🏥 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 💀 🏥 🚑 ♿ ⚠️
2827523 F OR 02/21/2025 DTAPHEPBIP
HEP
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 K4JH7
K4JH7
Y018157
Extra dose administered; Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered; Extra dose administered
2 Hep B given on the same day. 2 Hep B given on the same day.
2827524 87 M TX 02/21/2025 FLU3
 SEQIRUS, INC.
Brain fog, Dizziness Brain fog, Dizziness
dizzy, could not think straight , in a fog mentally, could not reason ect. dizzy, could not think straight , in a fog mentally, could not reason ect.
2827525 56 F UT 02/21/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
FLU3
FLU3
FLU3
FLU3
FLU3
FLU3
FLU3
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
 CVX312
CVX312
CVX312
CVX312
CVX312
CVX312
CVX312
CVX312
CVX312
CVX312
Anion gap, Atelectasis, Basophil count decreased, Basophil percentage decreased,... Anion gap, Atelectasis, Basophil count decreased, Basophil percentage decreased, Blood albumin normal; Blood bilirubin normal, Blood calcium normal, Blood chloride increased, Blood creatinine normal, Blood glucose normal; Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide decreased, Computerised tomogram thorax; Creatinine renal clearance decreased, Differential white blood cell count, Dizziness, Electrocardiogram, Eosinophil count decreased; Eosinophil percentage decreased, Fibrin D dimer increased, Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal; Immature granulocyte count, International normalised ratio normal, Lung opacity, Lymphocyte count decreased, Lymphocyte percentage decreased; Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume normal, Memory impairment; Monocyte count normal, Monocyte percentage, Neutrophil count normal, Neutrophil percentage increased, Platelet count normal; Protein total normal, Prothrombin time normal, Pulmonary embolism, Red blood cell count decreased, Red blood cell nucleated morphology; Red cell distribution width increased, White blood cell count normal; Anion gap, Atelectasis, Basophil count decreased, Basophil percentage decreased, Blood albumin normal; Blood bilirubin normal, Blood calcium normal, Blood chloride increased, Blood creatinine normal, Blood glucose normal; Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide decreased, Computerised tomogram thorax; Creatinine renal clearance decreased, Differential white blood cell count, Dizziness, Electrocardiogram, Eosinophil count decreased; Eosinophil percentage decreased, Fibrin D dimer increased, Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal; Immature granulocyte count, International normalised ratio normal, Lung opacity, Lymphocyte count decreased, Lymphocyte percentage decreased; Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume normal, Memory impairment; Monocyte count normal, Monocyte percentage, Neutrophil count normal, Neutrophil percentage increased, Platelet count normal; Protein total normal, Prothrombin time normal, Pulmonary embolism, Red blood cell count decreased, Red blood cell nucleated morphology; Red cell distribution width increased, White blood cell count normal More
1-Multiple subsegmental pulmonary emboli without acute cor pulmonale, Small volume subsegmental pul... 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale, Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease. 3- Mild atelectasis. 4-Dizziness, memory issues, More
✓
2827526 49 F NC 02/21/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 y013009
y013009
Feeling abnormal, Injection site erythema, Injection site pain, Injection site p... Feeling abnormal, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Malaise, Pain More
Intense pain, swelling, and redness at injection site. "Much worse than any other vaccine I... Intense pain, swelling, and redness at injection site. "Much worse than any other vaccine I've ever had, and I've had a lot of vaccines." Severe arm pain, not the typical muscle soreness, much more severe on Day 1. On Day 2, patient reports feeling "horrible" body aches, fever, extremely sick feeling. Day 3 redness is spreading out around injection site and further down upper arm and is now itching severely and not just on skin, feels like it is itching in the muscle. More
2827527 0.5 F MI 02/21/2025 DTAPHEPBIP
FLU3
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 D252F
4S5YG
Y005457
LJ5281
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
Vares completed 2/21 Vares completed 2/21
2827528 75 M WI 02/21/2025 COVID19
 MODERNA
 3043332
Injection site erythema, Injection site rash, Rash Injection site erythema, Injection site rash, Rash
Red area around shot site, rash from site to his elbow right arm and rash on face Red area around shot site, rash from site to his elbow right arm and rash on face
2827529 76 M MN 02/21/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
PFIZER\BIONTECH
 006M20A
040A21A
071F21A
054A22A
027E22A
3031900
LM2216
Death; Death; Death; Death; Death; Death; Death Death; Death; Death; Death; Death; Death; Death
Patient expired on 2/19/2025. Patient expired on 2/19/2025.
