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
2861200 28 F OH 09/24/2025 COVID19
 MODERNA
 064H21A
Allergy test, Inflammation, Urticaria Allergy test, Inflammation, Urticaria
Chronic hives and inflammation. Need to take antihistamine daily to stop adverse reactions. Chronic hives and inflammation. Need to take antihistamine daily to stop adverse reactions.
2861201 59 F IA 09/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 r2ha7
Pain in extremity, Paraesthesia Pain in extremity, Paraesthesia
Patient called about 30 minutes after receiving vaccination and reported pain in the arm that went a... Patient called about 30 minutes after receiving vaccination and reported pain in the arm that went away and now some mild tingly. Recommended to apply ice to the area and to follow up with her medical provider if symptoms persist. More
2861202 1.5 M CA 09/24/2025 COVID19
 PFIZER\BIONTECH
 LN7305
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Given COVID vaccine & then informed that it needed to be removed due to deauthorization. The vac... Given COVID vaccine & then informed that it needed to be removed due to deauthorization. The vaccine was still good with the expiration date & storage and handling. It was decided to be removed on the date of 8/28/25 but we were not informed until 9/22/25 when I called agency. More
2861233 56 F KS 09/24/2025 COVID19
 MODERNA
 3051995
Injection site erythema, Injection site induration, Injection site inflammation,... Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth More
Patient had received Engerix B and Capavaxive at Health Clinic on 9/18/25. She came to our pharmacy ... Patient had received Engerix B and Capavaxive at Health Clinic on 9/18/25. She came to our pharmacy on 9/20/25 and got Mnexspike. On 9/21/25 she had redness, inflammation, warm hard skin in the area of the immunizations. As the day went on the reaction spread out. On Monday 9/22/25 she had an appointment with her Rheumatologist who told her to keep and eye on it. If it didn't get better to contact her PCP. On Tuesday 9/23/25 the area was at its worst. Red, hard and hot over a larger area of her upper arm down to her elbow. She followed up with doctor on Wednesday 9/24/25. Patient states the area is smaller and not as red today. Patient was prescribed Cephalexin and told to continue to watch the area. If not better in a couple of days to follow up again. After he Dr appt she came to the pharmacy to tell us about the reaction. More
2861234 80 M NC 09/24/2025 FLU3
 SANOFI PASTEUR
 UT8781DA
Injection site pain, Neck pain, Pain, Pain in extremity Injection site pain, Neck pain, Pain, Pain in extremity
Patient states no issues on the day of vaccination. Upon awakening in the morning, patient complains... Patient states no issues on the day of vaccination. Upon awakening in the morning, patient complains of severe shooting arm pain in the arm which received the vaccine. The pain is radiating directly from the site of injection going up to his neck down and down to his fingers. Pharmacist recommended that patient be evaluated by primary care doctor or urgent care. More
2861235 38 F OH 09/24/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0590
U8823BA
Erythema, Oedema peripheral, Peripheral swelling, Skin warm; Erythema, Oedema pe... Erythema, Oedema peripheral, Peripheral swelling, Skin warm; Erythema, Oedema peripheral, Peripheral swelling, Skin warm More
REDNESS AND HOT TO TOUCH WITH SWELLING ON DELTOID OF ARM AND UNDERARM REDNESS AND HOT TO TOUCH WITH SWELLING ON DELTOID OF ARM AND UNDERARM
2861236 11 F CA 09/24/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 5kr3r
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse events, treatment, and outcome. No adverse events, treatment, and outcome.
2861237 12 M CA 09/24/2025 UNK
 UNKNOWN MANUFACTURER
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
Swelling and redness 3-4? from injection site. Pain. Swelling and redness 3-4? from injection site. Pain.
2861238 M AK 09/24/2025 DTAPIPV
HIBV
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 3RT93
Y005457
LG5574
2032353
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
No reported adverse event. Patient was inadvertently administered Kinrix. No reported adverse event. Patient was inadvertently administered Kinrix.
2861239 0.17 M AK 09/24/2025 DTAPIPV
HIBV
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
MERCK & CO. INC.
 3RT93
Y005457
LG5574
2032353
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered More
No reported adverse event. Patient was inadvertently administered Kinrix. No reported adverse event. Patient was inadvertently administered Kinrix.
2861240 63 F GA 09/24/2025 PNC21
 MERCK & CO. INC.
