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
2844223 57 F ND 06/06/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Z005765
Z005765
Chills, Fatigue, Headache, Induration, Injection site pain; Pain in extremity, P... Chills, Fatigue, Headache, Induration, Injection site pain; Pain in extremity, Peripheral swelling More
Pt messaged in stating: It hurt quite a bit at the time of vaccination, but didn?t think anything o... Pt messaged in stating: It hurt quite a bit at the time of vaccination, but didn?t think anything of it. Approximately 24 hours after I developed chills, severe fatigue and headache which I didn?t think too much of. My arm has continued to hurt since, is swollen and hard and is red 1/4 down my arm now. Advised to be seen for potential cellulitis. Had office visit at walk-in clinic on 6/5/25 for cellulitis, and ER visit 6/6/25 for concerns this is worsening. Placed on antibiotics. More
2844224 16 F KS 06/06/2025 HEPA
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
NOVARTIS VACCINES AND DIAGNOSTICS
 22GP3
X7R42
Condition aggravated, Seizure; Condition aggravated, Seizure Condition aggravated, Seizure; Condition aggravated, Seizure
seizures, pt was brought to ER, treatment unknown, pt was discharged home unmedicated seizures, pt was brought to ER, treatment unknown, pt was discharged home unmedicated
2844225 65 F MI 06/06/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 Unknown
Unknown
Cough, Influenza like illness, Neck pain, Productive cough, Respiratory tract co... Cough, Influenza like illness, Neck pain, Productive cough, Respiratory tract congestion; Sinus congestion More
Flu like symptoms: chest and sinus congestion, phlegm, cough, neck pain Flu like symptoms: chest and sinus congestion, phlegm, cough, neck pain
2844232 13 F CT 06/06/2025 HPV9
HPV9
HPV9
TDAP
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Y012865
Y012865
Y012865
3CA30C1
3CA30C1
3CA30C1
Adjustment disorder with mixed anxiety and depressed mood, Blood thyroid stimula... Adjustment disorder with mixed anxiety and depressed mood, Blood thyroid stimulating hormone, Computerised tomogram head, Drug screen, Full blood count; Hallucination, auditory, Metabolic function test, Pregnancy test urine, Psychotic disorder, Selective mutism; Suicidal ideation, Syphilis test, Urine analysis, Vitamin B12; Adjustment disorder with mixed anxiety and depressed mood, Blood thyroid stimulating hormone, Computerised tomogram head, Drug screen, Full blood count; Hallucination, auditory, Metabolic function test, Pregnancy test urine, Psychotic disorder, Selective mutism; Suicidal ideation, Syphilis test, Urine analysis, Vitamin B12 More
Approximately 3-4 weeks after receiving these vaccines, the patient developed selective mutism and s... Approximately 3-4 weeks after receiving these vaccines, the patient developed selective mutism and started to her voices in her head. 2 weeks later she developed suicidal ideations and was hospitalized for 4 days for adjustment disorder with mixed anxiety/depression with psychotic features More
โœ“
2844236 0.92 M OH 06/06/2025 HEPA
MMR
PNC20
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 Y013120
Y018703
MF0425
Y015558
Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash; Pyrexia, Rash
Patient had rash and fever that presented on 6/5. Did visit today on 6/6 - rash is currently present... Patient had rash and fever that presented on 6/5. Did visit today on 6/6 - rash is currently present. More
2844237 76 F CA 06/06/2025 PNC20
 PFIZER\WYETH
Contusion Contusion
patient came back on 6/6/25 AM presenting bruising in the left forearm region only. She reported tha... patient came back on 6/6/25 AM presenting bruising in the left forearm region only. She reported that it happened the next morning 5/31/25 after she was given Prevnar20 on 5/30/25. She reported no other symptoms besides the bruise in the middle of her left forearm with a bump. She reported the bruise was bigger but going away over time. not too much pain. Injection site had no sings of bruising or swelling and no fever. Patient was on warfarin. No previous reaction like this reported per patient. Advice to monitor and checked with PCP More
2844238 17 M TX 06/06/2025 MNQ
 SANOFI PASTEUR
 U7852AB
Syncope Syncope
brief syncope within 5 minutes of vaccine adminstration. Per mom, patient has history of syncope. Oc... brief syncope within 5 minutes of vaccine adminstration. Per mom, patient has history of syncope. Occurred once before without patient getting a vaccine More
2844239 72 F VA 06/06/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 2PG39
Hypoaesthesia, Lip swelling, Paraesthesia, Tongue erythema Hypoaesthesia, Lip swelling, Paraesthesia, Tongue erythema
Patient reported mouth tingling/numbness, swelling of the lips, and red spots on the tongue Patient reported mouth tingling/numbness, swelling of the lips, and red spots on the tongue
2844240 69 F CA 06/06/2025 PNC20
 PFIZER\WYETH
 LW1951
Fatigue Fatigue
Patient received the Prevnar 20 vaccine twice. Patient feels tired. Patient received the Prevnar 20 vaccine twice. Patient feels tired.
2844241 0.67 F OR 06/06/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 3RE73
Wrong product administered Wrong product administered
8 months old baby was here for a well child check for vaccines. Pt due for Dtap, IPV and PCV. Pt rec... 8 months old baby was here for a well child check for vaccines. Pt due for Dtap, IPV and PCV. Pt received Tdap instead of Dtap. Informed provider, provider talked to parents. " Patient inadvertently received Tdap in place of Dtap and WCC today, as noted in visit. After visit, reviewed CDC guidance more fully and found the following: Persons aged 2 months?6 years. If Tdap is administered inadvertently instead of DTaP as any one of the first 3 doses of the tetanus-diphtheria-pertussis vaccination series, the Tdap dose should not be counted as valid, and a replacement dose of DTaP should be administered. The replacement dose of DTaP can be administered as soon as feasible at any interval after the inadvertent Tdap dose. (Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Recommendations and Reports / April 27, 2018 / 67(2);1?44) Timing of Tdap not specific. Agency recommends Dtap within 72 hours or delay 4 weeks. D/w MA who called parents to schedule for Tdap as soon as possible within 72 hours. If parents prefer to wait, can receive at next WCC, but would recommend sooner."? More
2844242 65 F TX 06/06/2025 PNC21
 MERCK & CO. INC.
