🏥 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 💀 🏥 🚑 ♿ ⚠️
2824268 67 F CA 02/03/2025 COVID19
 MODERNA
Cerebral infarction, Computerised tomogram, Electrocardiogram, Magnetic resonanc... Cerebral infarction, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging head, Ultrasound head More
Cerebral infarction Stroke on October 23, 2024. Cerebral infarction Stroke on October 23, 2024.
✓ ✓
2824269 41 F NC 02/03/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 LP1780
LP1780
LP1780
Brain fog, Chills, Diarrhoea, Dizziness, Fatigue; Malaise, Muscle fatigue, Myalg... Brain fog, Chills, Diarrhoea, Dizziness, Fatigue; Malaise, Muscle fatigue, Myalgia, Oropharyngeal pain, Parosmia; Pyrexia, Retching, Rhinorrhoea, Taste disorder More
Fever, Chills, loose stools, Retching from the bowels during diarrhea, Sore throat, running nose, Br... Fever, Chills, loose stools, Retching from the bowels during diarrhea, Sore throat, running nose, Brain fog, Muscle Fatigue and Soreness especially around joints, Malaise, lightheaded or dizzy. Extreme tiredness, especially after physical activity. Problems with taste and smell. More
2824270 44 F NJ 02/03/2025 COVID19
COVID19
 MODERNA
MODERNA
 013L20A
016M20A
Autonomic nervous system imbalance, Postural orthostatic tachycardia syndrome; A... Autonomic nervous system imbalance, Postural orthostatic tachycardia syndrome; Autonomic nervous system imbalance, Postural orthostatic tachycardia syndrome More
I was diagnosed with POTS/ autonomic dysfunction 6/2024 by my rheumatologist Dr, PCP Dr, neurologi... I was diagnosed with POTS/ autonomic dysfunction 6/2024 by my rheumatologist Dr, PCP Dr, neurologist Dr and functional medicine and physiatrist Dr and cardiologist Dr More
✓
2824271 27 M OH 02/03/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 076C21A
076C21A
027H21B
027H21B
065K21A
065K21A
Congenital cystic kidney disease, Dyslipidaemia, Gene mutation identification te... Congenital cystic kidney disease, Dyslipidaemia, Gene mutation identification test positive, Hypertension, Laboratory test; Oedema, Psoriasis, Psoriatic arthropathy, Renal impairment, Ultrasound kidney; Congenital cystic kidney disease, Dyslipidaemia, Gene mutation identification test positive, Hypertension, Laboratory test; Oedema, Psoriasis, Psoriatic arthropathy, Renal impairment, Ultrasound kidney; Congenital cystic kidney disease, Dyslipidaemia, Gene mutation identification test positive, Hypertension, Laboratory test; Oedema, Psoriasis, Psoriatic arthropathy, Renal impairment, Ultrasound kidney More
At this time, I developed both symptoms of nonhereditary ADKPD and Psoriatic plaques which further ... At this time, I developed both symptoms of nonhereditary ADKPD and Psoriatic plaques which further developed into Psoriatic Arthritis. After further genetic testing, it was found that ADPKD was not inherited, but a sporadic mutation & a very fast progressive form of the disease. - the Nephrologist confirmed that this was a very rare form of the disease. I had developed hypertension, severe edema, and dyslipidemia. My kidney function declined to less than 40% within 6 months. The Psoriasis was also a very fast progressive form of the disease, one that was very unusual according to the Rheumatologist. I had skin plaques all over the extensor surfaces of my body. More
✓
2824272 7 M CA 02/03/2025 TDAP
 SANOFI PASTEUR
 u8232aa
Haematochezia, Influenza, Pyrexia Haematochezia, Influenza, Pyrexia
Mom reported - flu symptoms, mild fever, blood in stool Mom reported - flu symptoms, mild fever, blood in stool
2824273 4 M CA 02/03/2025 DTAPHEPBIP
DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 x9ep5
x9ep5
Haematochezia, Influenza, Injection site pain, Injection site reaction, Injectio... Haematochezia, Influenza, Injection site pain, Injection site reaction, Injection site swelling; Pyrexia, Rash erythematous More
