๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

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

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2871348 44 F FL 11/07/2025 UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 1805029
1805029
1805029
1805029
Aortic dilatation, Cardiac murmur, Chills, Computerised tomogram heart, Dyspnoea... Aortic dilatation, Cardiac murmur, Chills, Computerised tomogram heart, Dyspnoea; Echocardiogram abnormal, Fatigue, Headache, Hyperhidrosis, Mitral valve incompetence; Myalgia, Nausea, Oropharyngeal pain, Pain, Palpitations; Pulmonary valve incompetence, Pyrexia, Tricuspid valve incompetence More
Fever in excess of 101, sweating, chills, nausea, severe body aches, severe headache, sore throat, e... Fever in excess of 101, sweating, chills, nausea, severe body aches, severe headache, sore throat, extreme fatigue, muscle pain More
โœ“
2871350 43 M MI 11/07/2025 FLU3
 SANOFI PASTEUR
 UT8817NA
Extra dose administered Extra dose administered
Patient came in on 11/7/25 with his mother, who has guardianship, to receive vaccines. RN went over ... Patient came in on 11/7/25 with his mother, who has guardianship, to receive vaccines. RN went over vaccine record, name, and date of birth to confirm both clients and discussed receiving Flu and Covid-19 vaccines which mom agreed to. RN presented vaccine information statements to clients and went to retrieve vaccines. When RN prepped patient's arm and explained she was giving Flu and Covid to patient, after administration mom stated, "Oh, we actually both had Flu at pharmacy in September.". RN apologized to the client and explained she did not notice that on the vaccine record, and will report to supervisor and complete VAERS form. More
2871352 28 M CA 11/07/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0151
EW0151
EW0151
EW0151
Antiphospholipid syndrome, Chest pain, Dizziness, Dyspnoea, Epistaxis; Fatigue, ... Antiphospholipid syndrome, Chest pain, Dizziness, Dyspnoea, Epistaxis; Fatigue, Immune thrombocytopenia, Laboratory test, Magnetic resonance imaging, Pain in extremity; Platelet count decreased, Platelet transfusion, Pulmonary embolism, Rash, Thrombectomy; Thrombosis, Ultrasound scan More
pt says he started bleeding from his nose. He became tired, dizzy and developed all over body rash. ... pt says he started bleeding from his nose. He became tired, dizzy and developed all over body rash. He tolerated it for a couple of weeks but went and had labs. He received a call from doctor that his platelets levels were around 2000. He went to the ER to have a platelets transfusion but had a reaction while getting it. He was then given steroid pills. It helped for a couple of weeks but he continued to have symptoms so went back to the ER. . After being diagnosed with ITP that is now chronic, he will have to take one pill a day for the rest of his life. He was given Promacta for treating his condition. In 2023 he started have SOB. He went back to the ER about 3 times. He knew something was wrong. After the 4th visit he knew something was wrong. He was admitted for treatment for Block Flocks.. It was removed and no stent was needed. After being discharged he was given medicine. In 2024 he started having pain behind his right knee. They found block flocks and is being treated with Eliquis. He went home then had chest pains. He went back to the ER and they found that the block flocks moved from his to knee to his lungs. He is know taking another medication warfarin for the rest of his life. He also has to have labs every two weeks. His oncologist says if the pills no longer work he will need chemo. He has since been diagnosed with APS. They say he is a rare case because he has block flocks but has low platelets. Pt's family has no history of the diagnosis he has been given. More
โœ“ โœ“ โœ“
2871353 70 F NC 11/07/2025 COVID19
COVID19
 MODERNA
MODERNA
 80777-112-96
80777-112-96
Arthralgia, Asthenia, Chills, Diarrhoea, Headache; Myalgia Arthralgia, Asthenia, Chills, Diarrhoea, Headache; Myalgia
8 hours after injection: Diarrhea, headache, severe chills, weakness. 15 h ours after injection: Sev... 8 hours after injection: Diarrhea, headache, severe chills, weakness. 15 h ours after injection: Sever muscle and joint pain throughout my body making me immobile. This lasted 3+ hours. Symptoms tapered off gradually after 24-28 hours. More
2871354 48 11/07/2025 FLU3
 SANOFI PASTEUR
Computerised tomogram head normal, Diplopia, Headache, Magnetic resonance imagin... Computerised tomogram head normal, Diplopia, Headache, Magnetic resonance imaging head normal, Vision blurred More
11/5/25: Pt called to report that he was seen by Ophthalmology today. Still having double/blurry v... 11/5/25: Pt called to report that he was seen by Ophthalmology today. Still having double/blurry vision, however HAs have subside. Pt states that Ophthalmologist suggests this may be a temporary, vaccine-related inflammation of the 4th cranial nerve which contributes to the visual disturbances. P rovider referred Pt to ED for further evaluation. ED CT and MIR all wnl no stroke. Pt to f/u with Neuro opthomology and PCP not ruled out related to vaccine More
2871355 37 F VA 11/07/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 7354R
Impaired work ability, Limb injury Impaired work ability, Limb injury
Shoulder injury post vaccination, required physical therapy, modified work duty Shoulder injury post vaccination, required physical therapy, modified work duty
2871356 42 F FL 11/07/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 9jc49
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
he employee received a flu vaccine at Hospital on 11/5/25. That night, she developed swelling, pain,... he employee received a flu vaccine at Hospital on 11/5/25. That night, she developed swelling, pain, and redness at the injection site and self-medicated with Zyrtec, suspecting an allergic reaction. After symptoms persisted for over 36 hours, she visited the Employee Health Service Center on 11/7/25 and was referred to Urgent Care for further evaluation and treatment. More
2871357 27 F 11/07/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 AH2G4
Anaphylactic reaction, Anaphylaxis treatment, Intensive care Anaphylactic reaction, Anaphylaxis treatment, Intensive care
Anaphylaxis requiring multiple doses of IM epinephrine; continued with symptoms, admitted to Medical... Anaphylaxis requiring multiple doses of IM epinephrine; continued with symptoms, admitted to Medical ICU with continuous epinephrine infusion; discharged 2 days later More
โœ“ โœ“
2871359 46 F 11/07/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 LT9HP
Limb injury Limb injury
Shoulder injury post flu vaccination; continues with symptoms 2 weeks after vaccination Shoulder injury post flu vaccination; continues with symptoms 2 weeks after vaccination
2871360 0.17 M VA 11/07/2025 DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
 U8314AA
U8314AA
LX2498
LX2498
2139674
2139674
Ammonia decreased, Blood lactic acid decreased, Cyanosis, Hypotonia, Lethargy; U... Ammonia decreased, Blood lactic acid decreased, Cyanosis, Hypotonia, Lethargy; Unresponsive to stimuli; Ammonia decreased, Blood lactic acid decreased, Cyanosis, Hypotonia, Lethargy; Unresponsive to stimuli; Ammonia decreased, Blood lactic acid decreased, Cyanosis, Hypotonia, Lethargy; Unresponsive to stimuli More
Patient received vaccines on 11/6/2025 at approximately 9am and later had the adverse reaction on 11... Patient received vaccines on 11/6/2025 at approximately 9am and later had the adverse reaction on 11/6/2025 at approximately 12pm. Patient had approximately 35 minutes of lethargy, poor tone, perioral cyanosis and unresponsiveness. Patient was admitted to the hospital. More
โœ“
2871362 0.75 M MI 11/07/2025 FLU3
FLUN3
 SANOFI PASTEUR
MEDIMMUNE VACCINES, INC.