 z006889
Erythema, Pain in extremity, Peripheral swelling Erythema, Pain in extremity, Peripheral swelling
Patient reported some aching and swelling in in the upper arm with some redness, she said it develop... Patient reported some aching and swelling in in the upper arm with some redness, she said it developed after 6 days of vaccination More
2861241 57 F DE 09/24/2025 COVID19
 MODERNA
Incorrect route of product administration Incorrect route of product administration
Patient was concerned that the needle depth of the vaccine was insufficient. Vaccine only administer... Patient was concerned that the needle depth of the vaccine was insufficient. Vaccine only administered half an inch in depth More
2861242 52 F IL 09/24/2025 COVID19
FLU3
PNC20
RSV
 PFIZER\BIONTECH
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
 MY9547
TFAA2532
LX2498
MM9159
Cellulitis, Rash; Cellulitis, Rash; Cellulitis, Rash; Cellulitis, Rash Cellulitis, Rash; Cellulitis, Rash; Cellulitis, Rash; Cellulitis, Rash
Patient called on approximately on 09/19/25 stating that they have a rash on their right arm that wa... Patient called on approximately on 09/19/25 stating that they have a rash on their right arm that was about 5 inches in diameter. Patient was counseled to take a benadryl and ice the injection site and if the rash did not get better in 1-2 days to contact their primary care provider. On 09/23/25 patient called and notified that they were diagnosed with cellulitis of the upper skin and were prescribed bactrim DS. Contacted pt on 09/24/25 and reported they were doing well and taking their antibiotics. More
2861243 76 F 09/24/2025 COVID19
 MODERNA
 3052082
Headache, Injection site warmth, Pyrexia, Swelling Headache, Injection site warmth, Pyrexia, Swelling
headache, injection site hot, fever swelling 10 hours after inject. Pounding headache and bed bound... headache, injection site hot, fever swelling 10 hours after inject. Pounding headache and bed bound for 2 days. At time of report on 9/24/25. injection site still warm to the touch. Pt stated she took some tylenol to help with fever but not feel better More
2861244 93 F CO 09/24/2025 COVID19
 MODERNA
 3052734
Dysphagia, Malaise, Paraesthesia oral Dysphagia, Malaise, Paraesthesia oral
The patient was in the waiting room as instructed after the injection. She notified that she was not... The patient was in the waiting room as instructed after the injection. She notified that she was not feeling well and that her lips and tongue felt tingly and she felt as though she could not swallow. I instructed a technician to call 911 and went to the patient with an EpiPen to assess the situation. The patient did not appear to need an Epinephrine injection and 911 soon arrived. They took her into the counseling room and did an assessment. The paramedics also did not administer epinephrine. She refused to go to the ED, signed the consent forms, and shortly went home. I followed up with the patient that evening and she said she was feeling a lot better at that time. The patient had a minor allergic reaction during her first Covid vaccination series. The following year she was administered the vaccine under the care of a local allergist 60 minutes after receiving an antihistamine. The next two years (23/24) the patient was instructed to receive the vaccine the same way but at here local pharmacy. We administered both of those vaccination after discussion with the provider with no allergic response at that time. The vaccine was administered again under the same conditions and the patient appeared to have a minor allergic reaction that did not require epinephrine or any other treatment than the oral antihistamine the patient took prior to coming to the pharmacy. More
2861245 75 F AZ 09/24/2025 COVID19
 MODERNA
 3052036
Erythema, Pruritus, Swelling Erythema, Pruritus, Swelling
Patient noticed a slight itching sensation the evening of the 23rd and when she went to scratch noti... Patient noticed a slight itching sensation the evening of the 23rd and when she went to scratch noticed some redness and swelling of the area as well. Patient reported no signs of infection (such as hot to the touch, fever, etc). Counseled patient to monitor and contact MD if the reaction got worse or signs of infection. More
2861246 54 F AL 09/24/2025 PNC20
 PFIZER\WYETH
Erythema, Pain, Skin warm Erythema, Pain, Skin warm
Large red/warm area on arm?like at least 5 inches x 5 inches. Also had lots of pain for a few days f... Large red/warm area on arm?like at least 5 inches x 5 inches. Also had lots of pain for a few days following vaccine. I?ve had many vaccines and never had anything like this happen. More
2861247 60 M TX 09/24/2025 FLU3
 SANOFI PASTEUR
 U8830AA
Incorrect dose administered Incorrect dose administered
Patient given Fluzone HD despite not meeting criteria for receiving high dose. Patient given Fluzone HD despite not meeting criteria for receiving high dose.
2861248 35 M TX 09/24/2025 FLU3
 SANOFI PASTEUR
 U8830AA
Incorrect dose administered Incorrect dose administered
Patient given Fluzone HD despite not meeting criteria for receiving high dose vaccine. Patient given Fluzone HD despite not meeting criteria for receiving high dose vaccine.
2861249 32 F TX 09/24/2025 FLU3
 SANOFI PASTEUR
 U8830AA
Incorrect dose administered Incorrect dose administered
Patient received Fluzone HD despite not meeting criteria to receive high dose vaccine. Patient received Fluzone HD despite not meeting criteria to receive high dose vaccine.
2861270 0.5 M CA 09/24/2025 COVID19
DTPPVHBHPB
PNC20
RV5
 PFIZER\BIONTECH
MSP VACCINE COMPANY
PFIZER\WYETH
MERCK & CO. INC.
 LN7305
U8314AA
LX2496
Y020006
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Given COVID vaccine & then informed that it needed to be removed due to deauthorization. The vac... Given COVID vaccine & then informed that it needed to be removed due to deauthorization. The vaccine was still good with expiration date & storage and handling. It was decided to be removed on the date of 8/28/2025 but we were not informed until 9/22/25 when I called agency. More
2861271 M CA 09/24/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LN7305
UT8T79LA
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Given Covid vaccine & then informed that it needed to be pulled/removed due to deauthorization -... Given Covid vaccine & then informed that it needed to be pulled/removed due to deauthorization - The vaccine was still good with expiration date & storage and handling. It was decided to be removed on 8/28/25 but we were not informed until 9/22/25 when I called VFC. More
2860633 1 F AZ 09/23/2025 VARCEL
 MERCK & CO. INC.
