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
2853432 14 F MO 08/09/2025 HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.

Y015179
Y015179
Dizziness, Headache; Dizziness, Headache; Dizziness, Headache; Dizziness, Headac... Dizziness, Headache; Dizziness, Headache; Dizziness, Headache; Dizziness, Headache More
Headaches, dizziness Headaches, dizziness
2853433 56 F FL 08/09/2025 FLU3
VARZOS
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 TFAA2501
7zM55
Influenza like illness, Injection site erythema, Pyrexia; Influenza like illness... Influenza like illness, Injection site erythema, Pyrexia; Influenza like illness, Injection site erythema, Pyrexia More
Large red spot, taking up most of the upper arm. Fever and signs of high immune activity. Started th... Large red spot, taking up most of the upper arm. Fever and signs of high immune activity. Started the next day and continued for several days with the red injection site growing every day until it stopped. it is now beginning to go down and the flu like symptoms are resolving. More
2853434 67 F TX 08/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 GJ952
Lip swelling, Swelling face Lip swelling, Swelling face
Patient received 1st Shingrix vaccine 8/5/25. Patient also started a new face cream on 8/7/5 and lat... Patient received 1st Shingrix vaccine 8/5/25. Patient also started a new face cream on 8/7/5 and later has swelling of lips and face. More
2853435 71 F WA 08/09/2025 RSV
 PFIZER\WYETH
 MD5461
Burning sensation, Electric shock sensation, Pain in extremity Burning sensation, Electric shock sensation, Pain in extremity
Patient reported seeking medical care after receiving vaccine for soreness, burning, and electric sh... Patient reported seeking medical care after receiving vaccine for soreness, burning, and electric shock feeling in upper arm. More
2853436 12 M IA 08/09/2025 MNQ
 SANOFI PASTEUR
Erythema, Feeling hot, Swelling Erythema, Feeling hot, Swelling
warmth, redness, swelling-minimal, no pain, started several hours after the injection. redness and w... warmth, redness, swelling-minimal, no pain, started several hours after the injection. redness and warmth continued to grow in size. initial marking 8cm, secondary 13cm, last 16cm currently (marked by mother), no pain medication or antihistamines given in ER or at home. More
2853437 13 F FL 08/09/2025 HEPA
HPV9
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 L4EA4
Y013407
U8558AA
EB499
Syncope; Syncope; Syncope; Syncope Syncope; Syncope; Syncope; Syncope
Syncopal episode after receiving vaccines. Client recovered soon after syncopal episode after being ... Syncopal episode after receiving vaccines. Client recovered soon after syncopal episode after being given an ammonia inhalant. More
2853438 72 M IN 08/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93n4j
Arthralgia, Fatigue Arthralgia, Fatigue
Patient's wife stated that he woke up early the next morning with fatigue and pain in all of hi... Patient's wife stated that he woke up early the next morning with fatigue and pain in all of his joints. More
2853439 42 M NM 08/09/2025 COVID19
COVID19
 MODERNA
MODERNA
 032H20A
032H20A
Fatigue, Injection site pain, Injection site swelling, Myalgia, Pain; Somnolence Fatigue, Injection site pain, Injection site swelling, Myalgia, Pain; Somnolence
Swollen and sore at shot sight hour after shot I felt tired drowsy and sore Swollen and sore at shot sight hour after shot I felt tired drowsy and sore
โœ“ โœ“ โœ“
2853440 61 F MD 08/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 GJ952
Cellulitis, Rash Cellulitis, Rash
After she got second dose of Shingrix, she noticed rash next day. Next day she also had appointment ... After she got second dose of Shingrix, she noticed rash next day. Next day she also had appointment with doctor and they told her she had cellulitis. She was on antibiotics for 1-2 weeks More
2853442 77 F NV 08/09/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LN4929
LN4929
Dyspnoea, Erythema, Malaise, Pain in extremity, Peripheral swelling; Pyrexia Dyspnoea, Erythema, Malaise, Pain in extremity, Peripheral swelling; Pyrexia
Patient's son came in 8/9/25 to discuss the severe reaction that he states his mom experienced ... Patient's son came in 8/9/25 to discuss the severe reaction that he states his mom experienced upon receiving the Prevnar 20 vaccine. He states that patient experienced symptoms immediately starting after she arrived at home, including fever, arm pain/redness and swelling, etc. She began experiencing shortness of breath, but that went away after a short period of time. I asked if she experienced any other signs of anaphylaxis, and he stated no. She wasn't feeling better (ie "back to normal) until after one week. More
2853443 11 F IA 08/09/2025 MNQ
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR

Erythema, Injection site pain, Pain, Skin warm, Urticaria; Erythema, Injection s... Erythema, Injection site pain, Pain, Skin warm, Urticaria; Erythema, Injection site pain, Pain, Skin warm, Urticaria More
2 Hard swollen welts that are red and warm to touch as well as very painful. Seem larger today than ... 2 Hard swollen welts that are red and warm to touch as well as very painful. Seem larger today than yesterday. Been icing, which makes feel better for time being. She's keeping it protected from others touching as both sites hurt. More
2853444 53 F CT 08/09/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Injection site erythema, Injection site warmth, Rash Injection site erythema, Injection site warmth, Rash
Patient was given tdap viccine (Boostrix NDC: 58160-0842-52 Lot# 37f34 Exp. 10/24/2027) On 8/5/2025.... Patient was given tdap viccine (Boostrix NDC: 58160-0842-52 Lot# 37f34 Exp. 10/24/2027) On 8/5/2025. Patient called the pharmacy on 8/8/2025 to report an allergic reaction. I asked her to come in so I could see an check on it for her. Patient came in, patient's right arm around vaccine area was red and a little hot to the touch and a little swollen. She stated that the rash spread to her neck area. I did see that it did spread to the neck and chest area. I asked if her doctor's office was a wear she said yes and they referred her back to us at the pharmacy. I told her to take Benadryl and apply hydrocortisone to the chest area to help ease symptoms. She did not report any other major symptoms. I did call her the morning of 8/9/2025 to check on her. she was at a bridal shower and said she took Benadryl last night and is feeling better, that the rash is not getting worst. She will keep an eye on it and is aware that if her symptoms get worst to see her provider right away. Tried to report and document this yesterday. Did not go through properly, retrying today 8/9/2025. More
