๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ 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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก 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 "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ 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:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ 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?

โš ๏ธ 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
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2858156 88 M MN 09/11/2025 COVID19
 MODERNA
 026A21A
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
โœ“
2858158 69 M CO 09/11/2025 COVID19
 PFIZER\BIONTECH
Erythema, Skin discolouration Erythema, Skin discolouration
BACKS OF THE CALVES ALL RED (DO NOT ITCH OR PAIN), THEN TODAY 9/11/25 TURNING MORE BROWN THE LEGS BACKS OF THE CALVES ALL RED (DO NOT ITCH OR PAIN), THEN TODAY 9/11/25 TURNING MORE BROWN THE LEGS
2858159 65 F FL 09/11/2025 COVID19
 PFIZER\BIONTECH
 EWO171
Acoustic stimulation tests abnormal, Deafness unilateral, Eustachian tube dysfun... Acoustic stimulation tests abnormal, Deafness unilateral, Eustachian tube dysfunction, Magnetic resonance imaging head, Tinnitus More
Left ear Tinnitus, loss of hearing in left ear at 8000Hz to moderate loss. Eustachian tube dysfunc... Left ear Tinnitus, loss of hearing in left ear at 8000Hz to moderate loss. Eustachian tube dysfunction. Brain MRI to rule out other causes and the damage was permanent. More
โœ“
2858160 1.25 M TX 09/11/2025 DTAP
 SANOFI PASTEUR
 4CA03C2
Injection site swelling Injection site swelling
Vaccine was administered on right deltoid. As per caregiver no fever, no fuzziness, pt has been eati... Vaccine was administered on right deltoid. As per caregiver no fever, no fuzziness, pt has been eating well. Reaction was a little bump on the right arm of 2 cm More
2858161 88 M MN 09/11/2025 COVID19
 PFIZER\BIONTECH
 EN6199
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
โœ“
2858162 78 F FL 09/11/2025 PNC20
 PFIZER\WYETH
 LX4482
Inappropriate schedule of product administration Inappropriate schedule of product administration
There was not an adverse event reported but rather the patient received this dose of the vaccine off... There was not an adverse event reported but rather the patient received this dose of the vaccine off schedule. Her last dose was 9/14/24. This vaccine is not intended to receive every year. More
2858163 67 M NC 09/11/2025 FLU3
 SANOFI PASTEUR
 u8855ba
Extra dose administered Extra dose administered
Patient went to flu clinic thinking he was getting a covid vaccine. Patient had reported he received... Patient went to flu clinic thinking he was getting a covid vaccine. Patient had reported he received a flu vaccine on 9/10 so he received 2 doses of the flu shot for 25-26 season. Patient did not have an adverse reaction to the vaccine More
2858164 65 F AL 09/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 f4ac3
Extra dose administered, No adverse event Extra dose administered, No adverse event
vaccine registry was unavailable at time of vaccine request from patient. Vaccine registry now shows... vaccine registry was unavailable at time of vaccine request from patient. Vaccine registry now shows that patient received two doses of the vaccine. First vaccine was given November 2023 and second vaccine was given September 2025. Patient has not reported any adverse events following administration. More
2858165 4 M GA 09/11/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Cellulitis, Rash Cellulitis, Rash
Cellulitis, Rash Cellulitis, Rash
2858166 12 F FL 09/11/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 H4K3S
H4K3S
Fatigue, Injection site erythema, Injection site pruritus, Injection site urtica... Fatigue, Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth; Tremor, Urticaria More
on 09/08/2025 mom called to report "mom called and said that patient had a reaction to the vacc... on 09/08/2025 mom called to report "mom called and said that patient had a reaction to the vaccine given in her right arm (TDap) given on 09/08/2025. She stated that she had hives up her arm and on her neck she stated that two benadryl were given last night and that helped with the reaction but today she didn't wake until 10am and she's unusually tired. She stated where the injection was given is hot to the touch. She is wanting a call back from the nurse, please. No benadryl given today" . Dr called and spoke with mom on 09/09/2025 at 4:11pm stating "Discussed with mom. Arm still itchy and red, warm to the touch...but no other associated signs/symptoms. No systemic symptoms. If worsening, she will take her to the ER. If still red/warm/itchy/etc...she will bring her to walk-in clinic in the morning. Will you see what we need to do with respect to reporting from a vaccine reaction standpoint?" Sent to office manager who states "Please report to VAERS and do an ERS with a f\u phone call today to check how the child is doing." Patient into walk in clinic on 09/10/2025 at 09:00am vitals 44.2kg for weight, temp 97.3, respirations 18, pulse 86 and bp 112/74, pain 0, oxygen 98%. Dr evaluated patient and noted "Here with mom for f/u after rash that occurred on her right upper arm and neck after vaccines that were received on 9/8. Mom says the rash has essentially resolved. No face/mouth/lip swelling, no respiratory symptoms. No other systemic symptoms. Patient says her right arm still itches somewhat. No benadryl given since yesterday, still receiving famotidine bid to complete full 5-day course. Of note, mom has numerous allergies and patient has had allergies with amoxil and augmentin in the past." . Mom brought patient back into the office on 09/10/2025 at 11:46am for shaking. vital signs Vitals Temp: 98.3*F RR: 18 Weight: 44kg BP: 105/71 O2: 98% Pulse: 92 (Highest 106. Patient then evaluated again by Dr stating "Patient seen in clinic for f/u, also refer to visit from earlier this morning. Mom says that after leaving clinic this morning, they were sitting at store and patient had a new generalized tremor, with this lasting 2 minutes or less. No generalized tonic/clonic movements. No AMS. No LOC. No loss of bowel/bladder control. She did eat breakfast, no meal skipping. No recurrence of rash that was noted as potential side effect from vaccines that were received 2 days ago. She has had no further episodes since then and continues to act normally at time of re-examination circa 1145 this morning. Repeat exam at this time was also normal, including normal neurologic exam. No new findings. Mom to watch closely for new sick symptoms or further episodes of any kind...with any of these changes meaning that she would have to go directly to the ER. During re-exam, patient was writing in her notebook and when I asked her to raise her eyebrows during her neuro exam...she essentially batted her eyebrows as an act of physical comedy, which made both her mother and myself laugh. -- I'm not convinced that this is a true sequela/reaction from her vaccines, but when the previous vaccine reaction is reported, this should still be added to that case in the interest of completeness". On 09/11/2025 at 02:50pm I called mom to follow up on patient, mom said "she is doing well today. " Mom asked patient "is your arm still red?" Patient states "no, it is not red just a little itchy". More
2858167 62 M OH 09/11/2025 FLU3
 SEQIRUS, INC.
