🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2840407 49 M IL 05/11/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 FA6780
FA6780
FA6780
FA6780
FA6780
FA6780
FA7485
FA7485
FA7485
FA7485
FA7485
FA7485
Abdominal distension, Abdominal pain upper, Arthralgia, Back pain, Chemotherapy;... Abdominal distension, Abdominal pain upper, Arthralgia, Back pain, Chemotherapy; Computerised tomogram abdomen abnormal, Device related infection, Discomfort, Endoscopy upper gastrointestinal tract abnormal, Feeling abnormal; Gastric cancer stage IV, Hip arthroplasty, Hypoaesthesia, Infrequent bowel movements, Labral reconstruction; Lymphoma, Magnetic resonance imaging, Neuralgia, Obstruction gastric, Pain in extremity; Positron emission tomogram, Skin indentation, Spinal fusion surgery, Spinal nerve stimulator implantation, Spinal nerve stimulator removal; X-ray; Abdominal distension, Abdominal pain upper, Arthralgia, Back pain, Chemotherapy; Computerised tomogram abdomen abnormal, Device related infection, Discomfort, Endoscopy upper gastrointestinal tract abnormal, Feeling abnormal; Gastric cancer stage IV, Hip arthroplasty, Hypoaesthesia, Infrequent bowel movements, Labral reconstruction; Lymphoma, Magnetic resonance imaging, Neuralgia, Obstruction gastric, Pain in extremity; Positron emission tomogram, Skin indentation, Spinal fusion surgery, Spinal nerve stimulator implantation, Spinal nerve stimulator removal; X-ray More
The day after my second injection (Aug. 13th) my right leg went numb while driving my daughter to he... The day after my second injection (Aug. 13th) my right leg went numb while driving my daughter to her soccer game. I have had back issues for several years, but have NEVER had numbness down my legs. I immediately scheduled an appt. with Dr. with Pain Management Clinic. Met with her on Sept. 2nd, 2021 and she prescribed taking methylIPREDNISolone 4mg oral tablets. That seemed to help and got me through the football season (I was a college football coach at that time). At season's end and into January of 2022, the nerve pain and numbness started to show up again. At the end of January of 2022, I took a new coaching job as the Offensive Coordinator. The pain and numbness had returned in my right hip, lower lumbar on the right side, and down my leg. I scheduled a cortisone injectioon with Dr. with the Pain Management Clinic for January 25th, the day before I was leaving for my new job. The injection was ineffective and for the first six weeks on the job, I had to stand in meetings and they had to order me a stand-up desk because sitting had become so uncomfortable / painful due to the pain in my right hip and lower right lumbar area (I also developed an indention in my right shin during this time). After six weeks of pain and misery (and shooting myself up with Torodol every couple of days), I scheduled spinal fusion surgery and that was performed on March 9th of 2022. The surgery was successful and the pain was significantly reduced. However, in July of 2022, I was back in state for right hip labrum surgery once again with facility. Again, the surgery was a success and the pain was minimized quite a bit until late in the 2022 football season, when the nerve pain returned. Fast forward to February of 2023, and I was in the OR once again, this time to replace my right hip in an attempt to reduce / eliminate the nerve pain that continued to resurface. It was another successful surgery (I thought), until abour 5 weeks into my rehab I began having the same nerve issues in the same area. The last resort was to try a spine stimulator to trick the nerves with continuous stim throughout that arear and down my spine. The implant surgery was done in April of 2023 at facility. That apparatus proved to be very effective in eliminating the nerve pain, until it became infected in October of 2024 and had to be removed. Fast forward to February of 2025 when I checked myself into the ER on February 3rd with stomach pain and digestive issues that had been going on for a couple of months (very little bowel movement activity). On the morning of February 4th, 2025, a CT Scan showed a blockage in my stomach where the stomach leads into the small intestines. The blockage was preventing food from getting to where it is supposed to go, hence my issues with bloating and not being able to pass a bowel movement. Later that day, an endoscopy was performed by Dr. where he diagnosed me with a malignant stomach tumor, accompanied by two - three malignant lymph nodes as well, maiking me a Stage 3 diagnosis. I began chemotherapy with clinic on February 19th and have conrtinued with that every other week since. On April 14th - 15th, we traveled to visit with my Oncology Surgeon, Dr. The CT Scan performed there showed another cancerous lymph node, this one near my kindeny, which advanced me to Stage 4 cancer. I will have my 7th chemo infusion this Wednesday (May 14th), and will continue with two more additional chemo sessions before heading back to Clinic for another evaluation to see if the tumor has shrunk enough to perform surgery to remove it. I have lived an extremely healthy life for all of my 53 years. I was a 3-sport athlete in HS, a starting QB for four years and a person that takes pride in their overall health and well-being. I exercise regularly, and am in very good shape, even through chemotherapy. There is no doubt in my mind that everything changed for me the day I reluctantly had the second Covid 19 vaccine injetion. My life has not been the same since that day. More
✓ ✓ ✓
2840330 NV 05/10/2025 MMR
MMR
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No adverse event; Inbound call from HCP stating that a 2nd dose of MMR-II and VARIVAX were inadverte... No adverse event; Inbound call from HCP stating that a 2nd dose of MMR-II and VARIVAX were inadvertently administered before the recommended age. These vaccines were administered at 2 years old. The first dose of both of these vaccines were administered on May 3rd, 20; This spontaneous report was received from a consumer or other non health professional and refers to a) 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 03-MAY-2024, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 mL administered by unknown route (anatomical location, lot # and expiration date were not reported) and with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 0.5 mL administered by unknown route as prophylaxis (anatomical location, lot # and expiration date were not reported). The suspect vaccine were reconstituted with sterile diluent (lot # and expiration date were not reported). Then on 17-APR-2025 at 2 year of age, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (as described above) and with the second of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (as described above), inadvertently administered before the recommended age (inappropriate age at vaccine administration). Patient had not experienced any reactions (no adverse event). Lot # is being requested and will be submitted if received More
2840337 61 F NC 05/10/2025 PNC21
 MERCK & CO. INC.
