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
2851230 71 F CT 07/25/2025 VARZOS
VARZOS
VARZOS
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
99d52
99d52


Injection site erythema, Injection site pain, Injection site swelling; Asthenia,... Injection site erythema, Injection site pain, Injection site swelling; Asthenia, Incorrect route of product administration, Injection site erythema; Injection site erythema, Injection site pain, Injection site swelling; Asthenia, Incorrect route of product administration, Injection site erythema More
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection... Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild More
2851231 61 M ND 07/25/2025 COVID19-2
PFIZER\BIONTECH
L2210
Cerebrovascular accident Cerebrovascular accident
Systemic: Stroke-Severe Systemic: Stroke-Severe
โœ“
2851232 57 F NY 07/25/2025 VARZOS
VARZOS
VARZOS
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
99D52
99D52
99D52
99D52
Injection site erythema, Injection site pain, Injection site swelling; Inflammat... Injection site erythema, Injection site pain, Injection site swelling; Inflammation, Injection site swelling, Peripheral swelling, Pruritus; Injection site erythema, Injection site pain, Injection site swelling; Inflammation, Injection site swelling, Peripheral swelling, Pruritus More
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec... Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe More
2851233 55 F FL 07/25/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
23AH3
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium More
2851234 62 F SC 07/25/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
ft95n
Arthralgia, Chest pain, Injection site pain, Pain Arthralgia, Chest pain, Injection site pain, Pain
Site: Pain at Injection Site-Severe, Systemic: Pain radiation down shoulder into chest.-Severe, Syst... Site: Pain at Injection Site-Severe, Systemic: Pain radiation down shoulder into chest.-Severe, Systemic: Joint Pain-Severe, Additional Details: Event started two days after vaccine and has continued. Patient has seen doctor and was told to report. Doctor considering MRI. More
2851235 26 F OH 07/25/2025 MENB
NOVARTIS VACCINES AND DIAGNOSTICS
B4J4B
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection... Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild More
2851236 62 M MD 07/25/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
55th4
Injection site bruising, Injection site erythema, Injection site pain Injection site bruising, Injection site erythema, Injection site pain
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec... Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: Prevnar 20; Manufacturer: pfizer; LotNumber: lx4482; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 07/11/2025 More
2851237 53 F CA 07/25/2025 PNC20
PNC20
PFIZER\WYETH
PFIZER\WYETH
lp4947
lp4947
Chills, Injection site bruising, Injection site pain, Injection site reaction, I... Chills, Injection site bruising, Injection site pain, Injection site reaction, Injection site swelling; Pyrexia, Rash More
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injec... Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe More
2851238 27 M NV 07/25/2025 HEP
DYNAVAX TECHNOLOGIES CORPORATION
946063
Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Other Vaccines: Vacc... Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Other Vaccines: VaccineTypeBrand: GARDASIL 9 (HPV); Manufacturer: MERCK; LotNumber: 1965035; Route: IM; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Tdap (BOOSTRIX); Manufacturer: GSK; LotNumber: PD324; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN More
2851240 79 F MA 07/25/2025 PNC21
MERCK & CO. INC.
y013009
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at In... Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt came in to report a decent size rash has appeared on her arm about a week after her pneumonia shot, very red itchy some swelling too More
2851241 20 F CA 07/25/2025 MENB
PFIZER\WYETH
hp9987
Anxiety, Flushing, Hyperhidrosis, Vomiting Anxiety, Flushing, Hyperhidrosis, Vomiting
Systemic: vomiting-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild, Additional Deta... Systemic: vomiting-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild, Additional Details: Pt was anxious before the shot. vomited within minutes after the shot. felt better after vomited. He said it was due to his anxiety. gave him water to sip on and had him sit to make sure ok. Mom was with him. He left with Mom about 1/2 hour after vaccine. Mom did not know MD's name and phone number so she will email MD once gets home More
2851242 65 F AL 07/25/2025 VARZOS
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
3x97j
3x97j
Anaphylactic reaction, Injection site bruising, Injection site erythema, Injecti... Anaphylactic reaction, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling, Pruritus More
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec... Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Itch Generalized-Medium, Additional Details: n/a More
2851243 54 F IL 07/25/2025 PNC20
PNC20
PFIZER\WYETH
PFIZER\WYETH
ln4927
ln4927
Injection site bruising, Injection site erythema, Injection site pain, Injection... Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash; Injection site swelling, Injection site warmth More
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec... Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt started developing rash after 4 days of vaccination at injection site. it was red and hot to touch. it was itchy. at the doctor's appoinment pt was given antibiotic and anti histamine. pt is doing better know. pain still exsist but redness swelling is gone More
2851244 76 F NC 07/25/2025 COVID19
PFIZER\BIONTECH
MD3414
Injection site erythema, Injection site pain, Injection site pruritus, Injection... Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling More
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject... Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium More
2851246 58 M FL 07/25/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
9R397
Bell's palsy Bell's palsy
Systemic: Bell's Palsy-Medium Systemic: Bell's Palsy-Medium
โœ“
2851247 36 M MA 07/25/2025 VARCEL
MERCK & CO. INC.