 407799
Brain fog, Influenza virus test negative, SARS-CoV-2 test negative Brain fog, Influenza virus test negative, SARS-CoV-2 test negative
Brain fog while driving for a long road trip on 9/8/2025. Stopped after 2.5 hours and stayed overnig... Brain fog while driving for a long road trip on 9/8/2025. Stopped after 2.5 hours and stayed overnight in a hotel. Symptoms persisted on the morning of 9/9/2025 so I drove back home. Saw PA same day center on 9/10/2025. Needed a friend to drive me to the appointment. Symptoms still persist on 9/11/2025. Made appointment to see my primary care physician on 9/16/2025. More
2858168 73 M FL 09/11/2025 FLU3
 SANOFI PASTEUR
 4ca04c1
Extra dose administered Extra dose administered
Patient received Fluzone HD from pharmacy 9/5/25, we were notified by our corporate office that pati... Patient received Fluzone HD from pharmacy 9/5/25, we were notified by our corporate office that patient was also given a flu shot for the season at another facility (lot and date unknown). According to database, it is still currently unregistered that the other facility administered it. More
2858169 77 M CT 09/11/2025 FLU3
 SANOFI PASTEUR
 u876488
Extra dose administered, No adverse event Extra dose administered, No adverse event
Customer requested a Flu and Covid shot at the pharmacy. after Administration customer stated he thi... Customer requested a Flu and Covid shot at the pharmacy. after Administration customer stated he thinks he already had a Flu shot. Checking records he had a Flu shot already on 08/02/2025. No adverse reaction, but double vaccinated. More
2858170 89 M TN 09/11/2025 PNC21
 MERCK & CO. INC.
 Z003579
Arthralgia, Musculoskeletal stiffness, Neck pain, X-ray Arthralgia, Musculoskeletal stiffness, Neck pain, X-ray
SHOLDER & NECK PAIN; STIFFNESS AROUND THE AREA SHOLDER & NECK PAIN; STIFFNESS AROUND THE AREA
2858171 85 F NJ 09/11/2025 FLU3
 SANOFI PASTEUR
 u874bb
Joint swelling, Peripheral swelling Joint swelling, Peripheral swelling
Patient had swelling in upper arm and shoulder Patient had swelling in upper arm and shoulder
2858172 70 M NY 09/11/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946064
Pain in extremity, Peripheral swelling Pain in extremity, Peripheral swelling
PCP office received a notification that patient went to ER on 9/2/25 at 16:51 and discharged from ER... PCP office received a notification that patient went to ER on 9/2/25 at 16:51 and discharged from ER in same day at 19:32 . RN contacted the patient by phone. The patient reported that he went to ER due to swelling and pain in his left arm following a vaccine received on 8/27/2025. Pt was informed at ER that the symptoms were consistent with a vaccine-related reaction. During the call, the patient reported that the swelling and pain had improved. He declined an earlier f/u with PCP and stated he will keep his scheduled appt. on 10/01/2025 . More
2858173 13 F MO 09/11/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS


Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered More
Before giving my Vaccine that was ordered and confirmed by Dr. during my charting of the vaccine ... Before giving my Vaccine that was ordered and confirmed by Dr. during my charting of the vaccine it was dicorverd that instead of giving the patient the vaccine Meningococcal(lMenQuadf ) I accidentally gave the patient Meningococcal ( Bexsero . Patient was informed. More
2858174 5 M WA 09/11/2025 UNK
 UNKNOWN MANUFACTURER
Pain in extremity, Wrong patient received product Pain in extremity, Wrong patient received product
On September 10, 2025, my son, (name withheld) (DOB: 12/XX/2019), was mistakenly given MMR and Varic... On September 10, 2025, my son, (name withheld) (DOB: 12/XX/2019), was mistakenly given MMR and Varicella vaccines intended for his sibling at (withheld name) Pediatrics in (withheld city, state). After vaccination, Son began complaining of leg pain. No emergency care was needed, but we are monitoring his symptoms. I am reporting following the administration error. More
2858175 0.17 F WA 09/11/2025 RV5
 MERCK & CO. INC.
 2142099
Rash Rash
Infant developed rash almost immediately after finishing dose. Provider checked child and advised no... Infant developed rash almost immediately after finishing dose. Provider checked child and advised not to continue with remainder of vaccines for the day and gave mom instructions and signs to watch child for and prescribed Benadryl if needed. Breathing was not affected. More
2858176 17 M MO 09/11/2025 MNQ
 SANOFI PASTEUR
 U8574AA
Hypotonia, Immediate post-injection reaction, Loss of consciousness, Seizure Hypotonia, Immediate post-injection reaction, Loss of consciousness, Seizure
THIS PATIENT HAD A MILD SEIZURE WITH LOSS OF CONSCIOUSNESS FOR APPROXIMATELY 5 SECONDS. HE SLUMP... THIS PATIENT HAD A MILD SEIZURE WITH LOSS OF CONSCIOUSNESS FOR APPROXIMATELY 5 SECONDS. HE SLUMPED TO THE FLOOR SLOWLY, ALMOST IMMEDIATELY AFTER THE VACCINE WAS ADMINISTERED TO HIS RIGHT DELTOID MUSCLE. More
2858177 12 F NM 09/11/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 5XA2J
No adverse event, Wrong product administered No adverse event, Wrong product administered
Wrong Vaccine was given. No adverse reactions. Wrong Vaccine was given. No adverse reactions.
2858178 61 F GA 09/11/2025 PNC21
 MERCK & CO. INC.
 z006889
Injection site reaction, Injection site swelling Injection site reaction, Injection site swelling
she an injection site rejection that was red and swollen. she had been using benadryl cream and it h... she an injection site rejection that was red and swollen. she had been using benadryl cream and it helped but 8 days later still swollen and red. More
2858179 11 F CA 09/11/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 Y018297
7SS27
U8564AA
Dizziness, Hyperhidrosis; Dizziness, Hyperhidrosis; Dizziness, Hyperhidrosis Dizziness, Hyperhidrosis; Dizziness, Hyperhidrosis; Dizziness, Hyperhidrosis
Patient reported feeling sweaty and dizzy at 11:40 a.m. Patient was evaluated by Dr. and stayed for ... Patient reported feeling sweaty and dizzy at 11:40 a.m. Patient was evaluated by Dr. and stayed for observation. Patient's vital signs were taken and offered juice and crackers. Patient only took a couple bites of crackers and sips of water. At 12:10 p.m. patient reported feeling better and denied feeling dizzy and sweaty. More
2858180 65 F 09/11/2025 PNC21
 MERCK & CO. INC.
