🏥 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 💀 🏥 🚑 ♿ ⚠️
2772193 63 M OH 06/13/2024 VARZOS
IPV
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR

Hypoaesthesia, Injection site pain, Laboratory test normal, Paraesthesia; Blood ... Hypoaesthesia, Injection site pain, Laboratory test normal, Paraesthesia; Blood test, Injection site pain, Injection site paraesthesia, Magnetic resonance imaging, Metagenomic analysis More
pain at injection site; numbness and tingling from left arm going up shoulder to neck area.; numbnes... pain at injection site; numbness and tingling from left arm going up shoulder to neck area.; numbness and tingling from left arm going up shoulder to neck area.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included shingrix with an associated reaction of no adverse event (on an unknown date received 1st dose). In MAR-2024, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), tingling of extremity (Verbatim: numbness and tingling from left arm going up shoulder to neck area.) and numbness of upper extremities (Verbatim: numbness and tingling from left arm going up shoulder to neck area.). The outcome of the injection site pain was resolved and the outcome of the tingling of extremity and numbness of upper extremities were not resolved. It was unknown if the reporter considered the injection site pain, tingling of extremity and numbness of upper extremities to be related to Shingrix. It was unknown if the company considered the injection site pain, tingling of extremity and numbness of upper extremities to be related to Shingrix. Additional Information: GSK Receipt date: 07-JUN-2024 The patient self-reported. He had his first Shingrix vaccine with no issues, then 3 months later he received dose 2. He states he had pain at the injection site that lasted a few days and then he felt numbness and tingling that comes and goes. The numbness/tingling started in left arm and it's radiating up his left shoulder and into neck area. He went to HCP who referred him to neurology and all tests were negative. He states he had not started the prescribed steroids he plans on starting them in a few days. More
2827618 0.17 MI 02/22/2025 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
2827619 0.17 MI 02/22/2025 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
2827620 0.17 MI 02/22/2025 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
2827621 02/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash Rash
Had a rash; This non-serious case was reported by a consumer via interactive digital media and descr... Had a rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash 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 days after receiving Shingrix, the patient experienced rash (Verbatim: Had a rash). The outcome of the rash was not reported. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 12-FEB-2025 This case was reported by a patient via interactive digital media. Patient had a rash that appeared 2 days after the vaccine. The patient wanted to know was it safe to have 2nd vaccine. More
2827622 02/22/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise, Pain Malaise, Pain
I'm sore all over; feel like crap; This non-serious case was reported by a consumer via interac... I'm sore all over; feel like crap; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain 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 general body pain (Verbatim: I'm sore all over) and feeling bad (Verbatim: feel like crap). The outcome of the general body pain and feeling bad were not reported. It was unknown if the reporter considered the general body pain and feeling bad to be related to Shingles vaccine. It was unknown if the company considered the general body pain and feeling bad to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-FEB-2025 This case was reported by a patient via interactive digital media. Consumer reported that the damn Shingles shot might be worse than having shingles. The patient experienced sore all over and he/she felt like crap. More
2827623 0.5 F NJ 02/22/2025 DTPPVHBHPB
HEP
 MSP VACCINE COMPANY
GLAXOSMITHKLINE BIOLOGICALS
42B22
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
received a dose of Engerix-B and Vaxelis which contains HepB on same day; This non-serious case was ... received a dose of Engerix-B and Vaxelis which contains HepB on same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 6-month-old female patient who received HBV (Engerix B) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis. Co-suspect products included Vaxelis for prophylaxis. On 19-FEB-2025, the patient received Engerix B and Vaxelis. On 19-FEB-2025, an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: received a dose of Engerix-B and Vaxelis which contains HepB on same day). The outcome of the overdose 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: 19-FEB-2025 A medical assistant mentioned that a patient received a dose of Vaxelis, which contained Hepatitis B, and a dose of Engerix-B on the same day, which led to an overdose. The reporter was concerned about the extra dose of Hepatitis B. This case was linked with US2024083067, reported by same reporter.; Sender's Comments: US-GSK-US2024083067:same reporter More
2827635 58 F WV 02/22/2025 COVID19
COVID19
 MODERNA
MODERNA
 058H21A
058H21A
Dizziness, Dyspnoea, Gait disturbance, Impaired work ability, Palpitations; Pulm... Dizziness, Dyspnoea, Gait disturbance, Impaired work ability, Palpitations; Pulmonary embolism, Thrombosis, Tinnitus More
Developed very large severe blood clot in left leg from inside groin all the way down to just past t... Developed very large severe blood clot in left leg from inside groin all the way down to just past the knee - have tinnitus - get dizzy throughout the day for no reason - have heart palpitations, especially after eating. Am ow permanently on blood thinners to address blood clot that is still there. More
✓ ✓
2827636 54 M GA 02/22/2025 COVID19
COVID19
 MODERNA
MODERNA
 030b21a
016c21a
Tinnitus; Tinnitus Tinnitus; Tinnitus
Significant Tinnitus near immediate onset. No prior issues with ears ringing and they continue to t... Significant Tinnitus near immediate onset. No prior issues with ears ringing and they continue to this day More
✓
2827637 41 F 02/22/2025 COVID19
 PFIZER\BIONTECH
 FE4721
Fatigue, Myalgia, Pyrexia Fatigue, Myalgia, Pyrexia
Pyrexia, Fatigue, Myalgia Pyrexia, Fatigue, Myalgia
2827638 1 M NY 02/22/2025 MMR
 MERCK & CO. INC.
