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
2826279 77 F OH 02/14/2025 COVID19
 NOVAVAX
Acute kidney injury, Blood creatinine increased Acute kidney injury, Blood creatinine increased
Acute Kidney Injury (AKI) unknown cause per nephrology consultation atnephrology on Feb 14, 2025. I... Acute Kidney Injury (AKI) unknown cause per nephrology consultation atnephrology on Feb 14, 2025. I am a physician and strongly suspect AKI as a vaccine adverse reaction because there were no other interventions, medication changes, changes in health or activity, NSAID use, recreational drug use or other precipitant. Nephro also diagnosed Chronic Renal Insufficiency as a result of AKI based on duration of renal injury. More
2826280 61 M CA 02/14/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8732
ER8732
EW0158
EW0158
Acute myocardial infarction, Cholecystectomy, Cholecystitis, Coronary artery byp... Acute myocardial infarction, Cholecystectomy, Cholecystitis, Coronary artery bypass, Endocarditis; Pneumonia, Pneumothorax, Sepsis; Acute myocardial infarction, Cholecystectomy, Cholecystitis, Coronary artery bypass, Endocarditis; Pneumonia, Pneumothorax, Sepsis More
29-Dec-21, Inflammatory Heart attack Hospitalized (Medical Center) from 12/29/2021 to 12/31/2021 Not... 29-Dec-21, Inflammatory Heart attack Hospitalized (Medical Center) from 12/29/2021 to 12/31/2021 Note: transferred to Medical Center for surgery. 04-Jan-22, CABG Triple Bypass surgery, Hospitalized (Medical Center) from 01/01/22 to 01/11/22, Cardiologist: Dr., Surgeon: Dr. Internal Medicine - Cardiovascular Disease 25-Jan-22, Emergency Room Visit, Diagnosis: Tachycardia, 01-Mar-22, Emergency Room Visit, Hospitalized (MC) from 03/01/22 to 03/14/22, Diagnosis: Cholecystitis, Physician: Dr. Internal Medicine 06-May-22, Day surgery ๏ฟฝ Cholecystectomy, Hospitalized (MC) from 05/06/22 to 05/28/22 Physician: Dr. General Surgeon 06-May-22, Post-day surgery Cholecystectomy, Hospitalized (MC) from 05/06/22 to 05/28/22 Surgeon: Dr., Physician: Dr., Physician: Dr. Diagnosis: Numerous problems were encountered after the day-surgery procedure. (Sepsis, pneumonia, and a collapsed lung) 18-Jul-22, Endocarditis, Hospitalized (MC) from 7/18/22 to 07/28/22 Cardiologist: Dr., Infectious Disease: Dr. 15-Sep-22, Pneumonia, Hospitalized from 09/15/22 to 09/18/22 Physician: Dr., Physician: Dr. 08-Nov-22, Pneumonia and Residual Endocarditis, Hospitalized from 11/08/22 to 11/19/22, Physician: Dr., Physician: Dr., Infectious Disease: Dr. 10-Apr-23, Acute Myocardial Infarction, Hospitalized (MC) from 04/10/23 to 04/12/23 Physician Dr., Cardiologist Dr. More
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2826282 11 F MI 02/14/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB043A
No adverse event, Product preparation issue No adverse event, Product preparation issue
Medication was never mixed with the powder - unaware medication needed to be reconstituted. Pt was o... Medication was never mixed with the powder - unaware medication needed to be reconstituted. Pt was only given Saline only into Right deltoid on 02/11/2025 at 1425. No harm done to the pt. Mother notified that vaccine was not actually given (only saline) and patient will need to have this completed at a later date. Verbalized understanding. More
2826283 75 F MN 02/14/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EM9809
EN6202
FF8841
GH9697
Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test; Chills, Fatigue, Headache, ... Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test; Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test; Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test; Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test More
Mild fevers, chills, headache, fatigue Mild fevers, chills, headache, fatigue
2826284 68 F CO 02/14/2025 COVID19
 PFIZER\BIONTECH
 LM7786
Inappropriate schedule of product administration Inappropriate schedule of product administration
Vaccine was given out of the CDC recommended guidelines of once every 6 months. Patient received vac... Vaccine was given out of the CDC recommended guidelines of once every 6 months. Patient received vaccine at approximately 3 months from previous covid vaccine More
2826285 0.83 F SC 02/14/2025 DTPPVHBHPB
DTPPVHBHPB
 MSP VACCINE COMPANY
MSP VACCINE COMPANY
 U7767AA
U7767AA
