🏥 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 💀 🏥 🚑 ♿ ⚠️
2859682 32 M TX 09/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 B59DH
Device delivery system issue, Immediate post-injection reaction, Injection site ... Device delivery system issue, Immediate post-injection reaction, Injection site haematoma More
Hematoma formation immediately after injection with blood backflow in syringe. No aspiration perform... Hematoma formation immediately after injection with blood backflow in syringe. No aspiration performed per immunization administration standards. Pressure applied, bandage placed, no other adverse reactions noted. Patient did note has gotten larger flu shot localized reactions previously. Only with flu shots. More
2859683 65 F ID 09/18/2025 FLU3
 SANOFI PASTEUR
 U8800BA
Injection site erythema, Injection site induration, Injection site inflammation,... Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth More
Pt came back to pharmacy on 9/15, reporting large red area around injection site. Site was hot and f... Pt came back to pharmacy on 9/15, reporting large red area around injection site. Site was hot and firm to the touch. No attempts had been made to decrease inflammation (Benadryl, icepack...). recommended to pt to try both options, and to come back if there was no decrease, or of there was worsening symptoms. Pt has not reported back . More
2859684 65 M WI 09/18/2025 FLU3
 SANOFI PASTEUR
 U8800DA
Throat tightness Throat tightness
Patient states that he woke up morning after vaccine and throat felt like it was closing Patient states that he woke up morning after vaccine and throat felt like it was closing
2859685 7 M WA 09/18/2025 DTAP
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Daptacel given in error, patient is a year older than age range. NO adverse effects reported by par... Daptacel given in error, patient is a year older than age range. NO adverse effects reported by parent, and revaccination not recommended by manufacturer. More
2859686 55 F 09/18/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3t74x
Extra dose administered Extra dose administered
duplicate vaccine--we administered a 3rd unnecessary dose duplicate vaccine--we administered a 3rd unnecessary dose
2859687 80 F SC 09/18/2025 FLU3
HEP
PNC21
 SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
 u8859ba
946908
z003579
Arthralgia, Neck pain, Urticaria; Arthralgia, Neck pain, Urticaria; Arthralgia, ... Arthralgia, Neck pain, Urticaria; Arthralgia, Neck pain, Urticaria; Arthralgia, Neck pain, Urticaria More
patient woke up the day after the vaccine with pain in her neck and shoulder on the left side...2 da... patient woke up the day after the vaccine with pain in her neck and shoulder on the left side...2 days later she developed hives More
2859688 37 M FL 09/18/2025 COVID19
COVID19
 JANSSEN
PFIZER\BIONTECH

Condition aggravated, Depression, Hypertension; Condition aggravated, Depression... Condition aggravated, Depression, Hypertension; Condition aggravated, Depression, Hypertension More
Depression anxiety high blood pressure Depression anxiety high blood pressure
2859689 1.58 M CA 09/18/2025 PNC15
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Z005994
Z004246
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
The patient did not experience any adverse reactions. It was realized today as patient received his ... The patient did not experience any adverse reactions. It was realized today as patient received his vaccine that it was given in error and that he already did receive the fourth pneumococcal vaccine. The fourth dose was not transcribed into the chart. Also it was discovered today on a more detailed review of his records that the child did receive a varicella vaccine in error as well on a different date-given 8/21/2025. More
2859690 38 M TN 09/18/2025 COVID19
 PFIZER\BIONTECH
Infertility male, Palpitations Infertility male, Palpitations
Heart palpitations, fertility issues Heart palpitations, fertility issues
✓
2859691 60 M MI 09/18/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 5554G
Expired product administered Expired product administered
Patient given expired Influenza vaccination. Notified pharmacy. from drug information centerAccord... Patient given expired Influenza vaccination. Notified pharmacy. from drug information centerAccording to the CDC, the Vaccine Adverse Event Reporting System (VAERS) has noted that receiving expired flu vaccine does not pose additional risks for adverse events beyond those of appropriately dated vaccine. However, the potency of the vaccine may decline with time. Their recommendation is that any person who receives an expired influenza vaccine should be revaccinated with the current season?s influenza vaccine. Please be sure to remove any other expired vaccines from stock to prevent additional errors, and file an RL at your earliest convenience if not already reported. More
2859692 17 F MT 09/18/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 G334J
Injection site erythema, Local reaction Injection site erythema, Local reaction
Local Reaction, redness around injection site Local Reaction, redness around injection site
2859693 28 M TX 09/18/2025 COVID19
 JANSSEN
Atrial fibrillation, Cardiac ablation, Laboratory test, Pulmonary vein stenosis Atrial fibrillation, Cardiac ablation, Laboratory test, Pulmonary vein stenosis
I was diagnosed and treated for atrial fibrillation at emergency room. Further tests confirmed the ... I was diagnosed and treated for atrial fibrillation at emergency room. Further tests confirmed the condition. In 2023 I had a heart ablation done at Medical Center. After the heart ablation, I was diagnosed with pulmonary vein stenosis. More
✓
2859694 72 F CA 09/18/2025 COVID19
 MODERNA
 3052549
Blood blister, Contusion, Immediate post-injection reaction, Mouth haemorrhage, ... Blood blister, Contusion, Immediate post-injection reaction, Mouth haemorrhage, Stomatitis More
PATIENT HAD BIG BRUISES ALL OVER THE BODY, SAID GOT SORES RIGHT AFTER VACCINATION IN HER MOUTH AND W... PATIENT HAD BIG BRUISES ALL OVER THE BODY, SAID GOT SORES RIGHT AFTER VACCINATION IN HER MOUTH AND WHICH BURSTED AND NOW BLEEDING INSIDE MOUTH AND BLOOD CLOT ON LIPS More
2859695 44 M WA 09/18/2025 FLU3
 SEQIRUS, INC.
