🏥 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 💀 🏥 🚑 ♿ ⚠️
2862394 79 F 09/30/2025 COVID19
 MODERNA
Fatigue, Feeling abnormal, Headache, Neck pain Fatigue, Feeling abnormal, Headache, Neck pain
my neck hurts a little bit; I'm not nauseous and I don't really feel like eating.; headach... my neck hurts a little bit; I'm not nauseous and I don't really feel like eating.; headache; I feel very tired; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (my neck hurts a little bit), FEELING ABNORMAL (I'm not nauseous and I don't really feel like eating.), HEADACHE (headache) and FATIGUE (I feel very tired) in a 79-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included Pain in arm with Pfizer. On 25-Sep-2025 at 3:30 PM, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 26-Sep-2025, the patient experienced NECK PAIN (my neck hurts a little bit), FEELING ABNORMAL (I'm not nauseous and I don't really feel like eating.), HEADACHE (headache) and FATIGUE (I feel very tired). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. At the time of the report, NECK PAIN (my neck hurts a little bit), FEELING ABNORMAL (I'm not nauseous and I don't really feel like eating.) and HEADACHE (headache) had not resolved and FATIGUE (I feel very tired) outcome was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms and events. Patient took Tylenol to treat the symptoms with no resolution at the time of the report. She also reported the side effects after receiving Pfizer's Covid vaccines. She always got the Pfizer and didn't really have, just had a sore arm. Reporter did not allow further contact More
2862395 73 F 09/30/2025 COVID19
 MODERNA
Vomiting Vomiting
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING ... Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included CAPD (CAPD (dialysis)) since an unknown date. Concurrent medical conditions included Type 1 diabetes mellitus. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 28-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) had resolved. No concomitant medications were provided. It was reported that patient had taken all Covid vaccines since 2021 till now, which was 7-8 vaccines. It was reported that at each time almost 10 hours after the vaccine she would start vomiting every 20 to 30 minutes and this would last for 6-8 hours. There was other 4 vaccines, but she had no information about them. It was mentioned that she had diabetes type 1 and was on dialysis (CAPD). No treatment medication was provided. This case was linked to MOD-2025-789727, MOD-2025-789728, MOD-2025-789729, MOD-2025-789730 (Patient Link). More
2862396 43 M HI 09/30/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER
 30525810
Chills; Chills Chills; Chills
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chi... chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 43-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 30525810) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included COVID-19 on 13-Jan-2022. Concurrent medical conditions included Obesity. On 24-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 24-Sep-2025, the patient experienced CHILLS (chills). On 25-Sep-2025, CHILLS (chills) had resolved. The concomitant medication was not reported by the reporter. The patient experienced chills 12 hours after the injection. The chills were mitigated with additional clothing. It was unknown if the patient experienced any additional symptoms or events. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. There was no lab data or results available. The treatment medication was not reported by the reporter. More
2862397 M FL 09/30/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Had Covid 3 times; Had Covid 3 times; This is a spontaneous report received from a Consumer or other... Had Covid 3 times; Had Covid 3 times; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Overactive bladder" (unspecified if ongoing); "Slightly elevated blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure increased. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had Covid 3 times". Clinical course: Patient reported all times having Covid, were after receiving Covid vaccines. First time, was 2 and half years after pandemic broke out, was doing really good. First time with Covid, going to say, 2022, or no, was 2 and half years after Covid pandemic broke out. Had Covid 3 times, got all 5 vaccines: Clarified, this was third time having Covid. Had it 2 times before this time, this is third time on 16Sep2025. Never had any negative reaction to any shot. Concomitant Products included patient takes medications, for 3 minor conditions. Takes Losartan25mg, for slightly elevated blood pressure. Has rheumatoid arthritis, nothing major. taking something for that. Also taking something or overactive bladder. Patient did not require a visit to the Emergency Room or a visit to a Physician's Office. Patient is not allergic to any previous vaccination, medications, food or other products. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500186707 Same patient/AE, different vaccination (dose); More
2862398 77 F GA 09/30/2025 FLUX
 UNKNOWN MANUFACTURER
Injection site erythema, Injection site induration, Injection site inflammation,... Injection site erythema, Injection site induration, Injection site inflammation, Wrong technique in product usage process More