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient seen in office for WCC with twin brother (Mom, Dad, Grandmother all present for visit). Vacc... Patient seen in office for WCC with twin brother (Mom, Dad, Grandmother all present for visit). Vaccines ordered by Dr. (Vaxelis & PCV20) for both twins for their WCC's. Upon entry there was a discussion of what was easiest for the parents regarding vaccine admin & holding in laps or on the table. CCMA and RN were in room together and had each brought in a tray apiece. The trays were further away from RN as they were reviewing the vaccines. CCMA had grabbed the Vaxelis (which she was entered for) and RN grabbed for the PCV20 but grabbed from the siblings tray so she had the Vaxelis in her hand. Because they had already stated which vaccines they were administering, she didn't say it again. Upon administering the dose, they realized that both had given the vaxelis vaccine (we give vaccines with 2 people, both shots at the same time to decrease the time child is getting the vaccines). CCMA and RN stated they needed to get a provider and would be back. Parents immediately knew something had happened and felt scared and confused. Provider Dr. came in a few minutes later and communicated what they could based on the information from the CDC and listened to the parents concerns and questions. Parents stated they wanted to talk to someone in charge and wanted all documentation from the visit. As a site manager for multiple locations, I was not on the site of this location but was able to get here within 15 minutes. I immediately went in to talk with parents and apologize for their wait. Allowed them to express their fears and frustrations with me. Acknowledged what happened was not ok and this wasn't something anyone at clinic would take lightly. Informed them that over my time as a Pediatric Nurse I've experienced these situations more than once (not a norm, but also, I have experienced reviewing if this was ok for patients or not). Informed parents that I'm happy to get any information they may need and that studies show that for the most part, reactions are the same to a single administration as they are when multiple of the same vaccine are given. Informed them that a VAERS report would be completed and then sent their way to review. Informed them that provider Dr. would be calling this evening to follow up on how patient is doing and that I would be reaching out on Sunday to follow-up on the patient. Also discussed with parents that once further training for clinic as a whole was planned in light of this experience, I'd share that information with them. Patient was initially napping when I first arrived, but was awake and smiling before I left. No breathing changes. Legs did not appear red surround the administration sites. Did not palpate the area, but could see the legs when the grandmother turned her around. Child does have intrinsic eczema and had redness around her mouth that was from eczema. Otherwise, no color changes. Instructed parents that they will monitor her this evening and contact us with any concerns. Direct contact for myself given to mom so she can get through to me if she needs anything at all. While this is a very unfortunate event, parents verbalized understanding of the plan. Will continue to follow-up. More
2826286 4 F OR 02/14/2025 IPV
 SANOFI PASTEUR
 W1A191M
Extra dose administered Extra dose administered
Patient presented with siblings for catch up vaccinations. Patient was accidentally given two doses ... Patient presented with siblings for catch up vaccinations. Patient was accidentally given two doses of IPV, one in combo vaccine Vaxelis and one individual IPV vaccine. Two medical assistants were working together to inoculate all three siblings during the same appointment. MAs both reviewed vaccines that were drawn and prepared for patients, however both MAs missed the IPV dose within the Vaxelis combination. MD was consulted and CDC/manufacturer website were also viewed. Mother of patient and patient were explained the accidental double dose and possible side effects to look for. Mother and patient were understanding of incident and what to look for for possible side effects. Patient left clinic with mother and siblings feeling good and able to ambulate on her own. More
2826287 77 F MN 02/14/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 HF9298
EN6199
ER8732
FG3527
SARS-CoV-2 test; SARS-CoV-2 test; SARS-CoV-2 test; SARS-CoV-2 test SARS-CoV-2 test; SARS-CoV-2 test; SARS-CoV-2 test; SARS-CoV-2 test
Patient hospitalized. Was going to transfer to another hospital for higher level of care but no beds... Patient hospitalized. Was going to transfer to another hospital for higher level of care but no beds available. Other hospital requested COVID test. Patient had no definitive symptoms pointing to COVID. More
โœ“
2826288 69 F OK 02/14/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 B0005
U8515CA
Reaction to previous exposure to any vaccine; Reaction to previous exposure to a... Reaction to previous exposure to any vaccine; Reaction to previous exposure to any vaccine More
noticed the day after getting the shots. has been taking benadryl at bedtime only. noticed the day after getting the shots. has been taking benadryl at bedtime only.