Refusal of vaccination, Wrong product administered; Refusal of vaccination, Wron... Refusal of vaccination, Wrong product administered; Refusal of vaccination, Wrong product administered More
I, myself do not have the Flu shot. And Made myself a promise that I ll never give them to my childr... I, myself do not have the Flu shot. And Made myself a promise that I ll never give them to my children either. To receive a Shot record for my child and to see he has not one but two doses of The Flu Shot is heart wrenching. I am very disappointed. Can i please get assistance on this? More
2871363 57 F CO 11/07/2025 FLU3
FLU3
PNC21
PNC21
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 U8832CA
U8832CA
Z007878
Z007878
Back pain, Dizziness, Headache, Influenza B virus test positive, Malaise; Periph... Back pain, Dizziness, Headache, Influenza B virus test positive, Malaise; Peripheral swelling, Skin warm; Back pain, Dizziness, Headache, Influenza B virus test positive, Malaise; Peripheral swelling, Skin warm More
Patient said she feel sick after the shot on the left arm, she fell the arm is swollen and have a lo... Patient said she feel sick after the shot on the left arm, she fell the arm is swollen and have a lot of heat, she start to take ibuprofen and tylenol, she had headache, backache and dizziness . Her Nurse practictioner friend at her work place told her to go to urgent care. She went to urgent care and test positive in Influenza B. , As the day she come to see me Thursday November 6, 2025 at 3:40pm, her right arm is not swollen, but it have a little heat to it. Both size of the arm felt the same not swollen and does not have any lump of any kind. More
2871366 75 F PR 11/07/2025 COVID19
RSV
 MODERNA
PFIZER\WYETH
 3052133
MN0315
Erythema, Pruritus, Skin irritation, Skin warm; Erythema, Pruritus, Skin irritat... Erythema, Pruritus, Skin irritation, Skin warm; Erythema, Pruritus, Skin irritation, Skin warm More
Area of administration presented with redness, irritation, warm, and itching for since 11/06/2025, p... Area of administration presented with redness, irritation, warm, and itching for since 11/06/2025, patient used alcohol and Vicks vapor rub in the area. She was told to stop using those medication. More
2871367 45 M TN 11/07/2025 FLU3
 SANOFI PASTEUR
 U8881BA
Hypoaesthesia, Paraesthesia Hypoaesthesia, Paraesthesia
About one hour after vaccine patient complained of leg feeling numb and tingling around his left kne... About one hour after vaccine patient complained of leg feeling numb and tingling around his left knee. No other symptoms reported. More
2871369 68 M TX 11/07/2025 COVID19
 MODERNA
Haemophagocytic lymphohistiocytosis Haemophagocytic lymphohistiocytosis
Hemophagocytic lymphohistiocytosis Hemophagocytic lymphohistiocytosis
โœ“
2871370 36 M AL 11/07/2025 FLU3
 SANOFI PASTEUR
 U8848BA
Arthralgia, Mobility decreased Arthralgia, Mobility decreased
Pt walked into clinic today (7 Nov 25) at 1405 c/o residual shoulder pain from flu vaccine that was ... Pt walked into clinic today (7 Nov 25) at 1405 c/o residual shoulder pain from flu vaccine that was administered 30 Sep 25. Pt states he had limited range of motion in the right shoulder for a couple of days. He takes motrin 800mg occasionally for back pain. Slept with an ice pack on his shoulder for multiple days after injection. Pt states his pain scale now is about a 4/10 and has full ROM. Pt states "arm feels dead, like after a hard workout." He is currently in physical therapy for his back, but they had him do arm movements today. Recommended pt take his motrin every 8 hours and follow up with PCM. More
2871372 46 F AL 11/07/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 JS74H
Erythema, Skin warm, Swelling Erythema, Skin warm, Swelling
5X2 AREA OF REDNESS, HEAT AND SWELLING 5X2 AREA OF REDNESS, HEAT AND SWELLING
2871374 55 F PA 11/07/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052835
3052835
Cough, Erythema, Injection site erythema, Injection site pruritus, Pruritus; Thr... Cough, Erythema, Injection site erythema, Injection site pruritus, Pruritus; Throat irritation More
40 minutes after injection patient experiencing redness and itching to left arm extending to left up... 40 minutes after injection patient experiencing redness and itching to left arm extending to left upper back. C/o scratchy throat with cough. Blood pressure right arm 132/84. Benadryl 25mg PO times one administered, Pepcid 10mg PO times one administered, ice applied to affected area. Patient improved after 20 minutes. More
2871376 79 F TX 11/07/2025 COVID19
 MODERNA
Injection site bruising Injection site bruising
PATIENT REPORTED BRUISING AT INJECTION SITE AFTER 30 DAYS OF RECEIVING VACCINE; SOME BRUISING WAS S... PATIENT REPORTED BRUISING AT INJECTION SITE AFTER 30 DAYS OF RECEIVING VACCINE; SOME BRUISING WAS STILL PRESENT More
2871377 49 F 11/07/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA4459
U8837CA
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Fluzone High Dose (65+) given to client under the age of 65. Pt called to be notified. Fluzone High Dose (65+) given to client under the age of 65. Pt called to be notified.