✓
2827530 0.5 F MI 02/21/2025 DTAPHEPBIP
FLU3
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 D252F
4S5YG
Y005457
LJ5281
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Child came in for a visit to the office at 6 months and received a 3rd dose of PedvaxHIB that child ... Child came in for a visit to the office at 6 months and received a 3rd dose of PedvaxHIB that child was not due for. More
2827531 62 F MI 02/21/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 LN0591
LN0591
Abdominal X-ray, Abdominal discomfort, Abdominal pain, Abdominal pain upper, Blo... Abdominal X-ray, Abdominal discomfort, Abdominal pain, Abdominal pain upper, Blood test normal; Decreased appetite, Headache, Nausea More
Nausea, abdominal pain, cramping, stomach upset, loss of appetite, headache, inability to eat solid... Nausea, abdominal pain, cramping, stomach upset, loss of appetite, headache, inability to eat solid food due to stomach pain More
2827532 67 M TX 02/21/2025 COVID19
 PFIZER\BIONTECH
Gait disturbance, Hypoaesthesia Gait disturbance, Hypoaesthesia
Also had trivalent flu vaccine on 11/15/24, presented to ER on 1/25/25 with numbness from neck down ... Also had trivalent flu vaccine on 11/15/24, presented to ER on 1/25/25 with numbness from neck down and gait instability More
✓
2827533 0.5 M MI 02/21/2025 COVID19
DTAPHEPBIP
FLU3
HIBV
PNC20
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 LN8272
D252F
4S5YG
Y008355
LJ5281
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Child came in for a visit to the office at 6 months and received a 3rd dose of PedvaxHIB that child ... Child came in for a visit to the office at 6 months and received a 3rd dose of PedvaxHIB that child was not due for. More
2827534 0.5 M MI 02/21/2025 DTAPHEPBIP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 D252F
Y005457
LJ5281
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Child came in for a visit to the office at 6 months and received a 3rd dose of PedvaxHIB that child ... Child came in for a visit to the office at 6 months and received a 3rd dose of PedvaxHIB that child was not due for. More
2827535 1.17 M CO 02/21/2025 MMRV
 MERCK & CO. INC.
 W09295538
Expired product administered, No adverse event Expired product administered, No adverse event
The patient had received a expired vaccine. The patient didn't show any sign of adverse reactio... The patient had received a expired vaccine. The patient didn't show any sign of adverse reaction. The Provider was notified, and the provider said the patient will have to probably receive a new vaccine, so the patient gets the full dose of needed vaccine. More
2827536 14 F 02/21/2025 MMRV
 MERCK & CO. INC.
 X023599
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Pt was given MMRV instead of single dose of MMR and varicella given that pt is over the age of 12. P... Pt was given MMRV instead of single dose of MMR and varicella given that pt is over the age of 12. Provider confirmed dose as valid per immunize.org . Parent notified at time of visit. More
2827537 73 F CA 02/21/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Blood test normal, Computerised tomogram neck normal, Disability, Fatigue, Lymph... Blood test normal, Computerised tomogram neck normal, Disability, Fatigue, Lymphadenopathy; Pain, Pyrexia, SARS-CoV-2 test negative More
High fever up to 103 that persisted for five weeks. Swollen neck glands, body ache and fatigue. No ... High fever up to 103 that persisted for five weeks. Swollen neck glands, body ache and fatigue. No cold or flu symptoms. Went to ER twice (two different facilities) and and after multiple blood tests and cat scan of my neck (negative), negative Covid, neither ER could figute out what was causing my symptoms. I was completely dusabled for those five weeks andtook an additional month or two to fully recover my health. More
2827538 7 F MI 02/21/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Child was mistakenly given DTaP/IPV combination instead of age appropriate TDaP; patient experienced... Child was mistakenly given DTaP/IPV combination instead of age appropriate TDaP; patient experienced no adverse effects More
2827539 75 F PA 02/21/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 y019157
y019157
Confusional state, Erythema, Night sweats, Oral mucosal blistering, Pain in extr... Confusional state, Erythema, Night sweats, Oral mucosal blistering, Pain in extremity; Swelling, Tremor More
pt called 3 days after vaccine. Pt experienced mouth blister, red, sore arm, with swelling and shaki... pt called 3 days after vaccine. Pt experienced mouth blister, red, sore arm, with swelling and shaking and night sweats, pt felt confused at one point in the day and felt that we was out of it and had a lapse of time awareness. More
2827540 1 M OK 02/21/2025 HEPA
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 C2489
Y003677
Y010373
Abdominal X-ray, Abdominal pain, Haematochezia; Abdominal X-ray, Abdominal pain,... Abdominal X-ray, Abdominal pain, Haematochezia; Abdominal X-ray, Abdominal pain, Haematochezia; Abdominal X-ray, Abdominal pain, Haematochezia More
He developed abdominal pain and blood in his stool that night/early the next morning. He developed abdominal pain and blood in his stool that night/early the next morning.