2826289 57 F 02/14/2025 PNC21
 MERCK & CO. INC.
 y013009
Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth More
patient presented to pharmacy with injection site reaction; area was red slightly swollen warm to to... patient presented to pharmacy with injection site reaction; area was red slightly swollen warm to touch with slight itch More
2826290 55 F SC 02/14/2025 COVID19
COVID19
COVID19
 NOVAVAX
NOVAVAX
NOVAVAX


Arthralgia, Arthritis, Cartilage injury, Gait disturbance, Hip arthroplasty; Inf... Arthralgia, Arthritis, Cartilage injury, Gait disturbance, Hip arthroplasty; Inflammatory marker increased, Magnetic resonance imaging abnormal, Post procedural infection, Sepsis, Staphylococcal infection; Walking aid user More
I had 2 Pfizer vaccines in 2021. One in March and then another in April. I almost immediately starte... I had 2 Pfizer vaccines in 2021. One in March and then another in April. I almost immediately started having pain in my hip. Within a month of the 2nd dose I had to go to the dr. I was having trouble walking. I was scheduled with an orthopedic surgeon and they began to run tests thinking I had an autoimmune disease because my inflammatory levels were so high. I was tested by a rheumatologist and they ruled out autoimmune diseases. I had an MRI which showed that I had a lot of inflammation around my hip joint that had caused the cartilage to breakdown. It was an unexplained issue that had caused me to be on a walker. The surgeon did not specify vaccine injury but said that it was an unexplainable very aggressive arthritis he guessed. He told me I had no other choice but to have a hip replacement. I had not had any hip pain or hip problems before that vaccine so it was very confusing to all of us to have this happen to me so fast out of nowhere. I had the hip replacement by September 2021 (which was just a few months after my 2nd vaccine dose). I unfortunately developed sepsis from a staph infection from that hip replacement and almost died. I was hospitalized for weeks and had to be treated by infectious disease dr for the next year. I still have a lot of health issues today. I have researched and talked with many people and have come to realize that all of that happened immediately after the 2 covid vaccines that I had. I had one in March 2021 and 2nd in April 2021. I was at drs office in may and having hip replacement surgery by September. My surgeon never implied that it was caused by the vaccines. I had a dr in the hospital that suggested it might be a covid vaccine injury but nothing documented. I am convinced that it was caused by the 2 vaccines within a month of each other. Thank you for your time More
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2826291 81 M VA 02/14/2025 PNC20
 PFIZER\WYETH
Extra dose administered Extra dose administered
Pt was given 2nd shot of Prevnar by mistke today. Pt already had receive this shot in Nov 2024. Pt was given 2nd shot of Prevnar by mistke today. Pt already had receive this shot in Nov 2024.
2826292 52 F CA 02/14/2025 PNC20
 PFIZER\WYETH
 LJ5280
Fatigue, Injection site erythema, Injection site warmth, Pain Fatigue, Injection site erythema, Injection site warmth, Pain
Two days after the injection, a 3-inch by 3-inch red splotch has developed approximately 1-inch belo... Two days after the injection, a 3-inch by 3-inch red splotch has developed approximately 1-inch below and slightly left of the injection site. It is warm to the touch. It began smaller and has gotten larger over several days. It is itchy. It is still present on day 7; Before that, on day 2 I felt achy and extremely fatigued. The aches and fatigue had resolved by the time the splotch developed. More
2826293 73 U NY 02/14/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 Y013009
Y013009
Computerised tomogram head abnormal, Magnetic resonance imaging head abnormal, M... Computerised tomogram head abnormal, Magnetic resonance imaging head abnormal, Muscular weakness, Peripheral swelling, Transient ischaemic attack; Ultrasound scan More
pt had a tia, and has left foot weakness and right arm swelling pt had a tia, and has left foot weakness and right arm swelling
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2826294 41 M MI 02/14/2025 FLU3
 SEQIRUS, INC.
 946627
Pain, Pain in extremity, Sleep disorder Pain, Pain in extremity, Sleep disorder
Patient came to consultation window 2-12-25 in the evening stating his arm is still sore from the f... Patient came to consultation window 2-12-25 in the evening stating his arm is still sore from the flu shot on 1-19-25. I brought him into the consultation room and looked at right and did not notice any redness or swelling. I palpated the deltoid area and he did not complain of any pain, numbness or tingling. He stated it hurts when he raises his arm upward, outward and above head. Also states, he cannot sleep on that side. I asked him if he injured arm/shoulder at work or fell . He stated no and his job is a nail technician. I recommended he follow-up with his PCP. Today, 2-14-25, I left him a message to follow up with him to see if arm/shoulder is still sore and if he went to his PCP. More
2826295 5 M TX 02/14/2025 COVID19
DTAPIPV
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 3043000
5G23D
AE2J7
Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic; ... Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic More
Pruritic generalized erythematous rash excluding the face; started as small area per mother and slow... Pruritic generalized erythematous rash excluding the face; started as small area per mother and slowly worsened, came to the clinic on 02/13/2025 (pictures taken of the rash), no medications were administered since the rash started; afebrile, no respiratory of GI symptoms More
2826296 5 F CA 02/14/2025 MMR
MMR
VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.