 Z004301
Injection site erythema, Injection site inflammation, Injection site pruritus, I... Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site reaction, Injection site warmth More
patient presented today (eod) with delayed injection site reaction which she says began today (6 day... patient presented today (eod) with delayed injection site reaction which she says began today (6 days after receiving the vaccine). She presented with redness around the site about 3 inches in diameter, itchiness and warm to the touch, as well as skin being inflammed and hard only around the area. She did not have the symptoms anywhere else. No fever reported. Advised patient to get benadryl (either cream or tablets ) and to place an ice pack on it. If she gets worse to go to an urgent care clinic or visit her doctor. I told her I would call her tomorrow to check in on her. More
2844243 28 M GA 06/06/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0172
EW0172
Catheterisation cardiac, Chest pain, Echocardiogram, Electrocardiogram, Myocardi... Catheterisation cardiac, Chest pain, Echocardiogram, Electrocardiogram, Myocarditis; Troponin More
Intense chest pain,. Went to ED at Hospital. Testing indicated troponin levels of 12.6. Diagnosed wi... Intense chest pain,. Went to ED at Hospital. Testing indicated troponin levels of 12.6. Diagnosed with myocarditis. More
2844244 58 M WI 06/06/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Cancer surgery, Chemotherapy, Computerised tomogram, Joint noise, Magnetic reson... Cancer surgery, Chemotherapy, Computerised tomogram, Joint noise, Magnetic resonance imaging spinal abnormal; Sacral pain, Sarcoma More
Patient previously healthy. Started with back pain in SI joint in 2023. Then in April '25, had... Patient previously healthy. Started with back pain in SI joint in 2023. Then in April '25, had a snap in back. MRI showed large Lumbar sarcoma tumor. Requiring chemo and major surgery. These vaccines are causing cancer and no one is studying it because they don't believe it is from the vaccines but it is More
โœ“ โœ“
2844285 59 M FL 06/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient came in looking for second dose of Shingrix, misread date of first dose and administered sec... Patient came in looking for second dose of Shingrix, misread date of first dose and administered second dose, then after patient got shot the frame time between two doses was only 16 days. More
2844289 10 M NY 06/06/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 QYB4G
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
Patient developed redness, itching and mild swelling on left deltoid, site of T-dap vaccine vaccinat... Patient developed redness, itching and mild swelling on left deltoid, site of T-dap vaccine vaccination administration. Patient was prescribed Hydrocortisone cream and Benadryl More
2095686 44 F WA 06/05/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
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
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EL3302
EL3302
EL3302
EL3302
EL3302
EL3302
EL3302
EL3302
EL3302
EL3302
EL3302
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
EL3302
EL3302
EL3302
EL3302
EL3302
EL3302
EK5730
EK5730
EK5730
EK5730
EK5730
EK5730
Abdominal pain, Alpha tumour necrosis factor, Amnesia, Angle closure glaucoma, A... Abdominal pain, Alpha tumour necrosis factor, Amnesia, Angle closure glaucoma, Antigliadin antibody; Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Binocular eye movement disorder, Blood copper normal, Blood glucose normal; Blood zinc normal, Borrelia test, C-reactive protein normal, Chemokine test, Chills; Computerised tomogram head normal, Contusion, Cytokine increased, Diarrhoea, Dizziness; Full blood count normal, Granulocyte-colony stimulating factor test, Haematuria, Headache, Herpes simplex test positive; Heterophoria, Hyperacusis, Hypertension, Hypertensive crisis, Impaired work ability; Interferon gamma release assay, Interleukin level, Irritable bowel syndrome, Laboratory test normal, Macrophage inflammatory protein-1 alpha; Magnetic resonance imaging head normal, Memory impairment, Metabolic function test normal, Nausea, Pain; Pyrexia, Red blood cells urine positive, SARS-CoV-2 antibody test positive, Serum ferritin normal, Somnolence; Speech disorder, Tinnitus, Vascular endothelial growth factor assay, Vertigo, Vestibular migraine; Vision blurred, Weight decreased; Abdominal pain, Alpha tumour necrosis factor, Amnesia, Angle closure glaucoma, Antigliadin antibody; Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Binocular eye movement disorder, Blood copper normal, Blood glucose normal; Blood zinc normal, Borrelia test, C-reactive protein normal, Chemokine test, Chills; Computerised tomogram head normal, Contusion, Cytokine increased, Diarrhoea, Dizziness; Full blood count normal, Granulocyte-colony stimulating factor test, Haematuria, Headache, Herpes simplex test positive; Heterophoria, Hyperacusis, Hypertension, Hypertensive crisis, Impaired work ability; Interferon gamma release assay, Interleukin level, Irritable bowel syndrome, Laboratory test normal, Macrophage inflammatory protein-1 alpha; Magnetic resonance imaging head normal, Memory impairment, Metabolic function test normal, Nausea, Pain; Pyrexia, Red blood cells urine positive, SARS-CoV-2 antibody test positive, Serum ferritin normal, Somnolence; Speech disorder, Tinnitus, Vascular endothelial growth factor assay, Vertigo, Vestibular migraine; Vision blurred, Weight decreased; Abdominal pain, Colonoscopy, Computerised tomogram, Diarrhoea, Dizziness; Herpes simplex test, Impaired work ability, Laboratory test, Magnetic resonance imaging, SARS-CoV-2 antibody test positive; Tinnitus, Vertigo, Vestibular function test, Vestibular migraine; Blood immunoglobulin G, Chills, Dizziness, Feeling cold, Headache; Irritable bowel syndrome, Post-acute COVID-19 syndrome, SARS-CoV-2 test, Tinnitus, Tremor; Vestibular migraine; Abdominal pain, Colonoscopy, Computerised tomogram, Diarrhoea, Dizziness; Herpes simplex test, Impaired work ability, Laboratory test, Magnetic resonance imaging, SARS-CoV-2 antibody test positive; Tinnitus, Vertigo, Vestibular function test, Vestibular migraine; Blood immunoglobulin G, Chills, Dizziness, Feeling cold, Headache; Irritable bowel syndrome, Post-acute COVID-19 syndrome, SARS-CoV-2 test, Tinnitus, Tremor; Vestibular migraine; Abdominal pain, Colonoscopy, Computerised tomogram, Diarrhoea, Dizziness; Herpes simplex test, Impaired work ability, Laboratory test, Magnetic resonance imaging, SARS-CoV-2 antibody test positive; Tinnitus, Vertigo, Vestibular function test, Vestibular migraine; Blood immunoglobulin G, Chills, Dizziness, Feeling cold, Headache; Irritable bowel syndrome, Post-acute COVID-19 syndrome, SARS-CoV-2 test, Tinnitus, Tremor; Vestibular migraine More
12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills... 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer. Slept all day and for next several days until 1/12/2021. Taking Theraflu daily. Was able to telework. 1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs. Went to ER April 2021 at kids request where diagnosed with IBS. "I'm a shell of the person I was". Assigned case: current complaints attributed to receipt of Pfizer covid vaccine include: pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report. More
