🏥 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 💀 🏥 🚑 ♿ ⚠️
2823011 8 F TN 01/27/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 39j7a
Extra dose administered Extra dose administered
Patient had received flu vaccine during the school event on 10/29/2024, when I prepared for physical... Patient had received flu vaccine during the school event on 10/29/2024, when I prepared for physical appointment I did not see that he had gotten the vaccine and had administered the flu vaccine date of service 12/03/2024. More
2823012 41 F AZ 01/27/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0198
EW0198
EW0198
FA7485
FA7485
FA7485
Asthenia, Chest pain, Dizziness, Dyspnoea, Eczema; Electrocardiogram, Fear, Food... Asthenia, Chest pain, Dizziness, Dyspnoea, Eczema; Electrocardiogram, Fear, Food allergy, Heart rate increased, Intestinal barrier dysfunction; Sleep disorder; Asthenia, Chest pain, Dizziness, Dyspnoea, Eczema; Electrocardiogram, Fear, Food allergy, Heart rate increased, Intestinal barrier dysfunction; Sleep disorder More
I was a ?healthy? women who had never experienced shortness of breath, chest pain, rapidly beating h... I was a ?healthy? women who had never experienced shortness of breath, chest pain, rapidly beating heartbeat, faintness, dizziness. This all began after the vaccination. It was so debilitating that I was unable to sleep. I went to Urgent Care initially and I was immediately sent to the ER after doing a EKG. Urgent Care did not like the results so i drove myself to the ER. The ER then referred me to Cardiology for follow-up and testing. The chest pain was strong and scary. Since I have developed several Food Allergies resulting in Leaky Gut (Intestinal Permability) and Eczema on my hands. Never in my life had I been diagnosed or experienced any symptoms of these issues until after the Pfizer COVID vaccination. I attribute the decline in my health in its entirety to vaccine injury. More
2823013 80 F KY 01/27/2025 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS







Anaemia, Arthralgia, Back pain, Blood pressure decreased, Confusional state; Hea... Anaemia, Arthralgia, Back pain, Blood pressure decreased, Confusional state; Headache, Neck pain, Urinary incontinence, Vomiting; Diarrhoea, Illness, Movement disorder, Pain, Urinary incontinence; Vomiting; Anaemia, Arthralgia, Back pain, Blood pressure decreased, Confusional state; Headache, Neck pain, Urinary incontinence, Vomiting; Diarrhoea, Illness, Movement disorder, Pain, Urinary incontinence; Vomiting More
pt states she woke up in terrible pain. Her head, neck, shoulder and back were in terrible pain. She... pt states she woke up in terrible pain. Her head, neck, shoulder and back were in terrible pain. She was confused. She couldn't turn over or control her bladder/ Then she had to vomit. She could not remember what happened after that but woke up about 6 in the morning. She make coffee but couldn't drink it. She felt ill all day the following day. She had total confusion and laid around all day. Then the day after that her blood pressure dropped. More
2823014 6 M TN 01/27/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 39j7a
Extra dose administered Extra dose administered
Patient had received flu vaccine at school on 10/29/2024, when I prepared for physical appointment, ... Patient had received flu vaccine at school on 10/29/2024, when I prepared for physical appointment, I did not see that he had already gotten vaccine and administered another dose day of physical appointment. More
2823015 54 F MN 01/27/2025 HEP
HEP
PNC20
PNC20
 MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
 Y014323
Y014323
LG5577
LG5577
Chills, Injection site cellulitis, Injection site pain, Injection site swelling,... Chills, Injection site cellulitis, Injection site pain, Injection site swelling, Injection site warmth; Musculoskeletal stiffness, Pain, Pain in extremity; Chills, Injection site cellulitis, Injection site pain, Injection site swelling, Injection site warmth; Musculoskeletal stiffness, Pain, Pain in extremity More
Patient reported Pain in the arm, stiffness, chills, and body aches initially for several days. 60 h... Patient reported Pain in the arm, stiffness, chills, and body aches initially for several days. 60 hours after injection patient reported that the area was painful and hot to the touch, and swelling. More
2823016 46 F CA 01/27/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 95BJ9
No adverse event, Underdose No adverse event, Underdose
Administered pediatric dose to an adult patient. No side effects, signs or symptoms of adverse reac... Administered pediatric dose to an adult patient. No side effects, signs or symptoms of adverse reactions noted. Contacted on call provider for guidance. Need for re-vaccination of patient. Contacted patient who will schedule appointment. More
2823017 70 F FL 01/27/2025 COVID19
COVID19
 MODERNA
MODERNA
 037b22a
MOD044A21A
Coronary arterial stent insertion, Coronary artery occlusion, Dyspnoea, Gait ina... Coronary arterial stent insertion, Coronary artery occlusion, Dyspnoea, Gait inability, Myocardial infarction; Coronary arterial stent insertion, Coronary artery occlusion, Dyspnoea, Gait inability, Myocardial infarction More
None stated. None stated.