Decreased appetite, Dehydration, Diarrhoea, Erythema, Flushing; Pyrexia, Rash; D... Decreased appetite, Dehydration, Diarrhoea, Erythema, Flushing; Pyrexia, Rash; Decreased appetite, Dehydration, Diarrhoea, Erythema, Flushing; Pyrexia, Rash More
Over a few weeks pt had a full body rash. Cheecks were very blush and dry and rashy looking. Lack o... Over a few weeks pt had a full body rash. Cheecks were very blush and dry and rashy looking. Lack of appetite diarrhea, dehydration. Low grade fever. More
2826297 17 M WI 02/14/2025 COVID19
 MODERNA
 B0005
Expired product administered, No adverse event Expired product administered, No adverse event
Patient was given vaccine that was beyond Best Use by Date. Patient has no symptoms. Vaccine was n... Patient was given vaccine that was beyond Best Use by Date. Patient has no symptoms. Vaccine was noticed after being given. More
2826298 10 M TN 02/14/2025 COVID19
 PFIZER\BIONTECH
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
the child is 10 years old and i gave him the covid shot that is for 12 years and older and did not r... the child is 10 years old and i gave him the covid shot that is for 12 years and older and did not realize till after More
2826299 70 M MA 02/14/2025 COVID19
COVID19
FLU3
FLU3
 MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
 8079568
8079568
U8489BA
U8489BA
Arthralgia, Headache, Knee operation, Musculoskeletal stiffness, Myalgia; Periph... Arthralgia, Headache, Knee operation, Musculoskeletal stiffness, Myalgia; Peripheral swelling; Arthralgia, Headache, Knee operation, Musculoskeletal stiffness, Myalgia; Peripheral swelling More
VACCINES 9/30. ABOUT 1 WEEK LATER SORE MUSCLES/JOINTS, STIFF NECK, HEADACHE, SWOLLEN HANDS. DEALTH W... VACCINES 9/30. ABOUT 1 WEEK LATER SORE MUSCLES/JOINTS, STIFF NECK, HEADACHE, SWOLLEN HANDS. DEALTH WITH IT UNTIL (12/16) FOLLOW UP APPT WITH SURGEON FROM KNEE SURGERY (11/23) GAVE MEDROL DOSEPACK. HELPED UNTIL FINISHED PACK. GAVE ANOTHER MEDROL PACK (12/23). AGAIN HELPED UNTIL FINISHED. SAW PCP AND RECEIVED ANOTHER PACK (12/30). PCP REFERRED HIM TO RHEUMATOLOGIST (1/14). PCP PRESCRIBED NAPROXEN (1/10). RHEUMATOLOGIST, PCP, AND SURGEON AGREED THEY BELIEVE FROM VACCINE AND NOT ARTHRITIS. More
2826300 56 M ID 02/14/2025 COVID19
 PFIZER\BIONTECH
 33030BN
Tinnitus Tinnitus
The day after the booster vaccine I have suffered from tinnitus in both ears. The day after the booster vaccine I have suffered from tinnitus in both ears.
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2826301 1 F VA 02/14/2025 HEPA
MMRV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 22GP3
Y017206
LJ5284
Rash, Rash macular; Rash, Rash macular; Rash, Rash macular Rash, Rash macular; Rash, Rash macular; Rash, Rash macular
Scattered macular rash across trunk and back - onset 7 days after receiving MMRV vaccine; Diagnoses ... Scattered macular rash across trunk and back - onset 7 days after receiving MMRV vaccine; Diagnoses at visit on 02/14/25 Varicella without complication - B01.9 (Primary), Adverse effect of other viral vaccines, initial encounter - T50.B95A , Infection following immunization, initial encounter - T88.0XXA More
2826302 16 F TX 02/14/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 52N4S
Injection site erythema, Injection site pain Injection site erythema, Injection site pain
Pain and erythema at the site of injection Pain and erythema at the site of injection
2826303 1.08 M 02/14/2025 FLU3
HEPA
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 495MK
Y007472
Y0012077
Product use issue; Product use issue; Product use issue Product use issue; Product use issue; Product use issue
I asked a peer for help with vaccines for a well child check as I am a new MA and did not know exact... I asked a peer for help with vaccines for a well child check as I am a new MA and did not know exactly what I needed to do. The insurance part of the vaccinations made it more complicated, my peer said that when she does vaccines for her provider instead of doing multiple vaccines and having the child get poked more, they do a combo vaccine. She helped me draw up the vaccinations and instead of doing MMR and Varicella separately, she drew up MMRV. My provider has since talked to the parent of the patient. More
2826304 1 F FL 02/14/2025 DTAPIPVHIB
MMR
PNC15
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 UK024AA
X019101
Y010032
Y011712
Injection site bruising, Injection site cellulitis, Injection site inflammation,... Injection site bruising, Injection site cellulitis, Injection site inflammation, Injection site swelling; Injection site bruising, Injection site cellulitis, Injection site inflammation, Injection site swelling; Injection site bruising, Injection site cellulitis, Injection site inflammation, Injection site swelling; Injection site bruising, Injection site cellulitis, Injection site inflammation, Injection site swelling More
PATIENT WENT TO THE COUNTY HEALTH DEPARTMENT ON 2/12/2025 TO RECEIVE THEIR ONE YEAR OLD SET OF VACCI... PATIENT WENT TO THE COUNTY HEALTH DEPARTMENT ON 2/12/2025 TO RECEIVE THEIR ONE YEAR OLD SET OF VACCINES. ON 2/12/2025 PENTACEL, VARIVAX, MMR II, AND VAXNEUVANCE WAS ADMINISTERED TO THE PATIENT. THE MOTHER OF THE PATIENT NOTIFED US VIA PORTAL MESSAGE ON THE MORNING OF 2/14/2025 WITH A PICTURE AND CONCERN ON THE BABY'S RIGHT THIGH WHICH IN THE PICTURE LOOKED TO BE VERY VERY BRUISED WITH LOCALIZED SWELLING AND INFLAMMATION AND THE START OF CELLULITIS BASED OFF THE PICTURE. THE BABY WAS BROUGHT INTO OUR OFFICE TO BE ASSESSED THE SAME DAY AND WAS DIAGNOSED WITH CELLULITUS AND PRESCRIBED CEPHALEXIN ANTIBIOTICS TO TREAT THE CELLULITIS. More
2826305 33 F CA 02/14/2025 UNK
 UNKNOWN MANUFACTURER
Injection site erythema Injection site erythema
Area where the vaccine was administered has redness. Area where the vaccine was administered has redness.
