🏥 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 💀 🏥 🚑 ♿ ⚠️
2847206 33 M MA 06/25/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Headache, Immediate post-injection reaction, Injection site haemorrhage, Injecti... Headache, Immediate post-injection reaction, Injection site haemorrhage, Injection site pain, Musculoskeletal stiffness; Swelling More
Vaccine injected into upper right arm and into a vein. The site of injection started bleeding immedi... Vaccine injected into upper right arm and into a vein. The site of injection started bleeding immediately after needle was released from skin. I stated to the employee that she injected the vaccine into vein. She denied it and stating that there is only muscle at the site of injection. Symptoms that I'm currently experiencing are headache, arm stiffness, pain at the site of injection, and swelling. *CURRENTLY ON MY WAY TO EMERGENCY ROOM* More
2847207 30 M GA 06/25/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 l5229
Extra dose administered Extra dose administered
Pt received dose of Boostrix after having had one dose administered 09/15/2024 at pharmacy. Our syst... Pt received dose of Boostrix after having had one dose administered 09/15/2024 at pharmacy. Our system indicated he was due for a booster and database identified last vaccine was 2006. No symptoms as of today from vaccine 6/23/25 More
2847208 59 M AL 06/25/2025 TDAP
 SANOFI PASTEUR
 U8353AA
Joint swelling, Peripheral swelling, Skin warm, Tenderness Joint swelling, Peripheral swelling, Skin warm, Tenderness
The injection Site is not inflamed or irritated. Donor's left hand/wrist is swollen, red, and p... The injection Site is not inflamed or irritated. Donor's left hand/wrist is swollen, red, and painful to touch. Donor's hand and wrist is also warm to the touch. Counseled donor to seek outside care. More
2847209 39 M MD 06/25/2025 COVID19
 PFIZER\BIONTECH
Chest discomfort Chest discomfort
Was seen at urgent care and hospital for chest discomfort. Was seen at urgent care and hospital for chest discomfort.
2847210 62 M FL 06/25/2025 COVID19
UNK
 MODERNA
UNKNOWN MANUFACTURER

Acute myeloid leukaemia, Cardiac discomfort, Death, Fatigue, Heart rate increase... Acute myeloid leukaemia, Cardiac discomfort, Death, Fatigue, Heart rate increased; Acute myeloid leukaemia, Cardiac discomfort, Death, Fatigue, Heart rate increased More
2 weeks after 2nd shot April 14) of Moderna Covid 19 - patient began feeling extremely fatigued. Sc... 2 weeks after 2nd shot April 14) of Moderna Covid 19 - patient began feeling extremely fatigued. Scheduled Televisit with physician and told to check back of tonsils for white spots. Did so and told possibly Strep. Antibiotics given. Fatigue and increased heart rate continued. On May 16, 2021, Patient said heart felt that was going to explode. Went to ER and then diagnosed with Acute Myeloid Leukemia (AML) w/ FLT3 marker. Patient was perfectly healthy prior to COVID 19 shot. Diet considered of daily amounts of fruits, vegetables (greens) and meats. Very healthy/balanced. He exercised daily - resistance training and cardio. Never sick except for a cold. No history of cancer in family patient was required to take the vaccine due to his company mandate and visiting healthcare facilities. Again, a healthy individual, exceptional diet - minimal processed foods, exercised daily, not overweight and maintain a disciplined routine. It seems more than a coincidence the change in his health was only a couple weeks after the 2nd injection (4/14/21) of the Moderna vaccine. He had battled this diagnosis for 4 years in/out of remission 3 times. Ultimately passing due to complications of some of the final preventative treatments. Previous annual physicals were all good/normal. Could this vaccine targeted a dormant AML gene? Did it create the cancer. Some consulted physicians said it is a possibility but would not know for years and that is ONLY if the data is being gathered. We know of 3 other patients that were also very healthy within a 5-20 minute radius, also diagnosed with AML and at least 1 with the FLT 3 Marker during the same time frame. Pfizer Vac in May/June 2022 ; Pfizer Booster in Sept 2022 and SPIKEVAX Oct. 2023. I hope the CDC and other health agencies (physicians, hospitals, etc.). help with this data gathering with patience to improve patience mortality rates and not to cause cancer, chronic illnesses or death. We only will know what we are willing to do a "deep dive", study, learn, open-minded to build upon the science that constantly evolves. We need to do the research to build to confidence level in our vaccines. I know I'm skeptical because of knowing my husband as a healthy man at 63 and the extreme change in health in a matter of a couple weeks. We as a country did our best to get "something out there" for Covid - but it may cause harm to some. More
✓
2847211 0.17 M CA 06/25/2025 DTAP
DTAP
HIBV
HIBV
PNC15
PNC15
RV1
RV1
UNK
UNK
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 unknown
unknown
unknown
unknown
unknown
unknown
unknown
unknown
unknown
unknown
Choking, Cyanosis, Dyspnoea, Foaming at mouth, Seizure; Seizure like phenomena, ... Choking, Cyanosis, Dyspnoea, Foaming at mouth, Seizure; Seizure like phenomena, Skin discolouration; Choking, Cyanosis, Dyspnoea, Foaming at mouth, Seizure; Seizure like phenomena, Skin discolouration; Choking, Cyanosis, Dyspnoea, Foaming at mouth, Seizure; Seizure like phenomena, Skin discolouration; Choking, Cyanosis, Dyspnoea, Foaming at mouth, Seizure; Seizure like phenomena, Skin discolouration; Choking, Cyanosis, Dyspnoea, Foaming at mouth, Seizure; Seizure like phenomena, Skin discolouration More
