🏥 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 💀 🏥 🚑 ♿ ⚠️
2865029 F ME 10/10/2025 COVID19
 PFIZER\BIONTECH
Malaise Malaise
With previous doses would feel crummy for a day or two; This is a spontaneous report received from a... With previous doses would feel crummy for a day or two; This is a spontaneous report received from an Other HCP. A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 9), for Covid-19 immunization; Covid-19 vaccine (Dose 10), for Covid-19 immunization; Covid-19 vaccine (Dose 11), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "With previous doses would feel crummy for a day or two". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2865030 F ME 10/10/2025 COVID19
 PFIZER\BIONTECH
Malaise Malaise
would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other n... would feel crummy for a day or two; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 5, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 2: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 3: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy"; Bnt162b2 (Dose 4: in Left arm), for Covid-19 immunization, reaction(s): "With previous doses would feel crummy". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "would feel crummy for a day or two". Additional information: Caller has always had the Pfizer, has probably had 11 doses so far of the Pfizer COVID-19 vaccine, was working in healthcare before. Fifth dose date does not have dates handy at time of call, could get if needed. Dose, route, anatomical location: Thinks all doses were in left arm since caller was right handed. With early doses had no problems, just with the last two doses. With previous doses would feel crummy for a day or two, as people do after any immunization. Batch/lot number is not provided, and it cannot be obtained. More
2865031 10/10/2025 RSV
 UNKNOWN MANUFACTURER
Aphonia, Dry throat Aphonia, Dry throat
Dry throat; Losing voice; This is a spontaneous report received from a consumer. A patient (age and... Dry throat; Losing voice; This is a spontaneous report received from a consumer. A patient (age and gender not provided) received RSV Vaccine Prot.Subunit Pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRY THROAT (non-serious), outcome "unknown"; APHONIA (non-serious), outcome "unknown", described as "Losing voice". Additional Information: The patient wanted to ask a question about the Pfizer RSV shot (also reported as unspecified). The patient asked what some of the reactions from the RSV shots are because the patient had been having a dry throat and losing voice. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2865032 10/10/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Feeling abnormal; Feeling abnormal Feeling abnormal; Feeling abnormal
feeling sort of bad for a week or two; This is a spontaneous report received from a Consumer or othe... feeling sort of bad for a week or two; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789418 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2024 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown (booster), single intramuscular for covid-19 prophylaxis. The patient's relevant medical history included: "Osteopenia" (ongoing); "Selective IgG immunodeficiency", start date: 2014 (unspecified if ongoing); "Asthma", start date: 2021 (ongoing); "Sleep apnea", start date: 2020 (ongoing); "Allergy to gold" (unspecified if ongoing); "Contrast media allergy" (ongoing), notes: Iodinated contrast; "Adhesive tape allergy" (ongoing), notes: glue on tape; "Allergy to silk" (ongoing), notes: silk suture; "allergic to EKG leads" (unspecified if ongoing); "IgG deficiency", start date: 2014 (ongoing); "Allergy to metals" (ongoing). Concomitant medication(s) included: RALOXIFENE HYDROCHLORIDE taken for osteopenia, start date: 2022 (ongoing); FLUTICASONE FUROATE taken for asthma, start date: 2021. Past drug history included: Tymlos, reaction(s): "Drug allergy", notes: Ongoing: Yes; Limbrel, reaction(s): "Drug allergy", notes: Ongoing: Yes; Ampicillin, reaction(s): "Allergy to antibiotic", notes: Ongoing: Yes; Amoxicillin, reaction(s): "Allergy to antibiotic", notes: Ongoing: Yes; Erythromycin, reaction(s): "Allergy to antibiotic", notes: Ongoing: Yes. Vaccination history included: Pfizer biontech covid-19 vaccine (DOSE NUMBER UNKNWON, SINGLE (previously received multiple Pfizer doses).). The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "feeling sort of bad for a week or two". Additional information: This spontaneous case was reported by a consumer and describes the occurrence of feeling abnormal (feeling sort of bad for a week or two) in a patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Previously administered products included for Drug use for unknown indication: Tymlos, Limbrel, Ampicillin, Amoxicillin continued in additional info section. and Erythromycin; for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine (previously received multiple Pfizer doses). Past adverse reactions to the above products included No adverse effect with Amoxicillin, Ampicillin, Erythromycin, Limbrel, Pfizer BioNTech COVID-19 vaccine and Tymlos. Concurrent medical conditions included Osteopenia, Selective IgG immunodeficiency since 2014, Asthma since 2021, Sleep apnea since 2020, Allergy to gold, Allergy to antibiotic (Amoxicillin), Allergy to antibiotic (Ampicillin), Allergy to antibiotic (Erythromycin), Drug allergy (Limbrell), Contrast media allergy (Iodinated contrast), Adhesive tape allergy (glue on tape), Allergy to silk (silk suture) and Drug allergy (Tymlos). Concomitant products included Fluticasone Furoate (Arnuity ellipta) from 2021 to an unknown date for Asthma, Raloxifene hydrochloride (Raloxifene) from 2022 to an unknown date for Osteopenia. In 2024, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling sort of bad for a week or two). At the time of the report, FEELING ABNORMAL (feeling sort of bad for a week or two) had resolved. It was reported that the patient was allergic to EKG leads. Patient had previously received multiple Pfizer doses, a Moderna booster, and another Pfizer booster last year. Patient had felt sort of bad for a week or two after previous COVID-19 vaccinations but clarified it was nothing unusual. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported. This case was linked to MOD-2025-789628 (Patient Link). Most recent follow-up information incorporated above includes: On 24Sep2025: Significant follow-up information received contains reporter address, patient demographics, medical history, concomitant medicines added, and narrative updated. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : MOD-2025-789628 Patient Link; More
