🏥 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 💀 🏥 🚑 ♿ ⚠️
2860132 22 M IL 09/20/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052669
U8832BA
Fall, Loss of consciousness, Syncope; Fall, Loss of consciousness, Syncope Fall, Loss of consciousness, Syncope; Fall, Loss of consciousness, Syncope
Patient fainted and slipped out of the chair and was unconscious for about 10 seconds. Regained conc... Patient fainted and slipped out of the chair and was unconscious for about 10 seconds. Regained conciousness and stated that he had a history of syncope after vaccines and blood draws. More
2860133 83 F FL 09/20/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 U8764DB
Z006076
Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth More
Patient presented with a red, warm, swollen, itchy arm at site of injection. Patient presented with a red, warm, swollen, itchy arm at site of injection.
2860134 84 M FL 09/20/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 U8764DB
Z006076
Erythema, Pruritus; Erythema, Pruritus Erythema, Pruritus; Erythema, Pruritus
Patient presented with a red, itchy arm and was suggested to use an ice pack, take antihistamines an... Patient presented with a red, itchy arm and was suggested to use an ice pack, take antihistamines and use hydrocortisone cream. More
2860135 38 F CO 09/20/2025 FLU3
 SANOFI PASTEUR
 TFAA2504
Paraesthesia, Peripheral coldness Paraesthesia, Peripheral coldness
Patient complained of tingling and cold feeling in left arm, hand and fingers shortly after being va... Patient complained of tingling and cold feeling in left arm, hand and fingers shortly after being vaccinated. More
2860136 36 M MO 09/20/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052583
U8790AA
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Patient called on 9/20 ~11:35am and reported that he woke up this morning with a red bump on his arm... Patient called on 9/20 ~11:35am and reported that he woke up this morning with a red bump on his arm where he got the covid vaccine. Patient reports that it is warm to the touch and is painful. Pt reports that there is no rash or fever. Patient reported taking ibuprofen, tums, and benadryl to help. RPH recommended patient take pepcid and stop using tums. Counseled that should rash appear, bump become more painful or gets larger, or gets a fever, he should seek medical attention. More
2860137 56 F CA 09/20/2025 FLU3
FLU3
VARZOS
VARZOS
 SEQIRUS, INC.
SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Arthralgia, Back pain, Burning sensation, Condition aggravated, Feeling cold; In... Arthralgia, Back pain, Burning sensation, Condition aggravated, Feeling cold; Injection site erythema, Injection site urticaria, Pain in extremity, Pyrexia, Tenderness; Arthralgia, Back pain, Burning sensation, Condition aggravated, Feeling cold; Injection site erythema, Injection site urticaria, Pain in extremity, Pyrexia, Tenderness More
Red welt aroun 1.5 x 3 cm raised welt like hive appeared at injection site noticed around 11 pm. Le... Red welt aroun 1.5 x 3 cm raised welt like hive appeared at injection site noticed around 11 pm. Left arm experiencing noticeable intense pain and sensitivity to touch since injection. Woke up at 1 feeling feverish. Woke up at 2 am feeling cold (room is 77 F), continued throughout the day. Welt appeared to enlarge to 1 x 3 inches. Thursday. 2.5x3.5 inches by friday. Jount pain all over body feels like fire right pinky, left knee, extreme back pain, took tylenol More
2860138 70 M GA 09/20/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 F4AC3
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was received an extra dose of RSV, no adverse events noted. Patient was received an extra dose of RSV, no adverse events noted.
2860139 56 M WA 09/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 GJ952
Bell's palsy, Ear discomfort, Facial paralysis, Facial paresis, Influenza l... Bell's palsy, Ear discomfort, Facial paralysis, Facial paresis, Influenza like illness More
Patient states after about a month of getting the second dose of Shingrix, experienced right-side fa... Patient states after about a month of getting the second dose of Shingrix, experienced right-side facial weakness/paralysis and was diagnosed with Bell's Palsy. But initial symptoms were flu-like from the vaccine and felt like his right ear had an ear infection (but it wasn't). He is here today 9/20/25 to pick up his first treatment rx of valacyclovir 1g tabs to be taken 3 tabs once daily for 7 days. More
2860140 73 F SC 09/20/2025 COVID19
COVID19
 MODERNA
MODERNA

Body temperature increased, Fatigue, Headache, Hypotension, Nausea; Pain in extr... Body temperature increased, Fatigue, Headache, Hypotension, Nausea; Pain in extremity More
headache, tired, low blood pressure, soar arm, feel like throwing up, slight elevated temp. headache, tired, low blood pressure, soar arm, feel like throwing up, slight elevated temp.
