🏥 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 💀 🏥 🚑 ♿ ⚠️
2820316 74 F IA 01/10/2025 COVID19
 PFIZER\BIONTECH
 GH9693
Death Death
Death Death
✓
2820317 21 F MI 01/10/2025 MENB
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 A274J
3ZH27
Hyperhidrosis, Nervousness, Pallor; Hyperhidrosis, Nervousness, Pallor Hyperhidrosis, Nervousness, Pallor; Hyperhidrosis, Nervousness, Pallor
Patient proceed to leave the facility, made it to the waiting room then had to sit down, became very... Patient proceed to leave the facility, made it to the waiting room then had to sit down, became very shaky, sweating profusely and became pale. Brought patient back to the waiting room. Laid her down, ice pack, sucker for sugar intake. Stated she has POTS and this has happened before but not with vaccines. Is unsure if it was vaccine related or not. Patient laid there until she felt okay to leave and the provider checked back on her to make sure she was okay. Vitals were stable. Patient laid there for about 20 minutes until she left. More
2820318 94 F IA 01/10/2025 COVID19
 MODERNA
 3043332
Death Death
DEATH DEATH
✓
2820319 24 M WI 01/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 2B74N
Exposure during pregnancy, Product use issue, Wrong product administered Exposure during pregnancy, Product use issue, Wrong product administered
Pregnant patient. MD ordered Abrysvo and staff unintentionally administered Arexvy vaccine, which is... Pregnant patient. MD ordered Abrysvo and staff unintentionally administered Arexvy vaccine, which is contraindicated in pregnancy More
2820320 70 M FL 01/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 5A2ZNXP78
Extra dose administered Extra dose administered
Patient had already received an Arexvy vaccine on 3/23/24 with store. He signed up for another on 1... Patient had already received an Arexvy vaccine on 3/23/24 with store. He signed up for another on 1/6/25 and the 2nd dose was given. Due to guidelines this is outside of normal vaccine schedule/max number of doses. We have called and left voicemail for patient to call back to verify side effects if any. More
2820321 15 M CA 01/10/2025 FLU3
HPV9
MNQ
TDAP
 SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 U8518DA
Y007197
U8375AA
U8232AA
Dizziness, Immediate post-injection reaction, Syncope; Dizziness, Immediate post... Dizziness, Immediate post-injection reaction, Syncope; Dizziness, Immediate post-injection reaction, Syncope; Dizziness, Immediate post-injection reaction, Syncope; Dizziness, Immediate post-injection reaction, Syncope More
VIS was given to parent for review prior to vaccine administration. Informed parent and patient of c... VIS was given to parent for review prior to vaccine administration. Informed parent and patient of common side effects. HPV9#1 was administred on LD. Patient was sitting down I administred HPV9 and a couple seconds after, patient started feeling dizzy and fainted. I had him inhale Amonia and at the same time PA was assessing patient. A few seconds after, patient recovered and was on observation for 15mins. After 15mins, patient was fully recovered and went home. More
2820322 6 M CO 01/10/2025 FLU3
 SANOFI PASTEUR
 UT8434LA
Injection site reaction, Rash pruritic, Streptococcal infection Injection site reaction, Rash pruritic, Streptococcal infection
Bumpy/itchy rash developed 1 day after vaccination and rash/itching is limited to Left arm where vac... Bumpy/itchy rash developed 1 day after vaccination and rash/itching is limited to Left arm where vaccination was administered. More
2820323 73 F TN 01/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered, No adverse event Extra dose administered, No adverse event
This is the second RSV Arexvy vaccine received by this patient. The initial dose was given 1/5/2024.... This is the second RSV Arexvy vaccine received by this patient. The initial dose was given 1/5/2024. Patient is reporting no issues and is feeling good. More
2820324 28 F NM 01/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 ct3z7
Feeling hot, Flushing, Hypoaesthesia oral, Throat irritation Feeling hot, Flushing, Hypoaesthesia oral, Throat irritation
Gave vaccine in right deltoid and within one minute bottom right side of lip went numb like Novocain... Gave vaccine in right deltoid and within one minute bottom right side of lip went numb like Novocain was given then at minute 3 her upper right side lip when numb. Her face went flush and warm at minute 4 and throat was itchy. She does not have any breathing issue or throat swelling. Vitals 105/75 HR 83 O296 temp 37.1- Took OTC Benadryl More
2820325 4 F CA 01/10/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U8009AB
Y013583
Erythema, Skin warm, Tenderness; Erythema, Skin warm, Tenderness Erythema, Skin warm, Tenderness; Erythema, Skin warm, Tenderness
Received 2 injection on left tight 2 days ago. Yesterday woke up with redness and didn't want m... Received 2 injection on left tight 2 days ago. Yesterday woke up with redness and didn't want mom to touch her leg. This morning the redness is a little better, but still pain to touch and hot. More
2820326 34 M AL 01/10/2025 TD
TD
TD
TD
 SANOFI PASTEUR
SANOFI PASTEUR
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 U7745AA
U7745AA
U7745AA
U7745AA
Bell's palsy, Facial paralysis, Hypoaesthesia oral, Paraesthesia; Bell'... Bell's palsy, Facial paralysis, Hypoaesthesia oral, Paraesthesia; Bell's palsy, Dry eye, Eye pruritus, Facial paralysis, Paraesthesia oral; Bell's palsy, Facial paralysis, Hypoaesthesia oral, Paraesthesia; Bell's palsy, Dry eye, Eye pruritus, Facial paralysis, Paraesthesia oral More
Within 10 minutes of receiving the vaccine, the patient developed tongue numbness. Over the course ... Within 10 minutes of receiving the vaccine, the patient developed tongue numbness. Over the course of the next 48 hours, his symptoms progressed into paresthesia and paralysis of the left side of his face which prompted him to go to the emergency department where he was diagnosed with Bells palsy. More
2820327 0.75 M VA 01/10/2025 FLU3
 SANOFI PASTEUR
 UT8434MA
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Child received the the second flu vaccine 15 days after the first, too soon. No treatment was needed... Child received the the second flu vaccine 15 days after the first, too soon. No treatment was needed. Additional flu vaccine at the correct interval was required. More
2820328 5 M IL 01/10/2025 DTAP
FLU3
TDAP
VARCEL
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.