2826306 4 M TN 02/14/2025 DTAPIPV
MMR
VARCEL
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 U8209CB
Y005808
Y015559
Circumoral oedema, Lip oedema, Streptococcus test negative; Circumoral oedema, L... Circumoral oedema, Lip oedema, Streptococcus test negative; Circumoral oedema, Lip oedema, Streptococcus test negative; Circumoral oedema, Lip oedema, Streptococcus test negative More
Mild to moderate perioral edema with edema of upper and lower lip Mild to moderate perioral edema with edema of upper and lower lip
2826307 62 F IA 02/14/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 LN0588
LN0588
Injection site oedema, Large intestine polyp, Lipoma, Magnetic resonance imaging... Injection site oedema, Large intestine polyp, Lipoma, Magnetic resonance imaging, Pain; Pain in extremity, Ultrasound Doppler, Ultrasound scan, X-ray limb More
Incident onset: about two weeks ago; had covid booster in that arm about three weeks ago. There was ... Incident onset: about two weeks ago; had covid booster in that arm about three weeks ago. There was no injury mechanism. The quality of the pain is described as aching. The pain radiates to the right arm and right hand. The pain has been Worsening since the incident. Right upper arm: Edema (area of localizing edema to right tricep area; about baseball sized) present. More
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2826308 40 F PA 02/14/2025 COVID19
 MODERNA
Body temperature increased, COVID-19, Hypersomnia, Malaise, Pain Body temperature increased, COVID-19, Hypersomnia, Malaise, Pain
From each of 5 covid 19 shots I have received I was very sick for all of them. This last one in Dece... From each of 5 covid 19 shots I have received I was very sick for all of them. This last one in December was the worse of all. I had 102 temp for 3 days, everything hurt and all I did was sleep. I addition, since 2022 I have had covid 6 times. More
2826309 60 M CO 02/14/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LM2211
TE882444
Urticaria; Urticaria Urticaria; Urticaria
pt exerienced hives 2 weeks after receiving vaccines pt exerienced hives 2 weeks after receiving vaccines
2826310 76 F CO 02/14/2025 RSV
 PFIZER\WYETH
 LM5460
Arthralgia, Injected limb mobility decreased, Sleep disorder Arthralgia, Injected limb mobility decreased, Sleep disorder
Patient reports pain in shoulder where vaccine was administered, still persisting nearly 4 months la... Patient reports pain in shoulder where vaccine was administered, still persisting nearly 4 months later. Painful to sleep on arm. Reports it "feels frozen" when doing routine activities like applying deodorant under her arm. More
2826311 77 M CO 02/14/2025 RSV
 PFIZER\WYETH
 LM5460
Arthralgia, Mobility decreased, Sleep disorder Arthralgia, Mobility decreased, Sleep disorder
Patient reports pain in shoulder where vaccine was administered, still persisting nearly 4 months la... Patient reports pain in shoulder where vaccine was administered, still persisting nearly 4 months later. Painful to sleep on arm. Reports it "feels frozen" when doing routine activities like applying deodorant under his arm. More
2826312 85 F CA 02/14/2025 RSV
RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS


Arthralgia, Diarrhoea, Dizziness, Headache, Injection site erythema; Injection s... Arthralgia, Diarrhoea, Dizziness, Headache, Injection site erythema; Injection site pain, Injection site pruritus, Injection site swelling, Nausea, Neck pain; Pyrexia More
itching, aching, redness, swelling of injection area, fever, headache, nausea, diarrhea on days 2 an... itching, aching, redness, swelling of injection area, fever, headache, nausea, diarrhea on days 2 and 3 after. Day 2: ache extended up into neck on that side as well as shoulder and down to elbow. Day 3 awoke with dizziness and nausea. All reactions very unusual for me. More
2826320 U 02/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Ophthalmic herpes zoster Herpes zoster, Ophthalmic herpes zoster
shingles on eye; shingles on my face and nose; This serious case was reported by a consumer via inte... shingles on eye; shingles on my face and nose; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 6 days after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: shingles on eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: shingles on my face and nose). The outcome of the ophthalmic herpes zoster and facial herpes zoster were resolved (duration 8 weeks). It was unknown if the reporter considered the ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine. The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-JAN-2025 The case was received from the patient via interactive digital media. The patient got the shingle shot and about 6 days later, had shingles on his/her face, eye and nose. The patient got medications and it clear up again in his/her face and other spots . The patient reported that finally after 8 weeks, things cleared up. The patient did not get the second dose of the shot.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. More
2826321 M 02/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Meningitis, Nervous system disorder Herpes zoster, Meningitis, Nervous system disorder