 Y013009
Cellulitis, Erythema, Injection site reaction, Skin exfoliation, Swelling Cellulitis, Erythema, Injection site reaction, Skin exfoliation, Swelling
Cellulitis, treated with antibiotics at ER. Presented with redness and swelling the night she recei... Cellulitis, treated with antibiotics at ER. Presented with redness and swelling the night she received the vaccine. Now resolved with residual peeling at injection site. More
2840338 4 F VT 05/10/2025 COVID19
DTAPIPV
MMRV
 MODERNA
SANOFI PASTEUR
MERCK & CO. INC.
 3044079
U8209CB
Z002990
Headache, Pyrexia, Vomiting; Headache, Pyrexia, Vomiting; Headache, Pyrexia, Vom... Headache, Pyrexia, Vomiting; Headache, Pyrexia, Vomiting; Headache, Pyrexia, Vomiting More
Vomiting x 3 days, fever and headache Vomiting x 3 days, fever and headache
2840339 58 F AZ 05/10/2025 COVID19
VARZOS
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS

Death, Vomiting; Death, Vomiting Death, Vomiting; Death, Vomiting
Within an hour of getting the Covid booster and shingles vaccine my mom was throwing up every 20 min... Within an hour of getting the Covid booster and shingles vaccine my mom was throwing up every 20 minutes. The vomitting was so bad she had to get an I.V. For fluids. She was found dead in her bed the next day. I am searching for the doctors info. This was a new doctor that was supposed to do bloodwork but pushed vaccines on a new patient. More
✓
2840340 69 M IL 05/10/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Pain in extremity Pain in extremity
Patient is experiencing right arm pain. Patient is experiencing right arm pain.
2840341 57 F CA 05/10/2025 COVID19
 MODERNA
 unk
Malaise, Rash, Rash erythematous, Rash pruritic, Stress Malaise, Rash, Rash erythematous, Rash pruritic, Stress
Five min after shot had itchy red rash on face and neck, lasted 2 weeks. Every time she gets"si... Five min after shot had itchy red rash on face and neck, lasted 2 weeks. Every time she gets"sick" gets rash on torso, and if stressed gets rash on face and neck. More
2840342 1.75 F 05/10/2025 DTAP
MMR
 SANOFI PASTEUR
MERCK & CO. INC.
 3CA25C1
Y019108
Rhonchi, Swelling face, Tracheostomy, Urticaria, Vomiting; Rhonchi, Swelling fac... Rhonchi, Swelling face, Tracheostomy, Urticaria, Vomiting; Rhonchi, Swelling face, Tracheostomy, Urticaria, Vomiting More
approximately 2 hours after injections, patient developed full body hives, facial swelling, and vomi... approximately 2 hours after injections, patient developed full body hives, facial swelling, and vomiting x1. patient has a tracheostomy/stable airway, but did develop course rhonchi but no wheezing. was given 0.1 mg of IM epinephrine and Benadryl x1 with improvement of symptoms. Was hemodynamically stable throughout episode. More
2840343 75 F WA 05/10/2025 COVID19
 PFIZER\BIONTECH
 ME6072
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Left arm has an injection site reaction. The lower part of her upper arm is very red (about a baseba... Left arm has an injection site reaction. The lower part of her upper arm is very red (about a baseball's width in a circle) and is raised up. Patient has been using Tylenol and ice. More
2840344 75 F FL 05/10/2025 COVID19
 MODERNA
 3044069
Headache, Pain in extremity, Renal pain Headache, Pain in extremity, Renal pain
Patient was administered moderna spikevax vaccine (2024-2025) that was later identified as possible ... Patient was administered moderna spikevax vaccine (2024-2025) that was later identified as possible past suggested BUD but not past the expiration date on the box (06/14/2025). Called patient to explain situation and assess for side effects. Patient said they had minor headache and sore arm. Patient also reported minor kidney area soreness but said it was likely due to her working in her garden during the call. Patient reported they are feeling fine, and patient seemed to be feeling fine, alert, and fully responsive during the call. More
2840345 70 F NY 05/10/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 EK225
EK225
Chills, Fatigue, Injection site erythema, Injection site swelling, Injection sit... Chills, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth; Pain More
Patient presented today (3 days post injection) with affected area under injection site, red, swolle... Patient presented today (3 days post injection) with affected area under injection site, red, swollen, and warm to the touch. Patient explains she did have chills the day after vaccine, but did not check to see if she was running a fever, also complained of body aches, and tiredness. Stated that affected area has gotten larger, advised her to be seen by Dr. More
2840346 66 M 05/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Eyelid rash, Rash, Rash erythematous Eyelid rash, Rash, Rash erythematous
Red bumps on eye and face Red bumps on eye and face
2840347 64 F CA 05/10/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA



Abdominal distension, Brain fog, Cardiac flutter, Cardiac function test, Compute... Abdominal distension, Brain fog, Cardiac flutter, Cardiac function test, Computerised tomogram thorax; Dementia, Dry mouth, Dysarthria, Dysphagia, Dyspnoea; Heart rate increased, Insomnia, Laboratory test, Muscle spasms, Muscular weakness; Respiratory disorder More
