🏥 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 💀 🏥 🚑 ♿ ⚠️
2845003 9 F TX 06/14/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y013407
Y013407
Abdominal pain, Culture urine, Decreased appetite, Dehydration, Eye pain; Headac... Abdominal pain, Culture urine, Decreased appetite, Dehydration, Eye pain; Headache, Nausea, Streptococcus test negative, Urine analysis abnormal, Vomiting More
Per mom, patient got home from appointment adn started complainng of headache, abdominal pain and na... Per mom, patient got home from appointment adn started complainng of headache, abdominal pain and nausea. Then she started vomiting. Patient not wanting to eat or drink anything due to the nausea. Stating eyes hurt due to her headache. Gave Tylenol but vomited back up. Came to the office on 06/13/25 and evaluated for strep (neg) and checked urine (dehydration). Explained to parents most likely a vaccine reaction since it happened so soon after the vaccine and will not give the 2nd dose when it is due,. Prescribed ibuprofen and zofran and advised to come back to clinic in 3 days . More
2845004 06/14/2025 UNK
 UNKNOWN MANUFACTURER
Unevaluable event Unevaluable event
None stated. None stated.
2845005 77 F 06/14/2025 HEPAB
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 P2443
A9KR2
Injection site erythema; Injection site erythema Injection site erythema; Injection site erythema
THE PATIENT EXPERIENCED REDNESS AT SITE OF INJECTION THE PATIENT EXPERIENCED REDNESS AT SITE OF INJECTION
2845006 13 F CA 06/14/2025 HEPA
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 Y015027
U8493AA
U8389AA
Syncope; Syncope; Syncope Syncope; Syncope; Syncope
Vasovagal Syncope within 1 hr, while patient was leaving the clinic. Patient rested, drank water, vi... Vasovagal Syncope within 1 hr, while patient was leaving the clinic. Patient rested, drank water, vital signs stable before leaving clinic. More
2845007 62 F MO 06/14/2025 PNC21
 MERCK & CO. INC.
 Y011819
Injection site erythema, Injection site pain, Nausea, Vomiting Injection site erythema, Injection site pain, Nausea, Vomiting
N/V, Diarrhea, injection site redness / tenderness N/V, Diarrhea, injection site redness / tenderness
2845008 60 F AZ 06/14/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2FP37
75D3A
Diarrhoea, Headache, Malaise, Nausea, Vomiting; Diarrhoea, Headache, Malaise, Na... Diarrhoea, Headache, Malaise, Nausea, Vomiting; Diarrhoea, Headache, Malaise, Nausea, Vomiting More
PATIENT, A 60 YEAR OLD FEMALE RECEIVED HER AREXVY AND 2ND DOSE OF SHINGRIX VACCINE ON 6/13/2025 AT 1... PATIENT, A 60 YEAR OLD FEMALE RECEIVED HER AREXVY AND 2ND DOSE OF SHINGRIX VACCINE ON 6/13/2025 AT 12:33 PM. SHE CALLED ON 6/14/2025 AT AROUND 12:15 PM AND STATED 4 HOURS AFTER RECEIVNG AREXVY VACCINE AND 2ND DOSE OF SHINGRIX VACCINE SHE STARTED HAVING SYMPTOMS OF NAUSEA, HEADACHE, VOMITING, AND DIARRHEA. PATIENT STATED SHE CANNOT TOLERATE EATING ANYTHING AND IS UNABLE TO TAKE HER CURRENT MAINTENANCE MEDICATIONS DUE TO NOT FEELING WELL. THE CALL WITH THE PATIENT GOT DISCONNECTED WHILE SHE WAS SPEAKING TO ME. PHARMACY MANAGER ATTEMPTED TO CALL HER BACK AND LEFT VOICE MAIL ON 6/14/2025 AT 12:21 PM. More
2845009 57 M FL 06/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 PJ353
Headache, Pyrexia Headache, Pyrexia
Fever for 3 days and headache. Fever for 3 days and headache.
2845010 3 M MN 06/14/2025 MMRV
 MERCK & CO. INC.
Blister, Erythema, Varicella Blister, Erythema, Varicella
disseminated varicella vaccine chickenpox. multiple small vesicles on erythematous base consistent ... disseminated varicella vaccine chickenpox. multiple small vesicles on erythematous base consistent with chicken pox clinically. no cough. start 6/13/25. Empiric treatment with acyclovir 5 dys course started 6/14/25. More
2845011 75 F NY 06/14/2025 PNC21
 MERCK & CO. INC.