2827541 78 F NV 02/21/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 G22GH
BP74J
Eye contusion, Eyelid pain, Swelling of eyelid; Eye contusion, Eyelid pain, Swel... Eye contusion, Eyelid pain, Swelling of eyelid; Eye contusion, Eyelid pain, Swelling of eyelid More
PATIENT CALLED THE MORNING OF 2/21/25 AND STATED SHE "ESSENTIALLY HAS A BLACK EYE" WITH A ... PATIENT CALLED THE MORNING OF 2/21/25 AND STATED SHE "ESSENTIALLY HAS A BLACK EYE" WITH A SWOLLEN LOWER EYELID WHICH HAS TURNED BLACK AND IS PAINFUL. I ADVISED THE PATIENT SO GO SEE HER EYE DOCTOR AND A PRESCRIPTION FOR TOBRADEX WAS SENT IN. More
2827552 0.17 MI 02/21/2025 HIBV
HIBV
HIBV
 MERCK & CO. INC.
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; Extra dose administered, No adverse event More
15 children received a dose of PEDVAX HIB at 2 months old, 4 months old, and an extra dose at 6 mont... 15 children received a dose of PEDVAX HIB at 2 months old, 4 months old, and an extra dose at 6 months old; no additional AE reported.; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On an unknown date, at the age of 2 months the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), then, at the age of 4 months old, the patient was vaccinated with a second dose, and at the age of 6 months, the patient received an extra dose (Extra dose administered) (lot #s, dose descriptions, anatomical locations, routes of administration and expiration dates were not reported) as prophylaxis. No additional adverse event was reported. This is 1 of 15 cases received from the same reporter. More
2827553 0.17 MI 02/21/2025 HIBV
HIBV
HIBV
 MERCK & CO. INC.
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; Extra dose administered, No adverse event More
15 children received a dose of PEDVAX HIB at 2 months old, 4 months old, and an extra dose at 6 mont... 15 children received a dose of PEDVAX HIB at 2 months old, 4 months old, and an extra dose at 6 months old; no additional AE reported.; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On an unknown date, at the age of 2 months the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), then, at the age of 4 months old, the patient was vaccinated with a second dose, and at the age of 6 months, the patient received an extra dose (Extra dose administered) (lot #s, dose descriptions, anatomical locations, routes of administration and expiration dates were not reported) as prophylaxis. No additional adverse event was reported. This is 1 of 15 cases received from the same reporter. More
2827554 0.17 MI 02/21/2025 HIBV
HIBV
HIBV
 MERCK & CO. INC.
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; Extra dose administered, No adverse event More
15 children received a dose of PEDVAX HIB at 2 months old, 4 months old, and an extra dose at 6 mont... 15 children received a dose of PEDVAX HIB at 2 months old, 4 months old, and an extra dose at 6 months old; no additional AE reported.; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On an unknown date, at the age of 2 months the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), then, at the age of 4 months old, the patient was vaccinated with a second dose, and at the age of 6 months, the patient received an extra dose (Extra dose administered) (lot #s, dose descriptions, anatomical locations, routes of administration and expiration dates were not reported) as prophylaxis. No additional adverse event was reported. This is 1 of 15 cases received from the same reporter. More
2827555 0.17 MI 02/21/2025 HIBV
HIBV
HIBV
 MERCK & CO. INC.