2853445 67 F NY 08/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93N4J
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
redness and warmth at injection site that started 24 hours after injection redness and warmth at injection site that started 24 hours after injection
2853446 52 F FL 08/09/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 rw0178
rw0178
Eyelid infection, Fatigue, Feeling abnormal, Hordeolum, Immune system disorder; ... Eyelid infection, Fatigue, Feeling abnormal, Hordeolum, Immune system disorder; Impaired work ability, Inflammation, Swelling of eyelid More
After vaccine was injected, very next morning I was extremely tired and almost cry due to feel so ba... After vaccine was injected, very next morning I was extremely tired and almost cry due to feel so bad, Then My eyelid becomes Swallen and infected and few days later I had about 25000 stye under my upper eyelid, and I went to Employee Healths, they sent me home, my doctor had prescribed me antibiotics and a lot of other treatment. I was stayed out of work for about 2 weeks, until all inflammation and infections healed. And until they cleared me to back to work. All this record in my doctor's office chart and in hospital Employees health as well. I paid out of my packet for all medication, and for my sick days-its was took out of my vacation PTO time. And this medication was not by my choices-its was mandatory for hospital workers. My immune system never come back to Normal. More
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2853447 47 M GA 08/09/2025 FLU3
HEPAB
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 TFAA2502
AZ2A3
Hypoaesthesia, Paraesthesia; Hypoaesthesia, Paraesthesia Hypoaesthesia, Paraesthesia; Hypoaesthesia, Paraesthesia
patient says that the next day after receiving the TWINRIX and FLUBLOK vaccine he started to experie... patient says that the next day after receiving the TWINRIX and FLUBLOK vaccine he started to experience numbness and tingling in his left arm and fingers More
2853448 51 F TX 08/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 31252
Skin lesion Skin lesion
Patient returned to pharmacy for second shingles vaccination. Before administration, patient inform... Patient returned to pharmacy for second shingles vaccination. Before administration, patient informed pharmacist she thought she got a mild form of shingles a few days after first shingles dose was administered in May. She observed small lesions appeared on her hand and trunk area for about 10 days and disappeared. Pharmacist observed faint dots still on patient's hands. Patient advised patient to consult with doctor before she received second dose. Second dose was not administered More
2853449 62 F MA 08/09/2025 TDAP
 SANOFI PASTEUR
 U8252AA
Pain Pain
Patient reports having pain that began shortly after receiving the vaccine in January that never wen... Patient reports having pain that began shortly after receiving the vaccine in January that never went away More
2853450 77 F FL 08/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 bg5j4
Extra dose administered Extra dose administered
duplicate vaccine received arexvy 12/23/23 and again 8/8/25 database didn't indicate dose from ... duplicate vaccine received arexvy 12/23/23 and again 8/8/25 database didn't indicate dose from 12/23/23 so looked like she was due for RSV vaccine. More
2853451 37 F GA 08/09/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0158
EN6207
Autopsy, Death, Deep vein thrombosis, Pulmonary embolism, Unresponsive to stimul... Autopsy, Death, Deep vein thrombosis, Pulmonary embolism, Unresponsive to stimuli; Autopsy, Death, Deep vein thrombosis, Pulmonary embolism, Unresponsive to stimuli More
On 8/13/2023 Police was called to do a wellness check on patient because she did not report to work ... On 8/13/2023 Police was called to do a wellness check on patient because she did not report to work or answer multiple phone calls which was very unusual. Upon entering patient's home, she was found unresponsive with no sign of life. EMS was dispatched to the home where they confirmed that she was deceased. She was transported to Coroner's office where an autopsy was performed to determine the exact cause of death. The report indicated that she had passed from multiple Pulmonary Embolism and multiple Deep Vein Thrombosis. We believe her death was directly related the Pfizer Covid-19 SARS injections since she was otherwise a very healthy person who worked in the health system. More
โœ“
2853452 32 F TN 08/09/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Erythema, Immediate post-injection reaction, Induration, Pruritus, Skin warm; Sw... Erythema, Immediate post-injection reaction, Induration, Pruritus, Skin warm; Swelling More
Immediate itching, swelling and redness about 2-3 inches in diameter at 12 hours after injection, co... Immediate itching, swelling and redness about 2-3 inches in diameter at 12 hours after injection, continues to be hard, warm, painful, and itchy at 36 hours More
2853509 1.25 F ID 08/09/2025 DTAP
DTAP
DTAP
DTAP
DTAP
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 SKR3R
SKR3R
SKR3R
SKR3R
SKR3R
Y013350
Y013350
Y013350
Y013350
Y013350
Alanine aminotransferase normal, Aspartate aminotransferase normal, Basophil cou... Alanine aminotransferase normal, Aspartate aminotransferase normal, Basophil count, Blood albumin decreased, Blood alkaline phosphatase normal; Blood bilirubin decreased, Blood calcium normal, Blood chloride normal, Blood creatinine decreased, Blood magnesium increased; Blood potassium normal, Blood sodium normal, Carbon dioxide decreased, Electrocardiogram normal, Generalised tonic-clonic seizure; Haematocrit normal, Haemoglobin normal, Lymphocyte count, Neutrophil count, Platelet count normal; Protein total normal, White blood cell count normal; Alanine aminotransferase normal, Aspartate aminotransferase normal, Basophil count, Blood albumin decreased, Blood alkaline phosphatase normal; Blood bilirubin decreased, Blood calcium normal, Blood chloride normal, Blood creatinine decreased, Blood magnesium increased; Blood potassium normal, Blood sodium normal, Carbon dioxide decreased, Electrocardiogram normal, Generalised tonic-clonic seizure; Haematocrit normal, Haemoglobin normal, Lymphocyte count, Neutrophil count, Platelet count normal; Protein total normal, White blood cell count normal More