 Y013347
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Inadvertent administrations of VARIVAX after a temperature excursion/frozen tem ou... No additional AE; Inadvertent administrations of VARIVAX after a temperature excursion/frozen tem out of range given; This spontaneous report was received from a Physician Assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. Patients between 21-Jul-2025 and 22-Jul-2025,unsure if system will allow to determine which patients inadvertent were vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection , (lot #Z004455, expiration date: 13-Feb-2027), 1 dosage form(lot #Y017062, expiration date: 11-Oct-2026), and (lot #Y013347, expiration date: 02-Aug-2026) administered by Unknown route, for prophylaxis, after temperature excursion. No additional adverse event reported (Product storage error). The vaccines were reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), Solution for injection 1 dosage form administered by Unknown route (lot # and expiration date were not reported) for prophylaxis. The vaccines experienced a temperature time frame: 6 grade Fahrenheit for 45 minutes with previous temperature excursion 6.7 to 14 grade Fahrenheit for 45 minutes; 14 to 46 grade Fahrenheit for 15 minutes. There was no adverse effect reported. No product quality complaint was involved. This report is considered to be invalid due to lack of numbers of patients and patients' identifiers. Upon receipt of follow-up information on 05-SEP-2025 and it was determined that this case is now valid because patient identifier was received. Follow up information has been received from a Physician Assistant on 05-Sep-2025 regarding a 1-year-old female patient with no illness a t the time of vaccination or current conditions. The patient's medical history was not reported. No concomitant therapies administered. On 21-Jul-2025, the patient was inadvertently vaccinated with a first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection (lot #Y013347, expiration date: 02-Aug-2026), 1 dosage form administered by Subcutaneous route in Right thigh for prophylaxis, after temperature excursion(freezer temperature out range) (Product storage error) with public funds at private doctor's office. The freezer went out of range for 45 minutes. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), Solution for injection 1 dosage form administered by Subcutaneous route in Right thigh (dose number, lot # and expiration date were not reported) for prophylaxis, on the same date. Lot # will be requested and will be submitted if received. This is one of several reports received from the same reporter. More
2860634 4 M AZ 09/23/2025 UNK
 UNKNOWN MANUFACTURER
 Y013347
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Freezer temperature out of range; This spontaneous report was received from a Phys... No additional AE; Freezer temperature out of range; This spontaneous report was received from a Physician Assistant on 05-SEP-2025 and refers to a 4-year-old male patient with no illness at the time of vaccination or current conditions. The patient's medical history was not reported. No concomitant therapies administered. On 22-Jul-2025, the patient was vaccinated with second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y013347, expiration date: 02-Aug-2026), 1 dosage form administered by Subcutaneous route in Left Thigh for prophylaxis, after temperature excursion (freezer temperature out range) (Product storage error) with public funds at private doctor's office. The freezer went out of range for 45 minutes. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), 1 dosage form administered by Subcutaneous route in Left Thigh for prophylaxis, on the same date. The vaccine experienced a temperature time frame: 6 grade Fahrenheit for 45 minutes with previous temperature excursion 6.7 to 14 grade Fahrenheit for 45 minutes; 14 to 46 grade Fahrenheit for 15 minutes. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same source. Lot # is being requested and will be submitted if received. More
2860635 0.33 PA 09/23/2025 MMR
 MERCK & CO. INC.
 Y014094
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE reported.; MMR-II was administered to a 4-month-old for travel.; This spontaneous r... No additional AE reported.; MMR-II was administered to a 4-month-old for travel.; This spontaneous report was received from a physician and refers to a 4-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-Sep-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y014094, expiration date: 19-Aug-2026) for prophylaxis, and diluted with sterile diluent (Hollister-Stier STERILE DILUENT), (indication, expiration date, and lot # were not reported) for travel (Product administered to patient of inappropriate age). No additional adverse event was reported. More
2860636 68 OR 09/23/2025 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: with no reported adverse event; Initial information received on... Intentional Age Prescription by HCP: with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 68 years old and unknown gender patient who was prescribed with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] which was an intentional age prescription by health care professional 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 was prescribed with 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, frequency:once (lot number, expiry date and strength not reported) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) which was an intentional age prescription by health care professional: with no reported adverse event (off label use) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, the patient is 67 years old. per package insert, adacel is approved for use in persons 10through 64 years of age. Action taken was not applicable. More
2860637 13 F PA 09/23/2025 FLU3
 SANOFI PASTEUR
 UT8802MA
No adverse event, Product storage error No adverse event, Product storage error
