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
2850012 14 F MT 07/17/2025 DTPPVHBHPB
TDAP
 MSP VACCINE COMPANY
GLAXOSMITHKLINE BIOLOGICALS
 U8313AA
3RE73
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
Pt was given a Vaxilis and a Tdap. The person that gave the immunizations meant to grab a Hep B but ... Pt was given a Vaxilis and a Tdap. The person that gave the immunizations meant to grab a Hep B but grabbed a Vaxilis instead. No side effects or reactions reported as as of today. More
2850091 64 F NY 07/17/2025 PPV
PPV
 MERCK & CO. INC.
MERCK & CO. INC.

Arthralgia, Back pain, Chills, Headache, Myalgia; Pain in extremity, Pyrexia, Vo... Arthralgia, Back pain, Chills, Headache, Myalgia; Pain in extremity, Pyrexia, Vomiting More
I went to the doctor , on 7/15/2025, I got a Pneumonia shot on the right arm, later that evening I... I went to the doctor , on 7/15/2025, I got a Pneumonia shot on the right arm, later that evening I was trying to eat something when it came up. Later that evening I started feeling some muscle pain, whenever I sat down or getting up i felt pain. Later in the night i started having headaches, fever, pain in the lower back, lega and joints,chills and headaches,. I then went to the emergency room They gave me an IV Injection and motrin 500mg More
2850092 3 M GA 07/17/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 5JA57
Extra dose administered Extra dose administered
July 2024 through October 2024 implemented a new statewide vaccine registry. This child received imm... July 2024 through October 2024 implemented a new statewide vaccine registry. This child received immunizations during this time. However, October of 2024 vaccine registry was abandoned, and the state went back to the previous version and vendor for vaccine registry. The vaccines given to patients during and entered into vaccine registry, do not transfer to the current vaccine registry. There is NO access to view the vaccine registry version. This patient had told the nurse they receive care at facility or at the Health Department. The nurse on 7/15/2025 reviewed vaccine registry for verification of immunizations needed and gave the immunizations that were indicated on vaccine registry as due. Later during nursing note entry, it was found that the patient had received the vaccines 9/17/2024. More
2850093 5 M GA 07/17/2025 DTAPIPV
UNK
 GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER
 39T93
Y017516
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
July 2024 through October 2024 the state implemented a new statewide vaccine registry. This child re... July 2024 through October 2024 the state implemented a new statewide vaccine registry. This child received immunizations during this time. However, October of 2024 vaccine registry was abandoned, and the state went back to the previous version and vendor for vaccine registry. The vaccines given to patients during and entered into vaccine registry, do not transfer to the current vaccine registry. There is NO access to view the vaccine registry version. This patient had told the nurse they receive care at facility or at the Health Department. The nurse on 7/15/2025 reviewed vaccine registry for verification of immunizations needed and gave the immunizations that were indicated on vaccine registry as due. Later during nursing note entry, it was found that the patient had received the vaccines 9/17/2024. More
2850094 5 F NC 07/17/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U8383AB
Z007868
Decreased appetite, Fatigue, Irritability, Pyrexia, Sluggishness; Decreased appe... Decreased appetite, Fatigue, Irritability, Pyrexia, Sluggishness; Decreased appetite, Fatigue, Irritability, Pyrexia, Sluggishness More
Day after vaccination, mom called the office to report child was feeling sluggish. Afebrile, just mo... Day after vaccination, mom called the office to report child was feeling sluggish. Afebrile, just more tired than usual. Triage nurse said that this can happen after vaccines, but to watch for worsening or continued symptoms, fever etc. Called back on 7/15/2025 and reported that child was whiny, had a low grade fever and decreased appetite. Came to office for sick visit with Dr. on 7/15/2025 at 1610 and presented with temp of 102.5 ax, tired and decreased appetite. Performed CBC in office and MD determined sympmtoms could be related to vaccines given on 7/8/25. More
2850095 16 F CO 07/17/2025 COVID19
 MODERNA
 b0021
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
Redness, swelling and itching at injection site; treated with hydrocortisone cr 1% Redness, swelling and itching at injection site; treated with hydrocortisone cr 1%
2850096 1.33 F MD 07/17/2025 DTAP
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 YC239
MF0415
Expired product administered; Expired product administered Expired product administered; Expired product administered