Y019318
Rash Rash
Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient received vaccine on 06/30/2... Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient received vaccine on 06/30/2025, came in 07/19/2025 to report developed rash 2 weeks post vaccination. Resolved after 3-4 days. More
2851248 46 F FL 07/25/2025 MNQ
MNQ
MNQ
MNQ
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
z925l4
z925l4
z925l4
z925l4
Asthenia, Chills, Dizziness, Fatigue, Flushing; Headache, Hyperhidrosis, Injecti... Asthenia, Chills, Dizziness, Fatigue, Flushing; Headache, Hyperhidrosis, Injection site bruising, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Lethargy, Nausea, Pruritus; Pyrexia, Somnolence, Syncope, Tremor, Unresponsive to stimuli More
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec... Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: upon receipt of vaccinations patient experienced extreme fatigue, unable to wake up next day, sweating shaking, for the full day, heavy headache. day 2, patient noticed 3 bruised tender to touch, red swelling on the left bicep. day 5, swelling and redness still visible and still tender, Other Vaccines: VaccineTypeBrand: boostrix; Manufacturer: glaxosmithkline; LotNumber: 9jt4s; Route: intramuscular; BodySite: left deltoid; Dose: 1; VaxDate: 07/14/2025 More
2851250 60 M TX 07/25/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
9sb34
Injection site erythema Injection site erythema
Site: Redness at Injection Site-Mild, Systemic: Wife reported DVT-Severe, Other Vaccines: VaccineT... Site: Redness at Injection Site-Mild, Systemic: Wife reported DVT-Severe, Other Vaccines: VaccineTypeBrand: Capvaxive; Manufacturer: ; LotNumber: y019158; Route: IM; BodySite: LD; Dose: 1; VaxDate: 07/12/2025 More
2851251 63 F FL 07/25/2025 PNC20
PFIZER\WYETH
LN4928
Joint injury Joint injury
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)- Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
2851252 21 F OK 07/25/2025 VARCEL
VARCEL
MERCK & CO. INC.
MERCK & CO. INC.
2004455
2004455
Dizziness, Nausea, Seizure, Syncope, Tremor; Unresponsive to stimuli Dizziness, Nausea, Seizure, Syncope, Tremor; Unresponsive to stimuli
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Naus... Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild More
2851253 64 F FL 07/25/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
L7Y3G
Injection site erythema, Injection site pruritus, Pruritus, Pyrexia Injection site erythema, Injection site pruritus, Pruritus, Pyrexia
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch... Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Fever-Mild, Other Vaccines: VaccineTypeBrand: Boostrix TDAP; Manufacturer: ; LotNumber: 7936PT; Route: Left; BodySite: ; Dose: ; VaxDate: 07/15/2025, VaccineTypeBrand: Capvaxive; Manufacturer: ; LotNumber: Z006076; Route: Left; BodySite: ; Dose: ; VaxDate: 07/15/2025 More
2851254 68 M FL 07/25/2025 COVID19
PFIZER\BIONTECH
me6072
Injection site pain Injection site pain
Site: Pain at Injection Site-Severe, Systemic: Muscle Weakness of left arm-Severe, Systemic: Weaknes... Site: Pain at Injection Site-Severe, Systemic: Muscle Weakness of left arm-Severe, Systemic: Weakness-Severe, Additional Details: Patient states they have not been able to lift or use arm normally since vaccine, patient states arm is very painful, states they are having extreme muscle pain in arm. More
2851255 80 M VA 07/25/2025 RSV
GLAXOSMITHKLINE BIOLOGICALS
7RZ45
Cough, Dyspnoea Cough, Dyspnoea
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: cough-Mild, Additional Details: Patient cam... Systemic: Allergic: Difficulty Breathing-Mild, Systemic: cough-Mild, Additional Details: Patient came to pharmacy to inquire that he had rsv shot 4 days ago and for last couple days developed difficulty breathing and cough. Advised him to go to ER if problematic breathing and also contact his doctor to inform them. More