Extra dose administered, Product administered to patient of inappropriate age; E... Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age More
Nurse administered Tdap to 5 year old, then gave Dtap which was correct for age at same visit. Nurse administered Tdap to 5 year old, then gave Dtap which was correct for age at same visit.
2820329 8 F KS 01/10/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 J245K
Product storage error Product storage error
Vaccine deemed not viable due to temperature excursion Vaccine deemed not viable due to temperature excursion
2820330 12 M KS 01/10/2025 HPV9
 MERCK & CO. INC.
 X014788
Product storage error Product storage error
Vaccine deemed not stable due to temp excursion Vaccine deemed not stable due to temp excursion
2820331 56 F NC 01/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injury associated with device, Occupational exposure to product Injury associated with device, Occupational exposure to product
Pharmacist was capping the tip of the needle when she stuck her left index after administrating the... Pharmacist was capping the tip of the needle when she stuck her left index after administrating the shingrix vaccine into a pt. The entire shot was given to the pt but there may have been residue left on the tip that could have entered her finger. Her finger was cleaned with alcohol and covered with a bandage. She was instructed by corp office to complete VAERS report. More
2820332 8 F KS 01/10/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 J245K
Product storage error Product storage error
Vaccine deemed not stable due to temp excursion Vaccine deemed not stable due to temp excursion
2820333 16 F OR 01/10/2025 MNQ
 SANOFI PASTEUR
 U8438AA
Rash, Urticaria Rash, Urticaria
developed rash four hours after vaccine. rash was increased the next day at school, saw school nurs... developed rash four hours after vaccine. rash was increased the next day at school, saw school nurse, thought to be hives. was given epipen by nurse. other than rash no other sx. no resp compromise. was sent to ed for eval, diagnosed with urticaria. More
2820334 59 F WI 01/10/2025 COVID19
 MODERNA
 3043333
Expired product administered, No adverse event Expired product administered, No adverse event
Use by date was 12/29/30 and vaccine was administered on 12/30/24. Patient did not experience any un... Use by date was 12/29/30 and vaccine was administered on 12/30/24. Patient did not experience any unusual side effects to the dose. More
2820335 16 M KS 01/10/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 M23G5
Product storage error Product storage error
Vaccine deemed not stable due to temperature excursion Vaccine deemed not stable due to temperature excursion
2820336 18 M VA 01/10/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2724L
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient presented to vaccine clinic intended to receive boosters for bexsero and vatqa, however inst... Patient presented to vaccine clinic intended to receive boosters for bexsero and vatqa, however instead received seasonal influenza vaccine. Patient had not received this vaccine yet this season, and did not have allergy listed to it - also did not have any noted reaction. Patient informed of error and returned following day to receive correct boosters. No reactions noted so far. More
2820337 0.5 F KS 01/10/2025 DTAPHEPBIP
HIBV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 X9EP5
X022982
Product storage error; Product storage error Product storage error; Product storage error
Vaccine deemed not stable due to temperature excursion Vaccine deemed not stable due to temperature excursion
2820338 11 M MI 01/10/2025 DTAP
FLU3
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 BH57H
7KZ9R
U8271AB
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Vaccines being administer as normal but Dtap was given instead of Tdap for the 11 year old patient. ... Vaccines being administer as normal but Dtap was given instead of Tdap for the 11 year old patient. No adverse symptoms occured. More