Decreased activity, Fatigue, Food refusal, Gait inability, Pyrexia Decreased activity, Fatigue, Food refusal, Gait inability, Pyrexia
Very high fever 103 and more, fatigue. He is still not able to sit or walk. Refusing to eat and play... Very high fever 103 and more, fatigue. He is still not able to sit or walk. Refusing to eat and play up to 2 weeks after vaccination. More
2827639 28 F CA 02/22/2025 RSV
 PFIZER\WYETH
 HY1813
Delivery, Exposure during pregnancy Delivery, Exposure during pregnancy
Patient was vaccinated with first RSV vaccine on 1/5/2024 during first pregnancy (delivery date of 2... Patient was vaccinated with first RSV vaccine on 1/5/2024 during first pregnancy (delivery date of 2/XX/24) and was again vaccinated under doctor order during second pregnancy with vaccine date of 1/17/2025 (second child delivery date of 1/XX/2025). More
2827640 1 F CA 02/22/2025 HEPA
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR

Hypersensitivity, Rash; Hypersensitivity, Rash Hypersensitivity, Rash; Hypersensitivity, Rash
had severe rash all over her body right after the shot, she had DTAP and HEP A on that day. Her rash... had severe rash all over her body right after the shot, she had DTAP and HEP A on that day. Her rash got worse the day after specially on her legs. I took her to emergency and spoke to her primary doctor they said its an allergic reaction and not talk about vaccine reaction at all. She doesn't have any allergic reaction. And im certain this is a reaction to the vaccine. More
2827641 50 F IN 02/22/2025 COVID19
 MODERNA
 B0001
Product preparation error, Underdose Product preparation error, Underdose
The vaccine was administered but had not had adequate time to thaw. When the needle was removed from... The vaccine was administered but had not had adequate time to thaw. When the needle was removed from the arm, it was evident there was still vaccine left in the vial that did not get injected into the patient arm. A second vaccine was given to supplement what was left behind in the first vial. More
2827642 52 F OH 02/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 74nc9
Headache, Injection site erythema, Injection site warmth Headache, Injection site erythema, Injection site warmth
The evening of the date of the shot given, patient reports of headache, and redness at site of injec... The evening of the date of the shot given, patient reports of headache, and redness at site of injection. Patient reports continued redness and warmth at the site of injection. Patient visits take care clinic two days later to have it checked out. CNP prescribes clindamycin and triamcinolone cream. Upon RPH looking at the site reaction, consults patient to add Benadryl to her meds to help with the site reaction, also to continue to monitor into the start of next week. More
2827643 53 M CT 02/22/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LK6655
LK6655
Arthralgia, Chills, Decreased appetite, Injected limb mobility decreased, Inject... Arthralgia, Chills, Decreased appetite, Injected limb mobility decreased, Injection site pain; Nausea, Pain, Pain in extremity, Pyrexia More
severe arm pain not only in the actual injection area, but also through elbow and into shoulder, lim... severe arm pain not only in the actual injection area, but also through elbow and into shoulder, limited range of motion with left arm for 3 days. Severe body aches 3 days. Some mild fever 99-100 degrees 2 days. Loss of appetite. Headache 3 days. Body chills. Symptoms began Friday evening and lasted through early Monday. Some nausea. This vaccination was much worse than even my Covid vaccinations side effects. More
2827644 61 F TX 02/22/2025 FLU3
FLU3
MMR
MMR
PNC21
PNC21
VARZOS
VARZOS
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 U8447AA
U8447AA
X026222
X026222
Y011819
Y011819
M7G39
M7G39
Arthralgia, Back pain, Loss of personal independence in daily activities, Mobili... Arthralgia, Back pain, Loss of personal independence in daily activities, Mobility decreased, Neck pain; Pain, Pain in extremity; Arthralgia, Back pain, Loss of personal independence in daily activities, Mobility decreased, Neck pain; Pain, Pain in extremity; Arthralgia, Back pain, Loss of personal independence in daily activities, Mobility decreased, Neck pain; Pain, Pain in extremity; Arthralgia, Back pain, Loss of personal independence in daily activities, Mobility decreased, Neck pain; Pain, Pain in extremity More
Patient complains of having sore arms day 1 but then radiating pain throughout the body. It started ... Patient complains of having sore arms day 1 but then radiating pain throughout the body. It started with her legs then now her shoulders and back are hurting. She complains about her neck hurting and unable to move or function. More
2827645 77 F NM 02/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 58160082311
Chills, Decreased appetite, Headache, Myalgia, Pyrexia Chills, Decreased appetite, Headache, Myalgia, Pyrexia
Fever 101 F. shivering, 24 hours plus headache, muscle aches, loss of appetite for 24 hours Fever 101 F. shivering, 24 hours plus headache, muscle aches, loss of appetite for 24 hours
2827646 76 F NY 02/22/2025 TYP
 BERNA BIOTECH, LTD.