 y019158
Injection site swelling Injection site swelling
Patient reported to pharmacy 48 hours after vaccine with a read swollen arm at injection site. swell... Patient reported to pharmacy 48 hours after vaccine with a read swollen arm at injection site. swelling was increasing and she was advised to go to urgent care she was seen 72 hours after injection and treated with antibiotic and steroid for reaction More
2845012 61 F OH 06/14/2025 RSV
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LH4508
PJ353
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
Redness, swelling, and itching across large area of upper arm started 2 days after vaccines given an... Redness, swelling, and itching across large area of upper arm started 2 days after vaccines given and lasted 7 days. More
2845013 51 F IL 06/14/2025 HEP
PNC21
VARZOS
 DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 946062
Z002626
5A4XG
Furuncle, Headache, Nausea, Pyrexia, Vomiting; Furuncle, Headache, Nausea, Pyrex... Furuncle, Headache, Nausea, Pyrexia, Vomiting; Furuncle, Headache, Nausea, Pyrexia, Vomiting; Furuncle, Headache, Nausea, Pyrexia, Vomiting More
fever ( 101), nausea, headache, vommiting, boil on left arm fever ( 101), nausea, headache, vommiting, boil on left arm
2845014 85 M FL 06/14/2025 PNC20
 PFIZER\WYETH
 LX4482
Injection site pruritus, Pruritus Injection site pruritus, Pruritus
Patient received Prevnar 20 vaccine on 6/6/25 and noted no physical reactions to it in the immediate... Patient received Prevnar 20 vaccine on 6/6/25 and noted no physical reactions to it in the immediate time after. Patient came to pharmacy today (6/14/25) stating he developed significant redness and itching beginning on 6/12/25 that did not improve with topical cortisone cream. He showed me his right arm which was very red about 4-inch diameter around where he had received the vaccine. He believed the redness to be expanding so I instructed him to promptly go to urgent care. Patient followed up with me and informed me he was given a steroid injection and told he was having a delayed reaction from the vaccine. In addition to the steroid injection, the prescriber sent in famotidine 40 mg to be taken once daily for 7 days. More
2845015 52 F OH 06/14/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LN4930
PJ353
Injection site erythema, Injection site pruritus; Injection site erythema, Injec... Injection site erythema, Injection site pruritus; Injection site erythema, Injection site pruritus More
Severe redness and itching at the vaccination site, ibuprofen and Benadryl, and watching to see if t... Severe redness and itching at the vaccination site, ibuprofen and Benadryl, and watching to see if the redness spreads More
2130019 51 M NH 06/13/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8733
ER8733
ER8733
EW0175
EW0175
Brain fog, Fatigue, Inappropriate schedule of product administration, Malaise, M... Brain fog, Fatigue, Inappropriate schedule of product administration, Malaise, Muscular weakness; Fatigue, Headache, Malaise, Pain; Gait disturbance, Muscular weakness; Fatigue, Headache, Malaise, Pain; Gait disturbance, Muscular weakness More
severe fatigue; leg weakness; post exertion malaise; brain fog; Dose 1 on 24Mar2021 and Dose 2 on 02... severe fatigue; leg weakness; post exertion malaise; brain fog; Dose 1 on 24Mar2021 and Dose 2 on 02Apr2021; This is a spontaneous report received from a Consumer or other non HCP. A 51-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 at 16:00 as dose 2, single (Lot number: ER8733) at the age of 51 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 1, Single; Lot: EW0175; Anatomical location: Upper arm: Administration time: 11:00 AM), administration date: 24Mar2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Apr2021 at 16:00, outcome "unknown", described as "Dose 1 on 24Mar2021 and Dose 2 on 02Apr2021"; BRAIN FOG (non-serious) with onset 25Apr2021 at 06:00, outcome "not recovered"; MUSCULAR WEAKNESS (non-serious) with onset 25Apr2021 at 06:00, outcome "not recovered", described as "leg weakness"; MALAISE (non-serious) with onset 25Apr2021 at 06:00, outcome "not recovered", described as "post exertion malaise"; FATIGUE (non-serious) with onset 25Apr2021 at 06:00, outcome "not recovered", described as "severe fatigue". Therapeutic measures were not taken as a result of fatigue, muscular weakness, malaise, brain fog. Additional information: No known allergies. Patient did not received any other vaccines on the same date as the vaccine. Patient did not received any other vaccines within 4 weeks Prior to the vaccine. Patient was not taking any other medications within 2 weeks of the event starting. Reported as severe fatigue, leg weakness, post exertion malaise, brain fog. Patient need to know if there is a treatment for this poison you have produced. This has destroyed the quality of his life for over 4 years. Patient was asking whether can the effects of the spike protein be reversed. More
2844841 F 06/13/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y013009
7ZM55
Fatigue, Feeling abnormal, Pain; Fatigue, Feeling abnormal, Pain Fatigue, Feeling abnormal, Pain; Fatigue, Feeling abnormal, Pain
DYSSTASIA; FEELING ABNORMAL; PAIN; Information has been received from a Regulatory Authority (agency... DYSSTASIA; FEELING ABNORMAL; PAIN; Information has been received from a Regulatory Authority (agency # 2833086-1) and refers to a 68-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-MAR-2025, the patient was vaccinated with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Injection, lot #Y013009, expiration date was not reported but upon internal validation, was established as 17-Nov-2025, administered by Intramuscular in her Right Arm; and with a dose of (Varicella zoster vaccine rgE (CHO)) (SHINGRIX), lot #7ZM55 (expiration date, dose and strength were not reported), administered by Intramuscular route in her right arm; both vaccines were administered for prophylaxis. On 21-MAR-2025, the Patient stated that she felt achy, tired and had difficulty getting up and about like being hatted with a baseball bat. Reaction did not improve, and she saw her physician 2 days following administration. The physician gave her two "shots", but she was not sure what they were. Patient started feeling two days following being seen by her physician. In March 2025, the patient recovered from the events. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine was not provided. However, it was stated that MD told her "definitely due to (Varicella zoster vaccine rgE (CHO)) vaccine".; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-05-13 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2833086 , Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2844842 M 06/13/2025 PNC21
 MERCK & CO. INC.
