🏥 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 💀 🏥 🚑 ♿ ⚠️
2870238 3 F VA 11/03/2025 FLUC4
FLUC4
 SEQIRUS, INC.
SEQIRUS, INC.
 415014
415014
Abdominal pain upper, Asthenia, Dizziness, Fatigue, Flushing; Hyperhidrosis, Let... Abdominal pain upper, Asthenia, Dizziness, Fatigue, Flushing; Hyperhidrosis, Lethargy, Pallor More
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: stomach ... Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: stomach ache-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: Within 5-10 mins pt was flushed/pale, felt faint, weakness/fatigue, sweaty on neck. denies swelling, itchiness, rash. gave patient apple juice and water and had her lay down with feet elevated. After 30 mins, patient started to get color back and some physical strength back and able to walk around. Advised mom to have benadryl and tylenol handy at home and may go to urgent care for peace of mind if she wishes. More
2870239 23 F CT 11/03/2025 FLUR4
FLUR4
 PROTEIN SCIENCES CORPORATION
PROTEIN SCIENCES CORPORATION
 U8832BA
U8832BA
Abdominal pain, Abdominal pain upper, Cold sweat, Hyperhidrosis, Syncope; Unresp... Abdominal pain, Abdominal pain upper, Cold sweat, Hyperhidrosis, Syncope; Unresponsive to stimuli More
Systemic: Abdominal Pain-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Cold sweats/cla... Systemic: Abdominal Pain-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Cold sweats/clammy, diaphoresis-Medium, Additional Details: Patient returned to clinic approx 30 min after receiving vaccine with diaphoresis and complaints of severe stomach cramping. EMS was notified and pt transported to ED. While waiting for EMS to arrive, pt reported that she fainted in her car before coming back inside. More
2870241 75 F NC 11/03/2025 COVID19
 PFIZER\BIONTECH
 na4452
Joint injury Joint injury
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium
2870242 82 M CA 11/03/2025 FLUA4
FLUA4
 SEQIRUS, INC.
SEQIRUS, INC.
 407274
407274
Chest discomfort, Feeling abnormal, Flushing, Hyperhidrosis, Muscle tightness; P... Chest discomfort, Feeling abnormal, Flushing, Hyperhidrosis, Muscle tightness; Pain More
Systemic: back/lung tightness-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Patient... Systemic: back/lung tightness-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Patient came back to pharmacy 5-10 mins after receiving Fluad vaccine stating he "felt weird". We had patient sit and symptoms quickly progressed to what looked like excruciating pain. 911 was called. Patient not able to communicate well due to pain but described it as "tightness around his spine/back", later adding "tightness in his lungs". Confirmed no tightness in throat or trouble breathing. Patient alert and conscious when taken by EMS but still visibly in severe pain. More
2870244 102 NY 11/03/2025 FLUA4
 SEQIRUS, INC.
 407274
Injection site pain, Joint injury, Pain, Sleep disorder Injection site pain, Joint injury, Pain, Sleep disorder
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: Patient cam... Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: Patient came into the pharmacy on 10/30/2025 stating she was woken up in the middle of the night with extreme pain in the left arm radiating from her shoulder down to her elbow and occasionally up toward her neck. She can move her arm side to side with limited range and can not lift her arm. She states the pain is extreme., Other Vaccines: VaccineTypeBrand: fluad; Manufacturer: sequris; LotNumber: 407274; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN More
2870246 1.92 M CO 11/03/2025 FLU3
 SEQIRUS, INC.
 AX9142A
Incorrect dose administered Incorrect dose administered
Medication administration error - Afluria 0.5 ml administered. Unknown is patient had any adverse r... Medication administration error - Afluria 0.5 ml administered. Unknown is patient had any adverse reactions. More
2870247 72 F VA 11/03/2025 COVID19
 PFIZER\BIONTECH
Aphasia, Blood pressure increased, Cognitive disorder, Vomiting Aphasia, Blood pressure increased, Cognitive disorder, Vomiting
i got my shot at noon that friday, about 9 oclock that night i started throwing up. The next morning... i got my shot at noon that friday, about 9 oclock that night i started throwing up. The next morning my neighbor called me and i couldnt put my words together and so she came over and she called 911 and my blood pressure went up to 224/90 and my brain was just not working. I was then in the hospital for 4 days. More
✓
2870248 4 M NJ 11/03/2025 COVID19
 MODERNA
Urticaria Urticaria
My son developed full-body hives exactly two weeks after receiving the vaccine. He has never had hiv... My son developed full-body hives exactly two weeks after receiving the vaccine. He has never had hives or a vaccine reaction before. He still has the hives as of Nov. 3, 2025 and has been instructed by his dermatologist to take an antihistamine every day for six weeks. His hives are under control, but they come and go in patches on different parts of his body every day. More
2870249 68 F PA 11/03/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 NA0590
407259
