/he caught a COVID-19 infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (has tested posted for Covid/he caught a COVID-19 infection) in a 91-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: Moderna COVID-19 Vaccine (lot- 038K20A) on 08-Feb-2021, Moderna COVID-19 Vaccine (lot- 010A21A) on 08-Mar-2021 and Moderna COVID-19 Vaccine (lot- 076C21A) on 27-Oct-2021. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Blood pressure. In September 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. On 17-Feb-2025, the patient experienced COVID-19 (has tested posted for Covid/he caught a COVID-19 infection). At the time of the report, COVID-19 (has tested posted for Covid/he caught a COVID-19 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2025, SARS-CoV-2 test: Positive. The customer was prescribed several pills for blood pressure. The patient was not able to confirm in which arm the Moderna COVID-19 vaccine was administered but he confirmed that he had the Moderna COVID-19 vaccine shot in one arm and the Flu vaccine shot in the other arm on the same date of vaccination. As of reporting, patient was not sure if the patient was still positive for Covid. The patient did not experience any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2025: Live significant follow-up received: As reported term and vaccination date was updated, Current condition, historical vaccine and co-suspect added. More
2828465 M 02/26/2025 COVID19
 PFIZER\BIONTECH
Blood test, Electrocardiogram, Feeling abnormal, Illness, Malaise Blood test, Electrocardiogram, Feeling abnormal, Illness, Malaise
That shot made him super sick and he could barely function for a week or two and made him feel reall... That shot made him super sick and he could barely function for a week or two and made him feel really bad; That shot made him super sick and he could barely function for a week or two and made him feel really bad; Felt horrible; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 vaccination, reaction(s): "feel bad"; Bnt162b2 (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 vaccination, reaction(s): "feel bad"; Bnt162b2 (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 vaccination, reaction(s): "feeling bad". The following information was reported: ILLNESS (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "That shot made him super sick and he could barely function for a week or two and made him feel really bad"; MALAISE (non-serious), outcome "unknown", described as "Felt horrible". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was calling about Pfizer bivalent spike protein covid 19 booster, when he received it this was his 4th shot which he received in Nov2022 and that was the one that was supposed to be the updated shot for the omicron. That shot made him super sick and he could barely function for a week or two and made him feel really bad. He is trying to find assistance to try to feel better and see if there is something to reverse effects of the symptoms that he has had for two years. They were done with blood work and EKG and can't find anything wrong. The patient felt horrible. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2828466 74 M AZ 02/26/2025 COVID19
 PFIZER\BIONTECH
Herpes simplex Herpes simplex
I had a very recalcitrant HSV2 reaction; This is a spontaneous report received from a Consumer or ot... I had a very recalcitrant HSV2 reaction; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Jan2025 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hbp" (unspecified if ongoing); "hsv2" (unspecified if ongoing); "copd" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. Past drug history included: Tetracycline, reaction(s): "drug allergy". The following information was reported: HERPES SIMPLEX (non-serious) with onset 30Jan2025 at 07:00, outcome "recovered" (18Feb2025), described as "I had a very recalcitrant HSV2 reaction". Therapeutic measures were taken as a result of herpes simplex. Additional information: Patient didn't receive any other vaccines on the same date as the vaccine. Patient didn't receive any other vaccines within 4 weeks prior to the vaccine. Patient had a very recalcitrant HSV2 reaction. Patient has had hsv2 for many years but this episode was very difficult to deal with. It was not responding to famciclovir. Treatment received for the adverse event included Famciclovir. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2828467 AL 02/26/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Vomiting; Vomiting Vomiting; Vomiting
