🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2828622 11 F CA 02/27/2025 COVID19
HPV9
 PFIZER\BIONTECH
MERCK & CO. INC.
 LN7302
X025115
Cold sweat, Dizziness, Nausea; Cold sweat, Dizziness, Nausea Cold sweat, Dizziness, Nausea; Cold sweat, Dizziness, Nausea
Patient received 2 vaccines, HPV 2nd dose and Pfizer Pediatric dose. After few minutes, patient star... Patient received 2 vaccines, HPV 2nd dose and Pfizer Pediatric dose. After few minutes, patient start feeling light headed, cold sweat, and nauseous. Checked the blood pressure, it came out ~80/60. Asked them to drink water and monitored for ~1 hour and checked blood pressure every 10-15 minutes. After 1 hour, the blood pressure came out 110/80 and felt better. More
2828623 80 F IN 02/27/2025 PNC21
 MERCK & CO. INC.
 Y019157
Body temperature increased, Cellulitis, Erythema, Pain in extremity, Skin warm Body temperature increased, Cellulitis, Erythema, Pain in extremity, Skin warm
The patient called me today (2/27/25) and stated that her arm is painful, red, hot, and had a temper... The patient called me today (2/27/25) and stated that her arm is painful, red, hot, and had a temperature of 102. She went to urgent care on 2/26 and was diagnosed with cellulitis. More
2828625 8 M OR 02/27/2025 HPV9
 MERCK & CO. INC.
 1957404
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
HPV vaccine given too early due to documentation error of date of birth being written down wrong and... HPV vaccine given too early due to documentation error of date of birth being written down wrong and reviewing incorrect chart on our IIS. More
2828626 56 M NC 02/27/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Burning sensation, Erythromelalgia, Laboratory test, Loss of personal independen... Burning sensation, Erythromelalgia, Laboratory test, Loss of personal independence in daily activities, Pruritus; Rash, Temperature intolerance More
After the vaccine I developed a condition called Erythromelalgia. It cause flares when exposure to ... After the vaccine I developed a condition called Erythromelalgia. It cause flares when exposure to heat , stress sitting, standing walking. Hands , foot , ears and other areas get red or itchy and burning sensation. It causes rash and other skin symptoms making sleeping, walking and other tasks challenging. More
2828628 31 F GA 02/27/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9R2D7
Exposure during pregnancy, No adverse event, Wrong product administered Exposure during pregnancy, No adverse event, Wrong product administered
The provider ordered Boostrix (tdap) to be given, but the medical assistant administered Dtap (Infar... The provider ordered Boostrix (tdap) to be given, but the medical assistant administered Dtap (Infarix) instead. Patient was 27 weeks and 3 days pregnant at the time of administration. More
2828629 32 M MN 02/27/2025 PNC21
 MERCK & CO. INC.
Injection site erythema, Injection site mass, Injection site swelling, Injection... Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth More
Swollen, warm in the area of injection, light bumps, light red skin Swollen, warm in the area of injection, light bumps, light red skin
2828630 4 M KY 02/27/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 5G23D
Y017205
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
The patient received an additional dose of Kinrix and Proquad 6 months apart. No signs or symptoms h... The patient received an additional dose of Kinrix and Proquad 6 months apart. No signs or symptoms have been reported. More
2828631 66 F IN 02/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2SK93
Immune thrombocytopenia, Platelet transfusion Immune thrombocytopenia, Platelet transfusion
Patient says she developed idiopathyic thrombocytopenia purpura starting about a week or two after r... Patient says she developed idiopathyic thrombocytopenia purpura starting about a week or two after receiving Shingrix vaccine on 6/10/24. Patient saw doctor and was referred to hospital on 7/23/24 where she was admitted for 3 days and diagnosed. For treatment she received steroids and platelets. Was scheduled to received Rituxan, but since her platelet levels have recovered she did not need that treatment. As of now, patient states she is fully recovered. More
✓
2828632 34 F WA 02/27/2025 HPV9
 MERCK & CO. INC.
 Y007193
Injection site mass, Injection site pain Injection site mass, Injection site pain
Pt has a hard knot (feels like a small stone) in the injection site. No redness/warmth in evidence. ... Pt has a hard knot (feels like a small stone) in the injection site. No redness/warmth in evidence. Pt states that it is painful when touched. More
2828633 4 F CT 02/27/2025 DTAPIPV
DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Mutism, Respiratory disorder, Sleep disorder, Soft tissue foreign body, Wrong pr... Mutism, Respiratory disorder, Sleep disorder, Soft tissue foreign body, Wrong product administered; Wrong technique in product usage process More
My daughter was given the wrong shot and her daughter got the same shot twice and when she was given... My daughter was given the wrong shot and her daughter got the same shot twice and when she was given the vaccine she put the needle in her arm and just let go and it was dangling in her arm and it was like she dropped the needle in the arm. I had to tell her to grab it and she then wiggled it in her arm before giving it her. I noticed a huge change in her daughter behavior and has outburst. she was unable to talk and would just go mute. And her sleeping patterns go weird and she would wake up every hour or every other hour. And this is every single night. She also has gotten more respiratory issues and that she now might have asthma, I have to put a fan in front of her face for her breath at night. More
2828634 29 F CO 02/27/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Magnetic resonance imaging, Multiple sclerosis, Optic neuritis Magnetic resonance imaging, Multiple sclerosis, Optic neuritis
Optic Neuritis and subsequent Multiple Sclerosis diagnosis Optic Neuritis and subsequent Multiple Sclerosis diagnosis
✓