 3004089
Abdominal pain upper, Dehydration, Diarrhoea, Lip dry, Nausea Abdominal pain upper, Dehydration, Diarrhoea, Lip dry, Nausea
Client took the first dose of Oral typhoid on 02/18/2025 and has been experiencing severe diarrhea ,... Client took the first dose of Oral typhoid on 02/18/2025 and has been experiencing severe diarrhea , stomach pains, and nausea. States lips are becoming shriveled from dehydration. More
2827647 88 F OH 02/22/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Aneurysm, Blood pressure systolic increased, Condition aggravated, Dyspnoea exer... Aneurysm, Blood pressure systolic increased, Condition aggravated, Dyspnoea exertional, Echocardiogram abnormal; Magnetic resonance imaging abnormal, Myocarditis, Renal aneurysm, Ultrasound scan abnormal More
Prior to the first vaccine her blood pressure systolic was 120 to 140. With a healthy, low salt di... Prior to the first vaccine her blood pressure systolic was 120 to 140. With a healthy, low salt diet, we were able to reduce her dosage of cardizem from three down to one per day. This helped her kidney function. However the first week her blood pressure started going up so we increased her dosage from one to three and coordinated with her doctors. After her second vaccine a month or so later her blood pressure stayed high between 140 and 170. after the third vaccine, seven months after the second her blood pressure jumped even higher systolic from 180 to 200. The doctor then put her on losartan in addition to the 3 card we maintained. The losartan helped and her blood pressure came back down to pre-vaccine levels. However, during a subsequent MRI, it was found she had aneurysms that occurred. I believe one was near her kidney. in addition, she had pre-existing form of myocarditis on her left side that got dramatically worse after the vaccine . I had to ask the cardiologist office to compare that condition from a year ago and they concurred it got notably worse. She became very winded just a short walk, which was not the case before. if I could attach the chart I will it?s very good data and is very enlightening, I?m an aviation engineer who is run many scientific studies so this one was easy. The results are very telling. More
✓ ✓
2827648 52 M CA 02/22/2025 RSV
 PFIZER\WYETH
 HY1813
Extra dose administered, No adverse event Extra dose administered, No adverse event
The resident was given 2 doses of RSV vaccine . One on R deltoid and another one on L deltoid at sam... The resident was given 2 doses of RSV vaccine . One on R deltoid and another one on L deltoid at same day. More
2827649 58 M FL 02/22/2025 UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER




Abdominal pain upper, Arthralgia, Blood pressure decreased, Blood pressure incre... Abdominal pain upper, Arthralgia, Blood pressure decreased, Blood pressure increased, Bone pain; Candida infection, Colonoscopy, Computerised tomogram, Decreased appetite, Dizziness; Endoscopy abnormal, Headache, Injection site pain, Magnetic resonance imaging abdominal abnormal, Malaise; Nausea, Pain in extremity, Pyrexia, Sleep disorder, Ultrasound scan; Weight decreased More
FEBRUARY 19 APPROX. 3 PM FEELING FEVERISH LOW GRADE AND PAIN AT INJECTION SITE UPPER LEFT ARM PAIN ... FEBRUARY 19 APPROX. 3 PM FEELING FEVERISH LOW GRADE AND PAIN AT INJECTION SITE UPPER LEFT ARM PAIN INCREASED AND NAUSEA WITH PAIN INTERRUPTING SLEEP. FEB 20 (DAY 2) PAIN MIRGRATED TO LEFT SHOULDER JOINT INTENSIFYNG. CHRONIC INTENSE NAUSEA, BLOOD PRESSURE DROPIED 20 POINTS FOR BOTH SYSTOLIC/DYSTOLIC WITH LIGHTHEADEDNESS, WOOZY, ILL FEELING AND HEADACHE. FEB 21 DAY 3 INTENSE PAIN SPREAD TO BONES, EMANATING FROM WHAT SEEMED EVERY BONE. INTENSE CHRONIC NAUSEA AND LOW BLOOD PRESSURE. THIS LASTED INTO NEXT DAY AND STARTED IMPROVING. DAY 4 BY EVENING BONE PAIN DIMINISHED, PAIN LOCALIZED TO WHOLE LEFT ARM, CHRONIC EXTREME NAUSEA. DAY 5-12 LOW BLOOD PRESSURE, NAUSEA, HEADACHE, NO APPETITE, DIZZY. DAY 12 BLOOD PRESSUR BLOOD PRESSURE STARTED FLUCUATING WIDELY - NORMAL UPON WAKING, THEN LOW, THEN HIGH AND LOW AT BEDTIME. RETURNED TO DR ON MARCH 7, 2024 WITH EXPREME NAUSEA, SIGNIFICANT WEIGHT LOSS FROM NOT EATING, AND EXTREME UPPER RIGHT QUADRANT ABDOMINAL PAIN. HE TOLD ME TO GO TO EMGERGENCY ROOM FOR IMAGING AND TESTS OF GALLBLADDER. CT SCAN AND ULTRASOUND? AT ER. NOTHING DEFINITEVE DETECTECTED EXCEPT APPARENT ENLARGEMENT OF PREEXISITNG LIVER CYST. REFFEREED TO GASTRO DEPARTMENT. MONTHS OF NAUSEA AND ABDOMINAL PAIN. ABDOMINAL MRI WAS DONE. VERIFIED LARGER LIVER CYSTS BUT DERTERMINED NOT TO BE SOURCE OF PAIN. EVENTUALLY ENDOSCOPY WAS DONE AND CANDIDA INFECTION OF ESOPHAGOS WAS DISCOVERED. UPON TREATMENT, SYMPTOMS FINALLY DIMINISHED. NO EXPLANATION WAS EVER GIVEN FOR APPARANT INFLAMATORY RESPONSE RESULTING IN THE SEVERE BONE AND JOINT PAIN FOLLOWING WITHIN DAYS OF INJECTION AND BLOOD PRESSURE ISSUES. More
2827650 81 F TN 02/22/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 255T2
4HY3A
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient received dose of Arexvy in September 2024 and February 2025. Per patient, not experiencing a... Patient received dose of Arexvy in September 2024 and February 2025. Per patient, not experiencing any side effects at this time. More
2827651 24 F AZ 02/22/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Angiogram, Blood test, Brain fog, Headache, Hoffmann's sign; Hyperreflexia,... Angiogram, Blood test, Brain fog, Headache, Hoffmann's sign; Hyperreflexia, Hypoaesthesia, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Scan with contrast; Visual impairment More