adverse reaction 4 inches below the injection site. It was red, inflamed and hard to the touch, 4 in... adverse reaction 4 inches below the injection site. It was red, inflamed and hard to the touch, 4 inches in diameter patch; adverse reaction 4 inches below the injection site. It was red, inflamed and hard to the touch, 4 inches in diameter patch; adverse reaction 4 inches below the injection site. It was red, inflamed and hard to the touch, 4 inches in diameter patch; Initial information received on 22-Sep-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 77 years old female patient who had adverse reaction 4 inches below the injection site. it was red, inflamed and hard to the touch, 4 inches in diameter patch after receiving influenza vaccine The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Sep-2025, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, form, route, batch number, expiry date was unknown) in the right upper arm as immunization and that a tuberculin needle was used. No other vaccines were given On 20-SEP-2025 the patient had adverse reaction 4 inches below the injection site. it was red, inflamed and hard to the touch, 4 inches in diameter patch (vaccination site erythema) (vaccination site induration) (vaccination site inflammation) (Latency: 1 day) Action taken was not applicable. The patient was treated with Ibuprofen and ice bag for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events More
2862399 09/30/2025 COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR





Abdominal discomfort, Body temperature, Chills, Heart rate, Heart rate increased... Abdominal discomfort, Body temperature, Chills, Heart rate, Heart rate increased; Hypertension, Malaise, Pain in extremity, Pyrexia, Tremor; Vaccination site pain; Abdominal discomfort, Body temperature, Chills, Heart rate, Heart rate increased; Hypertension, Malaise, Pain in extremity, Pyrexia, Tremor; Vaccination site pain More
didn't feel well; chills; fever/later a fever of 101.9/ had fever of 101.6'F; I had the sh... didn't feel well; chills; fever/later a fever of 101.9/ had fever of 101.6'F; I had the shakes/ started getting the shakes at the left arm as well as right arm/both started shaking and couldn't stop; stomach was upset; high blood pressure; I went to move my arm and it felt like somebody was stabbing me with a knife. It was extremely painful." & "My arm was still a little sore, but by Sunday I was perfectly fine; pain and fever/extreme pain at the injection site/sore arm/went to move arm and it felt like somebody was stabbing with a knife/extremely painful/ arm really hurt/pain was terrible; heart rate wasn't too bad, it was 92 something; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from patient. This case involves an unknown age and unknown gender patient who had the shakes/ started getting the shakes at the left arm as well as right arm/both started shaking and could not stop, heart rate wasn't too bad, it was 92 something, stomach was upset, high blood pressure, went to move my arm and it felt like somebody was stabbing me with a knife. it was extremely painful." & "my arm was still a little sore, but by sunday i was perfectly fine, pain and fever/extreme pain at the injection site/sore arm/went to move arm and it felt like somebody was stabbing with a knife/extremely painful/ arm really hurt/pain was terrible, did not feel well, chills and fever/later a fever of 101.9/ had fever of 101.6 degree Fahrenheit after receiving influenza USP trival A-B subvirion NO preservative vaccine [Fluzone] and covid-19 vaccine MRNA. The patient's past vaccination(s) included covid-19 vaccine on 29-JAN-2021, Pfizer BioNTech covid-19 vaccine on 17-FEB-2021, Pfizer BioNTech covid-19 vaccine on 25-SEP-2021, Pfizer BioNTech COVID-19 vaccine on 22-APR-2022, Pfizer BioNTech covid-19 vaccine on 09-SEP-2022, Spikevax XBB.1.5 on 04-OCT-2023, Spikevax XBB.1.5 on 22-MAR-2024, spikevax 2024-2025 (KP.2) on 30-AUG-2024 with Dose 8 and spikevax 2024-2025 (KP 2) on 02-MAR-2025. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Hypertension in 2013, Arrhythmia in 2013 and Respiration abnormal in 2013 On 12-Sep-2025, the patient received 1 DF (Dosage form) of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (Unknown strength, lot and expiry date) via intramuscular route in unknown administration site for Influenza and dose 10 of 1 DF of suspect covid-19 vaccine MRNA Injection (Unknown strength, lot and expiry date) not produced by Sanofi Pasteur via intramuscular route in unknown administration site for covid-19 Prophylaxis. Information on the batch number was requested corresponding to the one at time of event occurrence On 12-SEP-2025 the patient had the shakes/ started getting the shakes at the left arm as well as right arm/both started shaking and could not stop (tremor), stomach was upset (abdominal discomfort), high blood pressure (hypertension), went to move my arm and it felt like somebody was stabbing me with a knife. it was extremely painful. And arm was still a little sore, but by Sunday i was perfectly fine (pain in extremity), pain and fever/extreme pain at the injection site/sore arm/went to move arm and it felt like somebody was stabbing with a knife/extremely painful/ arm really hurt/pain was terrible (vaccination site pain), chills and fever/later a fever of 101.9/ had fever of 101.6'f (pyrexia) (Latency same day) following the administration of influenza USP trival A-B