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
2857135 83 M FL 09/06/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 BG5J4
Extra dose administered Extra dose administered
Patient received duplicate vaccine Patient received duplicate vaccine
2857136 0.17 F NY 09/06/2025 RV1
RV1
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Blood bicarbonate normal, Dehydration, Diarrhoea, Metabolic function test, Rotav... Blood bicarbonate normal, Dehydration, Diarrhoea, Metabolic function test, Rotavirus test positive; Vomiting More
Received 2-month old vaccinations (including Rotavirus) on 9/2. Developed symptoms of vomiting, diar... Received 2-month old vaccinations (including Rotavirus) on 9/2. Developed symptoms of vomiting, diarrhea, and low-grade temperatures (100s) the next day. No recent illnesses or others sick at home. She came to the hospital on 9/5 because she was dehydrated, where she was tested and found to be positive for rotavirus on stool PCR. I was the pediatric hospitalist who cared for over in the hospital. Likely an adverse reaction for the rotavirus vaccine. She recovered well with oral rehydration measures in the hospital. No intussusception. I do not know the type/lot number of the vaccine that was given at her pediatrician's office. More
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2857137 0.17 F 09/06/2025 HEP
 MERCK & CO. INC.
 Y014090
Drooling Drooling
Excessive drooling Excessive drooling
2857138 64 F FL 09/06/2025 FLU3
 SANOFI PASTEUR
 u8790ba
Injection site mass, Product administered at inappropriate site Injection site mass, Product administered at inappropriate site
patient states a knot has formed to the side of where the vaccine was administered. patient believes... patient states a knot has formed to the side of where the vaccine was administered. patient believes vaccine may have been slightly too low. More
2857139 56 F KS 09/06/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 37r35
Dysgeusia Dysgeusia
15 mins after getting the vaccine, pt reports metallic taste in her mouth. Denies: numbness tinglin... 15 mins after getting the vaccine, pt reports metallic taste in her mouth. Denies: numbness tingling of tongue, mouth, shortness of breath, coughing, wheezing, chest pain, fainting or feels like throat closing. More
2857140 82 F PA 09/06/2025 PNC21
 MERCK & CO. INC.
 Z006889
Injection site bruising, Injection site erythema, Injection site haematoma, Inje... Injection site bruising, Injection site erythema, Injection site haematoma, Injection site pruritus More
Patient rec'd capvaxive vaccination on 8/30/25 and came to pharmacy 9/6/25 to report an adverse... Patient rec'd capvaxive vaccination on 8/30/25 and came to pharmacy 9/6/25 to report an adverse reaction that began on 9/5/25. The patient's entire left upper arm appeared red. She described it as hot to the touch and itchy. Bruising at the injection site was also visualized. The patient reported this to her doctor who advised benadryl as needed as well as daily zyrtec. More
2857141 2 M IL 09/06/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Decreased appetite, Discomfort, Dyspnoea, Fatigue, Listless; Wrong patient recei... Decreased appetite, Discomfort, Dyspnoea, Fatigue, Listless; Wrong patient received product More
Complaint and Claim Letter for Vaccination Error in a Minor. To Whom It May Concern: On August 25,... Complaint and Claim Letter for Vaccination Error in a Minor. To Whom It May Concern: On August 25, 2025, my son was vaccinated at Health Center. However, on that date, my baby received two vaccines that were meant for another child. When the nurse notified me that he was going to be vaccinated, I told her that he wasn't due for a vaccine; that at the previous appointment, the pediatrician had told me that we were up to date on all his vaccines and the next appointment would be for blood tests and a physical exam. She assured me that he was due for two vaccines and administered them. Then I noticed that the documents she was handing me weren't my son's, and I told her he wasn't on WIC. Apparently, she noticed and took them away from me, saying she'd be right back; I didn't have time to check his name on the documents. But I was already suspicious because I didn't see her again, and another nurse started treating me. I requested the vaccination records, but the vaccines my baby received that day weren't listed. My baby was tired, short of breath, listless, and had no appetite. I no longer had any doubt that something was wrong. I have evidence of how many calls I made without being able to speak with any member of the healthcare team caring for my son. They told me I had to make an appointment, and even though I explained what had happened and that I feared my son's discomfort was due to the vaccines, they told me that I could only have access to the medical team if I made an appointment, and they had appointments for September 