2860141 67 F CA 09/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Burning sensation, Injected limb mobility decreased, Injection site pain, Pain Burning sensation, Injected limb mobility decreased, Injection site pain, Pain
The shot was administered in my upper left arm at approximately 2:45pm. My arm began feeling sore af... The shot was administered in my upper left arm at approximately 2:45pm. My arm began feeling sore after dinner, 6:30pm. The soreness is in my left bicep. The pain began to throb around 9:00pm and there was a sort of burning sensation down to my thumb. I applied an icepack for relief. I was unable to lift my left arm, as it became so painful. My husband helped me take off my top. I took 2 advil and laid down in bed. I Finally found relief from the throbbing pain down my left arm by laying on my right side, with a pillow between my side and my arm. Today, after taking 2 advil, I'm not experiencing the throbbing but I'm not able to lift my arm. It's mainly painful in my left bicep to move at this time. 10:10am. I will be applying an ice pack throughout today. I don't have a headache, which is great. More
2860142 36 F CO 09/20/2025 FLU3
 SEQIRUS, INC.
 Ax4603a
Pruritus, Rash erythematous, Rash papular Pruritus, Rash erythematous, Rash papular
Pt had first flu shot in left arm at 1930 in left deltoid, while being observed she had been itching... Pt had first flu shot in left arm at 1930 in left deltoid, while being observed she had been itching left arm and had raised red rash, pt friend gave her 50mg of Benadryl and rash resolved, vs obtained and patient was sent home with her husband with instructions to seek medical help if rash reappeared. More
2860143 30 M OH 09/20/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FF2587
FF2587
EW0183
EW0183
Depression, Fatigue, Generalised anxiety disorder, Lethargy, Malaise; Nasal sept... Depression, Fatigue, Generalised anxiety disorder, Lethargy, Malaise; Nasal septal operation, Obstructive sleep apnoea syndrome, Rhinoplasty, Sleep study abnormal, Weight increased; Depression, Fatigue, Generalised anxiety disorder, Lethargy, Malaise; Nasal septal operation, Obstructive sleep apnoea syndrome, Rhinoplasty, Sleep study abnormal, Weight increased More
General malaise and fatigue led to sleep therapy referral and diagnoses of Moderate to Severe Obstru... General malaise and fatigue led to sleep therapy referral and diagnoses of Moderate to Severe Obstructive Sleep Apnea. Therapy has been ongoing, and two surgeries (septoplasty and rhinoplasty) have been conducted as part of treatment, with sleep therapy continuing. Still experiencing fatigue and malaise. Have not sought treatment for weight gain and anxiety/depression but intend to soon. More
✓
2860144 66 F PA 09/20/2025 COVID19
 PFIZER\BIONTECH
 my9548
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
at injection site, patients arm became swollen, red, and sore the night of the vaccination. at injection site, patients arm became swollen, red, and sore the night of the vaccination.
2860145 28 M AK 09/20/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0162
EW0162
Paternal exposure before pregnancy; Paternal exposure before pregnancy Paternal exposure before pregnancy; Paternal exposure before pregnancy
My wife and I currently have 3 healthy children (12, 9, 6 years old) all born prior to me being forc... My wife and I currently have 3 healthy children (12, 9, 6 years old) all born prior to me being forced to receive the COVID shot. Since then, we have had two separate births that were non-viable. Our daughter was born on March X, 2024 at 32 weeks and passed away shortly after due to complications with Pulmonary Hypoplasia. We were told by doctors that this was a "random fluke" since we had 3 previous children that were all born healthy. On August X, 2025 our son was born at 34 weeks with almost identical health issues. He also succumbed to Pulmonary Hypoplasia shortly after birth. We are still awaiting autopsy and genetic results to rule out potential recessive issues, but the only difference between our 3 healthy kids, and our 2 that have passed away is the COVID shot I received back in 2021. More
2860146 77 M TX 09/20/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Balance disorder, Body temperature increased, Dysstasia, Feeling cold, Hand-eye ... Balance disorder, Body temperature increased, Dysstasia, Feeling cold, Hand-eye coordination impaired; Headache, Loss of control of legs, Nausea, Nervousness More
Having countless flu shots (every year) plus all COVID shots I have never experienced any reaction. ... Having countless flu shots (every year) plus all COVID shots I have never experienced any reaction. Approximately ten hours after injection I started feeling very cold and shaky. Took temp.; was 103. Lost control of arms and lets; difficult to stand or type on keyboard. Slight loss of balance, headache, nausea. More
2860147 82 F GA 09/20/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052133
3052133
Chills, Headache, Injection site pain, Malaise, Nausea; Pain, Pyrexia Chills, Headache, Injection site pain, Malaise, Nausea; Pain, Pyrexia
Nausea, chills, body aches, headaches, fever, soreness at injection site, malaise. Nausea, chills, body aches, headaches, fever, soreness at injection site, malaise.