 Z004301
Cellulitis, Erythema, Peripheral swelling Cellulitis, Erythema, Peripheral swelling
5 days after receiving Capvaxive, patient's arm developed redness and swelling, precipitating a... 5 days after receiving Capvaxive, patient's arm developed redness and swelling, precipitating a trip to the ER. The diagnosis following the visit was cellulitis. The patient picked up Keflex 500mg on 8/12/25 to treat the cellulitis. We have not received an update from the patient following the antibiotic pick-up. More
2858181 4 F TX 09/11/2025 MMRV
 MERCK & CO. INC.
 Z008500
Injection site cellulitis, Injection site erythema, Injection site irritation, I... Injection site cellulitis, Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth More
swelling on left thigh with redness, irritation, warm to tough and fever, resulted to cellulitis of ... swelling on left thigh with redness, irritation, warm to tough and fever, resulted to cellulitis of the left thigh. Pt was prescribed antibiotics Amoxicillin x 10 days. More
2858182 13 F OR 09/11/2025 HPV9
 MERCK & CO. INC.
 y015760
Dizziness, Loss of consciousness, Syncope Dizziness, Loss of consciousness, Syncope
Patient received HPV vaccination in the right deltoid. About 1-2 minute later, patient complained of... Patient received HPV vaccination in the right deltoid. About 1-2 minute later, patient complained of soreness and then had syncopal event. Was guided to floor and regained consciousness in less than 10 seconds. Patient complained of feeling lightheaded but denied any other pain or concerns. Felt improved after drinking some water. More
2858183 F 09/11/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Asthenia, Decreased appetite, Fatigue, Headache, Injection site rash; Injection ... Asthenia, Decreased appetite, Fatigue, Headache, Injection site rash; Injection site swelling, Laryngitis, Pain, Pyrexia More
swelling and a rash at the injection site; swelling and a rash at the injection site; no energy, fat... swelling and a rash at the injection site; swelling and a rash at the injection site; no energy, fatigue; no energy, fatigue; no appetite; headache; body aches; feeling feverish; she is now starting to develop laryngitis; This spontaneous report was received from a female patient of unknown age who refers to herself. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 06-Aug-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) prefilled syringe (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On 09-Aug-2025, the patient developed swelling and a rash at the injection site. On 09-Aug-2025, the patient experienced swelling and a rash at the injection site. She stated that the swelling and rash spread to around 6 inches away from the injection site as well. On an unknown day in August 2025, the patient also experienced no energy, fatigue, no appetite, headache, body aches, and feeling feverish. On an unknown day in August 2025, she was also starting to develop laryngitis. The patient stated that she would not recommend Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) to anyone. The patient spoke with her doctor, but did not want to disclose what her doctor said. She refused to provide any demographic information. No further details were provided. At the reporting time, the patient had not recovered from the events. The action taken with Pneumococcal 21-valent Conjugate Vaccine was as not applicable. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) was not provided. Additional information is not expected. More
2858184 09/11/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
no adverse event; vaccine overdose; This spontaneous report was received from an employee and refers... no adverse event; vaccine overdose; This spontaneous report was received from an employee and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-Aug-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (dose, route of administration, vaccination site, lot # and expiration date were not reported) and with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, route of administration, vaccination site, lot # and expiration date were not reported), both administered for prophylaxis (vaccine overdose). The vaccines were reconstituted with sterile diluent, solution for injection (lot # and expiration date were not reported). The reporter did not have any further information. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). Lot # is being requested and will be submitted if received. More
2858185 64 MI 09/11/2025 HEPA
 MERCK & CO. INC.
 Y015910
No adverse event, Underdose No adverse event, Underdose
Nurse confirmed no symptomatic adverse events that she was aware of; administration of pediatric VA... Nurse confirmed no symptomatic adverse events that she was aware of; administration of pediatric VAQTA to an adult 64 year old patient; This spontaneous report was received from a nurse and refers to a 64-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-Aug-2025, the patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #Y015910, expiration date: 06-Feb-2026), dose number 1, (0.5 ml / once), (anatomical location and administration route were not reported) administered as prophylaxis. The reporting nurse called to report administration of a pediatric Hepatitis A Vaccine, Inactivated (VAQTA) to an adult 64-year-old patient. Nurse confirmed no symptomatic adverse events that she was aware of. More
2858186 13 F NJ 09/11/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, Injection site pain, Injection... Inappropriate schedule of product administration, Injection site pain, Injection site swelling, Pain in extremity; Inappropriate schedule of product administration, Injection site pain, Injection site swelling, Pain in extremity More
She developed a painful bump on her arm at the injection site; She developed a painful bump on her a... She developed a painful bump on her arm at the injection site; She developed a painful bump on her arm at the injection site on 28Aug2025.she had worsening arm pain; This consumer reports that her daughter recieved her first Gardasil 9 injection in Aug2024 and did not have any problems with it. She received her second Gardasil 9, 0.5ml injection intramuscularly on 28Aug2025; This spontaneous report has been received from a consumer, regarding to a 13-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On an unspecified date in August 2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), , then on 28-AUG-2024, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), both doses at a dose of 0.5 milliliter (ml), administered intramuscularly (IM), as prophylaxis (Anatomical site of injection, lot number and expiration date were not provided) (Inappropriate schedule of product administration). On 28-Aug-2025, she developed a painful bump on her arm at the injection site (Vaccination site mass, vaccination site pain). At the time of the report, the outcome of aforementioned events was not provided. The causality assessment between the events and the suspect vaccine was not provided. More
2858187 M GA 09/11/2025 PNC21
 MERCK & CO. INC.
