🏥 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 💀 🏥 🚑 ♿ ⚠️
1928069 55 M 12/07/2021 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH





Blindness, Headache, Magnetic resonance imaging, Magnetic resonance imaging head... Blindness, Headache, Magnetic resonance imaging, Magnetic resonance imaging head, Neck pain; Tinnitus, Vision blurred; Heat illness, Hypoaesthesia, Paraesthesia; Heat illness, Hypoaesthesia, Paraesthesia; Heat illness, Hypoaesthesia, Paraesthesia; Heat illness, Hypoaesthesia, Paraesthesia More
has been experiencing lost vision on one eye; ringing of his left ear; major pain on the top of his ... has been experiencing lost vision on one eye; ringing of his left ear; major pain on the top of his head and back of the neck; blurring of vision all the time; major pain on the top of his head and back of the neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 55 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS (medically significant) with onset 2021, outcome "not recovered", described as "has been experiencing lost vision on one eye"; TINNITUS (medically significant) with onset 2021, outcome "not recovered", described as "ringing of his left ear"; HEADACHE (medically significant), NECK PAIN (medically significant) all with onset 2021, outcome "not recovered" and all described as "major pain on the top of his head and back of the neck"; VISION BLURRED (medically significant) with onset 2021, outcome "not recovered", described as "blurring of vision all the time". The events "has been experiencing lost vision on one eye", "ringing of his left ear", "major pain on the top of his head and back of the neck", "blurring of vision all the time" and "major pain on the top of his head and back of the neck" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (2021) unknown results, notes: undergone an MRI for his eye and brain; magnetic resonance imaging head: (2021) unknown results, notes: undergone an MRI for his eye and brain. Therapeutic measures were taken as a result of blindness, tinnitus, headache, vision blurred, neck pain. Additional information: Treatment received with prednisone, benadryl, codeine and morphine. The lot number for bnt162b2 was not provided and will be requested during follow up. More
2854232 5 M MI 08/14/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 5c79n
z003311
Injection site rash; Injection site rash Injection site rash; Injection site rash
noticed rash formation around sub q injection about 19 to 20 hours after vaccination that has not go... noticed rash formation around sub q injection about 19 to 20 hours after vaccination that has not gotten worse nor better on day 4 post vaccine per email with online tele doc waiting to see if if subsides by day five if not schedule of apt will be needed to access more More
2854233 0.17 F NC 08/14/2025 RV5
 MERCK & CO. INC.
Abdominal pain upper, Haematochezia, Ultrasound abdomen normal, X-ray Abdominal pain upper, Haematochezia, Ultrasound abdomen normal, X-ray
Baby has stomach pain, with blood in her stool. She was in the ER twice first time and ultrasound wa... Baby has stomach pain, with blood in her stool. She was in the ER twice first time and ultrasound was conducted to rule out intussusception. On August 13 she was seen in her doctor office and she was concerned and sent us to the ER again. At that time an XRay was conducted. No findings. We dont know the outcome yet More
2854234 23 M ID 08/14/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 PL3183
PL3183
Bone pain, Brain fog, Dyspnoea, Feeling of body temperature change, Hyperhidrosi... Bone pain, Brain fog, Dyspnoea, Feeling of body temperature change, Hyperhidrosis; Malaise, Pyrexia, Vomiting More
the day after the covid vaccine injection, the next day I was extremely sick with the total time bei... the day after the covid vaccine injection, the next day I was extremely sick with the total time being 29 days. 7 of the first days was extremely hard to breathe, fever between 99-104 for the 7 days, hot and cold sweats all day long, little to no sleep, the first 3 days zero food consumption and little to no water, everything kept being thrown up, extreme brain flogged. from day 7-29 extremely sick still but fever was more on and off could hold down food. Extreme amount of bone pain, within knuckles and joints for the whole duration. More
2854235 23 M ID 08/14/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 301308A
301308A
Arthralgia, Asthenia, Cold sweat, Hot flush, Malaise; Nausea, Pyrexia, Sleep dis... Arthralgia, Asthenia, Cold sweat, Hot flush, Malaise; Nausea, Pyrexia, Sleep disorder, Vomiting More
Was extremely sick from the prior vaccine that I've made a previous report on that lasted the e... Was extremely sick from the prior vaccine that I've made a previous report on that lasted the entire time. I then had to receive this vaccine, which made my fever go back to 99-104 for 5 days, during the first 3 days of this Second round of vaccine I could not hold down any food and barely any water, Extreme cold sweats and hot flashes very little sleep. then for the following 16 days I was very sick with extreme joint pain that still was persisting from the prior vaccine into this vaccine, as well as just overall health feeling sick nauseous, very low and reduced energy. Basically, after getting this vaccine, I got extremely sick, as well as the first round of vaccine making me extremely sick as well. More
2854236 19 F GA 08/14/2025 PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 HM0312
HM0312
HM0312
Aphasia, Blood potassium decreased, Chest X-ray, Computerised tomogram head, Ele... Aphasia, Blood potassium decreased, Chest X-ray, Computerised tomogram head, Electroencephalogram normal; Hypersensitivity, Hypoaesthesia, Magnetic resonance imaging normal, Paraesthesia, Paraesthesia oral; White blood cell count increased More