2851256 66 F PA 07/25/2025 VARZOS
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
55th4
55th4
Asthenia, Confusional state, Fall, Fatigue, Injection site pain; Lethargy, Skin ... Asthenia, Confusional state, Fall, Fatigue, Injection site pain; Lethargy, Skin discolouration, Syncope, Unresponsive to stimuli More
Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Sever... Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: woke up on the floor, unconsciously fell out of bed-Severe, Systemic: Weakness-Severe, Additional Details: patient reported a sore arm the night of immunization delivery and took a few ibuprofen. woke up on the floor after going to bed, unaware of falling out of bed, black and blue mark on inner arm. felt extraordinarly fatigued (could not get the strength to get up for 2 hours) next day started to improve and is feeling back to normal as of report date 5 days later. More
2851257 23 M CA 07/25/2025 HEP
DYNAVAX TECHNOLOGIES CORPORATION
946904
Dizziness, Injection site pain, Syncope, Unresponsive to stimuli Dizziness, Injection site pain, Syncope, Unresponsive to stimuli
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting ... Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe More
2851258 74 F MA 07/25/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
9n2r2
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient states arm was red, hot, and swollen for 2 weeks around the injection site. The area is slowly improving. More
2851259 0.5 M NC 07/25/2025 DTPPVHBHPB
DTPPVHBHPB
PNC20
PNC20
RV5
RV5
MSP VACCINE COMPANY
MSP VACCINE COMPANY
PFIZER\WYETH
PFIZER\WYETH
MERCK & CO. INC.
MERCK & CO. INC.
U8265AA
U8265AA
LK6653
LK6653
2096661
2096661
Full blood count normal, Influenza A virus test negative, Influenza B virus test... Full blood count normal, Influenza A virus test negative, Influenza B virus test negative, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Urticaria; Full blood count normal, Influenza A virus test negative, Influenza B virus test negative, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Urticaria; Full blood count normal, Influenza A virus test negative, Influenza B virus test negative, Pyrexia, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Urticaria More
Pt woke up the morning after vaccines with Urticaria to upper and lower extremities and trunk with T... Pt woke up the morning after vaccines with Urticaria to upper and lower extremities and trunk with TMax fever of 100.5. Provider started Cetirizine with a follow up in 2 days. On 2 day follow up Urticaria and fever are resolved with instructions to continue Cetirizine. More
2851260 1.5 M TX 07/25/2025 PNC20
PNC20
PFIZER\WYETH
PFIZER\WYETH
LP4947
LP4947
Blood test, Dehydration, Irritability, Lethargy, Lumbar puncture; Urine analysis Blood test, Dehydration, Irritability, Lethargy, Lumbar puncture; Urine analysis
Mom thinks fussiness and lethargy was due to the vaccine. Pt was also found to be dehydrated at the ... Mom thinks fussiness and lethargy was due to the vaccine. Pt was also found to be dehydrated at the ER, so likely that is the cause, however mom wanted this incident reported. More
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2851261 4 FL 07/25/2025 DTAPIPV
GLAXOSMITHKLINE BIOLOGICALS
SKB Y49BZ
Chills, Pyrexia, Vomiting Chills, Pyrexia, Vomiting
7-18-2025 Phone message from Father stating son having fever, chills and vomiting today after receiv... 7-18-2025 Phone message from Father stating son having fever, chills and vomiting today after receiving vaccines yesterday. Call to father and informed him I was return his call - he asked if this was regarding the vaccines and when I replied "yes". The phone was then abruptly disconnected from the other side. Return call x2 attempted and call went to voice mail. No other information was available. More
2851262 14 F AZ 07/25/2025 HPV9
HPV9
MERCK & CO. INC.