2820339 10 M MI 01/10/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 42Y93
X023316
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
10 year old patient was given Dtap-IPV Kinrix instead of Dtap and IPV separated. No adverse symptom... 10 year old patient was given Dtap-IPV Kinrix instead of Dtap and IPV separated. No adverse symptoms reported. More
2820340 82 F VT 01/10/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LJ5280
LJ5280
Antinuclear antibody negative, Arthralgia, Asthenia, C-reactive protein, Fatigue... Antinuclear antibody negative, Arthralgia, Asthenia, C-reactive protein, Fatigue; Injection site erythema, Injection site mass, Injection site pruritus, Rheumatoid factor negative, Somnolence More
Per call from pt to triage nurse at office 12/16/24: "Pt states she has been experiencing sympt... Per call from pt to triage nurse at office 12/16/24: "Pt states she has been experiencing symptoms of chronic fatigue: no energy, "can't function and want to sleep all day and night" for approx 3 weeks." Per office visit 12/31/24: The patient reports having an adverse reaction to the pneumococcal vaccine (PCV20) approximately four weeks ago, manifesting as a large, hard, red, itchy lump at the injection site and diffuse, severe joint pain. The reaction persisted for over a month. It was also accompanied by severe fatigue that has persisted, although improved somewhat. More
2820341 16 M MI 01/10/2025 FLU3
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 7KZ9R
LG5578
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
16 year old patient was given PCV20 in place of Meningococcal B by mistake. No adverse symptoms occu... 16 year old patient was given PCV20 in place of Meningococcal B by mistake. No adverse symptoms occurred. More
2820342 4 F KS 01/10/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 5H95B
Product storage error Product storage error
Vaccine deemed non viable due to temperature excursion Vaccine deemed non viable due to temperature excursion
2820343 56 F WI 01/10/2025 COVID19
 MODERNA
 3043333
Expired product administered, No adverse event Expired product administered, No adverse event
Use by date was 12/29/24 and the vaccine was administered on 12/30/24. Patient did not experience an... Use by date was 12/29/24 and the vaccine was administered on 12/30/24. Patient did not experience any unusual side effects from dose. More
2820344 54 F CO 01/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93et2
Oropharyngeal discomfort Oropharyngeal discomfort
pt remained in clinic the first 15 minutes with complications. pt went to car and her throat starte... pt remained in clinic the first 15 minutes with complications. pt went to car and her throat started felling strange. Pt drank some coffee to help with the feeling but the problem progressed. pt returned to clinic to meet with RN who administered vaccine. Rn walked pt straight to ER More
2820345 17 M KS 01/10/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 EN939
Product storage error Product storage error
Vaccine deemed not stable due to temperature excursion Vaccine deemed not stable due to temperature excursion
2820346 M CA 01/10/2025 DTAPIPV
HIBV
PNC20
RV5
 SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 U8009AB
Y005248
HR3650
2051965
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
PT was given a dose of Quadracel for due doses of polio and Hib, this combo vaccine is intended for ... PT was given a dose of Quadracel for due doses of polio and Hib, this combo vaccine is intended for 4-6 year olds More
2820347 54 F MN 01/10/2025 FLU3
PNC20
VARZOS
 SEQIRUS, INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS


Lip swelling, Pain, Urticaria; Lip swelling, Pain, Urticaria; Lip swelling, Pain... Lip swelling, Pain, Urticaria; Lip swelling, Pain, Urticaria; Lip swelling, Pain, Urticaria More
Developed painful full body hives, urticaria, and lip swelling within 48 hours. Developed painful full body hives, urticaria, and lip swelling within 48 hours.