2828635 63 M WI 02/27/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8730
ER8730
Dizziness, Hyperhidrosis, Peripheral swelling, Pruritus, Rash; Visual impairment Dizziness, Hyperhidrosis, Peripheral swelling, Pruritus, Rash; Visual impairment
Morning of 9-7-2021 experienced full body sweats head torso both arms and legs and hands (pic availa... Morning of 9-7-2021 experienced full body sweats head torso both arms and legs and hands (pic available) Experienced crystal vision for about 5 minutes. Felt like passing out. Subsequently experienced severe swelling and almost painful itching in both hands. Symptoms of severe itching with rashes persist to this day. Calf?s. thighs, groin, abdomen, beneath each breast, both forearms, neck and back of head. Ex: rash and itching on legs mirror similar areas on left and right. Same with all other. Body areas. More
2828636 9 M OR 02/27/2025 COVID19
 PFIZER\BIONTECH
 LN0591
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
ADMINISTERED 12+ COVID VACCINE INSTEAD OF 9-YEAR-OLD BLUE CAP COVID VAX ADMINISTERED 12+ COVID VACCINE INSTEAD OF 9-YEAR-OLD BLUE CAP COVID VAX
2828637 51 F CA 02/27/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH









Blood test, Cardiac function test, Chest X-ray, Computerised tomogram, Computeri... Blood test, Cardiac function test, Chest X-ray, Computerised tomogram, Computerised tomogram spine; Dehydration, Diarrhoea, Dysphagia, Electrocardiogram, Feeling cold; Guillain-Barre syndrome, Head discomfort, Headache, Lumbar puncture, Magnetic resonance imaging head; Magnetic resonance imaging neck, Muscle tightness, Pain in extremity, Paraesthesia, Slow speech; Spinal cord compression, Urinary tract infection, Urine analysis; Blood test, Cardiac function test, Chest X-ray, Computerised tomogram, Computerised tomogram spine; Dehydration, Diarrhoea, Dysphagia, Electrocardiogram, Feeling cold; Guillain-Barre syndrome, Head discomfort, Headache, Lumbar puncture, Magnetic resonance imaging head; Magnetic resonance imaging neck, Muscle tightness, Pain in extremity, Paraesthesia, Slow speech; Spinal cord compression, Urinary tract infection, Urine analysis More
Here is a summary of the medical events for your VAERS application: Vaccine: 2/21/21 Booster 5/12/2... Here is a summary of the medical events for your VAERS application: Vaccine: 2/21/21 Booster 5/12/21 Symptoms Started: June 6, 2021 - woke up with sore forearms, difficulty swallowing, facial pulling, and slow speech. Urgent Care: June 7, 2021 ? Admitted, diagnosed with dehydration, given IV fluids and antibiotics for diarrhea. Symptoms Continued: June 7?10, 2021 ? Symptoms did not improve, continued diarrhea. Primary Doctor Appointment: June 10, 2021 ? Sent to ER. Tests: Blood work, EKG, heart test, chest X-ray, CT scan, urine sample. Diagnosis: Severe UTI, treated with antibiotics (oral and shot), advised to follow up with a neurologist for GBS. Follow-up: June 12, 2021 ? Felt the same, ER visit for an MRI as recommended by the primary doctor. Admission: June 12, 2021 ? Admitted received MRI of head and neck, spinal CT scan, and morphine for head pain. Transfer to CCU: June 13, 2021 ? Possible surgery for spinal cord compression, but doctors decided to delay surgery. Additional tests ordered to determine infection type. Lumbar Test: June 14, 2021 ? Fluid removed from spine, experienced tingling down the left leg and a cold sensation on the head. Severe headache treated with 100mg Tylenol, some relief. Symptoms Returned: June 14, 2021 ? Felt better in the morning but some symptoms, like a heavy head, returned in the evening after a visit from Dr. Status Update: June 15, 2021 ? Woke up feeling fair, PA updated on the status of the condition. diagnosed with GBS disease and attended Physical Therapy for months after More
✓ ✓
2828638 73 M NM 02/27/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42y93
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient received DTap (Kinrix) instead of Tdap (Boostrix). Patient was aware. No adverse reactions n... Patient received DTap (Kinrix) instead of Tdap (Boostrix). Patient was aware. No adverse reactions noted. Patient will come back for correct dose. More
2828639 55 F AR 02/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 59myc4
Eye pain, Ocular discomfort, Pain in extremity Eye pain, Ocular discomfort, Pain in extremity
Very sore arm overnight, persistent pain/pressure behind one eye (feelings of a migraine) Very sore arm overnight, persistent pain/pressure behind one eye (feelings of a migraine)
2828640 10 M NM 02/27/2025 COVID19
 PFIZER\BIONTECH
 LN7302
Expired product administered Expired product administered
Administered expired vaccine. 10-week expiration date was 12/31/2024 Administered expired vaccine. 10-week expiration date was 12/31/2024
2828652 M ID 02/27/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH



Malaise; COVID-19, SARS-CoV-2 test, Vaccination failure; Malaise; COVID-19, SARS... Malaise; COVID-19, SARS-CoV-2 test, Vaccination failure; Malaise; COVID-19, SARS-CoV-2 test, Vaccination failure More
Not feeling well; This is a spontaneous report received from a Consumer or other non HCP. A male pa... Not feeling well; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Oct2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 25Oct2024, outcome "unknown", described as "Not feeling well". Additional information: The patient received his COVID-19 shot on the same day as his wife. He started feeling unwell that evening. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202500007730 same reporter, drug, different patient and event;UM-PFIZER INC-202500043036 same patient, same product, same dose and different events; More
2828654 71 F ID 02/27/2025 COVID19
 PFIZER\BIONTECH
Blood triglycerides, Intervertebral disc disorder Blood triglycerides, Intervertebral disc disorder