Labored breathing, seizure like activity, convulsions, skin turned gray, lips and nails blue/purple,... Labored breathing, seizure like activity, convulsions, skin turned gray, lips and nails blue/purple, foaming out of mouth and choking. Went to physician on call, then ER. Was over a couple days. More
✓
2847212 0.42 F FL 06/25/2025 HIBV
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UK193AA
LX4482
Circumoral swelling, Eye swelling, Rash; Circumoral swelling, Eye swelling, Rash Circumoral swelling, Eye swelling, Rash; Circumoral swelling, Eye swelling, Rash
Patient started with a rash in the diaper area the next day and then the rash spread to her torso an... Patient started with a rash in the diaper area the next day and then the rash spread to her torso and back arms ands legs and then progressively got worse especially on her face- her eyes were swollen and around her mouth, this all happened over the span of 8 days with the worse on the morning of day 8. Prednisolone was prescribed and given x2 doses in 48 hours. The rash began to subside. More
2847213 4 M TX 06/25/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
6/23/25: SMALL RED AREA AROUND SITE SMALL AMOUNT SWELLING 6/24/25 REDNESS AROUND VACCINE SITE INCRE... 6/23/25: SMALL RED AREA AROUND SITE SMALL AMOUNT SWELLING 6/24/25 REDNESS AROUND VACCINE SITE INCREASED, SWELLING AND TENDERNESS INCREASED 6/25/25 SLIGHTLY LARGER AREA OF REDNESS AROUND VACCINE SITE, 2" CIRCUMFERENCE NOW, PAINFUL, TENDER. CALLED PCP 10:25 TODAY TO NOTIFY AND RTC FOR EVALUATION. More
2847214 53 F 06/25/2025 MMR
 MERCK & CO. INC.
Gastroenteritis Gastroenteritis
Severe acute gastroenteritis symptoms without any signs of viral or bacterial cause Severe acute gastroenteritis symptoms without any signs of viral or bacterial cause
2847215 11 M AZ 06/25/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 99G34
Wrong product administered Wrong product administered
Patient received a Bexsero meningococcal B vaccine when he is not of age for it; he was supposed to ... Patient received a Bexsero meningococcal B vaccine when he is not of age for it; he was supposed to receive a Menveo meningococcal 4 vaccine. More
2847216 16 F PA 06/25/2025 MENB
MENB
MENB
MENB
MENB
MENB
MENB
MENB
MENB
MENB
MNQ
MNQ
MNQ
MNQ
MNQ
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 LW8910
LW8910
LW8910
LW8910
LW8910
Antinuclear antibody negative, Arthralgia, Body temperature increased, Borrelia ... Antinuclear antibody negative, Arthralgia, Body temperature increased, Borrelia test negative, C-reactive protein normal; Full blood count normal, Headache, Myalgia, Peripheral swelling, Polyarthritis; Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus test negative, Vomiting; Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Nausea; Polyarthritis, Pyrexia, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus test negative; Antinuclear antibody negative, Arthralgia, Body temperature increased, Borrelia test negative, C-reactive protein normal; Full blood count normal, Headache, Myalgia, Peripheral swelling, Polyarthritis; Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus test negative, Vomiting; Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Nausea; Polyarthritis, Pyrexia, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus test negative; Antinuclear antibody negative, Arthralgia, Body temperature increased, Borrelia test negative, C-reactive protein normal; Full blood count normal, Headache, Myalgia, Peripheral swelling, Polyarthritis; Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus test negative, Vomiting; Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Nausea; Polyarthritis, Pyrexia, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus test negative More
patient reports temp of 103 8 hours after injection with headache, myalgias and vomited that lasted ... patient reports temp of 103 8 hours after injection with headache, myalgias and vomited that lasted for 48 hours. 6 days following injection patient had polyarthritis of elbows, knees, ankles and wrists with swelling of finger and toes. Swelling resolved 48 hours later and 15 days later patient still complains of wrist and ankle tenderness. - Blood work done by patients' father (a pediatrician) during episode to rule out rheumatoid process and all labs were normal More
2847217 3 M MI 06/25/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Inappropriate schedule of product administration Inappropriate schedule of product administration
Dose inadvertently given at wrong time; This was child's 3rd dose of DTaP and IPV and child was... Dose inadvertently given at wrong time; This was child's 3rd dose of DTaP and IPV and child was 3 years and 9 months at time of administration. More
2847218 13 M MI 06/25/2025 MMRV
 MERCK & CO. INC.
 y012341
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Was given to child age 13 yr and 8 months, outside the recommended age range of maximum age 12 years... Was given to child age 13 yr and 8 months, outside the recommended age range of maximum age 12 years and 11 months. No adverse reactions noted. No history of febrile seizures in family. More
2847219 18 PR 06/25/2025 MENB
 PFIZER\WYETH
 HJ1517
Injection site erythema, Injection site induration, Injection site urticaria Injection site erythema, Injection site induration, Injection site urticaria
MOTHER CONTACTS THE NURSING DEPARTMENT ON 06/25/25 AND REFERS "MY DAUGHTER WAS VACCINATED ON TH... MOTHER CONTACTS THE NURSING DEPARTMENT ON 06/25/25 AND REFERS "MY DAUGHTER WAS VACCINATED ON THURSDAY AND SHE GOT RED HIVES AND BECAME HARD. HER INVESTIGATION WAS CARRIED OUT AND REFERS THE AREA: "WHERE SHE WAS VACCINATED." SHE LATER REFERRED "I TOOK HER TO THE HOSPITAL YESTERDAY." More
2847220 0.67 M 06/25/2025 RV5
 MERCK & CO. INC.