Generalized tonic-clonic seizure. Self resolved. Lasted 2 minutes. Observed in ER and sent home. No ... Generalized tonic-clonic seizure. Self resolved. Lasted 2 minutes. Observed in ER and sent home. No fever More
2854431 M IL 08/09/2025 PNC20
 PFIZER\WYETH
 LN4929
Injection site rash, Injection site swelling, Injection site warmth Injection site rash, Injection site swelling, Injection site warmth
7/6/25 - started w/ a rash @ injection site. Warm, raised. half circle mark @ site 7/9/25 - spoke w/... 7/6/25 - started w/ a rash @ injection site. Warm, raised. half circle mark @ site 7/9/25 - spoke w/ patient and symptoms resolved. More
2853247 08/08/2025 COVID19
 PFIZER\BIONTECH
Brain fog, COVID-19, Dizziness, Drug ineffective, Fatigue Brain fog, COVID-19, Dizziness, Drug ineffective, Fatigue
fatigue; dizziness; fogginess; covid again the past Jun; covid again the past Jun; This is a spontan... fatigue; dizziness; fogginess; covid again the past Jun; covid again the past Jun; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid", start date: Jul2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3, BOOSTER), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "covid again the past Jun"; FATIGUE (hospitalization), outcome "unknown"; DIZZINESS (hospitalization), outcome "unknown"; BRAIN FOG (hospitalization), outcome "unknown", described as "fogginess". Clinical Course: Patient reported taking 4 pfizer vaccines and covid again the past Jun. Currently on leave because of neurological and vestibular symptoms due to covid. Patient was in the hospital diagnosed with fatigue, dizziness and fogginess and is interested in participating in a trial. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
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2853248 F 08/08/2025 FLU3
 SEQIRUS, INC.
 No batch number
Breast pain, Injection site pain, Pain Breast pain, Injection site pain, Pain
It hurt like a normal vaccine, but after two or three hours it started getting even worse; It was fr... It hurt like a normal vaccine, but after two or three hours it started getting even worse; It was from her elbow to shoulder, the vaccine was on the right hand side/ The pain went to entire upper arm; The pain went down almost to waist and the right side of upper torso; The pain landed in the breast; This spontaneous case, initially received on 30-Jul-2025, was reported by a non health professional and concerns an elderly female patient. Past medical history included biopsy. Concomitant Medications reported as unknown Administration of company suspect drug: On an unknown date in Nov-2022, the patient received Fluad (TIV) for influenza prophylaxis. Dose regimen: Not reported. Route of administration: Not reported. Anatomical location: right hand side. Lot number: No batch number available and would be requested upon follow up. No additional suspect drugs. Adverse reactions/events and outcomes: On Nov-2022, the patient experienced It hurt like a normal vaccine, but after two or three hours it started getting even worse (Medically Significant, outcome: Recovered/resolved), It was from her elbow to shoulder, the vaccine was on the right hand side / The pain went to entire upper arm (Medically Significant, outcome: recovered/resolved), The pain went down almost to waist and the right side of upper torso (Medically Significant, outcome: recovered/resolved), The pain landed in the breast (Medically Significant, outcome: recovered/resolved). Patient stated that she received Fluad back in Nov-2022 and blew up in her arm and upper torso. When asked if the adverse reaction started right after taking the vaccine, caller states: Not really. It hurt like a normal vaccine, but after two or three hours it started getting even worse. Through the night, it was from her elbow to shoulder, the vaccine was on the right hand side. The pain went to entire upper arm, and down almost to waist and the right side of upper torso. No hives, no breathing issues, it was just severe pain. When asked if there was any treatment associated with the adverse reaction, patient mentioned that once she got a hold of her doctor, the pain had already subsided except for the upper half portion of her torso. Transcribed from call: The pain lasted and eventually, she ended up going to the doctor, because the pain landed in the breast, and eventually went to the breast surgeon. Nobody could see anything but they could recognize that she was in a lot of pain. It went away everywhere else, except there. Patient ended up going to two different breast surgeons, two different hospitals, because everybody acknowledged that she was in pain but nobody could find anything. Gradually, it took about a year for the pain to finally dimmish. After the fact, she was hospitalized to get a biopsy done when she told her doctor about the symptoms she had experienced following vaccination; patient was then told by the doctor that due to the severity of the reaction, she should have gone directly to the emergency room. When asked to confirm if the hospitalization was due to the adverse reactions from the vaccine, caller said not for that. Stated that after consulting with two different breast surgeons, she was referred to an allergist so she could be tested for every component in the vaccine. Stated needing the PI for the 2022-2023 season so the doctors could be made aware of which ingredients to test for. Fluad (TIV) action taken: Not Applicable Reporter assessment: The reporter (patient), reporting 30-Jul-2025, on considered the events as serious (Medically Significant) and did not provide the causality assessment.; Reporter's Comments: Causality : Due to the spontaneous nature of the case, the events are considered related for reporting purposes. Related for events vaccination site pain, pain in extremity and radiating pain due to close temporal association and anatomical proximity (after2-3 hours of vaccine). Related for breast pain due to plausible temporal association (reported as "eventually pain landed in breast"). However there is insufficient information on biopsy details. More
2853264 F 08/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Death, Guillain-Barre syndrome Death, Guillain-Barre syndrome