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; Extra dose administered, No adverse event More
15 children received a dose of PEDVAX HIB at 2 months old, 4 months old, and an extra dose at 6 mont... 15 children received a dose of PEDVAX HIB at 2 months old, 4 months old, and an extra dose at 6 months old; no additional AE reported.; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On an unknown date, at the age of 2 months the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), then, at the age of 4 months old, the patient was vaccinated with a second dose, and at the age of 6 months, the patient received an extra dose (Extra dose administered) (lot #s, dose descriptions, anatomical locations, routes of administration and expiration dates were not reported) as prophylaxis. No additional adverse event was reported. This is 1 of 15 cases received from the same reporter. More
2827556 M 02/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Chills, Headache, Influenza like illness, Pain, Pyrexia Chills, Headache, Influenza like illness, Pain, Pyrexia
fever; Flu like symptoms including; shivering; headache; body aches; This non-serious case was repor... fever; Flu like symptoms including; shivering; headache; body aches; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of fever in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 14-FEB-2025, the patient received Shingrix (left deltoid). On 14-FEB-2025, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), influenza-like symptoms (Verbatim: Flu like symptoms including), shivering (Verbatim: shivering), headache (Verbatim: headache) and general body pain (Verbatim: body aches). On 14-FEB-2025, the outcome of the fever, influenza-like symptoms, shivering, headache and general body pain were resolved. The reporter considered the fever, influenza-like symptoms, shivering, headache and general body pain to be related to Shingrix. The company considered the fever, influenza-like symptoms, shivering, headache and general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 14-FEB-2025 The reporter reported that patient received the Shingrix vaccine and experienced Flu like symptoms including fever, shivering, headache, body aches. More
2827557 02/21/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Injection site pain; Injection site pain Injection site pain; Injection site pain
had some injection site pain for a few days but no other problems.; This non-serious case was report... had some injection site pain for a few days but no other problems.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Family history included shingles. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced injection site pain (Verbatim: had some injection site pain for a few days but no other problems.). 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 and Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 17-FEB-2025 This case was reported by a patient via interactive digital media. The patient got the two part Shingrix vaccine last year (2024) and had some injection site pain for a few days but no other problems. The patient saw his/her father go through several bouts of shingles. More
2827558 02/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; I got the shot and still got shingles; This serious case was reported... Suspected vaccination failure; I got the shot and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shot and still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-FEB-2025 This case was reported by a patient via interactive digital media. The patient got the shot and still got shingles. The patient said just because someone got the shot did not meant anything. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure?is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2827559 02/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I had the first shingles shot five years ago; This non-serious case was reported by a consumer via i... I had the first shingles shot five years ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose 5 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I had the first shingles shot five years ago). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date 18-FEB-2025 The reported asked if he/she should take the second one now or did she/he have to get both again. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. More
2827560 NY 02/21/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 3L339
Injection site pain, Product quality issue, Syringe issue Injection site pain, Product quality issue, Syringe issue
pain at injection site; several BEXSERO syringes having too much air and administered one dose which... pain at injection site; several BEXSERO syringes having too much air and administered one dose which included the air bubble; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) (batch number 3L339, expiry date 30-SEP-2027) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: pain at injection site), syringe issue (Verbatim: several BEXSERO syringes having too much air and administered one dose which included the air bubble) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain, syringe issue and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site pain and syringe issue to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain and syringe issue to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-JAN-2025 The reporter reported that patient had experienced problems with several Bexero syringes having too much air. The physician had have tried to expel the air with and without the syringe attached and suspect syringes have been discarded. The Physician now knows to save the suspect syringes if it happens again so attempted to enter both batch numbers into the M-ERP template, but it will not accept one of them. Two recent batches affected are: 3L339 and XX33P. They state that this has been happening intermittently with all batches since the new syringe presentation. They are aware of the documentation stating they did administer the vaccine with the air. They state that they did administer one dose which included the air bubble and the patient complained of lasting pain with the injection. The description of approximate size, shape, and color as 0.3-0.4 mL OF clear air. The physician explained that different from other syringes as vaccine cloudier, deposit more difficult to put in suspension, color was different but able to expel air from syringes. No visible damage present on the syringe and any temperature excursions during storage. The product at room temperature when particle observed at times out of fridge 10 to 15 minutes as per norm.; Sender's Comments: US-GSK-US2025009568:same reporter More
2827561 F MD 02/21/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