4th dose 26May2022: Intervertebral disc Mar2024; This is a spontaneous report received from a Consum... 4th dose 26May2022: Intervertebral disc Mar2024; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female patient received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid Reflux" (unspecified if ongoing), notes: Acid Reflux 60's; "A-fib" (unspecified if ongoing), notes: A-fib 50's; "Anxiety" (unspecified if ongoing), notes: Anxiety 60's; "Arthritis" (unspecified if ongoing), notes: Arthritis 60's; "Asthma" (unspecified if ongoing), notes: Asthma 60's; "Balance problems" (unspecified if ongoing), notes: Balance problems 80's; "Blepharitis birth" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing), notes: Bronchitis 60's; "Carpal tunnel both" (unspecified if ongoing), notes: Carpal tunnel both 80's; "Cataracts both", start date: 20May2015 (unspecified if ongoing); "C-diff", start date: 20Jun2015 (unspecified if ongoing); "Cervical degeneration" (unspecified if ongoing), notes: Cervical degeneration 60's; "Concussions", start date: 2016 (unspecified if ongoing), notes: Concussions 2016/2017; "Cholesterol" (unspecified if ongoing), notes: Cholesterol 70's; "Depression" (unspecified if ongoing), notes: Depression 60's; "Dermatofibroma", start date: 2014 (unspecified if ongoing); "Deviated septum", start date: 2012 (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing), notes: Diverticulitis 80's; "Dizziness" (unspecified if ongoing), notes: Dizziness 60's; "Duodenal ulcers" (unspecified if ongoing), notes: Duodenal ulcers 60's; "Esophageal polyps", start date: 2017 (unspecified if ongoing); "Exema", start date: 2016 (unspecified if ongoing); "Fibrocystic disease" (unspecified if ongoing), notes: Fibrocystic disease 60's; "Essential tremors" (unspecified if ongoing), notes: Essential tremors 60's; "Fibromyalgia" (unspecified if ongoing), notes: Fibromyalgia 60's; "Gall bladder", start date: May2002 (unspecified if ongoing); "Gastritis" (unspecified if ongoing); "Hearing loss" (unspecified if ongoing); "IBS" (unspecified if ongoing), notes: IBS 80's; "Keratosis" (unspecified if ongoing), notes: Keratosis 90's; "Migraines" (unspecified if ongoing), notes: Migraines 60's; "Osteoporosis" (unspecified if ongoing), notes: Osteoporosis 80's; "Pancreatitis", start date: 2007 (unspecified if ongoing); "Panic attacks" (unspecified if ongoing), notes: Panic attacks 60's; "Proteins deficiency", start date: Mar2004 (unspecified if ongoing); "Sinusitis" (unspecified if ongoing), notes: Sinusitis 60's; "Sleep apnea", start date: Mar2004 (unspecified if ongoing); "Stroke", start date: Mar2004 (unspecified if ongoing); "Transcranial magnetic stimulation" (unspecified if ongoing), notes: TMS 60's. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Location of injection/shot: Left Arm), administration date: 03Mar2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Location of injection/shot: Left Arm), administration date: 26Mar2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Location of injection/shot: Left Arm), administration date: 08Nov2021, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: INTERVERTEBRAL DISC DISORDER (non-serious) with onset Mar2024, outcome "unknown", described as "4th dose 26May2022: Intervertebral disc Mar2024". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2828655 M NJ 02/27/2025 PPV
 MERCK & CO. INC.
 X018278
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE reported; expired vaccine administered; This spontaneous report was received from a... No additional AE reported; expired vaccine administered; This spontaneous report was received from a/an Consumer or other non health professional and refers to a(n) 76-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (lot #X018278, expiration date: 24-Nov-2024) 0.5 mL (1 syringe / 0.5-mL dose), for an unknown indication. On 06-Feb-2025, the patient experienced expired vaccine administered. On an unknown date, the patient experienced No additional AE reported. At the reporting time, the outcome of expired vaccine administered and No additional AE reported was unknown. The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) was reported as not applicable. More
2828656 F UT 02/27/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y012776
Y008843
Accident at work, Skin laceration, Syringe issue; Accident at work, Skin lacerat... Accident at work, Skin laceration, Syringe issue; Accident at work, Skin laceration, Syringe issue More
1 of 10 PFS were damaged; The medical assistants were cut by the glass; This spontaneous report was ... 1 of 10 PFS were damaged; The medical assistants were cut by the glass; This spontaneous report was received from a consumer referring to a female patient of unknown age. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On an unknown date, the patient, a medical assistant, was cut by the glass of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot# was unable to be confirmed, could be lot#: Y008843 with expiration date of 27-NOV-2026 or lot#: Y012776 with expiration date of 08-JAN-2027 (Injury associated with device). The prefilled syringe was damaged (syringe broken). More
2828657 F UT 02/27/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y008843
Y012776
Skin laceration, Syringe issue; Skin laceration, Syringe issue Skin laceration, Syringe issue; Skin laceration, Syringe issue
injured by broken GARDASIL 9 PFSs; injured by broken GARDASIL 9 PFSs; This spontaneous report was re... injured by broken GARDASIL 9 PFSs; injured by broken GARDASIL 9 PFSs; This spontaneous report was received from a/an Consumer or other non health professional (reported as office manager) referring to a female patient (medical assistant) of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On an unknown date, the patient was injured by broken Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) prefilled syringes (PFSs) (injury associated with device, syringe broken). The patient was cut by the glass and no patients were involved. It was reported that there were 2 different lots of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) involved; lot #Y008843, expiration date: 27-Nov-2026, 1 of 10 PFS were damaged and lot #Y012776, expiration date: 08-Jan-2027, 2 of 10 PFS were damaged. It was unable to identify which lot # was caused the injury to this patient. More
2828659 58 F 02/27/2025 PNC21
 MERCK & CO. INC.