 Y013009
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING; INJECTION SITE PAIN; Information has been received... INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING; INJECTION SITE PAIN; Information has been received from a Regulatory Authority (agency # 2831941-1) and refers to a 52-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-MAR-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPAXVIVE) Injection, lot #Y013009, expiration date was not reported but upon internal validation was established as 17-NOV-2025 (dose and strength was not reported) administered by Intramuscular route his Right Arm for prophylaxis. On 09-MAR-2025, the patient experienced Injection site swelling, erythema and pain. At the reporting time, the patient had not recovered from the events. The causality assessment between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPAXVIVE) was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-05-13 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2831941 , Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2844843 NY 06/13/2025 VARCEL
 MERCK & CO. INC.
 Y017063
No adverse event, Product storage error No adverse event, Product storage error
No symptoms reported; Nurse called to report TE for VARIVAX and reports the VARIVAX was inadvertentl... No symptoms reported; Nurse called to report TE for VARIVAX and reports the VARIVAX was inadvertently administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-May-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) for prophylaxis (lot #Y017063 was verified to be a valid number, expiration date: 11-Oct-2026) (dose, scheme, route of administration, formulation and injection site were not reported) reconstituted with sterile diluent (BAXTER STERILE DILUENT) (dose, frequency, route of administration, expiration date and lot # were not reported). The vaccine underwent a temperature excursion of -11.5 Celsius degree for 24 minutes (product storage error). No symptoms were reported (no adverse event). More
2844844 GA 06/13/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Interchange of vaccine products Interchange of vaccine products
Received RECOMBIVAX as First Dose, and HEPLISAV-B as Second Dose; Initial report received on 12-May-... Received RECOMBIVAX as First Dose, and HEPLISAV-B as Second Dose; Initial report received on 12-May-2025. A pharmacist reported that a 43-year-old (gender, race, and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) as the second dose for hepatitis B immunization after receiving RECOMBIVAX as the first dose of the series. No medical history or concomitant medications were reported. On 04-Jan-2025, the patient received dose 1 of a hepatitis B vaccine [RECOMBIVAX (lot #, expiration date, NDC #, route, and site not available)]. On 14-Feb-2025, 41 days after the receiving RECOMBIVAX, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)]. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2844845 F TX 06/13/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination Incomplete course of vaccination
Had the First Dose of HEPLISAV-B in August 2024 and Have Not Had the Second Dose Yet; Initial report... Had the First Dose of HEPLISAV-B in August 2024 and Have Not Had the Second Dose Yet; Initial report received on 16-May-2025. A consumer reported that she, a female (age not reported), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in August 2024 but has not received the second dose. No medical history or concomitant medications were reported. In Aug-2024, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, and site not reported) intramuscularly. At the time of report, the patient has not received the second dose of HEPLISAV-B yet. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2844846 06/13/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Skin hyperpigmentation Skin hyperpigmentation
Hyperpigmentation On The Face; Initial report received on 21-May-2025. This report was retrieved ... Hyperpigmentation On The Face; Initial report received on 21-May-2025. This report was retrieved from a social media post. A consumer reported that a patient (gender, race, and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the developed hyperpigmentation on their face. No medical history or concomitant medications were reported. On an unknown date, the patient received an unspecified dose of hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available). One day following administration of the vaccine, the patient underwent a laser hair removal procedure. After the procedure, the patient developed hyperpigmentation on their face. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2844847 F MI 06/13/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination Incomplete course of vaccination
Received First Dose 10/24/2024, and Did Not Get Second Dose; Initial report received on 21-May-2025.... Received First Dose 10/24/2024, and Did Not Get Second Dose; Initial report received on 21-May-2025. A pharmacist reported that a female patient (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet. No medical history or concomitant medications were reported. On 24-Oct-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available). At the time of this report, the patient has not received the second dose yet. The patient received the first dose from a different facility than the facility that the reporter was in. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2844848 16 F CA 06/13/2025 YF
 SANOFI PASTEUR
 UK134AA
No adverse event, Product preparation error No adverse event, Product preparation error
