🏥 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 💀 🏥 🚑 ♿ ⚠️
2815367 72 M TX 12/11/2024 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 023C21A
023C21A
023C21A
023C21A
032H21A
032H21A
023H22A
023H22A
1AU3833D
1AU3833D
203G23A
203G23A
023C21A
023C21A
023C21A
Atrial fibrillation, Echocardiogram, Electrocardiogram, Generalised anxiety diso... Atrial fibrillation, Echocardiogram, Electrocardiogram, Generalised anxiety disorder, Imaging procedure; Laboratory test, Myopericarditis, Seizure; Atrial fibrillation, Echocardiogram, Electrocardiogram, Generalised anxiety disorder, Imaging procedure; Laboratory test, Myopericarditis, Seizure; Atrial fibrillation, Echocardiogram, Electrocardiogram, Generalised anxiety disorder, Imaging procedure; Laboratory test, Myopericarditis, Seizure; Atrial fibrillation, Echocardiogram, Electrocardiogram, Generalised anxiety disorder, Imaging procedure; Laboratory test, Myopericarditis, Seizure; Atrial fibrillation, Echocardiogram, Electrocardiogram, Generalised anxiety disorder, Imaging procedure; Laboratory test, Myopericarditis, Seizure; Atrial fibrillation, Echocardiogram, Electrocardiogram, Generalised anxiety disorder, Imaging procedure; Laboratory test, Myopericarditis, Seizure; Atrial fibrillation, Blood test, Brain fog, Cardiac murmur, Ear discomfort; Headache, Magnetic resonance imaging, Neck pain, Palpitations, Seizure; Tinnitus More
MODERNA #1 5/29/2021 MODERNA #2 6/26/2021 MODERNA #3 12/29/2021 MODERNA #4 12/28/2022 MODERNA #5 9/2... MODERNA #1 5/29/2021 MODERNA #2 6/26/2021 MODERNA #3 12/29/2021 MODERNA #4 12/28/2022 MODERNA #5 9/28/2023 MODERNA #6 4/9/2024 PATIENT HAD GENERALIZED SEIZURE AND PAROXYSMAL ATRIAL FIBRILLATION REQURING HOSPITALIZATION. DIAGNOSED WITH VACCINE INDUCED SEIZURES AND SUBCLINICAL MYOPERICARDITIS. TREATED WITH COLCHICINE, FLECAINIDE, IVERMECTIN AND PROTOCOL BASE SPIKE DETOXIFICATION. More
✓ ✓
2303547 78 M MN 05/31/2022 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 031L20A
031A21A
051F21A
031L20A
031A21A
051F21A
COVID-19, SARS-CoV-2 test positive; COVID-19, SARS-CoV-2 test positive; COVID-19... COVID-19, SARS-CoV-2 test positive; COVID-19, SARS-CoV-2 test positive; COVID-19, SARS-CoV-2 test positive; Cough, Exposure to SARS-CoV-2, Viral test; Cough, Exposure to SARS-CoV-2, Viral test; Cough, Exposure to SARS-CoV-2, Viral test More
Patient vaccinated against and then tested positive for COVID19. Patient vaccinated against and then tested positive for COVID19.
2836917 61 F NC 04/20/2025 PNC21
 MERCK & CO. INC.
 Y019158
Erythema, Peripheral swelling, Pruritus, Skin warm Erythema, Peripheral swelling, Pruritus, Skin warm
left arm, warm, swollen, red and itchy left arm, warm, swollen, red and itchy
2836918 44 M MI 04/20/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0182
EW0182
EW0182
Asthenia, Blood test, Electric shock sensation, Electrocardiogram, Fatigue; Head... Asthenia, Blood test, Electric shock sensation, Electrocardiogram, Fatigue; Headache, Impaired work ability, Insomnia, Laboratory test, Malaise; Mobility decreased, Scan brain, Sepsis, Sleep disorder More
Woke up from my sleep with around 2:30am with what felt like fireworks going off in my head. Felt ... Woke up from my sleep with around 2:30am with what felt like fireworks going off in my head. Felt like I was about to die and told my wife to call 911 then I went Sepsis. This happened around 12 hours after my injection. 911 showed up I back to and to and just wanted to go back to bed. When I woke up in the morning I still felt ver seriously wrong I couldn't get out of bed. Had my my call 911 again. they rushed me to the hospital and when i arrived i went Sepsis again. The stayed in the hospital over night while they ran tests. They were not able to find anything wrong but I still felt extremely weak and sick and could barley move. I had to take a leave from work and ended up having to leave my job because i was too sick to work. I returned to the hospital many times after this event because I was not getting better. The hospitals had no idea what to do so after years of no help I relied on my own research to help. Through supplementation and hard work I have over come many of my symptoms in the last 4 years. However still to this day suffer from adverse effects from the vaccine which I never had prior which include insomnia, fatigue, brain zaps. and other issues More
✓ ✓
2836919 61 F PA 04/20/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS

Injected limb mobility decreased, Injection site pain, Pain in extremity; Inject... Injected limb mobility decreased, Injection site pain, Pain in extremity; Injected limb mobility decreased, Injection site pain, Pain in extremity More
pt mentioned arm was right arm (where she received capvaxive) was quite sore and she couldn't l... pt mentioned arm was right arm (where she received capvaxive) was quite sore and she couldn't lift arm very well. the area of shot was sensitive as well. More
2836920 69 F NY 04/20/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Extra dose administered Extra dose administered
Patient was inadvertently given 3rd dose of shingles vaccine. Patient was inadvertently given 3rd dose of shingles vaccine.