Mom reported at the site of injection a raised painful red circle rash, roughly 3". Flu symptom... Mom reported at the site of injection a raised painful red circle rash, roughly 3". Flu symptoms, mild fever, blood in stool More
2824275 13 M CA 02/03/2025 COVID19
 PFIZER\BIONTECH
 ln0588
Disorientation, Pyrexia Disorientation, Pyrexia
fever initially along with feeling disoriented, fever resolved and now feels disoriented and like he... fever initially along with feeling disoriented, fever resolved and now feels disoriented and like he is not in his own body More
2824276 15 M NC 02/03/2025 COVID19
 MODERNA
 3042648
No adverse event, Product preparation error No adverse event, Product preparation error
Vaccine was not thawed properly before administration. Vaccine was thawed for 20-30 minutes before a... Vaccine was not thawed properly before administration. Vaccine was thawed for 20-30 minutes before administration. No reports of adverse side effects. More
2824278 71 M IN 02/03/2025 RSV
 PFIZER\WYETH
 LN 5493
Diarrhoea, Miosis, Vision blurred Diarrhoea, Miosis, Vision blurred
Blurred vision, constricted pupils, brief diarrhea Blurred vision, constricted pupils, brief diarrhea
2824279 48 M PA 02/03/2025 COVID19
 PFIZER\BIONTECH
 FF2590
Chest pain, Heart rate increased, Hyperhidrosis, Loss of consciousness Chest pain, Heart rate increased, Hyperhidrosis, Loss of consciousness
Extremely rapid heart beat, severe chest pain, extreme sweating, loosing consciousness Extremely rapid heart beat, severe chest pain, extreme sweating, loosing consciousness
2824280 50 F OH 02/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 L2ZK2
Influenza like illness, Pyrexia, Rash, Skin warm Influenza like illness, Pyrexia, Rash, Skin warm
Pt states she began having flu like symptoms on Friday evening. Pt had been advised this was a norma... Pt states she began having flu like symptoms on Friday evening. Pt had been advised this was a normal reaction. Pt states she ran a low grade fever that resolved. This was followed by a rash noted on Saturday Morning at 8:00 A.M. while showering. Rash is hot to touch and 7cm in diameter. Still present on 2/3/25 but seems to be improving per pt. More
2824281 88 M WI 02/03/2025 RSV
 PFIZER\WYETH
 ln5489
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administered wrong RSV immunization administered wrong RSV immunization
2824282 21 F NC 02/03/2025 MENB
TDAP
TYP
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
SANOFI PASTEUR
 99G34
3CA10C1
X1A261M
Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, L... Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, Loss of consciousness More
Pt verbalized feeling lightheaded shortly after receiving all 3 vaccinations. Followed by loss of co... Pt verbalized feeling lightheaded shortly after receiving all 3 vaccinations. Followed by loss of consciousness for approximately 30 seconds. Pt was moved to exam table to lay down. Snack provided. 4PM BP 98/58, HR 65, O2 99%. 4:06PM BP 101/61. 4:12PM BP 95/60. 4:21PM 113/78. Pt reported feeling much improved, declined ongoing lightheadedness. Pt ambulated safely out of clinic. More
2824283 0.17 M PA 02/03/2025 DTAPHEPBIP
HIBV
PNC13
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS



Depressed level of consciousness, Fluid intake reduced, Hyporesponsive to stimul... Depressed level of consciousness, Fluid intake reduced, Hyporesponsive to stimuli, Lethargy, Seizure; Depressed level of consciousness, Fluid intake reduced, Hyporesponsive to stimuli, Lethargy, Seizure; Depressed level of consciousness, Fluid intake reduced, Hyporesponsive to stimuli, Lethargy, Seizure; Depressed level of consciousness, Fluid intake reduced, Hyporesponsive to stimuli, Lethargy, Seizure More
hypotonic seizure, decreased arousal, decreased fluid intake, decreased responsiveness to stimuli, l... hypotonic seizure, decreased arousal, decreased fluid intake, decreased responsiveness to stimuli, lethargy More
2824284 42 F CA 02/03/2025 FLU3
 SEQIRUS, INC.