 948401
Dizziness, Nausea Dizziness, Nausea
Nausea and dizziness all day Nausea and dizziness all day
2859696 11 F AL 09/18/2025 HPV9
 MERCK & CO. INC.
 YO15760
Fall, Pallor Fall, Pallor
After receiving HPV vaccine pt fell back on to bed. No noted loss of consciousness. Pt was skin colo... After receiving HPV vaccine pt fell back on to bed. No noted loss of consciousness. Pt was skin color was pale. Pt was assisted up in a sitting position and given sips of water. Pt Vitals was checked noted to be WNL. Patient was observed for 20 min and was sent home. Parent advised to RTC if other symptoms arise....RN More
2859697 7 F VT 09/18/2025 DTAP
 SANOFI PASTEUR
 3CA11C1
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No reaction No reaction
2859698 21 M GA 09/18/2025 COVID19
 JANSSEN
Dyspnoea, Heart rate increased, Influenza like illness Dyspnoea, Heart rate increased, Influenza like illness
After shot I felt as though I got the flu. Ever since I?ve had shortness of breath and elevated hear... After shot I felt as though I got the flu. Ever since I?ve had shortness of breath and elevated heart rate from simple exercises. More
2859699 12 F MT 09/18/2025 HPV9
HPV9
MNQ
MNQ
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Z007396
Z007396
3E99M
3E99M
M77CC
M77CC
Anxiety, Hyperventilation, Hypoaesthesia, Pain in extremity, Panic attack; Parae... Anxiety, Hyperventilation, Hypoaesthesia, Pain in extremity, Panic attack; Paraesthesia, Pharyngeal swelling, Stridor; Anxiety, Hyperventilation, Hypoaesthesia, Pain in extremity, Panic attack; Paraesthesia, Pharyngeal swelling, Stridor; Anxiety, Hyperventilation, Hypoaesthesia, Pain in extremity, Panic attack; Paraesthesia, Pharyngeal swelling, Stridor More
Pt receiving vaccines during provider visit on this day. During well child visit/establishing care ... Pt receiving vaccines during provider visit on this day. During well child visit/establishing care appointment, dad reports patient allergies to bee stings/mosquito bites and pt uses epi-pen for reactions. Pt given 12 year old vaccines: Tdap, Men4, and HPV. Dad reports NKA. Vaccines given at 1635 back to back with RN on one side of patient. Roughly 1 minute after receiving HPV vaccine pt reports arm hurting so RN left room to get cold pack. Pt then started hyperventilating stating she was feeling tingly, so this writter yelled down the hall for RN to get pcp NP. O2 was given starting at 2 liters, while PCP gave verbal order for Methylprednisone 125mg injection to be given. Dr called 911 for ambulance. Methylprednisone 125mg was injected into Left arm at 1640. Vital signs were taken during this time. BP 114/71, HR 117. Patient was reporting feelings of numbness in face going down into arms, swelling in throat, and presented with small amounts of stridor during breaths. Fire truck and ambulance appeared to clinic around 1648 to do full assessment on patient. After assessing patient Paramedic determined that it was not an anaphylactic reaction and thought to be more of an anxiety/panic attack from vaccines. Gave parent of patient option to decide if he wanted pt to go to ER for further evaluation. Father denied trip to ER, EMS left, and patient reported feeling better at this time which was 1705. Pt was wheel chaired out of the facility to transportation. Advised dad to keep close eye on pt for remainder of the day. If pt began to experience difficulty breathing or felt like throat was swelling at home, report to ER. Dad states understanding. No other concerns. More