12th, and if anything happened to him, I would go to the emergency room. On September 4th, I called, but they didn't answer. I left a message with the nurse saying I needed the results of the tests they had done on August 25th and left contact information. That's how I managed to speak with a nurse. I told her I needed the names of the vaccines my son received that day. She kept me on hold for several minutes. She justified the wait by saying that her computer had shut down and she had to turn everything back on. She told me that the vaccines given were Hib and DTaP, and that they didn't cause those reactions or cause the flu. At this point, I don't trust any information anymore because they were clearly covering up the mistake they made and weren't able to tell me the truth. They lied to me, and I no longer trust anything they tell me unless they show me the vaccination record with the lot, date, inventory, and name of my son or the other child who was due. I have many reasons to distrust that they're telling the truth this time because in another call that same day with another nurse, she told me there were no vaccination records for my son, and those vaccines also don't appear in the record they gave me on August 25th. And then she asks me if I'd spoken with another nurse recently and tells me that I'd already been given the names of the vaccines and if I needed anything else. Not satisfied, I tried to access my son's patient portal and couldn't. I called support and asked for help. When I gave all my son's information to the agent who took the call, he hung up and left the interpreter and me alone. Then I got a call from the clinic. The person identified himself. He told me there had been a vaccination error. I told him that I had already discovered it and that I have an appointment on the 12th to analyze this incident. I need the nurse to accept her mistake and the consequences so she doesn't put another child's life at risk. Because she should have immediately acknowledged her error, and the clinic should have been attentive and monitoring my son's progress after the incompetence of one of its health professionals. I knew that my son had received all the doses corresponding to his age according to the childhood vaccination schedule and his medical record, and I let her know. This error represents an unnecessary administration of vaccines, which can increase the risk of adverse reactions and reflects a serious failure in the pre-immunization verification protocol. More
2857142 75 M 09/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 NR4T5
Herpes zoster, Pain Herpes zoster, Pain
Patient got Shingles 3 days after receiving Shingrix and was treated with Valtrex and Norco for pain... Patient got Shingles 3 days after receiving Shingrix and was treated with Valtrex and Norco for pain. More
2857143 56 F FL 09/06/2025 FLU3
 SANOFI PASTEUR
 u8790aa
Erythema, Muscle swelling Erythema, Muscle swelling
patient stated her bicep muscle felt swollen and red the next day after vaccine patient stated her bicep muscle felt swollen and red the next day after vaccine
2857144 71 F SC 09/06/2025 FLU3
HEP
 SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
 U8764DB
946064
Injection site erythema, Injection site infection, Injection site swelling, Inje... Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth; Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth More
Patient came to pharmacy on 9/6/25 and said she went to the urgent care and the nurse practitioner s... Patient came to pharmacy on 9/6/25 and said she went to the urgent care and the nurse practitioner sent her in an antibiotic. She said the nurse practitioner told patient the site was infected. I looked at the sight and it was red, a little swollen and warm to touch at the injection site. More
2857145 56 F FL 09/06/2025 FLU3
 SEQIRUS, INC.
Pruritus, Urticaria, Vasculitis Pruritus, Urticaria, Vasculitis
Flucelvax 2025-2026 Vasculitis on back of legs. Swollen hives, very itchy. My husband received a va... Flucelvax 2025-2026 Vasculitis on back of legs. Swollen hives, very itchy. My husband received a vaccine right after I did and is having the same symptoms. More
2857146 12 F 09/06/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 H4K3S
Dizziness, Nausea, Syncope Dizziness, Nausea, Syncope
Patient received Varivax in left arm. Technician then administered Boostrix in right arm. Patient be... Patient received Varivax in left arm. Technician then administered Boostrix in right arm. Patient became lightheaded and nauseated. She did briefly faint onto her mother. She did not fall or injure herself. Provided water and advised to put head between knees if dizziness persists. No chest tightness, breathing or heart issues. No sign of anaphylaxis. Patient recovered within 20 minutes and left the pharmacy feeling much better More
2857147 56 F MA 09/06/2025 FLU3
PNC21
 SEQIRUS, INC.
MERCK & CO. INC.