Injected limb mobility decreased, Limb injury, Product administered at inappropr... Injected limb mobility decreased, Limb injury, Product administered at inappropriate site More
Shot was injected too high into the shoulder causing injury. Pain and limited use of shoulder have b... Shot was injected too high into the shoulder causing injury. Pain and limited use of shoulder have been ongoing for almost 5 months. More
2824285 66 F FL 02/03/2025 FLU3
FLU3
FLU3
RSV
RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 2257N
2257N
2257N
HY1812
HY1812
HY1812
Acne, Allergy test, Condition aggravated, Dyspepsia, Formication; Hyperchlorhydr... Acne, Allergy test, Condition aggravated, Dyspepsia, Formication; Hyperchlorhydria, Hypersensitivity, Laboratory test, Rash, Rash macular; Sensitive skin, Skin disorder, Sleep disorder, Urticaria; Acne, Allergy test, Condition aggravated, Dyspepsia, Formication; Hyperchlorhydria, Hypersensitivity, Laboratory test, Rash, Rash macular; Sensitive skin, Skin disorder, Sleep disorder, Urticaria More
October 19th, 2024: Initial Symptom 15 minutes post vaccination, felt a high amount of stomach acid ... October 19th, 2024: Initial Symptom 15 minutes post vaccination, felt a high amount of stomach acid entering stomach. On or About 3 days post vaccine, continued having severe stomach acids and burning even after taking medication. A few days after taking the vaccine, I started getting bumps on my scalp and sporadic scattered pimples on my face and buttotocks. Started developing hives and a rash on my right arm. Went to Urgent Care and was prescribed sucralfate three times a day. As days passed, I started getting hives and spotty rashes in different areas of the body. Went to the dermatologist, they prescribed clindamycin topical lotion for scalp, also, ketoconazole 2% Shampoo, Mometasone Furoate 0.1% Soln. I had to return for three follow-up visits since symptoms did not improve. Dermatologist did not respond as to specifically why. Returned to the Urgent Care two weeks after. They stated that most likely it was a possible allergic reaction and received a cortisone injection. There after improve somewhat but continued developing new spotty rashes. Went to the ER and they could not do anything, there after I went back to urgent care for the 3rd time, they gave me a third shot of cortizone. Continued having sensitive skin and the feeling of insects crawling on my skin, cannot sleep at night. More
2824286 40 F LA 02/03/2025 UNK
 UNKNOWN MANUFACTURER
 76627
Incorrect route of product administration, Wrong product administered Incorrect route of product administration, Wrong product administered
Pt was to be administered influenza vaccine. Medical assistant notified provider that incorrect vacc... Pt was to be administered influenza vaccine. Medical assistant notified provider that incorrect vaccine was administered. Tuberculin PPD skin test 0.5mL was administered intramuscularly. No immediate reaction was observed. Provider spoke with pt at 12:15pm, and pt continued to experience no symptoms. Pt denies any injection site reaction as well. Spoke with CDC who referred me to TB control office for the state. Will follow up in 24 and 48 hours as well per the guidance of regional TB manager. More
2824287 75 F IN 02/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Asthenia, Mobility decreased, Nausea, Pain in extremity Asthenia, Mobility decreased, Nausea, Pain in extremity
Arm felt like it was breaking it hurt so bad, nausea. Took Ibuprofen. Still having soreness, weaknes... Arm felt like it was breaking it hurt so bad, nausea. Took Ibuprofen. Still having soreness, weakness, not able to move arm because of pain. Today could move arm slightly better than before. More
2824288 11 M WI 02/03/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 3E99M
3Zh27
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient received Menveo and TDaP after having received them in September of last year. Patient received Menveo and TDaP after having received them in September of last year.
2824289 70 M ID 02/03/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
 LN5489
LN5489
Dizziness, Dysstasia, Gait inability, Headache, Mobility decreased; Tremor, Visu... Dizziness, Dysstasia, Gait inability, Headache, Mobility decreased; Tremor, Visual impairment More
Dizziness, altered vision, immobility, shaking, headache, inability to dial phone, couldn't st... Dizziness, altered vision, immobility, shaking, headache, inability to dial phone, couldn't stand or walk. onset approximately 12 to 15 hours post vaccination and continued for approx. 3 hours More
2824290 58 F DE 02/03/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
HCP reported administering GARDASIL 9 to a 58 year old female.; No additional AE/PQC; This spontaneo... HCP reported administering GARDASIL 9 to a 58 year old female.; No additional AE/PQC; This spontaneous report was received from nurse practitioner and refers to a 58-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient received the dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No adverse event was reported. No follow up was required. More
2824291 F PA 02/03/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Received First Dose May-2024 and Second Dose in Nov-2024; Initial report received on 27-Dec-2024. ... Received First Dose May-2024 and Second Dose in Nov-2024; Initial report received on 27-Dec-2024. A pharmacist reported that a 28-year-old female (race, ethnicity not reported) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received the second dose six months later. No medical history or concomitant medications were reported. In May-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLIAV-B (lot #, expiration date, NDC #, site and route not reported). In Nov-2024, approximately six months after receiving HEPLISAV-B, the patient received the second dose of HEPLISAV-B. No adverse reactions were reported. The reporter declined to provided further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2824292 U TX 02/03/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient Received Second Dose of Heplisav-B a Couple of Weeks Later Than One Month After First Dose; ... Patient Received Second Dose of Heplisav-B a Couple of Weeks Later Than One Month After First Dose; Initial report received on 27-Dec-20. A quality assurance specialist reported that a patient (age, gender, race, ethnicity not reported) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization a couple of weeks later than one month after the first. Medical history was reported as an allergy to penicillin. No concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported). On an unknown date, a couple of weeks later than one month after the first dose, the patient received dose 2 of HEPLISAV-B (NDC # 43528-002-01, lot #, expiration date, site and route not reported). No further adverse effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2824293 M PA 02/03/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 944920