received a medication error with the YF-VAX was mixed with the incorrect diluent of sterile water, w... received a medication error with the YF-VAX was mixed with the incorrect diluent of sterile water, with no reported adverse event; Initial information received on 11-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 16 years old female patient who received Yellow fever vaccine - [YF-VAX] that was mixed with the incorrect diluent of sterile water, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jun-2025, the patient received a 0.5ml dose of suspect Yellow fever vaccine - Solution for injection standard strength (lot UK134AA) frequency once (expiry date-unknown) via intramuscular route in the left arm for Immunization and the vaccine was mixed with the incorrect diluent of sterile water, with no reported adverse event (product preparation error) (latency-same day). Reportedly- 2-consumers received a medication error with the YF-VAX and the consumers are family members. 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
2844863 06/13/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Immune system disorder, Pneumonia Immune system disorder, Pneumonia
severe pneumonia; immune system was damaged; This serious case was reported by a consumer via intera... severe pneumonia; immune system was damaged; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, 1 day after receiving RSV vaccine, the patient experienced pneumonia (Verbatim: severe pneumonia) (serious criteria GSK medically significant) and immune system disorder (Verbatim: immune system was damaged). The outcome of the pneumonia and immune system disorder were not reported. It was unknown if the reporter considered the pneumonia to be related to RSV vaccine. The reporter considered the immune system disorder to be related to RSV vaccine. The company considered the pneumonia to be unrelated to RSV vaccine. The company considered the immune system disorder to be related to RSV vaccine. Additional Information: GSK Receipt Date: 05-JUN-2025 This case was reported by a patient via interactive digital media. Patient had received the shot, and the next day, he/she began a five-month battle with severe pneumonia. Patient believe it had damaged his/her immune system, never again.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK RSV vaccine. More
2844864 56 NC 06/13/2025 DTAPIPVHIB
 SANOFI PASTEUR
No adverse event, Off label use No adverse event, Off label use
pentacel is prescribed with off label diagnosis code stem cells transplant status with no reported a... pentacel is prescribed with off label diagnosis code stem cells transplant status with no reported adverse event; Initial information received on 09-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 56-year-old patient of unknown gender who was prescribed the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV (Vero)/Hib (PRP-T) vaccine [Pentacel (Vero)] for an off-label diagnosis of stem cell transplant status, 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 was prescribed Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (4 times), Suspension for injection (unknown strength and expiry date) lot not provided via intramuscular route in unknown administration site for prophylactic vaccination (immunization) with off label diagnosis code stem cells transplant status with no reported adverse event (off label use). Information regarding batch number corresponding to the one at time of event occurrence is requested. Action taken was not applicable. More
2844867 44 F MA 06/13/2025 FLU4
FLU4
FLU4
FLU4
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 A45NH
A45NH
A45NH
A45NH
Allergy test positive, Antibody test negative, Arthralgia, Blood uric acid norma... Allergy test positive, Antibody test negative, Arthralgia, Blood uric acid normal, Borrelia test negative; C-reactive protein normal, Fatigue, Hepatitis viral test negative, Hypermobility syndrome, Immediate post-injection reaction; Migraine, Mood swings, Negative thoughts, Red blood cell sedimentation rate normal, Rheumatoid factor negative; Sleep disorder More
Joint hyper mobility syndrome and chronic joint pain. Started immediately after the influenza vaccin... Joint hyper mobility syndrome and chronic joint pain. Started immediately after the influenza vaccine received on 10/06/2023. She suffered from a major flare up of joint pain. Involved her knees, elbows, shoulders, left wrist and thumb. Pain lasted Oct 2023 - March 2024. Tried 4 sessions of acupuncture, minimal relief. Took Ibuprofen and Tylenol daily with some relief other symptoms: migraines, fatigue, disturbed sleep, dark thoughts, and sudden mood swings. More
2844897 4 MI 06/13/2025 VARCEL
 MERCK & CO. INC.
 Y010184
No adverse event, Product storage error No adverse event, Product storage error
HCP called to report TE where patient received the product. No Side effects or symptoms reported. No... HCP called to report TE where patient received the product. No Side effects or symptoms reported. No Additional information provided. No Additional AE/ No PQC; HCP called to report TE where patient received the product. No Side effects or symptoms reported. No Additional information provided. No Additional AE/ No PQC; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-May-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0,5 mL (lot #Y010184 and expiration date reported as 31-May-2026) (route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection. The reporter called to report a temperature excursion (TE) (-4.8C for 0 hours 39 minutes 0 seconds) where the patient received the product (product storage error). No previous excursions were noted. No side effects or symptoms were reported. No additional information was provided. No Additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). More