 406985
z005765
Gastrointestinal disorder, Headache, Pyrexia, Rash; Gastrointestinal disorder, H... Gastrointestinal disorder, Headache, Pyrexia, Rash; Gastrointestinal disorder, Headache, Pyrexia, Rash More
The patient came to the pharmacy on 9/5/25 and described to have experienced GI symptoms , fever ,he... The patient came to the pharmacy on 9/5/25 and described to have experienced GI symptoms , fever ,headache and a rash on her left fore arm. More
2857148 77 M FL 09/06/2025 RSV
 PFIZER\WYETH
 LN5466
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient received Arexvy vaccine on 12/04/2023. The RSV vaccine is indicated for only 1 vaccine in a... Patient received Arexvy vaccine on 12/04/2023. The RSV vaccine is indicated for only 1 vaccine in a lifetime. Patient received a dose of the Abrysvo RSV vaccine on 09/05/2025 which is a duplicate vaccine outside the recommended guideline of only 1 in a lifetime. Patient has experienced no side effects or adverse reactions at this time. More
2857149 17 F TX 09/06/2025 FLU3
MENB
 SANOFI PASTEUR
NOVARTIS VACCINES AND DIAGNOSTICS

Chills, Headache, Influenza like illness, Pain, Pyrexia; Chills, Headache, Influ... Chills, Headache, Influenza like illness, Pain, Pyrexia; Chills, Headache, Influenza like illness, Pain, Pyrexia More
FEVER, CHILLS, HEADACHE, BODY ACHES, MODERATELY SEVERE FLU-LIKE SYMPTOMS NECESSITATING EMERGENCY ROO... FEVER, CHILLS, HEADACHE, BODY ACHES, MODERATELY SEVERE FLU-LIKE SYMPTOMS NECESSITATING EMERGENCY ROOM EVALUATION & TREATMENT. More
2857150 22 F GA 09/06/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Dizziness, Dyspnoea, Erythema, Feeling cold, Heart rate increased; Tremor Dizziness, Dyspnoea, Erythema, Feeling cold, Heart rate increased; Tremor
Patient had allergic reaction to vaccination - turned red, trouble breathing, increase heart rate, f... Patient had allergic reaction to vaccination - turned red, trouble breathing, increase heart rate, felt cold and trembling, dizziness - administered epipen and contacted 911, EMT arrived and checked patient vitals, epipen stabilized patient and she declined riding ambulance to hospital, but was planning on following up with urgent care More
2857151 40 F CA 09/06/2025 PNC20
 PFIZER\WYETH
 MA2523
Flushing, Peripheral coldness, Pruritus Flushing, Peripheral coldness, Pruritus
Patient initially complained of cold hands, then flushing, itching. Patient was given, Benadryl, an... Patient initially complained of cold hands, then flushing, itching. Patient was given, Benadryl, and Pepcid. More
2857152 63 F VA 09/06/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 p2443
p2443
Asthenia, Blood glucose decreased, Dizziness, Feeling hot, Hyperhidrosis; Immedi... Asthenia, Blood glucose decreased, Dizziness, Feeling hot, Hyperhidrosis; Immediate post-injection reaction, Nausea, Pain in extremity, Paraesthesia More
immediately upon administration patient complained of the following: tingle in arm, my arm really h... immediately upon administration patient complained of the following: tingle in arm, my arm really hurts, sweating, feels nauseous, feels like fainting, hot, weak. More
2857197 2 M NY 09/06/2025 FLU3
 SEQIRUS, INC.
 406995
Injection site reaction Injection site reaction
Local reaction from injection site to proximal elbow. Reassurance, cool compress, monitor over next ... Local reaction from injection site to proximal elbow. Reassurance, cool compress, monitor over next 48 hours More
2856933 17 PA 09/05/2025 HEPA
 MERCK & CO. INC.
 Y017625
Incorrect dose administered Incorrect dose administered
no patient symptoms have been reported; an adult dose of VAQTA was inadvertently administered to a p... no patient symptoms have been reported; an adult dose of VAQTA was inadvertently administered to a pediatric patient; an adult dose of VAQTA was inadvertently administered to a pediatric patient; This spontaneous report was received from a nurse regarding a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 25-AUG-2025, the pediatric patient was inadvertently vaccinated with an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA) 50/1.0 U/ml Injection, 1 dosage form administered as prophylaxis (lot number reported as Y017625, which has been verified as valid, expiration date reported and validated 11-JUL-2026) (Accidental overdose, Product administered to patient of inappropriate age). No symptoms had been reported in the patient. This is 1 of 2 reports from the same reporter. More
2856934 F CO 09/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Allergy to plants, Incomplete course of vaccination, Seasonal allergy Allergy to plants, Incomplete course of vaccination, Seasonal allergy
allergic reaction to the plants; This non-serious case was reported by a consumer via sales rep and ... allergic reaction to the plants; This non-serious case was reported by a consumer via sales rep and described the occurrence of allergic reaction in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included allergy (plant/pollen allergies). Additional patient notes included Other Products: Not Provided. In JUL-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). In AUG-2024, less than 2 months after receiving Shingrix, the patient experienced allergic reaction (Verbatim: allergic reaction to the plants). In AUG-2024, the outcome of the allergic reaction was unknown. The reporter considered the allergic reaction to be unrelated to Shingrix. The company considered the allergic reaction to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 07-AUG-2025 and 08-AUG-2025. The patient reported that she received her first Shingrix dose in JUL-2024 and had not yet had the 2nd dose. She reported that, after her first dose, she developed an allergic reaction to the plants in her new residential surroundings. Her doctor stated to her that it was due to plant/pollen allergies, and not Shingrix. The patient inquired about the Shingrix vaccine, noting that they had received the first dose the previous year. Due to other medical complications, they had been unable to follow up with the second dose and had not revisited the matter until the current year. Upon seeking guidance regarding the necessity of the second shot, they were informed that it was indeed required. More
2856947 34 M MI 09/05/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052549
407799
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Requested appointment for Moderna mNEXSPIKE 2025-2026 vaccine. This variant was confirmed on the app... Requested appointment for Moderna mNEXSPIKE 2025-2026 vaccine. This variant was confirmed on the appointment confirmation email. At no point during the vaccination was I told a different variant was being used. Post vaccination record shows I was actually injected with Moderna SPIKEVAX 2025-2026 vaccine. Additionally the vaccine record shows both injections were given in left arm, but were actually given in the right arm. More
2856948 51 F WA 09/05/2025 PNC21
 MERCK & CO. INC.