✓
2823018 52 M CA 01/27/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
No adverse event, Underdose No adverse event, Underdose
Administered pediatric dose to an adult patient. No side effects, signs or symptoms of adverse reac... Administered pediatric dose to an adult patient. No side effects, signs or symptoms of adverse reactions noted. Contacted on call provider for guidance. Need for re-vaccination of patient. Contacted patient who will schedule appointment. More
2823019 7 M WA 01/27/2025 COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 LN7302
LN7302
LN7302
UT8506JA
UT8506JA
UT8506JA
Blood glucose normal, Body temperature increased, Chills, Dizziness, Fatigue; Fe... Blood glucose normal, Body temperature increased, Chills, Dizziness, Fatigue; Feeling abnormal, Influenza virus test negative, Injection site pain, Nausea, Pallor; SARS-CoV-2 test negative; Blood glucose normal, Body temperature increased, Chills, Dizziness, Fatigue; Feeling abnormal, Influenza virus test negative, Injection site pain, Nausea, Pallor; SARS-CoV-2 test negative More
Covid and flu vaccines administered to patient following routine well visit. Patient seemingly tole... Covid and flu vaccines administered to patient following routine well visit. Patient seemingly tolerated vaccines well and walked out of the office on his own being accompanied by his parents. Patient and family only made it out to the elevator of our office building before patient was brought back to the exam room being carried by his father for reports of feeling nauseous and lightheaded. Patient looked visibly pale and noticeably fatigued. Patient was laid down on the exam table and offered some apply juice. Patient kept closing his eyes and reporting that he felt tired. Remained arousable. No respiratory distress. Patient was able to drink sips of juice and keep them down. Never had any vomiting. Primary care provider was brought to the bedside and examined patient. Vitals were checked, temperature was 98.3 orally, heart rate was around 65 and oxygen was 98% on RA. Patient developed some chills and was promptly covered up with mother's jacket. Patient reported feeling "not too bad but not good." Temp checked again and it was 99.7. Blood sugar 123. Patient monitored closely, continued to have the chills and kept resting his eyes but continued to respond to questions appropriately. Denied further nausea. Reported that his left arm was sore around the injection sites. Temp checked again and found to be 101.5 temporally and heart rate 112. Motrin administered and patient was swabbed for flu and covid which both came back negative. Patient remained in clinic being closely monitored by RN and MD. About 30 minutes after motrin administration, patient's temperature was checked again and was 103 but patient visibly more alert, sitting upright and acting appropriately. Mother felt comfortable taking patient home and continuing to monitor for further fevers and other symptoms. Patient walked out of the office on his own, accompanied by his mother. More
2823020 73 M TX 01/27/2025 FLU3
PNC20
 SEQIRUS, INC.
PFIZER\WYETH
 388473
LG5575
Muscular weakness; Muscular weakness Muscular weakness; Muscular weakness
PATIENT REPORTED HAVING WEAKNESS IN HIS LEFT ARM AFTER GETTING PREVNAR 20 AND FLUAD IN THE LEFT ARM.... PATIENT REPORTED HAVING WEAKNESS IN HIS LEFT ARM AFTER GETTING PREVNAR 20 AND FLUAD IN THE LEFT ARM. HE STATES THAT HE EXPECTED IT TO GET BETTER BUT LITTLE IMPROVEMENT. More
2823021 17 M TN 01/27/2025 HEP
HEPA
IPV
MMR
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 95BJ9
A3X2K
W1C831M
Y000224
U8361AA
3RE73
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
PATIENT IN CLINIC FOR VACCINES. MOTHER STATES SHE DOES NOT HAVE A VACCINE RECORD AND UNDERSTANDS PA... PATIENT IN CLINIC FOR VACCINES. MOTHER STATES SHE DOES NOT HAVE A VACCINE RECORD AND UNDERSTANDS PATIENT WOULD NEED TO RESTART VACCINES. RECORD SENT BACK WITH PATIENT CONFIRMED THERE WERE NO RECORDED VACCINES. MOTHER VU AND GAVE CONSENT FOR PATIENT TO RECIEVE VACCINES. AFTER ADMINISTRATION OF THE VACCINE, IT WAS DISCOVERED THE PATIENT HAD 2 PROFILES IN SYSTEM AND HAD PREVIOULSY COMPLETED THE MMR SERIES. ALL OTHER VACCINES RECIEVED WERE DUE. More
2823022 47 F FL 01/27/2025 PNC20
 PFIZER\WYETH
 946607
Extra dose administered, No adverse event Extra dose administered, No adverse event
There was no physical side effects. This was a duplicate dose administered erroneously. A second dos... There was no physical side effects. This was a duplicate dose administered erroneously. A second dose given of a vaccine meant to be a single dose series. The patient is in good health and has been notified. More
2823023 14 F TN 01/27/2025 MMR
MNQ
 MERCK & CO. INC.