shingles diagnosis developed into Meningitis; Neurological complications; contracted shingles; This ... shingles diagnosis developed into Meningitis; Neurological complications; contracted shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 03-MAR-2024, the patient received Shingrix. On 05-MAR-2024, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: contracted shingles). On an unknown date, the patient experienced meningitis (Verbatim: shingles diagnosis developed into Meningitis) (serious criteria GSK medically significant) and nervous system disorder (Verbatim: Neurological complications). The outcome of the meningitis was not reported and the outcome of the shingles and nervous system disorder were resolved. It was unknown if the reporter considered the meningitis, shingles and nervous system disorder to be related to Shingrix. The company considered the meningitis to be unrelated to Shingrix. It was unknown if the company considered the shingles and nervous system disorder to be related to Shingrix. Additional Information: GSK Receipt Date: 31-JAN-2025 This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine and got shingles that was turned in to a Meningitis and put in the hospital. GlaxoSmithKline would not help with any of the medical bills and are immune from any lawsuits from this vaccine. The patient now have neurological complications nine months out. They did not tell this could happen, but it could, it did and people should know. The patient did not had anti vaccine, but advised to think twice before get this vaccine.; Sender's Comments: Meningitis is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2826322 U 02/14/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
vaccine was inadvertently administered sooner than recommended timeframe; This non-serious case was ... vaccine was inadvertently administered sooner than recommended timeframe; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug administration duration too short in a 10-year-old patient who received HAV (Havrix) for prophylaxis. Previously administered products included Havrix (Received first dose on unknown date). On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug administration duration too short (Verbatim: vaccine was inadvertently administered sooner than recommended timeframe). The outcome of the drug administration duration too short was unknown. Additional Information: GSK Receipt Date: 16-JAN-2025 The reporter reported that a patient received Havrix booster dose given less than 6 months which led to drug administration duration too short. A vaccine was inadvertently administered sooner than recommended timeframe, specifically for the Havrix (hepatitis A). Reporter was waiting for nurse manager to get back with more information. More
2826323 U 02/14/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
potential for missed dose of Hiberix at 6 months; This non-serious case was reported by a nurse via ... potential for missed dose of Hiberix at 6 months; This non-serious case was reported by a nurse via patient support programs and described the occurrence of incomplete course of vaccination in a 6-month-old patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient did not receive Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incomplete course of vaccination (Verbatim: potential for missed dose of Hiberix at 6 months). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 11-FEB-2025 The reporter reported that the patient received Hiberix but had confusion with transition among nursing staff. Unsure of actual missed doses and currently investigating but potential for missed dose of Hiberix at 6 months due to misunderstanding of transition guidelines. Till the time of reporting, the patient did not receive 2nd dose of Hiberix, which led to incomplete course of vaccination. More
2826324 U 02/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster Herpes zoster
got shingles most likely a mild case but it was very painful; This non-serious case was reported by ... got shingles most likely a mild case but it was very painful; 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 (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles most likely a mild case but it was very painful). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the first vaccine and later got shingles and most likely a mild case but it was very painful. The patient when had the 2nd vaccine became available got it but no problems. More
2826325 U 02/14/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu... Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure More
Suspected vaccination failure; had the two doses of shots and still get shingles; This serious case ... Suspected vaccination failure; had the two doses of shots and still get 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the two doses of shots and still get shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 31-JAN-2025 This case was reported by a patient via interactive digital media. The patient received two doses of shots and still get shingles. It was nerve wracking pain. Patient was currently (on the day of reporting) on his/her 6th episode after the shots. Apparently, the 99 percent effective results did not happen to be saw patient results. Patient reported he/she was the rare 1 percent. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2. More
2826326 M 02/14/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Antibody test positive, Herpes zoster, Vaccination failure; Antibody test positi... Antibody test positive, Herpes zoster, Vaccination failure; Antibody test positive, Herpes zoster, Vaccination failure More