Gillian Barre; This serious case was reported by a consumer via interactive digital media and descri... Gillian Barre; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female 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 guillain barre syndrome (Verbatim: Gillian Barre) (serious criteria death and GSK medically significant). The reported cause of death was guillain barre syndrome. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. The company considered the guillain barre syndrome to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 04-AUG-2025 This case was reported by a consumer via interactive digital media. Reporter did not get the shingles vaccine. He/she had a friend who got it, and she died from Guillain-Barre syndrome. Look it up.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingles vaccine, in a female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.; Reported Cause(s) of Death: Guillain-Barre syndrome More
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2853265 78 M 08/08/2025 UNK
 UNKNOWN MANUFACTURER
 UNK
Atrial fibrillation, Cardiac pacemaker insertion, Magnetic resonance imaging hea... Atrial fibrillation, Cardiac pacemaker insertion, Magnetic resonance imaging head abnormal, Sinus node dysfunction, Syncope More
sick sinus syndrome; Intermittent Syncope; Atrial Fibrillation; This 79-year-old male subject was en... sick sinus syndrome; Intermittent Syncope; Atrial Fibrillation; This 79-year-old male subject was enrolled in an open label study titled A phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and above. The subject received the 3rd dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) 120 ๏ฟฝg on 19-APR-2023, for prophylaxis. In DEC-2023, between 7 and 9 months after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 sick sinus syndrome (Verbatim: sick sinus syndrome) in DEC-2023 with serious criteria of hospitalization and moderate - grade 2 syncope (Verbatim: Intermittent Syncope) in DEC-2023 with serious criteria of hospitalization. The outcome of atrial fibrillation was not resolved. The outcome(s) of the additional event(s) included sick sinus syndrome (resolved in FEB-2024) and syncope (resolved in APR-2025). Relevant Tests: On Unk/Dec/2023, Subject reported a brain MRI (Magnetic resonance imaging) showed 2 posterior vessels were obstructed.. The investigator considered that there was no reasonable possibility that the atrial fibrillation, sick sinus syndrome and syncope may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation, sick sinus syndrome and syncope may have been caused by RSVPreF3 vaccine + AS01E. Linked case(s) involving the same subject: US2024051986, US2025100252 GSK receipt date: 23-Apr-2024 Hospital records pending Hospital records still pending as of 5/28/2024 Subject admitted to hospital for syncope. In February 2024, he had atrial fibrillation and a sick sinus syndrome for which a pacemaker was placed 14FEB2024. This was an AESI. 6/19/2024: Hospital records had not been received. Intermittent Syncope began unDEC2023 for which he was treated for as well during hospitalization. 11/13/2024: Hospital records had not been received. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 07-MAY-2024 Summary of change : Narrative updated. Follow up information received on 28-MAY-2024 On 28-May-2024, the case US2024051986 was identified as duplicate of US2024051985. The case US2024051986 was prepared for deletion and all future correspondence will be added to the case US2024051985. Summary of change : Narrative updated, Event term updated from Atrial Fibrillation to Atrial Fibrillation and Intermittent Syncope Follow-up information received on :- 10-Jul-2024 Summary of changes:- SAE term updated to Atrial Fibrillation from Atrial Fibrillation and Intermittent Syncope. AESI sentence updated in narrative. Follow up information received on 18 Jul 2024 and 19 Jul 2024 Summary of changes: General narrative was updated. Follow up information received 25-JUL-2024 Summary of changes: New events sick sinus syndrome, Intermittent Syncope and narrative updated. Follow up information received 18-Sep-2024. Summary of changes: "The subject withdraw from study due to event of Atrial Fibrillation" sentence removed and narrative was updated. Follow up information received 13-NOV-2024 Summary of changes: General narrative was updated. Follow up information received on 04-Aug-2025. Summary of changes: Outcome of events sick sinus syndrome and intermittent syncope updated from not recovered to recovered.; Sender's Comments: A case of Atrial fibrillation, Sinus node dysfunction and Syncope, between 7 and 9 months after receiving 3rd dose of RSVPreF3 vaccine + AS01E in a 79-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor for atrial fibrillation and sinus node dysfunction (age) and (brain MRI showed 2 posterior vessels were obstructed) for event syncope. US-GSK-US2024051986: US-GSK-US2025100252: More
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2853266 08/08/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; still got it; This serious case was reported by a consumer via inter... Suspected vaccination failure; still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: still got it). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK receipt date: 14-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she got the shot and still got it. This case was considered as suspected vaccination failure as details regarding time to onset for RSV and laboratory confirmation regarding RSV 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, medical history, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine. More
2853267 08/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
I didn't have sickness, only a sore arm.; This non-serious case was reported by a consumer via ... I didn't have sickness, only a sore arm.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: I didn't have sickness, only a sore arm.). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK receipt date: 28-JUL-2025 This case was reported by a patient via interactive digital media. Patient didn't had sickness, only a sore arm. More
2853268 18 F NE 08/08/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB044A
Product preparation issue Product preparation issue