MERCK & CO. INC.
Z007847
Z007847
Dizziness, Fatigue, Feeling cold, Heart rate decreased, Hypotension; Laboratory ... Dizziness, Fatigue, Feeling cold, Heart rate decreased, Hypotension; Laboratory test, Loss of consciousness, Loss of personal independence in daily activities, Pallor More
My daughter passed out five minutes after the injection, she has since been pale, low blood pressure... My daughter passed out five minutes after the injection, she has since been pale, low blood pressure, low heart rate, fatigued, tired, cold, and dizzy. She couldn?t attend school after the dizziness overwhelmed her. She has since been back to the doctor and the doctor ordered lab work done. More
2851263 1 M ID 07/25/2025 HIBV
MERCK & CO. INC.
X020943
Injection site mass Injection site mass
Patient has lump on the left thigh where HIB vaccine was given on 6/26/25. Mother reported this toda... Patient has lump on the left thigh where HIB vaccine was given on 6/26/25. Mother reported this today. There is no redness at the injection site. Patient does not complain of pain. Mother denies fevers. Patient will be evaluated by Primary care provider. More
2851264 11 M NC 07/25/2025 HEPA
HPV9
MNQ
TDAP
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
L4EA4
Y014510
DL4YY
793PT
Vaccination site erythema, Vaccination site reaction; Vaccination site erythema,... Vaccination site erythema, Vaccination site reaction; Vaccination site erythema, Vaccination site reaction; Vaccination site erythema, Vaccination site reaction; Vaccination site erythema, Vaccination site reaction More
LOCALIZED ALLERGIC REACTION. RIGHT UPPER ARM RECIEVED HEP A AND MENINGO VACCINES. ERYTHEMATOUS INDU... LOCALIZED ALLERGIC REACTION. RIGHT UPPER ARM RECIEVED HEP A AND MENINGO VACCINES. ERYTHEMATOUS INDURATED PATCH ON RIGHT UPPER EXTREMITY SURROUNDING THE VACCINE SITES 16CM X 16CM. SIMILAR PATCH ON LEFT UPPER EXTREMITY WHERE HPV AND TDAP WERE ADMINISTERED 9CM X 5CM. More
2851265 63 F SC 07/25/2025 COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH
FJ6369
FJ6369
Arthralgia, COVID-19, Diarrhoea, Expired product administered, Joint swelling; S... Arthralgia, COVID-19, Diarrhoea, Expired product administered, Joint swelling; Skin odour abnormal, Vomiting More
Course of events as follows: 2nd Dose:2-25-25 1. A middle aged female Pharmacist with white hair pic... Course of events as follows: 2nd Dose:2-25-25 1. A middle aged female Pharmacist with white hair picked up a vial with a small amount of fluid left in it from the counter. It had been sitting on the counter prior to my arrival. *I questioned her as to why it was on the counter instead of in the refrigerator and she advised it was fine and had another dose left in it. She drew the dose into the needle advised her shift was ending soon and handed it to a tech in ^trainng" to administer into my arm. 2. Mind you it was 4:30PM in the afernoon and left out on the counter for God only knows how long! 3. I asked her if I should anticipate any side effects from the Vax and she said," No that it was highly unlikely." More
2851266 74 M AL 07/25/2025 COVID19
COVID19
PFIZER\BIONTECH
PFIZER\BIONTECH
EN 6205
EN 6205
Brain fog, COVID-19, Chronic sinusitis, Paranasal sinus discomfort, SARS-CoV-2 t... Brain fog, COVID-19, Chronic sinusitis, Paranasal sinus discomfort, SARS-CoV-2 test positive; Tinnitus More
Chronic sinusitus, chronic sinus pressure, Tinnius, slight brain fog Chronic sinusitus, chronic sinus pressure, Tinnius, slight brain fog
2851267 16 M TX 07/25/2025 MENB
MNQ
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
7mn4c
d2343
Loss of consciousness; Loss of consciousness Loss of consciousness; Loss of consciousness
passed out about 5 min after vaccine passed out about 5 min after vaccine
2851271 MO 07/25/2025 MMRV
MMRV
MERCK & CO. INC.