 Z003579
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
PT EXPERIENCED REDNESS OF ARM NOT AT INJECTION SITE, BUT BELOW AND DOWN PAST ELBOW. VERY TENDER AND ... PT EXPERIENCED REDNESS OF ARM NOT AT INJECTION SITE, BUT BELOW AND DOWN PAST ELBOW. VERY TENDER AND SWOLLEN, STARTED AROUND DAY 3 AFTER VACCINE. PT WENT TO DR ON 9/4 AND GOT ANTIBIOTICS. More
2856949 23 F NC 09/05/2025 COVID19
 JANSSEN
Autoimmune disorder, Influenza like illness, Mast cell activation syndrome, Post... Autoimmune disorder, Influenza like illness, Mast cell activation syndrome, Postural orthostatic tachycardia syndrome More
Developed flu like symptoms and autoimmune and MCAS a week later. Developed flu like symptoms and autoimmune and MCAS a week later.
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2856960 09/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
suspected vaccination failure; after getting shots I still get them hurts like no other; This seriou... suspected vaccination failure; after getting shots I still get them hurts like no other; 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: after getting shots I still get them hurts like no other). 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: 22-AUG-2025 This case was reported by a patient via interactive digital media. The patient stated no one knew shingles unless get them and after getting shots, he/she still got them (shingles) hurts like no other. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2856961 09/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Oral herpes zoster, Vaccination failure Herpes zoster, Oral herpes zoster, Vaccination failure
Suspected vaccination failure; shingles in my mouth; shingles in my cuticles and nail beds; This se... Suspected vaccination failure; shingles in my mouth; shingles in my cuticles and nail beds; 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), oral herpes zoster (Verbatim: shingles in my mouth) and shingles (Verbatim: shingles in my cuticles and nail beds). The outcome of the vaccination failure, oral herpes zoster and shingles were not reported. It was unknown if the reporter considered the vaccination failure, oral herpes zoster 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 oral herpes zoster and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a Patient via interactive digital media. Patient supposed the vaccine had worked for him/her. He/she had not had shingles on his/her body, but he/she had experienced it in his/her mouth, cuticles, and nail beds. 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: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2856962 26 F OH 09/05/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Pruritus, Rash Pruritus, Rash
it is an intense rash; itching on arm; This non-serious case was reported by a other health professi... it is an intense rash; itching on arm; This non-serious case was reported by a other health professional via call center representative and described the occurrence of rash in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 11-JUN-2025, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced rash (Verbatim: it is an intense rash) and itchy upper limbs (Verbatim: itching on arm). The outcome of the rash and itchy upper limbs were unknown. It was unknown if the reporter considered the rash and itchy upper limbs to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the rash and itchy upper limbs to be related to Boostrix and Boostrix 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: 19-AUG-2025 Reporter stated that a patient presented after receiving Boostrix: The patient had a dermatological issue and was trying to attribute to Latex allergy. So, it was an intense rash and itching. She had some spots that she has itched open. Reporter stated that it had only seemed to be on the arm she received the vaccine. It was very bizarre. Was seen in the ED for symptoms. More
2856963 67 09/05/2025 TDAP
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
intentional age prescription by hcp: the patient is 67 years old per package insert, adacel is appro... intentional age prescription by hcp: the patient is 67 years old per package insert, adacel is approved for use in persons 10 through 64 years of age with no reported adverse event; Initial information received on 03-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves intentional age prescription by hcp (healthcare professional): the patient is 67 years old per package insert, Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] is approved for use in persons 10 through 64 years of age with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient had intentional age prescription by hcp of dosage 0.5 ml suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number, expiry not reported) via intramuscular route in unknown administration site as helps protect against tetanus, diphtheria, and pertussis with no reported adverse event (off label use) (latency: same day). Action taken: not applicable. More
2856994 0.75 MD 09/05/2025 MMR