Received fluzone np which was stored in a cooler with frozen ice packs, separated by a "barrier... Received fluzone np which was stored in a cooler with frozen ice packs, separated by a "barrier layer" of refrigerated packs to prevent freezing for 4 hours with human error with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA281885, US-SA-2025SA281863 and US-SA-2025SA281892 This case involves a 13 years old female patient who received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which was stored in a cooler with frozen ice packs, separated by a barrier layer of refrigerated packs to prevent freezing for 4 hours with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was administered. On 13-Sep-2025, the patient received 0.5ml (Dose 1) of Suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (once), (strength standard) lot UT8802MA and expiry date via intramuscular route in the right deltoid for immunisation, which was stored in a cooler with frozen ice packs, separated by a barrier layer of refrigerated packs to prevent freezing for 4 hours with human error with no reported adverse event (product storage error) (Latency Same day). Reportedly, this excursion occurred due to a human error, it was unknown if extended stability data cover the excursion, since the highest temperature reached was unknown. Previous excursion none. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA281885: US-SA-2025SA281863: US-SA-2025SA281892: More
2860638 13 F PA 09/23/2025 FLU3
 SANOFI PASTEUR
 UT8802MA
No adverse event, Product storage error No adverse event, Product storage error
temperature excursion for fluzone np vaccines with maximum\lowest temperature reached :unknown freez... temperature excursion for fluzone np vaccines with maximum\lowest temperature reached :unknown freezing for 4 hours with human error with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 13 years old female patient who administered Influenza Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which were stored in a cooler with maximum\lowest temperature reached :unknown freezing for 4 hours with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Sep-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot UT8802MA, expiry date:30-Jun-2026, frequency: once, strength: standard, via intramuscular route in the right deltoid for Immunization were exposed with temperature excursion with maximum\lowest temperature reached :unknown freezing for 4 hours with human error with no reported adverse event (latency: same day). Reportedly, human error was involved, previous excursion: none, Reason: Storage in cooler with ice Packs and product was administered. The extended stability data cover the excursion was unknown.They explained that FLUZONE NP vaccines were stored in a cooler with frozen ice packs, separated by a barrier layer of refrigerated packs to prevent freezing. This storage condition lasted for 4 hours before the vaccines were transferred to a refrigerator with within-range temperature. The clinic supervisor also stated that they could not provide the exact highest temperature that the vaccines reached. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. .; Sender's Comments: US-SA-2025SA281885:for FLUZONE NP US-SA-2025SA281965: More
2860639 0.42 M MD 09/23/2025 DTAPIPVHIB
 SANOFI PASTEUR
Expired product administered, No adverse event Expired product administered, No adverse event
expired product administered to patient with no reported adverse event; Initial information received... expired product administered to patient with no reported adverse event; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 months old male patient who was administered with expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported adverse event. Concomitant medications included Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) For Immunisation; And Fluoxetine Hydrochloride (Serotec [Fluoxetine Hydrochloride]) for Immunisation. On 18-Sep-2025, the patient received a 0.5ml expired dose (dose 2) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Powder and suspension for suspension for injection, standard strength, frequency-once, lot number-unknown, expired date-31-Aug-2025) intramuscular route in the left thigh for Immunization (expired product administered) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2860658 36 M MI 09/23/2025 COVID19
COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
JANSSEN
 1855194
1855194
1855194
1855194
Allergy to arthropod bite, Anxiety, Blood test normal, Brain fog, Cardiac stress... Allergy to arthropod bite, Anxiety, Blood test normal, Brain fog, Cardiac stress test normal; Derealisation, Dry skin, Electrocardiogram ambulatory normal, Electrocardiogram normal, Exercise tolerance decreased; Gastrointestinal disorder, Heart rate increased, Magnetic resonance imaging head normal, Magnetic resonance imaging heart normal, Presyncope; Skin disorder, Syncope, Tachycardia More
Received COVID-19 vaccine on December 10, 2021, while serving in the (withheld) (mandated). On June ... Received COVID-19 vaccine on December 10, 2021, while serving in the (withheld) (mandated). On June 28, 2022, experienced sudden onset of tachycardia while at rest, followed by syncope. Went to ER; EKG found no abnormalities. From June 2022 to July 2024, experienced persistent symptoms including elevated/bounding heart rate, severe anxiety, brain fog, derealization, exercise intolerance, dry skin, heightened reactions to insect bites, gastrointestinal issues, self-perceived immune dysfunction (frequent illnesses, slower recovery), and near-fainting episodes. Since July 2024, many symptoms have improved and are now at a more manageable level. However, I continue to experience bounding heart rate, GI issues, exercise intolerance, skin problems, anxiety, and persistent symptoms suggestive of immune system changes (self-reported). More
2860664 M 09/23/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Mechanical ventilation, Varicella zoster pneumonia Mechanical ventilation, Varicella zoster pneumonia
got shingles in his lungs two years ago; Nearly died several times; This serious case was reported ... got shingles in his lungs two years ago; Nearly died several times; This serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included rheumatoid arthritis (immunocompromised with rheumatoid arthritis). On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced shingles (Verbatim: got shingles in his lungs two years ago) (serious criteria hospitalization) and near death experience (Verbatim: Nearly died several times) (serious criteria hospitalization and GSK medically significant). The outcome of the shingles and near death experience were not resolved. It was unknown if the reporter considered the shingles and near death experience to be related to RSV vaccine. The company considered the shingles and near death experience to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 04-SEP-2025 This case was reported by a patient's wife via interactive digital media. The patient previously gotten shingles, so he got vaccinated. Nevertheless, he got shingles in his lungs two years ago and he was on a ventilator for 21 days and nearly died several times. Now (during the reporting days) he takes medicine for it daily and they could not go out in public without masks. The reporter said that if he had not been vaccinated that he would have died for sure. The reporter said take care and be very careful because you are still at risk even though it was lowered with vaccination; Sender's Comments: A case of Herpes zoster and Near death experience, unknown time after receiving RSV vaccine in a male patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (h/o shingles and concurrent immunocompromised with rheumatoid arthritis). More