โœ“
2843959 F 06/05/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.

Cyanosis, Erythema, Livedo reticularis, Pyrexia; Cyanosis, Erythema, Livedo reti... Cyanosis, Erythema, Livedo reticularis, Pyrexia; Cyanosis, Erythema, Livedo reticularis, Pyrexia More
marbled bluish red skin condition - diagnosed with Cutis Marmorata; consistent fever of 102 at night... marbled bluish red skin condition - diagnosed with Cutis Marmorata; consistent fever of 102 at night; This spontaneous report was received from a Nurse via company representative on 30-May-2025 concerning to her daughter a 1-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-May-2025,reported as a week ago, the patient was vaccinated with a first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)(lot # ,expiration date, dose, and route were not reported) and with sterile diluent (MERCK STERILE DILUENT)(lot # , expiration date, dose, and route of administration were not reported) for prophylaxis. On 24-May-2025, the patient experienced consistent fever of 102 at night despite Motrin and marbled bluish red skin condition. The Child was seen in the emergency department last night, on 29-MAY-2025 and was diagnosed with Cutis Marmorata. At the reporting time, the outcome of marbled bluish red skin condition/diagnosed with Cutis Marmorata and consistent fever of 102 at night was unknown. The causality between the event events, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II and with sterile diluent (MERCK STERILE DILUENT) was unspecified. More
2843960 MO 06/05/2025 MMR
MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.

Z002520
Extra dose administered, No adverse event, Wrong product administered; Extra dos... Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered More
No symptoms reported.; a patient who was inadvertently administered MMR-II instead of hepatitis B va... No symptoms reported.; a patient who was inadvertently administered MMR-II instead of hepatitis B vaccine (manufacturer unspecified) on 05/28/2025.; this was the patient's third dose of MMR-II (first dose was administered on 06/2023 and second dose was administered on 07/2023; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported. On an unknown date in June 2023 and July 2023, the patient was vaccinated with the first and second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 28-MAY-2025, the patient was inadvertently administered Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (0.5 ml/ dose, lot#: Z002520, expiration date: 07-JAN-2027; route of administration was not reported) instead of hepatitis B vaccine (manufacturer unspecified) for prophylaxis (wrong product administered and extra dose administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, strength, route of administration, lot#, and expiration date were not reported). No additional adverse events (AE) details were reported (no adverse event). More
2843961 KY 06/05/2025 MNQ
 SANOFI PASTEUR
 U6455CA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
a men b immunization was charted in the hcp's system, but the patient should not have had men b... a men b immunization was charted in the hcp's system, but the patient should not have had men b at their particular age with no reported adverse event; Initial information received on 27-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves child of unknown age and is reported meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] immunization was charted in the hcp's (healthcare progessional) system, but the patient should not have had men b at their particular age with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine Solution for injection of lot U6455CA and expiry date: 15-Nov-2020 (strength, dose: not reported) via unknown route in unknown administration site for immunization was charted in the hcp's system, but the patient should not have had men b at their particular age with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2843962 57 F NC 06/05/2025 YF
 SANOFI PASTEUR
 UK118AA
No adverse event, Product preparation error No adverse event, Product preparation error
YF-VAX was given to a patient and the diluent used was sterile water with no reported adverse event;... YF-VAX was given to a patient and the diluent used was sterile water with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves 57 years old female patient to whom yellow fever vaccine -[YF-VAX] was given and the diluent used was sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-May-2025, the patient received a dose of 0.5 ml of suspect yellow fever vaccine, Solution for injection (lot UK118AA, expiry date 30-Sep-2025, strength: standard, frequency: once) via subcutaneous route in unknown administration site for immunisation and the diluent used was sterile water with no reported adverse event (product preparation error) (Latency: same day). Reportedly, an inappropriate use due to the use of an alternate diluent and not using the one supplied with the product. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2843963 10 F AZ 06/05/2025 YF
 SANOFI PASTEUR
 UK137AA
Extra dose administered Extra dose administered
inadvertently giving an extra dose of YF-VAX to a patient with no reported adverse event; YF-VAX giv... inadvertently giving an extra dose of YF-VAX to a patient with no reported adverse event; YF-VAX given as IM to a patient with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 10 years old female patient who inadvertently administered an extra dose yellow fever vaccine - [YF-VAX] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications Included Typhoid Vaccine Polysacch VI (TYPHIM VI) for Immunisation. On 31-May-2025, the patient inadvertently received 2 doses of (0.5 ml dose) of suspect yellow fever vaccine, lot UK137AA, via subcutaneous route,UK137AA via intramuscular route both with (formulation :Solution for injection, expiry date:31-Jan-2026,strength :standard, frequency: once) in unknown administration site for Immunization with no reported adverse event (extra dose administered) (incorrect route of product administration) (latency: same day). Reportedly, She said that she had multiple patients that were going to another country; they needed a vaccination of YF-VAX and TYPHIM VI. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2843964 1.08 F GA 06/05/2025 DTAPIPVHIB