 UNKNOWN MANUFACTURER
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
no AE; 9-month-old vaccinated with MMR; 9-month old child was inadvertently vaccinated with mmr whil... no AE; 9-month-old vaccinated with MMR; 9-month old child was inadvertently vaccinated with mmr while on dupilumab; This spontaneous report was received from an other health professional and refers to a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-MAY-2025, the patient started therapy with dupilumab (DUPIXENT) solution for injection (strength, dose, frequency, route of administration, indication, expiration date, and lot # were not reported). On 23-MAY-2025, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) injection (reported as "MMR vaccine"), administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported) while on dupilumab (DUPIXENT) without presciber's knowledge (Product administered to patient of inappropriate age, Contraindicated product administered). The vaccine was reconstituted with sterile diluent (lot# and expiration date not reported). No adverse event was reported. Action taken with dupilumab (DUPIXENT) was reported as dose not changed. Lot# is being requested and will be submitted if received. More
2856995 RI 09/05/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y014437
Y011018
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
no additional adverse event reported; Inbound call from nurse who reports a 14 month old was given V... no additional adverse event reported; Inbound call from nurse who reports a 14 month old was given VARIVAX and PROQUAD on the same day, one vaccine in each leg. Date of administration was 7/30/2025 and there have been no reported side effects or symptoms at this time. No additional AE de; Information has been received from Business Partner/CRO on 11-Aug-2025. This spontaneous report was received from a Other health professional 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 30-Jul-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y014437, expiration date: 22-Feb-2026) for an unknown indication. On 30-Jul-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y011018, expiration date: 18-Jun-2026) for an unknown indication. On 30-Jul-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). On 30-Jul-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) (Overdose). No additional adverse event reported. More
2856996 F MA 09/05/2025 HPV9
 MERCK & CO. INC.
 Y010802
Exposure during pregnancy, No adverse event, Product use issue Exposure during pregnancy, No adverse event, Product use issue
Pharmacist reports patient that is pregnant received her first dose of GARDASIL 9 yesterday. Pharmac... Pharmacist reports patient that is pregnant received her first dose of GARDASIL 9 yesterday. Pharmacist consents to follow-up via email but does not wish to provide patient information at time of call due to not having consent from patient. No additi; No additional adverse event reported; Information has been received from Business Partner/CRO on 12-Aug-2025. This spontaneous Prospective pregnancy report was received from a Pharmacist and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-Aug-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), (lot #Y010802, expiration date: 01-Jan-2027), dose number 1, for an unknown indication. On an unknown date, the patient reported that the patient was pregnant received her first dose of GARDASIL 9 yesterday (Vaccine exposure during pregnancy). No additional adverse event was reported. This pregnancy involved 1 fetus. The patient's gravidity was reported as 0. The patient's parity was reported as 1. More
2856997 VA 09/05/2025 HPV9
 MERCK & CO. INC.
 Y013565
No adverse event, Product storage error No adverse event, Product storage error
no adverse reactions were experienced after the administered dose; HBP (in charge of vaccine storage... no adverse reactions were experienced after the administered dose; HBP (in charge of vaccine storage) called to report TE occurring on 8/16/2025 and 8/17/2025 for GARDASIL-9 and VAQTA that were administered after TE on 8/18/2025. (one patient was administered VAQTA & GARDASIL-9; and 3 patients were administered GARD; This spontaneous report was received from an Administrator / Supervisor (Office Manager) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 18-Aug-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (reported as injection) (valid lot #Y013565, expiration date: 01-Feb-2027) 0.5 mL administered for prophylaxis. Administered dose of suspect vaccine was exposed to the temperature excursion on 16-AUG-2025 and 17-AUG-2025: 1.5 Celsius degrees (C) for 2 hours, 24 minutes, 0 seconds and 0.9 C for 5 hours, 14 minutes, 0 seconds (product storage error, onset date: 18-Aug-2025). Previous temperature excursion was reported as on 08-JUL-2025: 8.3 C for 0 hours, 44 minutes, 0 seconds. There was no additional adverse event reported (no adverse event). This is one of several reports received from the same reporter. More
2856998 VA 09/05/2025 HPV9
 MERCK & CO. INC.