2871379 63 M TX 11/07/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0587
48823CA
Pain in extremity; Pain in extremity Pain in extremity; Pain in extremity
Patient complained of pain in left arm, mainly in shoulder on 11/6/25. He said that his left arm wa... Patient complained of pain in left arm, mainly in shoulder on 11/6/25. He said that his left arm was very sore for a few days and the pain is still there. More
2871380 33 F PA 11/07/2025 COVID19
 PFIZER\BIONTECH
 NA0846
Exposure during pregnancy, Underdose Exposure during pregnancy, Underdose
Incorrect dose of Comirnaty given, patient given the age 5 - 11 year dose and not the adult dose. P... Incorrect dose of Comirnaty given, patient given the age 5 - 11 year dose and not the adult dose. Patient is 22 weeks pregnant, EDD 03/08/2026 More
2871383 62 F MD 11/07/2025 COVID19
 PFIZER\BIONTECH
 MY9547
Muscle spasms Muscle spasms
RADIATING BACK SPASMS RADIATING BACK SPASMS
2871386 0.17 M 11/07/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Vaccine administration error- was given at 2 months when youngest approved age is 6 months old; no a... Vaccine administration error- was given at 2 months when youngest approved age is 6 months old; no adverse events occurred following vaccine administration More
2871388 75 F IN 11/07/2025 COVID19
 MODERNA
 3053777
Fall, Head injury, Syncope Fall, Head injury, Syncope
PATIENT REPORTS SYNCOPE EPISODE OVERNIGHT INTO THE NEXT MORNING. PATIENT STATES FELL AT HOME AND HIT... PATIENT REPORTS SYNCOPE EPISODE OVERNIGHT INTO THE NEXT MORNING. PATIENT STATES FELL AT HOME AND HIT HEAD ON FLOOR, WENT TO ER. PATIENT STATES HAS LONG-STANDING HYDROCEPHALUS WITH SHUNT BUT KNOWS HOW TO NAVIGATE HOME WHILE UNSTEADY ON FEET. More
2871391 82 M IA 11/07/2025 COVID19
 PFIZER\BIONTECH
 NA4452
Arthralgia, Injection site bruising, Injection site discolouration, Pain Arthralgia, Injection site bruising, Injection site discolouration, Pain
About two days after the injection the patient noticed some bruising and dark blood vessels near the... About two days after the injection the patient noticed some bruising and dark blood vessels near the injection site. The shoulder was tender, too. It looks somewhat like purpura but it continued to move down his arm over two weeks with bruising in the area as it moved down the arm. Two weeks out now and he reports his shoulder pain is gone and where the blood is darker under his skin it is tender as it moves down the arm. More
2871393 36 M FL 11/07/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 019F21A
019F21A
019F21A
032F21A
032F21A
032F21A
Allergy test positive, Computerised tomogram abnormal, Computerised tomogram hea... Allergy test positive, Computerised tomogram abnormal, Computerised tomogram head, Ear discomfort, Eustachian tube dysfunction; Facial discomfort, Hypersensitivity, Mucosal hypertrophy, Nasal congestion, Nasal obstruction; Paranasal sinus discomfort, Sinusitis, Tinnitus, Upper-airway cough syndrome; Allergy test positive, Computerised tomogram abnormal, Computerised tomogram head, Ear discomfort, Eustachian tube dysfunction; Facial discomfort, Hypersensitivity, Mucosal hypertrophy, Nasal congestion, Nasal obstruction; Paranasal sinus discomfort, Sinusitis, Tinnitus, Upper-airway cough syndrome More
After receiving the COVID-19 vaccination, I developed persistent nasal congestion, ear fullness, sin... After receiving the COVID-19 vaccination, I developed persistent nasal congestion, ear fullness, sinus pressure, and intermittent tinnitus within a few days. The symptoms gradually worsened and were accompanied by allergic-type reactions, including nasal blockage, facial pressure, and postnasal drip. More
โœ“
2871394 11 F 11/07/2025 COVID19
 PFIZER\BIONTECH
 NA4459
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Wrong dosage given 12 and above. Wrong dosage given 12 and above.