Extra Dose; This non-serious case was reported by a physician via call center representative and des... Extra Dose; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a female patient who received Rota (Rotarix liquid formulation) for prophylaxis. Previously administered products included Rotarix (received 1st dose of vaccine on unknown date) and Rotarix (received 2nd dose of vaccine on unknown date). On an unknown date, the patient received the 3rd dose of Rotarix liquid formulation (oral). On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced extra dose administered (Verbatim: Extra Dose). The outcome of the extra dose administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-JAN-2025 The pediatrician called on the day of reporting and stated that a child was given 3 doses of the vaccine Rotarix by mistake instead of two, which led to extra dose administered. More
2827562 NC 02/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Herpes zoster Herpes zoster
develop Shingles; This non-serious case was reported by a physician via sales rep and described the ... develop Shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: develop Shingles). The outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 28-JAN-2025 The Health Care Professional reported to have two different patients who developed shingles within 2 weeks of first dose. He would like to know if there was a correlation between receiving the vaccine and developing shingles and states this appears to be more than a coincidence. More
2827563 02/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Early 2nd dose; This non-serious case was reported by a pharmacist via call center representative an... Early 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). 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 drug dose administration interval too short (Verbatim: Early 2nd dose). The outcome of the drug dose administration interval too short was unknown. Additional Information: GSK Receipt Date: 30-JAN-2025 A pharmacist reported that a patient received Shingrix, the initial dose and then 10 days later inadvertently got the second dose, which led to shortening of the vaccination schedule. More
2827564 68 F NJ 02/21/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
she received Bexsero when she was 68 years old; This non-serious case was reported by a consumer via... she received Bexsero when she was 68 years old; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 68-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. The patient's past medical history included splenectomy. In AUG-2023, the patient received Bexsero. In AUG-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: she received Bexsero when she was 68 years old). The outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-JAN-2025 The patient received Bexsero when she was 68 years old which led to inappropriate age at vaccine administration. The patient stated that she received the vaccine as a recommendation from her doctor due to having her spleen removed by surgery. More
2827565 12 F OH 02/21/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product preparation error Product preparation error
Lyophilized vial reconstituted with sterile water; patients where administered with Menveo (2-vial) ... Lyophilized vial reconstituted with sterile water; patients where administered with Menveo (2-vial) not reconstituted properly; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 06-FEB-2025, the patient received Menveo. On 06-FEB-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Lyophilized vial reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: patients where administered with Menveo (2-vial) not reconstituted properly). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 10-FEB-2025 The reporter reported that two 2 where administered with Menveo (2-vial) not reconstituted properly, since the lyophilized component was diluted with sterile water instead of the liquid component vial which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Lot number and expiration date for the vaccine was unknown by reporter. It was the first dose of a Meningococcal vaccine for those two patients in that facility, but reporter did not know if any of the patients received a prior Meningococcal dose in another facility. This case is linked with US2025017240, reported by same reporter.; Sender's Comments: US-GSK-US2025017240:Same reporter/Different patient More
2827566 17 F OH 02/21/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product preparation error Product preparation error
Lyophilized vial reconstituted with sterile water and administered; Lyophilized vial reconstituted w... Lyophilized vial reconstituted with sterile water and administered; Lyophilized vial reconstituted with sterile water and administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 06-FEB-2025, the patient received the 1st dose of Menveo. On 06-FEB-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Lyophilized vial reconstituted with sterile water and administered) and inappropriate dose of vaccine administered (Verbatim: Lyophilized vial reconstituted with sterile water and administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 10-FEB-2025 Pharmacy manager explained that, 2 patients where administered with Menveo (2-vial) not reconstituted properly, since the lyophilized component was diluted with sterile water instead of the liquid component vial which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Lot number and expiration date for the vaccine was unknown by caller. It was the first dose of a meningococcal vaccine for those two patients in that facility, but caller did not know if any of the patients received a prior meningococcal dose in another facility. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments: US-GSK-US2025017237:Same reporter/Different patient More
2827567 53 F TX 02/21/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Incomplete course of vaccination, Malaise; Incomplete course of vaccination, Mal... Incomplete course of vaccination, Malaise; Incomplete course of vaccination, Malaise More