2859700 21 M CA 09/18/2025 COVID19
 PFIZER\BIONTECH
 EL 1283
Asthma, Dyspnoea, Magnetic resonance imaging thoracic abnormal, Pneumonia Asthma, Dyspnoea, Magnetic resonance imaging thoracic abnormal, Pneumonia
Contraction or Asthma, continual shortness of breath, pneumonia Contraction or Asthma, continual shortness of breath, pneumonia
2859701 65 F NC 09/18/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052030
407257
Anaphylaxis treatment, Dyspnoea, Loss of consciousness, Resuscitation; Anaphylax... Anaphylaxis treatment, Dyspnoea, Loss of consciousness, Resuscitation; Anaphylaxis treatment, Dyspnoea, Loss of consciousness, Resuscitation More
Patient after leaving the immunization room, came back and told the pharmacist that they could not b... Patient after leaving the immunization room, came back and told the pharmacist that they could not breathe. As soon as the patient sat down per the pharmacist's instructions the patient passed out. The pharmacist administered epinephrine and started chest compressions. More
2859702 53 F MO 09/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 NR4T5
NR4T5
Axillary mass, Erythema, Haemorrhage, Immediate post-injection reaction, Indurat... Axillary mass, Erythema, Haemorrhage, Immediate post-injection reaction, Induration; Injection site pain, Pain in extremity, Pyrexia More
Bleeding immediately after vaccine (administered Thursday morning), redness, arm sore, and 103 fever... Bleeding immediately after vaccine (administered Thursday morning), redness, arm sore, and 103 fever within a few hours of injection . Patient went to Dr on Tuesday had appointment scheduled and was prescribed 10 day course of Keflex 500 q6h-patient states Dr. said lump under arm and surrounding area felt hard like a turtle shell - treatment took care of issues- patient still today has tenderness at injection site but lump is gone More
2859703 3 F NY 09/18/2025 MMR
 MERCK & CO. INC.
Agitation, Discomfort, Pruritus, Urticaria Agitation, Discomfort, Pruritus, Urticaria
Patient developed a widespread outbreak of hives, beginning at her chin and extending down to her hi... Patient developed a widespread outbreak of hives, beginning at her chin and extending down to her hips, affecting her stomach and back. She was extremely itchy, uncomfortable, and highly agitated, which prompted us to take her to the doctor for evaluation. The physician explained that it is not possible to confirm with certainty whether the reaction was caused by the MMR vaccine. However, patient had no unusual exposures that day?she consumed her typical foods and had no contact with new products or allergens. The only new factor was the MMR vaccine, which she received within the timeframe during which the doctor noted a reaction could potentially occur. More
2859704 84 M GA 09/18/2025 UNK
 UNKNOWN MANUFACTURER
Pain in extremity Pain in extremity
Vaccination in left arm. Next day pain in right thigh Vaccination in left arm. Next day pain in right thigh
2859705 4 F WA 09/18/2025 CHIK
MMRV
 BAVARIAN NORDIC
MERCK & CO. INC.