difficulity sleeping difficulty speaking brain fog demenshia resportaty problem unable to breath blo... difficulity sleeping difficulty speaking brain fog demenshia resportaty problem unable to breath bloating muscel spassums heart rate up and fluttering weakness in legs and general al over problems come on at 4 pm. everyday and get worse dry mouth and hard to swolloe etc More
2840348 63 F CA 05/10/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 E754F
E754F
Anxiety, Dizziness, Dysgeusia, Hallucination, Headache; Hyperhidrosis, Laborator... Anxiety, Dizziness, Dysgeusia, Hallucination, Headache; Hyperhidrosis, Laboratory test, Nausea, Skin irritation, Weight decreased More
On 5/10/2025, the patient let the pharmacist know that patient had hallucination, irritation, sweati... On 5/10/2025, the patient let the pharmacist know that patient had hallucination, irritation, sweating, headache, dizziness and nausea on the first night after the vaccination on 5/5/2025. From 5/05/2025 to 5/10/2025, the patient lost some weight due to lack of sleep and bitter taste in the mouth, in addition to other side effects (irritation, headache and dizziness). On 5/10/2025, patient decided to go to ER because she was afraid that she might have stroke. ER doctors gave her medications to treat nausea, dizziness and anxiety. More
2840349 0.5 F KS 05/10/2025 DTPPVHBHPB
PNC20
RV5
 MSP VACCINE COMPANY
PFIZER\WYETH
MERCK & CO. INC.
 U7392AA
LG5575
2051970
Crying, Food refusal, Infant irritability, Lethargy, Pain; Crying, Food refusal,... Crying, Food refusal, Infant irritability, Lethargy, Pain; Crying, Food refusal, Infant irritability, Lethargy, Pain; Crying, Food refusal, Infant irritability, Lethargy, Pain More
Per mom: She was incredibly fussy, lethargic, refused to eat, would cry out in pain when mom picked ... Per mom: She was incredibly fussy, lethargic, refused to eat, would cry out in pain when mom picked her up and also when she would put her down. This lasted for around 3 days post vaccine until mom essentially forced her to take a bottle and started improving. More
2840350 54 F MO 05/10/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 MG5S9
Injection site erythema, Injection site pain, Injection site warmth Injection site erythema, Injection site pain, Injection site warmth
2 RED CIRCLE BELOW INJECTIONS SITE, TENDER, 1 IS 1IN AND OTHER ABOUT 3IN IN DIAMTER- WARM TO TOUCH ... 2 RED CIRCLE BELOW INJECTIONS SITE, TENDER, 1 IS 1IN AND OTHER ABOUT 3IN IN DIAMTER- WARM TO TOUCH - NO TREAMENT More
2840351 74 F MO 05/10/2025 RSV
 PFIZER\WYETH
 LN5487
Flushing, Vision blurred, Visual impairment Flushing, Vision blurred, Visual impairment
PATIENT REPORTED FLUSHED CHEEKS WITH VISUAL DISTURBANCES (BLURRED VISION AND "SPARKLES" IN... PATIENT REPORTED FLUSHED CHEEKS WITH VISUAL DISTURBANCES (BLURRED VISION AND "SPARKLES" IN FIELD OF VISION) SHORTLY AFTER RECEIVING IMMUNIZATION. PATIENT WAS ASKED TO SIT IN PHARMACY WAITING AREA FOR OBSERVATION. PATIENT WAS GIVEN A BOTTLE OF COLD WATER TO DRINK. AND ALLOWED TO REST WITH PHARMACY STAFF CHECKING ON HER FREQUENTLY. AFTER ABOUT 20 MINUTES, PATIENT FELT MUCH BETTER. FLUSHED CHEEKS AND VISUAL DISTURBANCES RESOLVED. More
2840158 4 DE 05/09/2025 HPV9
 MERCK & CO. INC.
 Y010656
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE reported; GARDASIL-9 was administered to a 4-year-old consumer; This spontaneous re... No additional AE reported; GARDASIL-9 was administered to a 4-year-old consumer; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-Apr-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y010656, expiration date: 29-Nov-2026) 0.5 mL administered by unknown route as prophylaxis (Product administered to patient of inappropriate age). No additional adverse event reported (No adverse event). No additional information provided. More
2840159 05/09/2025 MMRV
 MERCK & CO. INC.
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE reported; 1-year-old consumer received an expired dose of PROQUAD.; Information has... No additional AE reported; 1-year-old consumer received an expired dose of PROQUAD.; Information has been received from Business Partner/CRO on . This spontaneous report was received from a/an Unknown and refers to a(n) 1-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On Feb-2025, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), (lot # and expiration date were not reported). On Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # and expiration date were not reported). The patient started therapy with sterile diluent (BAXTER STERILE DILUENT), for the treatment of Prophylaxis. The patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for the treatment of Prophylaxis. On Jan-2025, the patient experienced 1-year-old consumer received an expired dose of PROQUAD.. On an unknown date, the patient experienced No additional AE reported. At the reporting time, the outcome of 1-year-old consumer received an expired dose of PROQUAD. and No additional AE reported was unknown. The action taken with sterile diluent and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live was reported as not applicable.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02801045-02801044 , CLIC number : , ESTAR number : , IRMS number : 500UW00000aFbwzYAC|07052025230039|7503 , Central date : 2025-05-08 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02801045 , MNSC interaction number : 02801044 , Integration log UniqueID : 500UW00000aFbwzYAC|07052025230039|7503 , Service cloud CaseID : 500UW00000aFbwzYAC More
2840160 14 F VA 05/09/2025 HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.