2860148 1.5 M MN 09/20/2025 DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR


Crying, Decreased appetite, Dysstasia, Gait disturbance, Hypersomnia; Irritabili... Crying, Decreased appetite, Dysstasia, Gait disturbance, Hypersomnia; Irritability, Myalgia, Pain, Pyrexia, Rash; Retching, Screaming, Sleep disorder More
On Monday 9/15 my son received the DTaP, HIB (PedvaxHIB), and PCV20 (Prevnar20) vaccines. The follow... On Monday 9/15 my son received the DTaP, HIB (PedvaxHIB), and PCV20 (Prevnar20) vaccines. The following day Tuesday 9/16 my son would not stand up nor walk without screaming cry due to extreme muscle aches that he?s never experienced before. Normally he is a little sore the day after the vaccine but has never had extreme muscle aches to the point where he won?t stand. Throughout Tuesday he slept a lot and was extremely hot running a really high fever of 101. He was having trouble sleeping because he could not move or stretch in his sleep causing him to fuss and disturbed sleep. Wednesday 9/17 he would still fuss a lot but I was able to get him to stand but he would not walk or bend down to grab things without crying, he also would not eat anything but a little bit of fruit and still was warm running a fever of 99-100. Thursday 9/18 I had taken him to daycare as he was able to sleep through the night and didn?t feel very warm, after taking him in I received a call from his daycare 10 minutes later explaining to me that he was very fussy, gagging, and had a fever of 101 so I had my mother pick him up and take him to her house as she stated to me throughout the day he was now bending over and grabbing things and walking normal and eating and playing around back to normal behavior. When I returned to get him he showed no signs of symptoms and had no fever. Come Friday 9/19 he has no symptoms and present day 9/20 he does have bumps all on his back that almost look like a healing reaction. Throughout the week I did give him baby Tylenol every 6-8 hours as instructed on the box but it didn?t seem like it was helping earlier in the week. We kept him very hydrated but symptoms did not go away until Thursday evening. More
2860149 82 M PA 09/20/2025 COVID19
 MODERNA
Cough, Respiratory tract congestion Cough, Respiratory tract congestion
The next morning I had a constant cough and congestion. The next morning I had a constant cough and congestion.
2860150 58 M MA 09/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site reaction, Injection site warmth, Rash erythematous, Rash papular,... Injection site reaction, Injection site warmth, Rash erythematous, Rash papular, Rash pruritic More
Patient noticed a rash at the vaccination site that first appeared 1 week after receiving the vaccin... Patient noticed a rash at the vaccination site that first appeared 1 week after receiving the vaccine. He describes the rash as red, slightly itchy, and slightly raised and warm, but not swollen or painful. He also does not have a fever at the time of reporting. He did not notice any rash or local reaction before today. His wife drew a circle around the rash for monitoring purposes. I advised him to take cetirizine, then call his doctor if the rash does not improve or gets worse. More
2860151 8 F TN 09/20/2025 FLU3
 SANOFI PASTEUR
 u8832BA
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
The patient was given the flublok when they should have been given fluzone due to their age. The pat... The patient was given the flublok when they should have been given fluzone due to their age. The patient has not had any adverse reactions or symptoms related to getting the vaccine. More
2860152 66 F MA 09/20/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 U8837DA
Y019158
Injection site erythema, Injection site rash, Injection site warmth; Injection s... Injection site erythema, Injection site rash, Injection site warmth; Injection site erythema, Injection site rash, Injection site warmth More
RASH, REDNESS, WARMTH AND RED PATCH ON LEFT ARM - SITE OF CAPVAXIVE ADMINISTRATION RASH, REDNESS, WARMTH AND RED PATCH ON LEFT ARM - SITE OF CAPVAXIVE ADMINISTRATION
2860153 78 M CO 09/20/2025 FLU3
 SANOFI PASTEUR
Typical aura without headache Typical aura without headache
I got a migraine aura the next day and again this morning. Just the aura; not a headache I got a migraine aura the next day and again this morning. Just the aura; not a headache
2860154 47 M 09/20/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 763184
763184
301558a
301558a
Dyspnoea, Gout, Haemoptysis, Magnetic resonance imaging thoracic abnormal, Perip... Dyspnoea, Gout, Haemoptysis, Magnetic resonance imaging thoracic abnormal, Peripheral coldness; Pulmonary thrombosis, Tenderness; Dyspnoea, Gout, Haemoptysis, Magnetic resonance imaging thoracic abnormal, Peripheral coldness; Pulmonary thrombosis, Tenderness More
Week after first shot Gout in my left big toe still tender in the cold. 4 weeks after second shot c... Week after first shot Gout in my left big toe still tender in the cold. 4 weeks after second shot coughing up frothy blood trouble breathing More
2860155 35 F FL 09/20/2025 FLU3
 SANOFI PASTEUR
 u8823aa
Dizziness, Vomiting Dizziness, Vomiting
Pt began throwing up and felt light headed about 5-10 minutes after shot. After sitting down and hav... Pt began throwing up and felt light headed about 5-10 minutes after shot. After sitting down and having some water, she was feeling better in a few minutes and left the store. More
2860156 28 F UT 09/20/2025 FLU3
 SANOFI PASTEUR
 U8832CA