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2860665 F 09/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Phantom limb syndrome, Vaccination failure Herpes zoster, Phantom limb syndrome, Vaccination failure
Suspected vaccination failure; I've had shingles twice; This serious case was reported by a co... Suspected vaccination failure; I've had shingles twice; 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've had shingles twice). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 18-SEP-2025 The case was received from the patient via interactive digital media. The patient stated that phantom pain could get, and you were afraid it had come back. 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 Shingrix in a female 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
2860666 F 09/23/2025 COVID19
 MODERNA
Fatigue, Nausea, Somnolence Fatigue, Nausea, Somnolence
fatigue; drowsiness/wanted to sleep all day; nausea; This spontaneous case was reported by a consume... fatigue; drowsiness/wanted to sleep all day; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsiness/wanted to sleep all day), NAUSEA (nausea) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (drowsiness/wanted to sleep all day), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, SOMNOLENCE (drowsiness/wanted to sleep all day), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication was not reported. It was reported that a patient preferred for the Moderna vaccine due to her overall positive experiences with it. Following her initial dose, she experienced mild nausea and drowsiness, which was resolved by nightfall. Importantly, no side effects were reported with subsequent doses. This experience had led her to continue choosing Moderna for all her vaccinations. Patient received 8 Moderna COVID-19 vaccine doses in total. The last dose was received in November 2024. Vaccinations were spaced according to public guidance (initial 3 doses close together, later boosters over time). After the first Moderna dose, patient experienced nausea for all day following vaccination. It was reported that the patient had extreme drowsiness/fatigue like she wanted to sleep all day. By nightfall, nausea had resolved, patient's energy returned and was wide awake. Patient had subsequent Moderna doses (7 in total) and had no side effects. Patient tolerated all additional doses without issues. Treatment medication was not reported. Reporter did not allow further contact More
2860667 67 F FL 09/23/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
UT8836JA
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
stated they mistakenly gave a patient the regular Fluzone instead of the hd with no adverse event; I... stated they mistakenly gave a patient the regular Fluzone instead of the hd with no adverse event; Initial information received on 18-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 67 year old female patient who was they mistakenly given Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] instead of the Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Sep-2025, the patient received an dose of 0.5ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine standard strength frequency once (lot UT8836JA and expiry date-30-Jun-2026) via intramuscular route in the left deltoid for Influenza (Influenza immunisation) instead of Fluzone Hd with no adverse event (wrong product administered) (latency-same day) (latency-same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2860734 FL 09/23/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y013348
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No additional AE; Customer called to report TE. VARIVAX was administered to on patient on 08/28/2025... No additional AE; Customer called to report TE. VARIVAX was administered to on patient on 08/28/2025.; This spontaneous report was received from an 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 28-AUG-2025, the patient was vaccinated with an improperly stored (8 F for 46 hours, no previous temperature excursions) varicella virus vaccine live (oka-merck) (VARIVAX) injection at a total dose of 0.5 mL, lot #Y013348, expiration date: 02-AUG-2026, administered for prophylaxis (route of administration and anatomical location were not reported) (Product storage error). The vaccine was reconstituted with sterile diluent (lot# and expiration date not reported). No additional adverse event was reported. More
2860735 M 09/23/2025 BCG
 UNKNOWN MANUFACTURER
Drug ineffective Drug ineffective
BCG - Drug ineffective (took BCG from 2011 to 2014); This spontaneous report was received from a con... BCG - Drug ineffective (took BCG from 2011 to 2014); This spontaneous report was received from a consumer and refers to currently 68-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date in 2011, the patient started therapy with BCG (TICE BCG LIVE) (dose, frequency, route of administration, lot #, expiration date, and indication were not reported). On an unknown date, the patient experienced BCG - Drug ineffective (he took BCG (TICE BCG LIVE) from 2011 to 2014). The outcome of Drug ineffective was unknown. The action taken with BCG (TICE BCG LIVE) regarding the event was unknown. The causal relationship between the event of drug ineffective and BCG (TICE BCG LIVE) was considered related. Lot # is being requested and will be submitted if received. More
2860736 13 M NJ 09/23/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Z009260
Hypoaesthesia, Inappropriate schedule of product administration, Paraesthesia, P... Hypoaesthesia, Inappropriate schedule of product administration, Paraesthesia, Piloerection; Hypoaesthesia, Inappropriate schedule of product administration, Paraesthesia, Piloerection More