 Y013565
No adverse event, Product storage error No adverse event, Product storage error
no adverse reactions were experienced; TE occurring on GARDASIL-9 and was administered after TE on 8... no adverse reactions were experienced; TE occurring on GARDASIL-9 and was administered after TE on 8/18/2025; Information has been received from an office manager, referred to a patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant therapy were not reported. On 18-Aug-2025, the patient vaccinated with improperly stored Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection (0.5 ml, frequency: total, lot #Y013565, expiration date: 01-Feb-2027, route, dose number unknown) for prophylaxis (Improper storage of product in use). No adverse reactions were experienced after the administered dose. The vaccine was exposure to temperature of 1.5 degree Celsius(C) for 2 hours and 24 minutes and 0.9 C for 5 hours and 14 minutes. The prior excursion was reported as on 08-Jul-2025, exposure to temperature of 8.3 C for 44 minutes. This is one of four cases received from the same reporter. More
2856999 F WV 09/05/2025 PNC13
PNC20
PPV
 PFIZER\WYETH
PFIZER\WYETH
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 More
she had received multiple pneumococcal vaccines, potentially too close together; No adverse event; T... she had received multiple pneumococcal vaccines, potentially too close together; No adverse event; This spontaneous report was received from the 75-year-old female patient, concerning herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), 0.5 mL administered by Unknown route (lot # and expiration date were not reported) for prophylaxis, with PREVNAR 13 and with PREVNAR 20 administered by Unknown route (indication, expiration date, and lot # were not reported). The patient had received multiple pneumococcal vaccines such as Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), PREVNAR 13 and PREVNAR 20, potentially too close together (Inappropriate schedule of product administration). No adverse event was reported. Batch/Lot number is being requested and will be submitted if received. More
2857000 M OH 09/05/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional adverse events were reported; A medical assistant called and reported that a male 5 ye... No additional adverse events were reported; A medical assistant called and reported that a male 5 year old twin and a female 5 year old twin both received a dose of GARDASIL 9 inadvertently.; This spontaneous report was received from an Other health professional (Medical Assistant) and refers to a 5-year-old twin male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event). This is one of two reports received from the same reporter (refers to other twin patient). Additional information is not expected. More
2857001 NY 09/05/2025 VARCEL
 MERCK & CO. INC.
 Y013349
No adverse event, Product storage error No adverse event, Product storage error
No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD ... No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD to any of the patients involved./No additional AE; HCP called to report TE occurring on 6/20/2025 for VARIVAX and PROQUAD that were administered on multiple different dates to multiple patients.; 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 24-Jun-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, lot # Y013349, expiration date: 02-Aug-2026 (dose number, route of administration and anatomical location were not reported), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). On 20-Jun-2025, the vaccine underwent a temperature excursion of ๏ฟฝ 10 up to 8 (-4.76) Celsius (C) degrees for 30 minutes. There were no previous excursions. No additional adverse event was reported. The action taken with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and sterile diluent (Hollister-Stier STERILE DILUENT) was considered as not applicable. This is one of several reports from the same reporter. More
2857002 NY 09/05/2025 MMRV
 MERCK & CO. INC.
 Z003307
No adverse event, Product storage error No adverse event, Product storage error
No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD ... No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD to any of the patients involved./No additional AE; HCP called to report TE occurring on 6/20/2025 for VARIVAX and PROQUAD that were administered on multiple different dates to multiple patients.; 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 14-Aug-2025, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, 0.5 ml, lot # Z003307, expiration date: 21-Jul-2026 (dose number, route of administration and anatomical location were not reported), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). On 20-Jun-2025, the vaccine underwent a temperature excursion of ๏ฟฝ 10 up to 8 (-4.76) Celsius (C) degrees for 30 minutes. There were no previous excursions. No additional adverse event was reported. The action taken with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and sterile diluent (Hollister-Stier STERILE DILUENT) was considered as not applicable. This is one of several reports from the same reporter.; Reporter's Comments: Keywords : MUL More
2857004 UT 09/05/2025 MMR
 MERCK & CO. INC.
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
a MMR II vaccine was inadvertently administered to a patient via IV; No additional AE/PQC reported.;... a MMR II vaccine was inadvertently administered to a patient via IV; No additional AE/PQC reported.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) inadvertently via intravenous (IV) for prophylaxis (wrong route). No additional adverse event (AE) was reported (no adverse event). This is a non-valid case due to unknown patient. More
2857005 TX 09/05/2025 VARCEL
 MERCK & CO. INC.
 S024362
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE reported; a patient received an expired dose of VARIVAX; This spontaneous report wa... No additional AE reported; a patient received an expired dose of VARIVAX; This spontaneous report was received from a consumer or other non-health professional 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 10-SEP-2021, the received an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (dose, route of administration, anatomical location were not reported, lot number S024362 which was verified to be valid, expiration date not reported but upon internal review established on 06-AUG-2021). the expired vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT). for prophylaxis. There was no adverse event reported. This is an invalid case due to the lack of patient identifiers. More
2857006 M RI 09/05/2025 PPV
UNK
 MERCK & CO. INC.