2865033 75 F NC 10/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
had the vaccine on the 11th of September, and I got COVID two weeks ago, today; had the vaccine on t... had the vaccine on the 11th of September, and I got COVID two weeks ago, today; had the vaccine on the 11th of September, and I got COVID two weeks ago, today; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 75-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization; Paxlovid, for Covid-19 treatment. The following information was reported: COVID-19 (non-serious) with onset 2025, outcome "unknown", DRUG INEFFECTIVE (non-serious) with onset 11Sep2025, outcome "unknown" and all described as "had the vaccine on the 11th of September, and I got COVID two weeks ago, today". Additional information: The patient said that I already had the vaccine two weeks about two and a half weeks before I got COVID, and it was Pfizer. So, and I've never had COVID. And I've always had Pfizer vaccines. It was my first time, and I've had all the vaccines, Right and I am 75 years old, so you know I need it I got very, very sick. I'm still sick, actually. Not as bad, after the Paxlovid. Definitely I think helped. When asked if Paxlovid was taken previously or if it was just the Pfizer vaccine, patient stated, I had the vaccine on the 11Sep, and I got COVID two weeks ago, today, because I've never had it before, and I've always gotten the COVID vaccines, the Pfizer, from the get-go, And I've ya know gotten it every day. I did not do the booster this year in the Spring. It was the first time I haven't done that so then, I wanted to go ahead and get it so, I got it on the 11th, and two weeks later, I have COVID. Which has nothing to do with that No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2865034 10/10/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
got infected; got infected; This is a spontaneous report received from a Consumer or other non HCP, ... got infected; got infected; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization Series Completed), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got infected". Clinical course: stated that after 4 or 5 vaccines, they still got infected. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500120053 Same reporter/product/event, different patient; More
2865035 M 10/10/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Impaired work ability, Initial insomnia, Local reaction, Loss of personal indepe... Impaired work ability, Initial insomnia, Local reaction, Loss of personal independence in daily activities, Mobility decreased; Sleep disorder More
local reaction(s) impacted performing daily life activities, taking care of themselves, performing h... local reaction(s) impacted performing daily life activities, taking care of themselves, performing household chores, their ability to work, their ability to do social activities, their ability to exercise; local reaction(s) impacted A LITTLE falling asleep, changing positions during the night; local reaction(s) impacted moving or lifting the arm; Initial information received on 30-Sep-2025 regarding a solicited valid serious case received from a consumer/non-hcp (healthcare professional), in the scope of post-marketing sponsored study (withheld). Study Title: Cross-sectional study to assess tolerability of the trivalent recombinant vaccine in individuals between 18 and 64 years old using the Vaccinees Perception of Injection. This case involves Adult male patient who experienced local reaction(s) impacted performing daily life activities, taking care of themselves, performing household chores, their ability to work, their ability to do social activities, their ability to exercise, local reaction(s) impacted a little falling asleep, changing positions during the night and local reaction(s) impacted moving or lifting the arm after receiving Influenza Trivalent Recombinant Vaccine. 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 Influenza Trivalent Recombinant Vaccine, Solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation). Information regarding batch number corresponding to the one at time of event occurrence is requested. On an unknown date the patient developed local reaction(s) impacted performing daily life activities, taking care of themselves, performing household chores, their ability to work, their ability to do social activities, their ability to exercise (loss of personal independence in daily activities), impacted a little falling asleep, changing positions during the night (initial insomnia) and impacted moving or lifting the arm (vaccination site movement impairment) (unknown latency) 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 Recovered / Resolved on an unknown date for all the events. Reporter causality: Not reported for all the events. Company causality: Reportable for all the events. Seriousness Criteria- This event was leading to disability.; Sender's Comments: Sanofi company comment dated 07-Oct-2025: This case involves Adult male patient who experienced local reaction(s) impacted performing daily life activities, taking care of themselves, performing household chores, their ability to work, their ability to do social activities, their ability to exercise, local reaction(s) impacted a little falling asleep, changing positions during the night and local reaction(s) impacted moving or lifting the arm after receiving Influenza Trivalent Recombinant Vaccine. Further information regarding exact timing of vaccination and symptom onset,specific age of the patient,medical history, particularly any history of hypersensitivity reactions or previous vaccine reactions,concomitant medications,detailed description of the local reaction (size, appearance, temperature, etc.),duration of symptoms before resolution,any medical intervention was sought or provided,specific injection technique and site,results of any physical examination or diagnostic procedures will aid in comprehensive case assessment. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
✓
2865038 F 10/10/2025 FLU3
 SANOFI PASTEUR
Injection site erythema Injection site erythema