2836921 62 F TX 04/20/2025 PNC20
 PFIZER\WYETH
 LK6651
Injection site erythema, Injection site swelling, Local reaction Injection site erythema, Injection site swelling, Local reaction
Mild Localized Reaction - Erythema and swelling at the injection site noted on left upper arm. Treat... Mild Localized Reaction - Erythema and swelling at the injection site noted on left upper arm. Treatment: symptomatic care and OTC meds recommended. Apply cold compress to the injection site for 20 minutes and repeat every 2-4 hours as needed. Consider OTC analgesic (pain reliever) unless contraindicated. Wear lightweight clothing over the injection site. Patient in no acute distress, strict UC/ER precautions provided. Recommended to monitor symptoms and follow up if symptoms worsen or do not improve as discussed. More
2836922 65 M MI 04/20/2025 PPV
PPV
 MERCK & CO. INC.
MERCK & CO. INC.
 K008409
K008409
Blood test, Chromaturia, Diagnostic procedure, Haematocrit decreased, Haemoglobi... Blood test, Chromaturia, Diagnostic procedure, Haematocrit decreased, Haemoglobin decreased; Haemolytic anaemia, Haptoglobin decreased, Jaundice More
hemolytic anemia (symptoms included jaundice, dark urine, undetectable haptoglobin, low hematocrit a... hemolytic anemia (symptoms included jaundice, dark urine, undetectable haptoglobin, low hematocrit and low hemoglobin), treated with Prednisone (60 mg/day for 3 wks, then 40 mg/day for 2 wks, then 30 mg/day for 2 wks, then 20 mg/day for 2 wks, then 15 mg/day for 2 wks, then 10 mg/day for 2 wks, then 5 mg/day for 3 wks, then 5 mg/on alternate days for 4 wks), resulting in restoration within 1 month and subsequent maintenance of normal hemoglobin levels - no recurrence over past 10 years More
✓
2836939 52 F CO 04/20/2025 COVID19
 MODERNA
Kaleidoscope vision, Visual field defect Kaleidoscope vision, Visual field defect
Approximately 34 hours after the vaccine, I developed a visual field deficit, which appeared like an... Approximately 34 hours after the vaccine, I developed a visual field deficit, which appeared like an arc of kaleidoscope or prism-like objects in my visual field. This madenit difficult to read sub-titles on the tv or even watch tv. The visual disturbance persisted after turning the tv off. It lasted 5 minutes and then resolved. I worried this was a TIA or stroke symptom, but did not go to the hospital since it quickly resolved. More
2836940 27 F WA 04/20/2025 COVID19
 MODERNA
Urticaria Urticaria
Hives, urticaria, Hives, urticaria,
2836950 66 F AL 04/20/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y013009
354M3
Dizziness, Fatigue, Injection site rash, Pyrexia; Dizziness, Fatigue, Injection ... Dizziness, Fatigue, Injection site rash, Pyrexia; Dizziness, Fatigue, Injection site rash, Pyrexia More
Beginning the night after vaccinations, patient experienced severe dizziness, fatigue, and fever. Al... Beginning the night after vaccinations, patient experienced severe dizziness, fatigue, and fever. Also rash around injection site. Treated with Tylenol and benadryl. More
2836892 71 F HI 04/19/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019157
Y019157
Chills, Headache, Injected limb mobility decreased, Injection site erythema, Pai... Chills, Headache, Injected limb mobility decreased, Injection site erythema, Pain; Palpitations More
Patient received Capraxive on 4/15/26 at 4:13pm and starting experiencing chills, headaches, and hea... Patient received Capraxive on 4/15/26 at 4:13pm and starting experiencing chills, headaches, and heart pounding at night. She had body ache, redness at injection site and difficulty lifting her injected arm and continued headaches the next day. Symptoms are slowly subsiding. She has a follow up appointment with Dr (primary care physician) on 4/21/25. More
2836893 33 F CA 04/19/2025 COVID19
 MODERNA
 013F21A
Antibody test positive, Delivery, Exposure during pregnancy, Rash, Urticaria Antibody test positive, Delivery, Exposure during pregnancy, Rash, Urticaria
Conceived 12/19/2021 (second pregnancy, carried to term), body welts/hives started 12/29/2021. Initi... Conceived 12/19/2021 (second pregnancy, carried to term), body welts/hives started 12/29/2021. Initially went to urgent care and later to ER (12/31/2021) because rash was unbearable. Was given multiple high doses of prednisone and then prescribed antihistamines (Zyrtec and Benadryl) for the entirety of my symptoms, which lasted for 15 months, though there are still lingering symptoms. Baby born, 8lbs. Coincidentally (or not), baby was rushed to the ER 4 days after his 2-month vaccines, and has since been diagnosed with congenital nystagmus with no co-occurring disease/disability, though his condition extends to balance and other vestibular functions. More
2836894 35 F NY 04/19/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FK9896
FK9896
FK9896
FK9896
Abdominal pain upper, Blood test abnormal, Colonoscopy, Decreased appetite, Diar... Abdominal pain upper, Blood test abnormal, Colonoscopy, Decreased appetite, Diarrhoea; Duodenitis, Dysgeusia, Dyspepsia, Endoscopy abnormal, Fatigue; Full blood count, Gastrooesophageal reflux disease, Haemoptysis, Metabolic function test, Nausea; Weight decreased, X-ray More