 Y013099
Myelitis transverse, Paraesthesia Myelitis transverse, Paraesthesia
Reported called on behalf of HCP who reported a 58-year-old female patient experienced tingling belo... Reported called on behalf of HCP who reported a 58-year-old female patient experienced tingling below her neck down to her breast (side of body unknown by reporter) after being administered CAPVAXIVE. Patient administered vaccine on 2/4/2025 and reported; This spontaneous report was received from a physician referring to a 58-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided. On 04-FEB-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution (CAPVAXIVE) injection, 0.5 ml administered intramuscularly (vaccination scheme frequency, and anatomical location were not provided; invalid lot number Y013099, with expiration date on 17-NOV-2028). On an unknown date, after being vaccinated, the patient experienced tingling below her neck down to her breast of body. On 17-FEB-2025, the patient reported the adverse event to the physician, and the physician stated he feels symptoms are due to transverse myelitis. It was not reported if the patient received any treatment for this adverse event. The physician reported the patient was sent and admitted to the hospital for a neurological workup. At the time of the reporting, the outcome of the event was unknown. The causal relationship between the event and the suspect vaccine was not reported. More
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2828660 F CA 02/27/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Syncope, Vaccine positive rechallenge; Syncope, Vaccine positive rechallenge Syncope, Vaccine positive rechallenge; Syncope, Vaccine positive rechallenge
faint; fainting; This spontaneous report was received from a pharmacist and referring a female patie... faint; fainting; This spontaneous report was received from a pharmacist and referring a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) for prophylaxis (dose, expiration date, and lot # were not reported). And the patient was fainting after the vaccination (syncope). On approximately December 2024 (reported as about 2 months ago), the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) for prophylaxis (dose, expiration date, and lot # were not reported). And patient fainted (syncope). At the reporting time, the outcome of both events was not reported. The causal relationship between both events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown/not reported/not provided. Upon internal review, the events of faint and fainting were determined to be medically significant. More
2828661 29 F SC 02/27/2025 HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Abdominal pain, Asthenia, Condition aggravated, Endometriosis, Exercise toleranc... Abdominal pain, Asthenia, Condition aggravated, Endometriosis, Exercise tolerance decreased; Fatigue, Fibromyalgia, Hypoaesthesia, Laboratory test, Loss of personal independence in daily activities; Muscle tightness, Ovarian cyst, Pain, Polycystic ovarian syndrome, Uterine enlargement More
fibromyalgia symptoms singificantly aggravated / numbness / body aches / fatigue / muscle tension / ... fibromyalgia symptoms singificantly aggravated / numbness / body aches / fatigue / muscle tension / pain; autoimmune injuries / GARDASIL-induced autoimmune disorder; autonomic injuries; neurological injuries; endometriosis / pelvic pain / abdominal cramping / enlarged uterus; polycystic ovary syndrome (PCOS) / ovarian cysts / enlarged uterus; Information has been received from a lawyer, regarding a case in litigation, and refers to an adult female patient (pt). The pt's medical history was not reported. Her current conditions included fibromyalgia. Concomitant therapies were not reported. On 25-May-2021, at the age of 29 years old, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis (reported as recommended by the pt's physician for preventing cervical cancer). On an unknown date, the pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) injection. On an unknown date, reported as within months of her injection, the pt started to experience severe numbness and body aches. It was reported to have gotten so bad that at some point, the pt went to an emergency room (ER) because of her symptoms. On an unknown date in 2022, reported as sometime in early 2022, the pt began experiencing severe debilitating pelvic and abdominal cramping, with episodes lasting up to three weeks. She described the pain as if two knives were embedded within her abdomen. In an attempt to find relief, the pt sought the expertise of a gynecologist. Following a series of diagnostic tests (unspecified, no results provided), the gynecologist diagnosed her with ovarian cysts and an enlarged uterus. The pt was later diagnosed with polycystic ovary syndrome (PCOS) and endometriosis. At some point, the pt also received a fibromyalgia diagnosis. Her fibromyalgia symptoms were significantly aggravated by her exposure to the suspect vaccine. Until the time of report, reported as "to this day", the pt experienced daily severe fatigue, muscle tension, and pain. As a result of her post-quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) symptoms, she had been unable to engage in activities that a normal young person would enjoy. Due to her quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL)-induced injuries, her social life had deteriorated. She could not even walk for more than 10 minutes at a time. Her dream of one day opening a restaurant was no longer possible. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to PCOS and endometriosis. The pt contended that her quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) injection caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to PCOS and endometriosis, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which alleged herein and all of which caused by the suspect vaccine or otherwise linked to her quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL)-induced autoimmune disorder. It was stated that as a proximate result of the Company's wrongful acts and quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) manufacturing defects, the pt had suffered and continued to suffer severe and permanent physical injuries and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. She also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by the suspect vaccine. As a direct and proximate result of her quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL)-induced injuries, the pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of all events was not recovered/not resolved/ongoing. All events were related to the suspect vaccine. Upon internal review, the events of PCOS, autoimmune disorder, and autonomic neuropathy were determined to be medically significant. All events were considered to be disabling/incapacitating. More
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2828663 M 02/27/2025 RVX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Cough, Malaise, Pyrexia, Respiratory syncytial virus infection, Respiratory sync... Cough, Malaise, Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive; Rhinitis, Secretion discharge, Vaccination failure More