Injection site erythema, Injection site inflammation, Local reaction Injection site erythema, Injection site inflammation, Local reaction
Localized site reaction including redness and inflammation below the injection site Localized site reaction including redness and inflammation below the injection site
2860157 34 F TX 09/20/2025 FLU3
FLU3
PNC20
PNC20
 SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH



Arthralgia, Bone pain, Chest pain, Immediate post-injection reaction, Injection ... Arthralgia, Bone pain, Chest pain, Immediate post-injection reaction, Injection site pain; Lymph node pain, Musculoskeletal pain, Neck pain, Paraesthesia, Pyrexia; Arthralgia, Bone pain, Chest pain, Immediate post-injection reaction, Injection site pain; Lymph node pain, Musculoskeletal pain, Neck pain, Paraesthesia, Pyrexia More
Immediate site pain and armpit lymph node pain through the evening followed by fever, joint pain, ne... Immediate site pain and armpit lymph node pain through the evening followed by fever, joint pain, neck pain, collarbone pain, shoulder blade pain and shoulder pain, and now a chest burning sensation with tingly fingers. More
2860158 78 F CA 09/20/2025 COVID19
 MODERNA
 3052669
Mobility decreased, Pain in extremity Mobility decreased, Pain in extremity
Patient reports sore arm and cannot life up shoulder due to sore arm Patient reports sore arm and cannot life up shoulder due to sore arm
2860159 50 F OR 09/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2HJ99
Dizziness, Feeling hot, Loss of consciousness, Nausea, Syncope Dizziness, Feeling hot, Loss of consciousness, Nausea, Syncope
Patient came for vaccine appointment. She was first given the flu and then the shingles at 11:30 am ... Patient came for vaccine appointment. She was first given the flu and then the shingles at 11:30 am on 9/20/2025. Symptoms started after administration of the shingles vaccine. Patient became light headed and then fainted. Upon waking up, patient reported symptoms of dizziness, light headed, hot, and nauseous. Patient has a history of fainting with blood draws and experiences similar symptoms, but typically recovers quickly. However, this time when the patient experienced the symptoms, the patient did not experience an improvement of symptoms for an hour. Emergency medical services were contacted and continued monitoring the patient. BP was <100/50 and HR was 51 bpm. Patient does not have any history of heart conditions, diabetes, asthma/lung disease, or immunocompromised. More
2860160 76 F MD 09/20/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 407254
407254
Blood pressure increased, Dizziness, Dyspnoea, Hypoaesthesia oral, Neck pain; Pa... Blood pressure increased, Dizziness, Dyspnoea, Hypoaesthesia oral, Neck pain; Paraesthesia oral, Tremor More
Patient received the vaccine and displayed no signs of adverse event. She walked into another aisle ... Patient received the vaccine and displayed no signs of adverse event. She walked into another aisle and immediately felt dizzy and had a pain behind her neck. She described having a numbness or tingling of her tongue a few minutes later and had heavy breathing. She began shaking but was able to communicate. She stayed seated in a chair and drank a few sips of water. Emergency medical services was called and the pharmacist and on-site police officer stayed with the patient. By the time emergency medical services arrived, the patient appeared less distressed. EMS asked if the patient wanted to go to the hospital. She declined. They checked her heart rate and blood pressure. Heart rate was normal, her blood pressure was slightly elevated ~140/90. Emergency medical services advised that she should follow up with her PCP or go to urgent care and get an allergy test done to verify what sort of reaction occurred. More
2860161 50 M KY 09/20/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 039k20a
039k20a
039k20a
039k20a
Acoustic stimulation tests, Chemotherapy, Computerised tomogram abnormal, Comput... Acoustic stimulation tests, Chemotherapy, Computerised tomogram abnormal, Computerised tomogram neck, Ear pain; Gastrointestinal tube insertion, Lymphadenopathy, Neck pain, Pain in jaw, Positron emission tomogram; Radiotherapy, Stomatitis, Swallow study, Tongue neoplasm malignant stage unspecified, Tonsil cancer; Tooth extraction, Tracheostomy, Trismus More
Within a week of getting the vaccine I got sores in my mouth that lasted several weeks , had one ver... Within a week of getting the vaccine I got sores in my mouth that lasted several weeks , had one very sore one on the left back side of my tongue under it , a few weeks later I started getting pains from my left jaw to left ear and pains in the back of my neck and limited jaw opening only 2 fingers wide,I went to chiropractor thinking it was tmj , it helped my neck but not my jaw about 2 months later I had a knot pop up under my chin on the left side I went to my primary dr and found it was my lymphoid swollen in December 2021 I had a ct scan which showed cancer in my left tonsil and left tongue base , i saw dr at cancer center , he recommended removing all my teeth a feeding tube and a trach . The trach was for anesthesia to remove my teeth and the feeding tube because of the limited jaw opening, on February 12 2022 I went to hospital to have my teeth removed, trach and feeding tube, I started radiation 35 treatments and 3 chemo treatments at cancer center I finished treatment in May 2022 , I still have limited jaw opening and not able to use dentures I had the trach removed in July 2022 and feeding tube removed in December 2022 I was off work from February to December 2022 More