2871396 14 M MN 11/07/2025 COVID19
 MODERNA
 3052860
Underdose Underdose
Patient came in for WCC Dad requested he receive the Covid and Flu vaccine. I mistakenly gave Patien... Patient came in for WCC Dad requested he receive the Covid and Flu vaccine. I mistakenly gave Patient a Pediatric Covid vaccine instead of an adult vaccine. After talking to CDC on 11/6/25 guidelines changed on 11/4/25 and patient should have the updated adult dose ASAP. I called parent who did not wish to have his son come back for the adult Covid and thought with getting the Flu vaccine also he would be fine for the year. I did tell him to let me know if he changes his mind. More
2871397 49 F TX 11/07/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FC3183
FC3183
FC3183
FC3183
FC3183
FC3183
FC3183
Antiphospholipid antibodies, Antiphospholipid syndrome, Arthralgia, Asthenia, Ba... Antiphospholipid antibodies, Antiphospholipid syndrome, Arthralgia, Asthenia, Balance disorder; Brain fog, Cardiac monitoring abnormal, Cardiolipin antibody positive, Chest discomfort, Chest pain; Cold sweat, Dizziness, Dyspnoea, Echocardiogram normal, Electrocardiogram normal; Exercise tolerance decreased, Fatigue, Flushing, Headache, Heart rate increased; Hyperhidrosis, Inappropriate sinus tachycardia, Livedo reticularis, Magnetic resonance imaging head, Magnetic resonance imaging spinal; Magnetic resonance imaging thoracic, Memory impairment, Myalgia, Nausea, Neck pain; Nerve conduction studies, Small fibre neuropathy, Tachycardia, Vomiting More
Tachycardia; frequent episodes of chest pain and shortness of breath (never experienced before) EKG ... Tachycardia; frequent episodes of chest pain and shortness of breath (never experienced before) EKG normal in office visit; was told it was anxiety; Followed up and was dismissed; Tachycardia episode (elevated for over 3 hours); May 2024 - was evaluated. diagnosed with inappropriate sinus tachycardia 2021 to present ----Exercise intolerance: Reduced strength, balance and endurance in general - lightheadedness when standing up from lying down; nausea, vomiting; Abnormal sweating, face flushing and cold clammy hands; Elevated heart rate and chest pain/tightness with activity Cycles of joint and muscle pain, more fatigue and much longer recovery periods after activity or standing Memory issues/brain fog Joint pain feet/ankles, wrists Chronic headaches and neck pain -Antiphospholipid syndrome Dx by dermatologist; livedo reticularis; high IgM aCL More
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2871399 79 F FL 11/07/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA2589
u8859BA
Pain in extremity, X-ray normal; Pain in extremity, X-ray normal Pain in extremity, X-ray normal; Pain in extremity, X-ray normal
pt stated that day after the vaccination, pt's arms has sored and painful. pt went to see ortho... pt stated that day after the vaccination, pt's arms has sored and painful. pt went to see orthopedics after 2 weeks because pain was on/off upon movement. MD did x-rays with negative result. pt still having pain after vaccination, pain in whole arm going down, subsides but comes back . More
2871409 33 F IA 11/07/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 99H9A
Extra dose administered Extra dose administered
Additional doses of FluLaval given; This non-serious case was reported by a other health professiona... Additional doses of FluLaval given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 33-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 99H9A, expiry date 30-JUN-2026) for prophylaxis. Concomitant products included Influenza vaccine inact split 3v (Flulaval). On 30-OCT-2025, the patient received the 2nd dose of FluLaval 2024-2025 season. On 30-OCT-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: Additional doses of FluLaval given). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-OCT-2025 The clinical manager reported that a patient accidentally received 2 doses of Flulaval within one month. The vaccine administration facility was the same as primary reporter. More
2871417 F 11/07/2025 COVID19
 MODERNA
 8080433
COVID-19, Pulmonary embolism, Thrombosis COVID-19, Pulmonary embolism, Thrombosis
Patient had blood clots in lungs/Patient had it for a while. It was in patient's leg, went to p... Patient had blood clots in lungs/Patient had it for a while. It was in patient's leg, went to patient's lungs; Blood clot was in my leg/I'm sure I've had it for a while. It was in my leg; It could have been related to the COVID; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Patient had blood clots in lungs/Patient had it for a while. It was in patient's leg, went to patient's lungs) and THROMBOSIS (Blood clot was in my leg/I'm sure I've had it for a while. It was in my leg) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080433) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Suspect product included Pre-filled Syringe injection (batch no. 8080433) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot no: 031L20A, Dose no: 1, dosage: 999 mL) on 18-Feb-2021, Moderna COVID-19 Vaccine (Lot no: 040A21A, Dose no: 2, dosage: 999 mL) on 23-Mar-2021, Moderna COVID-19 Vaccine (Lot no:058H21A, Dose no: 3, dosage: 0.25 mL) on 02-Dec-2021, Spikevax (Lot no:013B22A, Dose no: 4, dosage: 0.25 mL) on 25-Jul-2022, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Lot no:010H22A, Dose no: 5, dosage: 0.5 mL) on 12-Dec-2022, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Lot no:AS7185B, Dose no: 6, dosage: 0.5 mL) on 03-Jun-2023, SPIKEVAX 2023-2024 (Lot no:3030592, Dose no: 7 and dosage: 0.5 mL) on 13-Nov-2023. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), SPIKEVAX 2023-2024 and Spikevax. Concomitant products included Apixaban (Eliquis) for Thrombosis. On 06-Sep-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 16-May-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PULMONARY EMBOLISM (Patient had blood clots in lungs/Patient had it for a while. It was in patient's leg, went to patient's lungs) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced THROMBOSIS (Blood clot was in my leg/I'm sure I've had it for a while. It was in my leg) (seriousness criterion medically significant) and COVID-19 (It could have been related to the COVID). The patient was hospitalized on 16-May-2025 due to PULMONARY EMBOLISM. The patient was treated with Benzocaine, Benzyl nicotinate, Heparin sodium (Heparin) on 17-May-2025 for Thrombosis, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Patient had blood clots in lungs/Patient had it for a while. It was in patient's leg, went to patient's lungs) and THROMBOSIS (Blood clot was in my leg/I'm sure I've had it for a while. It was in my leg) was resolving and COVID-19 (It could have been related to the COVID) outcome was unknown. No concomitant medications were reported. In May 2025, patient was diagnosed with blood clots in her lungs. Doctors ran many tests but couldn't find a clear reason for the clots. She wondered if they might be related to COVID or the vaccines. She was frustrated because her doctors hadn't given her clear advice, and even her pharmacist couldn't help. She went to the emergency room on 16-May-2025, and was told the clot started in her leg and traveled to her lungs. After being treated with a heparin drip for a couple of days and started with Eliquis (5 mg twice daily), at night, possibly on May 18 or even May 19, but she was not certain of the exact date, which she now took permanently as advised by her hematologist Her last Moderna vaccine was given in 2024. She had received Moderna vaccines and had a record of 8 doses. She was still unsure if it's safe to get another booster and was looking for guidance. Patient had taken several Moderna vaccines, the original, and then 7 or 8 booster doses.; Reporter's Comments: Company comment: Concurrent COVID 19 is a confounder. Considering implausible temporal association with events occurring approx. 9 months after latest dose of Spikevax causality is assessed as not related for pulmonary embolism and thrombosis. The benefit-risk relationship of product is not affected by this report. More