Diarrhoea, Vomiting; Diarrhoea, Vomiting Diarrhoea, Vomiting; Diarrhoea, Vomiting
Vomiting and Diarrhea for 24 hours after vaccination Vomiting and Diarrhea for 24 hours after vaccination
2870251 0.33 F DE 11/03/2025 DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
PNC20
PNC20
RV5
RV5
RV5
RV5
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 U7829AA
U7829AA
U7829AA
U7829AA
LK4486
LK4486
LK4486
LK4486
Y018147
Y018147
Y018147
Y018147
Alanine aminotransferase increased, Aspartate aminotransferase increased, Band n... Alanine aminotransferase increased, Aspartate aminotransferase increased, Band neutrophil percentage, Blood albumin decreased, Blood calcium increased; Blood chloride normal, Blood creatinine increased, Blood lactic acid increased, Blood pH decreased, Blood potassium increased; Blood urea normal, Brain natriuretic peptide normal, Haematocrit normal, Haemoglobin normal, Platelet count normal; Sudden infant death syndrome, Troponin increased, White blood cell count increased; Alanine aminotransferase increased, Aspartate aminotransferase increased, Band neutrophil percentage, Blood albumin decreased, Blood calcium increased; Blood chloride normal, Blood creatinine increased, Blood lactic acid increased, Blood pH decreased, Blood potassium increased; Blood urea normal, Brain natriuretic peptide normal, Haematocrit normal, Haemoglobin normal, Platelet count normal; Sudden infant death syndrome, Troponin increased, White blood cell count increased; Alanine aminotransferase increased, Aspartate aminotransferase increased, Band neutrophil percentage, Blood albumin decreased, Blood calcium increased; Blood chloride normal, Blood creatinine increased, Blood lactic acid increased, Blood pH decreased, Blood potassium increased; Blood urea normal, Brain natriuretic peptide normal, Haematocrit normal, Haemoglobin normal, Platelet count normal; Sudden infant death syndrome, Troponin increased, White blood cell count increased More
Sudden Infant Death 2 days after vaccines given. Currently being ruled as SIDS. Sudden Infant Death 2 days after vaccines given. Currently being ruled as SIDS.
✓ ✓
2870252 55 M SC 11/03/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 5EF45
5EF45
Dry skin, Erythema, Pruritus, Rash, Rash erythematous; Skin burning sensation, S... Dry skin, Erythema, Pruritus, Rash, Rash erythematous; Skin burning sensation, Skin exfoliation More
First day was a red-streaked, burning, skin rash around base of neck and collarbone, and a couple of... First day was a red-streaked, burning, skin rash around base of neck and collarbone, and a couple of inflamed red patches on my right forearm that might not be related. The neck rash was not present at all the day the shot was administered and first appeared the next day. Affected areas are still noticeably red, dry, and slightly itchy, but not burning 3 days later. Some of the affected skin shows signs of flaking on day 4. RN from doctor's office didn't advise medical care, so I guess they want to see if it clears up on its own. More
2870253 1 F TX 11/03/2025 FLU3
HEPA
HIBV
MMR
PNC20
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 33CM4
42DM9
9N9PY
Y017527
LX2496
Z003767
Irritability, Rash, Rash macular, Rhinorrhoea, Tongue blistering; Irritability, ... Irritability, Rash, Rash macular, Rhinorrhoea, Tongue blistering; Irritability, Rash, Rash macular, Rhinorrhoea, Tongue blistering; Irritability, Rash, Rash macular, Rhinorrhoea, Tongue blistering; Irritability, Rash, Rash macular, Rhinorrhoea, Tongue blistering; Irritability, Rash, Rash macular, Rhinorrhoea, Tongue blistering; Irritability, Rash, Rash macular, Rhinorrhoea, Tongue blistering More
On 10/31/25 the mother noted a rash all over his body, associated with itchiness, fussiness, and a r... On 10/31/25 the mother noted a rash all over his body, associated with itchiness, fussiness, and a runny nose. He was evaluated by me and had an erythematous macular rash all over the body, a blister at the tip of the tongue, and mild clear nasal discharge. Denied fever, dyspnea, swelling on the body, vomiting, loss of appetite, or sick contacts. I prescribed Cetirizine and instructed to go to the ER if symptoms worsened and were associated with difficulty breathing. On 11/3/25, the mother was contacted by phone and she reported the rash has improved and was barely noticeable. More
2870254 23 F GA 11/03/2025 FLU3
 SANOFI PASTEUR
 UT8858KA
Loss of consciousness, Syncope Loss of consciousness, Syncope
After administration of the influenza vaccine, within 5 mins, pt experienced a vasovagal episode wit... After administration of the influenza vaccine, within 5 mins, pt experienced a vasovagal episode with syncope. Pt was help from a sitting position to the floor gently and did not hit or impact her head. She regained consciousness quickly with the raising of her legs. Pt recovered with time, water, and food. More
2870255 92 F 11/03/2025 FLU3
 SANOFI PASTEUR
Expired product administered Expired product administered
Expired Fluzone High Dose administered. Expired 06/2025, administered 10/31/2025. Expired Fluzone High Dose administered. Expired 06/2025, administered 10/31/2025.