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2860162 81 M TX 09/20/2025 PNC20
 PFIZER\WYETH
 ma2502
Erythema, Urticaria Erythema, Urticaria
pt presented with red whelp on left arm at the pharmacy 09/20 @ 9am, went to his physician and got d... pt presented with red whelp on left arm at the pharmacy 09/20 @ 9am, went to his physician and got doxycycling mono 100mg and a medrol dose pack, called in the evening at about 4pm saying it was subjectively getting worse and wanted to go to the emergency room. More
2860163 68 M OK 09/20/2025 FLU3
PNC21
RSV
TDAP
 SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS



Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
NONE REPORTED ; UNABLE TO CONTACT PATIENT; PT RECEIVED 2ND DOSE AREXVY ON 9/13/25 AND 1ST DOSE ON 02... NONE REPORTED ; UNABLE TO CONTACT PATIENT; PT RECEIVED 2ND DOSE AREXVY ON 9/13/25 AND 1ST DOSE ON 02/07/25; PATIENT WAS NOT SURE AND AND PHARMACIST WAS NOT AWARE OF THE 1ST DOSE AREXVY More
2860164 72 F 09/20/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Arthralgia, Gait inability, Headache, Pyrexia Arthralgia, Gait inability, Headache, Pyrexia
Patient stated her knees and hips felt like "ice picks" and "could not walk in her ho... Patient stated her knees and hips felt like "ice picks" and "could not walk in her house". She experienced a "powerful" headache and 101.6 degree fever. This all lasted for about 24 hours. More
2860165 52 F GA 09/20/2025 FLU3
 SANOFI PASTEUR
 U8790AA
Injection site pain, Pruritus, Rash, Rash erythematous Injection site pain, Pruritus, Rash, Rash erythematous
Pt has a large rash and it is painful. It is red and she is having pain at the injection site. Pt st... Pt has a large rash and it is painful. It is red and she is having pain at the injection site. Pt states she has been rubbering it which she states could have made it worse. She states this started to occur a few a hours after taking the injection. Advised pt to use cold compress, take Benadryl oral for the itching, and use hydrocortisone cream . Pt was advised this when she came back to the pharmacy today.. Called pt back this afternoon and she states she took motrin and use benadryl cream and the itching/pain has stopped, More
2860166 77 F OR 09/20/2025 FLU3
 SANOFI PASTEUR
 u18763ha
Extra dose administered Extra dose administered
patient received 2 flu shots. She received one on 9/4/25 and another on 9/20/25. patient received 2 flu shots. She received one on 9/4/25 and another on 9/20/25.
2860167 70 F AL 09/20/2025 PNC20
UNK
 PFIZER\WYETH
UNKNOWN MANUFACTURER
 LK6650
LN4927
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Pt received 2 pneumo20 shots = no adverse events reported Pt received 2 pneumo20 shots = no adverse events reported
2860168 25 M NV 09/20/2025 COVID19
 MODERNA
 139904
Dizziness, Hyperhidrosis, Malaise, Pain in extremity, Tinnitus Dizziness, Hyperhidrosis, Malaise, Pain in extremity, Tinnitus
I was on orders and received the shot near the base we were training at. The following morning after... I was on orders and received the shot near the base we were training at. The following morning after receiving the shot I felt sweaty and was able to move normally. My ears would ring loudly for maybe 20 minutes while I was sitting down and I felt like I would black out. I remember my arm being sore and not feeling well as we flew. More
2860169 3 M CA 09/20/2025 MMR
MMR
MMR
MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y017527
Y017527
Y017527
Y017527
Y017527
Abdominal pain upper, Aggression, Anger, Blunted affect, Chromaturia; Cough, Dec... Abdominal pain upper, Aggression, Anger, Blunted affect, Chromaturia; Cough, Decreased appetite, Defiant behaviour, Diarrhoea, Emotional distress; Faeces hard, Fatigue, Flushing, Injection site pain, Irritability; Listless, Loss of personal independence in daily activities, Middle insomnia, Oropharyngeal erythema, Poor quality sleep; Pyrexia, Restless legs syndrome, Skin warm, Sleep terror, Somnolence More
Name: MMR Manufacturer: Merck Sharp & Dohme Lot: Y017527 Expiration date:10/21/2026 Monday 6/3... Name: MMR Manufacturer: Merck Sharp & Dohme Lot: Y017527 Expiration date:10/21/2026 Monday 6/30 MMR administered at 11:30am Complains of soreness at injection site immediately following Long afternoon nap 1:30-5:40 very unusual prolonged sleep normally naps about 1 and a half hours Irritable flushing no fever but appears feverish Low appetite Complains of soreness at injection site Tuesday 7/1 Blunted affect at times irritable dry cough noted throughout day and night, restless leg type movements, fitful sleep, night wakening requesting water Declines preferred activity due to site soreness or malaise? Loose stool X 3 afternoon/evening, unformed no diet changes Wednesday 7/2 dry cough noted throughout day and night Blunted affect Loose stool X 2 morning and afternoon Thursday 7/3 dry cough noted throughout day and night Loose stool x 3 Bedtime listless Night: Night coughing X3 restless leg patterns Awakes upset flush and warm to touch (no fever) Friday 7/4 Am cough Blunted affect as baseline, clingy Saturday 7/5 Intermittent cough Fatigues more quickly Meltdowns with dissatisfaction Loose stool X 1 Blunted affect as baseline Sunday 7/6 Intermittent cough Blunted affect as new baseline Monday 7/7 Went to MD office, redness in throat noted Tuesday dark urine during afternoon Tuesday Night Wet-full diaper Midnight night terror waking with 102 fever checked a few times between 2am 102.9, drank 8 oz pedialyte