Received call from patient's mother stating patient started having symptoms of an allergic reac... Received call from patient's mother stating patient started having symptoms of an allergic reaction to vaccine around 5 PM on 08/12/25. The symptoms started as right arm tingling and numbess and quickly progressed to right eye tingling, tingling on the right upper and lower lips, and asphasia. Patient was transported to local emergency department by mother and arrived around 5:37 PM. A neurological evaluation was completed, as well as chest x-ray and head CT scan. Patient was given two baby aspirins. Results were normal per mother. Patient was then transported to hospital for MRI and additional testing. Per mother, patient had MRI and EEG, which were both normal. Mother states lab work revealed low potassium and WBC of 12.6. Patient received oral potassium. Symptoms slowly improved and completely resolved around 2 AM on 08/13/25. Patient received a normal neurological evaluation before discharge on 08/13/25 around 5 PM. More
2854237 27 M TX 08/14/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EP7533
EP7533
EW0161
EW0161
33063BD
33063BD
Antibody test positive, Deep vein thrombosis, Depression, Hypercoagulation, Post... Antibody test positive, Deep vein thrombosis, Depression, Hypercoagulation, Post-traumatic stress disorder; Pulmonary embolism; Antibody test positive, Deep vein thrombosis, Depression, Hypercoagulation, Post-traumatic stress disorder; Pulmonary embolism; Antibody test positive, Deep vein thrombosis, Depression, Hypercoagulation, Post-traumatic stress disorder; Pulmonary embolism More
Multiple severe DVTs, consecutive bilateral PEs, enrichment taken from life, debt and depression. PT... Multiple severe DVTs, consecutive bilateral PEs, enrichment taken from life, debt and depression. PTSD from painful blood thinning injections. More
✓
2854241 2 M UT 08/14/2025 MMR
 MERCK & CO. INC.
 Y01910B
Pain in extremity, Pyrexia Pain in extremity, Pyrexia
Fever of 101, leg pain Fever of 101, leg pain
2854243 12 F PA 08/14/2025 HPV9
 MERCK & CO. INC.
 Y015180
Product storage error Product storage error
POWER OUTAGE RESULTING IN IMMUNIZATION FRIDGE TEMPERATURE TO GO OUT OF RANGE POWER OUTAGE RESULTING IN IMMUNIZATION FRIDGE TEMPERATURE TO GO OUT OF RANGE
2854244 2.83 M PA 08/14/2025 DTAP
HEPA
HIBV
PNC20
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
 3CA25C1
H3N97
UK208AA
LJ5282
Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error More
Power outage resulting in immunization fridge temp. to go out of range. Power outage resulting in immunization fridge temp. to go out of range.
2854245 16 F PA 08/14/2025 MMR
PNC20
 MERCK & CO. INC.
PFIZER\WYETH
 Y011637
LJ5282
Product storage error; Product storage error Product storage error; Product storage error
Power outage resulting in immunizations fridge temp. to go out of range. Power outage resulting in immunizations fridge temp. to go out of range.
2854246 78 M FL 08/14/2025 COVID19
 MODERNA
Asthenia, Cardiac ventricular thrombosis, Catheterisation cardiac abnormal, Coug... Asthenia, Cardiac ventricular thrombosis, Catheterisation cardiac abnormal, Cough, Myocardial infarction More
STARTED with cough then weakness across my whole body 5-25-22 - Heart attack with 3 Blood Clots foun... STARTED with cough then weakness across my whole body 5-25-22 - Heart attack with 3 Blood Clots found. More
✓
2854427 F GA 08/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3J252
Blood test, Chest pain, Computerised tomogram thorax, Electrocardiogram Blood test, Chest pain, Computerised tomogram thorax, Electrocardiogram
Chest pain moving to left Arm Chest pain moving to left Arm
✓
2854429 18 F NY 08/14/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 K7JY3
Arthralgia, Myalgia, Pain, Product administered at inappropriate site Arthralgia, Myalgia, Pain, Product administered at inappropriate site
Bexsero was placed on 8/8/2025, pt started with symptoms 48 hrs later left shoulder joint and muscul... Bexsero was placed on 8/8/2025, pt started with symptoms 48 hrs later left shoulder joint and muscular pain, mom reported to the office on 8/11/2025 Per mom. Received Men B #2 on 8/8/25. Feels the injection was given "extremely high in her arm, almost to her shoulder." Had localized muscle pain that is almost gone. Complains that it hurts to move her shoulder "laterally and backwards." Hurts "in the shoulder joint." Not requesting an appt but instead wondering if this is normal since the injection was given higher?No localized redness or swelling. Well otherwise. Advised to monitor and Call in 3-4 days if pain persisting " Several attempts to get a progress Report on pt with No response from family 8/12/2025, 8/13/13/2025, finally 8/14/2025 pt's mom called back, pt was still having shoulder joint pain. Appointment given for pt to be evaluated in the office. Provider feels the Shoulder joint pain could be related to the vaccine. NO lump, no redness, or puncture mark present to confirm vaccine placement. Patient was given Naproxen Rx for discomfort and referral for Orthopedics for an ASAP appt. More
2854430 18 F NJ 08/14/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 LW8911
Myalgia, Pain, Pain in extremity Myalgia, Pain, Pain in extremity
Received MenB vaccine on 7/17/2025. Later that night painful over upper arm. Point to deltoid muscle... Received MenB vaccine on 7/17/2025. Later that night painful over upper arm. Point to deltoid muscle. No swelling pain there since. Pain over muscle deltoid and behind pain above the elbow. It is not shooting, no tingling, no radiation. Stabbing pain with movements. 8/10 last for seconds then thobbing after. Laterally raising arm causes stabbing pain or rotating shoulder shifting forward also hurts. Referred to ortho. More
2853850 VA 08/13/2025 VARCEL
 MERCK & CO. INC.