DTP
 SANOFI PASTEUR
UNKNOWN MANUFACTURER
 UK017AA
Extra dose administered, Inappropriate schedule of product administration, No ad... Extra dose administered, Inappropriate schedule of product administration, No adverse event, Wrong product administered; Extra dose administered, Inappropriate schedule of product administration, No adverse event, Wrong product administered More
inappropriate use due to administration of the wrong vaccine with no reported adverse event; giving ... inappropriate use due to administration of the wrong vaccine with no reported adverse event; giving the next dose of Hib too early with no reported adverse event; an extra dose of IPV was given with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old female patient who was inappropriately administered with wrong vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] instead of Diphtheria, Tetanus And Nos Pertussis Vaccine with no reported adverse event and The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio Vaccine Inact 3v (Vero) (Ipol Polio Vaccine) for Immunisation. On 02-Jun-2025, the patient was inappropriate administered with wrong vaccine of 0.5mL Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK017AA, expiry date 30-Jun-2025; strength standard and frequency once) via intramuscular route in the left thigh for Immunization (wrong product administered) instead of Diphtheria, Tetanus And Nos Pertussis Vaccine and the Hib vaccine was given earlier than scheduled with (inappropriate schedule of product administration) (latency same day) and (extra dose administered). Reportedly, the reporter called to report that Pentacel and Ipol were incorrectly administered to a patient. She explained that the vaccines to be given was suppose to be a Dtap and Polio. She also asked for any information or guidance in this event that an extra dose of IPV was given and that the Hib vaccine was given earlier than scheduled. She added that the patient's Hib vaccine was scheduled in October 2025 since it was given last April 2025. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA158247: More
2843965 1.08 F GA 06/05/2025 DTP
IPV
 UNKNOWN MANUFACTURER
SANOFI PASTEUR
X1C891M
Extra dose administered, No adverse event, Wrong product administered; Extra dos... Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered More
PENTACEL and IPOL were incorrectly administered to a patient and vaccines to be given was suppose to... PENTACEL and IPOL were incorrectly administered to a patient and vaccines to be given was suppose to be a Dtap and Polio with no reported AE; extra dose of IPV was given with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from nurse. This case involves a 13 months old female patient who incorrectly administered to IPV (Vero) [IPOL] and pentacel was suppose to be a Diphtheria, Tetanus And Nos Pertussis Vaccine and Polio and extra dose of IPV was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel) for Immunisation on 02-jun-2025. On 02-Jun-2025, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot X1C891M, expiry date 31-Oct-2026, strength standard and frequency once) via subcutaneous route in the left arm for Immunization. On an unknown date, the patient was suppose to received Diphtheria, Tetanus And Nos Pertussis Vaccine produced by unknown manufacturer (lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On 02-Jun-2025, the patient was incorrectly administered with IPV (Vero) and pentacel and was suppose to be a Diphtheria And Tetanus And Nos Pertussis Vaccine and polio with no reported ae (wrong product administered) and extra dose of ipv was given with no reported adverse event (extra dose administered) (latency same day). Reportedly, patient's Hib vaccine was scheduled in October 2025 since it was given last April 2025. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA157483: More
2843966 IL 06/05/2025 HIBV
 SANOFI PASTEUR
 UK092AA
Expired product administered, No adverse event Expired product administered, No adverse event
administered ACTHIB today that expired with no reported AE; Initial information received on 03-Jun-2... administered ACTHIB today that expired with no reported AE; Initial information received on 03-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who had administered expired hib (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Jun-2025, the patient received an unknown expired dose of suspect hib (PRP/T) vaccine, Powder and solvent for solution for injection, lot UK092AA,expiry date:31-May-2025, strength not reported via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2843967 0.92 M VA 06/05/2025 DTAPIPV
DTAPIPVHIB
 SANOFI PASTEUR
SANOFI PASTEUR
 U8209CB
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
11-month old patient received quadracel instead of pentacel with no reported adverse event; Initial ... 11-month old patient received quadracel instead of pentacel with no reported adverse event; Initial information received on 03-Jun-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 11 months old male patient who received diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (vero) vaccine [Quadracel] instead of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-May-2025, the patient received 0.5 ml dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (vero) vaccine Solution for injection lot U8209CB and expiry date- 31-MAY-2026 via intramuscular route in the left vastus lateralis instead of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported with no reported adverse event (wrong product administered) (latency- same day). Action taken -not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2843970 16 F AZ 06/05/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Cold flash, Dysphagia, Hot flush, Pain, Pyrexia; Rash, Tremor, Visual impairment... Cold flash, Dysphagia, Hot flush, Pain, Pyrexia; Rash, Tremor, Visual impairment, Vomiting More