2844898 CA 06/13/2025 RVX
 UNKNOWN MANUFACTURER
 Y014324
No adverse event, Product storage error No adverse event, Product storage error
No additional AE/No PQC.; HBP called regarding T/E for ROTATEQ and GARDASIL-9. HBP noted that ROTATE... No additional AE/No PQC.; HBP called regarding T/E for ROTATEQ and GARDASIL-9. HBP noted that ROTATEQ was administered to a patient; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-Jun-2025, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vials 0,5 mL (lot #Y014324 and expiration date reported as 21-Feb-2026) administered for prophylaxis. The reporter called regarding a temperature excursion (T/E) for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (low TE; duration of temperature excursion: (35.4F) for 1 hour 0 minutes 0 seconds) and Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9). No previous excursions were noted. It was noted that Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was administered to a patient and Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) was not administered to any patients (product storage error). No symptomatic events were reported (no adverse event). No additional adverse event (AE) and no product quality complaint (PQC) was noted. This case was considered to be invalid due to lack of patient's identifiers. More
2844899 VA 06/13/2025 RVX
 UNKNOWN MANUFACTURER
 2088619
No adverse event, Product storage error No adverse event, Product storage error
No side effects reported; ROTATEQ experienced excursion 5/29/2025 and was administered today 6/5/202... No side effects reported; ROTATEQ experienced excursion 5/29/2025 and was administered today 6/5/2025 to one patient; 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 29-MAY-2025, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# 2088619 underwent temperature excursion (3 hours, 7 minutes and 0 seconds in 11.7 degrees Celsius). There were no previous temperature excursions. On 05-JUN-2025, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution, administered orally, lot #2088619, expiration date was reported as 30-SEP-2026, however upon internal validation determined as 09-MAR-2026, for prophylaxis (dose was not reported); the administered vaccine underwent temperature excursion mentioned above (Product storage error). No side effects reported. More
2844900 1.17 M 06/13/2025 HEPA
MMR
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Incorrect dose administered, Irritability; Incorrect dose administered, Irritabi... Incorrect dose administered, Irritability; Incorrect dose administered, Irritability; Incorrect dose administered, Irritability More
Consumer was informed one week after that it was the wrong dosage.; Consumer stated that child was c... Consumer was informed one week after that it was the wrong dosage.; Consumer stated that child was cranky and it lasted five days; he would be more immune, it is not giving Tylenol he will not overdose; This spontaneous report was received from a consumer referring to a 14-month-old male patient. The patient's pertinent medical history included asthma. There were no drug reactions/allergies or concomitant therapies. On 23-May-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the three vaccines were all administered by Intramuscular route (strength, dose, dose number, anatomical site, lot # and expiration date were not reported) for prophylaxis (also reported as 15 months vaccinations). The Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) were reconstituted with sterile diluent (MERCK STERILE DILUENT) (Intramuscular route; strength, dose, lot # and expiration date were not reported). The consumer reported that their child healthcare professional office gave the child the 12-month vaccinations when he was 15 months. On the same day, the patient was cranky (irritability), the event was recovered on 29-May-2025 (conflicting information: also reported as lasted five days). Consumer was also informed one week after that it was the wrong dosage (Incorrect dose administered). The doctor stated that "he would be more immune, it is not giving Tylenol he will not overdose" (ill-defined disorder with onset unknown date in 2025). At the reporting time, the outcome of ill-defined disorder was unknown. The action taken with all suspect vaccines was not applicable. The causal relationship between the events of irritability and ill-defined disorder and the suspect vaccines was not provided. Lot# is being requested and will be submitted if received. More
2844901 19 F NY 06/13/2025 HEP
 MERCK & CO. INC.
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
No adverse effects were reported; a 19yr old patient was inadvertently administered the adult dose i... No adverse effects were reported; a 19yr old patient was inadvertently administered the adult dose instead of the pediatric dose of RECOMBIVAX HB. Lot; This spontaneous report was received from a nurse and refers to a 19-year-old female patient. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 24-MAY-2025, the patient was accidentally vaccinated with the adult dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) suspension for injection at a dose of 0.5 mL (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis, instead of the pediatric dose (Accidental overdose). No additional adverse events were reported (No adverse event). Lot# is being requested and will be submitted if received. More
2844902 14 F HI 06/13/2025 HPV4
 MERCK & CO. INC.