2870258 45 F TN 11/03/2025 FLU3
 SANOFI PASTEUR
 U8848AA
Hypoaesthesia, Hyporeflexia, Muscular weakness Hypoaesthesia, Hyporeflexia, Muscular weakness
weakness/ numbness in bilateral feet that has progressed to lower legs. decreased reflexes in left l... weakness/ numbness in bilateral feet that has progressed to lower legs. decreased reflexes in left leg and no reflexes in right leg More
2870259 30 M 11/03/2025 COVID19
 PFIZER\BIONTECH
Depression, Suicidal ideation Depression, Suicidal ideation
I suffer from chronic, severe depression. I heard that the covid vaccine would kill me and being tha... I suffer from chronic, severe depression. I heard that the covid vaccine would kill me and being that I am suicidal I thought this would be an easy way out. Not only did I survive the vaccine, but, when a bunch of people I know got covid and died, I did not get the virus and am fine. This horrid vaccine has forced me to endure life against my will. More
2870262 20 F PA 11/03/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052581
3052581
Deafness, Dizziness, Headache, Hyperhidrosis, Metamorphopsia; Pain in extremity,... Deafness, Dizziness, Headache, Hyperhidrosis, Metamorphopsia; Pain in extremity, Syncope, Tinnitus More
A few minutes after vaccination, patient experienced headache, dizziness/fainting, lightheadedness, ... A few minutes after vaccination, patient experienced headache, dizziness/fainting, lightheadedness, temporarily lost hearing (loud ringing in ears), visual problems (grainy), sweaty, arm hurting. 911 was immediately called and patient was sitting in chair against wall with feet up on another chair while waiting for EMS arrival. By the time EMS arrived she was feeling much better. Her vitals checked out okay and she declined transport to hospital, electing to go home with parents and just be monitored the balance of weekend. Mom stated she would go to primary care for follow-up. Per mom she had Moderna shot for the first time a year ago and also had same reaction but days later so they did not know it could have been from vaccine. Patient also recieved Flucelvax at same time (lot number 948418, exp 2026 June 30. I followed up with patient today and she has had no further issues since initial incident on 11/1. More
2870263 43 F SC 11/03/2025 FLU3
 SANOFI PASTEUR
 U8823DA
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received a flu vaccine at an off site clinic and after receiving vaccine reported she had re... Patient received a flu vaccine at an off site clinic and after receiving vaccine reported she had received a flu vaccine at pharmacy in September. Patient reports no adverse effects. More
2870264 63 F MI 11/03/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR

Asthenia, Headache, Myelitis; Asthenia, Headache, Myelitis Asthenia, Headache, Myelitis; Asthenia, Headache, Myelitis
Patient developed headache and weakness; diagnosed as myelitis; transferred to (withheld) University... Patient developed headache and weakness; diagnosed as myelitis; transferred to (withheld) University Hospital More
✓
2870265 24 M VT 11/03/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2CA5M
2CA5M
Dizziness, Face injury, Fall, Haemorrhage, Nausea; Syncope Dizziness, Face injury, Fall, Haemorrhage, Nausea; Syncope
A young man had his flu shot and said he felt faint. He was sitting at the time. I immediately got a... A young man had his flu shot and said he felt faint. He was sitting at the time. I immediately got a pulse ox on his finger, watched him and talked to him. His 02 and HR were within normal range. He said he felt nauseated, and I got him a trash can. The college's medical director, who was participating in the clinic, came in the room and suggested he move to a couch in the next room. It would have been better for him to have stayed seated or to lie down there with a pillow. The medical director got him up and started to walk with him. I tried to get to the other side of him but she stayed ahead of me. He then fainted and fell into the stair rail, hitting his chin hard enough to draw blood. We then called an ambulance. He said he was OK, but I said we had a hit-your-head, go-in-the-ambulance policy. The ambulance arrived 15 or 20 minutes later and took him to the hospital. More
2870269 0.42 M CA 11/03/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 4D255
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
A nurse reported administering a flu vaccine to a 5-month-old patient who will turn 6 months old in ... A nurse reported administering a flu vaccine to a 5-month-old patient who will turn 6 months old in two weeks. More
2870271 71 M TX 11/03/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 HY1813
U8862EA
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
Patient received expired RSV vaccine, no adverse event, patient tolerated well. Patient received expired RSV vaccine, no adverse event, patient tolerated well.