2820348 55 F 01/10/2025 PNC20
PNC20
VARZOS
VARZOS
 PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 LG5577
LG5577
N77J2
N77J2
Chills, Decreased appetite, Diarrhoea, Injection site bruising, Injection site r... Chills, Decreased appetite, Diarrhoea, Injection site bruising, Injection site rash; Migraine, Nausea, Pruritus, Vomiting; Chills, Decreased appetite, Diarrhoea, Injection site bruising, Injection site rash; Migraine, Nausea, Pruritus, Vomiting More
Pt complained of nausea, vomiting, diarrhea, injections site rash and bruise. Migraine, chills, and ... Pt complained of nausea, vomiting, diarrhea, injections site rash and bruise. Migraine, chills, and anorexia for 2 days. She is improving, but she still has itching, a visible bruise at this moment. More
2820349 77 F NY 01/10/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 im7786
u8519ca
Injection site mass; Injection site mass Injection site mass; Injection site mass
pt experienced post vaccination reaction keloid or bump-like at one of the injection sites (received... pt experienced post vaccination reaction keloid or bump-like at one of the injection sites (received both COVID-19 and FLU on the same arm on the same day). plans to follow up with a dermatologist. More
2820350 11 M PA 01/10/2025 COVID19
 PFIZER\BIONTECH
Wrong product administered Wrong product administered
Patient received COVID-19 12y+ vaccine. instead of Meningoccocal ACWY vaccine Patient received COVID-19 12y+ vaccine. instead of Meningoccocal ACWY vaccine
2820351 15 M PA 01/10/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No adverse reactions. Patient received vaccine early (due Dec 2025) No adverse reactions. Patient received vaccine early (due Dec 2025)
2820352 U CA 01/10/2025 VARCEL
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Healthcare worker reported that a 2 year old patient received the second dose of VARIVAX earlier tha... Healthcare worker reported that a 2 year old patient received the second dose of VARIVAX earlier than recommended interval / The patient received first dose of VARIVAX (unknown lot) on 12/19/2023 and second dose on 1/2/2025 (y007637, 4/11/2026); No additional AEs were reported; This spontaneous report has been received from a health care professional, regarding a 2-year-old patient of unspecified gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported. On 19-DEC-2024, the patient was vaccinated with the first does of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as prophylaxis (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported). Then on 02-JAN-2025, earlier than recommended, it received the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection as prophylaxis as well (lot number: Y007637, which was determined to be valid, with an expiration date on 11-APR-2026) (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported). (Inappropriate schedule of product administration). The healthcare worker stated that the patient should have received the second dose between 4 to 6 years of age. No adverse event nor additional information was provided. More
2820353 84 F AL 01/10/2025 PNC15
PNC21
PPV
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


Injection site erythema, Injection site mass; Injection site erythema, Injection... Injection site erythema, Injection site mass; Injection site erythema, Injection site mass; Injection site erythema, Injection site mass More
bump/red mark on her arm from the vaccine/round mark on her arm after her pneumonia vaccine; bump/re... bump/red mark on her arm from the vaccine/round mark on her arm after her pneumonia vaccine; bump/red mark on her arm from the vaccine/round mark on her arm after her pneumonia vaccine; This spontaneous report was received from a consumer via other company concerning to herself a currently 84-year-old female patient. The patient's medical history, historical drugs, known allergies, and further concurrent conditions were not reported. The patient's concurrent conditions included dermatitis atopic. Concomitant medications included estradiol , losartan, apixaban (ELIQUIS), flecainide, clonazepam (KLONOPIN) and trimethoprim. On 16-FEB-2021, the patient was started on therapy with dupilumab 300mg/2mL pre-filled syringe (also reported as solution for injection) 300 mg every other week (QOW), administered subcutaneously for atopic dermatitis-unspecified. On 11-NOV-2024 (reported as a week ago), the patient was vaccinated with the first dose of either pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, or pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection; administered in her arm (unspecified) for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided). On an unknown date in November 2024, the patient experienced a slight reaction to it as she had a bump/red mark on her arm from the vaccine (also reported as round mark on her arm after her pneumonia vaccine) (Vaccination site lump) (Vaccination site erythema). It was not reported if the patient received a corrective treatment for the events, it was also confirmed tat there was no interaction between the suspect vaccines and dupilumab. The therapy with dupilumab was continued. At the time of reporting, the outcome of the events was unknown. The reporter considered the events to be related to either of the suspect vaccines, but to be not related to dupilumab. Lot # is being requested and will be submitted if received. This is one of 2 reports received from the same reporter. ; Sender's Comments: US-009507513-2501USA000847: More
2820354 U LA 01/10/2025 PPV
 MERCK & CO. INC.
Antibody test negative, Extra dose administered Antibody test negative, Extra dose administered
not satisfied with their titer results stating the test is not showing immunity; No additional AE; T... not satisfied with their titer results stating the test is not showing immunity; No additional AE; This spontaneous report was received from a pharmacist referring to an adult patient of unknown gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, at a dose of 0.5 milliliter/series, administered for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). On an unspecified date, the patient was not satisfied with their titer results stating the test did not showed immunity (antibody test negative); therefore, the pharmacist was ordered to re-vaccinate the patient. No additional adverse event was reported. The outcome of the adverse event and the causal relationship between the event and the suspect vaccine was not reported. More