UNKNOWN MANUFACTURER

Pneumonia; Pneumonia Pneumonia; Pneumonia
pneumonia; pneumonia; pneumonia; pneumonia; pneumonia; pneumonia; pneumonia; This spontaneous report... pneumonia; pneumonia; pneumonia; pneumonia; pneumonia; pneumonia; pneumonia; This spontaneous report was received from a pharmacist on 03-Sep-2025, referring to an 82-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included COPD. Concomitant medications included Steroids. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), Pneumococcal vaccine conj 7v (CRM197) (PREVNAR) (reported as PREVNAR 12, conflicting information) (lot # and expiration date were not reported) as vaccination due to high risk of contracting pneumonia. In approximately 1995 (reported as about 30 years ago), he had pneumonia 6 times in 1 year. Most recent history of pneumonia was 2023. In June 2024, the patient was vaccinated with Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20). At the time of reporting, the outcome of the events was unknown. The action taken with the suspect vaccines was not applicable. The causal relationship between the events and the suspect vaccines was not provided. Upon internal review, the events of pneumonia were determined to be medically significant. More
2857007 FL 09/05/2025 RVX
 UNKNOWN MANUFACTURER
 2142142
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; temperature excursion; This spontaneous invalid report was received from a/an Cons... no adverse event; temperature excursion; This spontaneous invalid report was received from a/an Consumer or other non health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Sep-2025, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2142142, expiration date: 09-Jun-2026) administered by Oral route. On 04-Sep-2025, the patient experienced temperature excursion (temperature: 67.8 F ; Time frame: 48 hours 56 minutes). There was no previous temperature excursion. No adverse event was reported. This is an invalid report due to lack of patient's identifiers. More
2857008 F OH 09/05/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional adverse events were reported; A medical assistant called and reported that a male 5 ye... No additional adverse events were reported; A medical assistant called and reported that a male 5 year old twin and a female 5 year old twin both received a dose of GARDASIL 9 inadvertently.; This spontaneous report was received from an Other health professional (Medical Assistant) and refers to a 5-year-old twin female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event). This is one of two reports received from the same reporter (refers to other twin patient). Additional information is not expected. More
2857009 VA 09/05/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 h4k3s
Circumstance or information capable of leading to medication error, Syringe issu... Circumstance or information capable of leading to medication error, Syringe issue More
extra needle stick; administer a dose of BOOSTRIX to a patient, she could not depress the plunger; S... extra needle stick; administer a dose of BOOSTRIX to a patient, she could not depress the plunger; Syringe isue; Defect was discovered after partial use of the box - this was the last dose in the box.; This non-serious case was reported by a non-health professional via call center representative and described the occurrence of needle stick/puncture in a adult patient who received DTPa (Reduced antigen) (Boostrix) (batch number h4k3s) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced needle stick/puncture (Verbatim: extra needle stick), accidental underdose (Verbatim: administer a dose of BOOSTRIX to a patient, she could not depress the plunger), syringe issue (Verbatim: Syringe isue) and pharmaceutical product complaint (Verbatim: Defect was discovered after partial use of the box - this was the last dose in the box.). The outcome of the needle stick/puncture was unknown and the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the needle stick/puncture and syringe issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the needle stick/puncture and syringe issue to be related to Boostrix and Boostrix 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: 07-AUG-2025 The reporter was the healthcare professional who stated that a when attempting to administer a dose of Boostrix to a patient, she could not depress the plunger and had to use another dose. The defect was discovered after partial use of the box, this was the last dose in the box. When she encountered the initial resistance, she took the needle out from the patient. After manipulation, she was eventually able to push it. She used a different dose to administer to the patient. More
2857010 69 M VA 09/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ny2at
Product preparation issue Product preparation issue
Inappropriate preparation of medication; Inappropriate dose of vaccine administered; This non-seriou... Inappropriate preparation of medication; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number ny2at) for prophylaxis. On 20-AUG-2025, the patient received Shingrix. On 20-AUG-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate preparation of medication) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 25-AUG-2025 The reporter reported that patient accidentally received 2 vials of adjuvant instead of reconstituted Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2857011 74 F NY 09/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 GJ952
Inappropriate schedule of product administration Inappropriate schedule of product administration
Her second Shingrix dose was mistakenly given early on 25 Aug 2025; This non-serious case was report... Her second Shingrix dose was mistakenly given early on 25 Aug 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number GJ952, expiry date 25-APR-2027) for prophylaxis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On 25-AUG-2025, the patient received the 2nd dose of Shingrix. On 25-AUG-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Her second Shingrix dose was mistakenly given early on 25 Aug 2025). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 26-AUG-2025 The reporter was the pharmacist. A female patient received her first Shingrix dose. Her second Shingrix dose was mistakenly given early which led to drug dose administration interval too short. Nothing else was reported. More