2870273 27 F CA 11/03/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
 1805025
1805025
UT8861MA
UT8861MA
Injection site pain, Injection site pruritus, Injection site swelling, Injection... Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus; Urticaria; Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus; Urticaria More
@ around 3:30 pm on 10/31/2025 employee was vaccinated for covid vaccine on Left side deltoid. state... @ around 3:30 pm on 10/31/2025 employee was vaccinated for covid vaccine on Left side deltoid. states that on 11/01/2025 having very large bump on site and feels warm to touch and tender and itchy and the Flu vaccine was giving on right side deltoid states having symptoms on 10/31/2025 states that around same time having hives and itchy feeling. reported symptoms today 11/03/2025 advised to follow up with nurses @ clinic site More
2870274 16 F VA 11/03/2025 FLU3
HPV9
MNP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 N9CS2
Y013768
5S723
Head injury, Loss of consciousness, Product preparation issue; Head injury, Loss... Head injury, Loss of consciousness, Product preparation issue; Head injury, Loss of consciousness, Product preparation issue; Head injury, Loss of consciousness, Product preparation issue More
Two Separate Events Occurred - The Penmenvy when given was only given as the liquid component, there... Two Separate Events Occurred - The Penmenvy when given was only given as the liquid component, there fore the patent only received the Meningococcal B version of the vaccine. After discovering this error occurred on 11/3, the health care facility called the patient's guardian to let them know and have the patient come back in for re-vaccination per our MD. During the phone call, the patient's mother disclosed that at approximately 7pm on 10/31/25 after the vaccinations were administered, the patient lost consciousness, hit her head and had to be transported to the hospital via ambulance and was admitted for 1 day. Unsure of what the hospital state as the cause or any follow up as my clinic is not connected to hospital system. Mom stated patient is home now as of 11/3/25 but still out of it. More
✓
2870275 55 F MT 11/03/2025 FLU3
 SANOFI PASTEUR
 UT8861KA
Audiogram abnormal, Deafness neurosensory, Deafness unilateral, Sudden hearing l... Audiogram abnormal, Deafness neurosensory, Deafness unilateral, Sudden hearing loss More
Unilateral Sudden Sensorineural Hearing Loss (left) beginning 2 am 10/31/25 approximately 9.5 h afte... Unilateral Sudden Sensorineural Hearing Loss (left) beginning 2 am 10/31/25 approximately 9.5 h after injection More
✓
2870277 60 F IN 11/03/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 UT8779NA
UT8779NA
Abdominal distension, Deafness, Ear congestion, Ear pain, Headache; Hot flush, I... Abdominal distension, Deafness, Ear congestion, Ear pain, Headache; Hot flush, Inner ear disorder, Sleep disorder More
Patient called on 11/3/2025 and wanted to report "serious side effects" from her flu shot ... Patient called on 11/3/2025 and wanted to report "serious side effects" from her flu shot on 9/26/2025. She states that she was fine on Friday, the day she received the vaccine, and through the weekend. Two days later she developed a severe headache and bloat and hot flashes that caused her to lose sleep. Those symptoms eventually resolved. However, about 1 week later she developed ear congestion and pain and later hearing loss and want to urgent care where she was told she "had something inner ear and took azithromycin". She still has hearing loss and was referred to ENT. More
✓
2870278 75 F CT 11/03/2025 COVID19
FLU3
RSV
VARZOS
 PFIZER\BIONTECH
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 My9548
u8855CA
4ty55
3eg9b
Rash; Rash; Rash; Rash Rash; Rash; Rash; Rash
Patient came in requesting 4 vaccines, we tried advising her to get two and come back following week... Patient came in requesting 4 vaccines, we tried advising her to get two and come back following week for 2 more but she wanted all of them in the one day. Her husband come in 10/24 reporting she had a rash on both arms that started 1 week from immunizations. Pharmacist on duty got him OTC hydrocortisone and told him to report reactions to her GP and Cancer doctor. More
2870279 64 M MN 11/03/2025 COVID19
 PFIZER\BIONTECH
 na0590
Vomiting Vomiting
Patient's daughter stated he got a covid vaccine this morning around 10:30 and has been throwin... Patient's daughter stated he got a covid vaccine this morning around 10:30 and has been throwing up ever since. He recently finished a course of antibiotics for a sinus infection on friday 10/31/25. More
2870281 1.25 F MO 11/03/2025 COVID19
 PFIZER\BIONTECH
 LN8272
No adverse event, Recalled product administered No adverse event, Recalled product administered
No adverse reaction, VFC contacted stating that this needed to be reported due to vaccines needing t... No adverse reaction, VFC contacted stating that this needed to be reported due to vaccines needing to be sent back. Vaccine not expired at the time given More
2870288 78 F MA 11/03/2025 COVID19
 MODERNA
 3052995
Underdose Underdose
Patient received Spikevax pediatric formulation instead of mNexspike adult. Patient had no s/sx to r... Patient received Spikevax pediatric formulation instead of mNexspike adult. Patient had no s/sx to report. Pharmacy discovered error 2 days later. Patient received a second pediatric shot as recommened by the CDC website today 11/3/25. More
2870289 70 F VA 11/03/2025 COVID19
 MODERNA
 3052133
Pain Pain
PATIENT CAME TO PHARMACY AND REPORTED SHE HAD PAIN DUE TO VACCINE SHE RECEIVED ON 10/18/25 PATIENT CAME TO PHARMACY AND REPORTED SHE HAD PAIN DUE TO VACCINE SHE RECEIVED ON 10/18/25
2870290 5 F MA 11/03/2025 FLU3
 SEQIRUS, INC.