 U8209CB
Z008222
Erythema, Skin warm, Swelling, Tenderness, Wound; Erythema, Skin warm, Swelling,... Erythema, Skin warm, Swelling, Tenderness, Wound; Erythema, Skin warm, Swelling, Tenderness, Wound More
Redness, swelling, Hot to touch 5x5cm round erythematous. Puncture wound in the middle. Tender... Redness, swelling, Hot to touch 5x5cm round erythematous. Puncture wound in the middle. Tender to palpation More
2859706 65 F FL 09/18/2025 PNC20
 PFIZER\WYETH
 MA2502
Injection site swelling Injection site swelling
Patient presented to pharmacy on 9/18/25 complaining of swollen injection site Patient presented to pharmacy on 9/18/25 complaining of swollen injection site
2859707 0.33 F MI 09/18/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 u7829aa
Extra dose administered, No adverse event, Wrong product administered Extra dose administered, No adverse event, Wrong product administered
Vaxelis was given and the vaccine that was supposed to be given was Pentacel instead. Patient ended ... Vaxelis was given and the vaccine that was supposed to be given was Pentacel instead. Patient ended up with an extra hepatitis B due to this error. There was no adverse event reported. Staff noticed the error at the end of the day. Provider was notified and no treatment was needed. More
2859708 31 M TN 09/18/2025 COVID19
 PFIZER\BIONTECH
Cardiovascular symptom, Impaired driving ability Cardiovascular symptom, Impaired driving ability
Following my second dose of the COVID-19 vaccine, while driving to work I began experiencing symptom... Following my second dose of the COVID-19 vaccine, while driving to work I began experiencing symptoms that made me feel as though I was having a heart attack. I had to pull over and call an ambulance. I was evaluated and released with instructions to follow up with my doctor and/or the emergency department More
2859709 32 M TX 09/18/2025 COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
 1805020
1805020
1805020
Dyspnoea, Heart rate increased, Impaired work ability, Inflammation, Laboratory ... Dyspnoea, Heart rate increased, Impaired work ability, Inflammation, Laboratory test; Mobility decreased, Multisystem inflammatory syndrome, Pain, Respiratory disorder, Respiratory tract infection; Sinusitis, Supraventricular tachycardia, Tinnitus, Upper respiratory tract infection More
On January 1st 2022, I got a severe respiratory infection and since then have had some form of sinus... On January 1st 2022, I got a severe respiratory infection and since then have had some form of sinus or upper respiratory infection at least once every 90 days for the last 3 1/2 years. On May 26, 2024 I was admitted to the ER due to a Supraventricular Tachycardia. I was subsequently out of work for 2+ months due to inflammation that would change locations daily and was so painful that I spent the majority of time in bed. I was seen by Cardiology and Rheumatology over the course of the next year and a diagnosis or reason could not be determined. Though no diagnosis has been made, I still suffer from shortness of breath, tinitus of both ears, a higher resting heart rate than previously and random bouts of multisystem inflammation and respiratory illness. More
✓
2859710 29 F NC 09/18/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SEQIRUS, INC.
SEQIRUS, INC.
 3052550
3052550
407000
407000
Asthenia, Dizziness, Hyperhidrosis, Nausea, Syncope; Vertigo; Asthenia, Dizzines... Asthenia, Dizziness, Hyperhidrosis, Nausea, Syncope; Vertigo; Asthenia, Dizziness, Hyperhidrosis, Nausea, Syncope; Vertigo More
3 minutes after receiving injections, I started feeling nauseous. Within a few more seconds felt diz... 3 minutes after receiving injections, I started feeling nauseous. Within a few more seconds felt dizzy. Grabbed onto something and then fainted. During the fainting, everything was spinning around and I felt extremely weak. I didn?t fall or black out completely but I definitely fainted and would have fallen if I hadn?t grabbed onto something. After a minute of this fainting spell, I slowly went to a chair and sat for another few minutes. My body was all sweaty. Within a few more minutes I felt fine enough to drive home. More
2859711 86 F MT 09/18/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 5h777
5h777
Chills, Erythema, Injection site erythema, Injection site swelling, Limb discomf... Chills, Erythema, Injection site erythema, Injection site swelling, Limb discomfort; Peripheral swelling, Pyrexia More
Patient received the RSV vaccination on Monday 9/15 and didn't notice any issues. She stated on... Patient received the RSV vaccination on Monday 9/15 and didn't notice any issues. She stated on Tuesday 9/16 she had common side effects such as fever and chills. Then Wednesday 9/17 she reported that her whole right arm was swollen and red from the injection site down and is still that way after 24 hours. Patient stated it does not hurt it is just uncomfortable and seemed to be in okay spirits. More