 Y019318
No adverse event, Product storage error No adverse event, Product storage error
.No symptoms or side effects were reported by HCP; a patient received a dose of improperly stored VA... .No symptoms or side effects were reported by HCP; a patient received a dose of improperly stored VARIVAX; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 27-Jun-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0.5 mL (strength, frequency, route of administration, and site of administration were not provided) involved lot # was Y019318 which has been verified to be valid; and expiration date was 21-Nov-2026, given as prophylaxis. Temperature excursion was 52.2 degrees Fahrenheit (F), and time frame was unknown by reporter. There was no previous temperature excursion nor report of adverse effect or product quality complaint involved. More
2853852 MN 08/13/2025 MMR
 MERCK & CO. INC.
 Y011484
No adverse event, Product preparation error No adverse event, Product preparation error
CRT agent transfer nurse calling to report using the wrong sterile diluent to reconstitute and admin... CRT agent transfer nurse calling to report using the wrong sterile diluent to reconstitute and administer MMRII vaccine to a patient.; Patient reported no symptoms. No additional AE; This spontaneous report was received from an other health professional regarding a patient of unknown age and gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 01-Aug-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) solution for injection (lot #Y011484, expiration date: 27-Jun-2026), that was wrongly reconstituted with the water for injection (GSK STERILE DILUENT) (lot# J32PB, expiry date 31-Mar-2027), as opposed to the company's sterile diluent (DSM STERILE DILUENT). Nevertheless, the patient reported no symptoms. More
2853853 43 F 08/13/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Nausea, Product administered to patient of inappropriate age, Pyrexia Nausea, Product administered to patient of inappropriate age, Pyrexia
I am 43 year female and get 1st dose of vaccine yesterday; fever; nausea; This non-serious case was ... I am 43 year female and get 1st dose of vaccine yesterday; fever; nausea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a 43-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 01-AUG-2025, the patient received the 1st dose of Shingles vaccine. On 01-AUG-2025, an unknown time after receiving Shingles vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: I am 43 year female and get 1st dose of vaccine yesterday). In AUG-2025, the patient experienced fever (Verbatim: fever) and nausea (Verbatim: nausea). The outcome of the fever and nausea were not resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the fever and nausea to be related to Shingles vaccine. It was unknown if the company considered the fever and nausea to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-AUG-2025 This case was reported by the patient via interactive digital media. The patient received 1st dose of vaccine yesterday (day before reporting) and now (on the time of reporting) she had fever and nausea. Less than a week, after received Shingles vaccine, the patient experienced fever and nausea. The patient received 1st dose of Shingles vaccine earlier than the recommended age, which led to an inappropriate age at vaccine administration. More
2853854 M NE 08/13/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMXV072A
Product preparation issue Product preparation issue
they have one extra vial of the lyophilized component of Menveo, which means that a patient received... they have one extra vial of the lyophilized component of Menveo, which means that a patient received only the liquid portion; they have one extra vial of the lyophilized component of Menveo, which means that a patient received only the liquid portion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXV072A) for prophylaxis. On 29-JUL-2025, the patient received Menveo. On 29-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: they have one extra vial of the lyophilized component of Menveo, which means that a patient received only the liquid portion) and inappropriate dose of vaccine administered (Verbatim: they have one extra vial of the lyophilized component of Menveo, which means that a patient received only the liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 29-JUL-2025 A medical assistant mentioned that they have one extra vial of the lyophilized component of Menveo, which means that a patient received only the liquid portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. There were two possible patients that received only the diluent portion. For one of the patients, it was the second shot and for one of them it was the first dose. The reporter asked for recommendations on this situation. This was 1 of 2 linked cases , reported by the same reporter.; Sender's Comments: US-GSK-US2025097731:Same reporter/different patient More
2853855 8 NC 08/13/2025 DTAP
 SANOFI PASTEUR
 3CA55C1
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
daptacel inadvertently administered to an 8-year-old patient with no reported adverse event; Initial... daptacel inadvertently administered to an 8-year-old patient with no reported adverse event; Initial information received on 08-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 years old and unknown gender patient who was administered inadvertently to Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Aug-2025, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot 3CA55C1, expiry date 31-Aug-2026, strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and inadvertently administered to an 8-year-old patient with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853856 16 F 08/13/2025 MEN
MENB
 UNKNOWN MANUFACTURER
PFIZER\WYETH

Chest discomfort, Injection site rash, Pyrexia, Rash, Vomiting; Chest discomfort... Chest discomfort, Injection site rash, Pyrexia, Rash, Vomiting; Chest discomfort, Injection site rash, Pyrexia, Rash, Vomiting More