 406987
Injection site reaction, Injection site swelling, Rash erythematous Injection site reaction, Injection site swelling, Rash erythematous
Large red round rash at the vaccine site with swelling Large red round rash at the vaccine site with swelling
2870291 53 F FL 11/03/2025 FLU3
 SANOFI PASTEUR
 u8832aa
Unevaluable event Unevaluable event
medrol dosepak medrol dosepak
2870292 0.83 M TX 11/03/2025 FLU3
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 u8863da
z008499
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Patient was advised to come in the office to receive MMR vaccine per Dr. okay to give for travel can... Patient was advised to come in the office to receive MMR vaccine per Dr. okay to give for travel can be placed on schedule as a nurse visit. Employee pulled the patient back to give the MMR and Flu vaccine. Instead of administering the MMR that was for ages 12 month and older, she mistakenly grabbed the vaccine Proquad which contained MMR and Varicella. The patient received MMR and Varicella along with the Flu vaccine. After reviewing the chart the next day, she realized she gave the wrong vaccine. Manager and Dr. were notified. More
2870293 47 M MI 11/03/2025 FLU3
HEP
MMR
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
 U8863EA
95BJ9
Z002520
U8654AA
No adverse event; No adverse event; No adverse event; No adverse event No adverse event; No adverse event; No adverse event; No adverse event
No adverse events recorded No adverse events recorded
2870300 7 F UT 11/03/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052581
AX4604C
Incorrect dose administered, No adverse event; Incorrect dose administered, No a... Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event More
Moderna Spikevax for 12+ given to 7 year old in error. Director called and spoke to parents followin... Moderna Spikevax for 12+ given to 7 year old in error. Director called and spoke to parents following day, no adverse reactions reported More
2870302 84 F CA 11/03/2025 COVID19
 PFIZER\BIONTECH
 252816391341007
Blood potassium normal, Blood pressure diastolic decreased, Electrocardiogram am... Blood potassium normal, Blood pressure diastolic decreased, Electrocardiogram ambulatory, Heart rate decreased More
A precipitous drop in Heart Rate and lesser drop in diastolic blood pressure ....heart rate 78 and 7... A precipitous drop in Heart Rate and lesser drop in diastolic blood pressure ....heart rate 78 and 73 on two preceding dates, down to 42 43 after. Diastolic pressure 64 and 63 down to 52 and 51. More
2870310 11/03/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
I know three people who got the Shingles jab. A few weeks later there in the hospital with shingles;... I know three people who got the Shingles jab. A few weeks later there in the hospital with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a specified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I know three people who got the Shingles jab. A few weeks later there in the hospital with shingles) (serious criteria hospitalization). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 26-OCT-2025 This case was reported by a patient via interactive digital media. The reporter knew three people who got the Shingles jab. A few weeks later there in the hospital with Shingles. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Herpes zoster, several weeks after receiving Shingles vaccine, in a specified number of patients. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2025AMR101766:same reporter different patient More
✓
2870311 11/03/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Blindness Blindness
Our friend is blind from the shingles vaccine; This serious case was reported by a consumer via inte... Our friend is blind from the shingles vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of blind in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced blind (Verbatim: Our friend is blind from the shingles vaccine) (serious criteria GSK medically significant). The outcome of the blind was not reported. The reporter considered the blind to be related to Shingles vaccine. The company considered the blind to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 26-OCT-2025 This case was reported by a patient's friend via interactive digital media. The patient was blind from the Shingles vaccine, did the diagnosis The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Blindness, unknown time after receiving Shingles vaccine, in a patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2870325 F 11/03/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Ophthalmic herpes zoster, Vaccination failure Ophthalmic herpes zoster, Vaccination failure
Thanks i always got the shots but last year I got them in my eyes/Suspected vaccination failure; Tha... Thanks i always got the shots but last year I got them in my eyes/Suspected vaccination failure; Thanks i always got the shots but last year I got them in my eyes and had to take medicine for them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Thanks i always got the shots but last year I got them in my eyes/Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: Thanks i always got the shots but last year I got them in my eyes and had to take medicine for them) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster was not resolved. The reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 23-OCT-2025 This case was reported by a consumer via interactive digital media. The patient got the shot but last year (in 2024) the patient got them in eyes and had to take medicine. The batch number was not provided, and unable to contact the reporter. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Ophthalmic herpes zoster, unkown time after receiving Shingles vaccine in a female patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2870332 TN 11/03/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Expired product administered Expired product administered