1 hour post vaccination, experienced sour taste in mouth. 6 days post vaccine, spit out small blood ... 1 hour post vaccination, experienced sour taste in mouth. 6 days post vaccine, spit out small blood clots. Went to hospital. Within 1 month post vaccine, experienced anorexia, feeling of fullness, nausea, diarrhea, stomach pain, heartburn, acid reflux, extreme fatigue, weight loss of 26 pounds, (1. 5 months post vaccination.) More
✓
2836895 3 M CA 04/19/2025 UNK
 UNKNOWN MANUFACTURER
Unevaluable event Unevaluable event
Time course Time course
✓ ✓
2836896 72 M MI 04/19/2025 COVID19
 PFIZER\BIONTECH
 LN0590
Contusion Contusion
patient came in the morning after vaccination with a large bruise, with no pain, on the arm of the i... patient came in the morning after vaccination with a large bruise, with no pain, on the arm of the injection site. Patient was advised to go to the Emergency Room to have it checked out. More
2836898 34 F ID 04/19/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 JT8434JA
JT8434JA
Arthralgia, Arthritis, Injected limb mobility decreased, Magnetic resonance imag... Arthralgia, Arthritis, Injected limb mobility decreased, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint; Pain, Periarthritis, Tendonitis More
I felt like the vaccine was given higher up in my arm than it should have been. Then I started to ha... I felt like the vaccine was given higher up in my arm than it should have been. Then I started to have moderate R shoulder pain beginning later the same day that progressively worsened into the next day. I was unable to lift my arm up to take my clothes off, push down, pull up, or reach over my body without being in severe pain. Although somewhat improved, there is still ongoing pain. More
✓
2836899 77 F NE 04/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 H97H2
Herpes zoster, Rash Herpes zoster, Rash
Patient seen on 4/19/25 for shingles rash that started 4/17/25, the same day she received the vaccin... Patient seen on 4/19/25 for shingles rash that started 4/17/25, the same day she received the vaccine. It is unknown if the rash started before or after the vaccine as patient did not mention this at her visit. More
2836900 59 F LA 04/19/2025 PNC21
 MERCK & CO. INC.
 y011819
Urticaria Urticaria
broke out in hives all over body. pt went to urgent care and got treated. broke out in hives all over body. pt went to urgent care and got treated.
2836901 79 F FL 04/19/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 7L3ST
Injection site bruising, Injection site pain, Injection site swelling, Injection... Injection site bruising, Injection site pain, Injection site swelling, Injection site warmth More
Earlier this morning on Saturday April 19th, patient came to the consultation window to show a bruis... Earlier this morning on Saturday April 19th, patient came to the consultation window to show a bruise mark on her right arm from a Arexvy vaccine that she had received yesterday morning. During our consultation, I asked if she was taking any blood thinners and she stated yes, but I didn't see anything listed under her medication history. The name of the blood thinner is unknown. Patient has a bruise mark on her right arm probably "2 inches wide by one inch and 1/2 tall." The color is more purplish-blue than red. She stated this vaccine was more painful compared to the other vaccines she has received in the past. I asked patient to describe the level of pain on a pain scale from 1 to 10 (where 1 is the lowest and 10 is the highest), as she rated it a four. She stated it still felt warm to touch and a little swollen at the injection site. I recommended her to ice the site and monitor for any other signs in the next few days. More
2836902 73 F WA 04/19/2025 FLU3
 SANOFI PASTEUR
 U8499BA
Extra dose administered, No adverse event Extra dose administered, No adverse event
Additional dose error only, 2nd influenza vaccine in the 2024-2025 influenza season. Doses given aro... Additional dose error only, 2nd influenza vaccine in the 2024-2025 influenza season. Doses given around 6 months apart. No adverse effects noted after the vaccination. More
2836903 57 F NH 04/19/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Blood test normal, Contusion, Hypoaesthesia, Muscle spasms, Neuralgic amyotrophy... Blood test normal, Contusion, Hypoaesthesia, Muscle spasms, Neuralgic amyotrophy; Pain in extremity, Paraesthesia, X-ray normal More
Three days following the vaccine, I have experienced all of the symptoms described with Parsonage-Tu... Three days following the vaccine, I have experienced all of the symptoms described with Parsonage-Turner Syndrome. There were no other possible causes of these symptoms. I was diagnosed on the 4th day after with a muscle spasm by my upper left shoulder blade. I was prescribed a muscle relaxer and steroids for 5 days. There has been no relief. I have had 2 therapeutic massages which has brought temporary relief but not long after the massage. I have experienced pain, numbness and tingling that radiates down my arm to my fingers. They are often numb and tingling. I have an unexplained purple bruise in the top of my hand of the same arm. More
2836904 62 F IL 04/19/2025 PNC21
 MERCK & CO. INC.