local reactions at vaccination arm/site experienced following Flublok administration were a little i... local reactions at vaccination arm/site experienced following Flublok administration were a little intense; Initial information received on 04-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp(non-healthcare professional). This case involves Adult female patient who had local reactions at vaccination arm/site, were a little intense after receiving Influenza Trivalent Recombinant Vaccine [Flublok]. 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 Influenza Trivalent Recombinant Vaccine, Solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date, the patient developed local reactions at vaccination arm/site, were a little intense (vaccination site reaction) (latency unknown) following the administration of Influenza Trivalent Recombinant Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event. More
2865041 NY 10/10/2025 DTAPIPVHIB
FLU3
HIBV
MEN
TD
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
UNKNOWN MANUFACTURER
SANOFI PASTEUR
SANOFI PASTEUR





Product storage error; Product storage error; Product storage error; Product sto... Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error More
temperature excursions.products: menquadfi, acthib, pentacel, adacel, tenivac and fluzone duration o... temperature excursions.products: menquadfi, acthib, pentacel, adacel, tenivac and fluzone duration out of labelled range: 20.2c (first excursion) and -1.1c administered to a patient with no reported adverse event.; Initial information received on 07-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an unknown age and gender patient who had temperature excursions of products: Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone], Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac], Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel], Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel], HIB (PRP/T) Vaccine [ACT-HIB] and Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] duration out of labelled range: 20.2c (first excursion) and -1.1c administered to a patient 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 a dose of (all unopened) suspect Influenza Quadrival A-B Multidose Vaccine Preserved; Suspension for injection, Meningococcal A-C-Y-W135 (T Conj) Vaccine; Solution for injection, HIB (PRP/T) Vaccine; Powder and solvent for solution for injection, Diphtheria/Tetanus/5 HYBRID AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine; Suspension for injection, Diphtheria-2/Tetanus/5 AC Pertussis Vaccine; Suspension for injection and Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult; Suspension for injection all with unknown (lot number, strength, dose and exoriy date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation); temperature excursions; duration out of labelled range: 20.2c (first excursion) and -1.1c administered to a patient with no reported adverse event. (product storage error) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly:The first excursion occurred due to the refrigerator breaking. The second excursion occurred due to the data logger being placed in a plastic basket.Max/low temperature reached: 2 hours (first excursion) and 51 minutes (second excursion)Duration out of labelled range: 20.2C (first excursion) and -1.1C (second excursion)Human error? NO (first excursion) and YES (second excursion).Does extended stability data cover the excursion? NO If negative advice, was the product administered to a patient? YES Caller confirmed that some of the products were administered after the second excursion (when the products would have no longer been viable), but she wasn't sure which products were administered. 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
2865044 10/10/2025 UNK
 UNKNOWN MANUFACTURER
 No batch number
Cough Cough
Consistent coughing; This spontaneous case, initially received on 02-Oct-2025, was reported by a hea... Consistent coughing; This spontaneous case, initially received on 02-Oct-2025, was reported by a health professional and concerns an elderly patient. At the time of this report, the patient was elderly. Relevant medical history included comorbidities. Concomitant medication was unknown. Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease, Dose regimen: not reported, Route of administration: not reported; Anatomical Location: not reported, Lot number: No batch number available, would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Consistent coughing (Medically Significant, outcome: Unknown). An elderly patient with comorbidities was given a dose of Fluad and experienced overnight consistent coughing and ended up in the emergency room. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter considered the event Consistent coughing as serious (Medically Significant) and did not provide the causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the event is considered related for reporting purposes. Related for the event cough as there is an implied temporal plausibility (was given a dose of Fluad and experienced overnight consistent coughing). However, further information is required regarding relevant medical history, concomitant medications, final diagnosis etc to perform in-depth analysis. However patient's elderly age and underlying medical history of comorbidities could be a confounder for the event. More
2865057 65 F NC 10/10/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 na0587
ut8820ca
Dyspnoea, Pharyngeal swelling, Swelling face, Throat tightness; Dyspnoea, Pharyn... Dyspnoea, Pharyngeal swelling, Swelling face, Throat tightness; Dyspnoea, Pharyngeal swelling, Swelling face, Throat tightness More
Patient received vaccinations and then started experiencing swelling in face/throat. Throat started ... Patient received vaccinations and then started experiencing swelling in face/throat. Throat started to close with breathing worsening. Patient already had taken benadryl previous to vaccination, so epinephrine 0.3 mg injection was administered at 4:12 pm and ems was called and arrived at 4:19 pm. More
2865058 38 F 10/10/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Headache, Hot flush, Immediate post-injection reaction, Injection site pruritus,... Headache, Hot flush, Immediate post-injection reaction, Injection site pruritus, Injection site swelling; Throat tightness More
Immediately following administration of flu vaccine felt full body hot flash, throat closing up, and... Immediately following administration of flu vaccine felt full body hot flash, throat closing up, and headache. Shortly after itching and swelling at site of injection More
2865059 84 F NH 10/10/2025 COVID19
PNC20
RSV
 PFIZER\BIONTECH
PFIZER\WYETH
PFIZER\WYETH
 NA0589
MA2488
MM9161
Malaise, Nausea; Malaise, Nausea; Malaise, Nausea Malaise, Nausea; Malaise, Nausea; Malaise, Nausea
Patient reported experiencing nausea and feeling sick. She went to the hospital. Patient reported experiencing nausea and feeling sick. She went to the hospital.