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
a patient had received 1 dose of the 4-valent HPV vaccine when she was 14, and wanted further guidan... a patient had received 1 dose of the 4-valent HPV vaccine when she was 14, and wanted further guidance regarding completing the dose; No additional AE; This spontaneous report was received from a pharmacist and refers to a 25-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in approximately 2014, when the patient was 14-year-old, she was vaccinated with 1st dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The patient wanted further guidance regarding completing the dose (Inappropriate schedule of product administration). No additional adverse event was reported. Lot# is being requested and will be submitted if received. More
2844903 CA 06/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Facial paralysis Facial paralysis
Facial paralysis; This serious case was reported by a consumer via call center representative and de... Facial paralysis; This serious case was reported by a consumer via call center representative and described the occurrence of facial paralysis 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 facial paralysis (Verbatim: Facial paralysis) (serious criteria GSK medically significant). The outcome of the facial paralysis was unknown. It was unknown if the reporter considered the facial paralysis to be related to Shingrix. The company considered the facial paralysis to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 09-JUN-2025 The patient's friend reported this case The patient experienced facial paralysis after receiving the Shingrix injection.; Sender's Comments: Facial paralysis is a listed event which is considered related to GSK vaccine Shingrix. More
2844904 F 06/13/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Asthenia, Ehlers-Danlos syndrome, Erythema, Feeling hot, Pain in extremity; Swel... Asthenia, Ehlers-Danlos syndrome, Erythema, Feeling hot, Pain in extremity; Swelling More
Painful arm; large red; hot; swollen; weakness; Ehlers-Danlos syndrome; This non-serious case was re... Painful arm; large red; hot; swollen; weakness; Ehlers-Danlos syndrome; This non-serious case was reported by a consumer and described the occurrence of Ehlers Danlos syndrome in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on an unknown date). On 06-JUN-2025, the patient received the 2nd dose of Shingrix. On 07-JUN-2025, 1 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: Painful arm), erythema (Verbatim: large red), feeling hot (Verbatim: hot), swelling (Verbatim: swollen) and weakness (Verbatim: weakness). In JUN-2025, the patient experienced Ehlers Danlos syndrome (Verbatim: Ehlers-Danlos syndrome). The outcome of the Ehlers Danlos syndrome was not reported and the outcome of the pain in arm, erythema, feeling hot, swelling and weakness were not resolved. It was unknown if the reporter considered the Ehlers Danlos syndrome, pain in arm, erythema, feeling hot, swelling and weakness to be related to Shingrix. It was unknown if the company considered the Ehlers Danlos syndrome, pain in arm, erythema, feeling hot, swelling and weakness to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JUN-2025 Reporter stated that patient received second dose of Shingrix and had painful arm. Also stated patient had large red, hot, swollen and weakness. Patient had Ehlers-Danlos syndrome. More
2844905 F 06/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Heart rate decreased, Pain Heart rate decreased, Pain
Low heart rate; General aches and pains; This non-serious case was reported by a consumer via sales ... Low heart rate; General aches and pains; This non-serious case was reported by a consumer via sales rep and described the occurrence of heart rate low in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included heart disease, unspecified (had heart disease). On an unknown date, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, 36 hrs after receiving Shingrix, the patient experienced heart rate low (Verbatim: Low heart rate) and general body pain (Verbatim: General aches and pains). The outcome of the heart rate low was resolved and the outcome of the general body pain was not reported. The reporter considered the heart rate low to be related to Shingrix. It was unknown if the reporter considered the general body pain to be related to Shingrix. The company considered the heart rate low to be related to Shingrix. It was unknown if the company considered the general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 07-JUN-2025 A female patient had general aches and pains, low heart rate approximately 36 hours post vaccination. As per the reports, patient had a previous history of heart disease More
2844906 LA 06/13/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 UNK
U8122AA
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
administration of adacel outside of the recommended interval with no reported adverse event; This n... administration of adacel outside of the recommended interval with no reported adverse event; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of interchange of vaccine products in a 52-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (Adacel) (batch number U8122AA, expiry date 30-APR-2026) for prophylaxis. On 06-MAR-2025, the patient received Boostrix. On 29-APR-2025, the patient received Adacel (intramuscular use, right arm) .5 ml. On an unknown date, an unknown time after receiving Boostrix, the patient experienced interchange of vaccine products (Verbatim: administration of adacel outside of the recommended interval with no reported adverse event). The outcome of the interchange of vaccine products 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: 02-JUN-2025 The reporter reported that, the patient received an unknown dose (0.5 ml) of adacel via intramuscular route in the right arm for immunization and then, the patient received an unknown dose of Boostrix vaccine which led to interchange of vaccine products. More
2844907 MO 06/13/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Pain, Sleep disorder, Vaccination failure; Herpes zoster, Pain, S... Herpes zoster, Pain, Sleep disorder, Vaccination failure; Herpes zoster, Pain, Sleep disorder, Vaccination failure More
suspected vaccination failure; I developed shingles again all across my back and now it is locating ... suspected vaccination failure; I developed shingles again all across my back and now it is locating down my left buttock; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (patient had shingles twice). In MAR-2024, the patient received the 2nd dose of Shingrix. In DEC-2023, the patient received the 1st dose of Shingrix. In MAY-2025, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I developed shingles again all across my back and now it is locating down my left buttock). The patient was treated with valaciclovir (Valacyclovir). 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 Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 09-JUN-2025 The patient reported that he was going to be 72 years old this August. He/she had received the two Shingrix vaccines because he/she had shingles twice before. About one month ago, he/she developed shingles again, across his/her back, and then it spread down his/her left buttock. It was extremely painful, more than his/her previous two incidents of shingles. His/her physician prescribed Valacyclovir, and he/she was taking that. His/her question was whether it would be recommended to get another booster dose of the Shingrix vaccine. This episode was so painful that he/she could hardly sleep, much worse than the previous ones. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2844908 NH 06/13/2025 DTAP
DTAPHEPBIP