Inadvertent administration of Only the Liquid Conjugate Component of the 2-vial Presentation of Menv... Inadvertent administration of Only the Liquid Conjugate Component of the 2-vial Presentation of Menveo to a patient.; Inadvertent Administration of Only the Liquid Conjugate Component of the 2-vial Presentation of Menveo to a patient.; received a previous vaccination with Menveo two vial full dose/administered a Menveo two vial liquid component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB044A, expiry date 31-JUL-2025) for prophylaxis. Previously administered products included Menveo (received a previous vaccination with Menveo two vial full dose a couple of years before). On 21-JUL-2025, the patient received Menveo. On 21-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inadvertent administration of Only the Liquid Conjugate Component of the 2-vial Presentation of Menveo to a patient.), inappropriate dose of vaccine administered (Verbatim: Inadvertent Administration of Only the Liquid Conjugate Component of the 2-vial Presentation of Menveo to a patient.) and extra dose administered (Verbatim: received a previous vaccination with Menveo two vial full dose/administered a Menveo two vial liquid component). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and extra dose administered were not applicable. Additional Information: GSK Receipt Date: 23-JUL-2025 Clinic director called to ask about guidance because one of the medical assistant as at the facility administered only the liquid conjugate component of the 2-vial presentation of Menveo (as a third dose) to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered, and extra dose administered. The reporter wants to asked do the patient need to revaccinate or not. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. More
2853269 66 M FL 08/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9L944
Arthralgia, Injection site pain, Musculoskeletal stiffness Arthralgia, Injection site pain, Musculoskeletal stiffness
pain at injection site; sore shoulder; stiffness at the neck area; This non-serious case was reporte... pain at injection site; sore shoulder; stiffness at the neck area; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 9L944, expiry date 30-MAR-2025) for prophylaxis. Concomitant products included paracetamol (Tylenol) and hydrocortisone hydrogen succinate (Hydrocortisone). On 21-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), shoulder soreness (Verbatim: sore shoulder) and stiff neck (Verbatim: stiffness at the neck area). The outcome of the injection site pain, shoulder soreness and stiff neck were unknown. It was unknown if the reporter considered the injection site pain, shoulder soreness and stiff neck to be related to Shingrix. It was unknown if the company considered the injection site pain, shoulder soreness and stiff neck to be related to Shingrix. Additional Information: GSK Receipt Date: 25-JUL-2025 The reporter was the patient. He reported that he received the 1st dose of Shingrix vaccine on April 21st, 2025. He reported both doses were administered in the left arm at a immunization clinic. He reported with the first dose pain at injection site, sore shoulder and stiffness at the neck area.; Sender's Comments: US-GSK-US2025AMR098370:Same patinet dose 2nd More
2853270 M FL 08/08/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
62-year-old received Bexsero; This non-serious case was reported by a consumer via patient support p... 62-year-old received Bexsero; This non-serious case was reported by a consumer via patient support programs and described the occurrence of inappropriate age at vaccine administration in a 62-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. The patient's past medical history included splenectomy. On 24-MAR-2025, the patient received Bexsero .5 ml. On 24-MAR-2025, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 62-year-old received Bexsero). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 30-JUL-2025 Reporter requested billing and coding assistance and provided the indication of splenectomy as the reason the vaccine was administered. The report was not for an adverse event. 62-year-old received Bexsero which led to inappropriate age at vaccine administration. More
2853271 M VA 08/08/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 K4JH7
Underdose Underdose
pediatric dose administered to adult patient; pediatric dose administered to adult patient; This non... pediatric dose administered to adult patient; pediatric dose administered to adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 33-year-old male patient who received HBV (Engerix B pediatric) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis. On 30-JUN-2025, the patient received the 1st dose of Engerix B pediatric. On 30-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose administered to adult patient) and underdose (Verbatim: pediatric dose administered to adult patient). The outcome of the adult use of a child product and underdose were not applicable. It was unknown if the reporter considered the adult use of a child product and underdose to be related to Engerix B pediatric and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the adult use of a child product and underdose to be related to Engerix B pediatric and Engerix B Pre-Filled Syringe Device. 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: 16-JUL-2025 The practice manager called in to request data about the administration of the pediatric presentation of Engerix-B to an adult patient which led to, adult use of a child product and underdose. The dose was the first in the series. The Vaccine Administration Facility was the same as Primary Reporter. More
2853273 4 F IN 08/08/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 3RT93
Injection site erythema, Injection site rash, Injection site warmth, Pruritus Injection site erythema, Injection site rash, Injection site warmth, Pruritus
Tuesday, Aug. 5th, 2025 - Developed redness & rash around 1100 AM @ site of injection Tuesday, A... Tuesday, Aug. 5th, 2025 - Developed redness & rash around 1100 AM @ site of injection Tuesday, Aug. 5th, 2025 - Developed warmth @ injection site approximately 1900. Patient reports itching. Patient eating & sleeping fine. Patients mother reports she is going to take patient to convenient care. Patients primary care provider is Dr. 8/6/2025 - Spoke with FNP regarding patient's visit to facility. Advised he is deeming it a vaccine reaction. Requested records be faxed to office to attach to VAERS report. 8/7/2025 - Per facility staff, charting is not complete on patient. Requested be made aware we would like to have notes soon to submit VAERS report. Note being sent. More
2853310 FL 08/08/2025 VARCEL
 MERCK & CO. INC.