Abdominal pain, Brain fog, Complex regional pain syndrome, Constipation, Depress... Abdominal pain, Brain fog, Complex regional pain syndrome, Constipation, Depression; Disturbance in attention, Dyspepsia, Dyspnoea, Emotional distress, Fall; Fatigue, Headache, Hypoaesthesia, Loss of personal independence in daily activities, Mental disorder; Migraine, Musculoskeletal pain, Pain, Paraesthesia, Postural orthostatic tachycardia syndrome; Syncope, Tremor; Abdominal pain, Brain fog, Complex regional pain syndrome, Constipation, Depression; Disturbance in attention, Dyspepsia, Dyspnoea, Emotional distress, Fall; Fatigue, Headache, Hypoaesthesia, Loss of personal independence in daily activities, Mental disorder; Migraine, Musculoskeletal pain, Pain, Paraesthesia, Postural orthostatic tachycardia syndrome; Syncope, Tremor More
POTS: orthostatic hypotension,fainting spells,falling,headaches,migraines,brain fog,fatigue,lack of ... POTS: orthostatic hypotension,fainting spells,falling,headaches,migraines,brain fog,fatigue,lack of attention,difficulty concentrating,dizziness,difficulty breathing,brain fog,abdpain,constipation, anxiety,depression,mental anguish; autoimmune injuries; emotional distress; Small fiber neuropathy (SFN): odd numbness in her legs, tingling; Complex regional pain syndrome (CRPS): unexplained musculoskeletal pain, tremors, excessive pain; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning an adult female patient. Patient's current conditions, medical history and concomitant therapy was not reported. On an unknown date and on 28-AUG-2020, (at 14 (the first) and 15 (the second) years old), the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strengths, doses, lot numbers, expiration dates, routes of administration and anatomical locations were not provided) administered for prevention cervical cancer. On an unknown date, following her vaccination, pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her injection; following her vaccination, she deteriorated drastically. She experienced multiple orthostatic hypotension incidents during her classes, which included fainting spells and falling. She also started complaining of persistent daily headaches and migraines, brain fog, fatigue, lack of attention, difficulty concentrating, digestive issues, odd numbness in her legs, and unexplained musculoskeletal pain. She was seen by a neurologist and prescribed various medications, amitriptyline and nortriptyline antidepressants to try to prevent the headaches. None of the medications worked. As the months progressed, so did her symptoms. She was seen by multiple physicians and specialists for her complaints which now include migraines, dizziness, fainting, difficulty breathing, brain fog, numbness, tingling, tremors, abdominal pain, constipation, excessive pain, anxiety, depression, emotional distress and mental anguish. As a result of her post-vaccination symptoms, she has been unable to engage in activities that a normal young person would enjoy. She contends her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to Postural orthostatic tachycardia syndrome (POTS), Complex regional pain syndrome (CRPS), and Small fiber neuropathy (SFN), 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 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 Merck's misleading statements and omissions concerning the safety and efficacy of the vaccine, the pt have suffered and continue to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also have 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 their 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 their quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced injuries, Pt have suffered and continue to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and they will continue to incur these losses and expenses in the future. 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). All the events were considered as disabling by reporter. This is 1 of 6 cases received from the same reporter. More
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2840174 69 F CA 05/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93KK4
Headache, Injection site erythema, Injection site reaction, Neck pain, Urticaria Headache, Injection site erythema, Injection site reaction, Neck pain, Urticaria
Patient states that she got the 2nd dose of Shingrix on 5/6/25 at pharmacy and reports persistent bi... Patient states that she got the 2nd dose of Shingrix on 5/6/25 at pharmacy and reports persistent bilateral neck pain, HA, and redness/"welts" to her left upper arm since then. Pt has been taking ibuprofen at home for her s/s. Pt presented to Urgent Care clinic on 5/8/25 for evaluation with MD who prescribed the patient motrin to be sent to her pharmacy. More
2840175 0.5 M TN 05/09/2025 PNC15
 MERCK & CO. INC.
 Y010035
Feeling abnormal Feeling abnormal
Following the second dose of Vaxneuvance, Patient had 4 days of decreased activity, decreased smilin... Following the second dose of Vaxneuvance, Patient had 4 days of decreased activity, decreased smiling and social responsiveness, parents described him as "just zoned out". He has never had this reaction with other vaccines. More
2840176 16 M OR 05/09/2025 HPV9
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 Y007197
7GF79
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, S... Immediate post-injection reaction, Syncope; Immediate post-injection reaction, Syncope More
Patient developed syncope immediately after the Gardasil vaccine was given. I had the patient lied b... Patient developed syncope immediately after the Gardasil vaccine was given. I had the patient lied back in a reclining position. Gave water to drink and a cold compress was applied to the forehead. Patient stated feeling better after 10-20 minutes. More
2840177 18 M OR 05/09/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 Y007197
7GF79
U8252AA
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, S... Immediate post-injection reaction, Syncope; Immediate post-injection reaction, Syncope; Immediate post-injection reaction, Syncope More
Patient developed syncope immediately after the Gardasil vaccine was given. I had the patient lie ba... Patient developed syncope immediately after the Gardasil vaccine was given. I had the patient lie back in a reclining position gave water to drink and a cold compress was applied to forehead. Patient stated feeling better after 10-20 minutes. More
2840178 17 M OR 05/09/2025 HPV9
 MERCK & CO. INC.