 y019158
Injection site erythema, Injection site induration, Injection site pain, Injecti... Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus More
Redness, hardness, itching and pain at injection site- continued pain reported on 4/19/25. injected ... Redness, hardness, itching and pain at injection site- continued pain reported on 4/19/25. injected vaccine on 4/15/25. More
2836905 69 M 04/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Needle issue, Underdose Needle issue, Underdose
Needle was not screwed onto syringe tight enough and part of dose leaked out when being administered... Needle was not screwed onto syringe tight enough and part of dose leaked out when being administered. Called patient and notified him dose should be repeated. More
2836906 47 F FL 04/19/2025 COVID19
COVID19
HEP
HEP
IPV
IPV
MMR
MMR
TDAP
TDAP
VARCEL
VARCEL
 MODERNA
MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 8081260
8081260
4BX39
4BX39
Y1A212M
Y1A212M
Y011709
Y011709
39LB7
39LB7
Y015559
Y015559
Asthenia, Blood pressure decreased, Cyanosis, Dizziness, Electrocardiogram; Mala... Asthenia, Blood pressure decreased, Cyanosis, Dizziness, Electrocardiogram; Malaise, Peripheral coldness, Syncope, Unresponsive to stimuli; Asthenia, Blood pressure decreased, Cyanosis, Dizziness, Electrocardiogram; Malaise, Peripheral coldness, Syncope, Unresponsive to stimuli; Asthenia, Blood pressure decreased, Cyanosis, Dizziness, Electrocardiogram; Malaise, Peripheral coldness, Syncope, Unresponsive to stimuli; Asthenia, Blood pressure decreased, Cyanosis, Dizziness, Electrocardiogram; Malaise, Peripheral coldness, Syncope, Unresponsive to stimuli; Asthenia, Blood pressure decreased, Cyanosis, Dizziness, Electrocardiogram; Malaise, Peripheral coldness, Syncope, Unresponsive to stimuli; Asthenia, Blood pressure decreased, Cyanosis, Dizziness, Electrocardiogram; Malaise, Peripheral coldness, Syncope, Unresponsive to stimuli More
Patient came into Pharmacy requesting 6 vaccines. She has no history on (state) shots registry as sh... Patient came into Pharmacy requesting 6 vaccines. She has no history on (state) shots registry as she is new to the country ( < 1 yr). She stated no pregnancy and NKDA. After administering the last vaccine. She stated that she did not feel well. I told her to remain seated. She fainted for about 45 seconds to 1 minute. her lips and skin on face became purple, she was non-responsive and very cold hands. Paramedics were called. her bp was a bit low 80/60. I applied ice packs, and alcohol up to her nose to stimulate a response. she slowly regained consciousness but was still feeling dizzy and weak. Paramedics took her vital and perform EKG. She did not need hospitalization and was ok to go back home with her husband. More
2836907 65 F 04/19/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y019158
EK225
Erythema, Pain in extremity, Skin warm; Erythema, Pain in extremity, Skin warm Erythema, Pain in extremity, Skin warm; Erythema, Pain in extremity, Skin warm
red, hot painful arm red, hot painful arm
2836908 53 F 04/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ek225
Pain, Pyrexia, Rash Pain, Pyrexia, Rash
pt's husband reports fever and body aches for first two days. now pt is having a full body ras... pt's husband reports fever and body aches for first two days. now pt is having a full body rash More
2836909 33 F SC 04/19/2025 COVID19
 MODERNA
Blood follicle stimulating hormone increased, Premature menopause, Ultrasound sc... Blood follicle stimulating hormone increased, Premature menopause, Ultrasound scan More
Early menopause Early menopause
2836910 52 F OR 04/19/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 92nn/mg529
Dry skin, Rash, Skin fissures, Swelling face Dry skin, Rash, Skin fissures, Swelling face
Per patient, she developed a rash within 24 hours of receiving the vaccine. Vaccine was administered... Per patient, she developed a rash within 24 hours of receiving the vaccine. Vaccine was administered on 4/16/25 and reaction began 4/17/25. On 4/18/25, she developed facial swelling and noticed skin drying and cracking. Patient called at 5pm on 4/19/25 to report adverse event to pharmacy and was instructed to seek medical attention as soon as possible. Rash and some swelling is ongoing, but patient reported some relief when taking Benadryl. More
2836911 1 M 04/19/2025 MMR
 MERCK & CO. INC.