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2871418 59 M 11/07/2025 COVID19
 MODERNA
 027B21A
Influenza, Pain assessment, Polymyalgia rheumatica Influenza, Pain assessment, Polymyalgia rheumatica
polymyalgia rheumatica, right shoulder froze up, pain from shoulder to neck, couldn't move neck... polymyalgia rheumatica, right shoulder froze up, pain from shoulder to neck, couldn't move neck, spread to whole body, every muscle and every joint in body hurt; got so sick for 2 weeks, the worst flu; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia rheumatica, right shoulder froze up, pain from shoulder to neck, couldn't move neck, spread to whole body, every muscle and every joint in body hurt) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 033C2BA) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Spinal operation (spinal surgery). Concurrent medical conditions included Ulcerative colitis (prior to ever receiving a Covid vaccine, otherwise, "in very good shape"). On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia rheumatica, right shoulder froze up, pain from shoulder to neck, couldn't move neck, spread to whole body, every muscle and every joint in body hurt) (seriousness criterion medically significant) and INFLUENZA (got so sick for 2 weeks, the worst flu). The patient was treated with Sarilumab (Kevzara) at an unspecified dose and frequency; Prednisone in 2024 at a dose of 15 milligram; Prednisone in 2025 at a dose of 7 milligram and Prednisone in 2025 at a dose of 2 milligram. In 2021, INFLUENZA (got so sick for 2 weeks, the worst flu) had resolved. At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia rheumatica, right shoulder froze up, pain from shoulder to neck, couldn't move neck, spread to whole body, every muscle and every joint in body hurt) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 9 to 10 every day. No concomitant medications provided by the reporter. It was reported that the patient had complications post vaccination. It was reported that the patient was medically retired last year because of vaccination. It was reported that the post vaccination the patient was sick for two weeks. And the patient had the worst flu symptom he ever had in his life. After about 2.5 weeks or 3 weeks the patient right shoulder (where he had the shot injected) froze up. The patient went to the hospital. However, the doctor had no idea about what was wrong with the patient arm and the patient pain continued. A couple months later the patient went back to the hospital, and the doctor could not figure out what was wrong with his arm. The pain started from the shoulder to the patient and then the pain started into his neck, and the patient was unable move his neck. So, the patient went to the doctors, and they told him the pain was because of his spinal surgery. Further it was reported that for the patient the pain went to the neck, and it went down to the hip of the patient. The patient went to another doctor, and they told him the pain was because of his hip and doctor suggested to a need of new hip joint for the patient. The patient had multiple doctors visit due to his pain and the pain was spread for the patient in his whole body. It was reported that the patient every muscle and every joint in his body was hurt. It was reported that on 13-Jul-2021 the patient completely Paralyzed due to Polymyalgia rheumatica. The patient required a massive dose of steroids as treatment medication. The patient was on treatment medication Kevzara and it was reported that if the patient does not have the treatment for medication, then the patient going to be paralyzed. Then the patient was on 15 mg of prednisone. And within a few days, the patient started walking and the patient felt great. And then the prednisone dose was decreased for the patient. And the dose dropped down 1 mg every month for the patient. Then the patient symptoms such as aches and the pain were back. One month ago, the patient went to a brand-new rheumatologist. The rheumatologist told the patient put on 7 mg of prednisone. And the rheumatologist told to the patient to drop it down to 5 mg, then stopped, because he needs to stop the prednisone. The patient should not be on be on prednisone therapy. Hence the prednisone was going down 2 mg. Within 5 days, the patient was paralyzed again. And then he went back to the rheumatologist. Rheumatologist told him to go back to 10 mg, and that was where the patient was at right now.; Reporter's Comments: Causality for Influenza is assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report. More
2871419 78 M 11/07/2025 COVID19
 MODERNA
Body temperature, Cough, Pyrexia Body temperature, Cough, Pyrexia
cough; took his temperature and it was 100.1F; This spontaneous case was reported by a consumer and ... cough; took his temperature and it was 100.1F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and PYREXIA (took his temperature and it was 100.1F) in a 78-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Cough (on and on since June, coughs at night) and Phlegm (prescribed him prednisone to help alleviate the issue.). Concomitant products included Prednisone for Phlegm. On 28-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 29-Oct-2025, the patient experienced COUGH (cough) and PYREXIA (took his temperature and it was 100.1F). In October 2025, COUGH (cough) and PYREXIA (took his temperature and it was 100.1F) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2025, Body temperature: 100.1 F. The next day, after receiving his vaccine, the patient started coughing (29-Oct-2025). He then added that when he got up, he took his temperature, and it was 100.1F. On 30-Oct-2025, he felt much better. He was not coughing, compared to the previous day when he was not able to talk because of the cough he noted that he did not cough at all during the call. The patient had been having a cough on and off since June, and he coughed a lot at night. He saw an HCP 3 weeks ago, who noted hearing phlegm and prescribed him prednisone to help alleviate the issue. He was in the study for the vaccine in 2020 and found out he had taken the real vaccine in the study. He had stuck to Moderna ever since. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. More
2871420 71 F TX 11/07/2025 COVID19
 MODERNA
COVID-19, Vaccination failure COVID-19, Vaccination failure
COVID; mNEXSPIKE 25-26 does not work; This spontaneous case was reported by a consumer and describes... COVID; mNEXSPIKE 25-26 does not work; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and VACCINATION FAILURE (mNEXSPIKE 25-26 does not work) in a 71-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 17-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced COVID-19 (COVID) and VACCINATION FAILURE (mNEXSPIKE 25-26 does not work). At the time of the report, COVID-19 (COVID) had not resolved and VACCINATION FAILURE (mNEXSPIKE 25-26 does not work) outcome was unknown. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as unknown. No concomitant medication was reported. It was reported that mNEXSPIKE 25-26 did not work. The patient and her husband both received this vaccine and subsequently caught COVID on or around 17-Oct-2025. Two weeks later, they were still very sick and were coughing up mucus It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. This case was linked to MOD-2025-790818 (E2B Linked Report).; Reporter's Comments: Company Comment: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: MOD-2025-790818:Original Case Number : MOD-2025-790809 More
2871421 76 F 11/07/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Immunisation reaction, Myalgia, Product administered at inappropriate site; Immu... Immunisation reaction, Myalgia, Product administered at inappropriate site; Immunisation reaction, Myalgia, Product administered at inappropriate site More