2820355 7 F IN 01/10/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Kinrix given to a 7 year old/ overage; This non-serious case was reported by a nurse and described t... Kinrix given to a 7 year old/ overage; This non-serious case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis. On 05-NOV-2024, the patient received Kinrix. On 05-NOV-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 7 year old/ overage). The outcome of the inappropriate age at vaccine administration 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: 11-DEC-2024 The registered nurse and HCP (health care professional) reported that a subsequent dose of Kinrix given to a 7-year-old patient, which led to an inappropriate age at vaccine administration. The HCP wanted to know if this was a valid dose or if there was anything else they need to do. No other products were received by the patients. More
2820356 M NJ 01/10/2025 HEP
HEP
HEP
HEP
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Acute hepatitis B, Alanine aminotransferase increased, Analgesic drug level, Asp... Acute hepatitis B, Alanine aminotransferase increased, Analgesic drug level, Aspartate aminotransferase increased, Blood HIV RNA increased; Blood albumin normal, Blood alcohol increased, Blood alkaline phosphatase increased, Blood bilirubin normal, Hepatic enzyme increased; Hepatitis A antibody negative, Hepatitis B core antibody positive, Hepatitis B surface antibody negative, Hepatitis B surface antigen positive, Hepatitis C antibody negative; International normalised ratio normal, Liver function test abnormal, Mononucleosis heterophile test negative, Prothrombin time normal, Ultrasound abdomen normal More
The patient still developed an acute HBV infection; This serious case was reported in a literature a... The patient still developed an acute HBV infection; This serious case was reported in a literature article and described the occurrence of acute hepatitis b in a 30-year-old male patient who received Hepatitis B vaccine for prophylaxis. Literature Reference. Co-suspect products included cabotegravir for hiv infection, rilpivirine hydrochloride (Rilpivirine) for hiv infection and cabotegravir, rilpivirine (Cabotegravir + Rilpivirine) suspension for injection for hiv infection. The patient's past medical history included hospitalization, meningitis and condom. Previously administered products included efavirenz/emtricitabine/tenofovir with an associated reaction of no adverse event and bictegravir/emtricitabine/tenofovir alafenamide with an associated reaction of no adverse event. Concurrent medical conditions included hiv infection, acquired immunodeficiency syndrome, sexually transmitted disease (syphilis, chlamydia, and anal herpes papillomavirus), alcohol use, homosexual, cosmetic body piercing, syphilis, chlamydial infection and anorectal human papilloma virus infection. Concomitant products included atorvastatin, fenofibrate, bictegravir, emtricitabine and tenofovir alafenamide. On an unknown date, the patient received Hepatitis B vaccine. In OCT-2023, the patient started cabotegravir (oral) and Rilpivirine (oral). In NOV-2023, the patient started Cabotegravir + Rilpivirine (injection). On an unknown date, an unknown time after receiving Hepatitis B vaccine and an unknown time after starting cabotegravir, Rilpivirine and Cabotegravir + Rilpivirine, the patient experienced acute hepatitis b (Verbatim: The patient still developed an acute HBV infection) (serious criteria hospitalization and GSK medically significant). Cabotegravir was discontinued (Dechallenge was positive). Rilpivirine was discontinued (Dechallenge was positive). Cabotegravir + Rilpivirine was discontinued (Dechallenge was positive). The outcome of the acute hepatitis b was resolving. The reporter considered the acute hepatitis b to be possibly related to Hepatitis B vaccine. The reporter considered the acute hepatitis b to be related to cabotegravir, Rilpivirine and Cabotegravir + Rilpivirine. It was unknown if the reporter considered the acute hepatitis b to be related to cabotegravir + rilpivirine needle device, cabotegravir + rilpivirine syringe device and cabotegravir + rilpivirine vial adaptor device. The company considered the acute hepatitis b to be unrelated to Hepatitis B vaccine, cabotegravir, Rilpivirine, Cabotegravir + Rilpivirine, cabotegravir + rilpivirine needle device, cabotegravir + rilpivirine syringe device and cabotegravir + rilpivirine vial adaptor 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 06-JAN-2025 Author reported a 30-year-old man with a history of HIV who presented due to elevated liver enzymes. The patient has sex with men and was diagnosed with HIV and acquired immunodeficiency syndrome in 2013, when he was hospitalized for meningitis. He was initiated on an efavirenz/emtricitabine/tenofovir combination and took it until 2019. In 2019, the patient was switched to a combination of bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF). The patient is known to have insertive and receptive sex with multiple partners with occasional condom use. He has a history of various sexually transmitted diseases (syphilis, chlamydia, and anal herpes papillomavirus). The patient was transitioned to cabotegravir/rilpivirine (CAB/RPV) on October 2023 from a B/FTC/TAF due to pill fatigue, despite 100 percent adherence. The patient was vaccinated for HBV before switching HIV medications. The patient was referred to the hospital. On presentation, the patient was asymptomatic and denied having fever, chills, scleral icterus, arthralgias, abdominal pain or tenderness, extremity swelling, and shortness of breath. The patient denied known sick contacts, recent travel, history of smoking, intravenous drug use, and sharing needles or razors. He consumed alcohol socially. He acknowledged having continued sexual encounters with multiple male partners and intermittent use of protection. The patient