SANOFI PASTEUR
 Y000224
U8361AA
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
PATIENT RECIEVED DOSE BEFORE IT WAS DUE - MENINGOCOCCAL PATIENT RECIEVED AN EXTRA DOSE - MMR PATIENT RECIEVED DOSE BEFORE IT WAS DUE - MENINGOCOCCAL PATIENT RECIEVED AN EXTRA DOSE - MMR
2823024 74 F 01/27/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255t2
Extra dose administered Extra dose administered
Patient was administered a duplication of the RSV vaccine. Initial vaccination date was 11/3/2023. Patient was administered a duplication of the RSV vaccine. Initial vaccination date was 11/3/2023.
2823025 63 F NC 01/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 90750
Injection site erythema, Injection site rash, Injection site urticaria, Injectio... Injection site erythema, Injection site rash, Injection site urticaria, Injection site warmth More
Patient informed RN that she developed redness and warmth to left upper arm; she states that this co... Patient informed RN that she developed redness and warmth to left upper arm; she states that this covered almost her entire outer upper arm and the redness progressed to a hive type rash that lasted about 2 weeks. More
2823026 40 F AR 01/27/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Axillary mass, Cheilitis, Ear infection, Infection, Lymphadenitis; Oral discomfo... Axillary mass, Cheilitis, Ear infection, Infection, Lymphadenitis; Oral discomfort, Pyrexia, Stomatitis, Swelling face More
4 days after I had my third booster shot, I spiked a fever of 104.4. Then, after the fever, my lymp... 4 days after I had my third booster shot, I spiked a fever of 104.4. Then, after the fever, my lymph nodes became inflamed & I had an infection in my jaw. It was so swollen. I had sores all inside my mouth, lip & I couldn?t eat anything for at least 10 days. It burned so bad & was one of the most painful things I?ve ever experienced. I also had lumps under my arms. I had an ear infection too. I was given medication for mono. Lidocaine for the pain & a really powerful mouthwash. It has weighed on me for some time that I should?ve reported this. More
2823027 33 M MA 01/27/2025 COVID19
 MODERNA
 3042648
Death, Resuscitation, Unresponsive to stimuli Death, Resuscitation, Unresponsive to stimuli
Patient was found unresponsive in his cell, sitting in a chair. A Lucas machine was applied to patie... Patient was found unresponsive in his cell, sitting in a chair. A Lucas machine was applied to patient and continued until EMS arrived and confirmed death of patient. More
✓
2823028 75 M 01/27/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered Extra dose administered
Patient was given a duplicate RSV vaccine. Initial dose was administered 11/3/2023 Patient was given a duplicate RSV vaccine. Initial dose was administered 11/3/2023
2823029 69 F OH 01/27/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
 LG9827
LG9827
Chills, Cough, Dyspnoea, Fatigue, Pain; SARS-CoV-2 test negative, Wheezing Chills, Cough, Dyspnoea, Fatigue, Pain; SARS-CoV-2 test negative, Wheezing
Fatigue 3pm Friday/slept. Saturday/chills, fatigue, achy. Sunday around 1am woke to horrible dry cou... Fatigue 3pm Friday/slept. Saturday/chills, fatigue, achy. Sunday around 1am woke to horrible dry cough & continued other symptoms. Temperature was 100.2. Continuous coughing throughout the day with upper airway wheezing and some SOB. Went to Urgent Cate around 4:30pm on Sunday. Home COVID test negative. More
2823030 63 F WV 01/27/2025 FLU3
 SANOFI PASTEUR
 TFAA2443
Muscular weakness, Pain in extremity Muscular weakness, Pain in extremity
Patient called to say about a week after vaccine started to have bilateral leg pain and weakness. Sh... Patient called to say about a week after vaccine started to have bilateral leg pain and weakness. She's seeing doctor for issues and they are unsure of reason for on going leg problems. She was concerned about getting flubok in the future and wanted to know if she had had it in the past. More
2823031 38 F 01/27/2025 COVID19
 MODERNA
Tinnitus Tinnitus
Ringing began in both ears but stronger in my left ear after getting my first shot. It seems to happ... Ringing began in both ears but stronger in my left ear after getting my first shot. It seems to happen soon after getting the vaccination. More
2823032 80 F TN 01/27/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 CT3Z7
Unevaluable event Unevaluable event
NONE NONE
2823033 15 F WI 01/27/2025 COVID19
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 B0001
774N2
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
No adverse effect. Patient was given the covid moderna spikevax 12+ a day passed the beyond use date... No adverse effect. Patient was given the covid moderna spikevax 12+ a day passed the beyond use date (BUD). Vaccine was given on 1/22/25 and the BUD was 1/21/25. More
2823034 58 M OH 01/27/2025 COVID19
 PFIZER\BIONTECH
 ER8735
Pulmonary embolism, Thromboembolectomy Pulmonary embolism, Thromboembolectomy
billateral pulmonary embolism billateral pulmonary embolism
✓ ✓
2823035 72 M OH 01/27/2025 PPV
 MERCK & CO. INC.