chest felt heavy; rash all over stomach; Vomiting; 102 degree fever; rash on the vaccine injection s... chest felt heavy; rash all over stomach; Vomiting; 102 degree fever; rash on the vaccine injection site; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-healthcare professional. This case involves a 16 years old female patient (168 cm and 53.07 kg) who had chest felt heavy, rash all over stomach, rash on the vaccine injection site, vomiting and 102 degree fever after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] and meningococcal VACCINE B RFHBPA/FHBPB [Trumenba] The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy and Syncope with vasovagal syncope From: About two years ago, was related to the low iron To: Has not had episode of that in a year, still takes iron so doesn't come to that anymore since patient was passing out all of the time. Concomitant medications included ethinylestradiol, norethisterone acetate (junel) for Contraception and Heavy menstrual bleeding; levocetirizine dihydrochloride (xyzal) for Hypersensitivity; and ferrous sulfate for Blood iron decreased. On 11-Jul-2025, the patient received unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (Unknown strength, lot and expiry date) via unknown route in the left arm and unknown dose of suspect trumenba (Unknown strength, formulation, lot and expiry date) not produced by Sanofi Pasteur via unknown route in the right arm, all for Prophylactic vaccination (Immunisation) On 12-JUL-2025 the patient developed rash on the vaccine injection site (vaccination site rash) (Latency 1 day) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and trumenba. On 13-JUL-2025 the patient developed rash all over stomach (rash), vomiting and 102 degree fever (pyrexia) (Latency 2 days) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and trumenba. On 14-JUL-2025 the patient developed chest felt heavy (chest discomfort) (Latency 3 days) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and trumenba. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events. More
2853857 12 F NY 08/13/2025 TDAP
 SANOFI PASTEUR
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
patient received a Tdap dose after DTaP earlier than the recommendation from the prescribing informa... patient received a Tdap dose after DTaP earlier than the recommendation from the prescribing information with no reported adverse event; Initial information received on 07-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 12 years old female patient who received a Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] dose after dtap earlier than the recommendation from the prescribing information with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation and a tdap dose received after dtap earlier than the recommendation from the prescribing information with no reported adverse event (incorrect dose administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, se received Dtap at 4 yrs 7mos, and then Tdap at 7yrs 10 mos, then she received her 3rd dose of Tdap when she was almost 8 yrs old. Caller stated that she was now 12 yrs old and has an appointment today to receive the Tdap and she wantwd to know if it would be okay. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853858 F NY 08/13/2025 TDAP
 SANOFI PASTEUR
 4CA28C1
No adverse event, Occupational exposure to product No adverse event, Occupational exposure to product
drawing up ADACEL from the vial there was a lot of internal pressure in the vial, and it caused the ... drawing up ADACEL from the vial there was a lot of internal pressure in the vial, and it caused the adacel to spray out and abruptly splashed on the nurse, fluid splashed in her left eye, eye lash, eye brow, and skin with no ae; drawing up ADACEL from the vial there was a lot of internal pressure in the vial, and it caused the adacel to spray out and abruptly splashed on the nurse, fluid splashed in her left eye, eye lash, eye brow, and skin with no ae; drawing up ADACEL from the vial there was a lot of internal pressure in the vial, and it caused the adacel to spray out and abruptly splashed on the nurse, fluid splashed in her left eye, eye lash, eye brow, and skin with no ae; Initial information received on 07-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female nurse who was drawing up diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] from the vial there was a lot of internal pressure in the vial, and it caused the adacel to spray out and abruptly splashed on the nurse, fluid splashed in her left eye, eye lash, eye brow, and skin with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Aug-2025, the nurse who was drawing up diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength- standard, lot 4CA28C1, expiry date- 31-MAR-2027) once from the vial there was a lot of internal pressure in the vial, and it caused the adacel to spray out and abruptly splashed on the nurse, fluid splashed in her left eye, eye lash, eye brow, and skin with no reported adverse event (accidental exposure to product) (occupational exposure to product) (latency- same day). Reportedly, Number of units affected - 1 VIAL. The product was available for return. The needle used was safety needle, not sure exact size. Clear location of the leakage: out of the vial stopper from the puncture mark. She did go to occupational health and they took care of her there. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2853868 25 F SC 08/13/2025 COVID19
 MODERNA
 069H21A
Neuropathy peripheral Neuropathy peripheral
Neuropathy in all four extremities. More stronger on left side/arm as left arm was where injections ... Neuropathy in all four extremities. More stronger on left side/arm as left arm was where injections where given. I received initial shot and two boosters. All Moderna. Second booster is what gave me reaction. More
2853872 M 08/13/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Headache, Malaise, Nausea, Vomiting Headache, Malaise, Nausea, Vomiting
nausea; light vomiting; headache; extremely ill; This non-serious case was reported by a consumer an... nausea; light vomiting; headache; extremely ill; This non-serious case was reported by a consumer and described the occurrence of nausea in a 79-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 02-AUG-2025, the patient received Shingles vaccine. In AUG-2025, an unknown time after receiving Shingles vaccine, the patient experienced nausea (Verbatim: nausea), vomiting (Verbatim: light vomiting), headache (Verbatim: headache) and unwell (Verbatim: extremely ill). The outcome of the nausea and vomiting were not resolved and the outcome of the headache and unwell were not reported. It was unknown if the reporter considered the nausea, vomiting, headache and unwell to be related to Shingles vaccine. It was unknown if the company considered the nausea, vomiting, headache and unwell to be related to Shingles vaccine. Additional Information: GSK receipt date: 02-AUG-2025 The patient reported that he was healthy but this vaccine made him extremely ill, nausea, light vomiting and severe headache. The expiry date of Shingles vaccine was unknown. More