Wrong product administered Wrong product administered
Asked for TB Test But was Given IM HEPLISAV-B Instead; Initial report received on 30-Dec-2024. A ph... Asked for TB Test But was Given IM HEPLISAV-B Instead; Initial report received on 30-Dec-2024. A pharmacist reported that a 20-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization instead of receiving a tuberculosis (TB) test. Medical history included an allergy to penicillin. No concomitant medications were reported. On 23-Nov-2024, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 944920, expiration date 04-Dec-2026, and NDC 43528-0003-05) intramuscularly in the left arm. The patient came in and asked for a TB test but was given HEPLISAV-B vaccine instead in error. The pharmacist told the patient to return in a month. The patient thought he was returning to have his TB test read. The patient has previously received a three-dose hepatitis B vaccine series as a child. No further adverse effects were reported. Per the reporter, no other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2824294 F 02/03/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Muscular weakness Muscular weakness
A one time loss of muscle control trying to get out of bed and needed help to get back up; This non-... A one time loss of muscle control trying to get out of bed and needed help to get back up; This non-serious case was reported by a consumer and described the occurrence of muscle weakness in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included general symptom. Concomitant products included acetylsalicylic acid (Aspirin). On an unknown date, the patient received Shingles vaccine. In AUG-2024, an unknown time after receiving Shingles vaccine, the patient experienced muscle weakness (Verbatim: A one time loss of muscle control trying to get out of bed and needed help to get back up). The outcome of the muscle weakness was resolved. It was unknown if the reporter considered the muscle weakness to be related to Shingles vaccine. It was unknown if the company considered the muscle weakness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-JAN-2025 The patient self-reported this case for herself. The patient experienced a onetime loss of muscle control when trying to get out of bed and needed help to get back up. The symptoms were not treated. More
2824295 U 02/03/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
HCP called and reported 6 month old patient was given HAVRIX HEP A; This non-serious case was report... HCP called and reported 6 month old patient was given HAVRIX HEP A; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received HAV (Havrix) for prophylaxis. On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: HCP called and reported 6 month old patient was given HAVRIX HEP A). The outcome of the inappropriate age at vaccine administration was unknown. Additional Information: GSK Receipt Date: 07-JAN-2025 The health care professional reported that 6 month old patient was given Havrix Hepatitis A vaccine, which led to inappropriate age at vaccine administration. No symptoms or side effects reported. No additional adverse event/no product quality complaint. More
2824296 U 02/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; got shingles twice; This serious case was reported by a consumer via ... Suspected vaccination failure; got shingles twice; 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles twice). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 19-JAN-2025 This case was reported by a patient via interactive digital media. The patient said that the vaccine did not work for shingles. He/she got shingles twice with a vaccination garbage. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; 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 Shingrix. More
2824297 U 02/03/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). 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 Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 19-JAN-2025 This case was reported by a patient via interactive digital media. The patient had shingles vaccine two years in a row and now had shingles and the medicine was awful. 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 provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1 and Shingrix dose 2. More
2824298 U 02/03/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
received the shingles vaccine, still get shingles three times a year/ suspected vaccination failure;... received the shingles vaccine, still get shingles three times a year/ suspected vaccination failure; still get shingles three times a year; 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: received the shingles vaccine, still get shingles three times a year/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still get shingles three times a year). 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: 26-JAN-2025 This case was reported by the patient via interactive digital media. Patient received the shingles vaccine and still gets shingles three times a year. Patient was asking what can the patient do? This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles. More
2824299 F 02/03/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; aunt vaccinated and has had shingles; This serious case was reported ... Suspected vaccination failure; aunt vaccinated and has had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: aunt vaccinated and has had 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: 29-JAN-2025 The case was received from the consumer via interactive digital media. Reporter reported that his/her aunt vaccinated and she has had shingles. Reporter believed the vaccine lessened the pain though. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. This is 1 of 3 linked cases reported by the same reporter for different patients.; 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. US-GSK-US2025AMR013183:same reporter different patient US-GSK-US2025AMR013181:same reporter different patient More