goosebumps; first Gardasil 9 injection in Aug2024/ second Gardasil 9 28Aug2025; numbness and tinglin... goosebumps; first Gardasil 9 injection in Aug2024/ second Gardasil 9 28Aug2025; numbness and tingling on the left side of his face; numbness and tingling on the left side of his face; headache; This spontaneous report was received from a mother's patient and refers to a 13-year-old male patient. The patient's medical history included exercise induced asthma and used a rescue inhaler as needed. On August 2024, the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were not reported). It was reported after first dose the patient did not had any problem. On 28-AUG-2025, the patient was vaccinated with second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) injection, at a dose of 0.5 mL, administered by Intramuscular route in Left Deltoid for Prophylaxis (lot #Z009260, expiration date: 19-Aug-2027) (Inappropriate schedule of product administration). On the same date (reported as within 10 minutes of received his second injection), the patient developed goosebumps all over his body (Piloerection) and numbness and tingling on the left side of his face (Hypoaesthesia and Paraesthesia). He also experienced a headache. It was reported, the goosebumps and tingling resolved after half hour but the numbness on the left side of his face persisted and is not resolving or has had very little minor improvement; and headache resolved at an unknown time with no treatments. It was also mentioned he was still able to move his eyes and cheeks, and he did not have any drooping on 1 side of face, so she does not believe he has had any stroke-like symptoms, Bell's Palsy or anything like that. The causal relationship between the events of Hypoaesthesia, Paraesthesia, Piloerection and headache and Human Papillomavirus 9-valent Vaccine, Recombinant were not reporter. This is one of two reports from the same reporter. More
2860738 66 UT 09/23/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 Z006076
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
Confimed patient not symptomatic. No additional AE; extra dose of CAPVAXIVE administered to patient ... Confimed patient not symptomatic. No additional AE; extra dose of CAPVAXIVE administered to patient on 08/05/2025; This spontaneous report was received from a physician assistant and refers to a 66-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, anatomical site, lot # and expiration date were not reported) as prophylaxis. Then, on 05-Aug-2025, the patient received an extra dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Z006076, expiration date: 11-Sep-2026) (dose, route of administration and anatomical site were not reported) as prophylaxis (Extra dose administered). No additional adverse event (No adverse event). Batch/Lot number is being requested and will be submitted if received. More
2860739 09/23/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Mobility decreased, Pain Mobility decreased, Pain
I was bedridden; I felt pain in the same spot were got shingles 35 years ago; This non-serious case ... I was bedridden; I felt pain in the same spot were got shingles 35 years ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (35 years ago). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bedridden (Verbatim: I was bedridden) and pain (Verbatim: I felt pain in the same spot were got shingles 35 years ago). The outcome of the bedridden and pain were not reported. It was unknown if the reporter considered the bedridden and pain to be related to Shingles vaccine. It was unknown if the company considered the bedridden and pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-AUG-2025 This case was reported by a patient via interactive digital media. The reporter reported that had them in college and no pain medication and no healing drugs. The reporter mentioned he/she would not suggest the vaccine. The reporter mentioned shot 2 was horrible, he/she was bedridden and felt pain in the same spot where got shingles 35 years ago. More
2860740 09/23/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain Herpes zoster, Pain
Shingles; This non-serious case was reported by a consumer via interactive digital media and describ... Shingles; 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: Shingles). 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: 01-SEP-2025 The case was received from the patient via interactive digital media. The patient had shingles so painful, he got the first shot but not the second folks got the shot. More
2860741 F VA 09/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Dry skin, Injection site erythema, Injection site warmth Dry skin, Injection site erythema, Injection site warmth
she had a red injection site that was hot; she had a red injection site that was hot; Hot dry skin; ... she had a red injection site that was hot; she had a red injection site that was hot; Hot dry skin; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: she had a red injection site that was hot), injection site warmth (Verbatim: she had a red injection site that was hot) and hot dry skin (Verbatim: Hot dry skin). The outcome of the injection site erythema and hot dry skin were resolved and the outcome of the injection site warmth was not reported. It was unknown if the reporter considered the injection site erythema, injection site warmth and hot dry skin to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site warmth and hot dry skin to be related to Shingrix. Linked case(s) involving the same patient: US2025114529 Additional Information: GSK Receipt Date: 05-Sep-2025 The patient reported that six or seven years ago she received the Shingrix series. In 2018, the patient had all the reported events. For tolerance of second dose, refer case US2025114529.; Sender's Comments: US-GSK-US2025114529:same reporter More
2860742 09/23/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pruritus, Rash, Surgery; Herpes zoster, Pruritus, Rash, Surgery Herpes zoster, Pruritus, Rash, Surgery; Herpes zoster, Pruritus, Rash, Surgery