Meningococcal vaccine - Dr mentioned its the one required for college entry. Side effects 1 day aft... Meningococcal vaccine - Dr mentioned its the one required for college entry. Side effects 1 day after vaccine included: Low fever, vomited one time today (reported same day as symptoms occurred), hot and cold flashes, slight rash, can't swallow, hands shaking, vision goes faint, body aches. Patient is 16 years old and had prior hospitalization from MMR + chickenpox vaccine when she was 2. Patient was not sick prior to getting vaccine and was healthy. More
2843971 23 M CA 06/05/2025 RAB
RAB
SMALLMNK
SMALLMNK
 SANOFI PASTEUR
SANOFI PASTEUR
BAVARIAN NORDIC
BAVARIAN NORDIC



Depressed level of consciousness, Dizziness, Eye swelling, Headache, Muscle twit... Depressed level of consciousness, Dizziness, Eye swelling, Headache, Muscle twitching; Pharyngeal swelling; Depressed level of consciousness, Dizziness, Eye swelling, Headache, Muscle twitching; Pharyngeal swelling More
Twitching in neck, back and shoulders, lasted for 12 hours day 1 following injection. Swollen right ... Twitching in neck, back and shoulders, lasted for 12 hours day 1 following injection. Swollen right eye lasted for 12 hours day 3 following injection. Dizziness, headache, soreness behind eyes, lack of alertness, minor swelling of throat. More
2843972 11 F TN 06/05/2025 DTAP
DTAP
DTAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR


Asthenia, Blood test normal, Computerised tomogram normal, Endoscopy normal, Gai... Asthenia, Blood test normal, Computerised tomogram normal, Endoscopy normal, Gait inability; Loss of personal independence in daily activities, Malaise, Nausea, Nervous system disorder, Pain; Pallor, Pyrexia, Ultrasound scan normal, Vagus nerve disorder, X-ray normal More
Sick with fever aches 12/25/24. Jan 7, 2024 got SO SICK. Out of school the rest of the year due to ... Sick with fever aches 12/25/24. Jan 7, 2024 got SO SICK. Out of school the rest of the year due to extreme nausea. Pale. Vagus nerve affected. Nerves affected. Couldn?t walk after Feb 2024. Saw specialist. Every test normal. X-rays, ultra sounds, ct scans, blood work all normal. Saw Neuro. Cardiologist, and GI. Spent a week in the hospital. Finally a clinic in (redacted state) helped us! They believe it was vaccine injury, and she started seeing a chiropractor and (redacted) put her on special diet medication and supplements. Finally a lot better but not able to run. A very healthy 11 year old robbed of half of her 5th grade year. That was very scary. Very bizarre. And made no sense at all. More
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2843973 17 M TX 06/05/2025 MNQ
 SANOFI PASTEUR
 U8494AA
Immediate post-injection reaction, Injection site reaction, Muscle spasms, Synco... Immediate post-injection reaction, Injection site reaction, Muscle spasms, Syncope More
Deltoid muscle cramps were observed by the pharmacist on the injection arm as soon as the 0.5 ml of ... Deltoid muscle cramps were observed by the pharmacist on the injection arm as soon as the 0.5 ml of intramuscular MenACWY shot started. The patient fainted about a minute after receiving the shot. The patient was hold and placed in supine position on the floor, but quickly recover within a minute of fainting. After that the patient was alert and able to talk. He was closely observed by the pharmacist for 15 minutes with no symptoms and let go home at his request. His mom said he had once fainted after an injection but not with a vaccine. I think it could well be a vasovagal syncope rather than a reaction to the vaccine. More
2843974 37 F MN 06/05/2025 TYP
 SANOFI PASTEUR
Headache, Nausea, Vomiting Headache, Nausea, Vomiting
Nausea, emesis, mild headache Nausea, emesis, mild headache
2843979 41 M NJ 06/05/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 FJ8757
FJ8757
Drainage, Fatigue, Intensive care, Malaise, Sepsis; Tooth infection, Tracheostom... Drainage, Fatigue, Intensive care, Malaise, Sepsis; Tooth infection, Tracheostomy More
Tired, sick almost every few weeks Tired, sick almost every few weeks
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2843980 18 F TX 06/05/2025 MENB
MENB
MENB
MENB
MNQ
MNQ
MNQ
MNQ
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 LE5302
LE5302
LE5302
LE5302
U8494AA
U8494AA
U8494AA
U8494AA
Asthenia, Back pain, Blood creatine phosphokinase normal, Blood electrolytes nor... Asthenia, Back pain, Blood creatine phosphokinase normal, Blood electrolytes normal, Blood thyroid stimulating hormone normal; Chest pain, Chills, Dyspnoea, Electrocardiogram normal, Full blood count normal; Myalgia, Nasal congestion, Pain, Thyroxine free normal, Viral test negative; White blood cell count normal; Asthenia, Back pain, Blood creatine phosphokinase normal, Blood electrolytes normal, Blood thyroid stimulating hormone normal; Chest pain, Chills, Dyspnoea, Electrocardiogram normal, Full blood count normal; Myalgia, Nasal congestion, Pain, Thyroxine free normal, Viral test negative; White blood cell count normal More
7 hours after vaccine administration, patient developed body aches, chills, weakness, nasal congesti... 7 hours after vaccine administration, patient developed body aches, chills, weakness, nasal congestion, severe myalgias of legs, arms, and back, tremors, severe headache, chest pain & difficulty breathing. Tests done in ER-normal WBC, normal electrolytes, EKG nl. Normal saline bolus given & Toradol. Pt. discharged on Naproxen. F/u 5/21 pt. improved. More
2843982 16 F FL 06/05/2025 MENB
MENB
 PFIZER\WYETH
PFIZER\WYETH
 LF5302
LF5302
Headache, Influenza like illness, Influenza virus test negative, Malaise, Nausea... Headache, Influenza like illness, Influenza virus test negative, Malaise, Nausea; Pain in extremity, Pyrexia, SARS-CoV-2 test negative More
Patient developed nausea, headache 5 1/2 hours later. This AM (24 hours later) she developed fever, ... Patient developed nausea, headache 5 1/2 hours later. This AM (24 hours later) she developed fever, Tmax=103.6, malaise, headache, arm pain, flu-like symptoms. Office testing negative for flu & Covid. More
2843984 58 M CO 06/05/2025 COVID19
FLU3
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 LM2224
K9XL5
Injection site pain; Injection site pain Injection site pain; Injection site pain
Patient experienced prolonged injection site pain after vaccination. Patient experienced prolonged injection site pain after vaccination.