MERCK & CO. INC.
Y019171

No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No symptoms reported; patient who received improperly stored PROQUAD on 06/13/2025.; This spontaneou... No symptoms reported; patient who received improperly stored PROQUAD on 06/13/2025.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-JUN-2025, the patient was vaccinated with improperly stored (6.3 F for 16 minutes) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection at a dose of 0.5 mL, lot #Y019171, expiration date: 18-MAY-2026 (route of administration and anatomical location were not reported) for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiry date were not reported). No symptoms reported. This is one of several reports received from the same reporter. More
2851272 FL 07/25/2025 VARCEL
VARCEL
MERCK & CO. INC.
MERCK & CO. INC.
Z004454

No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AE; VARIVAX involved in temperature excursion has been administered; This spontaneous ... No additional AE; VARIVAX involved in temperature excursion has been administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-Jul-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), solution for injection (lot #Z004454, expiration date: 13-Feb-2027), 1 dosage form (1 dose) (route of administration, anatomical site and dose number in series were not reported), which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided), administered as prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36.5 Fahrenheit for 2 hours, 21 minutes and 0 seconds (Product storage error). No previous excursion was not reported. No adverse event. This is one of several reports from the same source. More
2851273 58 F 07/25/2025 PNC21
MERCK & CO. INC.

Erythema, Injection site discomfort, Rash Erythema, Injection site discomfort, Rash
she also noticed redness and a rash; she also noticed redness and a rash; felt "some injection ... she also noticed redness and a rash; she also noticed redness and a rash; felt "some injection site discomfort" shortly after administration which "seemed typical"; This spontaneous report was received from a consumer and refers to herself, a 58-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included estrogens conjugated (PREMARIN), progesterone), pregabalin (LYRICA), rosuvastatin . On 08-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection 0.5 mL administered by unknown route (vaccination site, lot # and expiration date were not reported) for pneumococcal conjugate vaccine. On 08-Jul-2025, the patient felt some injection site discomfort shortly after administration which seemed typical. On 15-jul-2025 (today), she also noticed redness and a rash. The patient reported to a health care professional (HCP) who recommended she took a picture, apply ice, and topical diphenhydramine (BENADRYL). HCP treating the adverse event (AE) provided permission to contact. The patient did have name of administering HCP at the time of the call. No additional AE and no product quality complaint (PQC) was noted. At the reporting time, the patient had not recovered from the reported adverse events. The causal relationship between the adverse events and the suspect vaccine was not reported. Lot # is being requested and will be submitted if received. More
2851274 VA 07/25/2025 VARCEL
MERCK & CO. INC.
Y019318
No adverse event, Product storage error No adverse event, Product storage error
No symptoms or side effects were reported by HCP; HCP reporting that a patient received a dose of im... No symptoms or side effects were reported by HCP; HCP reporting that a patient received a dose of improperly stored VARIVAX. Reference TE case #02843001. HCP reported that she did not know the date the excursion occurred, but knows the VARIVAX was administered following the excursion. HCP reported; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On 16-JUN-2025, the patient received a dose of improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot # Y019318, has been verified to be valid, expiration 21-NOV-2026) 0.5 mL (route, anatomical location were not reported) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not reported). The health care professional (HCP) reported that she did not know the date the excursion occurred, but knew the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was administered following the excursion. No symptoms or side effects were reported. The operator of device was HCP. It was reported that the temperature was 52.2 farenheit (F), it was unknown time frame. More
2851275 VA 07/25/2025 MMRV
MERCK & CO. INC.
Z003309
No adverse event, Product storage error No adverse event, Product storage error
No symptoms or side effects were reported by HCP. No additional AE; HCP reporting that a patient rec... No symptoms or side effects were reported by HCP. No additional AE; HCP reporting that a patient received a dose of improperly stored PROQUAD. HCP reported that she did not know the date the excursion occurred, but knows the PROQUAD was administered following the excursion.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 14-JUL-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 mL, administered for prophylaxis (lot number Z003309 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date not provided but upon internal validation established as 21-JUL-2026; formulation, route of administration, vaccination scheme frequency and anatomical site of injection were not reported), which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot number were not reported). The vaccine was administered following a temperature excursion (TE) that occurred at 52.2 degree Fahrenheit (F) (Product storage error). The time frame of the TE was unknown by the reporter. No symptoms, side effects or additional adverse events were reported for the patient. No additional information was provided. This is one of several reports from the same reporter. More
2851277 NV 07/25/2025 PNC21
MERCK & CO. INC.