Finally got diagnosed after 4 days; This non-serious case was reported by a consumer via interactive... Finally got diagnosed after 4 days; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included surgery (triggered shingles on my left arm (forearm area and on bicep)). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Finally got diagnosed after 4 days). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related 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: 11-SEP-2025 This case was reported by a patient via interactive digital media. The patient did get the vaccine and booster about 7 years ago. Unfortunately, there was no guarantee that you still won't get shingles and finally got diagnosed after 4 days of emails and pictures and of course since the patient off the harsh medications, there was some itching. While the patient was very lucky compared to many of you who have had it and having shingles really stinks. The patient had surgery and that triggered shingles on his/her left arm (forearm area and on my bicep), because the patient was on some strong pain pills there was no pain just suddenly these bumps and they seem to spread. The patient sent pictures to his/her primary care manager (PCM) and she wasn't sure, didn't think it was dermatitis nor shingles because the patient was not in pain or itching. More
2860744 55 F 09/23/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
JANSSEN
JANSSEN
JANSSEN
JANSSEN
JANSSEN
JANSSEN
JANSSEN









Anxiety disorder, Balance disorder, Biopsy, Biopsy peripheral nerve, Biopsy peri... Anxiety disorder, Balance disorder, Biopsy, Biopsy peripheral nerve, Biopsy peripheral nerve abnormal; Breast capsulectomy, Breast capsulotomy, Burning sensation, Chronic inflammatory demyelinating polyradiculoneuropathy, Cognitive disorder; Colonoscopy, Computerised tomogram, Contusion, Coordination abnormal, Cryoglobulinaemia; Debridement, Depression, Disturbance in attention, Emotional disorder, Emotional distress; Fall, Gait disturbance, Head injury, Immunoglobulin therapy, Impaired work ability; Incontinence, Laboratory test, Limb injury, Loss of employment, Loss of personal independence in daily activities; Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal, Magnetic resonance imaging thoracic, Mammoplasty, Memory impairment; Nervous system disorder, Ostectomy, Pain, Pain in extremity, Peripheral swelling; Post-traumatic stress disorder, Scan with contrast abnormal, Scar, Sensory disturbance, Tendon injury; Tenoplasty, Ultrasound scan, Visual impairment More
I complied with the mandate to be vaccinated and received the Johnson & Johnson COVID-19 vaccine... I complied with the mandate to be vaccinated and received the Johnson & Johnson COVID-19 vaccine and subsequent booster. Within months, my health collapsed. I was diagnosed with Cryoglobulinemia, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and most recently Chronic Immune Sensory Polyradiculopathy (CISP)?a condition so rare it is scarcely documented. These rare and debilitating diseases that have progressively eroded my ability to function physically, cognitively, and emotionally. CISP is a variant of CIDP that primarily affects the sensory nerve roots, causing profound proprioceptive loss, gait ataxia, and falls, often without motor weakness. Cryoglobulinemia is a rare autoimmune blood disorder in which abnormal proteins precipitate in cold temperatures, causing vascular inflammation, blood sludging, and peripheral nerve damage. Together, these diseases create a relentless cycle of pain, instability, and systemic dysfunction. Cognitive and Neurological Impairments ? Time conceptualization, concentration, and short-term memory are dramatically affected. I estimate 6% functionality in short-term memory, with similar deficits in multitasking and tracking time. ? Navigating daily life without losing or forgetting something is impossible. Interactive activities are overwhelming, and I often lose track of conversations, tasks, or even basic routines. Physical Limitations and Pain ? I feel a constant rolling sensation, a disconcerting unsteadiness that rarely eases. ? I am unable to walk safely on anything but a perfectly level surface. I fall 3?5 times per week, depending on terrain. A fall at the post office has led to making sure someone accompanies me in public. In June 2024, a fall caused a severe tendon tear, requiring surgery. Another fall resulted in a head injury, and others leaving bruises etc.. Continued unsteadiness and falls are physically and psychologically challenging. ? I can?t dance, turn head to either side, or look up without losing balance. ? I receive Gammagard IVIG infusions every 3 weeks, each lasting 5 hours. My functionality fluctuates depending on where I am in the treatment cycle. ? I experience daily incontinence, which adds to the physical and emotional burden. ? My vision is impaired, both near and far, making navigation and reading difficult. ? Standing for more than 10?20 minutes causes my feet to fill with burning pain. Sitting triggers pain down my thighs and into my calves and feet, which swell and burn. ? Any injury to a limb triggers a mirrored attack on the opposite limb. Repetitive pressure causes swelling and burning tissue pain. Even typing or intimate contact can provoke upper body flare-ups. ? My coordination is compromised, and I struggle with basic motor tasks. Emotional and Financial Devastation ? The emotional trauma is almost unbearable. Once fueled by a boundless enthusiasm for nature, work, and my beloved pets, I now feel my spirit fading as these sources of joy become inaccessible. ? I lost my job in the highly sophisticated space industry, a career that gave me purpose and pride. The loss of work, compounded by being denied benefits as an independent contractor, and still in appeal process, has left me with no income since December 2023. ? My home loan, retirement account, and savings are gone. Friends and family have helped as much as they can, but their resources are strained. My credit is maxed, and I now face the imminent loss of my home. These symptoms are not episodic?they are daily, progressive, and disabling. They prevent me from performing substantial gainful activity, managing basic household tasks, or engaging socially. I have fought to remain independent, but the progression of these conditions has made that no longer viable. Timeline November 30, 2021 ? J&J 1st Booster Mid-December 2021 onward ? Beginning of progression of disturbingly unusual symptoms January 2022 ? 3x visit with GP, then sent to specialist. 