2853873 08/13/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Feeding disorder, Herpes zoster, Herpes zoster oticus, Oral herpes zoster, Pain;... Feeding disorder, Herpes zoster, Herpes zoster oticus, Oral herpes zoster, Pain; Vaccination failure, Weight decreased More
lost 10 pounds; I could not eat; Suspected vaccination failure; Shingles in ear, hair and neck/face;... lost 10 pounds; I could not eat; Suspected vaccination failure; Shingles in ear, hair and neck/face; Shigles in mouth; 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. In NOV-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: Shingles in ear, hair and neck/face) and oral herpes zoster (Verbatim: Shigles in mouth). On an unknown date, the patient experienced weight loss (Verbatim: lost 10 pounds) and eating disorder (Verbatim: I could not eat). The outcome of the vaccination failure, herpes zoster, oral herpes zoster, weight loss and eating disorder were not reported. It was unknown if the reporter considered the vaccination failure, herpes zoster, oral herpes zoster, weight loss and eating disorder 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 herpes zoster, oral herpes zoster, weight loss and eating disorder to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-AUG-2025 This case was reported by a patient via interactive digital media. Patient had gotten shingles last year, from early November through December. It affected his/her ear, mouth, hair, neck, and face. The only thing that got his/her through was Jesus. The pain had been awful, even though he/she had received the shingles vaccine. Patient had gone to the physician and hospital, but only my physician assistant had helped. Patient had lost 10 pounds because he/she could not eat. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2853915 M PR 08/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Skin lesion Skin lesion
skin lesions in face and back; This serious case was reported by a pharmacist via sales rep and desc... skin lesions in face and back; This serious case was reported by a pharmacist via sales rep and described the occurrence of skin lesion in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included recurrent urinary tract infection. On 26-MAY-2025, the patient received the 1st dose of Shingrix. On 30-JUN-2025, 35 days after receiving Shingrix, the patient experienced skin lesion (Verbatim: skin lesions in face and back) (serious criteria other: Other medically imp. condition). The outcome of the skin lesion was not resolved. The reporter considered the skin lesion to be related to Shingrix. The company considered the skin lesion to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 05-AUG-2025 Patient reported skin lesions in face and back was reported as worsened. Patient with skin lesions (similar to shingles lesion) need to consult specialist dermatologist. The patient was taking antibiotics for Recurrent urinary tract infections.; Sender's Comments: A case of Skin lesion, 35 days after receiving Shingrix, in a 66-year-old male patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2853917 4 F MO 08/13/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019171
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No symptoms reported; patient who received improperly stored PROQUAD on 06/19/2025; This spontaneous... No symptoms reported; patient who received improperly stored PROQUAD on 06/19/2025; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-Jun-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), solution for injection (lot #Y019171, expiration date: 18-May-2026) 0.5 mL, (route of administration, anatomical site and dose number in series were not reported) the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date not provided) as prophylaxis (Product storage error). No symptoms were reported (No adverse event). The temperature reported was 6.3 Fahrenheit, during 0 hours 16 minutes 0 seconds. No previous excursion. This is one of several reports from the same source. Folow-up was received on 24-JUL-2025 from a nurse. The patients identifiers were updated such as name, date of birth and gender. More
2853918 M NY 08/13/2025 HPV9
 MERCK & CO. INC.
Injection site nodule Injection site nodule
palpable nodule at the injection site; 48 years old male received Gardasil 9; This spontaneous repor... palpable nodule at the injection site; 48 years old male received Gardasil 9; This spontaneous report was received from a physician and refers to a 48-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 an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection administered by Unknown route (lot # and expiration date were not reported) for prophylaxis, at the age of 48 years (Product administered to patient of inappropriate age). On an unknown date, the patient experienced palpable nodule at the injection site and it was reported that he still had a palpable nodule at the injection site at the reporting time (one month after administration). The causal relationship between the event of palpable nodule at the injection site and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown/not reported/not provided. More
2853919 15 OH 08/13/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered at inappropriate site No adverse event, Product administered at inappropriate site
no additional AE reported; another staff member administered GARDASIL 9 into a 15 year old patient&#... no additional AE reported; another staff member administered GARDASIL 9 into a 15 year old patient's "brachial bicep" muscle.; This spontaneous report was received from a medical assistant and refers to a 15-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection, administered intramuscularly, anatomical site: "brachial bicep" muscle, for prophylaxis (dose, lot # and expiration date were not reported) (Product administered at inappropriate site). No additional adverse event was reported. Additional information is not expected. More
2853920 TX 08/13/2025 HEPA
 MERCK & CO. INC.