2859712 78 F WA 09/18/2025 RSV
 PFIZER\WYETH
 LG9828
Injection site erythema, Injection site nodule Injection site erythema, Injection site nodule
Erythematous Nodule 2-3mm in diameter on left upper mid lateral arm. Not in the same spot as the inj... Erythematous Nodule 2-3mm in diameter on left upper mid lateral arm. Not in the same spot as the injection was given. More
2859713 28 F NE 09/18/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 H4K3S
Anaphylaxis treatment, Endotracheal intubation, Rash, Somnolence Anaphylaxis treatment, Endotracheal intubation, Rash, Somnolence
Tdap given at 1041, symptoms of rash to chest started around 1050. 911 called. Epipen given. Oxygen ... Tdap given at 1041, symptoms of rash to chest started around 1050. 911 called. Epipen given. Oxygen applied. Patient began to be more sleepy, second dose of Epipen given. Patient was taken to outside hospital by EMS. From limited view of outside hospital medication records, patient required intubation at outside hospital related to reaction. More
✓ ✓
2859714 28 M VA 09/18/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EN6199
EN6199
Biopsy skin abnormal, Dermatitis atopic, Eczema, Emotional distress, Phototherap... Biopsy skin abnormal, Dermatitis atopic, Eczema, Emotional distress, Phototherapy; Quality of life decreased, Rash More
I broke out with a rash within days of receiving the first shot and it became uncontrollable. I was ... I broke out with a rash within days of receiving the first shot and it became uncontrollable. I was first seen for medical help on 3/24/21 and eventually was elevated up to see a dermatologist regularly. I was forced to receive the second dose of Pfizer on 3/25/21 and the lot# was ER8730. I have been on multiple biologics, oral and subcutaneous steroids, phototherapy, and the latest being JAK inhibitors. It has been nonstop since the first shot and has cost me much of my quality of life and destroyed my mental health. More
✓
2859715 40 M AL 09/18/2025 COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
 1855191
1855191
1855191
Adverse drug reaction, Biopsy skin abnormal, COVID-19, Chest pain, Contusion; Im... Adverse drug reaction, Biopsy skin abnormal, COVID-19, Chest pain, Contusion; Immune system disorder, Impaired work ability, Rash, Rash macular, Skin discolouration; Tenderness More
Rash with tiny red spots that began inner thighs, then spread out over entire body until everything ... Rash with tiny red spots that began inner thighs, then spread out over entire body until everything but the face was covered over roughly 4 week period of time. Rash looked like mini sized chickenpox, just much closer together red bumps with discoloration of the skin even looking purple and bruised in large areas. (Photos are available). PCM continued to brush off, accuse of taking something that was causing a reaction yet no other medications or supplements had been taken other than vaccinations given. Healthy otherwise on vegetarian diet, non-smoker, non-drinker, no supplements or medications whatsoever. Even careful not to eat poppy seed food items. Was recommended by PCM cortisone cream, motrin, and prescriptions from the doctor that did not do anything to give relief. After multiple non-productive visits to the PCM, was sent to see dermatologist and she did a biopsy in 2 areas, sent out that came back confirming "drug reaction". Lasted total time roughly 4-6 weeks start to finish visibly. Never got actual help, just brushed off even after confirmed drug reaction was confirmed from the biopsy. Ended up having to be off work as it was painful to the touch, clothing was very uncomfortable. Could not work out, could not do everyday activities, did not go into work. Missed 4x as much work from this vaccine reaction than was lost from being sick with covid itself over christmas. More
2859716 66 F CA 09/18/2025 FLU3
 SANOFI PASTEUR
 U8855AA
Anaphylactic reaction, Dyspnoea, Pharyngeal swelling Anaphylactic reaction, Dyspnoea, Pharyngeal swelling
Anaphylactic reaction. Could not breathe, throat swelling. Anaphylactic reaction. Could not breathe, throat swelling.
2859717 71 F ID 09/18/2025 COVID19
FLU3
PNC21
 PFIZER\BIONTECH
SANOFI PASTEUR
MERCK & CO. INC.
 MY9547
U8800BA
Z006889
Injection site oedema, Injection site pain, Injection site rash; Injection site ... Injection site oedema, Injection site pain, Injection site rash; Injection site oedema, Injection site pain, Injection site rash; Injection site oedema, Injection site pain, Injection site rash More
Edema, rash, and pain starting just below the vaccine site to just above the elbow. Patient was inst... Edema, rash, and pain starting just below the vaccine site to just above the elbow. Patient was instructed to ice the arm, take benadryl and zyrtec and if no improvement in 24 hours she was instructed to call her primary care provider or if worsening of symptoms to seek urgent medical treatment. More
2859752 F SC 09/18/2025 PNC21
 MERCK & CO. INC.