Z003579
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
a 2 month old was administered CAPVAXIVE; no adverse event; This spontaneous report was received fro... a 2 month old was administered CAPVAXIVE; no adverse event; This spontaneous report was received from a medical assistant referring to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Injection (lot #Z003579, expiration date: 07-Sep-2026) (168 mcg/ml) administered as prophylaxis (dose, and route of administration were not reported) (Product administered to patient of inappropriate age). No adverse effects were reported (no adverse event). More
2851278 12 M MS 07/25/2025 HPV4
HPV4
HPV4
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Alopecia, Alopecia areata, Alopecia totalis; Alopecia, Alopecia areata, Alopecia... Alopecia, Alopecia areata, Alopecia totalis; Alopecia, Alopecia areata, Alopecia totalis; Alopecia, Alopecia areata, Alopecia totalis More
neurological injuries; autonomic injuries; extreme pain; Alopecia totalis/alopecia areata/hair loss/... neurological injuries; autonomic injuries; extreme pain; Alopecia totalis/alopecia areata/hair loss/autoimmune injuries,autoimmunne disorder; Information has been received from a lawyer regarding a case in litigation and refers to an adolescent (exact age was not provided) male patient (pt). The pt's concurrent conditions, medical history and concomitant therapies were not provided. Prior to receiving his human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections, the pt had no autoimmune, autonomic, or neurological issues. He was a healthy young man, who played baseball daily and was not being followed for any serious medical conditions. On 28-AUG-2014, at the age of 12 years old, the pt was vaccinated with the first dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact doses, routes of administration, anatomical locations, lot numbers and expiration date were not reported). On 03-NOV-2014, he received the second dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact dose, route of administration, anatomical location, lot number and expiration date were not reported) and on 30-MAR-2015 (at the age of 14 years old, conflicting information), the pt was vaccinated with the third dose of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) suspension for injection (exact dose, route of administration, anatomical location, lot number and expiration date were not reported). All doses were administered for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), with the pt's mother consent and the pt's physician (referred to as a doctor) recommendation. On 12-JUN-2015, the pt was seen at acupuncture clinic for hair loss that started approximately two weeks earlier. The pt's mother reported that she first noticed the hair loss after a recent haircut. In June 2015, the pt's parents took him to the university for an evaluation of his hair loss and he was treated with a triamcinolone (KENALOG) injection. The pt's hair loss persisted and his parents brought him back to acupuncture clinic on 29-JUN-2015, 03-JUL-2015, and 14-JUL-2015. As the hair loss persisted, on 15-JUL-2015 (also reported as 15-JUL-2025, conflicting information), the pt was seen by dermatologist for alopecia areata on the scalp and was administered a second round of steroid injections. A third round of injections was performed on 12-AUG-2015. Ultimately, the pt was diagnosed with alopecia totalis on 10-SEP-2015. As a result of his post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in normal activities that a normal young person would enjoy. He faced significant stigmatization due to his hair which has drastically affected his social life. He has also undergone numerous treatments to try and reverse the damage which have caused him extreme pain. Based upon his chronic and severe post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to alopecia totalis. The pt contended that his human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused him to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to alopecia totalis, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to his human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. The outcome of all events was considered to be not recovered. The reporter considered all events to be related to human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered all events to be disabling. More
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2851279 F TX 07/25/2025 HPV9
MERCK & CO. INC.

Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
No additional AE; Consumer reports she received her first dose of GARDASIL 9 in February of this yea... No additional AE; Consumer reports she received her first dose of GARDASIL 9 in February of this year and has not had her second dose yet. No adverse effects reported. No other information provided. No additional AE. No PQC.; This spontaneous report was received from a patient and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown day in February 2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (lot # and expiration date were not reported) as prophylaxis. At the time of the report, she had not received her second dose yet (inappropriate schedule of product administration). No adverse effects were reported. No other information was provided. No additional adverse event was reported. More
2851280 07/25/2025 TDAP
UNKNOWN MANUFACTURER
UNK
Incorrect route of product administration Incorrect route of product administration
incorrect route of vaccine administration; This non-serious case was reported by a physician via cal... incorrect route of vaccine administration; This non-serious case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a adolescent patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine (subcutaneous). On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced intramuscular formulation administered by other route (Verbatim: incorrect route of vaccine administration). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK Receipt Date:11-JUL-2025 The reporter called to report a possible incorrect route of vaccine administration. The reporter stated that Boostrix was possibly administered sub-q, which led to intramuscular formulation administered by other route. The reporter also stated that what if needle was only inserted halfway for an adolescent, what if needle hit the bone. The reporter stated vaccine administered was Tdap but was unable to verify if the medication administered was Boostrix. The reporter declined to provide any information. More
2851281 F NY 07/25/2025 VARZOS
VARZOS
VARZOS
VARZOS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
UNK
UNK
UNK
Computerised tomogram abdomen normal, Flank pain, Mononucleosis heterophile test... Computerised tomogram abdomen normal, Flank pain, Mononucleosis heterophile test positive, Ultrasound abdomen normal, Vaccination failure; Zoster sine herpete; Computerised tomogram abdomen normal, Flank pain, Mononucleosis heterophile test positive, Ultrasound abdomen normal, Vaccination failure; Zoster sine herpete More
Suspected vaccination failure/ lack of drug effect; internal shingles; currently experiencing flank ... Suspected vaccination failure/ lack of drug effect; internal shingles; currently experiencing flank pain/ intense pain/ it's been over 2 weeks of stabbing pain without a rash; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included mononucleosis (tested positive for mononucleosis). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JUN-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ lack of drug effect) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: internal shingles) and flank pain (Verbatim: currently experiencing flank pain/ intense pain/ it's been over 2 weeks of stabbing pain without a rash). The outcome of the vaccination failure and zoster sine herpete were unknown and the outcome of the flank pain was not resolved. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and flank pain 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 zoster sine herpete and flank pain to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 11-JUL-2025 The patient self-reported this case for herself. The consumer (patient) had received the complete series of Shingrix vaccine few years ago but was unsure of the dates and did not have the lot numbers of the medication. The patient stated prior to receiving Shingrix complete vaccine series she was diagnosed with a case of shingles on her spine (date not disclosed). The patient stated she presented to her local emergency department for flank pain and the pain was located on the front and back of her waist. She did not have a rash only intense pain. It had been over 2 weeks of stabbing pain without a rash. The patient stated the emergency department ruled out an issue with her spleen or her pancreas. Patient stated blood work was done, and she was tested positive for mononucleosis. However, the consumer stated she was told by the emergency department physician the flank pain she was experiencing might be an internal case of shingles. The consumer stated she was now in her 3rd week experiencing this flank pain that could not be explained after an ultrasound or a CT of the abdomen. The only explanation was shingles pain without the rash. The consumer stated the emergency room physician did not prescribe an antiviral medication. The consumer stated GlaxoSmithKline could contact the pharmacy that administered the vaccine to obtain that information. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding zoster sine herpete were unknown at the time of reporting. No further information was provided or obtained.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule and regarding laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2851282 F 07/25/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Erythema, Swelling Erythema, Swelling
Redness; Swelling; This non-serious case was reported by a physician via sales rep and described the... Redness; Swelling; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 01-MAY-2025, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Redness) and swelling (Verbatim: Swelling). On 16-JUL-2025, the outcome of the erythema and swelling were resolved. The reporter considered the erythema and swelling to be related to Shingrix. The company considered the erythema and swelling to be related to Shingrix. Additional Information: GSK receipt date: 16-JUL-2025 The patient experienced redness and swelling. More