Suspected vaccination failure; got shingles on his face; This serious case was reported by a consume... Suspected vaccination failure; got shingles on his face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Family history included shingles (patient's wife had shingles before Shingrix was available) and pain (patient's wife still had to hurt for a while). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: got shingles on his face). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient's wife via interactive digital media. The reporter reported that sorry but the only way to avoid getting shingles in later life was to have the chickenpox vaccine as a child. Most of the adult's had chickenpox as children, and that virus, herpes zoster, never goes away. It hides out at the base of the spine, and when we were older it comes back as shingles. The reporter had shingles before Shingrix was available. Her doctor gave her an antiviral, but still had to hurt for a while. Better believe got the 2 shot Shingrix vaccine as soon as it was available. The patient got it too. He got shingles late last year, but it was a mild case. It was on his face, but he had no pain and no permanent damage. He had an antiviral which helped him heal faster. He was given Gabapentin for pain, but never needed it. He believes in vaccines. Even if they did not totally stop the infection, they make it milder. It was proved that husband had shingles, by an antibody test. He had antibodies to herpes zoster, but not to herpes simplex which causes cold sores and genital herpes. This case was considered as suspected vaccination failure as details regarding time to onset for 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 time to onset and laboratory confirmation of herpes zoster) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). More
2826327 U 02/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Muscle spasms, Neck pain, Tremor Muscle spasms, Neck pain, Tremor
Shakes; leg cramps; pain up my neck; This non-serious case was reported by a consumer via interactiv... Shakes; leg cramps; pain up my neck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tremor in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (twice). On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced tremor (Verbatim: Shakes), leg cramps (Verbatim: leg cramps) and neck pain (Verbatim: pain up my neck). The outcome of the tremor, leg cramps and neck pain were not reported. It was unknown if the reporter considered the tremor, leg cramps and neck pain to be related to Shingles vaccine. It was unknown if the company considered the tremor, leg cramps and neck pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient received a Shingles vaccine and had day one the side effects of shakes, leg cramps and pain up in neck were terrible. More
2826328 U 02/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pruritus, Pyrexia Pruritus, Pyrexia
fever; itching; This non-serious case was reported by a consumer via interactive digital media and d... fever; itching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 06-FEB-2025, the patient received Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever) and pruritus (Verbatim: itching). The outcome of the fever and pruritus were not reported. It was unknown if the reporter considered the fever and pruritus to be related to Shingles vaccine. It was unknown if the company considered the fever and pruritus to be related to Shingles vaccine. Additional Information: GSK receipt date: 07-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had received Shingles vaccine day before reporting and wanted to know why it was itching with a fever around it. More
2826329 U 02/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Ophthalmic herpes zoster, Vaccination failure Ophthalmic herpes zoster, Vaccination failure
Suspected vaccination failure; diagnosed with shingles and my symptoms are different.Will I have a ... Suspected vaccination failure; diagnosed with shingles and my symptoms are different.Will I have a lighter case, it's in my eye; 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. On an unknown date, the patient received Shingrix. On an unknown date, more than a year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: diagnosed with shingles and my symptoms are different. Will I have a lighter case, it's in my eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 09-FEB-2025 This case was reported by a patient via interactive digital media. The patient had vaccine 2 years ago and now had been diagnosed with shingles with the symptoms was different. He/she had a lighter case, it was in the eye. 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. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2826330 U 02/14/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; I got both shots and I've had them off and on for like 7 months;... Suspected vaccination failure; I got both shots and I've had them off and on for like 7 months; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got both shots and I've had them off and on for like 7 months). 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 06-FEB-2025 This case was reported by a patient via interactive digital media. It was reported that the patient got both shots and have had them off and on for like 7 months. 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. The follow-up could not be possible as no contact details were available.; 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 Shingles vaccine dose 1 and Shingles vaccine dose 2. More
2826331 F 02/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; got the vax and did not help, she still got shingles; This serious ca... Suspected vaccination failure; got the vax and did not help, she still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: got the vax and did not help, she still got 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: 07-FEB-2025 This case was reported by a patient's sibling via interactive digital media. The patient got the vax and did not help, she still got shingles. This case was considered as suspected vaccination failure since the details regarding primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2025AMR017914, reported by the same reporter for friend's brother.; 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. US-GSK-US2025AMR017914:same reporter different patinet More