subvirion NO preservative vaccine and covid-19 vaccine MRNA. On 13-Sep-2025 the patient developed did not feel well (malaise) (Latency 1 day) following the administration of influenza USP trival A-B subvirion NO preservative vaccine and covid-19 vaccine MRNA. On an unknown date in SEP-2025 the patient developed heart rate was not too bad, it was 92 something (heart rate increased) (unknown latency) following the administration of influenza USP trival A-B SUBVIRION NO preservative vaccine and covid-19 vaccine MRNA. Relevant laboratory test results included: Body temperature - On 12-Sep-2025: 101.6 F; on 13-Sep-2025: 97.9 F Heart rate - In September 2025: 92 UNK [92] Action taken was not applicable. The patient was treated with paracetamol (tylenol) for Vaccination site pain, Pain in extremity and Pyrexia and codeine for Pain in extremity and Vaccination site pain. At time of reporting, the outcome was Recovering / Resolving for the event Vaccination site pain, was Recovered / Resolved on an unknown date Sep-2025 for the event Pain in extremity and was Unknown for other the events. More
2862400 70 M WY 09/30/2025 FLU3
 SANOFI PASTEUR
 UT8763GA
Influenza, Throat irritation Influenza, Throat irritation
Within the next two hours, they had the symptoms of a scratchy throat; Within twenty-four hours, it ... Within the next two hours, they had the symptoms of a scratchy throat; Within twenty-four hours, it developed into a full-blown flu which they have had all week; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 70 years old male patient who within the next two hours, had the symptoms of a scratchy throat and within twenty-four hours, it developed into a full-blown flu which they have had all week after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Sep-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot UT8763GA, frequency:once, strength and expiry date: 30-Jun-2026 via unknown route in the left arm for influenza and within twenty-four hours, it developed into a full-blown flu which they have had all week. On 16-Sep-2025 the patient within the next two hours, had the symptoms of a scratchy throat (throat irritation) and within twenty-four hours, it developed into a full-blown flu which they have had all week (influenza) (latency: same day). Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. More
2862401 0.75 F CA 09/30/2025 FLU3
 SANOFI PASTEUR
 U8881AA
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
vaccine administration incident where a 10-month-old patient received their very first dose of FLUZO... vaccine administration incident where a 10-month-old patient received their very first dose of FLUZONE NP on 17Sep2025 and received the second dose on 24Sep2025, with no reported adverse event; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a vaccine administration incident where a 10 months old female patient received their very first dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone) on 17sep2025 and received the second dose on 24sep2025, with no reported adverse event while receiving vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine. On 17-Sep-2025, the patient received a Dose 1 (0.5ml) suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine; Suspension for injection (lot U8881AA with expiry date 30-JUN-2026) with unknown (strength) via intramuscular route in the left thigh. On 24-Sep-2025 she also received a Dose 2 (0.5ml) of vaccine with an unknown (batch number and expiry date) via intramuscular route in the left thigh for Influenza; vaccine administration incident where a 10-month-old patient received their very first dose of fluzone np on 17sep2025 and received the second dose on 24sep2025, with no reported adverse event (inappropriate schedule of product administration) (latency: 7 days) Reportedly: Nurse mentioned that the doctors are wondering since the vaccines were only given a week apart from one another, does the patient need to have another dose and if so, when do they need to receive it. Regulatory Authority provided information from the attached SRD. 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
2862402 5 M GA 09/30/2025 UNK
 UNKNOWN MANUFACTURER
 U8832CA
No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered More
made an error and provided Flublok to a 5 year old child with no reported adverse event; Initial inf... made an error and provided Flublok to a 5 year old child with no reported adverse event; Initial information received on 27-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 5 years old male patient who was administered by an error to Influenza Trivalent Recombinant Vaccine [Flublok Tiv] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2025, the patient received 0.5mL of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection (lot U8832CA, expiry date 31-May-2026, strength standard and frequency once) via intramuscular route in the left deltoid for Influenza and by an error it was administred to a 5 year old child with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Reportedly, pharmacist explained that she was giving Flublok to the patient's mother and brother who were in the correct age for the vaccine and accidentally brought in a 3rd syringe of Flublok instead of an MMRvaccine and gave it to the child. Lot: U8823AA; Expiry date 31-May-2026. 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
2862410 NY 09/30/2025 MMR
 MERCK & CO. INC.