Pyrexia, Rash Pyrexia, Rash
Mild fever, rash primarily on torso and limbs, some rash on face Mild fever, rash primarily on torso and limbs, some rash on face
2836756 04/18/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product storage error Product storage error
multiple patients receiving frozen MMR vaccine; This non-serious case was reported by a pharmacist v... multiple patients receiving frozen MMR vaccine; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: multiple patients receiving frozen MMR vaccine). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 08-APR-2025 The Healthcare professional emailed to inquire about multiple patients receiving frozen MMR vaccine, which led to incorrect storage of drug. In email, Healthcare did not state if vaccine was frozen before or after re-constitution. Healthcare wondering if patients need re-vaccinated. Was there anything you would like to share about the primary disease. More
2836757 M 04/18/2025 DTAPHEPBIP
DTAPHEPBIP
DTAPHEPBIP
HIBV
HIBV
HIBV
PNC20
PNC20
PNC20
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 B532G
B532G
B532G
Y013470
Y013470
Y013470
LK6650
LK6650
LK6650
Y013470
Y013470
Y013470
LK6650
LK6650
LK6650
B532G
B532G
B532G
Death, Intensive care, Resuscitation, Unresponsive to stimuli; Death, General ph... Death, Intensive care, Resuscitation, Unresponsive to stimuli; Death, General physical health deterioration, Inappropriate schedule of product administration, Intensive care, Resuscitation; Unresponsive to stimuli; Death, Intensive care, Resuscitation, Unresponsive to stimuli; Death, General physical health deterioration, Inappropriate schedule of product administration, Intensive care, Resuscitation; Unresponsive to stimuli; Death, Intensive care, Resuscitation, Unresponsive to stimuli; Death, General physical health deterioration, Inappropriate schedule of product administration, Intensive care, Resuscitation; Unresponsive to stimuli; Death, Intensive care, Resuscitation, Unresponsive to stimuli; Death, General physical health deterioration, Inappropriate schedule of product administration, Intensive care, Resuscitation; Unresponsive to stimuli; Death, Intensive care, Resuscitation, Unresponsive to stimuli; Death, General physical health deterioration, Inappropriate schedule of product administration, Intensive care, Resuscitation; Unresponsive to stimuli; Death, Intensive care, Resuscitation, Unresponsive to stimuli; Death, General physical health deterioration, Inappropriate schedule of product administration, Intensive care, Resuscitation; Unresponsive to stimuli More
Unresponsive to stimuli/was no longer responsive; Infant was pronounced deceased; This serious case ... Unresponsive to stimuli/was no longer responsive; Infant was pronounced deceased; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B532G) for prophylaxis. Co-suspect products included HIB vaccine conj (OMPC) (PedvaxHIB) (batch number Y013470) for prophylaxis and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) (batch number LK6650) for prophylaxis. The patient's past medical history included hyperglycemia, neuroleptic malignant syndrome, encephalitis (non infectious), encephalopathy, meningitis, hypotonic-hyporesponsive episode and hypoglycemia. Previously administered products included Beyfortus. Concurrent medical conditions included diabetes mellitus, guillain barre syndrome and intussusception. Additional patient notes included Patient had no any allergies. On 13-MAR-2025, the patient received the 2nd dose of Pediarix (intramuscular), the 2nd dose of PedvaxHIB (intramuscular) and the 2nd dose of Prevnar 20 (intramuscular). On 13-MAR-2025 19:00, less than a day after receiving Pediarix, the patient experienced unresponsive to stimuli (Verbatim: Unresponsive to stimuli/was no longer responsive) (serious criteria hospitalization and GSK medically significant). On 14-MAR-2025 08:14, the patient experienced unknown cause of death (Verbatim: Infant was pronounced deceased) (serious criteria death, hospitalization and GSK medically significant). The outcome of the unresponsive to stimuli was not resolved. The patient died on 14-MAR-2025. The reported cause of death was unknown. The reporter considered the unknown cause of death and unresponsive to stimuli to be related to Pediarix and Pediarix Pre-Filled Syringe Device. The company considered the unknown cause of death and unresponsive to stimuli to be unrelated to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. Patient took vaccine such as Pediarix ,Pedvax and Prevenar 20 in right and left leg respectively via intramuscularly. Consumer reported that infant was found at home unresponsive around 19:00 on 13th March 2025, father began Cardiopulmonary Resuscitation, and infant was brought to nearest hospital where the infant was then stabilized for transfer to a facility with an available pediatric provider. Infant slowly declined and was no longer responsive to treatments in ICU (intensive care unit). The reporter considered the unknown cause of death and unresponsive to stimuli to be related to PedvaxHIB and Prevnar 20.; Sender's Comments: Death and Unresponsive to stimuli are unlisted events which are considered unrelated to GSK vaccine Pediarix and Pediarix Pre-Filled Syringe Device.; Reported Cause(s) of Death: Unknown cause of death More
✓ ✓
2836758 04/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Myalgia, Pain, Vaccination failure Herpes zoster, Myalgia, Pain, Vaccination failure