2851283 9 M IA 07/25/2025 MNQ
NOVARTIS VACCINES AND DIAGNOSTICS
AMVB064A
Product preparation issue Product preparation issue
patient received the liquid conjugate component only for Menveo; patient received the liquid conjuga... patient received the liquid conjugate component only for Menveo; patient received the liquid conjugate component only for Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 9-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (BOOSTRIX) and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9). On 15-JUL-2025, the patient received the 1st dose of Menveo (intramuscular). On 15-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received the liquid conjugate component only for Menveo) and inappropriate dose of vaccine administered (Verbatim: patient received the liquid conjugate component only for Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 17-JUL-2025 and 17-JUL-2025 The reporter was a nurse who called to report that a male patient had received only the liquid conjugate component of Menveo in his left leg on 15th July 2025, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The patient had also received Boostrix and Gardasil 9 at the same visit on 15th July 2025. All the information that was provided about this adverse event was reported.; Sender's Comments: US-GSK-US2025091789:same reporter, Different patient More
2851284 M FL 07/25/2025 VARZOS
GLAXOSMITHKLINE BIOLOGICALS

Inappropriate schedule of product administration Inappropriate schedule of product administration
received his first dose in February of 2020 and his 2nd in May of 2025; This non-serious case was re... received his first dose in February of 2020 and his 2nd in May of 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in February 2020). In MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular). In MAY-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received his first dose in February of 2020 and his 2nd in May of 2025). In MAY-2025, the outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 22-JUL-2025 The nurse reported that the patient received his first dose of Shingrix in February of 2020 and his 2nd dose in May of 2025. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. More
2851285 F 07/25/2025 COVID19
RVX
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNK
UNK
Allergy to vaccine, Contusion, Rash erythematous; Allergy to vaccine, Contusion,... Allergy to vaccine, Contusion, Rash erythematous; Allergy to vaccine, Contusion, Rash erythematous More
Small rash on leg above ankle/rash erythematous/rash is red; Allergy to vaccine; Contusion; This non... Small rash on leg above ankle/rash erythematous/rash is red; Allergy to vaccine; Contusion; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of red rash in a 72-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis and Dupilumab for nasal polyp. Concurrent medical conditions included nasal polyp. On an unknown date, the patient received RSV vaccine and COVID-19 VACCINE. In JUN-2024, the patient received Dupilumab (subcutaneous). On an unknown date, less than 9 months after receiving RSV vaccine and COVID-19 VACCINE and between 3 and 4 months after receiving Dupilumab, the patient experienced red rash (Verbatim: Small rash on leg above ankle/rash erythematous/rash is red), allergy to vaccine (Verbatim: Allergy to vaccine) and contusion (Verbatim: Contusion). The outcome of the red rash, allergy to vaccine and contusion were unknown. The reporter considered the red rash and contusion to be possibly related to RSV vaccine. It was unknown if the reporter considered the red rash, allergy to vaccine and contusion to be related to COVID-19 VACCINE. It was unknown if the reporter considered the red rash and contusion to be related to Dupilumab. The company considered the red rash and contusion to be possibly related to RSV vaccine. It was unknown if the company considered the red rash, allergy to vaccine and contusion to be related to COVID-19 VACCINE. It was unknown if the company considered the red rash and contusion to be related to Dupilumab. Additional Information: GSK receipt date: 27-JUN-2025 In 2024 the patient developed a non-serious events 'a reaction that started 5-6 months ago, could be due to RSV vaccine broke out in rash broken blood vessels now appear darker and spreading, small red patch on her leg spread larger to her ankle and knee' (contusion) (rash erythematous) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab,Covid-19 vaccine and RSV vaccine. In 2024 the patient developed a non-serious event 'small rash on leg above ankle' (rash) and 'a new allergy to covid vaccine' (allergy to vaccine) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Covid-19 vaccine. The patient stated that the rash was red but no itching. The patient saw her doctor when the patch was small but has not followed up since. Corrective treatment was not reported for all events. No additional information was provided. More
2851286 FL 07/25/2025 MENB
NOVARTIS VACCINES AND DIAGNOSTICS
UNK
Wrong product administered Wrong product administered
patient got Bexsero instead of Menquadfi; This non-serious case was reported by a pharmacist via oth... patient got Bexsero instead of Menquadfi; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of wrong vaccine administered in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis. On an unknown date, the patient received Bexsero and did not receive Menquadfi. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient got Bexsero instead of Menquadfi). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 14-JUL-2025 The pharmacist reported that the patient was supposed to get an injection of Menquadfi but got Bexsero instead, which led to, wrong vaccine administered. The reporter mentioned that the patient still wanted to get Menquadfi. The reporter wants to find out if there were any drawbacks to patient getting Menquadfi at these points. More