✓
2865060 38 F 10/10/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Headache, Hot flush, Immediate post-injection reaction, Injection site pruritus,... Headache, Hot flush, Immediate post-injection reaction, Injection site pruritus, Injection site swelling; Throat tightness More
Immediately after injection had full body hot flash, headache, and throat began closing up. Shortly ... Immediately after injection had full body hot flash, headache, and throat began closing up. Shortly after itching and swelling of arm where vaccine was injected More
2865061 4 M OR 10/10/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3053253
UT8858JA
Dyspnoea, Pallor, Tachycardia, Vomiting; Dyspnoea, Pallor, Tachycardia, Vomiting Dyspnoea, Pallor, Tachycardia, Vomiting; Dyspnoea, Pallor, Tachycardia, Vomiting
Patient received vaccines and then went to leave with family. On his way out, he vomited x 3 in the ... Patient received vaccines and then went to leave with family. On his way out, he vomited x 3 in the waiting room. Was brought back for monitoring and to retake vitals, where he appeared pale. Patient also noted he felt like it was hard to breathe transiently, but this resolved on its own. Vitals were stable aside from transient tachycardia, patient was monitored and then d/c without further intervention once returned to baseline. It should be noted patient was highly anxious to receive vaccines. More
2865062 64 F NC 10/10/2025 PNC20
 PFIZER\WYETH
 LX4486
Extra dose administered, Pain in extremity Extra dose administered, Pain in extremity
Patient was given second dose of Prevnar20. First dose given back in 2024. Patient stated she was on... Patient was given second dose of Prevnar20. First dose given back in 2024. Patient stated she was only experiencing a sore arm and no systemic effects. Informed patient to reach out to pcp if she notices any new adverse effects. More
2865067 18 F CA 10/10/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 MB599
Peripheral swelling Peripheral swelling
Arm swollen and hard to move. Arm swollen and hard to move.
2865068 70 F IN 10/10/2025 PNC20
 PFIZER\WYETH
 LG5576
Cellulitis Cellulitis
PT DEVELOPED CELLULITIS PT DEVELOPED CELLULITIS
2865069 44 F WA 10/10/2025 FLU3
 SEQIRUS, INC.
 948402
Lymph node pain, Lymphadenopathy Lymph node pain, Lymphadenopathy
Enlarged painful lymph node under left jaw. Enlarged painful lymph node under left jaw.