Expired product administered Expired product administered
patient given expired vaccine. vaccine expired October 2024 patient given expired vaccine. vaccine expired October 2024
2823037 11 M NY 01/27/2025 FLU3
MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8523AA
U8259AA
U8264AA
Nausea; Nausea; Nausea Nausea; Nausea; Nausea
Patient had his well child visit scheduled with his sibling. While Dr. was assessing the patient... Patient had his well child visit scheduled with his sibling. While Dr. was assessing the patient's sibling, the nurses brought the patient and his father into another exam room to administer scheduled vaccinations. Patient received MenQuadfi, Adacel, and Fluzone. After administration, patient stood up and returned to original exam room with his sibling. Patient then began feeling nauseous and the nurses prompted him to sit down in the chair. The nurses brought him an emesis bag, water, and a cold wash cloth then Dr. was notified. Patient was prompted to lay on the exam table with feet elevated with a pillow, patient did so. Patient recovered on the table for about 10 minutes and once feeling better they checked out. More
2823038 44 M MI 01/27/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Unevaluable event Unevaluable event
none none
2823039 63 F ND 01/27/2025 FLU3
PNC20
VARZOS
 SANOFI PASTEUR
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 U8523AA
HN5978
4H79Y
Injection site erythema, Injection site pruritus, Injection site swelling; Injec... Injection site erythema, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pruritus, Injection site swelling More
Patient mentioned the injection sites on her left arm was red, swollen, and itchy. Patient mentioned the injection sites on her left arm was red, swollen, and itchy.
2823040 13 M IA 01/27/2025 COVID19
FLU3
HPV9
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 3044211
Z29D3
4013712
Underdose; Underdose; Underdose Underdose; Underdose; Underdose
Covid vaccine- was administered a smaller dose than required for age Covid vaccine- was administered a smaller dose than required for age
2823041 17 F KY 01/27/2025 HPV9
HPV9
MNQ
MNQ
 MERCK & CO. INC.
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 Y01065
Y01065
7GF79
7GF79
Asthenia, Fall, Head injury, Headache, Hyperhidrosis; Musculoskeletal stiffness,... Asthenia, Fall, Head injury, Headache, Hyperhidrosis; Musculoskeletal stiffness, Pallor, Sinus rhythm, Vision blurred; Asthenia, Fall, Head injury, Headache, Hyperhidrosis; Musculoskeletal stiffness, Pallor, Sinus rhythm, Vision blurred More
1053 - Patient was given vaccinations and stated she was okay. 1056 - Patient fell off of the bed (3... 1053 - Patient was given vaccinations and stated she was okay. 1056 - Patient fell off of the bed (3 ft) and hit right side of head on to concrete floor. Patient tensed up, as if she was going to seize, and EMS was called by APRN and school nurse was called to bring emergency bag by RN. Vital signs were started as patient arose to sitting position. She stated she did not know what happened that caused her to be on the floor but had a headache, weakness, and was sweating. Stated last thing she remembered was her vision going fuzzy, having a headache, and feeling weak following the Gardasil vaccination. She said this started after medication was put in to arm. Patient was alert and orientated x3, eyes equal and reactive with no tunneling, felt like she was weak with headache and sweating, paleness noted on assessment. 1059-1101- AP RN attempted to call guardian. 1103 - Guardian called back on patient's sister's cell phone. APRN spoke with guardian over situation. Guardian stated she would be on her way to the school now, estimated to arrive in 10 minutes. 1105 - Patient was moved on to bed with the standby assist x3. Wet towel was placed on head and legs were raised. Patient will remain NPO at this time. Stated she last ate at 0730, chicken biscuit and 2 apple juices. 1110 - EMS arrived, report given. 1112 - Orthostatic vital signs and blood glucose check was started by EMS. 1118 - Cardiac monitor was placed on patient by EMS. HR 96, normal sinus rhythm per EMS. 1132 - Guardian arrived and given explanation of what happened from staff, then spoke with EMS workers. 1143 - Patients guardian spoke with EMS and staff, chose to sign EMS paperwork to refuse transportation. Stated that she would take her to Urgent Care for head evaluation after leaving. She was still complaining of headache but weakness and vision had improved. Patient was walking but APRN walked her to car as standby assist. 1150 - Report was given to Urgent Care (RN). 1157 - Supervisor, RN, made aware of the situation. 1221 - Added report given to Urgent Care (RN). 1243 - Spoke with RN, about appropriate reporting. More
2823042 54 F CA 01/27/2025 TDAP
 SANOFI PASTEUR
 3ca07c1
Injected limb mobility decreased, Injection site pain, Pain in extremity Injected limb mobility decreased, Injection site pain, Pain in extremity
Patient is presenting to our office on 1/27/2025 for left arm soreness that has been present since r... Patient is presenting to our office on 1/27/2025 for left arm soreness that has been present since receiving the Tdap booster on 4/22/24. Patient states that she began having left deltoid muscle soreness 2 days after receiving the vaccine and the pain has not gone away or improved. Pain is described as a 7/10, non-radiating, constant pain that makes it difficult to carry any objects with her left arm. Patient has not been to the hospital or seen a doctor previously for this complaint. She has not tried any medications for pain. More