never got her second dose; she was sick; not feeling good; This non-serious case was reported by a c... never got her second dose; she was sick; not feeling good; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included COVID vaccine (had COVID vaccines prior to receiving Shingrix (no product information provided)). In NOV-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received Shingrix. In NOV-2022, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness (Verbatim: she was sick) and feeling unwell (Verbatim: not feeling good). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: never got her second dose ). The outcome of the sickness and feeling unwell were resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the sickness and feeling unwell to be related to Shingrix. It was unknown if the company considered the sickness and feeling unwell to be related to Shingrix. Additional Information: GSK receipt date: 12-FEB-2025 Patient reported that she received her first dose of Shingrix in November 2022 and never got her second dose. Patient also reported that starting the day after the first dose of Shingrix, she was sick and not feeling good, and this lasted for a few days. Patient also stated that she had Covid vaccines prior to receiving Shingrix, no product information provided. The patient did not had Lot/Expiry/Location of Administration to provide. Till the time of reporting patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2827568 M CA 02/21/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Twinrix second dose was administered 6 months later and today patient wants to received the third do... Twinrix second dose was administered 6 months later and today patient wants to received the third dose ( 11 months apart).; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (patient that received Twinrix first dose back in March). On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix second dose was administered 6 months later and today patient wants to received the third dose ( 11 months apart).). The outcome of the drug dose administration interval too long was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 14-FEB-2025 Other HCP reported that an adult patient that received Twinrix first dose back in March. Twinrix second dose was administered 6 months later, which led to drug dose interval too long and on the day of reporting patient wanted to received the third dose at 11 months apart. Reporter decided to discussed this question with patient's doctor before arriving to an answer. More
2827569 MO 02/21/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 H3SG9
Expired product administered Expired product administered
Expired dose administered; This non-serious case was reported by a nurse via call center representat... Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number H3SG9, expiry date 03-JAN-2025) for prophylaxis. On 10-FEB-2025, the patient received the 1st dose of Twinrix. On 10-FEB-2025, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-FEB-2025 Registered nurse reported that a dose of Twinrix was administered on 10 February 2025, but then they noticed it had an expiration date of 03 January 2025 which led to expired vaccine used. No prior Hepatitis A or Hepatitis B vaccines were administered so far. Any patient demographics were not provided. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up. More
2827570 M 02/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Patient recived frist dose five years ago but still not recived second dose; This non-serious case w... Patient recived frist dose five years ago but still not recived second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose five years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient recived frist dose five years ago but still not recived second dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 18-FEB-2025 The reporter reported that a patient who had received the first shingles vaccine about 5 years ago and asked what should do now because he did not know whether to start the series again. The patient going to contacted but had various questions over the years, and he just wanted to know a definitive response. The patient did not have the information about the date of the 1st dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2827571 60 F IL 02/21/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 9JG23
Expired product administered Expired product administered
Engerix on February 18th 2025 but vaccine had an expiration date of February 10th 2025; This non-ser... Engerix on February 18th 2025 but vaccine had an expiration date of February 10th 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HBV (Engerix B) (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis. On 18-FEB-2025, the patient received the 1st dose of Engerix B. On 18-FEB-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix on February 18th 2025 but vaccine had an expiration date of February 10th 2025). 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: 18-FEB-2025 Pharmacist reported that a patient got Engerix B but vaccine was expired, which led expired vaccine used. The reporter consented to follow up. More
2827572 0.5 M CO 02/21/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 4BC5L
Product preparation issue Product preparation issue
administration of only diluent portion of Hiberix to a patient; administration of only diluent porti... administration of only diluent portion of Hiberix to a patient; administration of only diluent portion of Hiberix to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old male patient who received Hib (Hiberix) (batch number 4BC5L, expiry date 14-NOV-2028) for prophylaxis. On 13-FEB-2025, the patient received Hiberix. On 13-FEB-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: administration of only diluent portion of Hiberix to a patient) and inappropriate dose of vaccine administered (Verbatim: administration of only diluent portion of Hiberix to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date 19-FEB-2025 The reporter reported that administration of only diluent portion of Hiberix to a patient. Patient was administered the diluent of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2827573 02/21/2025 COVID19
 JANSSEN
Faeces discoloured, Vomiting Faeces discoloured, Vomiting
had light dark green stools; was throwing up; This spontaneous report received from a health care pr... had light dark green stools; was throwing up; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for . No concomitant medications were reported. On an unspecified date, the patient experienced had light dark green stools and was throwing up. The action taken with janssen covid-19 vaccine was not applicable. The outcome of had light dark green stools and was throwing up was not reported. This report was non-serious. More
2827574 M 02/21/2025 COVID19
 JANSSEN
Atrial fibrillation Atrial fibrillation
atrial fibrillation; This spontaneous report received from a patient concerned a male patient of uns... atrial fibrillation; This spontaneous report received from a patient concerned a male patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced atrial fibrillation. (dose series 1) The action taken with janssen covid-19 vaccine was not applicable. The outcome of atrial fibrillation was not reported. The reporter considered the causality between janssen covid-19 vaccine and atrial fibrillation as related. Company causality between janssen covid-19 vaccine and atrial fibrillation as possible. This report was serious (other medically important condition).; Sender's Comments: V0; Atrial fibrillation; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. More