2865070 6 M SC 10/10/2025 FLU3
 SANOFI PASTEUR
 UT8792KA
Injection site erythema, Pruritus Injection site erythema, Pruritus
Mom Stated: On 10/7/2025 arm was ok, he went played soccer; On 10/08/25 he went to the nurse at scho... Mom Stated: On 10/7/2025 arm was ok, he went played soccer; On 10/08/25 he went to the nurse at school said it was itching, the nurse saw light pink area due to him scratching the area but no swelling; woke up on 10/09/25 it was red from the injection site to the elbow, so she made an appointment with his pediatrician Dr for 1:45 pm; The mother did not medicate him, only the nurse had applied some topical Benadryl Cooling Anti Itch gel on 10/08/2025 once. More
2865071 22 F SC 10/10/2025 FLU3
HEPAB
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 u8832da
az2a3
Fall, Loss of consciousness; Fall, Loss of consciousness Fall, Loss of consciousness; Fall, Loss of consciousness
patient passed out and fell a few minutes after getting the two vaccines patient passed out and fell a few minutes after getting the two vaccines
2865073 80 F NM 10/10/2025 COVID19
FLU3
PNC20
 MODERNA
SANOFI PASTEUR
PFIZER\WYETH
 3052732
UT8763FA
MG7416
Seizure; Seizure; Seizure Seizure; Seizure; Seizure
patient had a seizure for 1 to 2 minutes, awakened and went about her day patient had a seizure for 1 to 2 minutes, awakened and went about her day
2865075 48 F NH 10/10/2025 COVID19
 PFIZER\BIONTECH
 my9548
Extra dose administered, No adverse event, Wrong product administered Extra dose administered, No adverse event, Wrong product administered
No adverse events reported. Documenting because patient inadvertently received 2 Covid 19 Vaccines ... No adverse events reported. Documenting because patient inadvertently received 2 Covid 19 Vaccines at a single visit rather than a flu and covid vaccine. More
2865076 79 F NC 10/10/2025 FLU3
 SANOFI PASTEUR
 u8859ca
Injection site pain, Injection site swelling Injection site pain, Injection site swelling
Patient received HD flu vaccination in left arm and subsequently a covid booster (MNEXSPIKE) in the ... Patient received HD flu vaccination in left arm and subsequently a covid booster (MNEXSPIKE) in the right arm. Injections were performed by certified immunizing pharmacy technician. Within a few minutes, the patient reported it felt like her arm was swelling. She noted there was some pain when the vaccine was originally administered. Placement of vaccine was reviewed as well as arm swelling by the pharmacist on duty. Vaccine placement was within appropriate deltoid region for vaccination. Swelling around the injection site was noted, but no erythema present. The patient was provided an ice pack that quickly reduced the swelling. Patient remained in pharmacy for monitoring for an additional 30 minutes until she requested to leave as she was feeling fine and swelling had gone down. She reported no signs of anaphylaxis or any additional symptoms. After confirming with patient she refused any additional treatment and arm swelling subsided, she left with husband. More
2865077 40 F ND 10/10/2025 FLU3
 SEQIRUS, INC.
Abdominal discomfort, Vomiting Abdominal discomfort, Vomiting
Upset stomach began approximately one hour after vaccine was administered and became increasingly wo... Upset stomach began approximately one hour after vaccine was administered and became increasingly worse until vomiting occurred approximately. three hours after vaccine was administered. More
2865078 53 F GA 10/10/2025 COVID19
 PFIZER\BIONTECH
 MY9550
Extra dose administered Extra dose administered
PATIENT RECEIVED COMIRNATY 2024-2025 ON 8/25/2025 AND COMIRNATY 2025-2026 ON 10/9/25. TWO DOSES LESS... PATIENT RECEIVED COMIRNATY 2024-2025 ON 8/25/2025 AND COMIRNATY 2025-2026 ON 10/9/25. TWO DOSES LESS THAN 2 MONTHS APART. PATIENT HAS NOT RESPONDED YET ABOUT ANY ISSUES. More
2865079 84 F FL 10/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 bg5j4
Extra dose administered Extra dose administered
unknown. this is patient's 3rd rsv shot. unknown. this is patient's 3rd rsv shot.
2865080 88 M FL 10/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 bg5j4
Extra dose administered Extra dose administered
unknown. called patient and had to leave voicemail on phone. this is patient's 3rd rsv dose. unknown. called patient and had to leave voicemail on phone. this is patient's 3rd rsv dose.
2865081 75 M FL 10/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 bg5j4
Extra dose administered Extra dose administered
Patient received an extra RSV vaccine. He received one in 2023, and again in 2025. Patient received an extra RSV vaccine. He received one in 2023, and again in 2025.