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2843985 74 F MI 06/05/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
 L20A
L20A
1B21A
1B21A
Asthenia, Constipation, Diarrhoea, Hysterectomy, Pelvic floor muscle weakness; T... Asthenia, Constipation, Diarrhoea, Hysterectomy, Pelvic floor muscle weakness; Tremor; Asthenia, Constipation, Diarrhoea, Hysterectomy, Pelvic floor muscle weakness; Tremor More
Constipation, diarrhea, internal shaking, weakness. Symptoms continue to get worse (I have been to c... Constipation, diarrhea, internal shaking, weakness. Symptoms continue to get worse (I have been to clinic- 2023-week pelvic floor, University 2x- pills for constipation, tried Naturopathic diet, Hysterectomy-04/2025) More
2843986 68 F MO 06/05/2025 COVID19
COVID19
 MODERNA
MODERNA
 AS7143C
AS7143C
Arthralgia, Cardiovascular symptom, Chest discomfort, Chest pain, Dyspnoea; Echo... Arthralgia, Cardiovascular symptom, Chest discomfort, Chest pain, Dyspnoea; Echocardiogram, Pain, Pericarditis More
Had all shots & boosters- After this Booster ๏ฟฝ It wasn't until last of April & May 20... Had all shots & boosters- After this Booster ๏ฟฝ It wasn't until last of April & May 2023 I started symptoms like heart attac chest tightness. Went to (redacted) ER first ๏ฟฝ gave me aspirin & check heart. A week later went back with more severe pain. They called heart Dr who ordered Echo gram & gave pain for shot. Had Echogram then while waiting for results went to (redacted) Hosp ER. At (redacted) I was in severe pain chest. They knew I had pericarditis so gave me pain med and said told me to see heart Dr next week. I did and he gave me medication 8 ibuprofen a day for 1 month an Colchicine for 2 months. But the time I got home at 4pm I just took 1st dose. My R shoulder started to hurt. I said I think it started here now. By 8 pm I hurt like in a vice from neck to waist and had to bend to knees to breath. Husband called ambulance and they sent that & air lift from home to (redacted) ER ๏ฟฝ was admitted for 5 day stay at (redacted) Hosp center. After Booster on 9/22/23 ๏ฟฝ 10 days & after I had recurrent Pericarditis. Saw at (redacted) Hosp. ER ๏ฟฝ started 6 mo treatment as before ๏ฟฝ Saw Heart Dr. did more recheck all possible inflammation with Dr then 2 wk 1 Dr ๏ฟฝ called and has me on ARC just > 200 shots q week. Past Covid19 Vaccination Moderna 007M20A 2/13/21 (redacted name) Pharmacy Moderna 040A21A 3/13/21 (redacted name) Pharmacy Moderna 037F21A 10/27/21 (redacted name) Family Health Clinic Moderna AS7143C 9/22/22 (redacted name) Health Dept. Moderna 3030371 9/22/23 (redacted name) Pharmacy More
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2844035 MD 06/05/2025 HEP
HEP
HEP
HEP
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y009551
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; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No symptoms reported and no additional details provided. No other AE/PQC; Caller states a patient re... No symptoms reported and no additional details provided. No other AE/PQC; Caller states a patient received 3 pediatric doses prior to the age of 19, however the third dose was administered too early at 4 months instead of 6 months.; Caller states the office inadvertently administered another 0.5ml dose instead of a 1.0 ml dose; This spontaneous report was received from a nurse and refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates, prior to the age of 19, the patient was administered 3 pediatric does of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0,5 ml administered intramuscularly for prophylaxis (lot # and expiry dates were not provided), however third dose was administered too early at 4 months instead of 6 months (inappropriate schedule of product administration). The reporter stated that as a result, the office chose to administer a booster dose to this patient that was now an adult and who already received 3 pediatric doses. On 13-May-2025, the patient was administered the fourth dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #Y009551, expiration date: 08-Dec-2026) 0.5 mL administered intramuscularly for prophylaxis. The office inadvertently administered another 0.5ml dose instead of a 1.0 ml dose (accidental underdose). No symptoms were reported and no additional details were provided. No other adverse event (AE) or product quality complaint (PQC) was noted (no adverse event). More
2844036 TX 06/05/2025 MMR
 MERCK & CO. INC.
 Y005808
Product storage error Product storage error
Nurse confirmed their facility has not received any reports of the patient involved experiencing any... Nurse confirmed their facility has not received any reports of the patient involved experiencing any medical concerns or side effects after being administered the improperly stored dose of MMR II.; Nurse calling with a report of an adverse event regarding an improperly stored and administered dose of MMR II. Nurse stated that the MMR II was involved in a temperature excursion on 3/4/2025 and administered to a patient on 3/31/2025; This spontaneous report was received from Nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Mar-2025, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #Y005808, expiration date: 12-Mar-2026) was involved in a temperature excursion and on 31-Mar-2025, the patient received 0.5 mL, of a two dose series of the improperly storage Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength and route of administration not provided) diluted with therapy with sterile diluent (MERCK STERILE DILUENT), 0.5 mL (indication, expiration date, and lot # were not reported) for prophylaxis. Nurse confirmed their facility had not received any reports of the patient involved experiencing any medical concerns or side effects after being administered the improperly stored dose of vaccine. More
2844037 IL 06/05/2025 PNC21
 MERCK & CO. INC.
Injection site reaction, Injection site swelling Injection site reaction, Injection site swelling
redness, and swelling at the injection site; redness, and swelling at the injection site; inflammati... redness, and swelling at the injection site; redness, and swelling at the injection site; inflammation/redness, and swelling at the injection site; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date in May 2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 ml (reported as 0.5 m) intramuscularly (anatomical location, lot # and expiration date were not provided) for prophylaxis. Since an unknown date in May 2025, post the suspect vaccination ,the patient suffered from redness, and swelling at the injection site. The area of redness and swelling stretched about 3 inches across and about 4-5 inches wide. The reporter noted inflammation but stated it did not appear to be infected. The patient sought medical attention. At the time of the report, the patient suffered from the events for at least 6 days. The outcome of the events was reported as not recovered. Causality assessment was not provided. Lot # is being requested and will be submitted if received. This is an invalid report due to lack of the patient's identifiers. More
2844038 1 F PA 06/05/2025 MMR
 MERCK & CO. INC.
 X014954
Expired product administered, No adverse event Expired product administered, No adverse event
No additional adverse event reported; A HCP called to report the administration of an expired dose o... No additional adverse event reported; A HCP called to report the administration of an expired dose of MMR II (Lot: X014954 Expiration: 05/24/2025) that occurred on 05/28/2025. The HCP stated the patient did not experience any adverse issues or side effect from the expired administered do; This spontaneous report was received from a nurse and refers to a 1-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-May-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X014954, expiration date: 24-May-2025) 0.5 mL for an unknown indication. On 28-May-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) (Expired vaccine used). No additional adverse event reported. More
2844043 5 M TN 06/05/2025 VARCEL
 MERCK & CO. INC.