 Z006076
Breath sounds abnormal, Chest discomfort, Pulmonary embolism, Respiratory tract ... Breath sounds abnormal, Chest discomfort, Pulmonary embolism, Respiratory tract congestion, SARS-CoV-2 test negative More
a right upper and lower lobe pulmonary embolism; congestion; This spontaneous report was received fr... a right upper and lower lobe pulmonary embolism; congestion; This spontaneous report was received from a Nurse Practitioner and refers to a male patient of unknown age. The patient's medical history included 2 occurrences of pulmonary embolism (in 2017 and 2020). His concurrent conditions and concomitant therapies were not reported. On 16-JUL-2025, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection, strength: 168 mcg/mL, at a total dose of 0.5 mL, lot #Z006076, expiration date: 11-SEP-2026, administered for prophylaxis (route of administration and anatomical location were not reported). On 18-JUL-2025, the patient returned to the office with congestion and chest discomfort. That day, coronavirus disease (COVID) test was negative, and his lung sound was decreased. The patient was sent to the Emergency Room. On an unspecified date in approximately July 2025, the patient was hospitalized and diagnosed with a right upper and lower lobe pulmonary embolism. He was not on anticoagulant at the time of the hospitalization. At the reporting time, the patient recovered from both events. Causality assessment was not provided. More
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2858188 CO 09/11/2025 MMRV
 MERCK & CO. INC.
 Z007212
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; a dose of PROQUAD was exposed to a temperature excursion today, 9/5/2025, and admi... No additional AE; a dose of PROQUAD was exposed to a temperature excursion today, 9/5/2025, and administered to a patient shortly after the excursion occurred; This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and gender. The patient's medical history, concurrent condition, concomitant therapies were not reported. On 05-Sep-2025, the vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z007212, expiration date: 05-Oct-2026) 0.5 mL (0.5 mL / Two dose series) was temperature excursion, and administered to a patient shortly after the excursion occurred (Product storage error) for prophylaxis. Nurse confirmed no reports of medical concerns regarding this report. No additional information provided. Consent granted for correspondence. Case number provided. No additional AE/PQC. More
2858190 78 F 09/11/2025 UNK
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Acute left ventricular failure, Atrial fibrillation, Echocardiogram, Electrocard... Acute left ventricular failure, Atrial fibrillation, Echocardiogram, Electrocardiogram abnormal, Irritable bowel syndrome; Pleural effusion, Pneumonia, Pneumonia pneumococcal, Rales, Upper respiratory tract infection; Acute left ventricular failure, Atrial fibrillation, Echocardiogram, Electrocardiogram abnormal, Irritable bowel syndrome; Pleural effusion, Pneumonia, Pneumonia pneumococcal, Rales, Upper respiratory tract infection More
Pneumonia both lower lobes; Atrial fibrillation; This 78-year-old female subject was enrolled in a b... Pneumonia both lower lobes; Atrial fibrillation; This 78-year-old female subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 12-SEP-2022, for prophylaxis. Concomitant products included tetrofosmin, zinc chloride (Myoview), simeticone (Simethicone), potassium chloride, sodium chloride, iopamidol (Isovue 370), atorvastatin (Atorvastatine), acetylsalicylic acid (Aspirin) and pantoprazole. On 31-OCT-2022, 49 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 lower lobe pneumonia (Verbatim: Pneumonia both lower lobes). Serious criteria included hospitalization. Additional event(s) included mild - grade 1 atrial fibrillation (Verbatim: Atrial fibrillation) on 31-OCT-2022 with serious criteria of hospitalization. The subject was treated with ceftriaxone, cefepime, heparin (Heparine), metoprolol succinate, metoprolol tartrate and furosemide (Lasix). The action taken with RSVPreF3 vs Placebo was no change. The outcome of lower lobe pneumonia was resolved on 20-DEC-2022. The outcome(s) of the additional event(s) included atrial fibrillation (resolved on 13-JAN-2023). Relevant Tests: On 02-NOV-2022 Transesophageal Echo (TEE) with possible cardioversion Diagnosis a-fib On 31-OCT-2022 ECG showed Paroxysmal atrial fibrillation with RVR.. Diagnostic results (reference ranges are provided in parenthesis if available): Electrocardiogram- 31-OCT-2022 abnormal. The investigator considered that there was no reasonable possibility that the lower lobe pneumonia and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the lower lobe pneumonia and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. GSK Receipt Date: 04-Nov-2022 Subject went to PCP (Primary care physician )on 10/31/2022 to follow-up on Upper Respiratory Infection, due to PI informing her at ARI (Acute respiratory infection) visit that he heard crackles on Left lung. PCP (Primary care physician) completed EKG (Electrocardiogram) at visit which was abnormal and sent subject straight to hospital where she was admitted from 10/31/22-11/3/22. Subject was diagnosed with Atrial fibrillation Per medical records subject was diagnosed with Pneumonia of both lower lobes due to Streptococcus pneumoniae, atrial fibrillation with rapid ventricular response 10/31/2022 and pleural effusion, bilateral Acute diastolic heart failure 11/3/2022 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 18-NOV-2022, Summary of change: Investigator text and Lab data updated. Follow-up information received on 09-DEC-2022 Summary of Changes: Outcome of event updated. Follow-up information received on 16-Feb-2023 Summary of Changes: Outcome of event updated. Follow-up information received on 02-MAR-2023. Summary of Changes: Medical history added, lab data added. Follow-up information received on 21-MAR-2023. Summary of Changes: Event term Pneumonia both lower lobes added and narrative updated. Follow-up information received on 03-APR-2023. Summary of changes: Medical history removed Follow-up information received on 23-MAY-2023. The subject received concomitant medication sennosides docusate sodium (8.6-50 mg) at a dose of 1 tablet, Once only, Oral, from 1/Nov/2022 to 1/Nov/2022, for indication Irritable Bowel Syndrome. The subject received treatment medication Diltiazem in NaCl at a dose of 100 mg, CO, from 31/Oct/2022 to 2/Nov/2022, for indication Atrial Fibrillation. Medical indication of ISOVUE 370 was CT Prep. Summary of Changes: Concomitant and treatment medication added. Follow-up information received on 31-MAY-2023. Summary of changes: End date for treatment drug metoprolol tartrate and ceftriaxone updated and route updated for drug Lasix. Upon internal review the case was updated on:01-Dec-2023 The subject received treatment concomitant SODIUM CHLORIDE 0.9% BOLUS for indication Dehydration Prevention with start date and stop date 31-OCT-2022 at dose 1797 ml Frequency single ROA Intravenous. The subject received treatment medication Heparin bolus for indication Atrial fibrillation with start date and stop date 31-OCT-2022 at dose 3708 ml Frequency single ROA Intravenous. Summary of changes: AESI and narrative updated. Follow-up information received on 02-Jul-2024 Summary of changes: The SAE Pneumonia both lower lobes LLT updated to as Lower lobe pneumonia from Lobar pneumonia. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of pneumonia and atrial fibrillation, 49 days after receiving 2nd dose of RSVPreF3 in a 78-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. More
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2858191 74 M 09/11/2025 UNK
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 UNKNOWN MANUFACTURER