sick; Vaccination failure; consumer reports he tested positive for RSV/lack of effect; This serious ... sick; Vaccination failure; consumer reports he tested positive for RSV/lack of effect; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In NOV-2024, the patient received RSV vaccine (left arm). On 02-JAN-2025, between 2 and 3 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: consumer reports he tested positive for RSV/lack of effect). On an unknown date, the patient experienced sickness (Verbatim: sick). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the sickness was resolved. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and sickness to be related to RSV vaccine. The company considered the vaccination failure, respiratory syncytial virus infection and sickness to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 24-FEB-2025 The patient was vaccinated with an RSV vaccine sometime in November of 2024. The consumer experienced coryza, excessive mucus production, cough and low-grade fever. Consumer stated he was sick for approximately one month but was not hospitalized. The consumer stated that he did not know which RSV vaccine he received in left arm. Consumer declined to provide any demographic information. No further information was provided including lot number, date of vaccination, vaccine name/manufacturer.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Respiratory syncytial virus infection and Illness are unlisted event which is considered unrelated to GSK RSV vaccine. More
2828664 M NY 02/27/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete cours... Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete course of vaccination More
first dose of SHINGRIX 8 years ago; diagnosed as shingles; This non-serious case was reported by a c... first dose of SHINGRIX 8 years ago; diagnosed as shingles; This non-serious case was reported by a consumer via patient support programs and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient did not receive the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: diagnosed as shingles) and incomplete course of vaccination (Verbatim: first dose of SHINGRIX 8 years ago). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the shingles was resolved (duration 1 day) and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the shingles to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 25-FEB-2025 The reporter stated he was vaccinated with his first dose of Shingrix 8 years ago. Consumer stated he had not had a second dose of Shingrix. Consumer stated last week he had a rash that was diagnosed as shingles. Consumer stated he was prescribed Valtrex and the rash cleared up in one day. Consumer stated he went to a different doctor and was told that he most likely did not have shingles. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2828665 F 02/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Injection site pain and redness; Injection site pain and redness; This non-serious case was reported... Injection site pain and redness; Injection site pain and redness; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 21-FEB-2025, the patient received the 2nd dose of Shingrix (unknown arm). In FEB-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain and redness) and injection site erythema (Verbatim: Injection site pain and redness). The outcome of the injection site pain and injection site erythema were resolved. The reporter considered the injection site pain and injection site erythema to be related to Shingrix. The company considered the injection site pain and injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 25-FEB-2025 The nurse reported that a patient received Shingrix vaccine after that experienced injection site pain and redness. More
2828666 02/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
arm was sore for 5 days, that's it; This non-serious case was reported by a consumer and descri... arm was sore for 5 days, that's it; This non-serious case was reported by a consumer and described the occurrence of pain in arm 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 pain in arm (Verbatim: arm was sore for 5 days, that's it). The outcome of the pain in arm was resolved (duration 5 days). It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 19-FEB-2025 The reporter reported that he/she took the Shingrix vaccine, arm was sore for 5 days, that's it. More
2828667 F 02/27/2025 COVID19
FLU3
TDAP
 UNKNOWN MANUFACTURER
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 602MF013
UT8506KA
5YB5G
Abscess limb, Acute kidney injury, Sepsis; Abscess limb, Acute kidney injury, Se... Abscess limb, Acute kidney injury, Sepsis; Abscess limb, Acute kidney injury, Sepsis; Abscess limb, Acute kidney injury, Sepsis More
Acute kidney injury; sepsis; abscess limb; This serious case was reported by a consumer via other ma... Acute kidney injury; sepsis; abscess limb; This serious case was reported by a consumer via other manufacturer and described the occurrence of acute kidney injury in a 60-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5YB5G) for prophylaxis. Co-suspect products included Influenza vaccine (Fluzone) (batch number UT8506KA) for prophylaxis and COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) (batch number 602MF013) for prophylaxis. The patient's past medical history included tobacco user. Concurrent medical conditions included asthma, hypertension, drug hypersensitivity, bipolar disorder, sinusitis bacterial and fungal skin infection. Concomitant products included fluticasone propionate, fluticasone propionate;salmeterol xinafoate (Advair), salbutamol (Albuterol), azelastine, buprenorphine, mirtazapine (Mirtazepine Teva), olanzapine, oxybutynin, propranolol and venlafaxine. On 29-OCT-2024, the patient received the 1st dose of Boostrix (intramuscular), Fluzone (intramuscular) and Novavax COVID-19 Vaccine (intramuscular). On 06-NOV-2024, 8 days after receiving Boostrix, the patient experienced acute kidney injury (Verbatim: Acute kidney injury) (serious criteria hospitalization, GSK medically significant, life threatening and other: Serious as per reporter), sepsis (Verbatim: sepsis) (serious criteria hospitalization, GSK medically significant, life threatening and other: Serious as per reporter) and abscess limb (Verbatim: abscess limb) (serious criteria hospitalization, life threatening and other: Serious as per reporter). The outcome of the acute kidney injury, sepsis and abscess limb were resolved. It was unknown if the reporter considered the acute kidney injury, sepsis and abscess limb to be related to Boostrix. The company considered the acute kidney injury, sepsis and abscess limb to be unrelated to Boostrix. Additional Information: GSK Receipt Date: 21-FEB-2025 The patient's past medical treatments, vaccinations and family history were not provided. At the time of the event, the patient had ongoing bacterial rhinosinusitis and fungal skin infection, Concomitant medications included Fluticasone propionate, Salmeterol xinafoate (Advair), Salbutamol (Albuterol), Azelastine, Buprenorphine, Mirtazapine (Mirtazepine Teva), Olanzapine, Oxybutynin, Propranolol and Venlafaxine. On 29-OCT-2024, the patient received a dose 1 of suspect Boostrix not produced by Sanofi Pasteur in unknown administration site (strength and expiration date: not provided) for drug used for unknown indication and received a dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection in unknown administration site (dose, strength and expiration date not provided) for drug used for unknown indication and received a dose of suspect Novavax covid-19 vaccine injection not produced by Sanofi Pasteur in unknown administration site (dose, strength and expiration date: not provided) for drug used for unknown indication. On 06-Nov-2024, 8 days after receiving Boostrix, Influenza USP trival A-B subvirion no preservative vaccine (Fluzone) and Novavax Covid-19 vaccine, the patient developed abscess limb, acute kidney injury and sepsis (latency-8 days). These events were assessed as medically significant and life-threatening, and the patient was hospitalized for these events. It was not reported if the patient received a corrective treatment for the events. It was unknown if the reporter considered the acute kidney injury, sepsis and abscess limb to be related to Fluzone and Novavax Covid-19 vaccine.; Sender's Comments: Acute kidney injury, Sepsis and Abscess limb are unlisted events which are considered unrelated to GSK vaccine Boostrix. More