Pt was here yesterday afternoon 7/16/25 for a late 15 month WCC with Dr. I administered the patient&... Pt was here yesterday afternoon 7/16/25 for a late 15 month WCC with Dr. I administered the patient's scheduled vaccines, her pneumococcal 20 (prevnar 20) and dtap (infanrix) immunizations. However, while preparing the vaccines to be ready for administration, the expiration date on the dtap (infanrix) vaccine was misread and documented as 7-13-2026 and therefore administered. However, after further investigation while gathering other vaccines in the fridge where they were stored, re-evaluation of the date revealed that the expiration of the vaccine was actually 7-13-2025. Therefore the vaccine was 3 days expired. The remaining 1 vaccine dose left in the package was then removed from the vaccine refrigerator and both office manager and Dr. was notified. Attempted to reach parents to inform them of mistake, but no answer. Left a voicemail to call us back to discuss the issue. Further called VFC vaccine management and spoke with someone who reports no further side effects to look for except for the potentially less effective dose due to the expiration date. VFC reports the patient should have another dose of the same vaccine but that is not expired and complete a Vaers form. Spoke with the mother of the patient this morning around 9:50am and explained the situation and offered my sincerest apologies and explained that there is no additional side effects to be watching for and that recommended next steps would be to re-administer a second dose of the same vaccine to ensure effectiveness. Mom was very understanding and appreciative of the notification and that I called and checked to ensure there are no additional side effects or harm conducted to patient. Mom reports she is going to talk to her fiance, the patients father, when he arrives home from work to determine when she can come in for the vaccine as he has the vehicle. vaers form will be completed. Dr. and others are aware of the situation. As of now, there are no known side effects to the patient. More
2850097 4 F TN 07/17/2025 IPV
 SANOFI PASTEUR
 Y1A201M
Wrong product administered Wrong product administered
Polio was given prior to the 6th month mark from previous dose. Discussed with parent when pt could ... Polio was given prior to the 6th month mark from previous dose. Discussed with parent when pt could receive 3rd dose (which would be in September based on dose 2). Knowing the intervals, Polio was given on accident instead of final HEPB vaccine. More
2850098 0.67 M 07/17/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 90696
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
NONE NONE
2850099 5 M DE 07/17/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U8383AB
Y018156
Dyskinesia, Injection site swelling, Lethargy, Pyrexia, Tremor; Dyskinesia, Inje... Dyskinesia, Injection site swelling, Lethargy, Pyrexia, Tremor; Dyskinesia, Injection site swelling, Lethargy, Pyrexia, Tremor More
Fever 103+ with jerking/ shaking. Left arm with minor injection site swelling at this time. Child is... Fever 103+ with jerking/ shaking. Left arm with minor injection site swelling at this time. Child is lethargic. Pt with reaction to previous vaccines similar per mom. More
2850101 68 M CO 07/17/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Asthenia, Dysstasia, Gait inability, Guillain-Barre syndrome, Hypoaesthesia; Lum... Asthenia, Dysstasia, Gait inability, Guillain-Barre syndrome, Hypoaesthesia; Lumbar puncture, Mobility decreased, Muscular weakness More
Patient started experiencing weakness in arms, legs, as well as numbness in fingertips and toes the ... Patient started experiencing weakness in arms, legs, as well as numbness in fingertips and toes the day after vaccine was administered. The second day after vaccine, he was unable to stand due to not having any strength in his lower body. Went to the emergency room and was admitted and Diagnosed with Guillain-Barre Syndrome. He is now in the hospital, unable to walk and with very minimum strength and mobility to his upper body. More
โœ“ โœ“ โœ“
2850102 0.33 M DE 07/17/2025 DTAPIPVHIB
PNC20
RV1
 SANOFI PASTEUR
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 UK015AA
LX4484
7E9Y2
Expired product administered; Expired product administered; Expired product admi... Expired product administered; Expired product administered; Expired product administered More
An expired vaccine accidentally was given to a 4-month-old baby. Mother was notified and was asked t... An expired vaccine accidentally was given to a 4-month-old baby. Mother was notified and was asked to come for a follow up appointment and for the patient to receive a new valid vaccine. More
2850103 56 F MA 07/17/2025 HEP
PNC20
VARZOS
 DYNAVAX TECHNOLOGIES CORPORATION
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 946064
MF0425
2HJ99
Injection site pain, Injection site rash, Injection site warmth, Rash erythemato... Injection site pain, Injection site rash, Injection site warmth, Rash erythematous; Injection site pain, Injection site rash, Injection site warmth, Rash erythematous; Injection site pain, Injection site rash, Injection site warmth, Rash erythematous More