 Z004454
No adverse event, Product storage error No adverse event, Product storage error
no additional AE; VARIVAX involved in the patients since being involved in themperature excursion ha... no additional AE; VARIVAX involved in the patients since being involved in themperature excursion has been administered to multiple excursion; This spontaneous report was received from a medical assistant 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-Jul-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Solution for injection (lot #Z004454, expiration date: 13-Feb-2027) (1 dose) which was diluted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (indication, expiration date, and lot # were not reported). The vaccine underwent a temperature excursion of3 36.5 F for 2 hours 21 minutes. There was no previous temperature excursion. No additional adverse event was reported. More
2853311 F 08/08/2025 DTPPVHBHPB
PNC15
RV1
 MSP VACCINE COMPANY
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 U7829AA
Z003633
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No other AE; HCP calling to report the inadvertent administration of a VAXNEUVANCE and VAXELIS dose ... No other AE; HCP calling to report the inadvertent administration of a VAXNEUVANCE and VAXELIS dose to a patient prior to the recommended age. Caller states this patient also received the ROTARIX Vaccine on the same day. No symptoms reported as of yet and no ad; This spontaneous report was received from an Other health professional and refers to a 6-day-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) lot #Z003633, which was confirmed to be a valid lot#, expiration date: 24-May-2027 (dose, units and route of administration were not reported) for prophylaxis. On the same day, the patient was vaccinated with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... (VAXELIS) lot #U7829AA, which was confirmed to be a valid lot#, expiration date: 14-Jul-2026, (dose, units and route of administration were not reported) for prophylaxis. Also on the same day, the patient was vaccinated with Rotarix (Rotavirus vaccine live oral 1v) administered by Oral route (lot # and expiration date were not reported) for prophylaxis. It was reported that the vaccines were administered inadvertently to the patient prior to the recommended age (Product administered to patient of inappropriate age). There were no symptoms reported, and no additional details provided (No adverse event).; Reporter's Comments: More
2853313 ME 08/08/2025 HEPA
 MERCK & CO. INC.
 Z27PB
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Clinical Manager called regarding a possible temp. excursion for VAQTA; This spont... No additional AE; Clinical Manager called regarding a possible temp. excursion for VAQTA; This spontaneous report has been received from a consumer, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 23-JUN-2025, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, inactivated (VAQTA) at a dose of 1 milliliter (ml), once (lot #Z27PB (invalid) expiration date: 27-Aug-2026) as prophylaxis (anatomical site of injection and route of administration was not provided). Administered doses were stored at a temperature of 50 degrees Fahrenheit (F), during a time frame of 148 hour (product storage error). There was not a previous temperature excursion reported. No additional adverse events were reported in the patient. This case was determined to be non-valid due to the lack of patient's identifiers. More
2853314 14 CO 08/08/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y015180
Y012776
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
No symptoms reported. No additional AE; patient was inadvertently administered a second dose of GARD... No symptoms reported. No additional AE; patient was inadvertently administered a second dose of GARDASIL 9 at a shorter interval than recommended; This spontaneous report was received from a Physician Assistant (reported as medical assistant) and refers to a 14-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 31-JUL-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), prefilled syringe, 0.5 mL/dose (lot number Y015180 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 28-JAN-2027). On 05-Aug-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), prefilled syringe, 0.5 mL/dose (lot number Y012776 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 08-JAN-2027); both doses were administered as prophylaxis (route of administration, dose form and anatomical site of injection were not reported for any of the vaccines). The second dose was administered at a shorter interval than recommended (Inappropriate schedule of product administration). No symptoms or additional adverse event were reported for the patient. More
2853315 08/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Asthenia, Bedridden, Guillain-Barre syndrome, Mobility decreased Asthenia, Bedridden, Guillain-Barre syndrome, Mobility decreased
I got the vaccine, and it triggered a chronic case of Gillian Barre Syndrome; Bedridden; I can'... I got the vaccine, and it triggered a chronic case of Gillian Barre Syndrome; Bedridden; I can't move at all; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: I got the vaccine, and it triggered a chronic case of Gillian Barre Syndrome) (serious criteria GSK medically significant), bedridden (Verbatim: Bedridden) and mobility decreased (Verbatim: I can't move at all). The outcome of the guillain barre syndrome, bedridden and mobility decreased were not resolved. It was unknown if the reporter considered the guillain barre syndrome, bedridden and mobility decreased to be related to Shingles vaccine. The company considered the guillain barre syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the bedridden and mobility decreased to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-AUG-2025 This case was reported by a patient via interactive digital media. Consumer reported that got the vaccine, and it triggered a chronic case of Gillian Barre Syndrome. He or she also reported that become so weak and can't move at all, and the treatment for Gillian Barre had started to affect my kidneys. He or she was now completely bedridden. The follow-up could not be possible as no contact details were available.; Sender's Comments: A case of Guillain-Barre syndrome, 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
2853317 51 F PA 08/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93n4j
Herpes zoster, Oral herpes zoster Herpes zoster, Oral herpes zoster