I spit out black stuff, it looked like mold; This is a spontaneous report received from a Consumer o... I spit out black stuff, it looked like mold; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Feb2025 at 11:30 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 21Feb2025 at 11:30 as dose number unknown , single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, lot number unknown), for COVID-19 immunisation; Comirnaty (DOSE 2, lot number unknown), for COVID-19 immunisation; Comirnaty (DOSE 3(BOOSTER), lot number unknown), for COVID-19 immunisation; Comirnaty (DOSE 4(BOOSTER), lot number unknown), for COVID-19 immunisation; Comirnaty (DOSE 5(BOOSTER), lot number unknown), for COVID-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 22Feb2025 at 09:30, outcome "unknown", described as "I spit out black stuff, it looked like mold". Additional information: The patient was vaccinated against Flu and Covid yesterday(21Feb2025) at the consulate around 11:30 am and today(22Feb2025) at 9:30, patient spit out black stuff, it looked like mold. Patient was worried that it's something bad. Proposed response: vomiting is listed as a commonly reported side effect, but no specific information was found on 'spitting out black stuff.' The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2828468 M 02/26/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month; Received Comirnaty;... Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month; Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month; 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)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose number unknown; religiously got it each year), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Feb2025, outcome "unknown" and all described as "Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2025) Positive. The patient received Comirnaty and religiously got it each year. Reporter have a disabled son (patient) also managed for the first time to get COVID, symptomatic COVID at the beginning of this month and put on Paxlovid. COVID positive on date 12Feb2025. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500042895 Same reporter and vaccine and event, different patients.;US-PFIZER INC-202500042913 Same reporter and vaccine and event, different patients.; More
2828469 F 02/26/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month; Received Comirnaty;... Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month; Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month; This is a spontaneous report received from a Consumer or other non HCP. 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Received Comirnaty; get COVID, symptomatic COVID at the beginning of this month". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2025) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500042863 Same reporter and vaccine and event, different patients; More
2828470 M 02/26/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, Vaccination failure COVID-19, SARS-CoV-2 test, Vaccination failure
received Comirnaty/get COVID, symptomatic COVID; received Comirnaty/get COVID, symptomatic COVID; Th... received Comirnaty/get COVID, symptomatic COVID; received Comirnaty/get COVID, symptomatic 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 04Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (primary immunization series completed), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2025, outcome "unknown" and all described as "received Comirnaty/get COVID, symptomatic COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2025) Positive; (20Feb2025) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient reported two adverse events that basically count as a vaccine failure and as a drug failure. There are three people (one of which is the patient). They all received Comirnaty and religiously got it each year. He has a disabled son, his wife, and him (the patient) managed for the first time to get COVID, symptomatic COVID at the beginning of this month (Feb2025) and they were put on Paxlovid and all of them have had rebound. All of them after coming off Paxlovid got even sicker. The patient became sick in 12Feb when he started taking the Paxlovid and then completed the five days course. He received the vaccine on 04Sep2024. He was positive by BinaxNOW test. When confirmed if all three to them were COVID positive on same date 12Feb2025, the patient confirmed Yes but they all differ a little bit. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500042863 same reporter/drug/event, different patient;US-PFIZER INC-202500042895 same reporter/drug/event, different patient;US-PFIZER INC-202500042863 Same reporter and vaccine and event, different patients.; More
2828471 38 M AK 02/26/2025 COVID19
 PFIZER\BIONTECH
Deep vein thrombosis, Ultrasound scan Deep vein thrombosis, Ultrasound scan
developed a DVT shortly after having the vaccine; This is a spontaneous report received from a Consu... developed a DVT shortly after having the vaccine; This is a spontaneous report received from a Consumer or other non HCP. A 38-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in arm (shoulder) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 15Apr2021 at 12:00, outcome "not recovered", described as "developed a DVT shortly after having the vaccine". The patient underwent the following laboratory tests and procedures: Ultrasound scan: unknown results. Therapeutic measures were taken as a result of deep vein thrombosis and included blood thinners. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2828472 80 M 02/26/2025 PNC20