mix Hard stool Wed 7/9 Called MD to check status, looking for signs or strategies to manage high fever if re-occurs. Long nap/drowsy during car ride Prefers liquids to solid foods No fever temp but warm to touch 5:00 irritable Wed 7/16 cough continues- wake up, yelling about mom taking out trash, blinds, donning clothings, throws diaper, attempts to kick and pinch mom during routine tasks. Wednesday: pinching throwing, and quick to meltdown difficulty separating from mom Thursday July 17th Cough persists, night time cough and restless sleep 3am and 4 am resumed sleep, similar awaking with distruption, you moved my pillow. C/o ?tummy hurts? Quick fight or flight response with brother sitting next to on couch in AM. Didn?t want to go to preschool, needed extra time and coaching. Afternoon/evening ?on edge? during transitions, fell asleep during short 4pm car ride, seemed constipated, firmer stools, time consuming to empty Night: Still coughing but less than last night July 29th Afternoon/evening 4 incidence of 4x successive dry cough. Ongoing differences in stool consistency Behaviorally short tempered, irritable and easily disregulated/defiant. More
2860170 4 F NY 09/20/2025 MMR
 MERCK & CO. INC.
Eyelid pain, Periorbital swelling, Swelling of eyelid, Urticaria, Visual impairm... Eyelid pain, Periorbital swelling, Swelling of eyelid, Urticaria, Visual impairment More
Pts left eye was puffy, and welted. She couldn't see out of it. And it was very swollen. And it... Pts left eye was puffy, and welted. She couldn't see out of it. And it was very swollen. And it hurt to blink. More
2859887 14 M KS 09/19/2025 MMR
 MERCK & CO. INC.
 X026330
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; temperature excursion; This spontaneous report was received from a nurse and refer... No additional AE; temperature excursion; This spontaneous report was received from a nurse and referred to two patients of unknown age and gender. The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported. On unknown dates, the patients were vaccinated with dose of improper stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot # X026330, expiration date: 07-NOV-2025; dose, dose number, strength, formulation, route and anatomical site were unknown), which was reconstituted with sterile diluent (HOLLISTER-STIER STERILE DILUENT) (lot # and expiration date were not reported) for prophylaxis (product storage error). The temperature excursions occurred on 20-AUG-2025 and 02-SEP-2025. The storage temperature of the vaccine was reported as 1.2 degrees Celsius for 1 hour and 43 minutes. There was a previous temperature excursion at 10.3 degrees Celsius for 35 minutes. No additional adverse event (no adverse event). The outcome of the events was unknown. This is an invalid report due to multiple unknown patients Follow up information was received from a nurse on 11-Sep-2025, referring to the patient. The case was updated to a valid case due to patient's identifier added. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE) Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid), Menquadfi (Meningococcal vaccine A/C/Y/W conj (tet tox)), Engerix b (Hepatitis b vaccine rHBsAg (yeast)), Havrix (Hepatitis a vaccine inact) . On 08-Sep-2025, the patient was vaccinated with first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X026330, expiration date: 07-Nov-2025), 1 dosage form administered by Subcutaneous route in left upper arm, which was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (lot # and expiration date were not reported) as prophylaxis after temperature excursion (product storage error). The medication error occurred at the point of storage in clinical practice. Preliminary of by VFC consult. The vaccine was resumed on 03-Sep-2025. The vaccine was used according to the instruction leaflet. Operator of vaccine was reported as healthcare professional. Temperature excursion occurred as a result of a reading from a digital data logger. Temperature excursions outside of manufacturer-recommended storage ranges. The refrigerator unit DDLs experienced temperature fluctuations outside of the recommended storage ranges due to the doors being open for brief periods of time; during each event the unit doors were kept closed until temperatures stabilized to normal storage ranges. Each event was reported to the VFC program, and approval for use was given for vaccines each time. After 2 excursions occurring within a short timeframe, It was requested inspection and maintenance services for the unit. An inspection found an issue with the thermostat sensor of the refrigerator, leading to over connection of temperature changes. The unit was repaired and the thermostat calibrated along with DDL to ensure accurate readings. No further issues with temperatures. Due to subsequent excursions, it was told to perform stability analysis on the vaccines in the refrigerator based on the cumulative times and temperature of all temperature fluctuations. Although it was previously informed that vaccines can be continued to use, it was told to wait for stability analysis.; Reporter's Comments: Keywords : MUL; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02869093-02869059 , CLIC number : , ESTAR number : , IRMS number : 500UW00000kzgvzYAA|11092025230033|1237 , Central date : 2025-09-12 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2327758 , MNSC case number : 02869093 , MNSC interaction number : 02869059 , Integration log UniqueID : 500UW00000kzgvzYAA|11092025230033|1237 , Service cloud CaseID : 500UW00000kzgvzYAA More