erythematous rash on left shoulder near the injection site, 10x10 cm ~ well demarcated with raised b... erythematous rash on left shoulder near the injection site, 10x10 cm ~ well demarcated with raised boarders, tender and warm. Treatment: Local reactions can be treated with tylenol or nonsteroidal antiinflammatory drugs (NSAIDs) such as naproxen as needed if pain or swelling is troublesome. -Cetirizine 10 mg nightly x7, can stop earlier if symptoms resolve -Due to complains of a reactive cough and worsening local erythema, prednisone 20 mg for 5 days was also sent. More
2850104 15 M IA 07/17/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Z007847
Z007847
Dizziness, Fatigue, Headache, Heart rate increased, Lymphadenopathy; Nasal conge... Dizziness, Fatigue, Headache, Heart rate increased, Lymphadenopathy; Nasal congestion, Nausea, Pharyngeal enanthema, Pyrexia More
Per 2 phone calls to/from parent: Patient experienced swollen lymph node on neck on the side he got ... Per 2 phone calls to/from parent: Patient experienced swollen lymph node on neck on the side he got his shot, throat was bumpy on the inside (strep throat like), light headedness, high fever, nauseous after eating, high heart rate after eating, extreme headaches, and fatigue since 07/09, today is first day he's feeling better. She states patient developed a fever and took Tylenol. At 1800-1900, temp was 101 (with Tylenol on board). Throat was the back of the throat with white bumps. He also had nasal congestion during the time and took Claritin to help with that. Swollen lymph node was on the left side of the neck. Injection was also given in the LD. More
2850105 9 M CA 07/17/2025 HPV9
 MERCK & CO. INC.
 Y015180
Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness
pt recevied the vaccine went to hall way ,pt passed out .and landed on the floor.loss of conciousnes... pt recevied the vaccine went to hall way ,pt passed out .and landed on the floor.loss of conciousness couple of seconds.alos eye rolled back,and arms and legs stiffen few seconds.according to father.pt was brought in to the room.lied down couple of minutes.and rechecked blood pressure vitals after 10 minutes.pt has no more dizziness.pt head was checked for head injury.no hematoma palpated.pt discharged with er precautions. More
2850106 52 M 07/17/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 Y019158
Y019158
Chills, Headache, Hyperhidrosis, Injection site erythema, Injection site pain; I... Chills, Headache, Hyperhidrosis, Injection site erythema, Injection site pain; Injection site warmth, Pyrexia More
Received Prevnar 21 pneumonia vaccine two days ago (7/15), followed by redness, tenderness, and warm... Received Prevnar 21 pneumonia vaccine two days ago (7/15), followed by redness, tenderness, and warmth at the left arm injection site along with symptoms of headache, chills, sweats, and fever peaking at 102๏ฟฝF, beginning a few hours post-vaccination. Redness has expanded some since the initial reaction. Differential diagnosis includes local injection site reaction versus cellulitis. More
2850107 21 F 07/17/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 946888
Asthenia, Cold sweat, Dizziness, Pallor Asthenia, Cold sweat, Dizziness, Pallor
after injection became dizzy, weak, pale and clammy. Had lay down and elevated feet above head. Mo... after injection became dizzy, weak, pale and clammy. Had lay down and elevated feet above head. Monitored for 30 minutes, bp 110/70 hr 70. Slowly recovered to a sitting position able to drink sips of water then to a standing position. Color returned to pink, no longer felt dizzy, weak or clammy More
2850108 1.08 F OH 07/17/2025 HIBV
IPV
MMR
PNC20
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 UK227AC
Y1A201M
Y011484
LN4932
Y019319
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Patient given Polio #4 when should have received another vaccine. Pt tolerated vaccine administratio... Patient given Polio #4 when should have received another vaccine. Pt tolerated vaccine administration well, no symptoms of adverse reaction noted after administration. Parents waited with child in lobby for 15 minutes before departing and were informed of the error. More
2850109 4 F ID 07/17/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
 U7908AB
Y013583
Injection site discolouration; Injection site discolouration Injection site discolouration; Injection site discolouration
With mom that it is uncertain which component of the vaccine she could be having a reaction to, but ... With mom that it is uncertain which component of the vaccine she could be having a reaction to, but it does appear she is having a immune mediated side effect from the vaccine localized to the dermis of the left arm. Not appear to be in erythema multiforme and there is no evidence of Stevens-Johnson or other reaction there is no evidence of hives any respiratory complaints. Parents was given to the mother and that now that it is hyperpigmented and more vascular appearing it may take a while for it to go away. More
2850110 44 F OR 07/17/2025 HPV9
 MERCK & CO. INC.
 Z002580
Injection site swelling Injection site swelling
Patient reports a bump remaining on her arm where she received the vaccine. Patient reports a bump remaining on her arm where she received the vaccine.