received Covid shots in the hip and had little reaction; little reaction (mostly just muscle sore); ... received Covid shots in the hip and had little reaction; little reaction (mostly just muscle sore); received Covid shots in the hip; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (received Covid shots in the hip and had little reaction), MYALGIA (little reaction (mostly just muscle sore)) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received Covid shots in the hip) in a 76-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Concurrent medical conditions included Muscle disorder. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (received Covid shots in the hip and had little reaction), MYALGIA (little reaction (mostly just muscle sore)) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received Covid shots in the hip). At the time of the report, IMMUNISATION REACTION (received Covid shots in the hip and had little reaction), MYALGIA (little reaction (mostly just muscle sore)) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received Covid shots in the hip) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not reported. Patient had been unable to take shots in the arm for most of her life due to the muscle reaction. It seems that there were probably many more people unable to get shots in the arm due to muscle and/or nerve reactions. She received Covid shots in the hip and had little reaction also had been getting flu shots in the hip for years with little reaction (mostly just muscle sore). It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. More
2871422 76 F IN 11/07/2025 COVID19
 MODERNA
Fatigue, Pain, Pyrexia Fatigue, Pain, Pyrexia
whole body was aching all over/sore; low grade fever; tired; This spontaneous case was reported by a... whole body was aching all over/sore; low grade fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body was aching all over/sore), PYREXIA (low grade fever) and FATIGUE (tired) in a 76-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (High Blood pressure). Past adverse reactions to the above products included Blood pressure high with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Blood pressure high (having high blood pressure). On 02-Nov-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 02-Nov-2025, the patient experienced PAIN (whole body was aching all over/sore), PYREXIA (low grade fever) and FATIGUE (tired). At the time of the report, PAIN (whole body was aching all over/sore), PYREXIA (low grade fever) and FATIGUE (tired) was resolving. The last time the consumer had the past vaccine, and the consumer had experienced this every time. She believed she started with Pfizer and not sure when she started Moderna. No concomitant medications were provided. The patient received the mNEXSPIKE on 02-Nov-2025 and, after that her whole body was aching all over, she believed she had a low-grade fever but was so sore and was tired to get out of bed to take her temperature. It was two days, and she started feeling much better. It was unknown if the patient experienced any additional symptoms/events. It was unknown if the patient had any risk factor. There were no lab data/results available. No treatment medication was provided. More
2871423 67 F WI 11/07/2025 COVID19
COVID19
 MODERNA
MODERNA

Fatigue, Headache, Vaccination site erythema, Vaccination site mass, Vaccination... Fatigue, Headache, Vaccination site erythema, Vaccination site mass, Vaccination site pain; Vaccination site warmth More
Large, red, hot and painful goose egg lump at injection site. Severe fatigue, headache.; Large, red,... Large, red, hot and painful goose egg lump at injection site. Severe fatigue, headache.; Large, red, hot and painful goose egg lump at injection site.; Large, red, hot and painful goose egg lump at injection site; Large, red, hot and painful goose egg lump at injection site.; Severe fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Large, red, hot and painful goose egg lump at injection site. Severe fatigue, headache.), VACCINATION SITE MASS (Large, red, hot and painful goose egg lump at injection site.), VACCINATION SITE PAIN (Large, red, hot and painful goose egg lump at injection site), VACCINATION SITE ERYTHEMA (Large, red, hot and painful goose egg lump at injection site.) and FATIGUE (Severe fatigue) in a 67-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Celiac disease. On 21-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 22-Sep-2025, the patient experienced VACCINATION SITE WARMTH (Large, red, hot and painful goose egg lump at injection site. Severe fatigue, headache.), VACCINATION SITE MASS (Large, red, hot and painful goose egg lump at injection site.), VACCINATION SITE PAIN (Large, red, hot and painful goose egg lump at injection site), VACCINATION SITE ERYTHEMA (Large, red, hot and painful goose egg lump at injection site.), FATIGUE (Severe fatigue) and HEADACHE (headache). On 14-Oct-2025, VACCINATION SITE WARMTH (Large, red, hot and painful goose egg lump at injection site. Severe fatigue, headache.), VACCINATION SITE MASS (Large, red, hot and painful goose egg lump at injection site.), VACCINATION SITE PAIN (Large, red, hot and painful goose egg lump at injection site), VACCINATION SITE ERYTHEMA (Large, red, hot and painful goose egg lump at injection site.), FATIGUE (Severe fatigue) and HEADACHE (headache) had resolved. The concomitant medication was not reported by the reporter. The patient did not have any additional medical history, concomitant disease or risk factor. The patient did not experience any additional symptoms or events. There was no lab data or results available. The treatment medication was not reported by the reporter. More
2871424 73 F 11/07/2025 COVID19
 MODERNA
Headache, Vaccination site pustule Headache, Vaccination site pustule
pretty bad headache; spot on my arm/white in the center and red around that white dot; This spontane... pretty bad headache; spot on my arm/white in the center and red around that white dot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PUSTULE (spot on my arm/white in the center and red around that white dot) and HEADACHE (pretty bad headache) in a 73-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID-19 shot. Past adverse reactions to the above products included No adverse effect with COVID-19 shot. Concurrent medical conditions included Rotator cuff tear. On 24-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced VACCINATION SITE PUSTULE (spot on my arm/white in the center and red around that white dot). On 25-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced HEADACHE (pretty bad headache). In 2025, HEADACHE (pretty bad headache) had resolved. At the time of the report, VACCINATION SITE PUSTULE (spot on my arm/white in the center and red around that white dot) was resolving. No concomitant medication was reported. Patient had unsure when she took the vaccine either on Thursday 23-Oct-2025 or Friday 24-Oct-2025. Later confirmed, she had received her vaccine about a week ago on Friday, it had been a little over a week, and patient still had a spot on her arm. It was white in the center and red around that white dot, and patient never had a reaction to any of the other COVID shots. This was the only thing. Patient was not sure which Moderna COVID19 vaccine she received (mnexspike or Spikevax). It was still there, but it looked better. The day after, patient had a pretty bad headache but it went away but patient knew those were normal side effects so that did not bother her, but these never happened and patient had all the shots. Patient also had a torn rotator cuff and would get a steroid injection on 05-Nov-2025. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. More
2871425 M 11/07/2025 COVID19
 MODERNA
 3044069