2865082 69 F CO 10/10/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 NA0738
NA0738
Chills, Injection site erythema, Injection site pain, Injection site warmth, Mal... Chills, Injection site erythema, Injection site pain, Injection site warmth, Malaise; Pruritus More
Patient reported having a sore arm at injection site with redness and discussed this with primary ca... Patient reported having a sore arm at injection site with redness and discussed this with primary care provider 2 days later, at the time it was deemed a common localized reaction associated with vaccinations. Patient called the pharmacy (me) the day after seeing primary care reporting that last night she had the chills and arm was very itchy, now feeling ill and redness at injection site now felt warm to the touch. Advised patient to reach out to primary care in case of localized infection. I also contacted primary care to notify them as well. Due to more generalized symptoms of infection also recommended patient to do at home covid test while waiting to see primary care. Patient requested reporting adverse reaction to VAERs and discussed self reporting options as well. Asked patient to follow up with us but also intend to reach out to patient for follow up if she doesn't call us back. More
2865083 63 F FL 10/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Fatigue, Pyrexia, Rash Fatigue, Pyrexia, Rash
Patient states she had extreme fatigue, fever, and rash over entire body the morning after vaccinati... Patient states she had extreme fatigue, fever, and rash over entire body the morning after vaccination. She states that she thinks she had a Shingrix series of two shots 10-15 years ago, and that she is very sensitive to medication and immunizations. More
2865084 67 F CA 10/10/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052731
UT8794CA
Cough, Pruritus, Respiratory disorder, Sneezing, Urticaria; Cough, Pruritus, Res... Cough, Pruritus, Respiratory disorder, Sneezing, Urticaria; Cough, Pruritus, Respiratory disorder, Sneezing, Urticaria More
Pt developed hives on ride side of body from breast to panty line that was also itching. She also de... Pt developed hives on ride side of body from breast to panty line that was also itching. She also developed cough, sneezing and breathing problems. She claimed she took "an anti itch pill" and that seemed to help. Pt declined further need for care, but would continue to take the pill as needed. More
2865085 68 M CA 10/10/2025 FLU3
 SANOFI PASTEUR
 UT8794CA
Extra dose administered Extra dose administered
Patient was accidently given the vaccine twice. (1st dose on 9/2/25 and 2nd dose on 10/9/25) Patient was accidently given the vaccine twice. (1st dose on 9/2/25 and 2nd dose on 10/9/25)
2865086 67 F CA 10/10/2025 FLU3
 SANOFI PASTEUR
 UT8794CA
Extra dose administered Extra dose administered
Patient was accidently given the vaccination twice. (1st dose on 9/25/25 and 2nd dose on 10/9/25) Patient was accidently given the vaccination twice. (1st dose on 9/25/25 and 2nd dose on 10/9/25)
2865088 34 M NV 10/10/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 947932
Dyspnoea, Peripheral swelling Dyspnoea, Peripheral swelling
Pt got 4 vaccines on 09/12/2025 Heplisav, Gardasil,Adacel,and Flublok, when pt comes back on 10/10/2... Pt got 4 vaccines on 09/12/2025 Heplisav, Gardasil,Adacel,and Flublok, when pt comes back on 10/10/2025 for 2nd dose of Heplisav he states that he must of had an alergic reaction to one of the vaccines because on 9/14/2025 his left arm was swollen and he was having trouble breathing. He went to ER and they drew blood and he was fine swelling eventually went down and pt was back for second dose today. He only has vaccines here and no primary MD to notify. More
2865089 36 F IL 10/10/2025 FLU3
FLU3
RSV
 SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
 TFAA2539
U8859DA
LN5492
Incorrect dose administered; Incorrect dose administered; Incorrect dose adminis... Incorrect dose administered; Incorrect dose administered; Incorrect dose administered More
Patient was given the Fluozone HD by mistake. Patient was also given Abrysvo and FLublok. Immunizing... Patient was given the Fluozone HD by mistake. Patient was also given Abrysvo and FLublok. Immunizing tech realized this and reported to the pharmacist on duty. Patient was informed and consulted. Pharmacy to contact patient to follow up and report on any adverse reactions that ma occur due to vaccination. More
2865272 70 F NJ 10/10/2025 FLUX
 UNKNOWN MANUFACTURER
Contusion Contusion
L arm bruise 30 min after vaccination received. L arm bruise 30 min after vaccination received.
2864498 F IL 10/09/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Human papilloma virus test positive; Human papilloma virus test positive; Human ... Human papilloma virus test positive; Human papilloma virus test positive; Human papilloma virus test positive More
patient came back with recent pap test abnormalities with positive for some of the unspecified HPV t... patient came back with recent pap test abnormalities with positive for some of the unspecified HPV types; This spontaneous report was received from a Nurse and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 27-Feb-2023, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), 1 dosage form, administered for prophylaxis (route of administration, anatomical site of injection, lot # and expiration date were not reported). On 01-Jun-2023, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), 1 dosage form, administered for prophylaxis (route of administration, anatomical site of injection, lot # and expiration date were not reported). On 05-Feb-2024, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), 1 dosage form, administered for prophylaxis (route of administration, anatomical site of injection, lot # and expiration date were not reported). On 29-Sep-2025, Pap test showed Pap test abnormalities with positive results for some of the unspecified HPV types and negative for type 16, 18, and 45 (Human papilloma virus test positive). At the reporting time, the outcome of the event was unknown. The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant was not reported. More
2864499 22 F CO 10/09/2025 UNK
 UNKNOWN MANUFACTURER
 U8823AA
Exposure during pregnancy, Extra dose administered, No adverse event Exposure during pregnancy, Extra dose administered, No adverse event