2850111 14 F CA 07/17/2025 HEP
HEPA
IPV
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 3N2ND
42DM9
Y1A212M
PG3RP
Excessive eye blinking, Hypertonia, Loss of consciousness, Syncope, Vomiting; Ex... Excessive eye blinking, Hypertonia, Loss of consciousness, Syncope, Vomiting; Excessive eye blinking, Hypertonia, Loss of consciousness, Syncope, Vomiting; Excessive eye blinking, Hypertonia, Loss of consciousness, Syncope, Vomiting; Excessive eye blinking, Hypertonia, Loss of consciousness, Syncope, Vomiting More
Patient arrived at clinic with her mother and 3 younger brothers for vaccines required for school. P... Patient arrived at clinic with her mother and 3 younger brothers for vaccines required for school. Patient was sleepy on arrival, lying back on procedure bed with her eyes closed while waiting. Sat up and was alert during administration of vaccines. After the 4th vaccine was given (Hep B), band aids were being applied and pt slumped into nurse's arms from a sitting position; no fall or head trauma. Patient lost consciousness for approximately 10-15 seconds and then blinked awake. Patient stated, "I didn't realize I had fallen asleep", pt continued to blink rapidly and appeared to be dizzy but was able to answer questions and speak coherently. Instructed patient to remain seated and to lie back on the bed. Nurse asked patient if she had eaten anything that morning to which patient responded she did not. Nurse provided apple juice and goldfish crackers to patient and encouraged the patient to remain seated/lying down. Patient did not initially drink the juice or eat the crackers. 2-3 minutes after syncope patient then vomited a small amount x1. Patient remained lying back on the bed for approximately 15 minutes, in and out of sleep. Nurse was able to schedule a same day appointment with a doctor in the clinic. Prior to standing, Nurse had the patient drink a few sips of the apple juice, then sit up slowly and take some deep breaths before standing. Patient was evaluated by MD and suspected to have had a vasovagal syncope episode. Per Mother of child, patient had a similar episode approximately 1 year ago during hot weather. MD provided Pedialyte and patient stated she was feeling better. Return to clinic instructions provided to patient and mother. Mother verbalized understanding. More
2850112 67 F CA 07/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2HJ99
Dizziness, Haematemesis, Nausea Dizziness, Haematemesis, Nausea
Patient reported dizziness, nausea, and vomiting happened at home few hours after vaccination. Patient reported dizziness, nausea, and vomiting happened at home few hours after vaccination.
2850113 3 M TX 07/17/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 735sx2
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
Redness noted to patient's left thigh approximately 5 inches in diameter and warm to touch. No ... Redness noted to patient's left thigh approximately 5 inches in diameter and warm to touch. No other symptoms noted. Dad has given the patient benadryl. More
2850114 17 F MN 07/17/2025 HPV9
MENB
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
SANOFI PASTEUR
 Y013768
CD44A
U8493AA
U8389AA
Head injury, Syncope, Vomiting; Head injury, Syncope, Vomiting; Head injury, Syn... Head injury, Syncope, Vomiting; Head injury, Syncope, Vomiting; Head injury, Syncope, Vomiting; Head injury, Syncope, Vomiting More
pt syncopized after her 4th immunization - recovered quickly, goose-egg on forehead but otherwise al... pt syncopized after her 4th immunization - recovered quickly, goose-egg on forehead but otherwise alright - zofran given after pt vomited More
2850115 0.5 M CA 07/17/2025 DTPPVHBHPB
PNC20
RV5
 MSP VACCINE COMPANY
PFIZER\WYETH
MERCK & CO. INC.
 U8265AA
LN4930
Z007575
Crying, Cyanosis, Hypotonia, Screaming; Crying, Cyanosis, Hypotonia, Screaming; ... Crying, Cyanosis, Hypotonia, Screaming; Crying, Cyanosis, Hypotonia, Screaming; Crying, Cyanosis, Hypotonia, Screaming More
Infant was at home and woke up from nap crying and then became limp for 25 minutes with some cyanosi... Infant was at home and woke up from nap crying and then became limp for 25 minutes with some cyanosis around the mouth, symptoms spontaneously resolved. Parents called 911 and patient was taken to the ER. He was found to be anemic at ER. He was discharged and followed up with his PCP. He has been referred to Cardiology. Dr. History Report: History of Present Illness The patient presents for evaluation of a brief resolved unexplained event (BRUE) and anemia. He is accompanied by his parents. Pale, limp event - About 2 hrs after receiving his vaccinations 2 days ago, he had a contact nap for approximately 1 hour and 20 minutes, which is typical for his afternoon rest. - Upon waking, he was screaming with his eyes closed. - His mother attempted to soothe him but noticed that he had turned pale and was limp. - His breathing was slow, and his lips had turned blue. - Mom tried to sit him up on her hip but couldn't, he was so limp. - She tried lying him down as if for a diaper change. He would normally grab his feet. Just limp. No eye contact but eyes at times open, lids at times droopy as if falling asleep. Not interacting but eyes not rolled back or deviated. - No stiffening movements. - This episode lasted about 25 minutes. - Called EMS. By the time the fire department arrived, his color had slightly improved, but his oxygen levels were low and he was crying faintly like a moan. - He was taken to the hospital where tests revealed severe anemia. Parents noted HR when crying was over 200. ED documented HR 153. More
2850116 11 M MI 07/17/2025 HPV9
MENB
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 Z004534
2P77Y
793PT
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Patient was given Men B instead of MCV4. No reaction reported. Patient was given Men B instead of MCV4. No reaction reported.