2824300 72 F ID 02/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 G97Y2
Product preparation issue Product preparation issue
Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine ... Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder; Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number G97Y2, expiry date 15-NOV-2026) for prophylaxis. On 04-JAN-2025, the patient received the 1st dose of Shingrix. On 04-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that who received Shingrix adjuvant alone without the powder as a Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2025001102, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2025001102:Same reporter/Different aptient More
2824301 U NH 02/03/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age, Underdose Product administered to patient of inappropriate age, Underdose
Maladministration in a 18 year old patient instead of a BOOSTRIX dose; Inappropriate schedule of vac... Maladministration in a 18 year old patient instead of a BOOSTRIX dose; Inappropriate schedule of vaccine (INFANRIX three dose schedule); Underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. Previously administered products included Boostrix (received Boostrix vaccine in 2014). On 03-JAN-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 03-JAN-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Maladministration in a 18 year old patient instead of a BOOSTRIX dose), adult use of a child product (Verbatim: Inappropriate schedule of vaccine (INFANRIX three dose schedule)) and underdose (Verbatim: Underdose). The outcome of the wrong vaccine administered, adult use of a child product and underdose were 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: 06-JAN-2025 The healthcare professional reported that an eighteen year old patient was administered with a Infanrix instead of a Boostrix vaccine, wrong vaccine administered, adult use of a child product and underdose. Last Boostrix vaccination was on 2014. The reporter reactively also mentioned this same patient received a three dose series schedule. More
2824302 M OK 02/03/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVA993A
Product preparation issue Product preparation issue
liquid portion inadvertently administered; liquid portion inadvertently administered; This non-serio... liquid portion inadvertently administered; liquid portion inadvertently administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 22-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A) for prophylaxis. On 08-JAN-2025, the patient received the 1st dose of Menveo. On 08-JAN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: liquid portion inadvertently administered) and inappropriate dose of vaccine administered (Verbatim: liquid portion inadvertently administered). The action taken with Menveo was unknown. The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist called and reported that they had a Menveo vaccine, which was supposed to be given and the nurse only gave 1 component of it the liquid portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Reporter called to ask if they could reconstitute the powder for the Men A with just sterile diluent and given properly. It was asked to the HCP if the patient only received the liquid portion and she replied as they provide both vials, but the powder was expired, and the liquid was not, so the nurse decided just to give the liquid component. Based on her answer, it seemed that the HCP only administered the liquid portion of the Menveo vaccine. More
2824303 M VA 02/03/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3T5L9
Underdose Underdose
pediatric dose given to adult; pediatric dose given to adult; This non-serious case was reported by ... pediatric dose given to adult; pediatric dose given to adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 57-year-old male patient who received HBV (Engerix B pediatric) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis. On 09-JAN-2025, the patient received Engerix B pediatric. On 09-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose given to adult) and accidental underdose (Verbatim: pediatric dose given to adult). The outcome of the adult use of a child product and accidental underdose were 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: 09-JAN-2025 Patient was accidentally given a pediatric dose of Engerix-B, which led to adult use of a child product and accidental underdose. More
2824304 M IL 02/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
not yet received the second dose; This non-serious case was reported by a pharmacist via call center... not yet received the 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 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 12-OCT-2023 with batch number 9T2L9 and lot expiry 28-MAY-2024). 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: not yet received the second dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 13-JAN-2025 The pharmacist reported that a patient received only one dose of Shingrix and had not yet received the second dose. The patient was in the pharmacy now, but at the time of reporting, a second dose has not yet been administered. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2824305 U MI 02/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
they got their first injection, and missed the second one in the 2-6 month window; This non-serious ... they got their first injection, and missed the second one in the 2-6 month window; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). 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: they got their first injection, and missed the second one in the 2-6 month window). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK receipt date: 14-JAN-2025 The physician started that the patient got their first injection, and missed the second one in the 2-6 month window and were now here a year later. The reporter clarified they did not had any additional details apart from these. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2824306 M AR 02/03/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Intercepted product prescribing error Intercepted product prescribing error