 X012268
Expired product administered Expired product administered
No side effects or symptoms reported; HCP called to report a patient received an expired dose of VAR... No side effects or symptoms reported; HCP called to report a patient received an expired dose of VARIVAX. The product expired 04/30/2025 and was administered 06/02/2025. Caller verified the product has not had any temperature excursions. No side effects or symptoms reported. No addition; This spontaneous report was received from a medical assistant and refers to a 5-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 02-Jun-2025, the patient was vaccinated with an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X012268, expiration date: 30-Apr-2025), dose number 1, 0.5 mL, that was reconstituted with sterile diluent for prophylaxis (expired product administered). No adverse event was reported. More
2844044 PA 06/05/2025 MMR
 MERCK & CO. INC.
 X013192
Expired product administered, No adverse event Expired product administered, No adverse event
no adverse event; an expired dose of MMRII; MMRII has also had a supported temperature excursion in ... no adverse event; an expired dose of MMRII; MMRII has also had a supported temperature excursion in the past of 13.7๏ฟฝC for 2 Hours 0 Minutes 0 Seconds; This spontaneous report was received from a Physician and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Jun-2025, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection (lot #X013192, expiration date: 08-May-2025) (Expired product administered) with sterile diluent (lot # and expiration date were not reported) for prophylaxis. This vaccine has also had a supported temperature excursion in the past of 13.7 degree Celsius for 2 Hours 0 Minutes 0 Seconds (Product storage error). No adverse event was reported. More
2844045 F WA 06/05/2025 HPV9
 MERCK & CO. INC.
Rash Rash
adverse reaction that consisted of a uh severe rash all throughout her body; This spontaneous report... adverse reaction that consisted of a uh severe rash all throughout her body; This spontaneous report has been received from a healthcare professional regarding a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered as prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On an unknown date, the patient experienced an adverse reaction that consisted of a severe rash all throughout her body (Rash). On an unknown date, the patient recovered from the event. The reporter considered the event of rash to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). More
2844046 11 F 06/05/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
schedule recommendations for GARDASIL 9/patient received their first dose at age 11 and their second... schedule recommendations for GARDASIL 9/patient received their first dose at age 11 and their second dose at age 18; No additional AE/No PQC.; This spontaneous report was received from a/an Nurse and refers to a(n) female patient of unknown age. 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 Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (.5 ml), (lot # and expiration date were not reported). The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), for the treatment of Prophylaxis. HCP called for information regarding alternate dosing schedule recommendations for Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). HCP stated that a female patient received their first dose at age 11 and their second dose at age 18. No additional patient information available at the time of the call. No symptoms reported at the time of the call. Consent to contact is Yes. No additional AE/No PQC. Lot # is being requested and will be submitted if received. More
2844047 70 M SC 06/05/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Autoimmune disorder, C-reactive protein increased, Erythema, Inflammation, Insom... Autoimmune disorder, C-reactive protein increased, Erythema, Inflammation, Insomnia; Muscle spasms, Myalgia, Pain, Peripheral swelling, Red blood cell sedimentation rate increased More
Autoimmune disorder; C reactive protein elevated; sedimentation rate elevated; Cramps leg; Swelling ... Autoimmune disorder; C reactive protein elevated; sedimentation rate elevated; Cramps leg; Swelling arm; Inflammation; Redness; Polymyalgia; Pain/ pain is in random places; Insomnia; This serious case was reported by a nurse via call center representative and described the occurrence of autoimmune disorder in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included shoulder replacement (Patient has a titanium left shoulder replacement.). Concurrent medical conditions included atrial fibrillation and hypertension. Concomitant products included propafenone, apixaban (Eliquis) and carvedilol (Coreg). On 29-JAN-2025, the patient received Arexvy (right arm). In JAN-2025, less than a week after receiving Arexvy, the patient experienced c-reactive protein increased (Verbatim: C reactive protein elevated) and elevated sedimentation rate (Verbatim: sedimentation rate elevated). On 31-JAN-2025, the patient experienced leg cramps (Verbatim: Cramps leg), swelling arm (Verbatim: Swelling arm), inflammation (Verbatim: Inflammation), redness (Verbatim: Redness), polymyalgia (Verbatim: Polymyalgia), pain (Verbatim: Pain/ pain is in random places) and insomnia (Verbatim: Insomnia). On an unknown date, the patient experienced autoimmune disorder (Verbatim: Autoimmune disorder) (serious criteria GSK medically significant). The patient was treated with prednisone and methotrexate. The outcome of the autoimmune disorder, leg cramps, swelling arm, inflammation, redness, polymyalgia, pain, insomnia, c-reactive protein increased and elevated sedimentation rate were not resolved. It was unknown if the reporter considered the autoimmune disorder, leg cramps, swelling arm, inflammation, redness, polymyalgia, pain, insomnia, c-reactive protein increased and elevated sedimentation rate to be related to Arexvy. It was unknown if the company considered the autoimmune disorder, leg cramps, swelling arm, inflammation, redness, polymyalgia, pain, insomnia, c-reactive protein increased and elevated sedimentation rate to be related to Arexvy. Additional Information: GSK receipt date: 03-JUN-2025 The reporter was the wife of the patient and a nurse called as a consumer. The reporter stated that her husband received the Arexvy vaccine on 19th January 2025 in his right arm. The reporter stated that 5 days after receiving the vaccine all his symptoms started and are concentrated on his left side. The patient's pain was in random places. All symptoms were persisting. The reporter stated that the patient's physician reported this AE on VAERS in February 2025 and diagnosed patient with an autoimmune response. The patient currently had abnormal labs, CRP and SED rate was elevated. Currently the physician was titrating Prednisone down and had started Methotrexate. The reporter stated that the doctor tried to titrate the Prednisone down before with negative results. The reporter had no information concerning the vaccine and stated that the doctor had all of the information about the vaccine because he did all of the previous reporting in VEARS.; Sender's Comments: Autoimmune disorder is an unlisted event which is considered unrelated to GSK vaccine Arexvy. More
2844048 79 F CA 06/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 75d3a
75d3a
Contusion, Headache, Injection site haemorrhage, Injection site rash, Pain in ex... Contusion, Headache, Injection site haemorrhage, Injection site rash, Pain in extremity; Rash pruritic More