Suspeceted vaccination failure; I had the vaccine before I got them. I still have pain in my bicep i... Suspeceted vaccination failure; I had the vaccine before I got them. I still have pain in my bicep in my left arm; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the vaccine before I got them. I still have pain in my bicep in my left arm). 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: 12-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that it was very painful. The patient had the vaccine before the patient got them. The patient had still have pain in his/her bicep in left arm. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2836759 1.5 M MI 04/18/2025 RVX
 UNKNOWN MANUFACTURER
 EX434
Extra dose administered Extra dose administered
Patient recieved 3rd dose of Rotarix; This non-serious case was reported by a nurse via call center ... Patient recieved 3rd dose of Rotarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-month-old male patient who received Rotavirus vaccine (batch number EX434, expiry date 01-JUN-2026) for prophylaxis. Previously administered products included Rotarix (1st dose received on 15th November 2023 with lot number YL9Y9) and Rotarix (2nd dose received on 29th January 2024 with lot number 737J5 and expiry date 5th October 2025). On 08-APR-2025, the patient received the 3rd dose of Rotavirus vaccine. On 08-APR-2025, an unknown time after receiving Rotavirus vaccine, the patient experienced extra dose administered (Verbatim: Patient recieved 3rd dose of Rotarix). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 08-APR-2025 The patient received 3rd dose of Rotarix at 18 months of age on 08th April 2025 which led to an extra dose administration. More
2836760 2 F FL 04/18/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Expired product administered Expired product administered
Havrix Expired dose administered; This non-serious case was reported by a pharmacist via call center... Havrix Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix) (expiry date 02-MAR-2025) for prophylaxis. On 07-APR-2025, the patient received the 1st dose of Havrix. On 07-APR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix Expired dose administered). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 10-APR-2025 Pharmacist Manager reported that in one of his clinics, a female patient received Havrix first expired dose which led to Expired vaccine administered. More
2836762 4 F TX 04/18/2025 MMRV
 MERCK & CO. INC.
 Y017512
Injection site erythema, Injection site reaction, Injection site swelling, Skin ... Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion More
Medical Assistant, 04/17/2025 went to dismissed patient after the 10mins from receiving vaccines, I ... Medical Assistant, 04/17/2025 went to dismissed patient after the 10mins from receiving vaccines, I noticed a small bump on the Left thigh. Alerted Dr. about possible vaccine reaction, and she followed up with the patient. Dr. 04/17/2025 evaluated pt in clinic, noted to have a large lesion to L lateral thigh. Lesion was round, about 5cm in diameter, with redness and swelling. No fluctuance. Pt also had a similar lesion to the inner R thigh that mom states was present since yesterday and thought it was a spider bite, mom states pt did not have have the lesion to L thigh prior to vaccine administration. Pt reports the lesion hurts, but does not itch. No other systemic symptoms such as hives, face/tongue/lip swelling, wheezing, coughing, SOB, vomiting or diarrhea. Advised mom that this is likely a mild reaction to the vaccine, apply warm compresses at home and monitor. Call MD if any changes such as enlargement of lesion. Go to ER if develops hives, fever, wheezing, cough, face/tongue/lip swelling or any other concerns. Mom expressed understanding and agrees with plan. Will ensure incident report is filed. More
2836794 MD 04/18/2025 VARCEL
 MERCK & CO. INC.
 Y011712
No adverse event, Product storage error No adverse event, Product storage error
no additional AE; temperature excursion on varivax; This spontaneous report was received from a/an C... no additional AE; temperature excursion on varivax; This spontaneous report was received from a/an Consumer or other non health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Mar-2025, the patient started therapy with improperly stored (Incorrect product storage) Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Solution for injection (lot #Y011712, expiration date: 02-Jul-2026) 0.5 mL administered by Unknown route for prophylaxis together with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported). Time frame of temperature excursion: 13 hours 15 minutes 0 seconds. Temperature: 14.65 Fahrenheit (F). The patient experienced no additional adverse event. There was no data logger involved. More
2836795 MD 04/18/2025 VARCEL
 MERCK & CO. INC.
 Y011712
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; improper storage of product in use; This spontaneous report was received from a ph... no adverse event; improper storage of product in use; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported. On 03-Mar-2025, the patient was vaccinated with improperly stored vaccine of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) injection (lot #Y011712, expiration date: 02-Jul-2026), 0.5 mL, diluted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported) as prophylaxis (improper storage of product in use). The vaccine was exposed to temperature excursion (Temperature: 14.65 F, Time frame: 13 hours 15 minutes 0 seconds) on 29-Jan-2025. No symptomatic events reported (no adverse event). There was no previous temperature excursion. More
2836796 13 M FL 04/18/2025 HPV9
 MERCK & CO. INC.