a patient was given a prescription for Shingrix by his doctor/The patient has not received the vacc... a patient was given a prescription for Shingrix by his doctor/The patient has not received the vaccine at the time of the call; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 43-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had Shingles in the past). On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted drug prescribing error (Verbatim: a patient was given a prescription for Shingrix by his doctor/The patient has not received the vaccine at the time of the call). The outcome of the intercepted drug prescribing error was unknown. Additional Information: GSK receipt date: 15-JAN-2025 The pharmacist reported that a patient was given a prescription for Shingrix by his doctor which led to, intercepted drug prescribing error. The patient was under 50 years of age and was not immunocompromised. The reason for the prescription for Shingrix was that the patient had Shingles in the past. The reporter stated that only the prescription was written. The patient had not received the vaccine at the time of the call. More
2824307 M FL 02/03/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
second dose of Arexvy was administered; This non-serious case was reported by a pharmacist via sales... second dose of Arexvy was administered; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of extra dose administered in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Arexvy (received 1st dose in 2023). Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: second dose of Arexvy was administered). The outcome of the extra dose administered was unknown. Additional Information: GSK receipt date: 15-JAN-2025 The reporter reported that the patient received second dose of Arexvy which led to, extra dose administered. The patient was vaccinated with Shingrix at the same time as the second dose of Arexvy was administered. No further information was known including dates of administration for both doses of Arexvy and the dose of Shingrix or patient demographics. This case is linked with US2025005048, reported by the same reporter.; Sender's Comments: US-GSK-US2025005048:Same reporter/Different Patient More
2824308 M 02/03/2025 COVID19
 JANSSEN
Death Death
Death; This spontaneous report received from a consumer concerned a male patient of unspecified age.... Death; This spontaneous report received from a consumer 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, route of admin not reported, batch number: Unknown) 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. No concomitant medications were reported. On an unspecified date, the patient experienced death. (dose series 1). The action taken with janssen covid-19 vaccine was not applicable. It was unknown if an autopsy was performed. Reported cause of death was unknown cause of death. The patient died on an unspecified date. This report was serious (death).; Sender's Comments: V0: Death. The event(s) 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(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: unknown cause of death More
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2824309 85 F 02/03/2025 COVID19
COVID19
 MODERNA
MODERNA

Asthenia, Dizziness, Mood swings, Nausea, Vertigo; Vomiting Asthenia, Dizziness, Mood swings, Nausea, Vertigo; Vomiting
she started having 'intermittent instability'; weak; vertigo; extreme dizziness; nausea; v... she started having 'intermittent instability'; weak; vertigo; extreme dizziness; nausea; vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MOOD SWINGS (she started having 'intermittent instability'), ASTHENIA (weak), VERTIGO (vertigo), DIZZINESS (extreme dizziness) and NAUSEA (nausea) in an 85-year-old female patient 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 20-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In January 2025, the patient experienced MOOD SWINGS (she started having 'intermittent instability'), ASTHENIA (weak), VERTIGO (vertigo), DIZZINESS (extreme dizziness), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MOOD SWINGS (she started having 'intermittent instability'), ASTHENIA (weak), VERTIGO (vertigo), DIZZINESS (extreme dizziness), NAUSEA (nausea) and VOMITING (vomiting) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient husband reported that a couple days later (unsure if it was the 27, 28, 29 of Jan) she had intermittent instability, nausea, extreme dizziness, weak, and vertigo. He stated that she was fine for two days and then it 'repeated again', that its not like her, she's very healthy. The wife came on the phone for a second and said she's had vomiting as well, she still had symptoms. No treatment medications were reported. More
2824310 M 02/03/2025 COVID19
 PFIZER\BIONTECH
 SC3180
Illness Illness
he had not been healthy since and it is just getting worse. caller states "I had been sick in t... he had not been healthy since and it is just getting worse. caller states "I had been sick in the past by 4 weeks.'; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: SC3180) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (Lot number: EW0198)), administration date: 2021, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he had not been healthy since and it is just getting worse. caller states "I had been sick in the past by 4 weeks.'". Additional information: The patient was hoping to get the information as to what the Pfizer COVID vaccine he took in 2021. The patient stated that after receiving the vaccine, he had not been healthy since and it was just getting worse. The patient stated, "I had been sick in the past by 4 weeks." No follow-up attempts are possible. More
2824312 F NY 02/03/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Abdominal pain upper, Chromaturia, Eye disorder, Illness, Macular degeneration; ... Abdominal pain upper, Chromaturia, Eye disorder, Illness, Macular degeneration; Ocular icterus, Pruritus More