Hyperreflexia, complete numbness on 1/2 of body, headache and brain fog, black spots in vision that ... Hyperreflexia, complete numbness on 1/2 of body, headache and brain fog, black spots in vision that remain to this day. Positive Hoffman sign. Treated with corticosteroids, LDN, etc. lasted for 3 months in most severe form, vision changes remain, numbness is intermittent More
✓
2827653 51 F UT 02/22/2025 PNC20
 PFIZER\WYETH
 LJ5283
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth More
2/16/2025: pain (5), redness soreness at injection site, painful to tough; hot to tough, slight swel... 2/16/2025: pain (5), redness soreness at injection site, painful to tough; hot to tough, slight swelling , redness below the injection site about the size of palm no fever; 2/19/2025 swelling and redness itchy but pain has gone away; 2/22/2025: no pain, color is no longer bright red, very itchy; never any difficulty breathing or swollen throat More
2827654 74 F SC 02/22/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 M7G39
M7G39
Fluid retention, Influenza like illness, Injection site erythema, Injection site... Fluid retention, Influenza like illness, Injection site erythema, Injection site reaction, Injection site warmth; Rash macular More
Area surrounding injection site became red, warm, blotchy skin, Pt experienced flu-like symptoms, ... Area surrounding injection site became red, warm, blotchy skin, Pt experienced flu-like symptoms, generalized fluid retention. More
2827655 53 F NC 02/22/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 LK59T
Dizziness, Flushing Dizziness, Flushing
Pt got vaccine approx 5:00Pm. She sat down in vaccine waiting area. about 5:05Pm she said she was di... Pt got vaccine approx 5:00Pm. She sat down in vaccine waiting area. about 5:05Pm she said she was dizzy but NO SOB. pt asked for icepack and pharmacist got her one and she put in on back of her neck. Pt was flushed and not feeling better and at 5:17pm the pharmacist called 911. Pt was alert with no difficulty breathing. she was hunched forward with elbows on legs sitting in chair. 5:22pm pt told pharmacist and technician that she took her "normal" vaccine protocol 30 mins prior to coming into the store for vaccine. This included 500mg APAP+10mg ZYRTEC+25mgbenadryl. 5:45 pharmacist got pt a bottle of water and she was sitting upright in chair. at aprox 6:00pm pt was transported by EMS with intended destination hospital. More
2827656 66 F FL 02/22/2025 COVID19
 MODERNA
 3043823
Discomfort, Pruritus, Rash Discomfort, Pruritus, Rash
Recurring rashes, itching and discomfort lasting three weeks Recurring rashes, itching and discomfort lasting three weeks
2827657 72 F MS 02/22/2025 HEPAB
TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 M4B34
XN575
334t3
Rash erythematous, Rash papular, Rash pruritic, Tracheostomy; Rash erythematous,... Rash erythematous, Rash papular, Rash pruritic, Tracheostomy; Rash erythematous, Rash papular, Rash pruritic, Tracheostomy; Rash erythematous, Rash papular, Rash pruritic, Tracheostomy More
Patient was administered Twinrix, Shingrix, Boostrix on same day 2/9/25. Patient's husband stat... Patient was administered Twinrix, Shingrix, Boostrix on same day 2/9/25. Patient's husband states a rash appeared on patient's stomach and back. The rash wrapped around stomach and backside like a belt. Rash appeared red with raised red bumps and itchy. Patient was referred to primary care provider for evaluation. Patient was seen by telehealth provider to determine cause of rash. Provider instructed patient to take Benadryl to alleviate itch and increased dosage of Valtrex due to suspected shingles rash from immunization. Provider did not provide clear diagnosis/cause of rash per patient's husband. The rash has improved over the course of 2 weeks and has cleared. More
2827789 74 F CA 02/22/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Abdominal pain, Blood test, Computerised tomogram abdomen abnormal, Diarrhoea ha... Abdominal pain, Blood test, Computerised tomogram abdomen abnormal, Diarrhoea haemorrhagic, Gastrointestinal disorder; Impaired work ability, Inflammatory bowel disease, Large intestine infection, Lymph node pain, Lymphadenopathy; Mobility decreased, Pyrexia, Stool analysis normal, Tachycardia, White blood cell count increased More
See Temporary VAERS 1052228 submitted yesterday. This is the second time I received inflammatory sy... See Temporary VAERS 1052228 submitted yesterday. This is the second time I received inflammatory symptoms within two to three weeks after receiving a Covid shot. This time, almost three weeks after the 1/2/2025 Covid shot my neck glands became painfully swollen and I started running high fevers (101+ which I kept down with Tylenol). It persisted and after two or two and a half weeks, I developed severe gastrointestinal symptoms - severe abdoiminal cramps and bloody diarrehea. Pain and diarrehea persisted for almost two weeks and started to ease. I went to the ER on 2/10/2025. They thought it was infectious colitis but CT scan of my abdomen said it could be either one, infectious or inflammatory. I have no prior history of inflammatory bowel disease. Multiple stool tests all came out negative. Symptoms are now easing but more than five weeks since onset of the fevers but am not yet free of symptoms. During this whole time, like in June 2024, I have been unable to work or do anything but lay in bed. More