 Y014585
No adverse event, Product storage error No adverse event, Product storage error
patient is not experiencing any symptoms/side effects; a VAQTA product was administered to a patient... patient is not experiencing any symptoms/side effects; a VAQTA product was administered to a patient in which a TE assessment had been completed; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-JUL-2025, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) suspension for injection at a dose of 0.5 mL, lot #Y014585, expiration date: 01-FEB-2026, for prophylaxis (route of administration and anatomical location were not reported). Before administration, the vaccine underwent temperature excursions (10 min in 50.5 F, 1 hour in -8.5 degrees Celsius); the temperature excursion assessment was completed on 22-JUL-2025 (Product storage error). The patient is not experiencing any symptoms or side effects. More
2853921 M 08/13/2025 PNC15
 MERCK & CO. INC.
Injection site pain Injection site pain
he is having soreness around injection site; This spontaneous report was received from a consumer re... he is having soreness around injection site; This spontaneous report was received from a consumer regarding himself, a male patient of unknown age. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) as prophylaxis (volume of injection, route of administration, anatomical location, lot # and, expiration date were not reported). On an unknown date, the patient experienced soreness around injection site (Vaccination site pain). At the reporting time, the outcome of this event was unknown. The causal relationship between the event and the suspect vaccine was not provided. Additional information was not expected. More
2853922 F 08/13/2025 UNK
VARCEL
 UNKNOWN MANUFACTURER
MERCK & CO. INC.

Antibody test negative, Autoimmune disorder, Rheumatoid arthritis, Systemic lupu... Antibody test negative, Autoimmune disorder, Rheumatoid arthritis, Systemic lupus erythematosus, Varicella virus test negative; Antibody test negative, Autoimmune disorder, Rheumatoid arthritis, Systemic lupus erythematosus, Varicella virus test negative More
Consumer calling reports VARIVAX AE. Consumer reports she recently had blood work done and it showed... Consumer calling reports VARIVAX AE. Consumer reports she recently had blood work done and it showed no immunity to chicken pox. Consumer reports she received the VARIVAX vaccine as a child (unknown age of administration) and now at 21 years old she; lupus; autoimmune disorder; have rheumatoid arthritis; Information has been received from Business Partner/CRO on 08-Aug-2025. This spontaneous report was received from an Consumer or other non health professional and refers to a 21-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot # and expiration date were not reported). On an unknown date, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of Prevention. On an unknown date, the patient experienced autoimmune disorder, lupus syndrome, rheumatoid arthritis and varicella virus test negative. The patient recently had blood work done and it showed no immunity to chicken pox. She is not sure if her current prescription could be causing the lack of immunity. She currently seeing a rheumatologist and taking a prescription Hydroxychloroquine to mitigate symptoms of a possible autoimmune disorder. The patient has symptoms of an autoimmune disorder and she may have rheumatoid arthritis or lupus but has not had an official diagnosis. At the reporting time, the patient had not recovered from the events The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable. The causal relationship between the events and sterile diluent was not provided. The causal relationship between the events and Varicella Virus Vaccine Live (Oka-Merck) was not provided. Upon internal review, the events of lupus autoimmune disorder and have rheumatoid arthritis were determined to be medically significant. More
2853923 CA 08/13/2025 HPV4
 MERCK & CO. INC.
 Y010466
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Medical assistant calling to report administering doses of GARDASIL 9 after a tem... No additional AE; Medical assistant calling to report administering doses of GARDASIL 9 after a temperature excursion; This spontaneous report was received from Other health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 11-AUG-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Injection, administered for prophylaxis (lot number Y010466 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 29-OCT-2026; dose number, route of administration and anatomical site of injection were not provided). The vaccine was administered after a temperature excursion (TE) at 2.9 degree Fahrenheit (F) for 5 minutes, with no previous TE (Product storage error). No additional adverse event was reported for the patient. This is one of two reports from the same reporter. More
2853924 PA 08/13/2025 PNC21
 MERCK & CO. INC.