got an itchy rash, size of a dime, near the injection site; got an itchy rash, size of a dime, near ... got an itchy rash, size of a dime, near the injection site; got an itchy rash, size of a dime, near the injection site; I've had minor headaches the last few days; bleeding during the injection; I got a sore arm; bruised arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 75d3a, expiry date 31-MAR-2027) for prophylaxis. The patient's past medical history included shingles (Mild case of shingles in the past). Concurrent medical conditions included thyroid disorder. Concomitant products included levothyroxine sodium (Levothyroxine). On 21-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). In MAY-2025, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: I got a sore arm) and bruising of arm (Verbatim: bruised arm). On 21-MAY-2025, the patient experienced injection site hemorrhage (Verbatim: bleeding during the injection). On 27-MAY-2025, the patient experienced injection site rash (Verbatim: got an itchy rash, size of a dime, near the injection site), injection site itching (Verbatim: got an itchy rash, size of a dime, near the injection site) and headache (Verbatim: I've had minor headaches the last few days). The patient was treated with ibuprofen sodium (Ibuprofen). On 28-MAY-2025, the outcome of the headache was resolved (duration 1 day). The outcome of the injection site rash and injection site itching were not resolved and the outcome of the injection site hemorrhage, pain in arm and bruising of arm were unknown. It was unknown if the reporter considered the injection site rash, injection site itching, injection site hemorrhage, pain in arm, bruising of arm and headache to be related to Shingrix. It was unknown if the company considered the injection site rash, injection site itching, injection site hemorrhage, pain in arm, bruising of arm and headache to be related to Shingrix. Additional Information: GSK Receipt Date : 28-MAY-2025 The patient received Shingrix and experienced sore and bruised arm. The day before reporting, she got an itchy rash, size of a dime, near the injection site. She had minor headaches the last few days, treatable with ibuprofen. Then the patient was called and she provided further details. She stated that she took a photo of the rash yesterday when it showed up. She mentioned that it was very itchy. The Shingrix shot number one was administered intramuscularly in the upper right arm and there was bleeding during the injection. She indicated that this was unusual as she normally did not bleed during a vaccination. She was not on aspirin. She indicated that she had a mild headache yesterday and also on the day of reporting. Each headache was treated with ibuprofen and resolved. She stated that headaches were uncommon for her, she said she hardly got headaches. More
2844049 F 06/05/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Respiratory syncytial virus infection, Vaccination failure Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; Patient got RSV six months after arexvy dose; This serious case was r... Suspected vaccination failure; Patient got RSV six months after arexvy dose; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, 6 months after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Patient got RSV six months after arexvy dose). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was unknown. The reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. The company considered the respiratory syncytial virus infection to be related to Arexvy. Additional Information: GSK Receipt Date: 02-JUN-2025 The patient got respiratory syncytial virus infection (RSV) six months after Arexvy dose. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Arexvy. More
2844051 F 06/05/2025 RSV
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Malaise, Pain in extremity; Malaise, Pain in extremity Malaise, Pain in extremity; Malaise, Pain in extremity
slightly sore arm; feel a bit under the weather; This non-serious case was reported by a consumer vi... slightly sore arm; feel a bit under the weather; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Zostavax with an associated reaction of pruritus (received in 2012 and had arm itch for a week), Shingrix with an associated reaction of malaise (received first dose in 2018 for tolerance of first dose refer case US2025AMR070529), Pneumovax 23 with an associated reaction of pain in extremity and Prevenar 20 with an associated reaction of pain in extremity. On an unknown date, the patient received the 2nd dose of Shingrix and Arexvy. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Arexvy, the patient experienced feeling unwell (Verbatim: feel a bit under the weather) and pain in arm (Verbatim: slightly sore arm). Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved (duration 36 hrs) and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Arexvy. It was unknown if the company considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Arexvy. Linked case(s) involving the same patient: US2025AMR070529 Additional Information: GSK Receipt Date: 28-MAY-2025 Patient received both Zostavax in 2012 and two doses of Shingrix in 2018. Zostavax, which is not much used these days, made her arm itch for a week and Shingrix made her feel a bit under the weather the day. She was fine after 24-36 hours, and after watching what her husband's mother went through with multiple bouts of shingles, she consider it was completely worth it. She had two different pneumonia vaccines, Pneumovax 23 and Prevnar 20. She was also in the Pfizer adult RSV clinical trial a few years back, but since they were not ready to unblind her, she just went ahead and got the Arexvy shot a year later. None of those shots gave her anything worse than a slightly sore arm. This case is linked with case US2025AMR070488, reporter by the same reporter.; Sender's Comments: US-GSK-US2025AMR070488:same reporter/male patient More
2844052 06/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site pain, Injection site swelling, Urticaria Injection site pain, Injection site swelling, Urticaria
I did have swollen arm at injection site; very sore at injection site; My question is if it is known... I did have swollen arm at injection site; very sore at injection site; My question is if it is known to cause hives what do the hives look like ,Because I am breaking out it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling 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 injection site swelling (Verbatim: I did have swollen arm at injection site), injection site pain (Verbatim: very sore at injection site) and hives (Verbatim: My question is if it is known to cause hives what do the hives look like ,Because I am breaking out it). The outcome of the injection site swelling and injection site pain were resolving and the outcome of the hives was not reported. It was unknown if the reporter considered the injection site swelling, injection site pain and hives to be related to Shingles vaccine. It was unknown if the company considered the injection site swelling, injection site pain and hives to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-MAY-2025 This case was reported by a patient via (Chatbot) interactive digital media. The patient reported that had a recent vaccination for Shingles and had read the side effects. The patient had a very sore and swollen arm at injection site , but it has gone down . The patient wanted to ask question if it was known to cause hives what the hives looked like, because he/she breaking out it. More
2844053 06/05/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
suspected vaccination failure; Had both shots still got the shingles; This serious case was reported... suspected vaccination failure; Had both shots still got the 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had both shots still got the 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 03-JUN-2025 This case was reported by a patient via interactive digital media. The patient had received both shots and still got the shingles. 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 Shingles vaccine(Dose 1 & 2). More
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