2732786 OH 02/21/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
FR2583
Illness, Malaise; Illness, Malaise; Illness, Malaise; Illness, Malaise; Amino ac... Illness, Malaise; Illness, Malaise; Illness, Malaise; Illness, Malaise; Amino acid level, Angiocardiogram, Anti-cyclic citrullinated peptide antibody, Anti-ganglioside antibody, Antinuclear antibody; Asthenia, Balance disorder, Biopsy skin, Blood copper, Blood creatine phosphokinase; Blood folate, Blood magnesium, Blood parathyroid hormone, Blood phosphorus, Blood thyroid stimulating hormone; Blood zinc, Borrelia test, C-reactive protein, Cardiac monitoring, Chest X-ray; Condition aggravated, Cryoglobulins, Dyspnoea, Echocardiogram, Electrocardiogram ambulatory; Electromyogram, Free thyroxine index, HIV test, Heavy metal test, Hepatitis B virus test; Hepatitis C virus test, Hepatitis viral test, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test; Palpitations, Presyncope, Protein total, Red blood cell sedimentation rate, Rheumatoid factor; Sjogren's syndrome, Spirometry, Thyroxine, Tilt table test, Treponema test; Tri-iodothyronine, Urine analysis, Vitamin B1, Vitamin B12, Vitamin B6; Vitamin D; Amino acid level, Angiocardiogram, Anti-cyclic citrullinated peptide antibody, Anti-ganglioside antibody, Antinuclear antibody; Asthenia, Balance disorder, Biopsy skin, Blood copper, Blood creatine phosphokinase; Blood folate, Blood magnesium, Blood parathyroid hormone, Blood phosphorus, Blood thyroid stimulating hormone; Blood zinc, Borrelia test, C-reactive protein, Cardiac monitoring, Chest X-ray; Condition aggravated, Cryoglobulins, Dyspnoea, Echocardiogram, Electrocardiogram ambulatory; Electromyogram, Free thyroxine index, HIV test, Heavy metal test, Hepatitis B virus test; Hepatitis C virus test, Hepatitis viral test, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test; Palpitations, Presyncope, Protein total, Red blood cell sedimentation rate, Rheumatoid factor; Sjogren's syndrome, Spirometry, Thyroxine, Tilt table test, Treponema test; Tri-iodothyronine, Urine analysis, Vitamin B1, Vitamin B12, Vitamin B6; Vitamin D More
I am sick and suffering and haven't been well ever since I received your vaccine; I am sick and... I am sick and suffering and haven't been well ever since I received your vaccine; I am sick and suffering and haven't been well ever since I received your vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. 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. Vaccination history included: Pfizer vaccine for covid (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "I am sick and suffering and haven't been well ever since I received your vaccine", "I am sick and suffering and haven't been well ever since I received your vaccine". The following information was reported: ILLNESS (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "I am sick and suffering and haven't been well ever since I received your vaccine". Additional information: The patient had Pfizer vaccine for covid. Two of them. And the patient was sick and suffering and hadn't been well ever since the patient received Pfizer vaccine. The patient stated "I have lost everything - my health, my quality of life, my job". The patient was an ultrasound technologist. 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-202500040022 Same patient/ product/AEs, different dose; More
2824799 TX 02/21/2025 COVID19
 PFIZER\BIONTECH
 LM2212
Pain in extremity Pain in extremity
sore arm; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old pat... sore arm; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 as dose 1, single (Lot number: LM2212) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "cataracts are forming over the last few years" (ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "tetracycline allergy" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "deaf/profound hearing loss" (ongoing), notes: 50+ years; "Wore oticon 380P hearing aids" (ongoing). Concomitant medication(s) included: LEVOXYL taken for thyroid disorder; CLARITIN [CLARITHROMYCIN]. Vaccination history included: BNT162b2 (Dose 2; Lot: EP6955), administration date: 27Mar2021, for covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (Dose 3; lot: EW0162), administration date: 19Apr2021, for covid-19 immunization, reaction(s): "sore arm"; bivalent (Dose 4; lot: GH9703), administration date: 12Oct2022, for covid-19 immunization, reaction(s): "sore arm"; comirnaty (Dose 5; lot: HD9876), administration date: 04Oct2023, for covid-19 immunization, reaction(s): "sore arm"; Biontech (Dose 1; lot: FL3198), administration date: Apr2020, for covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: The patient did not receive any other vaccines on the same date as Pfizer vaccine. The patient did not receive any other vaccine within 4 weeks prior to the first administration of the suspect vaccine. Patient reported that cataracts were forming before COVID vaccine and, therefore, cataract was not suspected due to Pfizer vaccine. No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500040762 same patient/product/event; different dose;US-PFIZER INC-202500040763 same patient/product/event; different dose;US-PFIZER INC-202500040764 same patient/product/event; different dose;US-PFIZER INC-202500040765 same patient/product/event; different dose;US-PFIZER INC-202500040766 same patient/product/event; different dose; More
2827398 F 02/21/2025 HPV4
 MERCK & CO. INC.