 Y007197
Immediate post-injection reaction, Syncope Immediate post-injection reaction, Syncope
Patient developed syncope immediately after the Gardasil vaccine was given. I had the patient lie ba... Patient developed syncope immediately after the Gardasil vaccine was given. I had the patient lie back in a reclining position gave water to drink and a cold compress was applied to forehead. Patient stated feeling better after 10-20 minutes More
2840179 14 M NJ 05/09/2025 HPV9
 MERCK & CO. INC.
 Y008986
Chronic spontaneous urticaria, Urticaria Chronic spontaneous urticaria, Urticaria
Feb 27, 2025 hives after HPV vaccine & cont. until today. Sees allergist HPV Lot # Y008986 Gar... Feb 27, 2025 hives after HPV vaccine & cont. until today. Sees allergist HPV Lot # Y008986 Gardasil Merck More
2840230 TX 05/09/2025 DTPPVHBHPB
HPV9
 MSP VACCINE COMPANY
MERCK & CO. INC.
 U8265AA
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 adverse event/ HCP confirmed that there were no symptomatic events; T/E for VAXELIS (prefilled),... No adverse event/ HCP confirmed that there were no symptomatic events; T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. See T/E case #02777949. HCP reported that VAXELIS and GARDASIL-9 were administered. HCP reported that PNEUMOVAX-23 was not administered to any patients.; This spontaneous report has been received from a Nurse Practitioner, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-Mar-2025, the patient was vaccinated with an improperly storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported) and of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine Suspension for injection (VAXELIS) (lot number: U8265AA, which was determined to be valid, with an expiration date on 31-Aug-2027 (also reported to be 31-Oct-2026, conflicting information) both as prophylaxis. The administered Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine Suspension for injection (VAXELIS) dose underwent a temperature excursion of 47.5 degrees Fahrenheit (F) for 36 minutes and 51 seconds with a previous one of 48 F for 1 hour and 13 minutes. For Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), it was reported that there was a temperature excursion but details were not given (within the product disclaimer administration allowance per the PI). HCP confirmed that there were no symptomatic events (no adverse event). Lot # is being requested and will be submitted if received. More
2840231 F MA 05/09/2025 HEP
HEP
HEP
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Hepatitis B surface antibody negative; Hepatitis B surface antibody negative; He... Hepatitis B surface antibody negative; Hepatitis B surface antibody negative; Hepatitis B surface antibody negative More
did not have protective HBV antibody titers after 3 doses of HBV vaccine; This literature marketed... did not have protective HBV antibody titers after 3 doses of HBV vaccine; This literature marketed report has been received from the authors of a published article, and refers to a 24-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included obesity. Concomitant therapies were not reported. On unknown dates, the patient received the series of 3 vaccinations with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (doses, route of administration, lot # and expiration dates were not reported) for prophylaxis. On an unknown date, the patient did not have protective HBV antibody titers after 3 doses of HBV vaccine. The outcome of the event was not reported. The reporter considered the event to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). This is one of two cases derived from the same literature article (cross referenced with case# 2284106). More
2840232 OH 05/09/2025 HEPA
MMRV
MMRV
MMRV
MMRV
RV5
VARCEL
VARCEL
VARCEL
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
Y013571
Z005150
Y017204
Y018154

Y017062
X023717
Y019318
Y015559
Y011018
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 adverse event, Product storage error; 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 adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error More
No additional AE; Precautionary AE for vaccines that experienced a temperature excursion on 04/28/20... No additional AE; Precautionary AE for vaccines that experienced a temperature excursion on 04/28/2025 and may have been administered. HBP (who is also a medical assistant) reported that she does not believe that they were administered, but is not certain.; This invalid spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender (number of patient or patients was not specified). The patient's medical history, concurrent conditions and concomitant therapies were not reported. A precautionary adverse event (AE) for vaccines that experienced a temperature excursion on 28-APR-2025 and may have been administered (for VARIVAX and PROQUAD: -3.77C (time frame: 1 hour 45 minutes 0 seconds); for ROTATEQ and VAQTA: 14.6C (time frame: 12 hours 0 minutes 0 seconds)). On an unknown date in April 2025 (28-APR-2025 or 29-APR-2025), the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y017062, expiration date: 11-Oct-2026) (The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)); with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #X023717, expiration date: 26-Sep-2025) (The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)); with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y019318, expiration date: 21-Nov-2026) (The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)); with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y015559, expiration date: 16-Sep-2026) (The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)); with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y011018, expiration date: 18-Jun-2026) (The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)); with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y013571, expiration date: 03-Feb-2026) (The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)); with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z005150, expiration date: 25-Aug-2026) (The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)); with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y017204, expiration date: 13-Apr-2026) (The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)); with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y018154, expiration date: 29-Apr-2026) (The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)); with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot # and expiration date were not reported); with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot # and expiration date were not reported) (dosages, routes of administration and vaccination sites were not provided) all administered for prophylaxis. The medical assistant reported that she did not believe that they were administered, but was not certain (product storage error). If any were administered, the date of administration was either 28-APR-2025 or 29-APR-2025. No additional information was noted. No additional AE and no product quality complaint (PQC) was noted (no adverse event). No previous temperature excursion was reported. Lot # is being requested and will be submitted if received This case was considered to be invalid due to lack of patient's identifiers. More
2840233 NY 05/09/2025 MMRV
 MERCK & CO. INC.