Arthralgia, Headache, Myalgia Arthralgia, Headache, Myalgia
headache; joint pain; muscle ache/a long reaction of a lot of muscle and joint pain; This spontaneou... headache; joint pain; muscle ache/a long reaction of a lot of muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle ache/a long reaction of a lot of muscle and joint pain) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3044069) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3044069) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Patient had been taking the Moderna vaccine whenever it has been available.). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. On 11-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 11-Apr-2025, the patient experienced HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle ache/a long reaction of a lot of muscle and joint pain). The patient was treated with Paracetamol (Tylenol) from 2025 to 2025 at an unspecified dose and frequency and Ibuprofen (Advil) from 2025 to 2025 at an unspecified dose and frequency. In June 2025, HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle ache/a long reaction of a lot of muscle and joint pain) had resolved. Concomitant medication was not provided. It was reported that the patient had developed side effects such as headache, joint pain, and muscle ache following vaccination with Spikevax. These symptoms reportedly lasted for approximately two months. The patient was now inquiring about the differences between Spikevax and mNEXSPIKE for the 2025/2026 vaccination season, as he was considering options for his next COVID-19 vaccination. The patient wanted to confirm whether mNEXSPIKE contained a lower dose than Spikevax. It was explained that the patient had consistently received the Moderna vaccine whenever it was available, and the most recent dose had been administered in April Spikevax 2023 or 2024, depending on availability at the time. It was inquired about the differences between the earlier versions and the Spikevax 2025๏ฟฝ2026 formulation. The patient wanted to determine whether there was something different about the Spikevax dose he had received, and whether similar differences existed in mNEXSPIKE that might explain or predict a similar reaction. It was noted that the basic ingredients appeared to remain consistent across the older vaccines, Spikevax, and mNEXSPIKE, and that the major differences seemed to lie in the mRNA sequence, dosage, and variant targeted. It was also asked whether the Spikevax dose patient received had the same dosage as previous vaccines or if it had been higher. They had been trying to understand whether the April dose had targeted a new variant and whether that could explain the prolonged muscle and joint pain he experienced for two months afterward. They were unsure if this reaction was a one-off event or a sign of how he might respond to future doses. Additionally, he had asked whether the body typically reacted to the variant encoded in the mRNA or to the other ingredients in the vaccine. He had expressed curiosity about whether the reaction was due to the mRNA variant or excipients, and whether non-mRNA vaccines might be a better alternative and also asked if Spikevax was simply a new name for the older vaccines and stated her belief that mNEXSPIKE had a weaker dosage. He had concluded that Spikevax might be the same as what had been available in 2022 or 2023, just under a new name. It was unknown if the patient experienced any additional symptoms or events. The patient had been advised by his healthcare provider to take Tylenol and Advil for two months. He had discontinued the medications once the symptoms had subsided. Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2025: Follow-up received and non-significant information includes medical history updated, updated reporter details and updated narrative. More
2871427 11/07/2025 COVID19
 PFIZER\BIONTECH
Headache, Influenza, Myalgia, Somnolence Headache, Influenza, Myalgia, Somnolence
flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or ot... flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790487 (Moderna). A 69-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Headache", "Flu", "Muscle ache", "Sleepiness"; Bnt162b2 nos (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "Headache", "Flu", "Muscle ache", "Sleepiness"; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization, reaction(s): "Headache", "Flu", "Muscle ache", "Sleepiness". The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; HEADACHE (non-serious), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness". Additional information: The reporter stated that patient has received 6 doses of the Pfizer COVID vaccine and had a reaction every time. The reporter states that patient would be sick for a day or two and it felt like the flu with muscle aches, headache, sleepiness and everything. The reporter states that patient is not looking forward to getting the vaccine, but on the flip side has never had COVID. The reporter states that even had COVID in the same house so feels like it works. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2871434 47 F DE 11/07/2025 COVID19
 PFIZER\BIONTECH
Menstruation delayed Menstruation delayed
The patient has not gotten period. It felt like it was coming prior to vaccination(cramps) but she h... The patient has not gotten period. It felt like it was coming prior to vaccination(cramps) but she have had delayed onset; This is a spontaneous report received from a Consumer or other non HCP. A 47-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Oct2025 at 09:30 as dose 1 , single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Oct2004. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 29Oct2025, outcome "not recovered", described as "The patient has not gotten period. It felt like it was coming prior to vaccination(cramps) but she have had delayed onset". Therapeutic measures were not taken as a result of menstruation delayed. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information: The patient menstrual cycle was regular and usually occurred every 27 to 29 days was due on the day of her vaccination, but as of 04Nov2024 had not gotten period. it had felt like it was coming prior to vaccination (cramps), but there was a delayed onset. More
2871435 74 M FL 11/07/2025 COVID19
RSV
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Blood test, Malaise, Movement disorder, Muscular weakness; Blood test, Malaise, ... Blood test, Malaise, Movement disorder, Muscular weakness; Blood test, Malaise, Movement disorder, Muscular weakness More
he couldn't push off of the chair as he was sitting on the couch; he was not able to move the c... he couldn't push off of the chair as he was sitting on the couch; he was not able to move the chair this morning as his muscles are so weak right now.; by 5 p.m. he was not feeling quite right, but wasn't feeling horrible; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 74-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Nov2025 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years intramuscular for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 04Nov2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for immunisation. The patient's relevant medical history included: "Congestive heart failure" (unspecified if ongoing). Concomitant medication(s) included: PLAVIX; ELIQUIS; METOPROLOL; FINASTERIDE; ATORVASTATIN. Vaccination history included: Moderna vaccines (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 04Nov2025 at 17:00, outcome "recovering", described as "by 5 p.m. he was not feeling quite right, but wasn't feeling horrible"; MOVEMENT DISORDER (non-serious) with onset 05Nov2025, outcome "not recovered", described as "he couldn't push off of the chair as he was sitting on the couch"; MUSCULAR WEAKNESS (non-serious) with onset 05Nov2025, outcome "not recovered", described as "he was not able to move the chair this morning as his muscles are so weak right now.