Cervical dysplasia, Cervix carcinoma Cervical dysplasia, Cervix carcinoma
cervical cancer; cervical dysplasia; This spontaneous report was received from a consumer (patient&#... cervical cancer; cervical dysplasia; This spontaneous report was received from a consumer (patient's mother) and refers to a currently 35-year-old female patient. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, as a child, the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient ended up with cervical cancer or cervical dysplasia. At the reporting time, the outcome of the events was unknown. Causality assessment was not provided. Upon internal review, the event of cervical cancer was determined to be medically significant. Lot # is being requested and will be submitted if received. More
2827399 F AZ 02/21/2025 HIBV
HIBV
HIBV
HIBV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Extra dose administered, Inappropriate schedule of product administration; Extra... Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration More
extra dose administered; extra dose administered; Inappropriate schedule of vaccine; This spontaneou... extra dose administered; extra dose administered; Inappropriate schedule of vaccine; This spontaneous report was received from a lawyer and refers to a 12-year-old female patient who was involved in a litigation process regarding quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (case). All details regarding the patient's medical history, concurrent conditions and concomitant therapies were captured in case. On 12-APR-2005, at the age of 1 month, the patient was vaccinated with the first dose Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (reported as Haemophilus Influenza Type B [Hb]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis. On 14-JUN-2005, the patient was vaccinated with the third dose Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (inappropriate schedule of product administration). On 16-AUG-2005, the patient was vaccinated with the second dose Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (extra dose administered). On 27-JUN-2006, the patient was vaccinated with the third dose Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (extra dose administered). This was one of several reports regarding the same patient. More
2827400 M MD 02/21/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
Received First Dose Heplisav-B, and Has Not Received Second Dose Yet; Initial report received on 04-... Received First Dose Heplisav-B, and Has Not Received Second Dose Yet; Initial report received on 04-Feb-2025. A pharmacist reported that a 33-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 27-Jul-2024 but has not received his second dose yet. No medical history or concomitant medications were reported. On 27-Jul-2024, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (NDC number 43528-003-05; expiration date and lot number not available) intramuscularly in the left arm. As of the date of report, 04-Feb-2025, 192 days after having received the first dose of HEPLISAV-B, the patient has not yet received his second dose. No side 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
2827401 F 02/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash Rash
Rash was reported as worsened; This non-serious case was reported by a consumer via sales rep and de... Rash was reported as worsened; This non-serious case was reported by a consumer via sales rep and described the occurrence of rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (received a 1st dose on 21st October 2024 in left arm and had Injection site pain, refer case US2024131039). On 21-JAN-2025, the patient received the 2nd dose of Shingrix (left deltoid). On 23-JAN-2025, 2 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash was reported as worsened). The outcome of the rash was not resolved. The reporter considered the rash to be related to Shingrix. The company considered the rash to be related to Shingrix. Linked case(s) involving the same patient: US2024131039 Additional Information: GSK Receipt Date: 23-JAN-2025 Patient was the reporter. Rash was reported as worsened. Patient received a subsequent dose of vaccine. For tolerance to 1st dose, refer case US2024131039.; Sender's Comments: US-GSK-US2024131039:Same patient More
2827402 M 02/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7LC49
Injection site erythema Injection site erythema
redness of the skin between the injection location and my armpit; This non-serious case was reported... redness of the skin between the injection location and my armpit; This non-serious case was reported by a consumer and described the occurrence of erythema of extremities in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number X5T42, expiry date 30-JAN-2027) and (batch number 7LC49) for prophylaxis. Concurrent medical conditions included hypertension and back pain. Concomitant products included gabapentin, losartan and meloxicam. On 14-FEB-2025, the patient received the 2nd dose of Shingrix .5 ml. On 16-FEB-2025, 2 days after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: redness of the skin between the injection location and my armpit). The outcome of the erythema of extremities was not resolved. It was unknown if the reporter considered the erythema of extremities to be related to Shingrix. It was unknown if the company considered the erythema of extremities to be related to Shingrix. Additional Information: GSK Receipt Date 17-FEB-2025 The patient received Shingrix and on the day of reporting noticed some redness of the skin between the injection location and his armpit (redness). More
2827403 02/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. 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. Consumer reported that he/she had the vaccine and just got shingles. 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 Shingles vaccine. More