pregnant patient who was given 2 shots of flu vaccines with no reported adverse event; pregnant pati... pregnant patient who was given 2 shots of flu vaccines with no reported adverse event; pregnant patient who was given 2 shots of flu vaccines with no reported adverse event; Initial information received on 03-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 22-year-old female pregnant patient who was given 2 shots of influenza trivalent recombinant vaccine [Flublok TIV] with no reported adverse event. Data regarding this pregnancy was received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient who was given 2 shots of flu vaccines with no reported adverse event occurred at 31 weeks of pregnancy, during third pregnancy trimester for Influenza Trivalent Recombinant Vaccine. The date of last menstrual period was reported as 21-Feb-2025. The estimated due date is 28-Nov-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 30-Sep-2025, the pregnant patient received a 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection of lot U8823AA and expiry date: 31-May-2026 strength: standard via unknown route in unknown administration site for influenza (influenza immunization) and immunization 2 shots of flu vaccines with no reported adverse event (extra dose administered) (exposure during pregnancy) (latency: on same day). Reportedly, AE (adverse event) symptoms: None and Flu PF on 23-SEP-2025 and Caller also mentioned that the patient would get an RSV (respiratory syncytial virus) vaccine, Abrysvo, a week later and asked if it was okay. No adverse reaction was reported 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
2864516 10 F OR 10/09/2025 COVID19
 PFIZER\BIONTECH
 MY9547
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Prefill syringe of Comirnaty 0.3 ml was given to patient instead of vial dose for child 5-11 year ol... Prefill syringe of Comirnaty 0.3 ml was given to patient instead of vial dose for child 5-11 year old. Mom insisted on getting the Covid 19 vaccine for her daughter. When we call to let her know her daughter got the prefill syringe for 12 years of age and older instead of the child dose vial mom said her daughter is doing ok, will monitor, and she will call doctor to get prescription for covid vaccine for her daughter if necessary. More
2864522 66 F AR 10/09/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 2N795
Incorrect route of product administration Incorrect route of product administration
Priorix vaccine it was given IM instead of SC; This non-serious case was reported by a pharmacist v... Priorix vaccine it was given IM instead of SC; 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 66-year-old female patient who received MMR (Priorix) (batch number 2N795) for prophylaxis. On 17-SEP-2025, the patient received Priorix (intramuscular). On 17-SEP-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix vaccine it was given IM instead of SC). 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: 17-SEP-2025 The Priorix vaccine had been given intramuscularly instead of subcutaneously. More
2864523 M MA 10/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Late second dose; This non-serious case was reported by a pharmacist via call center representative... Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Received 1st dose of vaccine on 9th January 2024 with batch number C4325 and expiry date 16-SEP-2025). The patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 17-SEP-2025 A pharmacist called to report that a patient had received the first dose of Shingrix on 9th January 2024. The pharmacist inquired whether the series needed to be restarted or if revaccination was required. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2864524 F MA 10/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ASKU
Herpes zoster, Post herpetic neuralgia Herpes zoster, Post herpetic neuralgia
shingles after vaccination; PHN after vaccination; This non-serious case was reported by a physician... shingles after vaccination; PHN after vaccination; This non-serious case was reported by a physician via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number ASKU) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, more than a year after receiving Shingrix, the patient experienced shingles (Verbatim: shingles after vaccination) and post herpetic neuralgia (Verbatim: PHN after vaccination). The patient was treated with gabapentin and valacyclovir. The outcome of the shingles and post herpetic neuralgia were unknown. It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix. Additional Information: GSK Receipt Date: 17-SEP-2025 MD reported that her first cousin, approximately 55 years old, had shingles and received the Shingrix vaccine a couple of years later (8 years ago). A year after the vaccination (7 years ago), she experienced breakthrough shingles, which never resolved. She had been on gabapentin for postherpetic neuralgia for 7 years and took Valacyclovir during recurrences, though the frequency of those episodes was unclear. More
2864529 41 F TN 10/09/2025 FLU3
 SANOFI PASTEUR
 UT8781BA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
41 years old who was erroneously given the fluzone high dose with no reported adverse event; Initial... 41 years old who was erroneously given the fluzone high dose with no reported adverse event; Initial information received on 06-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 41 years old female patient who was erroneously given the influenza USP trival A-B HIGH dose subvirion vaccine [fluzone HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20 and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix), both for Immunisation. On 06-Oct-2025, the patient erroneously given 0.5 ml of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of high strength with lot UT8781BA and expiry date 30-Jun-2026 via intramuscular route in the left deltoid for Influenza (Influenza immunisation) 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
2864567 11 CO 10/09/2025 HPV4
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, Interchange of vaccine product... Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event; Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event More
No additional AE; patient received his 1st dose of GARDASIL 4 valent on 11/6/2018 at age 11 years 10... No additional AE; patient received his 1st dose of GARDASIL 4 valent on 11/6/2018 at age 11 years 10 months and did not return for a second dose until 6/23/2025 and received GARDASIL 9 at that time; patient received his 1st dose of GARDASIL 4 valent on 11/6/2018 at age 11 years 10 months and did not return for a second dose until 6/23/2025 and received GARDASIL 9 at that time; patient received his 1st dose of GARDASIL 4 valent on 11/6/2018 at age 11 years 10 months and did not return for a second dose until 6/23/2025 and received GARDASIL 9 at that time; This spontaneous report was received from a pharmacist and refers to an 18-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-Nov-2018, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) suspension for injection, dose number 1, administered by unknown route (lot # and expiration date were not reported) as prophylaxis. On 23-Jun-2025, the patient received the 2nd dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) suspension for injection, administered by unknown route (lot # and expiration date were not reported) as prophylaxis (Inappropriate schedule of product administration, Interchange of vaccine products, Wrong product administered). No additional adverse events. At the reporting time, the outcome of the events was unknown. More
2864571 10/09/2025 PNC21
UNK
 MERCK & CO. INC.