 Z004301
Injection site reaction, Rash erythematous Injection site reaction, Rash erythematous
Injection site erythema; Injection site rash; Information has been received from FDA (agency #284389... Injection site erythema; Injection site rash; Information has been received from FDA (agency #2843894-1) and refers to a 69-year-old female patient. The patient's medical history included history of malignant neoplasm of breast. The patient's concurrent conditions included allergic rhinitis, cervical spondylosis, gastroesophageal reflux disease without esophagitis, hyperlipidemia, hypertension with disorder of left retina, hypertension with disorder of left retina, hypertensive heart disease without congestive heart failure, long-term drug therapy, neck pain, obese, class II osteopenia, polyp of nasal sinus, sleep apnea, vitamin D deficiency, and albuterol, lisinopril, Motrin allergy. Concomitant medications included Cephalexin (Cefalexin), Fluticasone propionate (Fluticasone propionate), Klor-con m10 (Potassium chloride), 2.5 mg Letrozole (Letrozole), Losartan potassium and hydrochlorothiazide (Hydrochlorothiazide;Losartan potassium), Metoprolol tartrate (Metoprolol tartrate), 10 mg Montelukast (Montelukast sodium), Potassium chloride (Potassium chloride), 10 mg Pravastatin (Pravastatin sodium), Tylenol (Paracetamol), 5000 IU Vitamin d3 (Colecalciferol), Zyrtec (Cetirizine hydrochloride) . On 27-May-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Solution for injection (lot #Z004301, expiration date: 07-Sep-2026), dose number 1, administered by Intramuscular route in Left Arm for an unknown indication. On 02-JUN-2025, the patient's entire upper left arm has a redness rash down to the elbow. On 03-Jun-2025, the patient experienced Injection site rash. On 03-Jun-2025, the patient experienced Injection site erythema. At the reporting time, the outcome of Injection site rash and Injection site erythema was unknown. The causal relationship between the event of injection site erythema and injection site rash and Pneumococcal 21-valent Conjugate Vaccine was not provided. More
2859753 MA 09/18/2025 HPV4
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Circumstance or information capable of leading to medication error, Inappropriat... Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration, No adverse event; Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration, No adverse event More
no adverse event; inappropriate schedule of vaccine administration; in May 2024, I received my first... no adverse event; inappropriate schedule of vaccine administration; in May 2024, I received my first dose of Gardasil 4. Due to personal circumstances, I was unable to follow the recommended schedule. On August 26, 2025, I received a dose of Gardasil 9; This spontaneous report was received from a consumer patient of unknown age and gender and refers to themself. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. In May 2024, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), Suspension for injection, dose number 1, (indication, expiration date, and lot # were not reported). Due to personal circumstances, the patient was unable to follow the recommended schedule. On 26-Aug-2025, the patient received second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) (interchange of vaccine products; inappropriate schedule of vaccine administration), Suspension for injection, dose number 2, (indication, expiration date, and lot # were not reported). The patient asked for advice how to proceed. Should one additional dose be received in 6 months to complete the series, or, since the initial Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) dose was more than one year ago, should the patient restart a full 3-dose Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) schedule beginning from today? No adverse event was reported. More
2859754 17 F TX 09/18/2025 HPV9
 MERCK & CO. INC.
 Y015179
No adverse event, Product storage error No adverse event, Product storage error
patient did not experience any adverse issues or reactions from the administered vaccine and no othe... patient did not experience any adverse issues or reactions from the administered vaccine and no other information was able to be provided; TE for GARDASIL 9 that took place on 07/08/2025 as well as 08/20/2025 and was inadvertently administered on 08/21/2025; This spontaneous report was received from a medical assistant and refers to a 17-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Aug-2025 and on 20-Aug-2025, temperature excursion for Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) took place was inadvertently administered on 21-Aug-2025, when the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), (lot #Y015179, expiration date: 28-Jan-2027) (0.5mL / once) for prophylaxis (improper storage of product in use). The patient did not experience any adverse issues or reactions from the administered vaccine and no other information was able to be provided (no adverse event). More
2859755 10 F TX 09/18/2025 HPV9
 MERCK & CO. INC.
 Y015179
No adverse event, Product storage error No adverse event, Product storage error
the patient did not experience any adverse issues or reactions from the administered vaccine; a TE f... the patient did not experience any adverse issues or reactions from the administered vaccine; a TE for GARDASIL 9 that took place on 07/08/2025 as well as 08/20/2025 and was inadvertently administered on 08/25/2025.; This spontaneous report was received from a medical assistant and refers to a 10-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JUL-2025, human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) lot #Y015179 underwent temperature excursion (47.3 F for 50 minutes 20 seconds). On 20-AUG-2025, the vaccine underwent another temperature excursion (46.4 F for 25 minutes 50 seconds). On 25-AUG-2025, the patient was inadvertently vaccinated with improperly stored human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection at a total dose of 0.5 mL, lot #Y015179, expiration date: 28-JAN-2027, administered for prophylaxis (route of administration and anatomical location were not reported) (Product storage error). The patient did not experience any adverse issues or reactions from the administered vaccine. This is one of several reports received from the same reporter. More
2859756 65 M CA 09/18/2025 MEN
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 U8493A A
No adverse event, Product preparation error, Wrong product administered; No adve... No adverse event, Product preparation error, Wrong product administered; No adverse event, Product preparation error, Wrong product administered More
No adverse event; Was supposed to receive MMR instead using correct diluent, was reconstitued with M... No adverse event; Was supposed to receive MMR instead using correct diluent, was reconstitued with Menquadfi; Wrong product administered; This spontaneous report was received from an Other-health professional and refers to a 65-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 05-Aug-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (M-M-R) vaccine (manufacturer unknown) (lot #, expiration date, strength, dose number, anatomical location not provided); which was supposed to be reconstituted with sterile diluent; however, it was reconstituted with Meningococcal vaccine A/C/Y/W conj (tet tox) (MENQUADFI) Solution for injection (lot #U8493A A, expiration date: 31-May-2028) (wrong diluent used), and was administered intramuscular as prophylactic vaccination. The patient was not supposed to get Meningococcal vaccine A/C/Y/W conj (tet tox) (MENQUADFI) at all (wrong product administered). No reported adverse events.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : Index date : 2025-09-03 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : GS / 2025SA229864 , Central date : 2025-09-03 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2859757 09/18/2025 HEP
RV5
 MERCK & CO. INC.