2850117 50 F WA 07/17/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 332l4
332l4
Injection site induration, Injection site rash, Skin warm; Injection site erythe... Injection site induration, Injection site rash, Skin warm; Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth; Injection site induration, Injection site rash, Skin warm; Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth More
Patient reported a 2 inch circular rash which was warm to touch and hard under the skin about 2 days... Patient reported a 2 inch circular rash which was warm to touch and hard under the skin about 2 days after injection More
2850118 14 M MT 07/17/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 MC7HK
Wrong product administered Wrong product administered
Wrong vaccine administered. Tdap administered instead of second HPV. Wrong vaccine administered. Tdap administered instead of second HPV.
2850119 50 F GA 07/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3273h
Burning sensation, Erythema, Pruritus, Swelling Burning sensation, Erythema, Pruritus, Swelling
07/04/25 large amount of swelling - about size of hand - very red, severe itching and burning. This ... 07/04/25 large amount of swelling - about size of hand - very red, severe itching and burning. This lasted for at least 4 days. As of 07/17/25 still about palm of hand sized swelling - not itching or burning now. More
2850120 73 F TX 07/17/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LN4930
LN4930
Dermatitis, Erythema, Fatigue, Gait disturbance, Myalgia; Skin warm, Slow speech... Dermatitis, Erythema, Fatigue, Gait disturbance, Myalgia; Skin warm, Slow speech, Somnolence, Swelling More
Muscle Aches, Fatigue, Drowsiness, Slow Speech, Shuffled Feet on Tuesday 07/15/2025, has improved. S... Muscle Aches, Fatigue, Drowsiness, Slow Speech, Shuffled Feet on Tuesday 07/15/2025, has improved. Slight swelling, redness, warm to the touch, Dermatitis on set today 07/17/2025. More
2850121 80 M OK 07/17/2025 PNC21
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
 y019158
u8564aa
Erythema, Induration, Pruritus, Swelling; Erythema, Induration, Pruritus, Swelli... Erythema, Induration, Pruritus, Swelling; Erythema, Induration, Pruritus, Swelling More
Large local swelling that appeared 6 days after the injection with itching, erythma and induration Large local swelling that appeared 6 days after the injection with itching, erythma and induration
2850122 45 F GA 07/17/2025 TDAP
 SANOFI PASTEUR
 U8353AA
Arthralgia Arthralgia
SHOULDER PAIN DISCOMFORT SHOULDER PAIN DISCOMFORT
2850123 73 F PR 07/17/2025 MNQ
 SANOFI PASTEUR
 u8438aa
Myalgia, Pruritus, Rash Myalgia, Pruritus, Rash
Patient have pain in the deltoid area, topical rash and itching 24 hour after administration Patient have pain in the deltoid area, topical rash and itching 24 hour after administration
2850124 1.33 F CO 07/17/2025 DTAP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
PFIZER\WYETH
 5KR3R
UK198AA
LN4930
Febrile convulsion; Febrile convulsion; Febrile convulsion Febrile convulsion; Febrile convulsion; Febrile convulsion
Febrile seizure 12 hours after administration. Resolved in 2 minutes. Febrile seizure 12 hours after administration. Resolved in 2 minutes.
2850125 1 M CA 07/17/2025 MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.

Eczema; Eczema Eczema; Eczema
Severe eczema that has lasted for years. Severe eczema that has lasted for years.