reported a recent piercing from a reputable piercing studio. Reported home medications were atorvastatin 10 mg and fenofibrate 48 mg, both taken daily. The LFTs were subsequently normalized. The patient's partner was scheduled to be screened for HBV. The patient was educated on HBV risks and transmission. Unlike the patient, however, anti-HBs levels were only checked after the patient tested positive for an acute HBV infection after CAB/ RPV initiation. The patient's anti-HBs levels confirmed immunity with a level greater than 10 mIU per mL (14 mIU per mL). Despite this, the patient still developed an acute HBV infection. It is important to note that the patient continued to participate in high-risk behavior after the switch to CAB/RPV. Though routine laboratory results were conducted monthly, HBV tests were not routinely done during follow-ups. This article is not available for regulatory reporting purpose due to copyright restrictions.; Sender's Comments: Acute hepatitis B is an unlisted event which is considered unrelated to GSK vaccine Hepatitis B vaccine and ViiV drug Cabotegravir, RILPIVIRINE HYDROCHLORIDE, Cabotegravir+ Rilpivirine , Cabotegravir + Rilpivirine NEEDLE DEVICE , Cabotegravir + Rilpivirine SYRINGE DEVICE , Cabotegravir + Rilpivirine VIAL ADAPTOR DEVICE. More
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2820357 U CA 01/10/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Diarrhoea, Nausea, Vomiting Diarrhoea, Nausea, Vomiting
Vomiting; Diarrhea; Nausea; This non-serious case was reported by a other health professional via sa... Vomiting; Diarrhea; Nausea; This non-serious case was reported by a other health professional via sales rep and described the occurrence of vomiting in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. In NOV-2024, the patient received Arexvy. In NOV-2024, less than a day after receiving Arexvy, the patient experienced vomiting (Verbatim: Vomiting), diarrhea (Verbatim: Diarrhea) and nausea (Verbatim: Nausea). The outcome of the vomiting, diarrhea and nausea were unknown. The reporter considered the vomiting, diarrhea and nausea to be unrelated to Arexvy. The company considered the vomiting, diarrhea and nausea to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 11-DEC-2024 The HCP (healthcare professional) reported that 20 patients of a nursing home received Arexvy about 2 weeks ago (from the date of reporting). That night, about 8-9 of these patients developed nausea, diarrhea, and vomiting. About 3 days later, other residents of the nursing home developed the same exact symptoms (nausea, diarrhea, and vomiting), but these residents did not receive the vaccine. The reporter believed the nausea, diarrhea, and vomiting experienced by the patients were not the result of the vaccine. More
2820358 67 F OK 01/10/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Incomplete course of vaccination, Therapeutic response unexpected; Incomplete co... Incomplete course of vaccination, Therapeutic response unexpected; Incomplete course of vaccination, Therapeutic response unexpected More
warts had completely disappeared/they were all gone; has been 11 months since her 1st dose, and she ... warts had completely disappeared/they were all gone; has been 11 months since her 1st dose, and she has not received the 2nd dose of Shingrix yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included plantar warts. On an unknown date, the patient received the 2nd dose of Shingrix. On 11-JAN-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: warts had completely disappeared/they were all gone) and incomplete course of vaccination (Verbatim: has been 11 months since her 1st dose, and she has not received the 2nd dose of Shingrix yet). The outcome of the unexpected therapeutic effect and incomplete course of vaccination were unknown. Additional Information: GSK Receipt Date: 11-DEC-2024 Patient reports that she wanted to report that she received an additional benefit that she can only think was related to her Shingrix injection. The patient reports that for 5 years she had been suffering with plantar warts and had multiple clusters of these on both feet. Patient reports that she had about 30 warts on both feet. Patient reports, they were very painful and since March 2024 noticed they were not hurting anymore and had less of them. Patient reports that by 4th July 2024, they had completely disappeared, which led unexpected therapeutic effect. The patient reports they were all gone. Patient also reports that it has been 11 months since her 1st dose, and she has not received the 2nd dose of Shingrix yet, which led incomplete course of vaccination. More
2820359 M WI 01/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received the first dose of Shingrix about 8 months ago; This non-serious case was reported by a cons... received the first dose of Shingrix about 8 months ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix in April 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix about 8 months ago). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 12-DEC-2024 The patient self-reported this case. He stated he received the first dose of Shingrix about 8 months ago in April 2024. He asks if he had to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination More
2820360 25 F VA 01/10/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 YY37B
Inappropriate schedule of product administration Inappropriate schedule of product administration
Second Dose Late/First dose was administered on 24 July 2024 and Second dose was given on 12 Decembe... Second Dose Late/First dose was administered on 24 July 2024 and Second dose was given on 12 December 2024; 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 25-year-old female patient who received HBV (Engerix B) (batch number YY37B, expiry date 24-AUG-2026) for prophylaxis. Previously administered products included Engerix B (First dose received on 24 July 2024). On 12-DEC-2024, the patient received the 2nd dose of Engerix B. On 12-DEC-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Second Dose Late/First dose was administered on 24 July 2024 and Second dose was given on 12 December 2024). 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: 12-DEC-2024 Pharmacist called regarding the hepatitis B vaccine, the vaccine Engerix. The doses schedule was supposed to be 0, 1 and 6 months. The patient got her first dose on 24 July 2024. She had second dose 4 to 5 months later on 12 December 2024 which led to Drug dose administration interval too long. The patient received 2nd dose of Engerix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2820361 10 U NY 01/10/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 GH32J