macular degeneration; eye surgery; my eyes turned yellow; my urine dark brown; sick; skin itchy; sto... macular degeneration; eye surgery; my eyes turned yellow; my urine dark brown; sick; skin itchy; stomach pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 82-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 and concomitant medications were not reported. Past drug history included: Vitamin d3. The following information was reported: MACULAR DEGENERATION (medically significant), outcome "unknown"; EYE DISORDER (medically significant), outcome "unknown", described as "eye surgery"; OCULAR ICTERUS (non-serious), outcome "unknown", described as "my eyes turned yellow"; CHROMATURIA (non-serious), outcome "unknown", described as "my urine dark brown"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PRURITUS (non-serious), outcome "unknown", described as "skin itchy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pain". Therapeutic measures were taken as a result of macular degeneration, eye disorder. Clinical course: The patient only used pfizer covid 19 vaccines and shortly after around same time she had an eye surgery and she started taking a vitamin for macular degeneration and, her white of her eyes turned yellow and her urine dark brown, skin itchy, stomach pain. She just thought that she was getting sick and then she was cleaning up her files and she found this symptoms related to Paxlovid. She asked why did she got this this time and when she should worry about her health, what the outcome of this she had never had a problem till this last dose, very itchy skin ishemade an appointment with the dermatologist but she had to wait weeks and she did not know what was going on. She could not stop scratching her legs and arms her stomach, so tell me what's happening. She is taking PreserVision 2 vitamin. She confirmed it was the vaccine she thought it was because of the vitamins the yellowing of her eyes. She had an appointment with the retina doctor in 2 weeks, but now that she found this she thought it is due to the Pfizer vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2824313 60 F AL 02/03/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0173
EW0173
EW0173
EW0173
EW0173
EW0173
Fear of injection, Investigation, Lumbar puncture, Magnetic resonance imaging, M... Fear of injection, Investigation, Lumbar puncture, Magnetic resonance imaging, Malaise; Multiple sclerosis, Thrombosis; COVID-19, Drug ineffective, Post-acute COVID-19 syndrome; Fear of injection, Investigation, Lumbar puncture, Magnetic resonance imaging, Malaise; Multiple sclerosis, Thrombosis; COVID-19, Drug ineffective, Post-acute COVID-19 syndrome More
blood clotting; never been feeling good or like herself; is terrified of any shots; Multiple scleros... blood clotting; never been feeling good or like herself; is terrified of any shots; Multiple sclerosis (MS); This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient received BNT162b2 (BNT162B2), on 01May2021 as dose 2, single (Lot number: EW0173) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot number: EW0161, Administration site: left arm), administration date: 10Apr2021, when the patient was 60-year-old, for Covid-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant) with onset 2023, outcome "unknown", described as "Multiple sclerosis (MS)"; THROMBOSIS (medically significant), outcome "not recovered", described as "blood clotting"; MALAISE (non-serious), outcome "unknown", described as "never been feeling good or like herself"; FEAR OF INJECTION (non-serious), outcome "unknown", described as "is terrified of any shots". The patient underwent the following laboratory tests and procedures: Test: (28Jan2024) has the blood clotting issues now; Lumbar puncture: (unspecified date) diagnosed with MS; Magnetic resonance imaging: (unspecified date) diagnosed with MS. Therapeutic measures were taken as a result of multiple sclerosis. Clinical course: She is calling about the covid vaccine, she only took the first two doses so she could get the vaccine card. She only took the first two doses since she had something going on. She was given a list of stuff to watch out for but what she was having was not what she was told to look out for. She is calling to report that she is now on the infusion Ocrevus since she was diagnosed with Multiple sclerosis (MS) in the beginning of 2023. Confirms she was diagnosed with MS after receiving the covid vaccine, states it took a while to get diagnosed. She is seeing another doctor besides her neurologist that is helping her with long covid. She has the blood clotting issues now, she just got those test results back yesterday. She has never been feeling good or like herself. She waited too late to get help to pay for things, states all of this is expensive. States it is the MRNA that is the problem, now she is terrified of any shots. She had to go through a lot of MRIs and a spinal tap to be diagnosed with MS. She just wanted it out there that MRNA is not a great thing. .; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021985 same patient, different doses/events; More
2824314 U 02/03/2025 COVID19
 PFIZER\BIONTECH
Dyspnoea, Pain Dyspnoea, Pain
Real bad pain/Hurting all over; Short of breath; This is a spontaneous report received from a Consum... Real bad pain/Hurting all over; Short of breath; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) 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 and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Real bad pain/Hurting all over"; DYSPNOEA (non-serious), outcome "unknown", described as "Short of breath". Additional information: The patient was calling to see what was this Pfizer deals about on these shots, what was the side effects. The COVID shots, clarified as Pfizer COVID-19 Vaccine. The patient did not know if it was cause of the shot. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2824315 62 M PA 02/03/2025 COVID19
 PFIZER\BIONTECH
COVID-19, SARS-CoV-2 test, Vaccination failure COVID-19, SARS-CoV-2 test, Vaccination failure
diagnosed with COVID/tested positive for COVID; diagnosed with COVID/tested positive for COVID; This... diagnosed with COVID/tested positive for COVID; diagnosed with COVID/tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient informed that there were no any other vaccinations within four weeks prior to the first administration date of Pfizer COVID Vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jan2025, outcome "unknown" and all described as "diagnosed with COVID/tested positive for COVID". The event "diagnosed with covid/tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jan2025) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The consumer informed that he obtained COVID on Wednesday, 29Jan, he was diagnosed with COVID. He informed that on Wednesday, he went to the doctor's and was tested, and he was tested positive for COVID, so that would be 29Jan (clarified as 29Jan2025). The patient informed that he just had a COVID vaccination done in Oct onsite in our (name withheld), (name withheld) building. The vaccination facility name was Pfizer, it was the working building, they have the infirmary with a nurse inside work building. He got the vaccination at work. The Pfizer has work building in (name withheld), (name withheld). The patient had it done at Pfizer by there on staff nurse." The consumer stated, "I have no idea what, it's the latest vaccine that has come out by Pfizer, that is why I have gotten it." The patient was yearly getting the Pfizer, he was getting the new strain every, he was going to get it every fall because Pfizer provided it. It was to prevent him from getting sick. The patient informed that no treatment for COVID, he has not. He just took like the 'regular'. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2824316 F MD 02/03/2025 COVID19