 Z003308
Circumstance or information capable of leading to medication error, Underdose Circumstance or information capable of leading to medication error, Underdose
No additional AE/PQC.; during administration of PROQUAD to a child, the child moved their arm near t... No additional AE/PQC.; during administration of PROQUAD to a child, the child moved their arm near the end of the dose which caused some of the residual liquid from the syringe to splash into the mother's eyes (; This spontaneous report was received from a Licensed practical nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions were not reported, and concomitant therapies were not reported. On 05-MAY-2025, the patient was vaccinated with dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z003308, expiration date: 21-JUL-2026), dose: 0.5 mL with sterile diluent (MERCK STERILE DILUENT), dose: 0.5 mL (lot # and expiration date were not reported) for prophylaxis. It was reported the child moved their arm near the end of the dose which caused some of the residual liquid from the syringe to splash into the mother's eyes (case#: 2282967 ), on 05-MAY-2025 (Accidental underdose). However, it was reported the licensed practical nurse believed that the child has received the full dose. No additional adverse event reported. This is a several reports from the same reporter. More
2840234 TX 05/09/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 X025116
Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
No additional AE/PQC.; first dose was given on 12/07/2024; second dose given on 02/05/2025; third do... No additional AE/PQC.; first dose was given on 12/07/2024; second dose given on 02/05/2025; third dose given on 03/05/2025; This spontaneous report was received from a pharmacist and refers to a 26-year-old patient of unknown gender. The patient's medical, concurrent conditions and concomitant therapies were not reported. The patient was vaccinated with on 07-DEC-2024 and on 05-FEB-2025 with a first and second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, anatomical location, lot # and expiration date were not reported) respectively for prophylaxis (Inappropriate schedule of product administration). Pharmacist reported that a patient received their third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) prefilled syringe, too early on 05-MAR-2025(lot #X025116, expiration date: 19-MAY-2026), dose: 0.5 mL ( anatomical location was not reported) for prophylaxis (Inappropriate schedule of product administration). Pharmacist reported that the patient was not experiencing any symptoms. More
2840235 CO 05/09/2025 MMRV
MMRV
 MERCK & CO. INC.
MERCK & CO. INC.
 X024656
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
Improperly stored vaccine administered before it expired.; No additional AE; This spontaneous report... Improperly stored vaccine administered before it expired.; No additional AE; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced a temperature excursion on 19-MAR-2025. Because they did not know that temp TRED 30-16R was temperature. Excursion by power outage in the morning, and they did not know, Why we didn't know: On 24-MAR-2025, the patient was vaccinated with an improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #X024656, expiration date: 09-APR-2025) (doses and routes of administration, were not reported) with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion 66 degrees Fahrenheit for 3 hours. There was no adverse effect reported, No product quality complaint was involved. This is one of several reports form the same source. More
2840236 F MA 05/09/2025 HEP
HEP
HEP
HEP
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Extra dose administered, Hepatitis B surface antigen positive; Extra dose admini... Extra dose administered, Hepatitis B surface antigen positive; Extra dose administered, Hepatitis B surface antigen positive; Extra dose administered, Hepatitis B surface antigen positive; Extra dose administered, Hepatitis B surface antigen positive More
HBsAg positive after booster dose; This literature marketed report has been received from the auth... HBsAg positive after booster dose; This literature marketed report has been received from the authors of a published article, and refers to a 24-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included obesity. Concomitant therapies were not reported. On unknown dates, the patient received the series of 3 vaccinations with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (doses, route of administration, lot # and expiration dates were not reported) for prophylaxis. On an unknown date, the patient received additional dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis, due to not having protective HBV antibody titers after 3 doses of HBV vaccine (captured in case# 2277533). On an unknown date, hepatitis B surface antigen (HBsAg) showed positive, which was considered to be a false positive test due to the vaccine. On an unknown date, the patient recovered from the event, as later, on an unknown date (reported as now), the HBsAg was negative. The reporter considered the event to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). This is one of two cases derived from the same literature article (cross referenced with case# 2277533). More
2840237 F TX 05/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fibromyalgia Fibromyalgia
diagnosed with fibromyalgia after receiving Shingrix; This non-serious case was reported by a consum... diagnosed with fibromyalgia after receiving Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of fibromyalgia in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fibromyalgia (Verbatim: diagnosed with fibromyalgia after receiving Shingrix). The outcome of the fibromyalgia was not resolved. It was unknown if the reporter considered the fibromyalgia to be related to Shingrix. It was unknown if the company considered the fibromyalgia to be related to Shingrix. Additional Information: GSK receipt date: 29-APR-2025 The patient reported that after receiving Shingrix vaccine she diagnosed with fibromyalgia. The patient reported fibromyalgia was reported as worsened. The batch/lot number of Shingrix were unknown at the time of reporting. More
2840239 05/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
sore arm; This non-serious case was reported by a consumer via interactive digital media and describ... sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that got a few days ago he/she received dose and also reported that other than a sore arm, no issues was there. More
2840240 05/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Hypersensitivity Hypersensitivity
Allergic reaction; This non-serious case was reported by a consumer via interactive digital media an... Allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergic reaction (Verbatim: Allergic reaction). The outcome of the allergic reaction was not reported. It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. It was unknown if the company considered the allergic reaction to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-APR-2025 The 27 percent peoples get vaccinated with Shingles vaccine and had allergic reaction. More
2840241 05/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity Pain in extremity