Flulaval - Expired dose, administered expired Flulaval; This non-serious case was reported by a phys... Flulaval - Expired dose, administered expired Flulaval; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal TIV Quebec (Flulaval) for prophylaxis. On an unknown date, the patient received Flulaval. On an unknown date, an unknown time after receiving Flulaval, the patient experienced expired vaccine used (Verbatim: Flulaval - Expired dose, administered expired Flulaval). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 17-OCT-2025 Reporter enquired that about how long does the patient need to wait before coming back in to get another flu shot that is in date. The batch number was not provided and a request for this information has been made. More
2870338 79 F 11/03/2025 COVID19
 MODERNA
Breast cancer female, Cancer screening Breast cancer female, Cancer screening
breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREA... breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER FEMALE (breast cancer) in a 79-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (had COVID-19 in 2022) in 2020. Past adverse reactions to the above products included COVID-19 with Moderna Covid-19 vaccine. Concurrent medical conditions included Arthritis (From 20 years ago), Migraine (patient had migraines before), Vascular disorder and Allergy to antibiotic (Severe allergies to antibiotics, From: as a child, so in distant past). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, the patient experienced BREAST CANCER FEMALE (breast cancer) (seriousness criterion medically significant). The patient was treated with Acetylsalicylic acid (Aspirin) for Vascular disorder, at a dose of 325 milligram once a day; Paracetamol (Tylenol) at a dose of 2 doses of extra strength and Surgery (Mastectomy and chemotherapy) for Breast cancer female. At the time of the report, BREAST CANCER FEMALE (breast cancer) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cancer screening: Breast cancer was found through routine screening, patient never felt a lump.. No concomitant medications were taken by patient. The patient had undergone mastectomy and chemotherapy, aside from childhood crap that people get. The patient received two Tylenol doses of extra strength and was able to go back to sleep with an ice pack. On 03-Oct-2025, the patient received a dose of Fluzone High-Dose (Sanofi Pasteur) for unknown indication. On 18-Oct-2025, the patient received 0.3 ml dose of Comirnaty (Pfizer) vaccine (expiry date: 09-Jul-2026, batch no.: NA4452) in upper left arm for an unknown indication. Patient had really bad reaction to Comirnaty vaccine within 12 hours of administration, and it made the caller woke up. Patient woke up with severe chest pressure, chills, migraine, body aches, joint pain, nausea, dizziness, and fatigue. Fatigue continued. Patient did take Aspirin, and normally took Aspirin at a dose of 325 mg at night for vascular issues. The patient did get up and took two Tylenol doses of extra strength and was able to go back to sleep with an ice pack. Patient has had COVID vaccine since it first came out, but this was patient's first time having Pfizer dose, and the patient usually got Moderna vaccine. Prior doses were all of Moderna COVID-19 vaccine. Patient got Comirnaty vaccine injection on 18-Oct-2025, and had severe chest pressure, chills, body aches, joint pain, nausea, and dizziness in overnight of 19-Oct-2025. All resolved by next morning, 19-Oct-2025. Patient just stayed tired for the day, that was it, and everything else went away, and patient confirmed that the symptoms of severe chest pressure, chills, body aches, joint pain, nausea, and dizziness all resolved. Patient was just enough to wake up and got scared. Patient had migraines for a little bit, not as migraine, but as a little headache. Patient has had migraines before. This case was linked to MOD-2025-790445 (Patient Link).; Reporter's Comments: Regulatory Authority causality for Breast cancer female was assessed as not related, due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report. More
2870339 F 11/03/2025 COVID19-2
 MODERNA
Pain in extremity Pain in extremity
Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurre... Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the left arm) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (1st dose) in 2021, Pfizer (2nd dose, 3 weeks later another Pfizer) in 2021 and Pfizer (3rd dose) in September 2021. Past adverse reactions to the above products included No adverse effect with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Asthma and Blood pressure high. On 04-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in the left arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the left arm) outcome was unknown. No concomitant medication was reported. It was reported that she had soreness in the left arm than experienced with COVID-19 vaccines. No treatment information was reported. This case was linked to MOD-2025-790544 (Patient Link). More
2870340 F 11/03/2025 COVID19
 MODERNA
COVID-19 COVID-19
Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Co... Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. In February 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid). At the time of the report, COVID-19 (Covid) outcome was unknown. No concomitant medications were provided. The patient had COVID after 2nd dose of the Moderna COVID-19 vaccine in February 2022. No treatment medication was provided. This case was linked to MOD-2025-790630 (Patient Link). More
2870341 50 F 11/03/2025 COVID19
 MODERNA
Body temperature increased, Influenza like illness Body temperature increased, Influenza like illness
Flu-like symptoms, high fever, chills, body aches; This spontaneous case was reported by a consumer ... Flu-like symptoms, high fever, chills, body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms, high fever, chills, body aches) in a 6-decade-old female patient 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 INFLUENZA LIKE ILLNESS (Flu-like symptoms, high fever, chills, body aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms, high fever, chills, body aches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: Usually have goes on for about 40. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. The patient received Moderna covid-19 vaccination since it came out. It was reported that post latest vaccination the patient symptom was lasted for 24 to 36 hours for last two time. And the symptoms were high fever, chills and body aches which were flu-like symptoms. It was also reported that in the past the symptom was lasted for 48 hours. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-790773 (E2B Linked Report). This case was linked to MOD-2025-790563 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790773:case for friends More