 X019107
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; HBP calling to report an expired dose of MMRII was inadvertently administered to a... No additional AE; HBP calling to report an expired dose of MMRII was inadvertently administered to a patient. Patient has not experienced any symptoms. Caller confirmed product did not undergo any temperature excursions and was supported per Post-Expiry Memo. Permissi; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 09-Sep-2025, the patient was vaccinated with expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X019107, expiration date: 16-Jul-2025 (exact dose, route od administration and anatomical location were not provided) for prophylaxis (expired product administered). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT). No additional adverse event reported (no adverse event). More
2862412 F 09/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Arthralgia, Headache, Nausea, Pain, Pyrexia Arthralgia, Headache, Nausea, Pain, Pyrexia
joint ache; Body ache; nausea; headache; fever; This non-serious case was reported by a consumer via... joint ache; Body ache; nausea; headache; fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date, refer case US2025AMR124367). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced joint pain (Verbatim: joint ache), general body pain (Verbatim: Body ache), nausea (Verbatim: nausea), headache (Verbatim: headache) and fever (Verbatim: fever). The outcome of the joint pain, general body pain, nausea, headache and fever were resolved (duration 48 hrs). The reporter considered the joint pain, general body pain, nausea, headache and fever to be related to Shingrix. The company considered the joint pain, general body pain, nausea, headache and fever to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR124367 Additional Information: GSK Receipt Date: 24-SEP-2025 The reporter stated be sure to plan on taking the day after getting the second shingles shot off. The patient was down all day with body, joint aches, nausea, headache. The patient had a fever of 100.7-degree F. The next day of vaccination, 48 hours later, patient was fine. This case was linked with case US2025AMR124423 and US2025AMR124422 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025AMR124423:Same reporter US-GSK-US2025AMR124367:same reporter diff dose More
2862415 9 F 09/30/2025 COVID19
 PFIZER\BIONTECH
 na0739
Incorrect dose administered Incorrect dose administered
No SE reported. Wrong version given to pediatric patient. She should have received pediatric version... No SE reported. Wrong version given to pediatric patient. She should have received pediatric version but received regular 12+ yo Pfizer vaccine instead. More
2862416 65 F MD 09/30/2025 FLU3
 SANOFI PASTEUR
 B7C5B
Rash, Rash erythematous, Swelling face Rash, Rash erythematous, Swelling face
Swollen face, and rash on right side of face red bumps Swollen face, and rash on right side of face red bumps
2862418 77 M FL 09/30/2025 COVID19
FLU3
PNC21
RSV
TDAP
 NOVAVAX
SEQIRUS, INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 6315MF002C
407264
Z006076
2293B
94KG2
Injection site vesicles; Injection site vesicles; Injection site vesicles; Injec... Injection site vesicles; Injection site vesicles; Injection site vesicles; Injection site vesicles; Injection site vesicles More
On the day after all five immunizations, a 15 mm by 5 mm thick-walled bullous blister was found at i... On the day after all five immunizations, a 15 mm by 5 mm thick-walled bullous blister was found at in injection site on right arm. I know I got two injections in the left arm and three in the right arm, so the pharmacy info is not correct. More
2862430 73 F OR 09/30/2025 RSV
 PFIZER\WYETH
 MY9159
Abdominal pain upper, Diarrhoea, Headache, Nausea Abdominal pain upper, Diarrhoea, Headache, Nausea
Starting 1 and 1/2 days after vaccine, patient reports: severe headache, nausea, diarrhea, upper st... Starting 1 and 1/2 days after vaccine, patient reports: severe headache, nausea, diarrhea, upper stomach pain lasting 2 weeks More
2862431 61 F CA 09/30/2025 PNC21
 MERCK & CO. INC.
 z006076
Erythema, Pyrexia, Skin warm, Swelling Erythema, Pyrexia, Skin warm, Swelling
The symptoms started on Tuesday around noon time (09/23/2025). It started with a local reaction- a r... The symptoms started on Tuesday around noon time (09/23/2025). It started with a local reaction- a red bump about 3cm radius big. In the meanwhile, patient experienced high grade fever at 100.2F. Later on, the whole upper right arm became red and warm to touch. Patient contacted her PCP and dr instructed her what to look for. The fever lasted 3 days. Patient had remained hydrated, taken 1 dose of tylenol (tylenol wasn't helping per patient), and ice packed the swollen area during the entire time. In the mid day of Thursday 09/25/2025, all side effects faded away and patient returned to normal since Friday 09/26/2025. More
2862432 58 F PA 09/30/2025 FLU3
 SEQIRUS, INC.