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2828669 02/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
Got sick with the shingles shot; This non-serious case was reported by a consumer via interactive di... Got sick with the shingles shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: Got sick with the shingles shot). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK receipt date: 21-FEB-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she took the shingles shot and got sick. The follow-up could not be possible as no contact details were available. More
2828670 02/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Asthenia, Fatigue, Pain in extremity Asthenia, Fatigue, Pain in extremity
my arm is so sore; I feel weak; tired; This non-serious case was reported by a consumer via interact... my arm is so sore; I feel weak; tired; 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 19-FEB-2025, the patient received the 1st dose of Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm is so sore), weakness (Verbatim: I feel weak) and tiredness (Verbatim: tired). The outcome of the pain in arm, weakness and tiredness were not reported. It was unknown if the reporter considered the pain in arm, weakness and tiredness to be related to Shingles vaccine. It was unknown if the company considered the pain in arm, weakness and tiredness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-FEB-2025. This case was reported by a patient via interactive digital media. Patient got first shot yesterday and patient arm was so sore. Patient felt weak and tired. The reporter asked if this was the side effects to getting that shot. More
2828671 02/27/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspect vaccination failure; shingles; This serious case was reported by a consumer via interactive ... suspect vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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: suspect 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 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: 23-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that they were vaccinated but still got shingles. The reporter had a request please did get vaccinated so at least it will be a milder case. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2828672 5 M PA 02/27/2025 HEP
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Second dose of Engerix-B was given earlier; Second dose of Havrix was given a month earlier; This no... Second dose of Engerix-B was given earlier; Second dose of Havrix was given a month earlier; 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 short in a 5-year-old male patient who received HAV (Havrix) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Previously administered products included Havrix (received 1st dose of vaccine on 15th march 2023 with batch number W023937 and expiry date 6th December 2023). Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On 16-AUG-2023, the patient received the 2nd dose of Havrix. On an unknown date, the patient received the 2nd dose of Engerix B. On 16-AUG-2023, an unknown time after receiving Havrix and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Second dose of Havrix was given a month earlier). On an unknown date, the patient experienced drug dose administration interval too short (Verbatim: Second dose of Engerix-B was given earlier). The outcome of the drug dose administration interval too short and drug dose administration interval too short 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: 30-JAN-2025 On 30th January 2025, a reporter called to report that a male child patient had received the first dose of Havrix in March 2023 and the second dose on 16th August 2023. Second dose of Havrix had been given a month earlier, which led to Drug dose administration interval too short. They asked if the vaccine needed to be redone and if the patient needed a booster dose. They also mentioned that it was the same scenario for Engerix-B. Second dose of Engerix-B was given earlier, which led to Drug dose administration interval too short. More
2828673 56 M WI 02/27/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Exposure via skin contact, Syringe issue Exposure via skin contact, Syringe issue
it sprayed out from the tip onto the patient skin; it sprayed out from the tip onto the patient skin... it sprayed out from the tip onto the patient skin; it sprayed out from the tip onto the patient skin; sprayed out from the tip; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of exposure via skin contact in a 56-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced exposure via skin contact (Verbatim: it sprayed out from the tip onto the patient skin), inadvertent exposure to vaccine (Verbatim: it sprayed out from the tip onto the patient skin), syringe leak (Verbatim: sprayed out from the tip) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the exposure via skin contact, inadvertent exposure to vaccine, syringe leak and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe leak to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the syringe leak to be related to Boostrix and Boostrix 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: 03-FEB-2025 The other health professional reported that Boostrix vaccine was administered by a experienced nurse. The nurse states that as the medication was being administered it sprayed out from the tip onto the patient skin which led to inadvertent exposure to vaccine. More
2828674 F CA 02/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 HA5HL
Immediate post-injection reaction, Injection site pain, Poor quality product adm... Immediate post-injection reaction, Injection site pain, Poor quality product administered, Product complaint, Wrong technique in product usage process More
Product Complaint; Injection hurt; bubbles like a soda/it was too bubbly; pharmacist did not shake t... Product Complaint; Injection hurt; bubbles like a soda/it was too bubbly; pharmacist did not shake the vial, it was gently swirled; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number 4H79Y, expiry date 13-NOV-2026) and (batch number HA5HL) for prophylaxis. This case was associated with a product complaint. On 03-FEB-2025, the patient received Shingrix. On 03-FEB-2025, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection hurt), poor quality vaccine administered (Verbatim: bubbles like a soda/it was too bubbly) and wrong technique in drug usage process (Verbatim: pharmacist did not shake the vial, it was gently swirled). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain was unknown and the outcome of the poor quality vaccine administered, wrong technique in drug usage process and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 04-FEB-2025 The pharmacist reported that during and after reconstitution, the Shingrix solution bubbles like a soda. The pharmacist floats to other pharmacies and had noticed this lately when reconstituting Shingrix, confirmed that the pharmacist did not shake the vial, it was gently swirled which led to wrong technique in drug usage process. The pharmacist reported, 2 doses day before reporting were from lot 4H79Y (adjuvant HA5HL) that was very bubbly which led to poor quality vaccine administered. The pharmacist had to discard one dose because she was unable to withdraw a full dose because it was too bubbly (was only able to withdraw 0.2 to 0.3 milliliters). The other she was able to eliminate most of bubbles from the syringe and administer a full dose. However, the patient complained that the injection hurt because the pharmacist left one small bubble. The defect was discovered during preparation for administration; after half way through the multipack. One dose was discarded (not administered), the other was administered. There was no visible damage present on the vial. There were no temperature excursions during storage. Bak Snap, 25 gauge, 1 inch needle was used. The particle observed when the adjuvant was introduced into the antigen vial. More