Extra dose administered Extra dose administered
3rd dose of series given to patient 34 weeks of age. 3rd dose of series given to patient 34 weeks of age.
2847221 68 F MI 06/25/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 EY57A
Inappropriate schedule of product administration Inappropriate schedule of product administration
Dose two was given a month early. Dose two was given a month early.
2847222 52 M NC 06/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ353
Headache, Oropharyngeal pain, Petechiae, Rash Headache, Oropharyngeal pain, Petechiae, Rash
2 days after receiving vaccines, petechial rash appeared on lower extremities bilaterally. the next ... 2 days after receiving vaccines, petechial rash appeared on lower extremities bilaterally. the next day he developed a rash on his arms. the next day developed sore throat and mild headache More
2847223 0.58 M WA 06/25/2025 DTPPVHBHPB
PNC20
 MSP VACCINE COMPANY
PFIZER\WYETH
 U8313AA
MF0416
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Patient was provided 2nd vaccine in series at wrong interval. Patient was provided 2nd vaccine in series at wrong interval.
2847224 50 F FL 06/25/2025 YF
 SANOFI PASTEUR
 UK138AA
Cough, Dyspnoea, Feeling abnormal, Mouth swelling Cough, Dyspnoea, Feeling abnormal, Mouth swelling
Patient walked in for yellow fever vaccine, technician entered details, reviewed patient VAR, and al... Patient walked in for yellow fever vaccine, technician entered details, reviewed patient VAR, and allergies, Patient stated she had idiopathic allergies and does not know what she is allergic to per her blood work from MD. Patient understood potential risk for reaction and wanted to proceed with vaccination for her trip (patient stated it is required for entry into the country) and stated she has an EpiPen. Patient received vaccine, was asked to wait a minimum of 15 minutes to monitor for adverse events. Approximately 5 minutes after receiving vaccine patient states her mouth feels swollen. I asked if she was having any difficulty breathing, she stated no. A few moments later when I checked in with her she requested Benadryl. I provided her with 50mg of Benadryl and continued to monitor for signs of anaphylaxis. Continued to monitor and informed patient she will need a driver to take her home after taking Benadryl. She contacted a family friend to come pick her up and another friend to drive her car home. I asked if anyone would be home to monitor her and she said her husband would be home at 5:30PM. I asked if her friend would be able to remain with her until her husband got home a to which she said yes. Shortly thereafter she stated her insides "feel weird". I asked if it could be anxiety related to which she stated she has a history of a panic attack 2 years ago. She was sitting in the lobby after taking Benadryl approximately 10 minutes later she became short of breath and began coughing. Code green was called. She appeared panicked and I asked if she was having trouble breathing she nodded. I asked if she would like me to administer EpiPen she couldn't agree verbally to which she nodded yes. I administered EpiPen 0.3mg into her left thigh and patient continued coughing until EMT arrived. EMT brought a stretcher and took her to the emergency room. More
2847225 0.33 M VT 06/25/2025 DTAPIPV
 SANOFI PASTEUR
 U7931AB
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Pt was given a vaccine that is intended for ages 4-6. Pt is 4 months old. Pt was given a vaccine that is intended for ages 4-6. Pt is 4 months old.
2847226 22 M CA 06/25/2025 MNQ
MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB043A
AMVB043A
AMVB043A
Abdominal pain upper, Blood test abnormal, Body temperature fluctuation, Chills,... Abdominal pain upper, Blood test abnormal, Body temperature fluctuation, Chills, Computerised tomogram; Diarrhoea, Nausea, Pain, Pollakiuria, Pyrexia; Urine analysis, Vomiting More
administered IM on Left deltoid. recent meningitis vaccine 6/20/25 Reason:starting 6/21/25 saturday ... administered IM on Left deltoid. recent meningitis vaccine 6/20/25 Reason:starting 6/21/25 saturday Fever/Chills/Bodyache/Nausea/Vomiting/diarrhea/stomach ache/ frequent urination. Pt was seen at ER on Monday morning due to fluctuating temperature. - had blood test- state abn labs, urine sample and ct scan - advised to be admitted, was admitted and was discharge last night. was advised to report to SHC as of today: fever ( 102-103) // diarrhea - verbalized watery stool, had 6x today of diarrhea// Vomiting x1 today// stomachache since saturday - today same( not worst not better from onset ) More
✓
2847227 52 F MN 06/25/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LN4928
LN4928
Erythema, Fatigue, Hypersensitivity, Limb mass, Local reaction; Pain, Pruritus, ... Erythema, Fatigue, Hypersensitivity, Limb mass, Local reaction; Pain, Pruritus, Pyrexia, Rash, Skin warm More