 407981
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse reaction reported. Patient is age 58 but was given high dose influenza vaccine (Fluad) fo... No adverse reaction reported. Patient is age 58 but was given high dose influenza vaccine (Fluad) for age 65 years and older at the immunization clinic. More
2862433 66 M CA 09/30/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 75GZ7
75GZ7
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient called to ask if he was complete with shingrix series and rph noticed he received 4 doses. P... Patient called to ask if he was complete with shingrix series and rph noticed he received 4 doses. Patient reported that he was fine and to just communicate to provider that he was complete. More
2862434 62 M FL 09/30/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 tfaa2530
z006889
Burning sensation, Coccydynia, Tendon pain; Burning sensation, Coccydynia, Tendo... Burning sensation, Coccydynia, Tendon pain; Burning sensation, Coccydynia, Tendon pain More
patient said that the day after vaccination ( Tuesday )he had pain in tailbone. Then on Wednesday th... patient said that the day after vaccination ( Tuesday )he had pain in tailbone. Then on Wednesday there was a burning sensation on left buttock. Then on Thursday there Achilles tendon pain . More
2862435 77 F CA 09/30/2025 COVID19
 MODERNA
 3052155
Diplopia, Vision blurred Diplopia, Vision blurred
patient describes that 6-7 hours after receiving the MnexSpike vaccine she started having double vis... patient describes that 6-7 hours after receiving the MnexSpike vaccine she started having double vision/ blurry vision and is still occurring the next day after. More
2862436 70 F FL 09/30/2025 PNC20
 PFIZER\WYETH
 LP4947
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Patient received a second dose of Prevnar20 on 8/28/25 and the 1st dose of Prevnar20 on 7/29/24. Pat... Patient received a second dose of Prevnar20 on 8/28/25 and the 1st dose of Prevnar20 on 7/29/24. Patient was ok and had no adverse reactions. More
2862437 61 F FL 09/30/2025 PNC20
 PFIZER\WYETH
 lx4486
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient appears to have received a duplicate pneumonia vaccine - prevnar 20 (4/10/2025 and 9/29/2025... Patient appears to have received a duplicate pneumonia vaccine - prevnar 20 (4/10/2025 and 9/29/2025). Patient was notified and patient did not report any adverse reactions at the time of the call. More
2862438 36 F NC 09/30/2025 RSV
 PFIZER\WYETH
 MD5465
Exposure during pregnancy, Extra dose administered Exposure during pregnancy, Extra dose administered
Patient is currently pregnant. Patient received a second dose of Abrysvo for a second pregnancy afte... Patient is currently pregnant. Patient received a second dose of Abrysvo for a second pregnancy after receiving a first dose in 2023, despite there being no recommendation for RSV in subsequent pregnancies. More
2862439 41 M CA 09/30/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 na0587
na0587
na0587
Arthralgia, Blood test, Cough, Electrocardiogram, Hypoaesthesia; Muscle spasms, ... Arthralgia, Blood test, Cough, Electrocardiogram, Hypoaesthesia; Muscle spasms, Nasal congestion, Pain, Pain in extremity, Sneezing; X-ray More
level 9 pain in right arm lasting for a over a week and numb fingers, still experiencing it today on... level 9 pain in right arm lasting for a over a week and numb fingers, still experiencing it today on 9/30, pain starts in shoulder and goes all the way to finger tips, muscle spasms in arm, numb fingers, really sick,body pain, cough, congestion, sneezing, lasting for 10 days after vaccine More
2862440 64 F AZ 09/30/2025 FLU3
 SANOFI PASTEUR
 U8823BA
Mobility decreased, Pain, Product administered at inappropriate site, Sleep diso... Mobility decreased, Pain, Product administered at inappropriate site, Sleep disorder More
vaccine was administered above the deltoid on the right shoulder, pt noticed the vaccine was given h... vaccine was administered above the deltoid on the right shoulder, pt noticed the vaccine was given high. within 24 hours pt was not able to move her arm for the next 6 days. pt returned to the pharmacy 1 week later to inform pharmacist of the event. She said the pain has been so intense it has kept her up at night. she has been putting ice and heat on it to help with the pain. she reports no redness or swelling in the area., just intense pain. More
2862441 42 F CA 09/30/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Injection site erythema, Injection site irritation, Injection site pain, Injecti... Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling, Injection site warmth More
PATIENT HAD SWELLING REDNESS PAIN WARMTH AT THE INJECTION SITE. IMPROVED A LITTLE SINCE SATURDAY BUT... PATIENT HAD SWELLING REDNESS PAIN WARMTH AT THE INJECTION SITE. IMPROVED A LITTLE SINCE SATURDAY BUT STILL TENDER AND WARMTH, IRRITATTED More
2862443 57 F WI 09/30/2025 FLU3
FLU3
FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

93NL9
93NL9
Contusion, Immediate post-injection reaction, Product administered at inappropri... Contusion, Immediate post-injection reaction, Product administered at inappropriate site; Contusion, Immediate post-injection reaction; Contusion, Immediate post-injection reaction, Product administered at inappropriate site; Contusion, Immediate post-injection reaction More
Administered at top of arm on shoulder causing an instant bruise Administered at top of arm on shoulder causing an instant bruise
2862444 38 F 09/30/2025 COVID19
FLU3
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 NA0739
9FG5M
Injection site erythema, Injection site pruritus, Injection site warmth; Injecti... Injection site erythema, Injection site pruritus, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site warmth More
Red, itchy patch of skin an inch below injection site that feels warm to the touch. Treating with an... Red, itchy patch of skin an inch below injection site that feels warm to the touch. Treating with antihistamines and cold compress. More
2862445 42 M ID 09/30/2025 COVID19
 MODERNA
 3052030
Loss of consciousness, Presyncope Loss of consciousness, Presyncope
Patient had vaso-vagal response and passed out after vaccine administration and quickly regained con... Patient had vaso-vagal response and passed out after vaccine administration and quickly regained consciousness More
2862446 22 F CA 09/30/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 ld9y5
Fall, Head injury, Joint injury, Nervousness, Syncope Fall, Head injury, Joint injury, Nervousness, Syncope
After receiving the Fluarix, patient was fainted and fell. Patient said that she was very nervous ... After receiving the Fluarix, patient was fainted and fell. Patient said that she was very nervous also. Her head and elbow hit the counter. More
2862448 0.33 F CO 09/30/2025 DTAPHEPBIP
HIBV
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.