2827575 60 F 02/21/2025 COVID19
 MODERNA
COVID-19 COVID-19
consumer has COVID after taking booster shot of Moderna and again has COVID this time; This spontane... consumer has COVID after taking booster shot of Moderna and again has COVID this time; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (consumer has COVID after taking booster shot of Moderna and again has COVID this time) in a 60-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19. Previously administered products included for COVID-19: Paxlovid in July 2022. Past adverse reactions to the above products included No adverse effect with Paxlovid. On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (consumer has COVID after taking booster shot of Moderna and again has COVID this time). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) (oral use) ongoing from 06-Feb-2025 for COVID-19, at a dose of 300-100 mg 3 tablets two times a day for five day; Ibuprofen at an unspecified dose and frequency; Dextromethorphan hydrobromide, Guaifenesin (Mucinex dm) at an unspecified dose and frequency; Zinc at an unspecified dose and frequency; Ergocalciferol (Vitamin d) at an unspecified dose and frequency; Ascorbic acid (Vitamin C) at an unspecified dose and frequency and Acetylsalicylic acid, Caffeine, Paracetamol (Excedrin) at an unspecified dose and frequency. At the time of the report, COVID-19 (consumer has COVID after taking booster shot of Moderna and again has COVID this time) outcome was unknown. The patient was unsure of the patient's weight but it was about 155 (units : not reported). No concomitant medication was reported. Patient had Paxlovid before in Jul-2022 and then she had COVID-19 and received Paxlovid again. Patient received booster dose of Moderna vaccine and also received all of the booster doses. More
2827576 F 02/21/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Heavy metal increased, Investigation; Heavy metal increased, Investigation Heavy metal increased, Investigation; Heavy metal increased, Investigation
high presence of mercury in my body; This spontaneous case was reported by a patient and describes t... high presence of mercury in my body; This spontaneous case was reported by a patient and describes the occurrence of HEAVY METAL INCREASED (high presence of mercury in my body) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. In May 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY METAL INCREASED (high presence of mercury in my body). At the time of the report, HEAVY METAL INCREASED (high presence of mercury in my body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: After some testing during travels, patient discovered a high presence of mercury in body. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown. No concomitant medication was reported. The patient recently had several booster vaccinations in May 2024 for travel reasons. Following some tests conducted during her travels, she found elevated levels of mercury in her system and was currently investigating possible sources. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2025: Live non-significant follow up received: reference number added. More
2827577 74 F CA 02/21/2025 COVID19
 MODERNA
Dizziness, Pain, Pain in extremity, Pyrexia Dizziness, Pain, Pain in extremity, Pyrexia
aches; painful hands; dizziness; fever; This spontaneous case was reported by a non-health professio... aches; painful hands; dizziness; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (aches), PAIN IN EXTREMITY (painful hands), DIZZINESS (dizziness) and PYREXIA (fever) in a 74-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), PAIN IN EXTREMITY (painful hands), DIZZINESS (dizziness) and PYREXIA (fever). At the time of the report, PAIN (aches), PAIN IN EXTREMITY (painful hands), DIZZINESS (dizziness) and PYREXIA (fever) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Patient had no medical history, concomitant disease or risk factor. Concomitant product use was not provided by the reporter. Patient did not experience any additional symptoms or events. There were no lab data or results were available. Treatment information was not provided. Reporter causality was not reported. More
2827579 M 02/21/2025 PNC20
 PFIZER\WYETH
Injection site erythema Injection site erythema
Red round mark where the injection site is, it feels like kind of a reddish circle, like a round red... Red round mark where the injection site is, it feels like kind of a reddish circle, like a round reddish mark; This is a spontaneous report received from a Consumer or other non HCP. A male 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: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Red round mark where the injection site is, it feels like kind of a reddish circle, like a round reddish mark". Additional information: consumer stated, he took it on Wednesday, 6 days ago and you know, no bad reactions. Well now today he noticed back, back like underneath where the injection site was on the triceps. It feels like kind of a reddish circle, like a round reddish mark, you know not a little tiny mark, a big mark which raised my concern level. So, he just went online and did some research and then he would have gone back to his GP who gave him the shot but her office for some reason was closed. So, he went to a emergency care but the guy looked at it and said, sometimes the reactions are delayed but he is not an expert in this vaccine like you are. consumer stated, "Six days later right. It does not itch, there was no pain, it might hurt a little tiny bit but there was no pain. He was not trying to downplay it and just telling you the facts, but it was there, and he did not notice it there prior to today. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2827580 F GA 02/21/2025 COVID19
 PFIZER\BIONTECH
Aphasia, Pneumothorax, Pulmonary thrombosis, Swelling Aphasia, Pneumothorax, Pulmonary thrombosis, Swelling