 PFIZER\BIONTECH
Pain in extremity Pain in extremity
arm was "very sore"; This is a spontaneous report received from a Consumer or other non HC... arm was "very sore"; This is a spontaneous report received from a Consumer or other non HCP. A 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 and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was "very sore"". Additional information: The reporter stated that her arm was "very sore" after she received her COVID-19 vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2824317 82 M OH 02/03/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
now I have COVID. I just tested positive; now I have COVID. I just tested positive; This is a sponta... now I have COVID. I just tested positive; now I have COVID. I just tested positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 86-year-old male patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "now I have COVID. I just tested positive". The event "now i have covid. i just tested positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2025) Positive. Additional information: During an inbound call for financial support for Paxlovid, the caller (patient) stated, "I was part of your clinical trial for the Covid vaccine back 5 years ago. Well, it's taken me 5 years to get the Covid. Now I have Covid. I just tested positive." The patient hasn't had a current prescription, called the doctor today. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2824318 M TX 02/03/2025 COVID19
 UNKNOWN MANUFACTURER
Non-small cell lung cancer stage III, Respiratory disorder Non-small cell lung cancer stage III, Respiratory disorder
non-small cell lung cancer stage 3A; health problems especially respiratory; This is a spontaneous r... non-small cell lung cancer stage 3A; health problems especially respiratory; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An adult male patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "smoker" (unspecified if ongoing), notes: 1 to 2 packs of cigarettes a day for 30 years; "COPD" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "cervical and lumbar spinal injuries" (unspecified if ongoing); "cervical and lumbar spinal injuries" (unspecified if ongoing); "heart problems" (unspecified if ongoing); "hooked on heroin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (dose number unknown), for COVID-19 immunization; Comirnaty (dose number unknown), for COVID-19 immunization, reaction(s): "6 shots of the vaccine/covid-19 Vaccine 7 times in a span of 2 months/9 vaccine shots for COVID-19/9 vaccine shots for COVID-19/at least 20 covid 19 Pfizer shot's". In (place name) they were paying people to get the shot's and we did like at least 20 covid 19 Pfizer shot's in a time period of one to two months, we have all of our prepaid credit cards, and the "vacation card" with the information on each one we used different names now. The following information was reported: NON-SMALL CELL LUNG CANCER STAGE III (medically significant), outcome "unknown", described as "non-small cell lung cancer stage 3A"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "health problems especially respiratory". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198847 same patient/reporter, different drug dose/events; More
2824319 0.5 M TX 02/03/2025 DTAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
U8231AA
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
administered the patient with ADACEL instead of DTAP (Infanrix) with no reported adverse event; Init... administered the patient with ADACEL instead of DTAP (Infanrix) with no reported adverse event; Initial information received on 29-Jan-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 6 months old male patient to whom administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] instead of dtap (Infanrix) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB vaccine; Pneumococcal vaccine conj (Pneumococcal conjugate vaccine) and Rotavirus vaccine (Rotavirus vaccine) all for Prophylactic Vaccination (Immunisation). On 29-Jan-2025, the patient received 0.5 mL dose 3 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (frequency: once) (strength: standard) (lot U8231AA and expiry date: May-2026) via intramuscular route in the right thigh for Immunization instead of dtap (Infanrix) not produced by Sanofi Pasteur (lot number and expiry date not reported) with no reported adverse event (wrong product administered) (Latency: same day). Reportedly, No Adverse Event, patient did not even cry. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2824320 M LA 02/03/2025 HIBV
 SANOFI PASTEUR
 UK021AA
No adverse event, Product preparation issue No adverse event, Product preparation issue
another nurse administered the diluent of the ACTHIB, and not the vaccine itself with no reported ad... another nurse administered the diluent of the ACTHIB, and not the vaccine itself with no reported adverse event; Initial information received on 29-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 months old male patient and it was reported another nurse administered the diluent of the HIB (PRP/T) vaccine [ACT-HIB], and not the vaccine itself with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Jan-2025, another nurse administered the diluent of the HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot: UK021AA; expiry date: 28-Feb-2025), and not the vaccine itself with no reported adverse event (product preparation error) (latency: same day) via unknown route in unknown administration site for Immunization. Reportedly, the medication itself was still in the fridge. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
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