2826332 M 02/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; My friends brother got the vaccine, he still got shingles; This serio... Suspected vaccination failure; My friends brother got the vaccine, he still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: My friends brother got the vaccine, he still got 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: 07-FEB-2025 This case was reported by a consumer interactive digital media. The reporter reported that his/her friend's brother got the shingles vaccine and he still got shingles. This case was considered as suspected vaccination failure since the details regarding primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2025AMR017906, reported by the same reporter for his/her sister.; 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. US-GSK-US2025AMR017906:same reporter different patient More
2826333 U AZ 02/14/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Device connection issue, Underdose Device connection issue, Underdose
Defective vaccine potentially administered; getting leakage between the needle and the luer lock on ... Defective vaccine potentially administered; getting leakage between the needle and the luer lock on the Prefilled Syringe; getting leakage between the needle and the luer lock on the Prefilled Syringe; Product Complaint; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Hib (Hiberix) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental underdose (Verbatim: Defective vaccine potentially administered), syringe leak (Verbatim: getting leakage between the needle and the luer lock on the Prefilled Syringe), syringe connection issue (Verbatim: getting leakage between the needle and the luer lock on the Prefilled Syringe) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose, syringe leak, syringe connection issue and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the syringe leak and syringe connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device. It was unknown if the company considered the syringe leak and syringe connection issue to be related to Hiberix and Hiberix And Diluent 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: 17-MAY-2024 GlaxoSmithKline Representative stated he was calling on behalf of an Office Administrator who reported a Product Quality Complaint this morning, mentioning that their clinic was having issues with Hiberix, when they put the needle onto the Prefilled Syringe and then try to draw they were getting leakage between the needle and the luer lock on the Prefilled Syringe. The Healthcare Provider mentioned it was 2 incidents out of this box, but understanding of the caller is that several kids were administered that morning which led to accidental underdose, syringe leak, syringe connection issue and pharmaceutical product complaint. Patient demographics, lot number or expiration date were unknown. Upon internal review case was updated on 14-FEB-2024 The suspect product was recoded. More
2826334 M NJ 02/14/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
had a dose of boostrix approximately 6 months earlier; This non-serious case was reported by a pharm... had a dose of boostrix approximately 6 months earlier; 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 male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Previously administered products included Boostrix (Patient received a dose approximately six months ago). On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: had a dose of boostrix approximately 6 months earlier). The outcome of the drug dose administration interval too short was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-JAN-2025 The Health Care Professional was the reporter. The patient received a dose of Boostrix after having had a dose of Boostrix approximately 6 months earlier which drug dose administration interval too short. No further information is known including date vaccine was administered More
2826335 F TN 02/14/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
57 year old patient received Bexsero; This non-serious case was reported by a consumer via call cent... 57 year old patient received Bexsero; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. The patient's past medical history included neoplasm (part of her pancreas was removed due to a tumor) and splenectomy. In OCT-2024, the patient received the 1st dose of Bexsero. In OCT-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 57 year old patient received Bexsero). The outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 16-JAN-2025 Patient reported that she received first shot of Bexsero in early October 2024, her physician has ordered this vaccine for her due to her pre-existing medical condition. Patient received Bexsero at the age of 57 years which led to inappropriate age at vaccine administration. More
2826336 F CO 02/14/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 33G3M
Extra dose administered Extra dose administered
administered with a second dose on January 16th 2025; This non-serious case was reported by a nurse ... administered with a second dose on January 16th 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 39-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 33G3M, expiry date 30-JUN-2025) for prophylaxis. Previously administered products included Flulaval (received 1st dose on 8th October 2024, batch number 33G3M, expiry date 30th June 2025.). On 16-JAN-2025, the patient received the 2nd dose of FluLaval 2024-2025 season. On 16-JAN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: administered with a second dose on January 16th 2025). The outcome of the extra dose administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-JAN-2025 Nurse mentioned that a patient who received a prior dose of FluLaval back on October 8th 2024 was administered with a second dose on January 16th 2025 which led to Extra dose administered. Lot number and expiration date were the same for both doses. More
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