 2G273
549JB
LJ5282
2037483
Decreased appetite, Diarrhoea, Ear infection; Decreased appetite, Diarrhoea, Ear... Decreased appetite, Diarrhoea, Ear infection; Decreased appetite, Diarrhoea, Ear infection; Decreased appetite, Diarrhoea, Ear infection; Decreased appetite, Diarrhoea, Ear infection More
Severe diarrhea, loss of appetite, ear infection. All resulting in ER visit for IV fluids. Diarrhea ... Severe diarrhea, loss of appetite, ear infection. All resulting in ER visit for IV fluids. Diarrhea began before any antibiotics were prescribed. 1 pee diaper in a 24 hour period resulting in ER visit where they tested her blood and found she was moderately dehydrated. All symptoms progressively began 24-72hrs after the vaccines. More
2862449 72 F OR 09/30/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 MY9550
MY9550
Device connection issue, Pain in extremity, Underdose; Device connection issue, ... Device connection issue, Pain in extremity, Underdose; Device connection issue, Pain in extremity, Underdose More
The first vaccination had a mechanical failure in which the vaccine expelled out of the needle junct... The first vaccination had a mechanical failure in which the vaccine expelled out of the needle junction as the needle may have come loose during administration. This resulted in a subtherapeutic dose. As a result, a second dose was given to the patient to give the patient a full dose. This vaccine was given on the same arm but should have been given on opposite arm to help prevent/lessen side effects. Patient was called on 9/30/25 for follow-up. They described extreme pain from the injection arm that lasted a couple of days after injection. The patient contacted the provider where the provider stated that the injection may have been given too high on the arm. They stated that the pain had subsided to a slight soreness by 9/30/25. More
2862450 72 M AZ 09/30/2025 COVID19
 MODERNA
 3052669
Wrong product administered Wrong product administered
Patient has filed a complaint with the agency after being given Spikevax in lieu of mNexSpike. Patient has filed a complaint with the agency after being given Spikevax in lieu of mNexSpike.
2861917 FL 09/29/2025 MMRV
 MERCK & CO. INC.
 Z007852
No adverse event, Product storage error No adverse event, Product storage error
No additional AE reported; t PROQUAD was administered during a T/E to 1 patient on 8/13/2025.; This ... No additional AE reported; t PROQUAD was administered during a T/E to 1 patient on 8/13/2025.; This spontaneous report was received from a Physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-AUG-2025, a temperature excursion occurred for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at 23.3 degree Fahrenheit (F) for 5 hours, with no previous TE. On 13-AUG-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD), Injection, administered for prophylaxis (lot number Z007852 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date 19-OCT-2026; dose, route of administration and anatomical site of injection were not reported) (Product storage error), which was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (expiration date and lot number were not reported). No additional adverse event was reported for the patient. No other information was provided. This is one of two reports from the same reporter. More
2861918 CA 09/29/2025 MMRV
 MERCK & CO. INC.
 Z008867
Product storage error Product storage error
vaccine was administered after temperature excursion; This spontaneous report was received from a ph... vaccine was administered after temperature excursion; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. The patient's medical history, drug history, concurrent conditions and concomitant therapies were not reported. On 11-Sep-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z008867, expiration date: 10-Nov-2026) 0.5 mL total, administered by subcutaneous route (anatomical site and dose number in series were not reported); the vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported) as prophylaxis (Product storage error). The reported temperature was 32 Fahrenheit for a time frame of 4 hours 30 minutes 0 seconds. No previous temperature excursion. This is one of several reports from the same source. More
2861919 WA 09/29/2025 HEPA
 MERCK & CO. INC.