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Atrial fibrillation, Chills, Decreased appetite, Delirium, Diarrhoea; Encephalop... Atrial fibrillation, Chills, Decreased appetite, Delirium, Diarrhoea; Encephalopathy, Escherichia pyelonephritis, Flank pain, Lumbar puncture normal, Nausea; Nephrolithiasis, Nephrostomy, Obstructive nephropathy, Septic shock, Vomiting; Atrial fibrillation, Chills, Decreased appetite, Delirium, Diarrhoea; Encephalopathy, Escherichia pyelonephritis, Flank pain, Lumbar puncture normal, Nausea; Nephrolithiasis, Nephrostomy, Obstructive nephropathy, Septic shock, Vomiting More
Obstructive nephropathy (left kidney obstruction); Atrial fibrillation with rapid ventricular rate; ... Obstructive nephropathy (left kidney obstruction); Atrial fibrillation with rapid ventricular rate; E. Coli pyelonephritis; left nephrolithiasis; Septic shock; This 74-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 28-SEP-2022, for prophylaxis. The subject's past medical history included ex-smoker (former). Concurrent medical conditions included hypertension. On 05-DEC-2022, 68 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 obstructive nephropathy (Verbatim: Obstructive nephropathy (left kidney obstruction)). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 atrial fibrillation with rapid ventricular response (Verbatim: Atrial fibrillation with rapid ventricular rate) on 05-DEC-2022 with serious criteria of hospitalization, severe - grade 3 escherichia pyelonephritis (Verbatim: E. Coli pyelonephritis) on 05-DEC-2022 with serious criteria of hospitalization, severe - grade 3 nephrolithiasis (Verbatim: left nephrolithiasis) on 05-DEC-2022 with serious criteria of hospitalization and severe - grade 3 septic shock (Verbatim: Septic shock) on 05-DEC-2022 with serious criteria of hospitalization. The subject was treated with metoprolol tartrate (Metoprolol Xl), amiodarone and rivaroxaban (Xarelto). The action taken with RSVPreF3 vs Placebo was no change. The outcome of obstructive nephropathy was resolved on 03-FEB-2023. The outcome(s) of the additional event(s) included atrial fibrillation with rapid ventricular response (resolved on 30-DEC-2022), escherichia pyelonephritis (resolved on 30-DEC-2022), septic shock (resolved on 30-DEC-2022) and nephrolithiasis (resolved on 31-JAN-2023). Relevant Tests: On Unknown date in DEC2022,Spinal tap showed infection did not reach brain or spinal fluid. Requested records for more information.. The investigator considered that there was no reasonable possibility that the obstructive nephropathy, atrial fibrillation with rapid ventricular response, escherichia pyelonephritis, nephrolithiasis and septic shock may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the obstructive nephropathy, atrial fibrillation with rapid ventricular response, escherichia pyelonephritis, nephrolithiasis and septic shock may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023027420 GSK Receipt Date: 05-JAN-2023 Subject went to the hospital for pain. Subject was transferred to a second hospital where he was admitted for sepsis and kidney stones. Subject will follow-up with urologist for kidney stones. Will request medical records for more information. Medical records reviewed. Present to hospital 05Dect2022 with left sided flank pain, nausea, vomiting, diarrhea, and chills. Also, head decreased appetite x2 days. Found to have left sided ureteral stone (8mm) in left distal ureter causing moderate up stream hydroureteronephrosis. Found E. Cli pyelonephritis. Developed septic shock secondary to pyelonephritis (which was due to obstructing renal stone). Required vasopressors and was transferred to tertiary medical center for urological procedure. Underwent left percutaneous nephrostomy tube 06DEC2022. Was treated with ciprofloxacin, later changed to cefazolin, then changed to ceftriaxone for pyelonephritis and septic shock. The hospital course was complicated with atrial fibrillation with RVR, treated with Xarelto, metoprolol and amiodarone. Also subject had delirium/encephalopathy for which he underwent a lumbar puncture and was placed on Seroquel. Was discharged in stable condition home 20DEC2022. Unclear if subject had pneumonia. Will request further records. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 06-JAN-2023 Summary of changes: Event term updated (Septic shock, Obstructing left nephrolithiasis, E. Coli pyelonephritis and Atrial fibrillation with rapid ventricular rate, concomitant medication (Xarelto, Amiodarone and metoprolol XL) and investigator text were updated. Follow-up information received on 10-Jan-2023. Summary of Changes: SAE term splited to Left kidney obstruction and left nephrolithiasis. Follow-up information received on 13-Jan-2023. Summary of Changes: Event start date updated and TTO updated. Concomitant updated as treatment medication. Event term updated. Follow-up information received on 02-MAR-2023. Summary of Changes: SAE outcome for Obstructive nephropathy (left kidney obstruction) was updated Follow-up information received on 17-MAR-2023. Summary of Changes: Xarelto end date updated Follow-up information received on 25-APR-2023 and 27-APR-2023 Summary of Changes: Action taken and outcome of event for left nephrolithiasis updated Follow-up information received on 31-Oct-2023. Summary of Changes: Medical history former smoker and hypertension added. Upon internal review the case was updated on: 04-Dec-2023. Summary of changes: AESI statement added. Follow-up information received on 28-MAY-2024 Summary of changes: End date was updated for Treatment medication Amiodarone and ongoing was updated for treatment medication Metoprolol xl. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of obstructive nephropathy , nephrolithiasis, atrial fibrillation, escherichia pyelonephritis and septic shock, 459 days after receiving 1st dose of RSVPreF3, in a 74-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, and alternative etiology nephrolithiasis for the event obstructive nephropathy and hypertension for atrial fibrillation. US-GSK-US2023027420: More
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2858192 68 M 09/11/2025 UNK
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 UNKNOWN MANUFACTURER
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Acute myocardial infarction, Atrial flutter, Cardioversion, Chest X-ray normal, ... Acute myocardial infarction, Atrial flutter, Cardioversion, Chest X-ray normal, Echocardiogram; Echocardiogram normal, Electrocardiogram abnormal, Thrombocytopenia, Troponin increased; Acute myocardial infarction, Atrial flutter, Cardioversion, Chest X-ray normal, Echocardiogram; Echocardiogram normal, Electrocardiogram abnormal, Thrombocytopenia, Troponin increased More