2827404 67 M MD 02/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Eye inflammation, Lacrimation increased, Ocular hyperaemia Eye inflammation, Lacrimation increased, Ocular hyperaemia
Bilateral eye inflammation; Bilateral eye tearing; Bilateral eye redness; This non-serious case was ... Bilateral eye inflammation; Bilateral eye tearing; Bilateral eye redness; This non-serious case was reported by a consumer via call center representative and described the occurrence of eye inflammation in a male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included eye operation (had 23 eye surgeries in his lifetime due to a problem with his eyes since birth). On 24-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). In SEP-2024, 5 weeks after receiving Shingrix, the patient experienced eye inflammation (Verbatim: Bilateral eye inflammation), eyes tearing (Verbatim: Bilateral eye tearing) and eye redness (Verbatim: Bilateral eye redness). The outcome of the eye inflammation, eyes tearing and eye redness were not resolved. It was unknown if the reporter considered the eye inflammation, eyes tearing and eye redness to be related to Shingrix. It was unknown if the company considered the eye inflammation, eyes tearing and eye redness to be related to Shingrix. Additional Information: GSK Receipt Date: 24-JAN-2025 The reporter was the patient who had received his first dose of Shingrix on 24th August 2024 and 5 weeks later had developed bilateral eye redness, tearing, and inflammation symptoms that had not resolved. The patient stated he had been to the ophthalmologist 6 times since having the vaccine. The patient also told that he had 23 eye surgeries in his lifetime due to a problem with his eyes since birth. More
2827405 1.25 F CA 02/21/2025 HIBV
HIBV
MMR
MMR
PNC20
PNC20
UNK
UNK
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER







Crying, Discomfort, Injection site rash, Malaise, Pyrexia; Rash papular; Crying,... Crying, Discomfort, Injection site rash, Malaise, Pyrexia; Rash papular; Crying, Discomfort, Injection site rash, Malaise, Pyrexia; Rash papular; Crying, Discomfort, Injection site rash, Malaise, Pyrexia; Rash papular; Crying, Discomfort, Injection site rash, Malaise, Pyrexia; Rash papular More
2 weeks after vaccine, she developed a round, raised rash on either side of her thighs with a fever ... 2 weeks after vaccine, she developed a round, raised rash on either side of her thighs with a fever where the injection site was of her vaccines. She clearly is uncomfortable and crying from not feeling good. More
2827410 73 F NC 02/21/2025 UNK
 UNKNOWN MANUFACTURER
Asthenia, Injection site swelling, Nausea, Skin reaction, Somnolence Asthenia, Injection site swelling, Nausea, Skin reaction, Somnolence
Slight swelling at injection sight Large red area size of an orange Nausea for 2 days Lack of energy... Slight swelling at injection sight Large red area size of an orange Nausea for 2 days Lack of energy and sleepy for 7 days More
2827419 13 M CA 02/21/2025 DTAP
DTAP
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 9R2D7
Inappropriate schedule of product administration, Wrong product administered; In... Inappropriate schedule of product administration, Wrong product administered; Inappropriate schedule of product administration, Wrong product administered More
Infanrix dose was given unintendedly to a patient who was supposed to receive a Tdap vaccine; Infanr... Infanrix dose was given unintendedly to a patient who was supposed to receive a Tdap vaccine; Infanrix dose 3rd given on 15-JAN-2025 and Dtap 2nd dose on 15th October 2011; 13 years patient received Infanrix vaccine; has 2 previous doses of Dtap (September 14, 2011 and October 15, 2011); This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old male patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and DTPa (DTaP vaccine) for prophylaxis. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (DTaP vaccine). On 15-JAN-2025, the patient received the 3rd dose of Infanrix. On an unknown date, the patient received Tdap Vaccine. On 15-OCT-2011, the patient received the 2nd dose of DTaP vaccine. On 15-OCT-2011, not applicable after receiving Infanrix and Tdap Vaccine and an unknown time after receiving DTaP vaccine, the patient experienced drug dose administration interval too short (Verbatim: has 2 previous doses of Dtap (September 14, 2011 and October 15, 2011)). On 15-JAN-2025, the patient experienced wrong vaccine administered (Verbatim: Infanrix dose was given unintendedly to a patient who was supposed to receive a Tdap vaccine), drug dose administration interval too long (Verbatim: Infanrix dose 3rd given on 15-JAN-2025 and Dtap 2nd dose on 15th October 2011) and inappropriate age at vaccine administration (Verbatim: 13 years patient received Infanrix vaccine). The outcome of the wrong vaccine administered, drug dose administration interval too long, inappropriate age at vaccine administration and drug dose administration interval too short 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: 22-JAN-2025 The medical assistant reported that an Infanrix dose was given unintendedly to a patient who was supposed to receive a Tdap vaccine, which led to wrong vaccine administered. The patient had 2 previous doses of Dtap vaccine and no previous Tdap doses. The patient received a 3rd dose of Infanrix at an inappropriate age, which led to inappropriate age at vaccine administration. The patient received 3rd dose of Infanrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 2nd dose of DTaP earlier than recommended interval, which led to shortening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter. More
2827462 55 M MD 02/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Fatigue, Influenza like illness, Pain, Pain in extremity, Restlessness Fatigue, Influenza like illness, Pain, Pain in extremity, Restlessness