just a sore arm for a few days; This non-serious case was reported by a consumer via interactive dig... just a sore arm for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: just a sore arm for a few days). The outcome of the pain in arm was resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 30-APR-2025 This case was reported by a patient via interactive digital media. Just a sore arm for a few days. He/she had both and the shot hurts just as much as the shingles. More
2840242 05/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Inflammation, Pruritus, Vaccination failure Herpes zoster, Inflammation, Pruritus, Vaccination failure
Suspected vaccination failure; just was diagnosed with shingles; This serious case was reported by a... Suspected vaccination failure; just was diagnosed with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: just was diagnosed with shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient just was diagnosed with shingles, it was very mild. Had very little inflammation and small spots mildly itchy. If he/she did not get the immunization shot it would have been hell. He/she broke out under his/her hair on his/her neck. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. More
2840243 05/09/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Abdominal pain, Screaming Abdominal pain, Screaming
colic might not be about an upset stomach/ was in agony for four months; Screaming; This non-serious... colic might not be about an upset stomach/ was in agony for four months; Screaming; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of colic in a patient who received DTPa (Infanrix) for prophylaxis. On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced colic (Verbatim: colic might not be about an upset stomach/ was in agony for four months) and screaming (Verbatim: Screaming). The outcome of the colic was not reported and the outcome of the screaming was resolved. The reporter considered the colic and screaming to be related to Infanrix and Infanrix Pre-Filled Syringe Device. The company considered the colic and screaming to be related to Infanrix and Infanrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 30-APR-2025 This case was reported by the reporter via interactive digital media. The reporter (parent) think colic might not be about an upset stomach. The parent stated that kid was in agony for four months and was screaming for hours. This case is linked with US2025AMR055504, reported by same reporter.; Sender's Comments: US-GSK-US2025AMR055504:same reporter More
2840244 05/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; 7 years later, i developed shingles; This serious case was reported b... Suspected vaccination failure; 7 years later, i developed shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included influenza and bronchial infection. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 7 years later, i developed shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 30-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that had the series of Shingrix when it first came out and 7 years later, consumer developed shingles and had the flu and a bronchial infection earlier. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2840245 74 F MA 05/09/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Contusion, Feeling hot, Headache, Malaise, Pain; Swelling Contusion, Feeling hot, Headache, Malaise, Pain; Swelling
Pain, swelling, severe bruising, heat. Headache, malaise lasting 2 weeks. I also got a flu vaccine ... Pain, swelling, severe bruising, heat. Headache, malaise lasting 2 weeks. I also got a flu vaccine in the right arm that day. No adverse symptoms on that arm. More
2840246 4 M AR 05/09/2025 DTAPIPV
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
 U7908AA
Y015559
Injection site erythema, Injection site pain, Injection site rash, Injection sit... Injection site erythema, Injection site pain, Injection site rash, Injection site swelling; Injection site erythema, Injection site pain, Injection site rash, Injection site swelling More
Upon waking up the morning after the vaccines, 5/7/25, mom noticed his right arm was swollen with sl... Upon waking up the morning after the vaccines, 5/7/25, mom noticed his right arm was swollen with slight redness around the band-aid and the child complained of pain in his arm where he had received the vaccines. At about 4:45 pm, mom notice the redness and swelling was worst and had spread down to his elbow. She also noticed a rash in the area of redness and child stated it was itching. Mom marked the area of redness and swelling to note the area. Mom took him to urgent care. Child was examined, had his temperature taken (it was normal at this time). Mom was told it was probably a reaction to the Dtap in his vaccine. Mom was told to treat with Benadryl and to give him Tylenol or Motrin for the fever and pain. Mom continued the Benadryl every 4 hours after going home. Mom states he slept all night, but he tossed and turned all night. The swelling in his arm was worse this morning, 5/8/25 and the redness was still present and had moved up into his right shoulder. He was given Benadryl at 6:30 am and again at 11:00 am today. At 11:00 the redness did not look as bad, but the swelling was still there. Mom picked child up from school at 4:15 and his arm was still very swollen and red, but the redness seems to be a little better, but has spread to under his arm. He denied having pain. More
2840247 4 F OK 05/09/2025 DTAPIPV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4L454
Z003311
Injection site induration, Injection site swelling, Pain in extremity, Periphera... Injection site induration, Injection site swelling, Pain in extremity, Peripheral swelling, Tenderness; Injection site induration, Injection site swelling, Pain in extremity, Peripheral swelling, Tenderness More
Patient had Kinrix & ProQuad administered to left arm on 5/5/2025. On 5/7/2025, she presented to... Patient had Kinrix & ProQuad administered to left arm on 5/5/2025. On 5/7/2025, she presented to clinic now displaying symptoms of tender/painful & swollen left arm. Symptoms reportedly began 5/7/2025 according to parent. Doctor noted quarter-sized induration & erythema accompanying swelling on the left deltoid. Doctor recommended use of cold pack & children's Motrin to control symptoms. Advised follow-up in 24 hours if symptoms had not subsided. On 5/9/2025, the patient was unable to be reached by phone in order to ascertain if symptoms persisted. Submitted an online MyChart message to the parent inquiring about the status of the patient. No follow-up appointment has been made by the parent at this time. More
2840248 17 M MO 05/09/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 55N34
Injury associated with device, Product administration error Injury associated with device, Product administration error
This nurse inadvertently picked up the meningococcal B syringe that she had just administered into ... This nurse inadvertently picked up the meningococcal B syringe that she had just administered into this patient's R deltoid and inserted it into the L Deltoid, pushed the plunger and noted the plunger had already been depressed. Nurse then realized she had not picked up the Meningococcal (Menquadfi) that she intended to administer, but instead had picked up the used Men B syringe she had just injected into this patient. The needle cover was covering the needle, but had not locked into place. Patient did receive both intended vaccines. More
2840249 39 M VA 05/09/2025 VARCEL
 MERCK & CO. INC.