 Y013120
No adverse event, Underdose No adverse event, Underdose
no symptoms; an adult patient received a pediatric dose of VAQTA that was administered on 9/11/2025;... no symptoms; an adult patient received a pediatric dose of VAQTA that was administered on 9/11/2025; This spontaneous report was received from a nurse and refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On 11-Sep-2025, the patient was vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) injection (lot #Y013120, expiration date: 26-Dec-2025) (25 units intramuscularly/Second dose of the series), dose number 2, administered by intramuscular route as prophylaxis by health professional (Underdose). The patient had no symptoms (no adverse event). More
2861920 F MO 09/29/2025 MMR
VARCEL
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Abortion spontaneous, Antibody test negative, Exposure during pregnancy; Abortio... Abortion spontaneous, Antibody test negative, Exposure during pregnancy; Abortion spontaneous, Antibody test negative, Exposure during pregnancy More
The patient recently had a miscarriage (before PROQUAD administration); HCP reports that the patient... The patient recently had a miscarriage (before PROQUAD administration); HCP reports that the patient has received her MMR and varicella vaccines in the past (unknown brand name) but recently undergone titer testing that did not show immunity.; the patient has received her MMR and varicella vaccines in the past; the patient recently had a miscarriage; This spontaneous report was received from a physician assistant (reported as medical assistant and refers to a 27-year-old female patient. The patient's concurrent conditions included drug allergy (minocycline). Historical drugs included minocycline. The patient concomitant therapies, previous drugs reactions and allergies were not reported. This was a retrospective pregnancy case. On an unknown date, the subject became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported. On an unknown date (reported as in the past), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (reported as MMR vaccine) (manufacturer unknown, reported as unknown brand name) and with a dose of varicella virus vaccine live (oka-merck) (VARIVAX) (reported as varicella vaccine) (manufacturer unknown reported as unknown brand name) both administered as prophylaxis (strengths, Lot numbers, expirations dates, dose numbers, exact dose quantity volumes, routes and anatomical locations of administration and vaccination scheme frequencies were not provided); that were reconstituted with sterile diluent (Lot No., expiration date, route and indication were not reported). On an unspecified date (reported as recently) it was stated that the patient undergone a titer testing that did not show immunity (antibody test abnormal) and that the patient recently had a miscarriage (abortion spontaneous) (exposure during pregnancy). On an unknown date, the patient was inadvertently given a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (PROQUAD)(product use issue) in order to provide a booster for the series (captured in PV smart # 2333373). The outcome of the events of antibody test abnormal and abortion spontaneous was not reported. The outcome of exposure during pregnancy was reported as recovered. The causal relationship between the events of antibody test abnormal and abortion spontaneous was not reported. Upon internal review, the event of abortion spontaneous was determined to be medically significant. More
2861922 F GA 09/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Atrial fibrillation Atrial fibrillation
A fib with no history on same day of vaccine; This serious case was reported by a physician via sal... A fib with no history on same day of vaccine; This serious case was reported by a physician via sales rep and described the occurrence of atrial fibrillation in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, less than a day after receiving Shingrix, the patient experienced atrial fibrillation (Verbatim: A fib with no history on same day of vaccine) (serious criteria GSK medically significant and other: serious as per reporter). The outcome of the atrial fibrillation was resolved. The reporter considered the atrial fibrillation to be related to Shingrix. The company considered the atrial fibrillation to be unrelated to Shingrix.; Sender's Comments: A case of Atrial fibrillation, less than a day after receiving Shingrix, in a 52-year-old female 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
2861923 09/29/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Bell's palsy Bell's palsy
Bell's palsy; This serious case was reported by a consumer via interactive digital media and de... Bell's palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy 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 bell's palsy (Verbatim: Bell's palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. The company considered the bell's palsy to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 22-SEP-2025 This case was reported by a patient via interactive digital media. Reporter stated that patient got the shingles vaccine and had a reaction causing Bell's palsy. This case is linked with case US2025AMR122529, reported by the same reporter.; Sender's Comments: A case of Bell's palsy ,an unknown date, an unknown time after receiving Shingles vaccine, in a female 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-US2025AMR122529:same reporter More
2861924 09/29/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Guillain-Barre syndrome, Paralysis, Wheelchair user Guillain-Barre syndrome, Paralysis, Wheelchair user
After the vaccine patient got the dreaded Guillain Barre; paralyzed; This serious case was reported ... After the vaccine patient got the dreaded Guillain Barre; paralyzed; 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 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 guillain barre syndrome (Verbatim: After the vaccine patient got the dreaded Guillain Barre) (serious criteria hospitalization and GSK medically significant) and paralysis (Verbatim: paralyzed) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome and paralysis were not reported. It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to RSV vaccine. The company considered the guillain barre syndrome and paralysis to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 23-SEP-2025 This case was reported by a patient via interactive digital media. The patient spent the next and half months in the hospital paralyzed and came home in a wheelchair. The patient said he/she would rather have had the virus.; Sender's Comments: A case of Guillain-Barre syndrome and Paralysis, an unknown time 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
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2861925 F PA 09/29/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5G23D
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Kinrix was administered instead of Pedirix to a four-month-old patient; Underage administration of K... Kinrix was administered instead of Pedirix to a four-month-old patient; Underage administration of Kinrix instead of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Concomitant products included Pediarix. On 05-SEP-2025, the patient received Kinrix. The patient did not receive Pediarix. On 05-SEP-2025, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was administered instead of Pedirix to a four-month-old patient) and inappropriate age at vaccine administration (Verbatim: Underage administration of Kinrix instead of Pediarix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. More