Expired product administered Expired product administered
Nurse gave an expired dose of Boostrix to a patient; This non-serious case was reported by a physici... Nurse gave an expired dose of Boostrix to a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 10-year-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number GH32J, expiry date 29-NOV-2024) for prophylaxis. On 12-DEC-2024, the patient received Boostrix. On 12-DEC-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Nurse gave an expired dose of Boostrix to a patient). The outcome of the expired vaccine used 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: 12-DEC-2024 Physician stated that her Nurse gave an expired dose of Boostrix to a patient on 12 December 2024 and vaccine expired back on 29 November 2024, which led to expired vaccine used. Doctor only had limited information at the time of reporting and they did not had initials or gender of the patient, but she gave consent to follow up. More
2820362 50 F MA 01/10/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Anxiety, Dehydration, Hypersensitivity, Mobility decreased, Vomiting; Weight dec... Anxiety, Dehydration, Hypersensitivity, Mobility decreased, Vomiting; Weight decreased More
vomited for 15 hours straight about 80 times; almost killed/I almost died/feel myself dying within 2... vomited for 15 hours straight about 80 times; almost killed/I almost died/feel myself dying within 24 hours; could not move; dehydrated; lost 10 lbs in 24 hours; severe allergic reaction; This non-serious case was reported by a consumer via call center representative and described the occurrence of impending doom in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included healthy patient. On 10-DEC-2024, the patient received the 1st dose of Shingrix. On 10-DEC-2024, less than a day after receiving Shingrix, the patient experienced impending doom (Verbatim: almost killed/I almost died/feel myself dying within 24 hours). On 11-DEC-2024, the patient experienced vomiting (Verbatim: vomited for 15 hours straight about 80 times). In DEC-2024, the patient experienced mobility decreased (Verbatim: could not move), dehydration (Verbatim: dehydrated), weight loss (Verbatim: lost 10 lbs in 24 hours) and allergic reaction (Verbatim: severe allergic reaction). The outcome of the impending doom, mobility decreased, weight loss and allergic reaction were unknown and the outcome of the dehydration and vomiting were resolved. It was unknown if the reporter considered the impending doom, mobility decreased, dehydration, vomiting, weight loss and allergic reaction to be related to Shingrix. It was unknown if the company considered the impending doom, mobility decreased, dehydration, vomiting, weight loss and allergic reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 12-DEC-2024 and 13-DEC-2024 The patient self-reported this case. The patient was aggressive and raising her voice and had received 1st dose of Shingrix and on the next day she woke up at 5:30 am in the morning and had uncontrollable vomiting about 80 times for 15 hours straight. The patient lost 10 pounds in one night was so dehydrated the doctor said she would had been dead in another hour, because she guessed she had a really severe allergic reaction and said your shot almost killed her in 24 hours (within a day). She was pissed beyond belief and asked what was her life worth to you and said apparently nothing since you knowingly sell these shots that can kill a person in a day. She got no information from her doctor about anything to expect. She reported it to healthcare professional and stated HCP office was rude and did not care and she would not be seeing HCP, so no HCP consent. She was posting on social media how Shingrix could kill people and that GSK did not care. She also stated she was getting a lawyer. The case US2024157516 was identified as follow-up of case US2024157513. The case US2024157516 was deleted due to being created in error and all future correspondence would be added in the present case US2024157513 which stands as case of record. More
2820363 F CA 01/10/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
suspected vaccination failure; they got an episode of shingles; This serious case was reported by a ... suspected vaccination failure; they got an episode of shingles; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: they got an episode of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 03-JAN-2025. The reporter had a patient that received 2 doses of the Shingrix vaccine in year 2019. In 2023, patient had an episode of shingles. The reported asked the patient to repeat the series of Shingrix vaccine. Reporter tried to check CDC and this website but was not able to find answer. The reporter asked information regarding this. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose) More
2820364 M 01/10/2025 COVID19
 MODERNA
 UNKNOWN
Biopsy, Therapeutic response unexpected Biopsy, Therapeutic response unexpected