Localized reaction to pneumococcal vaccine-symptoms started 1 hour after shot. Shot was given on 5/... Localized reaction to pneumococcal vaccine-symptoms started 1 hour after shot. Shot was given on 5/30/25 at office visit for a routine physical, patient called the RN triage line to on 6/3/25 to report symptoms of increased redness, pain 10/10, body aches and fatigue Stated she felt feverish but had not taken her temp. Skin on Left arm was hot, red with small fluid filled bumps forming. Patient reported that area was also itchy. Was deposed to go to Urgent care to be seen. She did so and was diagnosed with focal reaction to recent pneumococcal vaccine. The redness and swelling is due to focal inflammatory allergic response. Assessment/ Plan Diagnoses and associated orders for this visit: Allergic reaction, initial encounter - CREATINE KINASE; Future - C-REACTIVE PROTEIN, INFLAMMATORY; Future - famotidine (PEPCID) 40 mg oral Tablet; Take 1 Tablet (40 mg) by mouth in the morning and 1 Tablet (40 mg) in the evening. Do all this for 7 days. - methylPREDNISolone (MEDROL DOSPACK) 4 mg oral Tablets, Dose Pack; Take 1-6 Tablets (4-24 mg) by mouth as directed for 6 days. Take per package instructions. - triamcinolone acetonide (KENALOG) 0.1 % topical Cream; Apply to the affected area(s) as needed in the morning and as needed in the evening for rash. Denies any trouble breathing no lip or tongue swelling no dizziness no weakness. Focal reaction to recent pneumococcal vaccine pictures uploaded into my chart I think the redness and swelling is from focal inflammatory allergic response Treating with above medications discussed I did not think this was cellulitic but if symptoms not improving with above treatment or worsening to return to clinic they are agreeable with plan attempted to reach out to patient x3 for follow up and left message to call back.. no return call. to date. More
2847228 0.5 M KY 06/25/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 GG39D
Expired product administered Expired product administered
Administered expired DTap, Mother notified, no symptoms reported. Will follow up. Return to clinic ... Administered expired DTap, Mother notified, no symptoms reported. Will follow up. Return to clinic in 2 weeks for repeat Dtap vaccine. More
2847229 70 F FL 06/25/2025 MMR
TDAP
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y020517
Y3Z9P
Contusion; Contusion Contusion; Contusion
BRUISING/HEMATOMA FROM DELTOID TO BICEP BRACHII BRUISING/HEMATOMA FROM DELTOID TO BICEP BRACHII
2847230 64 M CA 06/25/2025 PNC21
 MERCK & CO. INC.
 Y013009
Pain, Pyrexia Pain, Pyrexia
Patient had high fever, chills, fatigue and body aches starting 3 hours after the vaccine administra... Patient had high fever, chills, fatigue and body aches starting 3 hours after the vaccine administration and has taken Tylenol and Motrin for fever and body aches which partially resolved the symptoms. Continues to have mild symptoms 24 hours later More
2847231 56 M GA 06/25/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 39H2S
39H2S
Bell's palsy, Candida infection, Lethargy, Loss of personal independence in... Bell's palsy, Candida infection, Lethargy, Loss of personal independence in daily activities, Pain; Pyrexia More
PATIENT REPORTED DEVELOPING BELL'S PALSEY 8 DAYS AFTER RECEIVING THE SHINGLES VACCINE. PATIENT ... PATIENT REPORTED DEVELOPING BELL'S PALSEY 8 DAYS AFTER RECEIVING THE SHINGLES VACCINE. PATIENT REPORTS NO OTHER SIGNNIFICANT CHANGES TO HIS DAILY ROUTINE AND EXPERIENCED FEVER, LETHARGY, AND SORENESS THE DAY FOLLOWING THE VACCINE. PATIENT ALSO REPORTS DEVELOPING THRUSH 4 DAYS AFTER RECEIVING VACCINE. More
2847232 1 M CO 06/25/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4SB5S
Cough, Rash, Rash morbilliform, Rhinorrhoea Cough, Rash, Rash morbilliform, Rhinorrhoea
Rash, cough, runny nose 12 days after vaccine . No fever. Rash is morbilliform on trunk, arms, leg... Rash, cough, runny nose 12 days after vaccine . No fever. Rash is morbilliform on trunk, arms, legs More
2847233 8 M WA 06/25/2025 HEPA
IPV
MMR
TDAP
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 J4K4X
W1C741M
Y009430
5YB5G
Y011019
Paraesthesia, Pruritus, Skin discolouration, Skin hypopigmentation; Paraesthesia... Paraesthesia, Pruritus, Skin discolouration, Skin hypopigmentation; Paraesthesia, Pruritus, Skin discolouration, Skin hypopigmentation; Paraesthesia, Pruritus, Skin discolouration, Skin hypopigmentation; Paraesthesia, Pruritus, Skin discolouration, Skin hypopigmentation; Paraesthesia, Pruritus, Skin discolouration, Skin hypopigmentation More
Said experienced an adverse reaction following administration of five vaccines at his last well-chil... Said experienced an adverse reaction following administration of five vaccines at his last well-child visit. Symptoms included immediate onset (within 2 hours) of generalized pruritus lasting 1-2 days, tingling sensation persisting for 4-5 days, and development of white spots on his face. Physical examination revealed a 1x2 cm hypopigmented region collateral to the right nostril. The reaction's specific cause is unclear due to multiple vaccines being administered simultaneously. More
2847234 11 M FL 06/25/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8271AB
U8252AA
Cellulitis, Injection site swelling, Injection site vesicles, Ultrasound scan, X... Cellulitis, Injection site swelling, Injection site vesicles, Ultrasound scan, X-ray; Cellulitis, Injection site swelling, Injection site vesicles, Ultrasound scan, X-ray More
Seen at ER on 6/22/2025 left upper arm became swollen and blisters had xray and ultrasound; had I... Seen at ER on 6/22/2025 left upper arm became swollen and blisters had xray and ultrasound; had ID evalaution was admitted for 24 hours, diagnosed with Left Arm Cellulitis and prescribed Cephalexin 500 MG Antibiotics Orally daily no fever or tenderness. More
✓
2847235 37 F NC 06/25/2025 HPV9
 MERCK & CO. INC.