MERCK & CO. INC.
 z004729
Z004726
No adverse event, Product lot number issue, Wrong product administered; No adver... No adverse event, Product lot number issue, Wrong product administered; No adverse event, Product lot number issue, Wrong product administered More
wrong vaccine; No additional AE; Product lot number issue; This spontaneous report has been received... wrong vaccine; No additional AE; Product lot number issue; This spontaneous report has been received from a pharmacist, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On an unknown date, the patient was vaccine with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Z004726, expiration date: 31-Oct-2026) or Hepatitis B Vaccine (Recombinant) (lot number z004729, expiration date) On an unknown date, the patient started therapy with Hepatitis B Vaccine (Recombinant) (lot #z004729) (expiration date ), both as prophylaxis, also it was reported a possible PQC, it was reported that lot #z004726 which was documented 70 times as administered doses for RECOMBIVAX HB, this agency placed the HCP on hold and caller with employee who stated lot# z004726 was associated with ROTATEQ and not RECOMBIVAX HB. The employee said he was unable to provide or confirm the NDC number for lot z004726 though so the NDC number was still unknown. The caller was informed the lot # z004726 was for ROTATEQ and the caller then provided additional details saying he had doses of RECOMBIVAX HB with the lot #z004729, but that he doesn't suspect this was user error as the lot #z004726. (Wrong product administered, Product lot number issue). No additional adverse events were reported in the patient. This case was determined to be non-valid due to the lack of patient identifiers.; Sender's Comments: Priority : 5 , Is case serious : No , number : 02864013-02863993 , number : , number : , number : 500UW00000k5Y55YAE|29082025170007|3316 , Central date : 2025-08-29 , Classification : , Attachment description : Call , Safety case number : , case number : 02864013 , interaction number : 02863993 , Integration log UniqueID : 500UW00000k5Y55YAE|29082025170007|3316 , Service cloud CaseID : 500UW00000k5Y55YAE More
2859758 09/18/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Malaise, Pulmonary oedema, Upper respiratory tract infection Malaise, Pulmonary oedema, Upper respiratory tract infection
fluid in the lungs a week after getting the shot; The vaccine made me very sick; upper respiratory I... fluid in the lungs a week after getting the shot; The vaccine made me very sick; upper respiratory Infection; This serious case was reported by a consumer via interactive digital media and described the occurrence of pulmonary edema in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, 1 week after receiving RSV vaccine, the patient experienced pulmonary edema (Verbatim: fluid in the lungs a week after getting the shot) (serious criteria GSK medically significant), sickness (Verbatim: The vaccine made me very sick) and upper respiratory tract infection (Verbatim: upper respiratory Infection). The outcome of the pulmonary edema, sickness and upper respiratory tract infection were not reported. It was unknown if the reporter considered the pulmonary edema and upper respiratory tract infection to be related to RSV vaccine. The reporter considered the sickness to be related to RSV vaccine. The company considered the pulmonary edema to be unrelated to RSV vaccine. The company considered the sickness to be related to RSV vaccine. It was unknown if the company considered the upper respiratory tract infection to be related to RSV vaccine. Additional Information: GSK receipt date: 04-SEP-2025 This case was reported by a patient via interactive digital media. The vaccine made the patient very sick. The patient got an upper respiratory Infection and fluid in the lungs a week after getting the shot.; Sender's Comments: A case of Pulmonary oedema, 1 week after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2859759 8 M TX 09/18/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 cd44A
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
reports that yesterday an 8 year old patient received Bexsero.; This non-serious case was reported b... reports that yesterday an 8 year old patient received Bexsero.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received Men B NVS (Bexsero) (batch number cd44A, expiry date 31-AUG-2028) for prophylaxis. On 11-SEP-2025, the patient received Bexsero (intramuscular, left arm). On 11-SEP-2025, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: reports that yesterday an 8 year old patient received Bexsero.). The outcome of the inappropriate age at vaccine administration 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: 12-SEP-2025 The reporter was a medical assistant from a children clinic. The reporter reported that on 11st September 2025 an 8 year old patient received Bexsero which led to inappropriate age at vaccine administration. More
2859760 09/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Hypoaesthesia, Pain Hypoaesthesia, Pain