orofacial mucocutaneous shingle; Orofacial mucocutaneous shingles; This non-serious case was reporte... orofacial mucocutaneous shingle; Orofacial mucocutaneous shingles; This non-serious case was reported by a physician via call center representative and described the occurrence of oral herpes zoster in a female patient who received Herpes zoster (Shingrix) (batch number 93n4j) for prophylaxis. The patient's past medical history included shingles (shingles 1 month before the vaccine). On 16-JUN-2025, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced oral herpes zoster (Verbatim: orofacial mucocutaneous shingle) and facial herpes zoster (Verbatim: Orofacial mucocutaneous shingles). The outcome of the oral herpes zoster and facial herpes zoster were not resolved. It was unknown if the reporter considered the oral herpes zoster and facial herpes zoster to be related to Shingrix. It was unknown if the company considered the oral herpes zoster and facial herpes zoster to be related to Shingrix. Additional Information: GSK receipt date: 30-JUL-2025 Reporter was the HCP (MD) who stated that a patient received her first dose of Shingrix on 16th June 2025. She received the vaccine a month after a case of shingles. The patient now had recurrent orofacial mucocutaneous shingles. More
2853318 F 08/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
felt horrible; felt ill; This non-serious case was reported by a nurse via sales rep and described t... felt horrible; felt ill; This non-serious case was reported by a nurse via sales rep and described the occurrence of feels awful in a adult female 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 feels awful (Verbatim: felt horrible) and feeling unwell (Verbatim: felt ill). The outcome of the feels awful was not reported and the outcome of the feeling unwell was resolved. It was unknown if the reporter considered the feels awful to be related to Shingles vaccine. The reporter considered the feeling unwell to be related to Shingles vaccine. It was unknown if the company considered the feels awful to be related to Shingles vaccine. The company considered the feeling unwell to be related to Shingles vaccine. Additional Information: SK receipt date: 30-JUL-2025 The patient felt horrible and would rather have shingles everyday than get the vaccine again. More
2853319 08/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site warmth, Rash erythematous Injection site warmth, Rash erythematous
red rash; warm injection site; This non-serious case was reported by a consumer via call center repr... red rash; warm injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis. In JUL-2025, the patient received the 2nd dose of Shingrix. In JUL-2025, less than a week after receiving Shingrix, the patient experienced red rash (Verbatim: red rash) and injection site warmth (Verbatim: warm injection site). The outcome of the red rash and injection site warmth were not resolved. It was unknown if the reporter considered the red rash and injection site warmth to be related to Shingrix. It was unknown if the company considered the red rash and injection site warmth to be related to Shingrix. Additional Information: GSK receipt date: 28-JUL-2025 The patient received 2nd Shingrix vaccine 3 days ago and now had a red rash and it was warm by the injection site. The patient asked what can he/she do to relieve this? More
2853320 08/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; still have symptoms; had the shingles got the shots; This serious cas... Suspected vaccination failure; still have symptoms; had the shingles got the shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still have symptoms) and drug use for unapproved indication (Verbatim: had the shingles got the shots). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the drug use for unapproved indication was not applicable. 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: 27-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the shingles got the shots and still have symptoms and it has been 2 and a half years it really sucks been on all different medications and nothing was helping. The patient had shingles and got the shot, which led to drug used for unapproved indication. 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: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2853321 08/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; My friend got the shot and got them horrible; This serious case was r... Suspected vaccination failure; My friend got the shot and got them horrible; 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: My friend got the shot and got them horrible). 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: 31-JUL-2025 This case was reported by a patient via interactive digital media. The reporter mentioned their friend got the shot of Shingles vaccine and got shingles which was horrible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2853322 08/08/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
had my 1st shot today I heard very painful; This non-serious case was reported by a consumer via int... had my 1st shot today I heard very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 30-JUL-2025, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: had my 1st shot today I heard very painful). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Additional Information: GSK receipt date: 30-AUG-2025 This case was reported by a patient via interactive digital media. Patient had 1st shot on the day of reporting and heard very painful More
2853323 08/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; Just got diagnosed today with shingles under the breast; This serious... Suspected vaccination failure; Just got diagnosed today with shingles under the breast; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had Shingles under the breast in 2003). In OCT-2024, the patient received Shingles vaccine. On 02-AUG-2025, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Just got diagnosed today with shingles under the breast). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 02-AUG-2025 This case was reported by a patient via interactive digital media. The patient just got diagnosed today with shingles on 02nd August 2025. The patient had shingles in 2003. The patient took the shot in October 2024. The patient guesses that anything can happen. The patient used oatmeal boiled in milk last time to put over it and it helped with pain. So, the patient will do it again. The patient wished that everyone who suffers with it experiences less pain. The patient had shingles in same place as last time under the breast. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2853324 08/08/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; had the shots and still get them not as bad; This serious case was re... Suspected vaccination failure; had the shots and still get them not as bad; 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 the shots and still get them not as bad). 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-AUG-2025 This case was reported by a patient via interactive digital media. The patient had the shots and still got shingles, not as bad but the patient got them. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided, regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine More
2853325 48 F MO 08/08/2025 HEPA
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 42DM9