2870342 65 M 11/03/2025 COVID19
 MODERNA
Ageusia, Amnesia, Anosmia, Asthenia, Weight decreased Ageusia, Amnesia, Anosmia, Asthenia, Weight decreased
Memory loss; Taste and smell loss; Taste and smell loss; Lost weight; Lack of energy; This spontaneo... Memory loss; Taste and smell loss; Taste and smell loss; Lost weight; Lack of energy; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss), AGEUSIA (Taste and smell loss), ANOSMIA (Taste and smell loss), WEIGHT DECREASED (Lost weight) and ASTHENIA (Lack of energy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Cardiovascular disease, unspecified. In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced AMNESIA (Memory loss), AGEUSIA (Taste and smell loss), ANOSMIA (Taste and smell loss), WEIGHT DECREASED (Lost weight) and ASTHENIA (Lack of energy). At the time of the report, AMNESIA (Memory loss), AGEUSIA (Taste and smell loss), ANOSMIA (Taste and smell loss), WEIGHT DECREASED (Lost weight) and ASTHENIA (Lack of energy) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medications were not reported. It was reported that patient had cardiovascular disease before taking the shots and started experiencing memory loss, taste and smell loss after taking the shot. Patient had also lost weight. Patient also had lack of energy. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2870343 42 M 11/03/2025 COVID19
COVID19
 MODERNA
MODERNA

Arthritis, Bronchoscopy, COVID-19, Computerised tomogram, Haematuria; Hepatic cy... Arthritis, Bronchoscopy, COVID-19, Computerised tomogram, Haematuria; Hepatic cyst, Intervertebral disc degeneration, Sarcoidosis, Tinnitus More
Tinnitus in both ears; Passing micro blood in urine on multiple collections; Covid infection; Now de... Tinnitus in both ears; Passing micro blood in urine on multiple collections; Covid infection; Now developed something going on his liver as well possibly a cyst or bleed; Arthritis in almost every joint; Disc degeneration in every vertebral space from lumbar region up through cervical spine; Chronic sarcoidosis; This spontaneous case was reported by a consumer and describes the occurrence of SARCOIDOSIS (Chronic sarcoidosis), ARTHRITIS (Arthritis in almost every joint) and INTERVERTEBRAL DISC DEGENERATION (Disc degeneration in every vertebral space from lumbar region up through cervical spine) in a 42-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In 2022, the patient experienced SARCOIDOSIS (Chronic sarcoidosis) (seriousness criterion medically significant). In 2023, the patient experienced ARTHRITIS (Arthritis in almost every joint) (seriousness criterion medically significant) and INTERVERTEBRAL DISC DEGENERATION (Disc degeneration in every vertebral space from lumbar region up through cervical spine) (seriousness criterion medically significant). In 2025, the patient experienced HEPATIC CYST (Now developed something going on his liver as well possibly a cyst or bleed). On an unknown date, the patient experienced TINNITUS (Tinnitus in both ears), HAEMATURIA (Passing micro blood in urine on multiple collections) and COVID-19 (Covid infection). The patient was treated with Prednisone at a dose of Unknown. At the time of the report, SARCOIDOSIS (Chronic sarcoidosis), ARTHRITIS (Arthritis in almost every joint), INTERVERTEBRAL DISC DEGENERATION (Disc degeneration in every vertebral space from lumbar region up through cervical spine), TINNITUS (Tinnitus in both ears), HEPATIC CYST (Now developed something going on his liver as well possibly a cyst or bleed) and HAEMATURIA (Passing micro blood in urine on multiple collections) had not resolved and COVID-19 (Covid infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bronchoscopy: chronic sarcoidosis. On an unknown date, Computerised tomogram: chronic sarcoidosis. No concomitant medications provided by the reporter. It was reported that the patient received 4 rounds of Moderna-COVID-19 vaccine and each time after vaccination the patient came down with Covid infection. After first vaccine he developed tinnitus in both ears within 10 days. In late 2022 to early 2023 the patient began to feel not well and lost approximately 40 lbs. within 7 months. The patient was diagnosed with sarcoidosis which could not be treated with steroids. Prednisone had no effect. From mid 2023 to present he developed arthritis almost all in his every joint and the patient had disc degeneration in every vertebral space from lumbar region up through cervical spine. The treatment medication NSAIDs provide no relief to the patient and currently the patient did not receive any treatment medication. Rheumatology confirmed that the patient had no typical blood markers for inflammation or rheumatoid arthritis. At present the patient lived in constant pain and the patient life quality has been diminished. It was reported that the patient began passing micro blood in urine on multiple collections and have now developed something going on in his liver as well possibly a cyst or bleed.; Reporter's Comments: Intervertebral disc degeneration could be secondary to sarcoidosis. The benefit-risk relationship of product is not affected by this report. More
2870344 77 F 11/03/2025 COVID19
 MODERNA
Cerebrovascular accident Cerebrovascular accident
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASC... Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. In 2024, 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-Aug-2025, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. Concomitant medication use information was not provided by reporter. The patient suffered a stroke in the first week of August and experienced it for the first time on 11-Aug-2025. The COVID-19 vaccine was available last year, and the reporter was pretty sure that the patient received that one. So, if the patient got it, then it would probably be okay to get it again. It was reported that there was no implication at any point that her stroke was related to receiving the vaccine. However, it was mentioned that she possibly received Spikevax 24/25 last year and had a stroke this year. It was unknown if the patient experienced any additional symptoms or events. Treatment medication use information was not provided by reporter.; Reporter's Comments: The age is a confounder for the event. Due to nonsuggestive temporal association (long latency), the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