2828675 55 F NV 02/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 334T3
Product preparation issue Product preparation issue
adjuvant portion of the Shingrix vaccine was administered to a patient; adjuvant portion of the Shin... adjuvant portion of the Shingrix vaccine was administered to a patient; adjuvant portion of the Shingrix vaccine was administered to a patient; 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 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 334T3, expiry date 29-OCT-2026) for prophylaxis. On 23-JAN-2025, the patient received Shingrix. On 23-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant portion of the Shingrix vaccine was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: adjuvant portion of the Shingrix vaccine was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 10-FEB-2025 On 10th February 2025, reporter called to report that only the adjuvant portion of the Shingrix vaccine was administered to a patient on 23th January 2025, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. More
2828676 75 M TX 02/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Exposure via skin contact, Syringe issue, Underdose Exposure via skin contact, Syringe issue, Underdose
Incomplete 2nd dose; Vaccine in contact with the patient skin; Vaccine in contact with the patient s... Incomplete 2nd dose; Vaccine in contact with the patient skin; Vaccine in contact with the patient skin; the needle was not secure enough; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in October 2024). On 07-FEB-2025, the patient received the 2nd dose of Shingrix. On 07-FEB-2025, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Incomplete 2nd dose), exposure via skin contact (Verbatim: Vaccine in contact with the patient skin), inadvertent exposure to vaccine (Verbatim: Vaccine in contact with the patient skin) and wrong technique in product usage process (Verbatim: the needle was not secure enough). The outcome of the incomplete dose administered, exposure via skin contact, inadvertent exposure to vaccine and wrong technique in product usage process were not applicable. Additional Information: GSK Receipt Date: 17-FEB-2025 On 17th February 2025 a registered pharmacist called and reported the following that they had an incident, where they were administering the 2nd dose for Shingrix vaccine, and the needle wasn't secure enough which led to wrong technique in product usage process, so when they injected the vaccine some squirted out for in-between the needle and the syringe which led to incomplete dose administration. Do they need to readminister the 2nd dose? The vaccine administration facility was the same as primary reporter. The 1st dose was administered in October 2024, but never specified the date. Healthcare professional mentioned that due to the situation the vaccine got in contact with the patient's skin which led to exposure via skin contact and inadvertent exposure to vaccine. More
2828677 02/27/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
received their second dose of Twinrix 6 months after the first; This non-serious case was reported b... received their second dose of Twinrix 6 months after the first; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received their second dose of Twinrix 6 months after the first ). The outcome of the drug dose administration interval too long was unknown. 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: 20-FEB-2025 The pharmacist reported that a patient received their second dose of Twinrix 6 months after the first dose. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2828678 M VA 02/27/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 2345B
Incorrect dose administered, Product administered to patient of inappropriate ag... Incorrect dose administered, Product administered to patient of inappropriate age More
12 month old patient received an adult dose of Havrix; 12 month old patient received an adult dose o... 12 month old patient received an adult dose of Havrix; 12 month old patient received an adult dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 12-month-old male patient who received HAV (Havrix adult) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis. The patient's past medical history included thrombocytopenia. On 17-FEB-2025, the patient received Havrix adult. On 17-FEB-2025, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: 12 month old patient received an adult dose of Havrix) and adult product administered to child (Verbatim: 12 month old patient received an adult dose of Havrix). The outcome of the accidental overdose and adult product administered to child 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: 21-FEB-2025 The healthcare provider reported that a 12 month old patient received an adult dose of Havrix which led to accidental overdose and adult product administered to child. The reporter mention that patient has history of thrombocytopenia. More
2828679 F TX 02/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 E3XT9
Inappropriate schedule of product administration Inappropriate schedule of product administration
Shingrix early second dose; This non-serious case was reported by a pharmacist via call center repre... Shingrix early second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number E3XT9, expiry date 19-JUN-2026) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). On 21-AUG-2024, the patient received the 2nd dose of Shingrix. On 21-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix early second dose). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 25-FEB-2025 The pharmacist asked if a patient should be revaccinated with Shingrix after she had the second dose 50 days after the first dose which led to shortening of vaccination schedule. The vaccine administration facility was the same as primary reporter. More
2828680 F 02/27/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
A 43 years old female patient received the first dose of Twinrix on 10/17/2023 and did not came back... A 43 years old female patient received the first dose of Twinrix on 10/17/2023 and did not came back for the 2nd and 3rd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 43-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 17-OCT-2023 with batch number H3SG9 and lot expiry 03-JAN-2025). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: A 43 years old female patient received the first dose of Twinrix on 10/17/2023 and did not came back for the 2nd and 3rd dose.). The outcome of the incomplete course of vaccination 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: 25-FEB-2025 The pharmacist reported that a patient received the first dose of Twinrix but never came back for the 2nd and the 3rd dose. The reporter was ask what would be the dosing schedule. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. More
2828681 52 F CA 02/27/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 B9279