7XY23
Inappropriate schedule of product administration, Underdose; Inappropriate sched... Inappropriate schedule of product administration, Underdose; Inappropriate schedule of product administration, Underdose More
Pediatric dose mistakenly administered to adult patient; Pediatric dose mistakenly administered to a... Pediatric dose mistakenly administered to adult patient; Pediatric dose mistakenly administered to adult patient; late second dose for Twinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 48-year-old female patient who received HAB (Twinrix) (batch number 7XY23, expiry date 29-APR-2023) for prophylaxis. Co-suspect products included HAV (Havrix pediatric) (batch number 42DM9, expiry date 22-JAN-2027) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 30-MAR-2023, the patient received the 2nd dose of Twinrix. On 09-JUL-2025, the patient received Havrix pediatric. On 30-MAR-2023, an unknown time after receiving Twinrix and not applicable after receiving Havrix pediatric, the patient experienced drug dose administration interval too long (Verbatim: late second dose for Twinrix). On 09-JUL-2025, the patient experienced accidental underdose (Verbatim: Pediatric dose mistakenly administered to adult patient) and adult use of a child product (Verbatim: Pediatric dose mistakenly administered to adult patient). The outcome of the drug dose administration interval too long, accidental underdose and adult use of a child product 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: 10-JUL-2025 The Certified Medical Assistant explained that an adult patient had accidentally received a pediatric dose of Havrix in an attempt to complete the Hepatitis A series which led to, accidental underdose and adult use of a child product. The reporter stated that the patient had received 2nd dose of Twinrix was late which led to, drug dose administration interval too long. However, the patient had missed the third dose of Twinrix. To complete the Hepatitis B series, the patient had received a Hepatitis B vaccine from GlaxoSmithKline on October 10th, 2023, at another facility (brand name unknown, lot number 9JG23). The patient received Engerix B on 04th November 2023 (lot number 9JG23 with expiry date 10th February 2025). The case was transferred to a second-line Medical Information Specialist for further assistance. During the call, the Medical Assistant provided additional clarification and mentioned that they were unsure whether the patient had actually received the Twinrix doses. More
2853326 M AZ 08/08/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5KR3R
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Maladministration of DTAP (Infanrix) instead of TDAP (Boostrix); Maladministration of DTAP (Infanrix... Maladministration of DTAP (Infanrix) instead of TDAP (Boostrix); Maladministration of DTAP (Infanrix); This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 5KR3R, expiry date 06-FEB-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 16-JUL-2025, the patient received Infanrix. The patient did not receive Boostrix. On 16-JUL-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Maladministration of DTAP (Infanrix) instead of TDAP (Boostrix)) and inappropriate age at vaccine administration (Verbatim: Maladministration of DTAP (Infanrix)). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 18-JUL-2025 Registered nurse called to report that the maladministration of the wrong vaccine diphtheria, tetanus, and pertussis (Infanrix) instead of tetanus, diphtheria, and pertussis vaccine (Boostrix) to twin brothers, which led to wrong vaccine administered. The patient received Infanrix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration. The reporter wants guidance on this situation. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. This is 1 of 2 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025092571:case for twin brother More
2853327 F GA 08/08/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 3S54K
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
adult dose given to a pediatric patient; adult dose given to a pediatric patient; This non-serious c... adult dose given to a pediatric patient; adult dose given to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 6-year-old female patient who received HAV (Havrix) (batch number 3S54K, expiry date 18-DEC-2025) for prophylaxis. On 23-JUL-2025, the patient received Havrix. On 23-JUL-2025, an unknown time after receiving Havrix, the patient experienced adult product administered to child (Verbatim: adult dose given to a pediatric patient) and accidental overdose (Verbatim: adult dose given to a pediatric patient). The outcome of the adult product administered to child and accidental overdose 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: 24-JUL-2025 The medical assistant called asking for advice because an adult dose of Havrix was administered by mistake to a six-year-old pediatric patient which led to, adult product administered to child and accidental overdose. The Vaccine Administration Facility was the same as Primary Reporter. More
2853328 F AZ 08/08/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7NX57
GC3M4
Underdose; Underdose Underdose; Underdose
Engerix-B administration of pediatric doses to adult patient; Engerix-B administration of pediatric ... Engerix-B administration of pediatric doses to adult patient; Engerix-B administration of pediatric doses to adult patient; Engerix-B administration of pediatric doses to adult patient; Engerix-B administration of pediatric doses to adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a female patient who received HBV (Engerix B) (batch number 7NX57) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number GC3M4) for prophylaxis. On 02-APR-2025, the patient received the 3rd dose of Engerix B. On 23-OCT-2024, the patient received the 2nd dose of Engerix B. On 23-OCT-2024, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: Engerix-B administration of pediatric doses to adult patient) and underdose (Verbatim: Engerix-B administration of pediatric doses to adult patient). On 02-APR-2025, the patient experienced adult use of a child product (Verbatim: Engerix-B administration of pediatric doses to adult patient) and underdose (Verbatim: Engerix-B administration of pediatric doses to adult patient). The outcome of the adult use of a child product, underdose, adult use of a child product and 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: 24-JUL-2025 The pharmacist reported regarding Engerix-B administration of pediatric doses to adult patients and stated that the patient received 3 pediatric doses, which led to adult use of a child product and underdose The reporter wanted to know if revaccination with adult doses was required to complete the series or restarting it again. The Vaccine Administration Facility is the same as Primary Reporter More
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