 Z006076
No adverse event, Underdose No adverse event, Underdose
No additional AE; did not receive the full dose; This spontaneous report was received from other hea... No additional AE; did not receive the full dose; This spontaneous report was received from other health professional, concerning to a patient of unknown age and gender. The patient's medical, concurrent conditions and concomitant therapies were not reported. On 12-Aug-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (lot #Z006076 has been verified to be valid as a pre-filled syringe, expiration date reported and confirmed as 11-Sep-2026) (Strength 168 mcg/ml); as prophylaxis. On 12-Aug-2025, the patient flinched during administration and did not receive the full dose (Accidental underdose). No additional adverse event reported (No adverse event). More
2853925 08/13/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Guillain-Barre syndrome, Immediate post-injection reaction, Paraplegia Guillain-Barre syndrome, Immediate post-injection reaction, Paraplegia
believed it was called GBS; paralyzed from the waist down; This serious case was reported by a consu... believed it was called GBS; paralyzed from the waist down; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: believed it was called GBS) (serious criteria GSK medically significant) and acute paraplegia (Verbatim: paralyzed from the waist down) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and acute paraplegia were not reported. It was unknown if the reporter considered the guillain barre syndrome and acute paraplegia to be related to Shingles vaccine. The company considered the guillain barre syndrome and acute paraplegia to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 04-AUG-2025 This case was reported by the friend of the patient via interactive digital media. The reporters buddy (patient) received the vaccine for this and was almost instantly paralyzed from the waist down. The reporter believed that it was called Guillain-Barre Syndrome (GBS), it was rare, but it happened.; Sender's Comments: A case of Guillain-Barre syndrome and Paraplegia, immediately after receiving 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
2853926 F 08/13/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Death Death
passed way yesterday do to the vaccine; This serious case was reported by a consumer via interacti... passed way yesterday do to the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On 06-AUG-2025, an unknown time after receiving RSV vaccine, the patient experienced unknown cause of death (Verbatim: passed way yesterday do to the vaccine) (serious criteria death and GSK medically significant). The patient died on 06-AUG-2025. The reported cause of death was unknown. The reporter considered the unknown cause of death to be related to RSV vaccine. The company considered the unknown cause of death to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 07-AUG-2025 This case was reported by a patient's sibling via interactive digital media. The patient passed away yesterday due to the RSV vaccine .; Sender's Comments: The company considers that there was no reasonable possibility that the event death may have been caused by RSV vaccine. Based on the available information a possible causality that the events was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.; Reported Cause(s) of Death: Unknown cause of death More
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2853927 54 F RI 08/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster Herpes zoster
she developed shingles; This non-serious case was reported by a consumer and described the occurren... she developed shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 27-APR-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: she developed shingles). The outcome of the shingles was resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 04-AUG-2025 The patient reported she received the first shot of Shingrix and a couple months after receiving the vaccine she developed shingles in 2024. The patient reported she never received the second dose of vaccine. More
2853928 08/13/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Scab, Vaccination failure; Herpes zoster, Pain, Scab, Vacci... Herpes zoster, Pain, Scab, Vaccination failure; Herpes zoster, Pain, Scab, Vaccination failure More
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interacti... Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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. In JUL-2025, 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: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. 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: 04-AUG-2025 This case was reported by a patient via interactive digital media. The reporter stated that they were right, it was worse than a toothache. Patient had shingles and had been dealing with them since July. He/she went to the physician twice and got a shot each time, but they still hurt. They started to dry up a little, but the pain was still there. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). More
2853929 08/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
I need to start over or continue with the second dose; This non-serious case was reported by a consu... I need to start over or continue with the second dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose some years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: I need to start over or continue with the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 02-AUG-2025 The reporter reported that he/she took 1st shingles vaccine some years ago. The reporter asked did he/she needed to start over or continue with the second dose. Till the time of reporting the patient did not received 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2853930 08/13/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; Shingles two times on back that hurt; This serious case was reported ... Suspected vaccination failure; Shingles two times on back that hurt; 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. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles two times on back that hurt). 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: 05-AUG-2025 This case was reported by a patient via interactive digital media. The patient had Shingled three times. The first was before the shot. It was so bad that patient don't know a word that described it. When they came out with a shot, the patient jumped at it. They told the patient that if the patient waited for a while he/she wouldn't have to pay. The patient said that he/she would rather pay than go through that pain again. If the patient hadn't seen the next two, he/she might have not known that he/she had shingles. They were on the back and hurt every time the patient breathed.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2853931 08/13/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Gastrointestinal disorder Gastrointestinal disorder
Stomach problem; This non-serious case was reported by a consumer via interactive digital media and ... Stomach problem; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of gastric disorder 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 gastric disorder (Verbatim: Stomach problem). The outcome of the gastric disorder was not resolved. It was unknown if the reporter considered the gastric disorder to be related to Shingles vaccine. It was unknown if the company considered the gastric disorder to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-AUG-2025 This case was reported by a patient via interactive digital media. Patient had the injection for the shingle like a year ago ever since then, patient been having stomach Problems and wanted to know could it be caused by it. More
2853932 17 F IL 08/13/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 X4T99
Incorrect route of product administration Incorrect route of product administration
instead of administering intramuscularly give this vaccine subcutaneously; This non-serious case was... instead of administering intramuscularly give this vaccine subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis. On an unknown date, the patient received Menveo (subcutaneous). On an unknown date, an unknown time after receiving Menveo, the patient experienced intramuscular formulation administered by other route (Verbatim: instead of administering intramuscularly give this vaccine subcutaneously). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK Receipt Date: 28-JUL-2025 The pharmacist reported that the reporter had an immunization question that was for Menveo. The reporter question was one of staff vaccination, instead of administering intramuscularly give this vaccine subcutaneously to a 17 years old patient which led to intramuscular formulation administered by other route. The reporter asked did they need to readminister. More