 Z002903
No adverse event, Product storage error No adverse event, Product storage error
no symptomatic adverse events were reported; the vaccines were late right away; one dose of GARDASIL... no symptomatic adverse events were reported; the vaccines were late right away; one dose of GARDASIL-9 was administered to a patient; This spontaneous report was received from a nurse and refers to a(n) 13-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Apr-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL-9) injection, lot #Z002903, expiration date: 15-Dec-2026, 0.5 ml / once, product quantity: 1, administered for prophylaxis (strength and route, anatomical site were not provided). The Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL-9) that had arrived after the "must receive by date" (Product shipment delay). The vaccine was received on 07-Apr-2025 and had a must receive by date of 06-Apr-2025. It was reported that they did not catch that the vaccines were late right away and the vaccines appeared to still be cool (Improper storage of product in use). It was confirmed no symptomatic adverse events were reported in the patient who received the dose (No adverse event). Reporter was returning 19 of the 20 doses she ordered.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02784533-02784524 , CLIC number : , ESTAR number : , IRMS number : 500UW00000Y0zmKYAR|08042025150020|7379 , Central date : 2025-04-08 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02784533 , MNSC interaction number : 02784524 , Integration log UniqueID : 500UW00000Y0zmKYAR|08042025150020|7379 , Service cloud CaseID : 500UW00000Y0zmKYAR More
2836797 93 F WA 04/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Back pain, Chest pain, Computerised tomogram normal, Dyspnoea, Imaging procedure... Back pain, Chest pain, Computerised tomogram normal, Dyspnoea, Imaging procedure; Laboratory test normal, Painful respiration, Sleep disorder, Speech disorder, Ventilation/perfusion scan More
Hard time talking; Chest pain/she woke up during the night Tuesday morning, 8-APR-2025 with pain in ... Hard time talking; Chest pain/she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest; Back pain/pain in lower back and is still experiencing these events today, 10-APR-2025.; Can not Breathe/she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues today, 10-APR-2025; Hurts; This non-serious case was reported by a consumer via call center representative and described the occurrence of chest pain in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-APR-2025 15:00, the patient received the 1st dose of Shingrix (left arm). On 08-APR-2025, 1 days after receiving Shingrix, the patient experienced chest pain (Verbatim: Chest pain/she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest), back pain (Verbatim: Back pain/pain in lower back and is still experiencing these events today, 10-APR-2025.), difficulty breathing (Verbatim: Can not Breathe/she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues today, 10-APR-2025) and pain (Verbatim: Hurts). On an unknown date, the patient experienced speech disorder (Verbatim: Hard time talking). The outcome of the chest pain, back pain, difficulty breathing, pain and speech disorder were not resolved. It was unknown if the reporter considered the chest pain, back pain, difficulty breathing, pain and speech disorder to be related to Shingrix. It was unknown if the company considered the chest pain, back pain, difficulty breathing, pain and speech disorder to be related to Shingrix. Additional Information: GSK Receipt Date: 10-APR-2025 The reporter reported that a patient that received the first dose of Shingrix and reports that she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest and lower back and was still experiencing these events. The patient also reports that she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues. The patient reports that she is having a hard time talking. The patient went to the emergency room on 9-APR-2025, and they did a Cat Scan, Lung Scan, Lab Work, and Imaging (no further information provided), and did not find anything wrong with the patient. The patient was sent home the same day (unclear if ante meridiem or post meridiem), with pain medication to take every six hours (unknown product information). More
2836798 65 F MA 04/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Dizziness Dizziness
Dizzy spells; This non-serious case was reported by a consumer via call center representative and de... Dizzy spells; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizzy spells in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 04-APR-2025, the patient received Shingles vaccine (intramuscular, left deltoid) .5 ml. On 04-APR-2025, 4 hrs after receiving Shingles vaccine, the patient experienced dizzy spells (Verbatim: Dizzy spells). The outcome of the dizzy spells was not resolved. It was unknown if the reporter considered the dizzy spells to be related to Shingles vaccine. It was unknown if the company considered the dizzy spells to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-APR-2025 The reporter was a patient's husband. The reporter states that the patient started having intermittent episodes of dizziness approximately 4 hours after receiving suspect vaccine. Dizzy spells were ongoing, and patient was seeing her physician at the time of reporting. More
2836799 M MD 04/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
has not received his second dose.; This non-serious case was reported by a consumer via call center ... has not received his second dose.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 5 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not received his second dose.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 10-APR-2025 The case was self reported by patient. The patient who received his first dose of Shingrix about 5 years ago and had not received his second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2836800 M IN 04/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
sore arm; This non-serious case was reported by a consumer via call center representative and descri... sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 10-APR-2025 Reporter is the patient who stated that he experienced a sore arm with first dose of Shingrix, he received his first dose in his left arm. This case is linked with case US2025044420, reported by the same reporter.; Sender's Comments: US-GSK-US2025044420:same reporter More
2836801 F IN 04/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Dyspnoea, Fatigue, Feeling cold, Pain in extremity, Pruritus; Urticaria Dyspnoea, Fatigue, Feeling cold, Pain in extremity, Pruritus; Urticaria