2823043 70 F FL 01/27/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8519DA
U8519DA
Arthralgia, Loss of personal independence in daily activities, Mobility decrease... Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Myalgia, Pain in extremity; Product administered at inappropriate site, Sleep disorder More
Patient reports she developed severe pain of left shoulder within hours of administration. She repo... Patient reports she developed severe pain of left shoulder within hours of administration. She reports her immunization was given in an improper location and was given too high. She is still experiencing pain from top of shoulder into neck muscles, and down elbow. She is currently in Physical Therapy. Motrin and heat are not improving pain. Range of motion has been affected. She has difficulty sleeping and dressing. She has been instructed to avoid laying on left side. She is a left side sleeper previous to this event. She has been instructed to ice it daily. She is being evaluated by one of her primary care physicians tomorrow. She will continue with Physical Therapy. She will also be scheduled acute follow up with the clinic who administered her flu vaccine when an appointment is available. More
2823044 77 F OH 01/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5y4tl
Erythema, Peripheral swelling Erythema, Peripheral swelling
red and some swelling in the right arm red and some swelling in the right arm
2823045 0.17 M TX 01/27/2025 DTAPHEPBIP
MMRV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 B532G
Y014305
LJ5281
Crying, Product administered to patient of inappropriate age; Crying, Product ad... Crying, Product administered to patient of inappropriate age; Crying, Product administered to patient of inappropriate age; Crying, Product administered to patient of inappropriate age More
nothing on site, MD did research on administration at this age and then spoke with parents and educa... nothing on site, MD did research on administration at this age and then spoke with parents and educated on S/s that they should look for. The Proquad was administered 1in below the Pediarix on the Rt thigh. Pt was alert and crying and observed for 20-30 min after administration before leaving the clinic with mother. More
2823046 52 F NM 01/27/2025 COVID19
FLU3
HEP
MMR
PNC20
TDAP
VARCEL
VARZOS
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
PFIZER\WYETH
SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 B0005
N7374
94565S
X026330
HN5980
3CA22C1
Y011017
D243K
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
Patient was inappropriately given varicella and shingrix vaccines. Patient should not have received ... Patient was inappropriately given varicella and shingrix vaccines. Patient should not have received both. Patient was informed of the error, given information on what to do in the case of increased symptoms, and provided the clinic number if she had any additional questions or concerns. The patient required a translator and was contacted by a translatory assisted and expressed understanding. More
2823047 56 F TX 01/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 4H79Y
Injection site vesicles Injection site vesicles
The next morning after Shingrix injection, the patient stated that four blisters appeared at injecti... The next morning after Shingrix injection, the patient stated that four blisters appeared at injection site, left arm. Patient stated that 5 days later the blisters resolved. More
2823063 18 F TN 01/27/2025 HEP
 MERCK & CO. INC.
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
no additional AEs/No other information provided; Caller reports adult formulation of RECOMBIVAX HB w... no additional AEs/No other information provided; Caller reports adult formulation of RECOMBIVAX HB was administered to a 18 year old female. No other information provided. No additional AEs/PQC reported. Caller declined AE follow up letter.; This spontaneous report was received from a pharmacist and referred to an 18-year-old female patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported. On 15-JAN-2025, the patient was vaccinated adult formulation with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 10 Microgram/1.0 ml intramuscular injection, 1.0 ml, administered intramuscularly for prophylaxis (lot #, anatomical site of administration and expiry date were not provided) (overdose) by Health Professional. No other information provided. No additional adverse events (AEs). Additional Information is not expected. More
2823064 14 F NY 01/27/2025 HPV4
 MERCK & CO. INC.
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
No additional AE; initiated the series with GARDASIL approximately 10 years ago. Patient never recei... No additional AE; initiated the series with GARDASIL approximately 10 years ago. Patient never received the subsequent doses in the series and would like to complete the series with GARDASIL 9; This spontaneous report was received from a nurse practitioner and refers to a currently 24-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date in 2015 (reported as approximately 10 years ago), the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, (0.5 milliliter, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) administered for prophylaxis. Patient never received the subsequent doses in the series and would like to complete the series with GARDASIL 9 (Inappropriate schedule of vaccine administered). No additional AE/No PQC (No adverse event). Additional information is not expected. More
2823065 U PA 01/27/2025 MMR
 MERCK & CO. INC.