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient received second dose of Twinrix late; This non-serious case was reported by a pharmacist via... Patient received second dose of Twinrix late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old female patient who received HAB (Twinrix) (batch number B9279, expiry date 12-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose of Twinrix on 6th May 2023 with batch number 2PG309 and expiry date 19th September 2025). On 09-JAN-2025, the patient received the 2nd dose of Twinrix. On 09-JAN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Patient received second dose of Twinrix late). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-FEB-2025 The reporter contacted GlaxoSmithKline to report that a 52 year old female patient received a dose of Twinrix on 6th May, and the second one on 9th January 2025 They wanted to know how the second dose should have been administered. Patient received second dose of Twinrix late, which led to Drug dose administration interval too long. This case is linked with US2025023743, reported by same reporter; Sender's Comments: US-GSK-US2025023743:same reporter More
2828682 57 F 02/27/2025 COVID19
 MODERNA
Transient ischaemic attack Transient ischaemic attack
had mini strokes; This spontaneous case was reported by a patient family member or friend and descri... had mini strokes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (had mini strokes) in a 57-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (had mini strokes) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (had mini strokes) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that, the reporter filled for her sister a years ago but never heard back from anyone. The patient was not able to live on her own. They had to retire her from her job and sold her home. She lived in a home then so others could help take care of her because it got too stressful for her to live with their other sister. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2828683 53 F SC 02/27/2025 COVID19
 MODERNA
 047A21A
Tinnitus Tinnitus
Severe tinnitus, both ears and middle ear; This spontaneous case was reported by a patient and descr... Severe tinnitus, both ears and middle ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Severe tinnitus, both ears and middle ear) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 prophylaxis. No Medical History information was reported. On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 19-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Severe tinnitus, both ears and middle ear). At the time of the report, TINNITUS (Severe tinnitus, both ears and middle ear) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. More
2828684 LA 02/27/2025 RSV
 PFIZER\WYETH
 LG9829
Device connection issue Device connection issue
they had 2 abrysvo and it broke apart when they tried to enter the diluent into it; This is a sponta... they had 2 abrysvo and it broke apart when they tried to enter the diluent into it; This is a spontaneous report received from a Pharmacist from product quality group, Program ID. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LG9829, Expiration Date: Oct2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "they had 2 abrysvo and it broke apart when they tried to enter the diluent into it". Causality for "they had 2 abrysvo and it broke apart when they tried to enter the diluent into it" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Additional information: The pharmacist on the line was calling about Abrysvo and reported that they had 2 abrysvo and it broke apart when they tried to enter the diluent into it. They are seeking replacement. One of the Abrysvo was just broke. The top of the diluent was broken. She just needs the diluent replaced. It broke apart before they even inserted it into the vial. She was not dealing with the second one and doesn't know how it broke, but the diluent broke on that one as well. The caller said that both of the Abrysvo were all from the same box. The caller confirmed no patient involvement. More
2828685 M 02/27/2025 COVID19
 PFIZER\BIONTECH
Vitiligo Vitiligo
vitiligo; This is a spontaneous report received from a Physician from a sales representative. A mal... vitiligo; This is a spontaneous report received from a Physician from a sales representative. A male patient 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURE UNKNOWN), for COVID-19 immunisation. The following information was reported: VITILIGO (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of vitiligo. Additional information: the patient was convinced it was related to COVID-19 vaccination. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2828686 02/27/2025 PNC20
 PFIZER\WYETH
Pruritus, Rash, Urticaria Pruritus, Rash, Urticaria
itching; rash; hives; This is a spontaneous report received from a Consumer or other non HCP from me... itching; rash; hives; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 65-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching"; RASH (non-serious), outcome "unknown"; URTICARIA (non-serious), outcome "unknown", described as "hives". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2828687 M 02/27/2025 COVID19
 PFIZER\BIONTECH
Hallucination, Memory impairment Hallucination, Memory impairment
thought there were people in the house; He had an extremely bizarre incident that went on through th... thought there were people in the house; He had an extremely bizarre incident that went on through the night; He did not know where we were, he did not recognized me, he did not knew our home; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Feb2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown, single; had covid shots before ), for COVID-19 immunisation. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset 24Feb2025, outcome "recovered", described as "He had an extremely bizarre incident that went on through the night; He did not know where we were, he did not recognized me, he did not knew our home"; HALLUCINATION (medically significant) with onset 24Feb2025, outcome "recovered", described as "thought there were people in the house". Clinical course: The patient's wife reported that after receiving the COVID shot, the patient experienced an extremely bizarre incident that lasted through the night. Although the patient had received the COVID shot before, this time he did not recognize his wife and did not know their home. The patient also thought there were people in the house, which had never happened before. The patient's wife is asking if this could possibly be a side effect of the vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2828688 F 02/27/2025 RSV
RSV
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Cough, Decreased appetite, Dysphonia, Lethargy, Pyrexia; Weight decreased Cough, Decreased appetite, Dysphonia, Lethargy, Pyrexia; Weight decreased
lingering cough; voice problems (hoarseness); fever; lethargy; no appetite; 11 lb weight loss; This ... lingering cough; voice problems (hoarseness); fever; lethargy; no appetite; 11 lb weight loss; This is a spontaneous report received from an Other HCP, Program ID. A 62-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Dec2024 as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "lingering cough"; DYSPHONIA (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "voice problems (hoarseness)"; PYREXIA (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "fever"; LETHARGY (non-serious), 2 days after the suspect product(s) administration, outcome "unknown"; DECREASED APPETITE (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "no appetite"; WEIGHT DECREASED (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "11 lb weight loss". Relevant laboratory tests and procedures are available in the appropriate section. More
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