 PFIZER\WYETH
Discomfort, Malaise, Pruritus Discomfort, Malaise, Pruritus
experienced itching/feeling itchy; feeling uncomfortable and unwell/uncomfortable; feeling uncomfort... experienced itching/feeling itchy; feeling uncomfortable and unwell/uncomfortable; feeling uncomfortable and unwell/he does not feel that well; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 80-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Feb2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 25Feb2025, outcome "unknown", described as "experienced itching/feeling itchy"; MALAISE (non-serious) with onset 25Feb2025, outcome "unknown", described as "feeling uncomfortable and unwell/he does not feel that well"; DISCOMFORT (non-serious) with onset 25Feb2025, outcome "unknown", described as "feeling uncomfortable and unwell/uncomfortable". Therapeutic measures were taken as a result of pruritus, discomfort, malaise. Additional information: The patient took an antihistamine (Allegra 24 hour); has no known allergies. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2828473 02/26/2025 COVID19
 PFIZER\BIONTECH
Memory impairment Memory impairment
lost all sense of recognition; This is a spontaneous report received from a Consumer or other non HC... lost all sense of recognition; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 65-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 0.3ml 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: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "lost all sense of recognition". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500043515 same reporter/event, different patient; More
2828474 F MD 02/26/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH





Basophil count, Blood bicarbonate, Blood chloride, Blood creatinine, Blood gluco... Basophil count, Blood bicarbonate, Blood chloride, Blood creatinine, Blood glucose; Blood potassium, Blood sodium, Blood urea, Body mass index, COVID-19; Chest X-ray, Drug ineffective, Eosinophil count, Haematocrit, Haemoglobin; Immature granulocyte count, International normalised ratio, Lymphocyte count, Mean cell volume, Monocyte count; Neutrophil count, Platelet count, Post-acute COVID-19 syndrome, Prothrombin time, Red cell distribution width; Troponin, White blood cell count More
She had received three vaccinations (Pfizer for the first two and Moderna for the third) but still c... She had received three vaccinations (Pfizer for the first two and Moderna for the third) but still contracted the virus; She had received three vaccinations (Pfizer for the first two and Moderna for the third) but still contracted the virus; She had received three vaccinations (Pfizer for the first two and Moderna for the third) but still contracted the virus; This is a literature report for the following literature source(s). CASE HISTORY: A previously healthy 41-year- old female (BMI 27.4) with history of migraines developed Long-COVID symptoms after contracting COVID-19 in February 2022. Her migraines intermittently occurred two-four times per month since adolescence. She had received three vaccinations (Pfizer for the first two and Moderna for the third) but still contracted the virus. The patient's symptoms at the time of diagnosis of acute COVID-19 included a sore throat, headache, fever, cough, post-nasal drip, fatigue, body aches, altered sense of taste (everything tasted extremely salty), and diminished sense of smell. After the acute phase of the illness resolved, 1 month after diagnosis, the patient continued to experience post-COVID symptoms, including severe anxiety, depression, insomnia, joint pain (hips, knees, shoulders, jaw), cognitive issues (brain fog, poor reading comprehension and endurance, word finding, and short-term memory), headaches, and a sharp decrease in libido. METHODS: Complete blood count, basic metabolic panel, coagulation values, and inflammatory biomarkers were within normal limits during this period. On chest X-ray, there was no evidence of cardiopulmonary or pleural disease. The patient also reported an intense unique headache, which was different from her migraines. This headache was a global pressure-like feeling that occurred almost daily for 2-12 h without nausea, photophobia, or phonophobia. These symptoms persisted for 3 months. The patient tried various traditional treatment options to manage her symptoms, including graded return to activity and medications. She was taking dimenhydrinate 200 mg (daily for 3 months) for insomnia during this time. Her headaches subjectively improved up to 60% maximum relief with sumatriptan 