 Y010046
Device leakage, Syringe issue, Underdose Device leakage, Syringe issue, Underdose
Merck Sterile Diluent syringe experienced suction when twisting the needle onto the hub of syringe; ... Merck Sterile Diluent syringe experienced suction when twisting the needle onto the hub of syringe; causing cap of syringe to pop off; MMRII was administered to a patient that was reconstituted using the defective sterile diluent syringe; caller unsure if patient received full amount of dose as some of the diluent leaked out due to the suction.; unsure if patient received full amount of dose; No additional AE; This spontaneous report was received from a nurse, concerning to a 15-month-old. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the syringe device of the sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion (lot # 1973242 has been verified for that product, expiration date reported and confirmed as 17-FEB-2026) experienced suction when twisting the needle into the hub of the syringe (Device malfunction), causing the cap to pop off (Syringe issue). Also, on an unknown date, using that defective syringe device to reconstituted, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA] (M-M-R II) injection, 0.5 milliliter, administered for prophylaxis (strength and route of administration were not provided; lot # Y010046 has been verified to be valid for this vaccine, expiration date reported and confirmed as 29-MAY-2026). (Poor quality device used). The reporter was unsure if the patient received the full dose as some diluent leaked out due to the suction (Device leakage) (Accidental underdose). No symptoms were reporter. No additional adverse event (No adverse event). More
2823066 U IL 01/27/2025 VARCEL
 MERCK & CO. INC.
 Y006522
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; The HCP reports that VARIVAX was inadvertently administered after suffering from a... No additional AE; The HCP reports that VARIVAX was inadvertently administered after suffering from a Temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 22-NOV-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/series, lot #Y006522, expiration date: 25-MAR-2026, administered for prophylaxis (strength and route of administration was not provided) inadvertently after suffering from a temperature excursion (Product storage error). Varicella virus vaccine live (oka/merck) (VARIVAX) reached -11.6 degree Celsius but previous excursions for 3 hours 5 minutes. But previous excursions could not be confirmed. No symptomatic adverse events were reported. Lot# and expiration date of the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) were unknown. No additional AE (No adverse event). More
2823067 F 01/27/2025 COVID19
TDAP
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 6024MF014A
X449Y
Computerised tomogram abdomen, Mesenteric vein thrombosis, Mesenteric venous occ... Computerised tomogram abdomen, Mesenteric vein thrombosis, Mesenteric venous occlusion, Ultrasound abdomen; Computerised tomogram abdomen, Mesenteric vein thrombosis, Mesenteric venous occlusion, Ultrasound abdomen More
Mesenteric vein thrombosis; Mesenteric venous occlusion; This serious case was reported by a consume... Mesenteric vein thrombosis; Mesenteric venous occlusion; This serious case was reported by a consumer via other manufacturer and described the occurrence of mesenteric vein thrombosis in a 41-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X449Y) for prophylaxis. Co-suspect products included COVID-19 VACCINE PROT. SUBUNIT (NVX COV 2373) (NOVAVAX COVID-19 VACCINE) (batch number 6024MF014A) for covid-19 immunization. Previously administered products included Boostrix (First dose received on an unknown date.), Boostrix (Second dose received on an unknown date.) and Boostrix (Third dose received on an unknown date.). Concurrent medical conditions included hepatic disease and drug allergy (Allergy to codeine and erythromycin). Concomitant products included azathioprine, prednisone, furosemide (Lasix) and spironolactone. On 01-OCT-2024, the patient received the 4th dose of Boostrix (intramuscular) and the 4th dose of NOVAVAX COVID-19 VACCINE (intramuscular). On 02-DEC-2024, 62 days after receiving Boostrix, the patient experienced mesenteric vein thrombosis (Verbatim: Mesenteric vein thrombosis) (serious criteria disability and GSK medically significant) and occlusion mesenteric vein (Verbatim: Mesenteric venous occlusion) (serious criteria disability). The outcome of the mesenteric vein thrombosis and occlusion mesenteric vein were not resolved. It was unknown if the reporter considered the mesenteric vein thrombosis and occlusion mesenteric vein to be related to Boostrix and Boostrix Pre-Filled Syringe Device. The company considered the mesenteric vein thrombosis and occlusion mesenteric vein to be unrelated to Boostrix and Boostrix Pre-Filled Syringe Device. 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: 13-JAN-2025 On 01-Oct-2024, the patient received dose 4 of Boostrix and dose 4 of Novavax. It was reported as the patient was not sure if she had the right kind of Tdap listed. her chart showed Tdap-adol/adult-Lot # X449Y. The reaction she believed was to the COVID vaccine. she received imaging several times a year to monitor her liver disease. On 26 September 2024, the ultrasound report showed color doppler imaging demonstrated no portal vein thrombus. Then when she went to visit another clinic on 02 December 2024, the CT scan revealed complete occlusion of the cephalic end of the superior mesenteric vein. For the portal vein thrombosis to go from small to non existent to total clot in the superior mesenteric vein in not even 3 months time did not seem to be a coincidence. The reporter's causality assessment between the Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula), and events mesenteric vein thrombosis and mesenteric venous occlusion was captured as possible.; Sender's Comments: Mesenteric vein thrombosis and Mesenteric venous occlusion are unlisted events which are considered unrelated to GSK vaccine Boostrix and Boostrix PRE-FILLED SYRINGE DEVICE. More