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, movement disorder, muscular weakness. Additional information: The patient stated that he took the Comirnaty vaccine yesterday around 11 a.m. in which he was fine after the vaccine. The patient stated by 5 p.m. he was not feeling quite right, but wasn't feeling horrible. He stated this morning around 6 or 7, he wasn't feeling bad when he got up, however he couldn't push off of the chair as he was sitting on the couch. He was not able to move the chair this morning as his muscles are so weak right now. The patient provided that he was still experiencing this problem. He asked how long will it take to get rid of the symptoms. He stated that he did not have any other symptoms. He provided that he had previous Moderna vaccines and have never had this issue. The patient got a COVID shot (Comirnaty) yesterday at about 11 o'clock in the morning and progressively started feeling symptoms by 5 o'clock last night. They were not horrible but anyway. O5Nov2025 morning his muscles were so weak, he couldn't even push off a chair. Asking if its that part of symptoms. Treatment for the event was Tylenol, 500 milligrams, each, he took two, orally. Severity: Consumer stated, "Improved." He took RSV vaccine on same day to prevent respiratory tract problem. The information on the batch/lot number for BNT162b2 omicron (lp.8.1), rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2871436 M 11/07/2025 COVID19
 PFIZER\BIONTECH
Hypersensitivity Hypersensitivity
allergic reaction; This is a spontaneous report received from a Consumer or other non HCP. A male p... allergic reaction; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergic reaction". Additional information: Reported as, he had an allergic reaction to the Pfizer covid vaccine back in 2021 and he was trying to figure out how much polyethylene glycol was in the vaccine back then. He does not know how relevant it would be 4 years later. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2871437 F FL 11/07/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Alopecia, Bone disorder, Breast cancer, Neuropathy peripheral, Pain; Weight, Wei... Alopecia, Bone disorder, Breast cancer, Neuropathy peripheral, Pain; Weight, Weight decreased More
i was diagnosed with breast cancer 4 months after i took the Pfizer vaccines.; neuropathy; bone issu... i was diagnosed with breast cancer 4 months after i took the Pfizer vaccines.; neuropathy; bone issues; aches; loss of hair; loss of hair, weight; The initial case was missing the following minimum criteria: Unspecified Product. Upon receipt of follow-up information on 03Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 55-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: BREAST CANCER (hospitalization, medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "i was diagnosed with breast cancer 4 months after i took the Pfizer vaccines."; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy"; BONE DISORDER (non-serious), outcome "unknown", described as "bone issues"; PAIN (non-serious), outcome "unknown", described as "aches"; ALOPECIA (non-serious), outcome "unknown", described as "loss of hair"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "loss of hair, weight". The patient was hospitalized for breast cancer (start date: 30Nov2021). The patient underwent the following laboratory tests and procedures: Weight: Weight loss. Therapeutic measures were taken as a result of breast cancer. Treatment included chemo from 30Nov2021 to 20Aug2023, radiation and excision (the patient lost both breasts). The patient took anastrozole for breast cancer. The patient was diagnosed with breast cancer 4 months after she took the Pfizer vaccines. She had cancer side effects, bones issues, neuropathy and much more. She was suffering with neuropathy, daily aches (a great deal of pain), bone issues, loss of hair, weight which she was dealing daily. When she could not eat because of chemo, she had to keep trying different things: vitamins, foods, drinks, etc.Her mental health and her daughters had not been the same. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500217085 Same reporter, drug and similar event, different patient.; More
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2871438 F 11/07/2025 COVID19
 PFIZER\BIONTECH
Nausea Nausea
nausea; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A fema... nausea; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: Bnt162b2 (Dose number unknown, Single), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown". Additional information: she got all of the Pfizer Covid vaccines, and she's been having extreme nausea. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2871439 F 11/07/2025 COVID19
 PFIZER\BIONTECH
Lymphoedema Lymphoedema
lymphedema in one arm. It's mild; This is a spontaneous report received from a Consumer or othe... lymphedema in one arm. It's mild; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mastectomy", start date: 2008 (not ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHOEDEMA (non-serious) with onset 2025, outcome "unknown", described as "lymphedema in one arm. It's mild". Additional information: Reporter stated that she has been getting the updated Covid-19 vaccine and she has lymphedema in one arm. It's mild. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2871440 M 11/07/2025 COVID19
 PFIZER\BIONTECH
Brain fog, COVID-19, Memory impairment Brain fog, COVID-19, Memory impairment
Patient reported extreme brain fog; long COVID like symptoms; memory issues for a 1 week period; Thi... Patient reported extreme brain fog; long COVID like symptoms; memory issues for a 1 week period; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 70-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: Covid-19 vaccine (Primary series of Immunization completed; Unknown Manufacturer), for Immunization. The following information was reported: BRAIN FOG (non-serious) with onset 2025, outcome "unknown", described as "Patient reported extreme brain fog"; COVID-19 (non-serious) with onset 2025, outcome "unknown", described as "long COVID like symptoms"; MEMORY IMPAIRMENT (non-serious) with onset 2025, outcome "unknown", described as "memory issues for a 1 week period". Additional information: Patient reported extreme brain fog, and long COVID like symptoms including memory issues for a 1 week period following receiving the Pfizer vaccine for COVID. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2871441 11/07/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Back pain, Headache, Insomnia; Back pain, Headache, Insomnia Back pain, Headache, Insomnia; Back pain, Headache, Insomnia
patient experienced BACK PAIN (lower backache); INSOMNIA (couldn'tsleep); HEADACHE (terrible he... patient experienced BACK PAIN (lower backache); INSOMNIA (couldn'tsleep); HEADACHE (terrible headaches); This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790767 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single intramuscular for covid-19 prophylaxis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "patient experienced BACK PAIN (lower backache)"; INSOMNIA (non-serious), outcome "unknown", described as "INSOMNIA (couldn'tsleep)"; HEADACHE (non-serious), outcome "unknown", described as "HEADACHE (terrible headaches)". Additional information: It was reported that the patient had a bad reaction to all the Covid vaccines that has gotten before (that includes the Moderna and the Pfizer Covid vaccines) with terrible headaches, lower backache was so bad for the patient and the patient unable to sleep. So, the patient always dreaded going to get a Covid vaccine. The patient never had any reaction to any vaccine except the Covid vaccines. No treatment medications were reported. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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