Pain for entire month; Foot and toes are numb/ When I try to walk a bit my whole leg goes numb; This... Pain for entire month; Foot and toes are numb/ When I try to walk a bit my whole leg goes numb; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: Pain for entire month) and numbness in leg (Verbatim: Foot and toes are numb/ When I try to walk a bit my whole leg goes numb). The outcome of the pain was resolved and the outcome of the numbness in leg was not reported. It was unknown if the reporter considered the pain and numbness in leg to be related to Herpes Zoster vaccine. It was unknown if the company considered the pain and numbness in leg to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 20-AUG-2025 This case was reported by a patient via interactive digital media. Patient had been in pain for an entire month. Patient's foot and toes were numb. When patient try to walk his/her whole leg goes numb. More
2859761 09/18/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Incomplete course of vaccination Incomplete course of vaccination
had a shingles shot in 2019 and did not receive the second dose; This non-serious case was reported ... had a shingles shot in 2019 and did not receive the 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 patient who did not receive Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (1st dose received in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. The patient experienced incomplete course of vaccination (Verbatim: had a shingles shot in 2019 and did not receive the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 28-AUG-2025 The patient received the Shingles shot in 2019 and wanted to know if the second dose is required. The patient did not receive the second dose till the time of reporting which led to incomplete course of vaccination. More
2859762 09/18/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Chronic obstructive pulmonary disease, Dyspnoea Chronic obstructive pulmonary disease, Dyspnoea
diagnosed after the shot with copd/trouble taking deep breaths; This non-serious case was reported b... diagnosed after the shot with copd/trouble taking deep breaths; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chronic obstructive pulmonary disease in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced chronic obstructive pulmonary disease (Verbatim: diagnosed after the shot with copd/trouble taking deep breaths). The patient was treated with salbutamol (Albuterol). The outcome of the chronic obstructive pulmonary disease was not resolved. It was unknown if the reporter considered the chronic obstructive pulmonary disease to be related to RSV vaccine. It was unknown if the company considered the chronic obstructive pulmonary disease to be related to RSV vaccine. Additional Information: GSK Receipt Date: 03-SEP-2025 This case was reported by a patient via interactive digital media. The patient had the RSV shot and thought that he/she still got Respiratory syncytial virus infection (RSV). The patient had trouble taking deep breaths and was diagnosed after the shot with chronic obstructive pulmonary disease (COPD) The patient was now using albuterol nebulizer. More
2859763 09/18/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; I too got shingles again, after both the vaccines; This serious case... Suspected vaccination failure; I too got shingles again, after both the vaccines; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I too got shingles again, after both the vaccines). 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: 05-SEP-2025 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. This case is linked with US2025AMR115068 reported by same reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine and Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR115068:Original Case Number : US2025AMR115053 More
2859764 09/18/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; had the two shots, and currently have shingles, have three small dots... Suspected vaccination failure; had the two shots, and currently have shingles, have three small dots and taking a antiviral, very mild; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the two shots, and currently have shingles, have three small dots and taking a antiviral, very mild). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 08-SEP-2025 This case was reported by a patient via interactive digital media. Patient indicated that shots worked in his/her opinion.; Sender's Comments: A case of Vaccination failure, unknown time after receiving 2nd dose of Shingles vaccine and 1st dose of Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2859765 F 09/18/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; I got 2 vaccines, and I still got them; This serious case was reporte... Suspected vaccination failure; I got 2 vaccines, and I still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got 2 vaccines, and I still got them). 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 Shingrix and Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 14-SEP-2025 This case was reported by a patient via interactive digital media. Consumer reported that got 2 vaccines and still got them. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Herpes zoster, less than a day after receiving Shingrix (Dose 1 and Dose 2) in a female patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
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