85 mg and naproxen sodium 500 mg but persisted. The patient also tried non-traditional treatments such as massage therapy and intermittent fasting with very mild to no relief. The patient participated in four sessions of chiropractic and osteopathic therapy with resulting non-enduring mild relief on day of treatment. One session of acupuncture led to a non-enduring 15%-20% improvement the day of treatment. She found the fasting and meditation only mildly helpful, and the improvement persisted only as long as the activity occurred. The patient was referred to a Long-COVID clinic but was never seen due to long waitlists (Late August/Early September). In the meantime, the patient decided to try psychedelics as a form of treatment under the guidance of a therapist who recommended a protocol of 3,4-methyle nedioxymethamphetamine (MDMA) and golden teacher psilocybin cubensis dried mushrooms. CONCLUSION AND RESULTS: The patient's first dosing session was on May 05, 2022, where she consumed 1 g of dried whole golden teacher psilocybin cubensis mushrooms from an online store. The patient subjectively reported a 20% improvement in her depression, fatigue, joint pains, and headache for 7 days. However, she also reported chills and shivering with a sensation of being cold while "coming up". The patient's second dosing session was 24 days later on May 29th where she consumed a single dose of MDMA 125 mg, 1 h later 2 g of whole dried golden teacher psilocybin cubensis mushrooms prepared in a tea, and 1 h later a second dose of 2 grams of whole dried golden teacher psilocybin cubensis mushrooms prepared in a tea. The substances were reportedly verified. The patient reported a slower build-up without shivering and reported feeling very detached from Long-COVID symptoms. The patient's experience while under the influence of MDMA and psilocybin was reported as feelings of being in a childlike state, having an intense connection to nature, and of being in an alternate reality. Though the patient experienced transient nausea and emesis 40 min after ingestion of psychedelics, she endorsed 0/10 pain within 1 h of ingestion irrespective of the nausea. After this second dosing session, the patient subjectively reported significant improvement in her post-COVID symptoms including fatigue, depression, anxiety, joint pain, and headaches. The patient was able to return to work and her cognitive function improved, allowing her to resume her PhD studies. The patient's insomnia also improved, and she was able to stop taking antihistamines. The patient's unique headache, which was different from her migraines, decreased in severity and frequency. Headache frequency reduced to approximately once per week compared with a May 2022 baseline of 5 per week. Headache duration also decreased to less than 2-4 h per attack-an improvement from the typical 8-12 h duration in May 2022. After the July dosing session, her headaches intensity remained at 30% of their former peak intensity. Overall, the patient indicated her symptom improvement was approximately 80% when asked to self-report on a scale of 0%-100%. Six weeks later (on July 16th), her head pressure returned at approximately 30% of its previous severity. After another 2 g dose of psilocybin cubensis mushrooms, her symptoms abated to 90% relief of symptoms. She was able to work part-time thereafter and return full-time in September. After several months of improvement, the patient reported experiencing an early November relapse of her post-COVID- 19 symptoms in the setting of a non-COVID- 19 flu-like illness. Her headache returned, although it was less severe and not as frequent as before. The patient decided to try another dosing session with psychedelics on November 24th. This time, 2 g of dried golden teacher psilocybin cubensis mushrooms led to a remission of her symptoms. The patient subjectively reported complete resolution of her symptoms. The patient was again able to return to work 3 days later and continue with her PhD studies. DISCUSSION: Long-COVID, also known as PASC, is a condition where individuals continue to experience symptoms of COVID-19 long after the acute phase of the illness has resolved. The symptoms of Long-COVID can be diverse and can range from mild to severe, making it challenging to manage and treat. Traditional treatment options for Long-COVID include rehabilitation, physical therapy, and medications for specific symptoms such as pain and fatigue.5 However, these treatment options may not be effective for all individuals, and there is a need for alternative treatment options. A recent review has suggested that psychedelics could be an effective treatment option for the mental health sequelae of COVID-19. Psychedelics have been traditionally used in spiritual and religious practices, but in recent years, there has been a resurgence of research on the therapeutic potential of psychedelics. Psychedelics have shown promise in the treatment of various medical conditions such as depression, anxiety, PTSD, and addiction. The mechanisms by which psychedelics could improve Long-COVID symptoms are not understood. The pathophysiology of Long-COVID symptoms include chronic neuroinflammation and neurologic dysfunction. 