2861926 OK 09/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
patient was administered only the diluent for the dose of Shingrix and it was not reconstituted with... patient was administered only the diluent for the dose of Shingrix and it was not reconstituted with the powder; patient was administered only the diluent for the dose of Shingrix and it was not reconstituted with the powder; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: patient was administered only the diluent for the dose of Shingrix and it was not reconstituted with the powder) and inappropriate preparation of medication (Verbatim: patient was administered only the diluent for the dose of Shingrix and it was not reconstituted with the powder). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date:11-SEP-2025 The patient was administered only the diluent for the dose of Shingrix and it was not reconstituted with the powder. More
2861927 F TX 09/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Peripheral swelling Peripheral swelling
arm got swollen after receiving Shingrix.; This non-serious case was reported by a consumer via pat... arm got swollen after receiving Shingrix.; This non-serious case was reported by a consumer via patient support programs and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included acetylsalicylic acid, ascorbic acid (Aspirin) and metoprolol succinate (Metoprolol). In APR-2025, the patient received Shingrix. In APR-2025, less than a day after receiving Shingrix, the patient experienced swelling arm (Verbatim: arm got swollen after receiving Shingrix.). The outcome of the swelling arm was not resolved. It was unknown if the reporter considered the swelling arm to be related to Shingrix. It was unknown if the company considered the swelling arm to be related to Shingrix. More
2861928 F 09/29/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 C3207
Urticaria Urticaria
Hives; This non-serious case was reported by a consumer and described the occurrence of hives in a 2... Hives; This non-serious case was reported by a consumer and described the occurrence of hives in a 24-year-old female patient who received HBV (Engerix B) (batch number C3207) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced hives (Verbatim: Hives). The outcome of the hives was not resolved. It was unknown if the reporter considered the hives to be related to Engerix B. It was unknown if the company considered the hives to be related to Engerix B. Additional Information: GSK receipt date: 16-SEP-2025 The seriousness for hives was reported as intervention required. The reporter would like to be contacted to provide the whole story and context of the severity of the reaction. More
2861929 F AZ 09/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Inappropriate vaccine schedule; This non-serious case was reported by a consumer via call center rep... Inappropriate vaccine schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (first dose was administered approximately three years ago). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: Inappropriate vaccine schedule). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 16-SEP-2025 The patient self-reported this case for herself. More
2861930 09/29/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; shingles/most painful experience; This serious case was reported by a... Suspected vaccination failure; shingles/most painful experience; 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 (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included aneurysm (in 2008 and operated 8 times). 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/most painful experience). 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 Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 28-AUG-2025 This case was reported by a patient via interactive digital media. The patient had shingles for 6 times, and it was the most painful experience that I've ever had. The patient had an aneurysm in 2008 and was operated on eight times but still the patient can't remember this pain at all. I could not anything more painful This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, on an unknown after receiving Herpes Zoster vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received More
2861931 M 09/29/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure 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. 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: 20-SEP-2025 The reporter's husband had the shingles shot and still got shingles. He had them right now at the time of reporting. 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: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a male 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
2861932 09/29/2025 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 it on my head twice; This serious case was reported by a consumer... Suspected vaccination failure; Had it on my head twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. 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 it on my head twice). 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: 21-SEP-2025 The patient had shingles on head twice, 30 years apart. The reporter was mentioned the second time was really killer and got both jab 2 shots of the vaccine. 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, an unknown time after receiving Shingles vaccine (dose 1 and dose 2), 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
2861933 09/29/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had on and off since was a teenager in the same spots). 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 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: 22-SEP-2025 This case was reported by a patient via interactive digital media. The patient broke out with another round of shingles about two months ago after completing the series of shots, but the vaccine did not work. The patient mentioned having another flare up, except there was no rash and just pain in the same areas as usual. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine ( 1st and 2nd dose), 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
2861934 0.17 M MO 09/29/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Unapproved age/ 2 months old received Kinrix; 2 months old received Kinrix instead of Pediarix; This... Unapproved age/ 2 months old received Kinrix; 2 months old received Kinrix instead of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On an unknown date, the patient received Kinrix and did not receive Pediarix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age/ 2 months old received Kinrix) and wrong vaccine administered (Verbatim: 2 months old received Kinrix instead of Pediarix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 28-AUG-2025 The reporter reported that they had a baby in their practice who was administered a Kinrix vaccine in 2025, and it looks like he, the vaccine that, he should have been administered was the Pediarix because his age at the time of the administration was three to two months old. The reporter had question for his following shot, it looked like the only difference between the two, was that the Kinrix have a Hepatitis component was that correct and so, if patient received the Hepatitis B and the Kinrix, separately, it affects the spacing of any of his following vaccines. Ther reporter asked that they need to change anything with his schedule. More
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