DTAPIPV
HEP
HEPA
HEPAB
MENB
MNQ
RV1
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS









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; Product storage error; Product storage error; Product storage error; Product storage error More
product Storage Error; This non-serious case was reported by a other health professional via call ce... product Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HAB (Twinrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis. On an unknown date, the patient received Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Twinrix, Engerix B and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Twinrix, Engerix B and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: product Storage Error). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 05-JUN-2025 The Other Health Professional requested stability data for the following vaccines Bexsero, Menveo (1-vial), Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Twinrix, Engerix-B, and Rotarix (liquid formulation) that had been stored at 9.6 degree Celsius for 30 minutes which led to, incorrect storage of drug. There had been no prior temperature excursions. Patient involvement was suspected, as the excursion had occurred on Monday, June 2, 2025. The number of patients affected, and the number of vaccines administered remained unknown. More
2844909 68 F 06/13/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration, Liver function test abnormal Inappropriate schedule of product administration, Liver function test abnormal
Possible Twinrix second dose administration out of the recommended time interval; This non-serious c... Possible Twinrix second dose administration out of the recommended time interval; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received HAB (Twinrix) for prophylaxis. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX). On 04-JUN-2025, the patient received the 2nd dose of Twinrix. On 04-JUN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Possible Twinrix second dose administration out of the recommended time interval). The outcome of the drug dose administration interval too long 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: 05-JUN-2025 The patient called to asked if it was okay that she "went up high, from the bottom line to almost the top" in a certain liver test (she couldn't recall which specific measurement) after receiving Twinrix as a second dose. Although she mentioned that she was "feeling okay." The patient received 2nd dose of Twinrix B, later than the recommended interval, which led to lengthening of vaccination schedule. More
2844910 F OH 06/13/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 9452S
Underdose Underdose
accidentally administered a pediatric dose of Engerix-B to an adult patient; accidentally administer... accidentally administered a pediatric dose of Engerix-B to an adult patient; accidentally administered a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 37-year-old female patient who received HBV (Engerix B pediatric) (batch number 9452S, expiry date 14-SEP-2025) for prophylaxis. On 02-JUN-2025, the patient received the 1st dose of Engerix B pediatric. On 02-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: accidentally administered a pediatric dose of Engerix-B to an adult patient) and accidental underdose (Verbatim: accidentally administered a pediatric dose of Engerix-B to an adult patient). The outcome of the adult use of a child product and accidental underdose 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: 06-JUN-2025 Registered Nurse called to report that they accidentally administered a pediatric dose of Engerix-B to an adult female patient (37 years old), which led to adult use of a child product and accidental underdose. More
2844911 06/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
one of the patients did not receive the full vaccination; one of the patients did not receive the fu... one of the patients did not receive the full vaccination; one of the patients did not receive the full vaccination; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication 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 preparation of medication (Verbatim: one of the patients did not receive the full vaccination) and inappropriate dose of vaccine administered (Verbatim: one of the patients did not receive the full vaccination). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 05-JUN-2025 and 06-JUN-2025 The reporter had a customer one day before the reporting date who informed that their patient did not receive both components of the Shingrix vaccine. The back office coordinator called and they had identified 7 patients that were given the Shingrix vaccination, however they discovered that their component vials did not match, so then they determined that one of the 7 patients only received the adjuvant part of Shingrix, so they did not know which patient received just the adjuvant, it was misadministered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Honestly, he did not tell that which, he/she was assuming it was the adjuvant part, he did not tell which vial, let's just say one of the patients did not receive the full vaccination, they only received 1 vial. The reporter did not do any of the patient's information, did know that this was all of their first shots in the series. Field representative did not have lot number or expiration date of the vaccines, but she mentioned: the back office coordinator would know that. Caller did not know either date of administration for any of the 7 patients. Field representative gave vaccine service center phone number to the healthcare provider, but they do not know if the healthcare provider already called. Field representative mentioned that the healthcare provider requested for protocols for the 7 patients, but for that the representative did a medical query already, so they covered, and no medical information case was open during this call; the caller was only contacting us today to report the adverse event to Safety Team. Field representative gave consent from her side to follow up with Safety Team, but she also mentioned that she does not have further details. More
2844912 M NC 06/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received 1 dose of Shingrix and not the full series; This non-serious case was reported by a pharmac... received 1 dose of Shingrix and not the full series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 20th December 2021). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received 1 dose of Shingrix and not the full series). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 06-JUN-2025 Pharmacist reported that a male patient that received 1 dose of Shingrix on 20th December 2021 (not the full series) and he had now a prescription for a Shingrix shot which led to incomplete course of vaccination. More
2844913 GA 06/13/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
patient did not receive both components of the Shingrix vaccine; patient did not receive both compon... patient did not receive both components of the Shingrix vaccine; patient did not receive both components of the Shingrix vaccine; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient did not receive both components of the Shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: patient did not receive both components of the Shingrix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 06-JUN-2025 Reporter asked about the protocol if patient did not receive both components of the Shingrix vaccine during their first dose in the series, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2844914 IL 06/13/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Product storage error Product storage error