sore arm; Feeling cold; Fatigue; hives on both arms; Itching; breathing heavy; This non-serious case... sore arm; Feeling cold; Fatigue; hives on both arms; Itching; breathing heavy; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included diclofenac sodium (Diclofenac), thyroid, cholesterol and cortisone acetate (Cortisone). In MAR-2025, the patient received the 1st dose of Shingrix. On 09-APR-2025, less than a month after receiving Shingrix, the patient experienced hives (Verbatim: hives on both arms), pruritus (Verbatim: Itching), labored respiration (Verbatim: breathing heavy) and fatigue (Verbatim: Fatigue). On an unknown date, the patient experienced pain in arm (Verbatim: sore arm) and feeling cold (Verbatim: Feeling cold). The outcome of the hives, pruritus, labored respiration and fatigue were not resolved and the outcome of the pain in arm was resolved and the outcome of the feeling cold was unknown. It was unknown if the reporter considered the hives, pruritus, labored respiration, pain in arm, fatigue and feeling cold to be related to Shingrix. It was unknown if the company considered the hives, pruritus, labored respiration, pain in arm, fatigue and feeling cold to be related to Shingrix. Additional Information: GSK Receipt Date: 10-APR-2025 The reporter is the patient's husband. He stated that the patient received her first dose of Shingrix about 2 or 3 weeks ago. She experienced a sore arm which went away. Yesterday, she developed hives on both her arms. She was also experiencing itching on her back. The reporter applied some cortisone cream to her back last night. The patient was also breathing heavy, has fatigue, and is feeling cold. This case was linked with case US2025044416 from the same reporter.; Sender's Comments: US-GSK-US2025044416:same reporter More
2836802 17 M IL 04/18/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Dd72h
Injection site nodule, Peripheral swelling, Wrong technique in product usage pro... Injection site nodule, Peripheral swelling, Wrong technique in product usage process More
site developed a knot; administered the vaccine with the air pocket in the prefilled syringe; Arm sw... site developed a knot; administered the vaccine with the air pocket in the prefilled syringe; Arm swelling; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site nodule in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number Dd72h) for prophylaxis. On 13-MAR-2025, the patient received Bexsero (left arm). On 13-MAR-2025, less than a day after receiving Bexsero, the patient experienced swelling arm (Verbatim: Arm swelling). On an unknown date, the patient experienced injection site nodule (Verbatim: site developed a knot) and wrong technique in product usage process (Verbatim: administered the vaccine with the air pocket in the prefilled syringe). The outcome of the injection site nodule, swelling arm and wrong technique in product usage process were unknown. It was unknown if the reporter considered the injection site nodule and wrong technique in product usage process to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The reporter considered the swelling arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site nodule and wrong technique in product usage process to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the swelling arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 07-APR-2025 Other HCP reported that they followed updated guidelines and administered the vaccine with the air pocket in the prefilled syringe, which led to wrong technique in product usage process. Reporter stated that right away the site developed a knot. More
2836803 04/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Feeling abnormal Feeling abnormal
made me feel bad; This non-serious case was reported by a consumer via interactive digital media and... made me feel bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: made me feel bad). The outcome of the feeling bad was not reported. It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine. It was unknown if the company considered the feeling bad to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-APR-2025 This case was reported by a patient via interactive digital media. The patient took first shot of Shingles vaccine and it made him/her feel bad. The patient reported he/she never got around to getting second one. The patient stated that they say if you get the vaccines and get shingles they would not be as bad. The patient stated only think they have one vaccine now. More
2836804 04/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Influenza Influenza
flu; This non-serious case was reported by a consumer via interactive digital media and described th... flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included varicella zoster vaccine (Patient had first dose on unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza (Verbatim: flu). The outcome of the influenza was not reported. It was unknown if the reporter considered the influenza to be related to Shingles vaccine. It was unknown if the company considered the influenza to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-APR-2025 This case was reported by a patient via interactive digital media. Reporter stated that their second shot was far worse than the first they thought they had the flu. More
2836805 04/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
My arm is sore but worth the light pain; This non-serious case was reported by a consumer via intera... My arm is sore but worth the light pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had a light case of shingles at 45 yrs old) and shingles (In July 2024 came down with severe case of Shingles). Previously administered products included Shingles vaccine (old probably 10 years ago got the Shingles vaccination). On 11-APR-2025, the patient received the 1st dose of Shingles vaccine. On 11-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: My arm is sore but worth the light pain). The outcome of the pain in arm was not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date 11-APR-2025 and 13-APR-2025 This case was reported by a patient via interactive digital media. The patient had a light case of shingles at 45 yrs old Probably 10 years ago got the Shingles vaccination. In July 2024 came down with severe case of Shingles. The reporter was not aware of new vaccination but believe him/her now. The patient got the first shot three days ago and arm was sore but worth the light pain. The reporter also reported he/she would get the second shot in 2 months. More
2836806 04/18/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspeceted vaccination failure; I had a mild case of shingles; This serious case was reported by a c... Suspeceted vaccination failure; I had a mild case of 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had a mild case of 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 11-APR-2025 This case was reported by a patient via interactive digital media. The patient reported he/she had two vaccines and physician said he/she had a mild case of shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). More
2836807 M 04/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
they never got their Second dose; This non-serious case was reported by a pharmacist via call center... they never got their 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 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received their First Shingrix dose on April, 2014). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: they never got their Second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date 14-APR-2025 Pharmacist reported that he/she had a couple of questions. So, he/she had a Patient that received their First Shingrix dose in April, 2014 and they never got their Second dose. Pharmacist wants to ask is ok to go ahead and take their second Dose now or not. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case has been had linked with US2025AMR046253,reported by the same reporter; Sender's Comments: US-GSK-US2025AMR046253: More
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