 Y014059
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
Patient received first dose on 2/26, second dose on 3/31/25, and last dose on 6/25/25. According to ... Patient received first dose on 2/26, second dose on 3/31/25, and last dose on 6/25/25. According to ACIP guidelines, patient meets 2/3 requirements for the minimal intervals between doses. She meets the 4 week requirement between dose 1 and 2, and the 12 week requirement between dose 2 and 3. However, she does not meet the 5 month requirement between dose 1 and 3. More
2847236 68 M VA 06/25/2025 UNK
 UNKNOWN MANUFACTURER
 Shingrix Vial K
Arthralgia, Magnetic resonance imaging, Pain in extremity, X-ray Arthralgia, Magnetic resonance imaging, Pain in extremity, X-ray
Major pain in left shoulder. 10 out of10! Extremely painful at certain times in the upper left arm... Major pain in left shoulder. 10 out of10! Extremely painful at certain times in the upper left arm. Always painful, but pain varied. Treatment: Meloxicam, Pregabalin Steroid 7-day course, and steroid injection. Methocarbamol and Tylenol. Lots of ice. More
2847237 65 F CA 06/25/2025 PNC21
 MERCK & CO. INC.
 Y019157
Injection site pain, Injection site pruritus, Injection site swelling, Injection... Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth More
Patient came to the pharmacy and reported that her left arm around the injection site started to sw... Patient came to the pharmacy and reported that her left arm around the injection site started to swell, feeling hot like inflamed and itchy, sore to the touch . The side effects started 4 days after administered Capvaxive. Patient didn't take anything but Tylenol. She cannot take Benadryl due to working , doesn't want to get drowsy from Benadryl. I advised patient to seek help or go to the doctor if it doesn't go away. More
2847238 20 F GA 06/25/2025 YF
 SANOFI PASTEUR
 UK136AB
No adverse event No adverse event
There were no adverse effects from the vaccine in the 20 minute waiting period. The patient was abso... There were no adverse effects from the vaccine in the 20 minute waiting period. The patient was absolutely fine and we will be checking on her daily for the next several days and if there are adverse effects. we will report them. More
2847239 1.42 F TX 06/25/2025 MMR
 MERCK & CO. INC.
 x014954
Injection site erythema, Injection site mass Injection site erythema, Injection site mass
mom noticed Red area on thigh where vaccine was administered. Site still has pea size knot at this ... mom noticed Red area on thigh where vaccine was administered. Site still has pea size knot at this time More
2847256 IL 06/25/2025 HEP
 MERCK & CO. INC.
 Y006509
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
no adverse event; the consumer inadvertently received the adult dose of the RECOMBIVAX HB vaccine ra... no adverse event; the consumer inadvertently received the adult dose of the RECOMBIVAX HB vaccine rather than another pediatric dose; This spontaneous report was received from a nurse referring to an 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. In May 2025, the patient received a pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). On 20-Jun-2025, the patient inadvertently received the adult dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #Y006509, expiration date: 11-Feb-2027) rather than another pediatric dose, 1.0 ml administered as prophylaxis by health professional (accidental overdose). No adverse event was reported (no adverse event). Lot # is being requested and will be submitted if received. More
2847257 54 F CA 06/25/2025 PPV
PPV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y016291
Y016291
Extra dose administered, Injection site erythema, Injection site swelling; Extra... Extra dose administered, Injection site erythema, Injection site swelling; Extra dose administered, Injection site erythema, Injection site swelling More
HBP calling to report AE for PNEUMOVAX 23. Patient was administered the vaccine twice within the sam... HBP calling to report AE for PNEUMOVAX 23. Patient was administered the vaccine twice within the same month.; Patient experienced swelling and redness at the injection site.; Patient experienced swelling and redness at the injection site.; This spontaneous report was received from a consumer referring to a 54-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided. On 03-JUN-2025, the patient received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) for vaccination, (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number Y016291, with expiration date on 06-DEC-2026). On 19-JUN-2025, she received an extra dose of Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) for vaccination, (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number Y016291, with expiration date on 06-DEC-2026) (Extra dose administered). On an unknown date, the patient experienced swelling and redness at the injection site (Vaccination site swelling) (Injection site erythema). On an unknown date, she recovered from the events of vaccination site swelling and injection site erythema. The causal relationship between the events occurrence and Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) was not reported. More
2847258 F 06/25/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Cardiac operation Cardiac operation
undergo open heart surgery; This serious case was reported by a consumer via interactive digital med... undergo open heart surgery; This serious case was reported by a consumer via interactive digital media and described the occurrence of open heart surgery in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced open heart surgery (Verbatim: undergo open heart surgery) (serious criteria clinically significant/intervention required). The outcome of the open heart surgery was not reported. It was unknown if the reporter considered the open heart surgery to be related to RSV vaccine. The company considered the open heart surgery to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 18-JUN-2025 The patient got vaccinated with Respiratory Syncytial Virus vaccine and had undergo open heart surgery last month of reporting.; Sender's Comments: Cardiac operation is an unlisted event which is considered unrelated to GSK RSV vaccine. US-GSK-US2025AMR077284:same reporter different patient More
2847259 M 06/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Feeling abnormal, Pyrexia Fatigue, Feeling abnormal, Pyrexia