BEXSERO was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature rea... BEXSERO was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: BEXSERO was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions.). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-JUN-2025 Medical assistant reported that Bexsero was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024) which led to incorrect storage of drug. Highest temperature reached was 9.76 celsius and they were above range for 1 hour and 15 minutes in total 75 minutes. No other excursions. The majority of all vaccines reported were administered to patients. healthcare professional did not have patient, product, other adverse event details available during call. This was 1 of 6 linked cases reported by same reporter, different suspect.; Sender's Comments: US-GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect More
2844915 IL 06/13/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
FLULAVAL was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature re... FLULAVAL was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: FLULAVAL was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 06-JUN-2025 MA reports that Flulaval was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions. The majority of all vaccines reported were administered to patients.; Sender's Comments: US-GSK-US2025071800:Same reporter, Different suspect GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect GSK-US2025071801:Same reporter, Different suspect More
2844916 IL 06/13/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
kinrix was exposed to 5 excursions in 2024 and 2025; This non-serious case was reported by a other h... kinrix was exposed to 5 excursions in 2024 and 2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) for prophylaxis. On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: kinrix was exposed to 5 excursions in 2024 and 2025). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-JUN-2025 Medical assistant reported that kinrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024) which led to incorrect storage of drug. Highest temperature reached was 9.76 celsius and they were above range for 1 hour and 15 minutes in total 75 minutes. No other excursions. The majority of all vaccines reported were administered to patients. healthcare professional did not have patient, product, other adverse event details available during call. This was 1 of 6 linked cases reported by same reporter, different suspect.; Sender's Comments: GSK-US2025071804:Same reporter, Different suspect GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect More
2844917 IL 06/13/2025 RVX
 UNKNOWN MANUFACTURER
Product storage error Product storage error
Rotarix was exposed to 5 excursions in 2024 and 2025; This non-serious case was reported by a other ... Rotarix was exposed to 5 excursions in 2024 and 2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced incorrect storage of drug (Verbatim: Rotarix was exposed to 5 excursions in 2024 and 2025). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 06-JUN-2025 Medical assistant reported that Rotarix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was 9.76 Celsius and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions reported. The majority of all vaccines reported were administered to patients, which led to incorrect storage of drug. Caller transferred from vaccine reimbursement center, the reporter did not have patient, product, other adverse event details available during call. This is 1 of 8 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect More
2844918 62 F WV 06/13/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 BL473
Extra dose administered Extra dose administered
a patient was given another dose of AREXVY vaccine today; This non-serious case was reported by a nu... a patient was given another dose of AREXVY vaccine today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number BL473, expiry date 13-OCT-2026) for prophylaxis. Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY). On 06-JUN-2025, the patient received the 2nd dose of Arexvy. On 06-JUN-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: a patient was given another dose of AREXVY vaccine today). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 06-JUN-2025 Licensed Practical Nurse called to report a patient was given another dose of Arexvy vaccine today, which led to Extra dose administered. First dose was administered 21-03-2025. Licensed practical nurse wanted to know if there as any safety concern or guidance about this situation. No further information was obtained in this call. The reporter was consented to follow up. More
2844919 M MN 06/13/2025 HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS


Antibody test negative, Therapy non-responder; Antibody test negative, Therapy n... Antibody test negative, Therapy non-responder; Antibody test negative, Therapy non-responder; Antibody test negative, Therapy non-responder More
didn't respond to the vaccine; This non-serious case was reported by a consumer via sales rep a... didn't respond to the vaccine; This non-serious case was reported by a consumer via sales rep and described the occurrence of therapy non-responder in a male patient who received HBV (Engerix B adult) for prophylaxis. Co-suspect products included HBV (Engerix B adult) for prophylaxis and HBV (Engerix B adult) for prophylaxis. On an unknown date, the patient received the 3rd dose of Engerix B adult, the 2nd dose of Engerix B adult and the 1st dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, Engerix B adult and Engerix B adult, the patient experienced therapy non-responder (Verbatim: didn't respond to the vaccine). The outcome of the therapy non-responder was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-JUN-2025 The reporter would like to know the rate of non-responsiveness to hepatitis b vaccine. He himself said he did not respond to the vaccine. For more information, please contact the field agent, the vaccine administration facility was the same as primary reporter. More
2844920 0.08 F KY 06/13/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 4D333
Product storage error Product storage error
Engerix-B stored at 18.8 celsius 9hrs 20mins on May, 17, 2025; This non-serious case was reported by... Engerix-B stored at 18.8 celsius 9hrs 20mins on May, 17, 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-month-old female patient who received HBV (Engerix B) (batch number 4D333, expiry date 14-AUG-2026) for prophylaxis. On 19-MAY-2025, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Engerix-B stored at 18.8 celsius 9hrs 20mins on May, 17, 2025). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-JUN-2025 Nurse requested stability data for Havrix, Kinrix, Boostrix, Infanrix, Engerix-B stored at 18.8 Celsius for 9 hours 20 minutes on 17th May 2025 which led to incorrect storage of drug. Excursion caught when doing monthly quality check. No prior excursions. Engerix-B had been used in patients. More
2844921 06/13/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 F3Y25
Expired product administered Expired product administered
expired dose administered; This non-serious case was reported by a nurse via call center representat... expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix 720) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis. On 10-JUN-2025, the patient received Havrix 720. On 10-JUN-2025, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used 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:11-JUN-2025 The registered nurse reported that yesterday a patient received an expired dose of Havrix vaccine, which led to expired vaccine used More
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