2853933 F SC 08/13/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4FB5F
Product storage error Product storage error
frozen vaccine administered; This non-serious case was reported by a other health professional via c... frozen vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received MMR (Priorix) (batch number 4FB5F, expiry date 01-MAR-2027) 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: frozen vaccine administered). 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: 30-JUL-2025 The reporter reported that the Priorix was frozen, placed in the freezer by an employee that did not usually work there. Exposed to negative 27.4 degrees celsius. One dose was administered to a patient which led to incorrect storage of vaccine. More
2853934 RI 08/13/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patients supposed to received the 3rd Twinrix dose at 20-Jul-2025; This non-serious case was reporte... patients supposed to received the 3rd Twinrix dose at 20-Jul-2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received first dose of Twinrix on an unknown date) and Twinrix (received second dose of Twinrix on an unknown date). On an unknown date, the patient did not receive the 3rd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: patients supposed to received the 3rd Twinrix dose at 20-Jul-2025). The outcome of the incomplete course of vaccination 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: 31-JUL-2025 The nurse called and reported that one of their patients supposed to receive the 3rd Twinrix dose at 20 Jul 2025, but they incorrectly set the appointment until next dose The healthcare professional mentioned that the 1st and 2nd dose were properly administer but did mentioned any dates. Till the time of reporting, the patient did not receive third dose of Twinrix, which led to incomplete course of vaccination. More
2853935 27 F NY 08/13/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 49M2F
Incorrect route of product administration Incorrect route of product administration
a patient received priorix intramuscular instead of subcutaneous; This non-serious case was reported... a patient received priorix intramuscular instead of subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 27-year-old female patient who received MMR (Priorix) (batch number 49M2F, expiry date 01-DEC-2026) for prophylaxis. On 05-AUG-2025, the patient received Priorix (intramuscular). On 05-AUG-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: a patient received priorix intramuscular instead of subcutaneous). The outcome of the subcutaneous injection formulation administered by other route 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: 06-AUG-2025 A patient received priorix intramuscular instead of subcutaneous, which led to subcutaneous injection formulation administered by other route. The vaccine administration facility was the same as primary reporter. More
2853936 73 F 08/13/2025 COVID19
FLUX
PPV
 MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Asthma, Pneumonia, Respiratory syncytial virus infection; Asthma, Pneumonia, Res... Asthma, Pneumonia, Respiratory syncytial virus infection; Asthma, Pneumonia, Respiratory syncytial virus infection; Asthma, Pneumonia, Respiratory syncytial virus infection More
It triggered my asthma; pneumonia and put me into the hospital; caught RSV a year and a half ago; Th... It triggered my asthma; pneumonia and put me into the hospital; caught RSV a year and a half ago; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (It triggered my asthma), PNEUMONIA (pneumonia and put me into the hospital) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) in a 73-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect products included non-company products Pneumococcal vaccine for an unknown indication and Influenza vaccine for an unknown indication. The patient's past medical history included Respiratory syncytial virus infection. Concurrent medical conditions included Asthma (acute asthma) and Immune system disorder (compromised immune system). On 03-Apr-2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 03-Aug-2025, received dose of Influenza vaccine (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine (unknown route) 1 dosage form. In February 2024, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) (seriousness criterion hospitalization). On an unknown date, the patient experienced ASTHMA (It triggered my asthma) (seriousness criterion hospitalization) and PNEUMONIA (pneumonia and put me into the hospital) (seriousness criteria hospitalization and medically significant). At the time of the report, ASTHMA (It triggered my asthma) and PNEUMONIA (pneumonia and put me into the hospital) outcome was unknown and RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) was resolving. No concomitant medication was reported. Patient was interested in receiving the RSV vaccine as she had RSV a year and a half ago. She was recovering from it. It triggered her asthma, had pneumonia and went to the hospital. Patient was up to date with every single COVID booster that the patient got. Patient was up to date with pneumonia and flu vaccines. Patient got influenza vaccine on 03-Apr-2025 and got another one 03-Aug-2025. Patient got every vaccine she needed to get only with the exception of the two that were shingles and the RSV. No additional details provided. It is unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter did not allow further contact; Reporter's Comments: Co-suspect products Pneumococcal and Influenza vaccine; past medical history of Respiratory syncytial virus infection, asthma and Immune system disorder are contributors for the events. Due to lack of biological plausibility, the causality of the events Pneumonia and Respiratory syncytial virus infection was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
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2853937 94 F 08/13/2025 COVID19
 MODERNA
Neoplasm malignant Neoplasm malignant
had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday; This spontaneous case was repo... had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday) in a 94-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Family history included Cancer (The reporter states that cancer runs in her family) since an unknown date. Concurrent medical conditions included Systemic lupus erythematosus (auto immune disorders (lupus)) and Autoimmune disorder (Patient has a bunch of autoimmune diseases and she is a wreck. The reporter confirmed that her autoimmune illnesses were present before receiving the COVID vaccine). On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2025, the patient experienced NEOPLASM MALIGNANT (had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday) outcome was unknown. No concomitant medication was reported. The reporter stated that she had 5 Moderna COVID vaccines and was diagnosed with cancer a day before reporting, even though she had known it for 8 months. The reporter stated that she really needed the COVID vaccine because there were many things wrong with her and she had a house full of people who won't go by the rules. The reporter stated that she did not believe there to be a connection to the vaccine. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.; Reporter's Comments: Concurrent medical condition Systemic lupus erythematosus is a contributor for the event. Due to lack of biological plausibility, the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
2853938 61 M PA 08/13/2025 COVID19
 MODERNA
Guillain-Barre syndrome Guillain-Barre syndrome
GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination; This spontaneous ca... GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) in a 61-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2023, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2023, after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) had resolved with sequelae. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events. The patient did not know the details of medication and reason for taking the medicine. No treatment medications were reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2853939 11 M MI 08/13/2025 DTAP
 SANOFI PASTEUR
Wrong product administered Wrong product administered
given Dtap, but should have been given Tdap given Dtap, but should have been given Tdap
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