Patient felt bad; Tired; Fever; This non-serious case was reported by a nurse via sales rep and des... Patient felt bad; Tired; Fever; This non-serious case was reported by a nurse via sales rep and described the occurrence of feeling bad in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Patient felt bad), tiredness (Verbatim: Tired) and fever (Verbatim: Fever). The outcome of the feeling bad, tiredness and fever were resolved (duration 4 days). The reporter considered the feeling bad, tiredness and fever to be related to Shingrix. The company considered the feeling bad, tiredness and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 20-JUN-2025 The nurse reported that a patient received Shingrix vaccine and had felt bad, tired, and had fever for approximately 4 days. The patient would not receive second Shingrix dose. More
2847260 06/25/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
Suspected vaccination failure; Got shingles and was very painful; This serious case was reported by ... Suspected vaccination failure; Got shingles and was very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUN-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles and was very painful). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 18-JUN-2025 This case was reported by a patient via interactive digital media. The patient was 70 years old. The patient had both shingles shots and still got shingles. It was very painful. The doctor gave some medicines and cream to put on it. The patient was on the second week of the shingles. The patient believed that if the patient hadn't got the shots, the shingles would have been worse. This case was considered as suspected vaccination failure as details regarding time to onset for shingles 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 regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2). More
2847261 F TN 06/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain Injection site pain
She reports injection site pain and soreness after both doses; This non-serious case was reported by... She reports injection site pain and soreness after both doses; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: She reports injection site pain and soreness after both doses). The outcome of the injection site pain was resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR077808 Additional Information: GSK receipt date: 12-JUN-2025 The patient has had both doses of Shingrix. She reported that injection site pain and soreness after both doses. She did not report how long the pain and soreness lasted. For tolerance of 2nd dose refer case US2025AMR077808.; Sender's Comments: US-GSK-US2025AMR077808:same patient dose 2 More
2847262 F TN 06/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain Injection site pain
She reports injection site patient and soreness after both doses; This non-serious case was reported... She reports injection site patient and soreness after both doses; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose and had injection site pain and soreness, refer case US2025AMR077805). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: She reports injection site patient and soreness after both doses). Rechallenge with Shingrix was positive. The outcome of the injection site pain was resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR077805 Additional Information: GSK receipt date: 12-JUN-2025 The patient has had both doses of Shingrix. She reported that injection site pain and soreness after both doses. She did not report how long the pain and soreness lasted.; Sender's Comments: US-GSK-US2025AMR077805:same patient dose 2 More
2847263 06/25/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
My child got vaccinated with engerix-B using adult dose; My child got vaccinated with engerix-B usin... My child got vaccinated with engerix-B using adult dose; My child got vaccinated with engerix-B using adult dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of adult product administered to child in a child patient who received HBV (Engerix B adult) for prophylaxis. On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: My child got vaccinated with engerix-B using adult dose) and overdose (Verbatim: My child got vaccinated with engerix-B using adult dose). The outcome of the adult product administered to child and overdose were not applicable. Additional Information: GSK receipt date: 17-JUN-2025 child got vaccinated with Engerix-B using adult dose, which led to adult product administered to child and overdose. More
2847264 M 06/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Headache Fatigue, Headache
Headache; fatigue; This non-serious case was reported by a consumer via call center representative a... Headache; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache) and fatigue (Verbatim: fatigue). The outcome of the headache and fatigue were resolved. It was unknown if the reporter considered the headache and fatigue to be related to Shingrix. It was unknown if the company considered the headache and fatigue to be related to Shingrix. Additional Information: GSK Receipt Date: 12-JUN-2025 Patient received his first dose on 23rd or 24th October 2024. Patient had fatigue and a headache and stated that he does not remember how long it lasted after the first dose.; Sender's Comments: US-GSK-US2025073371:same patient More
2847265 06/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Sensory disturbance Herpes zoster, Sensory disturbance
Shingles; This non-serious case was reported by a consumer via interactive digital media and describ... Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-JUN-2025 This case was reported by a patient via interactive digital media. Patient went to get his/her second shot and told the physician his/her hip felt strange. Physician looked at it, chuckled, and said patient already had shingles. More
2847266 1 F NY 06/25/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 Z53J4
Expired product administered Expired product administered
Administration of expired dose; This non-serious case was reported by a other health professional vi... Administration of expired dose; 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 18-month-old female patient who received DTPa (Infanrix) (batch number Z53J4, expiry date 07-JUN-2025) for prophylaxis. On 14-JUN-2025, the patient received Infanrix. On 14-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-JUN-2025 The patient received an expired dose of Infanrix, which led expired vaccine used. The reporter consented to follow up. More
2847267 F 06/25/2025 COVID19
 MODERNA
Arthralgia, Discomfort, Joint swelling, Oedema peripheral, Paraesthesia Arthralgia, Discomfort, Joint swelling, Oedema peripheral, Paraesthesia