Atrial Flutter; This 68-year-old male subject was enrolled in a blinded study. The subject received ... Atrial Flutter; This 68-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 26-SEP-2022, for prophylaxis. Concurrent medical conditions included atrial fibrillation (A-Fib). Concomitant products included apixaban (Eliquis). On 30-DEC-2022, 95 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial flutter (Verbatim: Atrial Flutter). Serious criteria included hospitalization. The subject was treated with diltiazem, acetylsalicylic acid (Aspirin), paracetamol (Acetaminophen), sodium chloride and heparin. The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial flutter was resolved on 04-JAN-2023. Relevant Tests: On 31DEC2022 Echocardiogram showed Normal On unknown Dec 2022 normal chest x-rays we do not have the ECG tracings but have the readings of A. Flutter with RVR On 04JAN2023 Echo Transesophageal No evidence of intracardiac thrombus. Diagnostic results (reference ranges are provided in parenthesis if available): Troponin-In DEC-2022 elevated. The investigator considered that there was no reasonable possibility that the atrial flutter may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial flutter may have been caused by RSVPreF3 vs Placebo. GSK Receipt date: 17-JAN-2023 Subject was hospitalized from 31DEC2022 until 04JAN2023 for atrial fibrillation. On 04JAN2023 had cardioversion on 04JAN2023 and was given Eliquis started taking on 04JAN2023 and continues. 17JAN2023 +/+ subj stated 31DEC2022 (to) 04JAN2023 'heart flutter' (atrial fib) Eliquis 04JAN2023 'shock heart in place' Clarification 'cardioversion' Subj went to PCP on 16JAN2023 for follow up and stated 'all clear.' Also asked subject about releasing medical records; subj stated he was not sure he should allow this since he told me all the information needed for his condition. 23FEB2023 medical release signed Per PI, further discussion of Adverse Event of Special Interest. Clinical considerations, - subject has AFIB since 1990, no known history of hyperthyroidism or amyloidosis or other predisposing pathologies for Fib/flutter. He was admitted for A flutter on 31DEC2022. Concurrent medical conditions nonsignificant for atrial flutter/fibrillation genesis of continuation. He does have thrombocytopenia. Subject had successful cardioversion on 04JAN2023. He also had presumptive diagnosis of NSTEMI treated with Cardizem IV, anticoagulation was begun, we do not have the ECG tracings but have the readings of A. Flutter with RVR. Per medical records troponin assessed approx 30Dec2022. Follow-up information received on 18-JAN-2023 Summary of change: Eliquis was updated to treatment medication from concomitant medication. Follow-up information received on 23-JAN-2023 Summary of change: Lab data removed (Atrial Fibrillation) Follow-up information received on 25-Jan-2023 Summary of change: Concomitant medication was updated to treatment medication and investigator text was updated. Follow-up information received on 27-APR-2023 Summary of changes: Action taken updated. Follow-up information received on 09-MAY-2023 Summary of changes: Narrative updated. Follow-up information received on 01-Jun-2023. Summary of changes: Narrative updated, event updated from Atrial Fibrillation to Atrial Flutter. Follow-up information received on 05-JUN-2023. Summary of changes: Relevant medical condition updated. Follow-up information received on 14-JUN-2023. This case contains an event assessed by the investigator as a adverse event of special interest (AESI). Summary of changes: Narrative updated Follow-up information received on 22-JUN-2023. The subject received concomitant medication Heparin from 31/Dec/2022 to 14/Jan/2023, 12.0 unknown at Continuous infusion for the Indication of Stroke Prophylaxis Intravenously. Summary of changes: Concomitant medication and lab data added. Follow-up information received on 11-JUL-2023 Summary of changes: Narrative updated. Follow-up information received on 17-JUL-2023 Summary of changes: Lab test updated. Follow-up information received on 29-AUG-2023 Summary of changes: Narrative updated. Follow-up information received on 25-OCT-2023 Summary of changes: Narrative updated. Follow-up information received on 03-JUN-2024 Summary of changes: concomitant drugs updated to treatment drugs. Follow up information received on 04-JUL-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial flutter, 527 days after receiving 2nd dose of RSVPreF3 vaccine + AS01E in a 68-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factor (h/o atrial fibrillation). More
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2858193 75 M 09/11/2025 UNK
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Atrial fibrillation, Atrial flutter, Condition aggravated, Electrocardiogram abn... Atrial fibrillation, Atrial flutter, Condition aggravated, Electrocardiogram abnormal, Tachycardia; Troponin normal; Atrial fibrillation, Atrial flutter, Condition aggravated, Electrocardiogram abnormal, Tachycardia; Troponin normal More
worsening of atrial fibrillation; This 76-year-old male subject was enrolled in a blinded study. The... worsening of atrial fibrillation; This 76-year-old male subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 23-AUG-2022, for prophylaxis. The subject's past medical history included coronary stent placement and pneumothorax spontaneous. Concurrent medical conditions included anxiety, chronic obstructive pulmonary disease, ischemic heart disease, coronary artery disease, myocardial infarction, hyperlipidemia and atrial fibrillation. On 05-APR-2023, 225 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 atrial fibrillation aggravated (Verbatim: worsening of atrial fibrillation). Serious criteria included hospitalization. The subject was treated with metoprolol and apixaban (Eliquis). The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation aggravated was resolved on 06-APR-2023. Relevant Tests: On 04-May-2023 ECG obtained: Done at 2136. Heart rate 167. ER doctor's interpretation, Regular, narrow complex tachycardia, likely atrial flutter with rapid ventricular response. Repeated at 2224.HR 96, Normal Sinus Rhythm.. Diagnostic results (reference ranges are provided in parenthesis if available): Heart rate-In APR-2023 significantly improved after Lopressor. Troponin-In APR-2023 normal. The investigator considered that there was no reasonable possibility that the atrial fibrillation aggravated may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation aggravated may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2023071796 GSK receipt date: 19-MAY-2023 Spoke to subject yesterday for contact. During the call he mentioned that he had gone to the ER on 05APR2023 for an episode of atrial fibrillation to which he has a history of. He was admitted overnight. He was started on Eliquis 5mg. He was discharged on 06APR2023. He has followed up with his primary care physician who has continued the Eliquis and increased his dose of Metoprolol. Subject reports doing well. Will follow up once more information was received. As stated above, subject has a history of atrial fibrillation. Please advise if this event needs to report as an AESI. Site requested guidance from CRA but has not received any information at this time. Reporting as an SAE for safety. Per hospital records: labs obtained/reviewed-unremarkable, normal troponin. Heart rate significantly improved after Lopressor. He had one episode where his heart rate was back in the 120's but spontaneously converted back to sinus rhythm immediately. Subject reported significant improvement. Discharged home with cardiology follow up. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 12-JUN-2023 Summary of changes: Relevant medical history, action taken of suspected drug and lab data has been updated. Follow-up information received on 16-Jun-2023. Previously investigator considered AE as Potential Immune Mediated Disease (pIMD) now it has been downgraded to NO. Summary of changes: Lab data and narrative updated. Follow-up information received on 29-FEB-2024. Summary of changes: Narrative updated. Follow-up information received on 10-MAY-2024. Summary of changes: Ongoing checked for treatment drugs Metoprolol and Eliquis. Follow up information received on 04-Jul-2024 End of study unblinding completed.; Sender's Comments: A case of Atrial fibrillation aggravated, 615 days after receiving 1st dose of RSVPreF3, in a 76-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor (h/o known atrial fibrillation). US-GSK-US2023071796: More
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2858194 84 F 09/11/2025 UNK
 UNKNOWN MANUFACTURER
 UNK
Atrial fibrillation Atrial fibrillation