2859888 OH 09/19/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.

Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
no adverse event; Pharmacist stated 2 doses of MMR-II was administered in a 5 years old patient; ... no adverse event; Pharmacist stated 2 doses of MMR-II was administered in a 5 years old patient; This spontaneous report was received from a Pharmacist and refers to a 5-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-Sep-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (dose, anatomical location, route of administration, lot # and expiration date were not reported) reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) lot # and expiration date were not reported). On 16-Sep-2025, the patient received second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT)(inappropriate schedule od product administration) at another facility. No adverse event was reported. More
2859889 54 F CT 09/19/2025 COVID19
 PFIZER\BIONTECH
Axillary pain, Fatigue, Headache, Injection site pain, Lethargy Axillary pain, Fatigue, Headache, Injection site pain, Lethargy
Left arm pain at injection site and surrounding area; Left arm pit pain; headache; lethargy; feeling... Left arm pain at injection site and surrounding area; Left arm pit pain; headache; lethargy; feeling exhausted.; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 15Sep2025 at 02:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 15Sep2025 at 23:00, outcome "recovering", described as "Left arm pain at injection site and surrounding area"; AXILLARY PAIN (non-serious) with onset 15Sep2025 at 23:00, outcome "recovering", described as "Left arm pit pain"; FATIGUE (non-serious) with onset 15Sep2025 at 23:00, outcome "recovering", described as "feeling exhausted."; HEADACHE (non-serious) with onset 15Sep2025 at 23:00, outcome "recovering"; LETHARGY (non-serious) with onset 15Sep2025 at 23:00, outcome "recovering". Therapeutic measures were not taken as a result of injection site pain, axillary pain, headache, lethargy, fatigue. Additional information: Patient did not receive any other vaccines on the same date as the vaccine(s) for which they are reporting and patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. Patient took other medications within 2 weeks of the event starting. Patient reported no allergies. Additionally patient took Levoxyl (Jan2006), Hydrochlorothiazide (26Aug2025), Sertraline HCl (Aug2023), Amlodipine (Jan2025), Omega-3 Fish oil (Jan2023). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859890 25 M NJ 09/19/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER
 MY9550
Back pain, Fatigue, Pain in extremity; Back pain, Fatigue, Pain in extremity Back pain, Fatigue, Pain in extremity; Back pain, Fatigue, Pain in extremity
Major join pain lower back; Right leg pain from ankle to thighs; Extremely fatigue; This is a sponta... Major join pain lower back; Right leg pain from ankle to thighs; Extremely fatigue; This is a spontaneous report received from a Consumer or other non HCP. A 25-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 16Sep2025 at 15:30 as dose 1, single (Lot number: MY9550) at the age of 25 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 16Sep2025, in left arm for immunisation. The patient's relevant medical history included: "I have aspergers" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 16Sep2025 at 17:00, outcome "not recovered", described as "Extremely fatigue"; BACK PAIN (non-serious) with onset 16Sep2025 at 17:00, outcome "not recovered", described as "Major join pain lower back"; PAIN IN EXTREMITY (non-serious) with onset 16Sep2025 at 17:00, outcome "not recovered", described as "Right leg pain from ankle to thighs". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. Device Date: 16Sep2025. More
2859891 M 09/19/2025 COVID19
 PFIZER\BIONTECH
Condition aggravated, Osteoarthritis Condition aggravated, Osteoarthritis
experiencing pronounced effects on his osteoarthritis including severe pain; experiencing pronounced... experiencing pronounced effects on his osteoarthritis including severe pain; experiencing pronounced effects on his osteoarthritis including severe pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "osteoarthritis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunization; Comirnaty (DOSE 2), for COVID-19 immunization; Comirnaty (DOSE 3), for COVID-19 immunization; Comirnaty (DOSE 4), for COVID-19 immunization. The following information was reported: OSTEOARTHRITIS (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2025, outcome "unknown" and all described as "experiencing pronounced effects on his osteoarthritis including severe pain". Additional information: the patient reported that he received all previous COVID vaccinations with the Pfizer vaccine. The patient stated he had five vaccinations. The patient stated he was experiencing pronounced effects on his osteoarthritis including severe pain. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2859892 F NY 09/19/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Arthralgia, Fatigue, Hypersomnia, Migraine, Nausea; Pain Arthralgia, Fatigue, Hypersomnia, Migraine, Nausea; Pain