Sore arm at 3 hours, fatigue at 6 hours, restlessness all night, and full body aches in the followin... Sore arm at 3 hours, fatigue at 6 hours, restlessness all night, and full body aches in the following morning, with continued fatigue. Feels like flu More
2827463 55 F FL 02/21/2025 HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 T5D73
T5D73
T5D73
Blood magnesium normal, Computerised tomogram head normal, Computerised tomogram... Blood magnesium normal, Computerised tomogram head normal, Computerised tomogram neck normal, Differential white blood cell count, Electrocardiogram abnormal; Full blood count, Hyperacusis, Hypoacusis, Metabolic function test, Scan with contrast normal; Sinus bradycardia, Tinnitus More
Patient received the Hep B vaccine in the Left Deltoid on 02/19/2025 at 0846 am. Tinnitus-like sympt... Patient received the Hep B vaccine in the Left Deltoid on 02/19/2025 at 0846 am. Tinnitus-like symptoms started on 02/19/25 at 1530 pm in both ears. Patient self-medicated with ibuprofen the evening of 02/19/25 but experienced little relief. Patient woke up 02/20/25 to worsened symptoms and experienced amplified sensitivity to sound and wind, and heard vibrations when she spoke. Patient experienced difficulty hearing bilaterally, but diminished hearing was worse in the left ear than the right. Patient was seen in the ED on 02/20/25 around 0800 am for worsening symptoms. CT of the head and neck with and without contrast were performed while in the ED. CT results were normal. EKG and blood work were also done. A referral to otolaryngology was made for the patient. Patient is also following up with a location to have an audiology test performed as of today, 02/21/25. More
2827464 75 F FL 02/21/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received a second dose of Arexvy (RSV) vaccine in error. First dose received on 02/29/2024. ... Patient received a second dose of Arexvy (RSV) vaccine in error. First dose received on 02/29/2024. Patient reports no adverse effects. More
2827465 78 M FL 02/21/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received a second dose of Arexvy (RSV) vaccine in error. First dose received on 02/29/2024. ... Patient received a second dose of Arexvy (RSV) vaccine in error. First dose received on 02/29/2024. Patient reports no adverse effects. More
2827466 27 F MI 02/21/2025 COVID19
 PFIZER\BIONTECH
Pericarditis Pericarditis
pericarditis pericarditis
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2827467 52 F MI 02/21/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 HG7557
HG7557
COVID-19, Headache, Hypoxia, Respiratory failure, Respiratory syncytial virus in... COVID-19, Headache, Hypoxia, Respiratory failure, Respiratory syncytial virus infection; Wheezing More
Age: 54 y.o. Admit date: 2/14/2025 Discharge date: 2/15/25 Attending Physician at the Time of D... Age: 54 y.o. Admit date: 2/14/2025 Discharge date: 2/15/25 Attending Physician at the Time of Discharge: D.O. Reason for Admission: RSV/COVID respiratory failure Brief Summary of Hospital Stay: presented hypoxic with wheezing found to have covid/rsv. Treated with decadron/remdesivir with rapid improvement. Ambulated staying 94% on room air. Wanted to dc home, was deemed appropriate and stable for this. Had headaches with infection that resolved with advil. Return precautions given and r/u recommendations if headaches fail to improve/resolve with resolution of infection given. No red flag symptoms noted. The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home. More
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2827468 1 F ME 02/21/2025 HIBV
 SANOFI PASTEUR
 UK169AC
No adverse event, Product preparation error No adverse event, Product preparation error
HIB vaccine was reconstituted with a sterile diluent and not the saline diluent that it is supposed ... HIB vaccine was reconstituted with a sterile diluent and not the saline diluent that it is supposed to be mixed with. Patient had no reaction, but vaccine is sub-potent so will have to be re-given More
2827469 60 M MI 02/21/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8735
ER8735
ER8735
Acute kidney injury, COVID-19, Diarrhoea, Hypophagia, Hypotension; Hypovolaemic ... Acute kidney injury, COVID-19, Diarrhoea, Hypophagia, Hypotension; Hypovolaemic shock, Influenza, Renal mass, Septic shock, Ultrasound kidney normal; Viral infection More
Age: 64 y.o. Admit date: 2/14/2025 Discharge date: 2/16/2025 Attending Physician at the Time o... Age: 64 y.o. Admit date: 2/14/2025 Discharge date: 2/16/2025 Attending Physician at the Time of Discharge: DO Primary Care Physician: MD Reason for Admission: shock Brief Summary of Hospital Stay: 64 y.o. male with dilated cardiomyopathy (EF 25-30%) presented to ED with viral syndrome and hypotension. Admitted with viral/hypovolemic shock related to flu/covid. Hypovolemia from diarrhea and poor intake combined with recent medication increase likely contributing. Placed on IV fluid support with resolution of hypotension and Acute kidney injury. He will resume metoprolol alone (decreased dose) and follow with Cardiology to re-initiate CHF treatment. Problem list: Septic/hypovolemic shock, resolved Influenza/covid -tamiflu -tessalon, guaifenesin-dextromethorphan Dilated Cardiomoypathy (EF 25-30%) without clinical heart failure -resume toprol at decreased dose -hold Entresto, spironolactone, Jardiance -follow with Cardiology as above, may not need diuretics with no history of overload Chronic LBBB, history of NSVT -toprol resumed Acute kidney injury, resolved Right renal lesion on ultrasound -CT recommended by Radiology, follow with PCP, discussed Although leaving today, this patient will require ongoing assessment and treatment, with adjustments to the plan as appropriate. Medicine is complicated and unforseen changes in status may occur. Discharged to Home. More
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