Atrial Fibrillation; This 84-year-old female subject was enrolled in an open label study. The subjec... Atrial Fibrillation; This 84-year-old female subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular use, left deltoid) 120 ๏ฟฝg on 03-SEP-2024, for prophylaxis. Previously administered products included Influenza vaccine (The subject received first dose of Influenza vaccine on 01-Oct-2023 via intramuscular route for prophylaxis) and Shingrix Vaccine (The subject received first dose of Shingrix Vaccine on 20-Jun-2022 and second dose on 11-Nov-2022 via intramuscular route for prophylaxis). Concurrent medical conditions included hypertension and chronic obstructive pulmonary disease (moderate). Concomitant products included metoprolol, amlodipine, alprazolam, salbutamol (Albuterol), carmellose sodium (Theratears), ibuprofen, paracetamol (Acetaminophen), acetylsalicylic acid (Aspirin), fluticasone furoate;umeclidinium bromide;vilanterol trifenatate (Trelegy Ellipta) and fluoxetine. On 12-FEB-2025, 162 days after receiving RSVPreF3 vaccine + AS01E, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with flecainide acetate (Tambocor). The outcome of atrial fibrillation was resolved on 14-FEB-2025. The investigator considered that there was a reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. GSK Receipt date: 13-Mar-2025 Subject was admitted to hospital and diagnosed with Atrial Fibrillation on 12-FEB-2025. Subject was discharged home on 14-FEB-2025. Site was awaiting hospital records for details. 28-MAR-2025, site continued to await medical records, per PI (principal investigator) discretion AF (Atrial Fibrillation) would be considered related to investigational product until records determine that is not true. No updates as of 21-Apr-2025. Participant was a former smoker. Participant was taking Metoprolol but Rx for hypertension, participant did not receive rhythm or rate-control medication prior to event onset, Participant did not received any anticoagulation medication prior to event onset. SAE was related to study treatment RSVPreF3 OA Vaccine. SAE was not related to Study Participation Activities other than Study Treatment This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). This was a new disease and not the exacerbation of an existing disease. Date event became serious: 12-FEB-2025 The subject received Vitamin D from 2013 to ongoing at a dose of 2000 iu, qd, orally for osteoporosis Follow-up information received on 13-MAR-2025 Summary of changes: Type of drug from concomitant to treatment for Tambocor were updated. Upon internal review case was updated on 25-MAR-2025. The event was upgraded from non-serious to serious with seriousness criteria hospitalization, events causality was upgraded from no to yes, hospitalization dates, general narrative comments were updated. Follow up information received on 28-MAR-2025 Summary of changes: General narrative comment updated. Follow up information received on 03-APR-2025 Summary of changes: Concurrent medical conditions hypertension and chronic obstructive pulmonary disease were updated. Follow up information received on 21-APR-2025 Summary of changes: General narrative comment updated. Follow up information received on 09-MAY-2025 Summary of changes : Concomitant medication Fluoxetine was added.General narrative was updated. Follow up information received on 20-Jun-2025 Summary of changes: General narrative comment updated. Follow up information received on 27-Jun-2025 Summary of changes: General narrative comment updated.; Sender's Comments: It is reported as a case of atrial fibrillation, 162 days after receiving 1st dose of RSVPreF3 vaccine + AS01E in a 84-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, age, and concurrent medical conditions hypertension as an alternative risk factor. More
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2858195 09/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3273H
Product preparation issue Product preparation issue
When nurse was doing her inventory she realized that a patient only received the adjuvant of Shingri... When nurse was doing her inventory she realized that a patient only received the adjuvant of Shingrix; only received the adjuvant of Shingrix; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 3273H, expiry date 03-MAR-2027) for prophylaxis. On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: When nurse was doing her inventory she realized that a patient only received the adjuvant of Shingrix) and inappropriate dose of vaccine administered (Verbatim: only received the adjuvant of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 14-AUG-2025 The patient only received the adjuvant of Shingrix. More
2858196 M TN 09/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site reaction, Malaise Injection site reaction, Malaise
had round circle reaction at the vaccination site; not feeling well for about 12 hours; This non-ser... had round circle reaction at the vaccination site; not feeling well for about 12 hours; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site reaction in a adult male 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 injection site reaction (Verbatim: had round circle reaction at the vaccination site) and feeling unwell (Verbatim: not feeling well for about 12 hours). The outcome of the injection site reaction was resolved and the outcome of the feeling unwell was resolved (duration 12 hrs). It was unknown if the reporter considered the injection site reaction and feeling unwell to be related to Shingrix. It was unknown if the company considered the injection site reaction and feeling unwell to be related to Shingrix. Additional Information: GSK Receipt Date: 13-AUG-2025 An approximately 50-year-old patient had round circle reaction at the vaccination site which was about 3 inches circle after vaccination The problems resolved, and he planned to receive the second dose after a two-month interval. More
2858197 09/11/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Therapeutic response unexpected Therapeutic response unexpected
the vaccine actually likely saved my life; This non-serious case was reported by a consumer via inte... the vaccine actually likely saved my life; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Concurrent medical conditions included asthma. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced unexpected therapeutic effect (Verbatim: the vaccine actually likely saved my life). The outcome of the unexpected therapeutic effect was not applicable. Additional Information: GSK Receipt Date: 15-AUG-2025 The patient was asthmatic. It was reported that if you understand the pathology of that disease, it causes scarring of lung tissue over time and repeated flares. The vaccine actually likely saved the patient's life. The patient was back to pre-covid lung status now. The asthmatics were considered high risk, and their chances of permanent damage is high. Plus their age puts them at a high risk. The morbidity is much higher, and the vaccine, in fact, lessons these outcomes. More
2858198 09/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Ophthalmic herpes zoster, Vaccination failure Ophthalmic herpes zoster, Vaccination failure