I jokingly believe that your COVID vaccine cures cancer; This spontaneous case was reported by a pat... I jokingly believe that your COVID vaccine cures cancer; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I jokingly believe that your COVID vaccine cures cancer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination. The patient's past medical history included Colon cancer stage IV (I had surgery to remove about 2 feet of my colon and underwent 12 rounds of chemo therapy) in 2016, Metastases to liver, Metastasis in lung, Colectomy, Liver resection and Lung wedge resection. Previously administered products included for Product used for unknown indication: IRINOTECAN and Oxaliplatin. Past adverse reactions to the above products included No adverse effect with IRINOTECAN; and Peripheral neuropathy with Oxaliplatin. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I jokingly believe that your COVID vaccine cures cancer). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I jokingly believe that your COVID vaccine cures cancer) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: confirmed that the cancer had metastasized to my lungs. No concomitant medications were reported. The patient developed severe neuropathy in his hands and feet, also had a relapse in 2018, a few spots on his liver, one-third of his liver was removed, and underwent additional rounds of chemo (irinotecan). The patient had a difficult time with the second chemo and had to stop after 6 rounds rather than completing the 8 rounds that were scheduled. In late 2020, there were three nodules spotted on my lungs - 2 on the right lobe, 1 on the left lobe. The nodules were too small to test via biopsy, so instead, they did a wedge removal surgery for the nodules and then biopsied them after the surgery (right lung was done in Dec-2020 and the left in Mar-2021). The patient had no additional chemo or immunotherapy treatments after this surgery. However, four days after the surgery in March, the patient received the first COVID-19 shot and had been religious about getting the next dose whenever it was recommended through the medical system. The patient received 12 doses of the vaccine, and the chart was showing that he would schedule another dose in early February. Immediately after the surgery, the patient had follow-up CT scans every three months and then was on a 6-month schedule. He was headed into my 9th year since having been diagnosed with Stage IV colon cancer and had been completely cancer-free since 2021 (almost 4 years) after the last surgery. The only medical treatment that he had not related to the cancer was the COVID-19 vaccines. The patient had no idea if your vaccine was contributing to the non-recurrence of his colon cancer but couldn't help but think that there was some positive benefit. No treatment medications were reported. More
2820365 71 F NM 01/10/2025 COVID19
COVID19
 MODERNA
MODERNA

Decreased appetite, Fatigue, Feeling hot, Headache, Insomnia; Malaise, Oropharyn... Decreased appetite, Fatigue, Feeling hot, Headache, Insomnia; Malaise, Oropharyngeal pain, Pain, Rhinorrhoea, Sneezing More
By 11pm, she was starting to fill up with lots of mucus, which was frightening to her/extreme amount... By 11pm, she was starting to fill up with lots of mucus, which was frightening to her/extreme amounts of mucus building in her throat, chest, and nose for the next 10 days.; Sore throat; She could not stop squeezing/sneezing from all the mucus in her lungs; Body ache; The mucus turned into a headache; Fatigue is unbearable; She was so sick she could not go anywhere; She has no appetite; Insomnia; Get extremely hot and then it'll go away; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (By 11pm, she was starting to fill up with lots of mucus, which was frightening to her/extreme amounts of mucus building in her throat, chest, and nose for the next 10 days.), DECREASED APPETITE (She has no appetite), INSOMNIA (Insomnia) and FEELING HOT (Get extremely hot and then it'll go away) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Nov-2024 at 11:00 AM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In 2024, the patient experienced DECREASED APPETITE (She has no appetite), INSOMNIA (Insomnia), FEELING HOT (Get extremely hot and then it'll go away), MALAISE (She was so sick she could not go anywhere) and FATIGUE (Fatigue is unbearable). In November 2024, the patient experienced SNEEZING (She could not stop squeezing/sneezing from all the mucus in her lungs), PAIN (Body ache) and HEADACHE (The mucus turned into a headache). On 15-Nov-2024 at 9:00 PM, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 15-Nov-2024 at 11:00 PM, the patient experienced RHINORRHOEA (By 11pm, she was starting to fill up with lots of mucus, which was frightening to her/extreme amounts of mucus building in her throat, chest, and nose for the next 10 days.). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (By 11pm, she was starting to fill up with lots of mucus, which was frightening to her/extreme amounts of mucus building in her throat, chest, and nose for the next 10 days.), DECREASED APPETITE (She has no appetite), INSOMNIA (Insomnia), SNEEZING (She could not stop squeezing/sneezing from all the mucus in her lungs), PAIN (Body ache), MALAISE (She was so sick she could not go anywhere), HEADACHE (The mucus turned into a headache) and FATIGUE (Fatigue is unbearable) had not resolved and FEELING HOT (Get extremely hot and then it'll go away) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not provided. Patient stated that by 9pm she started having a sore throat (she had not had one since she was 6 years old) and by 11pm, she was starting to fill up with lots of mucus, which had frightened her. The mucus turned into a headache, a body ache, and there were extreme amounts of mucus building in her throat, chest, and nose for the next 10 days. She stated she woke her husband up because she could not stop squeezing/sneezing from all the mucus in her lungs. At the end of those 10 days, she spoke to a physician online who just told her it should wear off, but it did not. Two weeks later, she went to see another doctor because she was so sick and could not go anywhere. She stated that if she did not know how to do the Neti, she would have been in the hospital. She did the Neti 3 times a day to get the stuff out of her body. She then said things had decreased as far as mucus and stuff, but the fatigue was unbearable. She also said that out of nowhere she would get extremely hot and then it would go away. She had no appetite and the most incredible case of insomnia. She had never had it before, and it was terrible. She said nothing had been the same since then. She was very healthy, works out 3 times a week, she has a bow flex, an elliptical and did yoga and it all had been circumvented by the vaccine. Treatment information was not reported. More
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