Tingling, pain on inner side of knees; pain on inner side of knees; swelling extended to her thighs,... Tingling, pain on inner side of knees; pain on inner side of knees; swelling extended to her thighs, had hard lumps behind knees and up to top of thighs; swelling extended to her thighs, had hard lumps behind knees and up to top of thighs; Discomfort continued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling, pain on inner side of knees), ARTHRALGIA (pain on inner side of knees), JOINT SWELLING (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) and OEDEMA PERIPHERAL (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 29-Apr-2025, the patient experienced PARAESTHESIA (Tingling, pain on inner side of knees) (seriousness criterion medically significant) and ARTHRALGIA (pain on inner side of knees) (seriousness criterion medically significant). In 2025, the patient experienced JOINT SWELLING (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) (seriousness criterion medically significant), OEDEMA PERIPHERAL (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) (seriousness criterion medically significant) and DISCOMFORT (Discomfort continued). At the time of the report, PARAESTHESIA (Tingling, pain on inner side of knees) outcome was unknown, ARTHRALGIA (pain on inner side of knees), JOINT SWELLING (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) and OEDEMA PERIPHERAL (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) had resolved and DISCOMFORT (Discomfort continued) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No Concomitant medication was reported. A reporter reporting that patient suffered side effects after vaccinated with Moderna vaccine on 19-Apr-2025. It was mentioned the following: Tingling, pain on inner side of knees, around 29-Apr-2025. Discomfort continued and swelling extended to her thighs, had hard lumps behind knees and up to top of thighs. Reporter added that similar symptoms happened around 3 years ago, after Moderna vaccine. it was started manual lymphatic drainage for lymphedema after first episode. Patient contacted GP 3rd week in May for pain relief, and started manual lymphatic drainage again as was successful after 18 months. It was unknown if the patient experienced any additional symptoms/events. No treatment drug was reported. This case was linked to MOD-2025-787686 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2847268 M 06/25/2025 COVID19
 MODERNA
Burning sensation, General physical health deterioration, Nerve injury, Paraesth... Burning sensation, General physical health deterioration, Nerve injury, Paraesthesia, Suicidal ideation More
he's just dying/suffering and wants to die/it destroyed him/ life away from him; burning/ start... he's just dying/suffering and wants to die/it destroyed him/ life away from him; burning/ started having burning in his feet/ It left his feet and it spread through his whole body, including his face; it ruined his nerves; it ruined his whole system; started tingling; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (he's just dying/suffering and wants to die/it destroyed him/ life away from him) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. 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. On an unknown date, the patient experienced SUICIDAL IDEATION (he's just dying/suffering and wants to die/it destroyed him/ life away from him) (seriousness criterion medically significant), BURNING SENSATION (burning/ started having burning in his feet/ It left his feet and it spread through his whole body, including his face), NERVE INJURY (it ruined his nerves), GENERAL PHYSICAL HEALTH DETERIORATION (it ruined his whole system) and PARAESTHESIA (started tingling). At the time of the report, SUICIDAL IDEATION (he's just dying/suffering and wants to die/it destroyed him/ life away from him), BURNING SENSATION (burning/ started having burning in his feet/ It left his feet and it spread through his whole body, including his face), NERVE INJURY (it ruined his nerves), GENERAL PHYSICAL HEALTH DETERIORATION (it ruined his whole system) and PARAESTHESIA (started tingling) had not resolved. No concomitant medication was reported. Patient administered vaccine 4 years ago. Ever since patient got the vaccine, he was just dying, his life was going down the drain. And it was not that easy going down the drain, it was a suffering down the drain. It was stated that patient received two vaccines, and now he was suffering and wanted to die. Patient did not want to suffer anymore. It was stated that before the vaccines, patient was a strong, very healthy, very strong man, and there was nothing he couldn't do. After his second shot of the vaccine, it destroyed him, it ruined his nerves, it ruined his whole system. Patient started burning, started tingling, started having burning in his feet. It left his feet, and it spread through his whole body, including his face. Still going on today. It was indicated that patient was bedridden. Reporter indicated that Moderna was part of the plan to kill people. It was stated that Moderna took patient's life away from him and stated that the vaccine that hurt to patient. it appeared that patient only received the first and second vaccines. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787695 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787695:Multiple patient case More
2847269 73 F MA 06/25/2025 COVID19
 MODERNA
 3046732
Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Reemergence of stroke symptoms, facial droop and slight speech issues; This spontaneous case was rep... Reemergence of stroke symptoms, facial droop and slight speech issues; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Reemergence of stroke symptoms, facial droop and slight speech issues) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046732) for COVID-19 prophylaxis. The patient's past medical history included Carotid artery dissection (Prior stroke 2016 due to dissection of carotid). Previously administered products included for COVID-19 prophylaxis: Moderna vaccine. Past adverse reactions to the above products included No adverse effect with Moderna vaccine. Concurrent medical conditions included Stroke (Prior stroke 2016 due to dissection of carotid). On 22-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 22-May-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced CEREBROVASCULAR ACCIDENT (Reemergence of stroke symptoms, facial droop and slight speech issues) (seriousness criterion medically significant). On 23-May-2025, CEREBROVASCULAR ACCIDENT (Reemergence of stroke symptoms, facial droop and slight speech issues) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: (Negative) negative for stroke. On an unknown date, Magnetic resonance imaging: (Negative) negative for stroke. No concomitant medication was reported. The patient had reemergence of stroke symptoms, facial droop, and slight speech issues. Prior stroke 2016 due to dissection of carotid. The patient went to ER had CAT scan and follow up MRI all results were negative for stroke. The patient had previous Moderna covid vaccines with no adverse effects. All vaccines were administered at local pharmacy. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2847270 79 F 06/25/2025 COVID19-2