6 Psychedelics are known to modulate the activity of neurotransmitters such as serotonin and dopamine, leading to changes in brain connectivity and potentially increasing neural plasticity. Psychedelics activate areas of the brain that are involved in self-referential processing, emotional regulation, and alter connectivity within and between intrinsic brain networks such as the default mode network (DMN).7 It has been hypothesized that the ability of psychedelics to alter DMN connectivity infers benefit in chronic neuropathic conditions by improving efficiency of these networks. There is research showing alterations in default mode network connectivity in patients with Long-COVID symptoms.8 Other research has pointed to the effects of psychedelics on gene expression as a means of influencing synaptic plasticity and neural inflammation as well as decreasing acute phase reactants, which could underlie the sustained benefits seen in studies of depression and other chronic neuropathic conditions. Psilocybin and MDMA are not yet authorized for use in the United States by the FDA. The Drug Enforcement Agency qualified both psilocybin and MDMA as Schedule I drugs in the Controlled Substances Act, indicating their lack of acceptance for medical use and high abuse potentials.10 Common side effects of these psychedelics include headache, nausea, dizziness, anxiety, dysphoria, transient increases in blood pressure, and drug-drug interactions,11-13 though prior literature suggests that their safety profile is largely benign at lower doses. In June 2023, the FDA to release the First Draft Guidance on Clinical Trials with Psychedelic Drugs, as recent research in the medical uses of psychedelics has garnered significant attention. To date, there are no consensus guidelines for standard dosing or administration protocols, though there are several reports in the literature citing 0.143 mg/kg for chronic headaches. No prior literature was found regarding the use of MDMA or psilocybin for Long-COVID treatment; therefore, the natural history of the disease treated with psychedelics is not well-known. As with any case report, the present study is limited in its generalizability. A universal cause-effect relationship between psychedelics and Long-COVID may not be drawn, particularly given the lack of blinding, randomization, and direct oversight over psychedelics dosing protocol in this study. However, this case reinforces the need for more robust investigation with larger sample sizes into the psychedelics use for a poorly controlled chronic illness such as Long-COVID. Long-COVID is a complex condition that can be challenging to manage and treat. Traditional treatment options may not be effective for all individuals, and there is a need for alternative treatment options. We report a case of a patient using psychedelics and seeing dramatic improvement in her Long-COVID symptoms. Further research is needed to determine whether psychedelics are safe and effective for Long-COVID and to understand the potential mechanisms of action.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded. Consider also possible contributory effects interchange in vaccine products wherein a different brand of CoVID-19 vaccine was given for the 3rd dose of the patient. Based on known disease pathophysiology, the event post-acute COVID-19 syndrome is assessed as not related to BNT162B2, and more likely a complication or sequelae of the CoVID-19 infection. More
2828475 F 02/26/2025 COVID19
 PFIZER\BIONTECH
Illness Illness
sick; This is a spontaneous report received from a Consumer or other non HCP. An 88-year-old female... sick; This is a spontaneous report received from a Consumer or other non HCP. An 88-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), 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. Past drug history included: Dupixent, start date: 08Apr2022, stop date: 06Nov2024, for atopic dermatitis unspecified, reaction(s): "walking issues", notes: solution for injection of strength 300mg/2ml at a dose of 300 mg QOW subcutaneous; Dupixent, start date: 08Apr2022, stop date: 06Nov2024, for atopic dermatitis unspecified, reaction(s): "gotten really sick", notes: solution for injection of strength 300mg/2ml at a dose of 300 mg QOW subcutaneous. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information: Patient reported she had held off on taking Dupixent about 2 weeks ago due to getting a Covid shot. Patient stated it had made her very sick. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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