migraine level headache; joint and body aches; joint and body aches; extreme nausea; exhaustion; Abo... migraine level headache; joint and body aches; joint and body aches; extreme nausea; exhaustion; About 24 hours after the injection I went to sleep for almost 16 hours then awake for 1 hour and asleep again until the next morning; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: other health problems. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "mild headache". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "migraine level headache"; ARTHRALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "joint and body aches"; NAUSEA (non-serious), outcome "unknown", described as "extreme nausea"; FATIGUE (non-serious), outcome "unknown", described as "exhaustion"; HYPERSOMNIA (non-serious), outcome "unknown", described as "About 24 hours after the injection I went to sleep for almost 16 hours then awake for 1 hour and asleep again until the next morning". Additional information: Just wanted you to know how the new Covid vaccine affected her. In the past 5 years every time all she got after the shot was a mild headache. This one however left her with migraine level headache, joint and body aches, extreme nausea, and exhaustion. About 24 hours after the injection, she went to sleep for almost 16 hours then awake for 1 hour and asleep again until the next morning. She had diabetes and other health problems. Let me know if you have any questions. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2859893 09/19/2025 PNC20
 PFIZER\WYETH
Neutropenia, Pyrexia Neutropenia, Pyrexia
Neutropenia; high fever; This is a spontaneous report received from a Physician. A 12-month-old pat... Neutropenia; high fever; This is a spontaneous report received from a Physician. A 12-month-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUTROPENIA (hospitalization) with onset 2024, outcome "recovered"; PYREXIA (hospitalization) with onset 2024, 1 day after the suspect product(s) administration, outcome "recovered", described as "high fever". Neutropenia corrected in the following couple months. Patient was referred to hematologists. The reporter consider event as caused by suspect product. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported events neutropenia and fever was related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate. More
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2859894 MO 09/19/2025 IPV
 SANOFI PASTEUR
No adverse event, Product storage error No adverse event, Product storage error
IPOL maximum/minimum temperature reached: 47.426�F / 8.57�C/ duration of temperature excursion: ... IPOL maximum/minimum temperature reached: 47.426�F / 8.57�C/ duration of temperature excursion: 1 Hour with no reported adverse event; Initial information received on 16-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] post excursion with maximum/minimum temperature reached: 47.426�f / 8.57�c/ duration of temperature excursion: 1 hour with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect punctured Ipv (Vero), Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for immunization, post excursion with maximum/minimum temperature reached: 47.426�f / 8.57�c/ duration of temperature excursion: 1 hour with no reported adverse event (product storage error. Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Human error was involved, reason for excursion: transportation and product was used. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2859905 36 M CA 09/19/2025 COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
 212A21A
212A21A
212A21A
Amnesia, Blindness, Cognitive disorder, Cough, Dizziness; Headache, Loss of cons... Amnesia, Blindness, Cognitive disorder, Cough, Dizziness; Headache, Loss of consciousness, Memory impairment, Muscle spasms, Post-acute COVID-19 syndrome; Testicular swelling More
Dissyness, loss of memory, severe an cramping , swollen testicle, long covid (memory, cough, cogni... Dissyness, loss of memory, severe an cramping , swollen testicle, long covid (memory, cough, cognitive function) sever headache , loss of vision and passing out More
2859906 31 F NM 09/19/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA




Abdominal discomfort, Alopecia, Antiphospholipid antibodies negative, Anxiety, B... Abdominal discomfort, Alopecia, Antiphospholipid antibodies negative, Anxiety, Blood calcium increased; Blood test abnormal, Brain fog, Colonoscopy abnormal, Diarrhoea, Dry skin; Endoscopy, Fatigue, Malaise, Nausea, Palpitations; Poor peripheral circulation, Temperature intolerance, Thyroid function test normal, Vitamin D decreased, Vomiting; Weight decreased More
October 2022 through March 2023, I was severely ill. I had heart palpitations constantly, intense fa... October 2022 through March 2023, I was severely ill. I had heart palpitations constantly, intense fatigue, majority of meals unable to keep down either causing massive GI upset resulting in diarrhea or vomitting. Dry skin, hair loss, and brain fog. Consuming food would result in nausea resulting in anexity from worrying about potentially getting ill from eating. I went from 155 to 135 pounds. Intolerable to cold, poor circulation. Blood work was clear. In April 2023 I experienced a bit of relief from my symptoms. I had no previous health issues or mental health issues until after receiving the vaccine as a mandate for employment. More
2859909 09/19/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Sepsis Sepsis
I went septic; This serious case was reported by a consumer via interactive digital media and descri... I went septic; This serious case was reported by a consumer via interactive digital media and described the occurrence of sepsis in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sepsis (Verbatim: I went septic) (serious criteria GSK medically significant). The outcome of the sepsis was not reported. The reporter considered the sepsis to be related to RSV vaccine. The company considered the sepsis to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 04-SEP-2025 This case was reported by a patient via interactive digital media. Patient's physician had told him/her into it and he/she had nearly died. Patient had gone septic.; Sender's Comments: A case of Sepsis, unknown time after receiving unknown dose of RSV vaccine in a subject. 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
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