UNKNOWN MANUFACTURER

Laryngeal pain, Pain, Pain of skin; Laryngeal pain, Pain, Pain of skin Laryngeal pain, Pain, Pain of skin; Laryngeal pain, Pain, Pain of skin
left side scalp sore; area behind left ear intermittent pain; left side of larynx sore; This spontan... left side scalp sore; area behind left ear intermittent pain; left side of larynx sore; This spontaneous report was received from a patient and refers to themself, 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 Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Solution for injection (exact dose, dose number, route of administration, lot # and expiration date were not reported); and with respiratory syncytial virus (RSV) vaccine (GSK) (formulation, exact dose, dose number, route of administration, lot # and expiration date were not reported) both for prophylaxis. On an unspecified date in 2025 (afterwards), the patient experienced left side scalp sore, area behind left ear intermittent pain, and left side of larynx sore. All symptoms except scalp soreness have disappeared. Therefore, on an unspecified date in 2025, the patient recovered from the events of area behind left ear intermittent pain and left side of larynx sore. At the reporting time, the patient had not recovered from left side scalp sore. The action taken with suspect vaccines regarding the events was assessed as not applicable. The causal relationship between the events and suspect vaccines was unknown (the patient was trying to figure out if some of the symptoms he/she experienced afterwards were from the vaccines). Lot # is being requested and will be submitted if received. More
2864573 F IL 10/09/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Arthralgia, Headache, Incomplete course of vaccination; Arthralgia, Headache, In... Arthralgia, Headache, Incomplete course of vaccination; Arthralgia, Headache, Incomplete course of vaccination More
Aching joints; Inappropriate schedule of vaccine administered; Headache; This non-serious case was r... Aching joints; Inappropriate schedule of vaccine administered; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In AUG-2020, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. The patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), joint pain (Verbatim: Aching joints) and incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the headache was resolved (duration 24 hrs) and the outcome of the joint pain was resolved and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the headache and joint pain to be related to Shingrix. It was unknown if the company considered the headache and joint pain to be related to Shingrix. Additional Information: GSK Receipt Date: 22-SEP-2025 The patient received the 1st dose of Shingrix Vaccine and had headache and aching joints for about 24 hours. She reports she received the vaccine at a local pharmacy. The patient reports she has not received the 2nd dose yet. She inquired, can she get the 2nd dose after 5 years. Batch number "UNK" and follow-up has been requested: The batch number was not provided and a request for this information has been made. More
2864574 M CA 10/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Underdose Underdose
did not know if that meant just that patients received just the adjuvant or half of the reconstitute... did not know if that meant just that patients received just the adjuvant or half of the reconstituted vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis. In JUN-2025, the patient received Shingrix. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: did not know if that meant just that patients received just the adjuvant or half of the reconstituted vaccine). The outcome of the incomplete dose administered was not applicable. Additional Information: GSK receipt date: 24-SEP-2025 Physician stated that patient received half a dose of Shingrix instead of the full dose, she did not know if that meant just that patients received just the adjuvant or half of the reconstituted vaccine. Also stated that dates of administration were between 23-JUN-2025 to 27-JUN-2025. This case is one of the linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025122806:Same reporter/Different patient US-GSK-US2025122813: More
2864575 M CA 10/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Underdose Underdose
did not know if that meant just that patients received just the adjuvant or half of the reconstitute... did not know if that meant just that patients received just the adjuvant or half of the reconstituted vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In JUN-2025, the patient received Shingrix. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: did not know if that meant just that patients received just the adjuvant or half of the reconstituted vaccine). The outcome of the incomplete dose administered was not applicable. Additional Information: GSK receipt date: 24-SEP-2025 Physician stated that patient received half a dose of Shingrix instead of the full dose, she did not know if that meant just that patients received just the adjuvant or half of the reconstituted vaccine. Also stated that dates of administration were between 23-JUN-2025 TO 27-JUN-2025. The batch number was not provided and a request for this information has been made. This case is one of the linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025122806:Same reporter/Different patient US-GSK-US2025122813: More
2864577 M 10/09/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
suspected vaccination failure; Shingles; This serious case was reported by a physician via sales rep... suspected vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 05-OCT-2025 Physician reported that patient was vaccinated with both doses of Shingrix about a year ago from the day of reporting and got shingles after that. The reporter stated that immunization did not prevent the patient from getting shingles. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving 1st and 2nd dose of Shingrix in a 70-year-old male subject. 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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