 Y014868
Inappropriate schedule of product administration Inappropriate schedule of product administration
On April 08/ 2025 , A nurse inadvertently administered varicella vaccine before the minimum interval... On April 08/ 2025 , A nurse inadvertently administered varicella vaccine before the minimum interval. More
2840250 2.75 F PA 05/09/2025 IPV
PNC15
TDAP
 SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
 y1A201M
y005351
u8252aa
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
CLIENT PRESENTED TO CLINIC WITH MOTHER. BEHIND ON VACCINES. NURSE ADMINISTERED OVERDUE VACCINES. CLI... CLIENT PRESENTED TO CLINIC WITH MOTHER. BEHIND ON VACCINES. NURSE ADMINISTERED OVERDUE VACCINES. CLIENT MONITORED FOR 15 MINUTES. NO ADVERSE REACTION. AFTER CLIENT LEFT CLINIC NURSE WENT TO DOCUMENT VACCINES GIVEN AND NOTICED ERROR MADE. TDAP LOT# U8252AA WAS GIVEN INSTEAD OF DTAP. More
2840251 35 F TX 05/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 CT3Z7
Rash, Rash pruritic Rash, Rash pruritic
Patient reported development of an itchy rash on or about 5/2/2025 that started on the right shoulde... Patient reported development of an itchy rash on or about 5/2/2025 that started on the right shoulder and spreading across her chest. More
2840252 79 M NC 05/09/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Arthralgia, Asthenia, Back pain, Chest discomfort, Chest pain; Computerised tomo... Arthralgia, Asthenia, Back pain, Chest discomfort, Chest pain; Computerised tomogram, Dizziness, Dysstasia, Gait disturbance, Impaired driving ability; Musculoskeletal stiffness, Neck pain, Pain, X-ray More
My father had a severe adverse reaction after receiving the Moderna COVID-19 vaccine. He experienced... My father had a severe adverse reaction after receiving the Moderna COVID-19 vaccine. He experienced chest tightness and pain, along with intense stiffness and severe pain in his neck when turning his head in any direction. The pain radiated into his shoulder and upper back. He also experienced weakness and dizziness, which made it difficult for him to walk or stand for extended periods, and he was unable to drive for several days. More
2840253 11 M SC 05/09/2025 DTPPVHBHPB
HPV9
MNQ
TDAP
 MSP VACCINE COMPANY
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 U7776AA
Y010466
U8361AA
U8252AA
Extra dose administered, No adverse event, Wrong product administered; Extra dos... Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered More
VAXELIS WAS GIVEN BY MA IN ERROR. WHEN SHE CHECKED THE VACCINES OUT TO ME I REALIZED SHE HAD PULL VA... VAXELIS WAS GIVEN BY MA IN ERROR. WHEN SHE CHECKED THE VACCINES OUT TO ME I REALIZED SHE HAD PULL VAXELIS INSTEAD OF TDAP. SHE AND I WENT TO PULL THE TDAP AND RETURN VAXELIS TO THE ACCUVAX. SHE PULLS UP THE VAXELIS TO RETURN IT AND PLACE THE HPV VACCINE INTO THE MACHINE INSTEAD OF VAXELIS. AFTER GIVING VACCINES UPON DOCUMENTING SHE NOTICED THE ERROR. SHE THEN NOTIFIED ME, HER SUPERVISOR THAT VAXELIS, TDAP, MCV4 WAS GIVEN. PROVIDER, PATIENT'S MOTHER AND PATIENT NOTIFIED OF ERROR. THE HPV WAS THEN PULLED AND GIVEN TO PATIENT, SO HE RECEIVED ALL VACCINES NEEDED TO BE UP TO DATE. PATIENT WAS OBSERVED IN OFFICE FOR 15MINS. NO SIGN OR SYMPTOMS NOTED. PATIENT'S MOTHER WAS ADVISED TO CALL US OR SEEK MEDICAL CARE, IF ANY SYMPTOM OCCURS. SHE VOICED UNDERSTAND. More
2840254 26 F MI 05/09/2025 COVID19
 PFIZER\BIONTECH
 LN0590
Expired product administered, No adverse event Expired product administered, No adverse event
No adverse outcome, dose was expired. Expiration date was 5/7/2025, it was given on 5/9/2025. No adverse outcome, dose was expired. Expiration date was 5/7/2025, it was given on 5/9/2025.
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