2022 ? Spine Specialist 2022 ? Dermatologist 2022 - Hematologist 2022 ? Neurologist 2022 ?DISESAE DIAGNOSIS (LAB): Procedure: Lab Draws Diagnosis: cryoglobulinemia, a disease suspected of presenting over underlying disorder not yet discovered 2022 ? Action: Referred to UCSF Hematology Program 2022 ? Referred to Neurologist April 2023 ? SURGERY Procedure: Abdominal Fat Pad Biopsy to rule out amyloidosis ? Anes- General. Diagnosis: Inconclusive July 11, 2023 ? SURGERY Sural Nerve Biopsy Procedure: Nerve Biopsy Sural with Allograft Repair Diagnosis: Chronic Inflammatory Demyialating Polyneuropathy Treatment: IVIG Gammagard 3x Kickstart, ongoing IVIG infusions (Gammagard administered every 3rd-week). August 3, 2023 ? SURGERY Breast Capsulotomy/Capsulectomy; Bilateral (Bilateral: Breast) Mastoplexy Periareolar (Bilateral: Chest) Sept 2023 ? Began IVIG Treatment 3x 3-day Kickstarts. Change to: 1x every 4th week. Change to: 1x every 3rd week Oct 2023 ? SURGERY Colonoscopy Dec 27, 2023 ? Lost income due to Inability to perform. Feb 2024 ? Applied for Federal and State disability benefits April 2024 ? Hard fall in garden injuring right forearm. GP Referral Orthopedic specialist visit in August. November 16, 2024 ? Terminated legal REPRESENTATION November 18, 2024 ? SURGERY Diagnosis: Severe tearing from fall in April 2024, and chronic scar tissue on undersurface of common extensor tendon, right elbow. Surgery: Debridement and repair of common extensor tendon right elbow, with partial ostectomy. May 27, 2025 ? REASSAIGNMENT DIAGNOSIS + DISORDER RESUMPTION (MRI?s (brain, cervical, thoracic, lumbar), LAB?s, BRAIN Study): Diagnosis 1: Reassignment of CIDP to CISP. Action: Schedule new MRI Brain with Contrast Diagnosis 2: Resumption of cryoglobulinemia. Action1: LABS ordered. Action2: Referring to Hematologist. Diagnosis 3: Mild Neurocognitive Disorder (provisional); Unspecified Depressive Disorder, Unspecified Anxiety Disorder, PTSD (by history); R/O Somatic Symptom Disorder. Action: Recommendations for treatment using various therapies to be reviewed with core team and patient. More
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2860745 11 F IL 09/23/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
SANOFI PASTEUR
 Z005486
U8600AA
U8670BA
Urticaria; Urticaria; Urticaria Urticaria; Urticaria; Urticaria
urticarial rash that started on RLQ abdomen and ears; spread to bilateral arms, chest, legs, face, n... urticarial rash that started on RLQ abdomen and ears; spread to bilateral arms, chest, legs, face, neck, back More
2860746 11 F IL 09/23/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 Y012921
3443E
U7983AA
Injection site nodule, Injection site pain; Injection site nodule, Injection sit... Injection site nodule, Injection site pain; Injection site nodule, Injection site pain; Injection site nodule, Injection site pain More
subcutaneous nodule in left deltoid; slightly tender to palpation subcutaneous nodule in left deltoid; slightly tender to palpation
2860747 5 M TN 09/23/2025 FLU3
 SEQIRUS, INC.
 406985
No adverse event, Wrong patient No adverse event, Wrong patient
During school flu clinic, school nurse brought patient into clinic room and introduced him incorrect... During school flu clinic, school nurse brought patient into clinic room and introduced him incorrectly. Pt did not speak local language and did not know his birthdate. When confirming the patient's mother's name, he nodded his head yes. School nurse confirmed to nurse administering vaccine and this nurse administered vaccine. 5 minutes later school nurse brought another student and repeated same name - I informed her I had already completed that patient's vaccine and we realized then that the wrong patient had come previously. Patient's parents were contacted by school nurse and informed of incident and the mother verbalized understanding and consented to flu vaccine. The child has NKA and had no adverse event from vaccination. More
2860748 39 F NY 09/23/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.

Cancer screening normal, Heavy menstrual bleeding, Menstruation irregular; Cance... Cancer screening normal, Heavy menstrual bleeding, Menstruation irregular; Cancer screening normal, Heavy menstrual bleeding, Menstruation irregular More
On 10/19/24 I received the Pfizer covid vaccine as well as my annual flu shot at a local Pharmacy at... On 10/19/24 I received the Pfizer covid vaccine as well as my annual flu shot at a local Pharmacy at which point my menstrual cycle was about 2 or 3 days late to arrive. As soon as I got home from receiving the shots, literally no more than 5 minutes later because I left right away and the pharmacy is down the block from my house, my menstrual cycle came down heavily. Thereafter I ended up bleeding for 30 days until having to start hormone treatment with progesterone to get it under control. It is still not under control entirely it has been irregular ever since. I was thoroughly screened for cancer which was negative. I had a bilateral salpingectomy two and a half years prior which increased my pain and bleeding during menstruation initially but I all along had kept a regular schedule of bleeding every 28 to 35 days. I'm now at a place in my life if I miss a progesterone pill I will bleed long term with great difficulty to stop it. More
2860749 F 09/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Burning sensation, Herpes zoster, Pain, Rash, Vaccination failure Burning sensation, Herpes zoster, Pain, Rash, Vaccination failure
Suspected vaccination failure; had shingles 6 times in 2 years; This serious case was reported by a ... Suspected vaccination failure; had shingles 6 times in 2 years; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 6 times in 2 years). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 17-SEP-2025 This case was reported by a patient via interactive digital media. Reporter stated that she had taken the shingle vaccine and have had shingles 6 times in 2 years. The pain and burning were just as horrible as if she had never had the vaccine. The rash was not as angry though. Lasted 3 months each time as if she had no vaccine. 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 Shingrix, in a adult female 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
2860751 42 M FL 09/23/2025 COVID19
 PFIZER\BIONTECH
 MY9550
Dizziness Dizziness
Patient felt dizziness Patient felt dizziness
2860752 1.25 F PA 09/23/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 M52GG
Circumstance or information capable of leading to medication error, Underdose Circumstance or information capable of leading to medication error, Underdose
When administering infanrix (Dtap) in the R leg, the patient yanked her leg away from me and the nee... When administering infanrix (Dtap) in the R leg, the patient yanked her leg away from me and the needle left the muscle and by my approximation, 2/3 of the vaccine squirted on the exam table. Patient was not stuck again by the same needle. Informed parents and office manager. A call to the manufacturer will be happening to confirm if there is any actions that need taken. More
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