✓
2823068 F 01/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles again in 2020; I have been diagnosed with Shingles yesterday... Suspected vaccination failure; Shingles again in 2020; I have been diagnosed with Shingles yesterday; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingrix. On 01-JAN-2025, more than 2 years after receiving Shingrix, the patient experienced shingles (Verbatim: I have been diagnosed with Shingles yesterday). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles again in 2020). The outcome of the vaccination failure and shingles were not reported and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 12-JAN-2025 The patient had received Shingrix vaccine in 2017. She had been diagnosed with Shingles the day before reporting. She had Shingles again in 2020 as well. The patient enquired if the drug was not effective for some people. The patient wonder if there is a booster that would be effective. The patient symptoms were treated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2823069 U SC 01/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Nodule Nodule
large knot on my arm; This non-serious case was reported by a consumer via call center representativ... large knot on my arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling 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 local swelling (Verbatim: large knot on my arm). The outcome of the local swelling was not reported. It was unknown if the reporter considered the local swelling to be related to Shingles vaccine. It was unknown if the company considered the local swelling to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-JAN-2025 The reporter self-reported this case for himself/herself. The reporter need to know after getting a shingle shot it has left a large knot on my arm. The reporter asked was this normal More
2823070 U 01/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient never had shingles until got the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2823071 F NJ 01/27/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 43G92
Incorrect route of product administration Incorrect route of product administration
given a PRIORIX dose intramuscularly instead of subcutaneously; This non-serious case was reported b... given a PRIORIX dose intramuscularly instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 39-year-old female patient who received MMR (Priorix) (batch number 43G92, expiry date 01-MAY-2025) for prophylaxis. On 03-JAN-2025, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: given a PRIORIX dose intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was unknown. 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: 03-JAN-2025 The Healthcare professional reported that a female patient was given a Priorix dose intramuscularly instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route. More
2823072 8 F PA 01/27/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 9R5LC
Expired product administered Expired product administered
expired Havrix vaccine was administered; This non-serious case was reported by a other health profes... expired Havrix vaccine was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-year-old female patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis. On 14-JAN-2025, the patient received Havrix. On 14-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired Havrix vaccine was administered). The outcome of the expired vaccine used was unknown. 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: 14-JAN-2025 The office manager reported that an expired Havrix vaccine was administered to a patient which led to, expired vaccine used. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. This case had been link with US2025004475, reported by the same reporter.; Sender's Comments: US-GSK-US2025004475:Same reporter/Different patient More
2823073 46 M 01/27/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Allergy to vaccine, Bronchitis; Allergy to vaccine, Bronchitis Allergy to vaccine, Bronchitis; Allergy to vaccine, Bronchitis
new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,; Pat... new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,; Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic) and ALLERGY TO VACCINE (new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,) in a 46-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for Immunisation. Co-suspect products included non-company products Influenza vaccine for Immunisation and Dupilumab (Dupixent) solution for injection for Asthma and Eczema. Concurrent medical conditions included Eczema and Asthma. On 26-Sep-2023, the patient started Dupilumab (Dupixent) (Subcutaneous use) 600 milligram once a day. On 10-Oct-2023, Dupilumab (Dupixent) (Subcutaneous use) dosage was changed to 300 milligram. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. In October 2023, the patient experienced BRONCHITIS (Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic). On an unknown date, the patient experienced ALLERGY TO VACCINE (new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,). In 2023, BRONCHITIS (Patient reports had bronchitis 2 weeks ago that was resolved with an antibiotic) had resolved. At the time of the report, ALLERGY TO VACCINE (new allergies to influenza vaccine and moderna covid MRNA (messenger RiboNucleic Acid) vaccine,) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that eczema related symptoms were as severe over the past week just as they were prior to therapy. Physician was aware of it. These severe symptoms continued to be the same since the start of therapy with no reported adverse event. It was unknown if physician was aware of it. The bronchitis was resolved with taking antibiotics. Physician was aware of it. More
2823074 F NY 01/27/2025 COVID19