suspected vaccination failure; shingles in right eye; This serious case was reported by a consumer ... suspected vaccination failure; shingles in right eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: shingles in right eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 28-AUG-2025 This case was reported by a patient via interactive digital media. The patient had shingles in right eye, and he/she was in hospital. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles in eye were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Ophthalmic herpes zoster, unknown time after receiving Shingrix, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2858199 09/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; had shingles; This serious case was reported by a consumer via intera... Suspected vaccination failure; had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-SEP-2025 This case was reported by a patient via interactive digital media. The patient received shingles shot and had shingles 6 times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2858200 09/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv... suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 69-year-old patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. The patient's past medical history included aneurysm (in 2008). On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 01-SEP-2025 This case was reported by a patient via interactive digital media. The patient did not remember having a chickenpox. The patient had shingles and gone to physician 3 times. The patient stated this was the worst pain in the world. The patient never experienced the pain of shingles, and he/she gave suggestion to others to get the shot. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Herpes Zoster, in a 69-year-old patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2858201 09/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Back pain, Herpes zoster, Musculoskeletal chest pain, Vaccination failure Back pain, Herpes zoster, Musculoskeletal chest pain, Vaccination failure
Suspected vaccination failure; shingles was causing all this pain; This serious case was reported by... Suspected vaccination failure; shingles was causing all this pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. In AUG-2025, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles was causing all this pain). 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 Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 02-SEP-2025 This case was reported by a patient via interactive digital media. The patient reported they had just got out of the hospital because it was hurting so bad and under ribs around back and thought they had pulled a muscle and maybe broke a rib. But later was turned-out to shingles which was causing all the pain which then broke out on back and underneath arm on left side. The patient had symptom, and was still going through it, it had been about 4 days. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2025AMR116800, reported by same reporter for different patient.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Herpes Zoster vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2025AMR116800:same reporter /different patient More
2858202 09/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Discomfort, Herpes zoster, Vaccination failure Discomfort, Herpes zoster, Vaccination failure
Suspected vaccination failure; just got over shingles; They were uncomfortable; This serious case w... Suspected vaccination failure; just got over shingles; They were uncomfortable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: just got over shingles) and discomfort (Verbatim: They were uncomfortable). The outcome of the vaccination failure was not reported and the outcome of the shingles and discomfort were resolved. It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and discomfort to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-AUG-2025 This case was reported by a patient via interactive digital media. Patient got the shots about a year ago in 2024. Patient indicated that without having the Shingles shot, his /her getting them, patient would have suffered more. So, patient suggested to get the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2858203 09/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Herpes zoster; This serious case was reported by a consumer via inter... Suspected vaccination failure; Herpes zoster; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patients experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Herpes zoster). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-AUG-2025 This case was reported by a consumer via interactive digital media. Reporter had several people who got the shot said the same thing. Reporter believed them. It had happened after they got the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2025AMR112713, reported by same reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2025AMR112713:same reporter More
2858204 09/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; reoccurring shingles on back and hip; This serious case was reported ... Suspected vaccination failure; reoccurring shingles on back and hip; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: reoccurring shingles on back and hip). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-SEP-2025 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2858205 OH 09/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Product preparation error Product preparation error
possible wrong diluent; Menveo was reconstituted with sterile water; This non-serious case was repor... possible wrong diluent; Menveo was reconstituted with sterile water; This non-serious case was reported by other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: possible wrong diluent) and wrong solution used in drug reconstitution (Verbatim: Menveo was reconstituted with sterile water). The outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were not applicable. Additional Information: GSK Receipt Date: 12-AUG-2025 The reporter reported that there was a possible instance in which Menveo was reconstituted with sterile water instead of the provided reconstitution ingredients. Reporter asked if a revaccination was required to ensure adequate protection for the patient. More
2858206 M CA 09/11/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5H773
Expired product administered Expired product administered
Maladministration After the Expiration Date; This non-serious case was reported by a other health pr... Maladministration After the Expiration Date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis. On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Maladministration After the Expiration Date). 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: 12-AUG-2025 The reporter reported that patient was administered with an expired dose of Infanrix, which led to expired vaccine used. Vaccine detail and patient demographics were obtained in this call. No vaccination date was obtained in this call. No further information was obtained in this call. More
2858207 1.58 F MN 09/11/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 39KS9
Extra dose administered Extra dose administered
Extra Dose Administered; This non-serious case was reported by a physician via call center represent... Extra Dose Administered; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 19-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 39KS9, expiry date 07-SEP-2025) for prophylaxis. Previously administered products included Pediarix (received 1st dose on 27-FEB-2024) and Pediarix (received 2nd dose on 27-JUN-2024). On 31-JUL-2025, the patient received the 3rd dose of Pediarix. On 31-JUL-2025, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Extra Dose Administered). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-AUG-2025 and 13-AUG-2025 The reporter had a patient in clinic that received the Pediarix product and when it was administered, after it was administered, the nurse figured out that neither of the patient that got that product, needed the Hep B and got actually a Fourth of the Hep B component, the Hepatitis B component. So, he/she was wondering if there was any follow-up recommended from the manufacturer on that. The patient completed the Hep B series and so they got a fourth dose of Hepatitis B what was not recommended, which led to extra dose administered. The reporter consented to follow up. The case had been linked to US2025104067, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2025104067:for 1 st patient More
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