COVID19-2
COVID19-2
 MODERNA
MODERNA
MODERNA


Asthenia, Diarrhoea, Dizziness, Fatigue, Feeling abnormal; Hypoacusis, Influenza... Asthenia, Diarrhoea, Dizziness, Fatigue, Feeling abnormal; Hypoacusis, Influenza, Neck pain, Ocular discomfort, Tinnitus; Vertigo More
feel so bad and oftentimes, practically every night; but it appears like it's internal, not lik... feel so bad and oftentimes, practically every night; but it appears like it's internal, not like the room is spinning around , but it feels, feels like it's inside [the] head from [the] eyes; dizziness; tired; Pressure on the eyes; pain in the back of the neck; Hearing also goes in and out patient wears a hearing aid; recently developed Humming in the head; got a bad flu coming on or a real bad high fever; have no energy; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Pressure on the eyes), NECK PAIN (pain in the back of the neck), HYPOACUSIS (Hearing also goes in and out patient wears a hearing aid), TINNITUS (recently developed Humming in the head) and INFLUENZA (got a bad flu coming on or a real bad high fever) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in 2020. Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (Dose 1) on 21-Jan-2021, Moderna Covid-19 vaccine (Dose 2) on 18-Feb-2021, Moderna Covid-19 vaccine (Dose 3) on 22-Oct-2021 and Moderna Covid-19 vaccine (Dose 4) on 14-Apr-2022. Past adverse reactions to the above products included No adverse effect with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine. On 01-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In 2023, the patient experienced DIARRHOEA (diarrhea). On 20-Jan-2024, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced OCULAR DISCOMFORT (Pressure on the eyes), NECK PAIN (pain in the back of the neck), HYPOACUSIS (Hearing also goes in and out patient wears a hearing aid), TINNITUS (recently developed Humming in the head), INFLUENZA (got a bad flu coming on or a real bad high fever), ASTHENIA (have no energy), VERTIGO (but it appears like it's internal, not like the room is spinning around , but it feels, feels like it's inside [the] head from [the] eyes), DIZZINESS (dizziness) and FATIGUE (tired). On an unknown date, the patient experienced FEELING ABNORMAL (feel so bad and oftentimes, practically every night). In December 2023, DIARRHOEA (diarrhea) had resolved. At the time of the report, OCULAR DISCOMFORT (Pressure on the eyes), NECK PAIN (pain in the back of the neck), HYPOACUSIS (Hearing also goes in and out patient wears a hearing aid), TINNITUS (recently developed Humming in the head), INFLUENZA (got a bad flu coming on or a real bad high fever), ASTHENIA (have no energy), DIZZINESS (dizziness) and FATIGUE (tired) had not resolved and FEELING ABNORMAL (feel so bad and oftentimes, practically every night) and VERTIGO (but it appears like it's internal, not like the room is spinning around , but it feels, feels like it's inside [the] head from [the] eyes) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had no symptoms until Oct-2023 when she developed diarrhea that lasted until Dec-2023. She was good. There wasn't a thing wrong with until waking up on 20-Jan-2024 with the following symptoms which persisted. She had pressure on the eyes and dizziness, but it appears like it's internal, not like the room was spinning around her, but it felt, like it's inside the head from the eyes her head, the spinning would sometimes usually so bad that she had to, kept from walking into a wall. Also, every once in a while, she got a bad, pain in the back of the neck. She had also gone to a chiropractor and a psychologist and a psychiatrist, trying to figure out if it's mental and she had been to a psychologist for 18 months. Hearing also went in and out (patient wore a hearing aid but reported they were fine). She had recently developed humming in the head. The doctor who was for 48 years, could not figure it out. All tests came back good, which was a blessing. but she didn't have a life anymore because she couldn't do anything. Because the patient felt so bad and oftentimes, practically every night, usually in the evening, patient felt like a bad flu coming on or a real bad high fever, although patient didn't have a fever. Patient was tired, had no energy, it's constant, it never stopped from the time from patient opening her eyes, till going to sleep. Patient had seen 14 doctors of all different disciplines, she had numerous tests done; MRI, VMG, had been to ENTs, neurologist, cardiologists. Patient tried to figure out what's causing these symptoms. Patient had been told by several doctors to look into Covid/long covid/lingering covid. The physician told her that there's been a lot of feedback out there in the medical community about the COVID shots. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2025: Live significant follow-up received: Suspect product updated, medical history added, new events added. Also, secondary reporter added, and reference number added. More
2847271 F MI 06/25/2025 COVID19
 PFIZER\BIONTECH
Confusional state, Fatigue Confusional state, Fatigue
It was confusion and then like extreme like fatigue to the point where the patient like, they ended ... It was confusion and then like extreme like fatigue to the point where the patient like, they ended up not attending an important meeting that they had; It was confusion and then like extreme like fatigue to the point where the patient like, they ended up not attending an important meeting that they had; This is a spontaneous report received from a Nurse. A 70-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for hyperlipidaemia. The following information was reported: CONFUSIONAL STATE (non-serious), FATIGUE (non-serious) all with onset 2025, outcome "unknown" and all described as "It was confusion and then like extreme like fatigue to the point where the patient like, they ended up not attending an important meeting that they had". Additional information: The patient is reaching out from a doctor's office, internal medicine. We do have patient that recently completed one of the Pfizer like the vaccines for COVID (Later clarified as Pfizer COVID-19 vaccine) and so, the next day, the patient had some side effects that doctor wanted to report. So, it was confusion and then like extreme like fatigue to the point where the patient like, they ended up not attending an important meeting that they had. Reporter stated, it has been about a month since the start date of side effects. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
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