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2850126 56 F ID 07/17/2025 PNC20
 PFIZER\WYETH
 LK6655
Injection site swelling, Injection site warmth Injection site swelling, Injection site warmth
Pneumonia vaccine was received on 07/11/25. The next day the patient experienced swelling at the inj... Pneumonia vaccine was received on 07/11/25. The next day the patient experienced swelling at the injection site as well as skin feeling hot. Treatment was prescribed. Keflex for a 7 day supply for four times a day if symptoms persist were to be taken. More
2850127 11 M MO 07/17/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 2JS53
H4279
Injection site rash, Injection site warmth; Injection site rash, Injection site ... Injection site rash, Injection site warmth; Injection site rash, Injection site warmth More
Rash at injection site with local warmth Rash at injection site with local warmth
2850128 52 F CO 07/17/2025 PNC20
PNC20
PNC20
VARZOS
VARZOS
VARZOS
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 LX4484
LX4484
LX4484
3X97J
3X97J
3X97J
Areflexia, Blood test, Fall, Fatigue, Guillain-Barre syndrome; Hypoaesthesia, Lu... Areflexia, Blood test, Fall, Fatigue, Guillain-Barre syndrome; Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging spinal, Muscular weakness, Myalgia; Paraesthesia; Areflexia, Blood test, Fall, Fatigue, Guillain-Barre syndrome; Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging spinal, Muscular weakness, Myalgia; Paraesthesia More
On 4/20/2025 I started to develop fatigue and muscle aches that worsened through the week which was ... On 4/20/2025 I started to develop fatigue and muscle aches that worsened through the week which was followed by muscles weakness, numbness and tingling and ultimately a fall due to weakness with led being hospitalized and diagnosed Guillain Barre Syndrome at Hospital on 4/25/2025. More
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2850129 1.92 M GA 07/17/2025 PNC13
 PFIZER\WYETH
 GG6263
Expired product administered Expired product administered
PCV 13 dose expired 05/31/2025, and expired dose was administered. Additional dose is required due t... PCV 13 dose expired 05/31/2025, and expired dose was administered. Additional dose is required due to inefficiency of expired vaccine. More
2850166 5 M MO 07/17/2025 VARCEL
 MERCK & CO. INC.
 Y015108
No adverse event, Product storage error No adverse event, Product storage error
no symptoms reported; received improperly stored VARIVAX; This spontaneous report was received from ... no symptoms reported; received improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-Jun-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection 0.5 mL (lot# Y015108, expiration date: 06-Sep-2026; strength, route of administration and anatomical site were not reported) administered by a health professional for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, route of administration, lot # and expiration date were not reported). It was reported that the vaccine was administered after being improperly stored at 6.3 F for 16 minutes (Product storage error). No symptoms were reported (No adverse event). This is one of several reports received from the same reporter. Follow up information has been received from the nurse on 11-Jul-2025. This report referred to a 5-year-old male patient. On 19-Jun-2025, the patient also received Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid (Kinrix). There had been no patient events occurring since the vaccination. More
2850167 KS 07/17/2025 MMR
 MERCK & CO. INC.
 Y015995
Device connection issue, Exposure via skin contact Device connection issue, Exposure via skin contact
the needle hub became loose and began leaking between the plastic hub and the syringe itself; HCP al... the needle hub became loose and began leaking between the plastic hub and the syringe itself; HCP also reports that some of the liquid came in contact with the patients skin.; HCP also reports that some of the liquid came in contact with the patients skin.; the needle hub became loose and began leaking between the plastic hub and the syringe itself; HCP reports she is unsure if patient received the entire dose; needle hub/luer lock Adaptor (syringe hub) became loose; This spontaneous report was received from a nurse and refers to a(n) patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 03-Jul-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #Y015995, expiration date: 24-Sep-2026 (information established upon internal review, also reported as 25-Sep-2026), 0.5 mL administered by intramuscular route (anatomical location was not provided)) for prophylaxis (reported as: immunization against MMR). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). On the same date, while administering reconstituted Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) using sterile diluent (MERCK STERILE DILUENT) syringe, the needle hub became loose and began leaking between the plastic hub and the syringe itself. It was confirmed that the luer lock Adaptor (syringe hub) became loose (Device connection loose, Syringe leak, Poor quality device used). HCP reported no issues with sterile diluent (MERCK STERILE DILUENT) syringe during preparation of dose. HCP reported that she was unsure if patient received the entire dose (Accidental underdose). HCP also reported that some of the liquid came in contact with the patient's skin (Accidental exposure to product, Exposure via skin contact). HCP was wearing gloves and therefore no contact was made with her skin. No symptoms report by patient at this time. HCP stated she has discarded the sterile diluent (MERCK STERILE DILUENT) syringe and was unable to provide photos. At the reporting time, the outcome of the events was unknown. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was not applicable. More
2850168 M VA 07/17/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Depressed level of consciousness, Inappropriate schedule of product administrati... Depressed level of consciousness, Inappropriate schedule of product administration, Sluggishness; Depressed level of consciousness, Inappropriate schedule of product administration, Sluggishness More
Caller noted that her 14 year old son had received his 2nd shot for GARDASIL-9 around 23 months afte... Caller noted that her 14 year old son had received his 2nd shot for GARDASIL-9 around 23 months after receiving the first dose; AE was filed as caller noted that her son had become depressed and sluggish, however, has since balance back out.; This spontaneous report was received from a consumer or other non health professional and refers to a 14-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9 (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis. On an unknown date, around 23 months after receiving the first dose, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9 (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis (inappropriate schedule of product administration) On 19-May-2025, the reporter's son had become depressed and sluggish. The outcome of the event was considered to be recovered since the reporter noted, that he had "since balance back out". No additional information was provided. No additional adverse event (AE) and no product quality complain (PQC) was noted. Lot # is being requested and will be submitted if received. More
2850169 FL 07/17/2025 VARCEL
 MERCK & CO. INC.