left lung collapsed due to a small clot like those from birth control pills; left lung collapsed due... left lung collapsed due to a small clot like those from birth control pills; left lung collapsed due to a small clot like those from birth control pills; aphasia; noticed some swelling near her breast underneath the armpit; This is a spontaneous report received from a Nurse from medical information team, Program ID. A 79-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMOTHORAX (medically significant), PULMONARY THROMBOSIS (medically significant), outcome "unknown" and all described as "left lung collapsed due to a small clot like those from birth control pills"; APHASIA (non-serious), outcome "unknown"; SWELLING (non-serious), outcome "not recovered", described as "noticed some swelling near her breast underneath the armpit". Clinical course: The patient was a retired nurse calling for herself as she took her first covid shot on her left arm and had a reaction and next shot is on her right arm and had the same reaction, and now unable to fit on her coat. The first COVID-19 vaccine she had was some years ago and she had aphasia. Her left lung collapsed due to a small clot like those from birth control pills. Then, a few months later, she noticed some swelling near her breast underneath the armpit. It doesn't go away. Patient was asking if she can get the next shot on her hip or she will do it by herself as she knew how to do it. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events pneumothorax, and pulmonary thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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. ,Linked Report(s) : US-PFIZER INC-202500039797 same patient/drug, different event/drug dose.; More
2827581 50 F CA 02/21/2025 COVID19
 PFIZER\BIONTECH
Headache, Illness, Influenza like illness Headache, Illness, Influenza like illness
severe headaches; made her feel like she had the flu; sick; This is a spontaneous report received fr... severe headaches; made her feel like she had the flu; sick; This is a spontaneous report received from a Nurse from medical information team. A 50-year-old female patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing), notes: diagnosed at least 15 years ago. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (medically significant) with onset 19Jan2021, outcome "recovered" (20Jan2021), described as "sick"; HEADACHE (non-serious), outcome "recovered", described as "severe headaches"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "made her feel like she had the flu". Clinical course: The patient informed that she had both of Pfizer's Covid vaccines in the past and they made her very sick for several days. She informed that the doctor was not involved. Her symptoms occurred the day after she received the injections. The second dose made her sicker than the first. With both of them, she had a reaction and clarified that she had severe headaches, and it made her feel like she had the flu. The first shot she was sick for 2 days and with the 2nd shot she was sick in bed for 4 days. She has completely recovered from this. The event very sick was reported as serious as other medically important condition. The reporter relatedness of drug to reaction/events was yes. The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Based on the close temporal relationship, the association between the event sick with BNT162b2 can not be fully excluded. 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.,Linked Report(s) : US-PFIZER INC-202500039829 same reporter/patient/events, different dose; More
2827582 34 F NY 02/21/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EN6203
EN6203
Autonomic nervous system imbalance, Investigation, Laboratory test, Menstrual di... Autonomic nervous system imbalance, Investigation, Laboratory test, Menstrual disorder, Postural orthostatic tachycardia syndrome; Small fibre neuropathy, Von Willebrand's factor antigen test, Von Willebrand's factor multimers abnormal More
Dysautonomia; Postural orthostatic tachycardia syndrome; Small fiber neuropathy; Changes in my menst... Dysautonomia; Postural orthostatic tachycardia syndrome; Small fiber neuropathy; Changes in my menstrual cycle with abnormal bleeding; von Willebrand factor high; This is a spontaneous report received from a Consumer or other non HCP. A 34-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EN6203) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for depression, anxiety. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL9267), administration date: 17Mar2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (medically significant), outcome "unknown", described as "Dysautonomia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "Small fiber neuropathy"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Changes in my menstrual cycle with abnormal bleeding"; VON WILLEBRAND'S FACTOR MULTIMERS ABNORMAL (non-serious), outcome "unknown", described as "von Willebrand factor high". The patient underwent the following laboratory tests and procedures: factor eight assay: (2021) high; Lab work: (unspecified date) Unknown results, notes: Yes a lot of it actually; Von Willebrand's factor antigen test: (2021) high, notes: von Willebrand factor activity is high. Therapeutic measures were taken as a result of autonomic nervous system imbalance. Clinical course: Consumer stated, that she developed the disorder Dysautonomia, Pots postural orthostatic tachycardia syndrome, also developed small fiber neurotherapy and She experienced some changes in menstrual cycle with abnormal bleeding, those she thinks are the most distinguishable right now."Consumer stated, "I am not prior to this but my doctors have put me on IVIG on this and I am also taking Lexapro for anxiety and depression."Consumer stated, "So right now it is finding that I have the factor for von Willebrand, factor is coming back high and if we go back to 2021 I have elevated sedimentation rates. The von Willebrand factor antigen is high, the factor eight assay is high and the von Willebrand factor activity is high." More
2827583 M NJ 02/21/2025 COVID19
 PFIZER\BIONTECH
Pre-existing condition improved, Therapeutic response unexpected Pre-existing condition improved, Therapeutic response unexpected
after got the shot, hasn't for a long time, has no need for asthma medicine anymore/very good f... after got the shot, hasn't for a long time, has no need for asthma medicine anymore/very good for asthma; after got the shot, hasn't for a long time, has no need for asthma medicine anymore; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "after got the shot, hasn't for a long time, has no need for asthma medicine anymore". Additional information: Calling to let know caller got the COVID-19 shot from Pfizer two times and caller was suffering with asthma for a long time, many years, for 15 or 18 years. Confirmed asthma was prior to caller getting any of the Pfizer COVID-19 shots. After caller got the shot, hasn't for a long time, has no need for asthma medicine anymore. Usually by Spring time caller was not even able to go outside, after got the shot for the last 3 years feeling good. Confirmed both doses were the Pfizer COVID-19 shot. 1st dose: Date: Unknown, doesn't remember, in Spring time, but does not have card at time of call to provide information. Patient received 2nd dose, about 6 months later. Batch/lot number is not provided, and it cannot be obtained. More
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