2857012 30 F PA 09/05/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 D4J9J
Exposure during pregnancy Exposure during pregnancy
Drug exposure during pregnancy; This non-serious prospective pregnancy case was reported by a nurse ... Drug exposure during pregnancy; This non-serious prospective pregnancy case was reported by a nurse via registry and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number D4J9J, expiry date 11-JUL-2027) for prophylaxis. On 06-AUG-2025, the patient received the 1st dose of Boostrix (intramuscular). On an unknown date, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug exposure during pregnancy). The outcome of the vaccine exposure during pregnancy was not applicable. Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 07-AUG-2025 The patient received Boostrix during pregnancy. More
2857013 09/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Decreased appetite, Influenza like illness, Nausea, Pain, Pyrexia Decreased appetite, Influenza like illness, Nausea, Pain, Pyrexia
Felt like had flu/Ran fever/aches and pains/no appetite/felt nauseous; This non-serious case was rep... Felt like had flu/Ran fever/aches and pains/no appetite/felt nauseous; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 13-AUG-2025, the patient received the 2nd dose of Shingles vaccine. In AUG-2025, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Felt like had flu/Ran fever/aches and pains/no appetite/felt nauseous). The outcome of the influenza-like symptoms was resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine. It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine. Additional Information: GSK receipt date: 18-AUG-2025 The case was received from the patient via interactive digital media. The patient felt like he or she had the flu until Sunday ante meridiem (17-AUG-2025). All the symptoms the pharmacist told him or her. The patient did not want to get the shingles though. A good friend of the patient had it for 17 weeks. More
2857014 MD 09/05/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Extra dose administered Extra dose administered
Extra Vaccine Administered (Trumenba); This non-serious case was reported by a physician via call c... Extra Vaccine Administered (Trumenba); This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (patient had 1st dose on unknown date). On 19-MAR-2025, the patient received the 2nd dose of Bexsero. On 08-JAN-2025, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: Extra Vaccine Administered (Trumenba)). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 19-AUG-2025 Child B received 2nd dose of Bexsero on March 19, 2025. reporter asked if need to administer a 3rd dose of Bexsero or are the 2 doses sufficient for immunogenicity. This case is linked with US2025106910 reported by same reporter.; Sender's Comments: US-GSK-US2025106910:same reporter different patient More
2857015 09/05/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete cours... Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete course of vaccination More
Shingles; received 1st shot of Shingrix couple of years ago and going to get the Shingrix shot again... Shingles; received 1st shot of Shingrix couple of years ago and going to get the Shingrix shot again in the next week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (I got Shingles when I was 35 years old, I contracted Shingles again and again) and pain (I was in severe pain through it). On an unknown date, the patient received the 1st dose of Shingrix and did not receive 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) and had incomplete course of vaccination (Verbatim: received 1st shot of Shingrix couple of years ago and going to get the Shingrix shot again in the next week). The outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a patient via interactive digital media. Patient had shingles when he/she was 35, and it was extremely painful. Patient kept getting it again and again, so he/she got the Shingrix vaccine a couple of years ago. The last episode was not as bad. He/she planned to get another Shingrix shot within the next week or two, hoping it would prevent shingles from coming back again. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2857016 09/05/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Rash pruritic, Skin burning sensation, Vaccination failure Herpes zoster, Rash pruritic, Skin burning sensation, Vaccination failure
Suspected vaccination failure; believe shingles; burning and itchy rash; burning and itchy rash; Thi... Suspected vaccination failure; believe shingles; burning and itchy rash; burning and itchy rash; 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. In AUG-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: believe shingles), itchy rash (Verbatim: burning and itchy rash) and burning sensation (Verbatim: burning and itchy rash). The outcome of the vaccination failure, shingles, itchy rash and burning sensation were not reported. It was unknown if the reporter considered the vaccination failure, shingles, itchy rash and burning sensation 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, itchy rash and burning sensation to be related to Shingles vaccine. Additional Information: GSK receipt date: 22-AUG-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine but have had a rash this past week that was burning and itchy. The patient just came back from dermatologist, and they believed he/she had shingles. The patient was starting the treatment as he/she wrote this. 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: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
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