 Z004454
Product storage error Product storage error
Caller stated no patient symptoms have been reported.; medical assistant who reported VARIVAX involv... Caller stated no patient symptoms have been reported.; medical assistant who reported VARIVAX involved in temperature excursion has been administered; This spontaneous report was received from a medical assistant on 14-Jul-2025 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-Jul-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), vial (lot #Z004454, expiration date: 13-Feb-2027), 1 dose, (route, anatomical location, and dose number were not reported) Prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (route, lot# expiration date, dose, dose number were unspecified) for Prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36.5 Fahrenheit for 2 hours, 21 minutes and 5. With no Previous excursion was not reported. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same source. More
2850170 TX 07/17/2025 HPV9
 MERCK & CO. INC.
 Y015179
No adverse event, Product storage error No adverse event, Product storage error
No symptoms reported; HCP reported administration of GARDASIL 9 that experienced two temperature exc... No symptoms reported; HCP reported administration of GARDASIL 9 that experienced two temperature excursions; This spontaneous report was received from a Registered medical assistant 15-Jul-2025 and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 14-Jul-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (lot #Y015179, expiration date: 28-Jan-2027) prefilled syringe, dose: 0.5 mL (dose number, route and anatomical location was not reported) for prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion of 47.3 Fahrenheit for 50 minutes and 24 seconds. Previous excursion was not reported as 47.5 Fahrenheit for 36 minutes and 51 seconds. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same source. More
2850171 F ID 07/17/2025 HPV9
HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.




Agitation, Alopecia, Amnesia, Anxiety, Asthenia; Autoimmune thyroiditis, Brain f... Agitation, Alopecia, Amnesia, Anxiety, Asthenia; Autoimmune thyroiditis, Brain fog, Decreased appetite, Depression, Dizziness; Eye pain, Fatigue, Headache, Hyperhidrosis, Hypothyroidism; Impaired work ability, Libido decreased, Loss of personal independence in daily activities, Mood swings, Palpitations; Temperature intolerance, Thyroid function test abnormal, Thyroiditis More
heart palpitations; autoimmune, autonomic, and neurological injuries; autoimmune, autonomic, and neu... heart palpitations; autoimmune, autonomic, and neurological injuries; autoimmune, autonomic, and neurological injuries; headache; diaphoresis; instability, dizziness,; loss of appetite; anxiety, agitations,; ocular pain; Hashimoto's Disease and Thyroiditis, depression, brain fog, memory loss, low sex drive, cold intolerance, hair loss, extreme mood swings, and severe weakness, hypothyroidism; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a 25-year-old female patient (pt). The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On an unknown date, the pt was vaccinated with the first (when she was 25 years old) and second (when she was 26 years old) doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for preventing cervical cancer. The pt experienced serious and debilitating injuries, including but not limited to autoimmune, autonomic, and neurological injuries. It was reported that on an unknown date (reported as following her first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection), the pt began to experience headaches, heart palpitations, diaphoresis, instability, dizziness, loss of appetite, extreme fatigue, anxiety, agitations, depression, brain fog, memory loss, low sex drive, cold intolerance, hair loss, ocular pain, extreme mood swings, and severe weakness. The pt reached out to her primary care provider and had bloodwork performed. Her thyroid test came back abnormal, and she was urgently referred to an endocrinologist. In December 2022, the pt was diagnosed with hypothyroidism. After multiple visits with the endocrinologist and extensive thyroid testing, she was ultimately diagnosed with Hashimoto's Disease and Thyroiditis in July 2023. As the months progressed, so did pt's injuries. She was seen by multiple physicians and specialists for her complaints which now included: hypothyroidism, headaches, heart palpitations, diaphoresis, instability, dizziness, loss of appetite, extreme fatigue, anxiety, agitations, depression, brain fog, memory loss, low sex drive, cold intolerance, hair loss, ocular pain, extreme mood swings, and severe weakness. The pt continued to experience daily fatigue, memory loss, and depression, which were made worse during a Hashimoto flare-up. The pt was on thyroid medication and continued to see multiple providers. She had also enrolled in numerous outpatient programs. As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been unable to engage in activities that a normal young person would enjoy. Following her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, the pt experienced symptoms that negatively affected her career, ultimately leading to her discharge. Additionally, pt's symptoms had also made it challenging to keep up with her responsibilities for her child and her job at a veterinary clinic. Furthermore, the pt was unable to complete her typical weekly 5k runs or participate in the various sports she once enjoyed prior to receiving the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune and neurological injuries, including but not limited to Hashimoto's Disease and thyroiditis, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of the company's alleged wrongful acts and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) manufacturing defects, pt suffered and continued to suffer severe and permanent physical injuries and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. Also, she had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, she suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur those losses and expenses in the future. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The events Hashimoto's disease, anxiety, autonomic nervous system imbalance, decreased appetite, diaphoresis, dizziness, headache, ocular pain, palpitations and neurological disorder, were considered disabling by the reporter. More
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2850172 M CA 07/17/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
Accidentally Gave the HEPLISAV-B SubQ Instead of IM; Initial report received on 01-Jul-2025. A phar... Accidentally Gave the HEPLISAV-B SubQ Instead of IM; Initial report received on 01-Jul-2025. A pharmacist reported that a 26-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization subcutaneously instead of intramuscularly. No medical history or concomitant medications were reported. On 30-May-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 30-Jun-2025, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot number 946062, expiration date 18-May-2027, and NDC number 43528-003-05)] subcutaneously in the right arm. No side effects were reported. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2850173 F IN 07/17/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945665
Yellow skin Yellow skin
Arm is Yellow on the Underside Both Above the Elbow and Bellow the Elbow; Initial report received on... Arm is Yellow on the Underside Both Above the Elbow and Bellow the Elbow; Initial report received on 03-Jul-2025. A pharmacist reported that a female patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient's underside of her arm both above and below the elbow was yellow. No medical history or concomitant medications were reported. On 02-Jul-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 945665, expiration date 03-Jan-2027, and NDC number 43528-0003-05; site not available) intramuscularly. On 03-Jul-2025, 1 day after receiving HEPLISAV-B, the patient reported her arm is yellow on the underside both above and below the elbow. No other adverse effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2850174 NM 07/17/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Incomplete course of vaccination, No adverse event Incomplete course of vaccination, No adverse event
Received First Dose And It Has Been More Than One Month; Initial report received on 03-Jul-2025. A ... Received First Dose And It Has Been More Than One Month; Initial report received on 03-Jul-2025. A pharmacist reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the next dose more than one month later. No medical history or concomitant medications were reported. On 28-May-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 03-Jul-2025, 37 days after receiving the first dose of HEPLISAV-B, the reporter noted that more than one month had passed since the patient's first injection. No adverse reactions were reported. The reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2850175 52 F OH 07/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 73pp9
Expired product administered Expired product administered
vaccinated on 7 JUL 2025 in the left arm with SHINGRIX/product expired 30 MAY 2024; This non-serious... vaccinated on 7 JUL 2025 in the left arm with SHINGRIX/product expired 30 MAY 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 73pp9, expiry date 30-MAY-2024) for prophylaxis. On 07-JUL-2025, the patient received Shingrix (intramuscular, left arm) .5 ml. On 07-JUL-2025, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: vaccinated on 7 JUL 2025 in the left arm with SHINGRIX/product expired 30 MAY 2024). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 07-JUL-2025 HCP was the reporter. Stated that a patient was vaccinated on 7th July 2025 in the left arm with Shingrix. HCP stated that the product expired on 30th May 2024, which led to expired vaccine used. No further information was provided/obtained. More
2850176 M FL 07/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
received first dose of Shingrix in 2023 and has not yet had 2nd dose; This non-serious case was repo... received first dose of Shingrix in 2023 and has not yet had 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose of Shingrix received intramuscularly in 2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: received first dose of Shingrix in 2023 and has not yet had 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 08-JUL-2025 The patient received his first dose of Shingrix in 2023 and had not yet had his 2nd dose which led to incomplete course of vaccination. More
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