COVID19
 MODERNA
MODERNA
 8080803
8080803
Erythema, Hypokinesia, Limb discomfort, Myalgia, Pain in extremity; Rash macular Erythema, Hypokinesia, Limb discomfort, Myalgia, Pain in extremity; Rash macular
slight arm pain would happen within the 24 hour period, but the pain was really intense/excruciating... slight arm pain would happen within the 24 hour period, but the pain was really intense/excruciating pain; There's just a slight discomfort when I lift my arm a certain way; I couldn't move my arm; Arm redness; The arm had a big blotch of red, about 4 to 5 inches in length and about 2 inches in width, and the pain lasted for a week and a half; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (slight arm pain would happen within the 24 hour period, but the pain was really intense/excruciating pain), LIMB DISCOMFORT (There's just a slight discomfort when I lift my arm a certain way), HYPOKINESIA (I couldn't move my arm), ERYTHEMA (Arm redness) and RASH MACULAR (The arm had a big blotch of red, about 4 to 5 inches in length and about 2 inches in width, and the pain lasted for a week and a half) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080803) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in July 2024 and Muscle pain. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Patient received 6 shots since 2019) in September 2023; for Muscle pain: Lipitor. Past adverse reactions to the above products included No adverse effect with COVID-19 Vaccine and Lipitor. On 05-Jan-2025, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 05-Jan-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PAIN IN EXTREMITY (slight arm pain would happen within the 24 hour period, but the pain was really intense/excruciating pain). In January 2025, the patient experienced LIMB DISCOMFORT (There's just a slight discomfort when I lift my arm a certain way), HYPOKINESIA (I couldn't move my arm), ERYTHEMA (Arm redness), RASH MACULAR (The arm had a big blotch of red, about 4 to 5 inches in length and about 2 inches in width, and the pain lasted for a week and a half) and MYALGIA (muscle pain). In January 2025, ERYTHEMA (Arm redness) and RASH MACULAR (The arm had a big blotch of red, about 4 to 5 inches in length and about 2 inches in width, and the pain lasted for a week and a half) had resolved. At the time of the report, PAIN IN EXTREMITY (slight arm pain would happen within the 24 hour period, but the pain was really intense/excruciating pain) outcome was unknown, LIMB DISCOMFORT (There's just a slight discomfort when I lift my arm a certain way) and MYALGIA (muscle pain) had not resolved and HYPOKINESIA (I couldn't move my arm) was resolving. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient had slight arm pain would happen within the 24 hour period, but the pain was really intense. The arm had a big blotch of red, about 4 to 5 inches in length and about 2 inches in width, and the pain lasted for a week and a half. Patient couldn't move her arm. When lifted it, had excruciating pain. Normally when patient get the shot, move her arm around. Patient didn't have anything like that with the other 6 shots that received since 2019. And the redness got worse within the weeks' time. Then it started going down and patient could move the arm little bit. Patient still have a little bit of more like muscle pain. It wasn't like the injection pain. It was a muscle pain. It was the same kind of pain patient experienced when she was on Lipitor and they increased dosage, the muscle pain, that kind of pain. There's just a slight discomfort when patient lift up the arm a certain way, but the redness was gone. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-781695 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781695:male case More
2823075 M 01/27/2025 COVID19
 MODERNA
Brain fog, Headache Brain fog, Headache
headaches; brain fog; This spontaneous case was reported by a patient and describes the occurrence o... headaches; brain fog; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headaches) and BRAIN FOG (brain fog) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (headaches) (seriousness criterion medically significant) and BRAIN FOG (brain fog) (seriousness criterion medically significant). At the time of the report, HEADACHE (headaches) and BRAIN FOG (brain fog) had not resolved. No concomitant medications were reported. It was reported that patient had received the covid vaccine when it came out, the first dose was fine then a month later, received the 2nd shot. It was from a different batch. Patient developed headaches, a terrible brain fog. Patient stated that mid-April will be the 4th year that have suffered with this. Patient would like to know if Moderna would be able to help, or if something to reverse the shot. It also stated that patient was permanently disabled from the Moderna shot and would like to get this head out that Moderna and that vaccine did a job to the patient. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report. More
2823076 70 M 01/27/2025 COVID19
 MODERNA
COVID-19 COVID-19
COVID19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (C... COVID19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 07-Jan-2025, the patient experienced COVID-19 (COVID19). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) at an unspecified dose and frequency. In January 2025, COVID-19 (COVID19) had resolved. No concomitant medication was reported. He had received five doses of the Moderna covid-19 vaccine since 2021 and was recently diagnosed with covid-19 this month, with detection on 7-Jan-2025. He reports having taken Paxlovid for five days and currently felt well, stating, no problem right now, no coughed, nothing right now. He was feeling very well right now. He believes he was fully recovered right now and had not received a covid-19 vaccine for the 2024-2025 season. No treatment medication was reported. More
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