2870345 81 F 11/03/2025 COVID19
COVID19
 MODERNA
MODERNA

COVID-19, Cholangitis, Cholecystitis acute, Cough, Hepatic mass; Malaise, Pyrexi... COVID-19, Cholangitis, Cholecystitis acute, Cough, Hepatic mass; Malaise, Pyrexia, SARS-CoV-2 test More
bile ducts Look totally inflamed.; 1 gall bladder attack; cough worsening; general malaise; nodules ... bile ducts Look totally inflamed.; 1 gall bladder attack; cough worsening; general malaise; nodules in the liver; fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CHOLANGITIS (bile ducts Look totally inflamed.) and CHOLECYSTITIS ACUTE (1 gall bladder attack) in an 81-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus erythematosus (Lupus, diagnosed in 1989) since 1989, NASH (diagnosed 29 years ago) since 1996 and Cough (has always had cough). In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2024, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced CHOLANGITIS (bile ducts Look totally inflamed.) (seriousness criterion medically significant), CHOLECYSTITIS ACUTE (1 gall bladder attack) (seriousness criterion medically significant), COUGH (cough worsening), MALAISE (general malaise), HEPATIC MASS (nodules in the liver) and PYREXIA (fever). At the time of the report, CHOLANGITIS (bile ducts Look totally inflamed.) and HEPATIC MASS (nodules in the liver) outcome was unknown, CHOLECYSTITIS ACUTE (1 gall bladder attack), COUGH (cough worsening) and COVID-19 (COVID-19) was resolving and MALAISE (general malaise) and PYREXIA (fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2024, SARS-CoV-2 test: Positive. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication included as other monoclonal antibodies and antibody drug conjugates for lupus. Patient had gotten all Moderna Covid vaccines from 2020-2024. Had always had a cough. Since the vaccinations were offered in 2020, Patient had received all the vaccinations until last year. 2024 in the fall, doctor said, at this point it was probably October, get the flu shot now and got the RSV shot now, and then hold off on getting Covid. So held off and patient got the COVID, the disease. Patient received last Covid vaccine sometime in 2024, "it was 2024 And patient also got monoclonal antibodies besides getting the Moderna shot because patient have lupus. Patient contracted Covid in December 2024. It was reported to patient always had a cough. However, in December of 2024, went to urgent care (Medical Center) for the cough worsening and tested positive for Covid. It was reported that that cough lingered, lingered, lingered, lingered. It was still somewhat there, but patient always had a cough, so it was kind of hard to distinguish. Most of October patient has been feeling really well. also reported to always get sick following all Covid vaccines. "Patient did necessarily do really well with the vaccination. Patient usually sick for 2 or 3 days afterwards. Reported symptoms might be a fever. thought just general malaise, just all over. And then it went away, all those symptoms went away. Pre-existing NASH led to diagnosis of nodules in the liver. patient had an ongoing liver problem, and there were nodules on liver. It was also reported following 1 gall bladder attack, patient had an outpatient cholecystectomy in May 2025. Patient had to have gallbladder out, had one attack. So, patient saw the surgeon. Patient was told by the HCP, the gallbladder looks, diseased or whatever, but the bile ducts Looked totally inflamed. it was reported feeling fine from the gallbladder now. No specific treatment drug was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790561 (E2B Linked Report). This case was linked to MOD-2025-790559 (Patient Link).; Reporter's Comments: Company comment: Causality for cholangitis, hepatic mass (liver nodule) and acute cholecystitis is assessed as not related considering patient's advanced age and underlying Lupus erythematosus and Metabolic dysfunction-associated steatohepatitis. Event of cough is assessed as not related as associated with COVID 19 infection. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790561:husband case More
2870346 56 F 11/03/2025 COVID19
 MODERNA
Body temperature, Influenza like illness Body temperature, Influenza like illness
just high fever and chills and you know, body aches, like a flu-like symptoms"; This spontaneou... just high fever and chills and you know, body aches, like a flu-like symptoms"; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (just high fever and chills and you know, body aches, like a flu-like symptoms") in a 56-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concomitant products included Influenza vaccine for an unknown indication. In November 2024, 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. In November 2024, the patient experienced INFLUENZA LIKE ILLNESS (just high fever and chills and you know, body aches, like a flu-like symptoms"). At the time of the report, INFLUENZA LIKE ILLNESS (just high fever and chills and you know, body aches, like a flu-like symptoms") had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2024, Body temperature: Usually have goes on for about 40. It was reported that the patient received concomitant medication the unspecified flu vaccine (Influenza vaccine) about 3 weeks, 2 or 3 weeks ago before the last COVID-19 vaccination. The patient received Moderna covid-19 vaccination since it came out. The patient was unsure how many doses he took 6 or 7. It was reported that post latest vaccination patient symptom was lasted for 24 to 36 hours. And the symptoms were high fever, chills and body aches which were flu-like symptoms. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-790773 (E2B Linked Report). This case was linked to MOD-2025-790774 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790773:Invalid case for friends (same reporter case) More
📋 Privacy Policy & Data Disclaimer