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
2855633 73 F FL 08/26/2025 PNC20
 PFIZER\WYETH
 LP4947
Extra dose administered, Pain in extremity Extra dose administered, Pain in extremity
PREVNAR WAS ADMINISTERED TO PTATIENT 8/25/2025. FLSHOT DID NOT SHOW THAT PATIENT GOT A DOSE ON 6/5/... PREVNAR WAS ADMINISTERED TO PTATIENT 8/25/2025. FLSHOT DID NOT SHOW THAT PATIENT GOT A DOSE ON 6/5/2025 AT OUR PHARMACY. PATIENT WAS INFORMED. OTHER THEN SORE ARM, SHE HAS NO OTHER SIDE EFFECTS More
2855634 14 F MD 08/26/2025 HEPA
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 LC5483
LC5483
Vaccination error; Vaccination error Vaccination error; Vaccination error
Vaccine Administered In Error Vaccine Administered In Error
2855635 53 F FL 08/26/2025 PNC20
 PFIZER\WYETH
 lk6550
Arthralgia, Pain, Pain in extremity Arthralgia, Pain, Pain in extremity
Patient called to report a sore arm after receiving a prevnar 20 vaccine. She says the pain is radi... Patient called to report a sore arm after receiving a prevnar 20 vaccine. She says the pain is radiating from her shoulder to her elbow. She says the pain is severe enough that she is going to Urgent Care and Tylenol/Ibuprofen is not relieving the pain. I will also report the event to VAERS. She is going to follow up with us after her doctor appointment. More
2855636 81 F VA 08/26/2025 FLU3
 SANOFI PASTEUR
 UT8817KA
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
Upper L arm red, swollen, and painful Upper L arm red, swollen, and painful
2855637 7 M KS 08/26/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient was given Infanrix (DTaP) after the age of 7. Patient should have received Tdap or Td. Physi... Patient was given Infanrix (DTaP) after the age of 7. Patient should have received Tdap or Td. Physician and PCP nurse made aware. More
2855638 32 F GA 08/26/2025 TYP
YF
 SANOFI PASTEUR
SANOFI PASTEUR
 Y2A031M
uk138AA
Cough, Dyspepsia, Oropharyngeal pain, Urticaria, Wheezing; Cough, Dyspepsia, Oro... Cough, Dyspepsia, Oropharyngeal pain, Urticaria, Wheezing; Cough, Dyspepsia, Oropharyngeal pain, Urticaria, Wheezing More
About 1 hour after vaccines, cough, sore throat, and indigestion. Progressed within 45 minutes to w... About 1 hour after vaccines, cough, sore throat, and indigestion. Progressed within 45 minutes to wheezing and hives on face and upper body. Also noted heartburn. More
2855639 55 M MO 08/26/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR

Chest X-ray, Chest discomfort, Computerised tomogram abdomen, Computerised tomog... Chest X-ray, Chest discomfort, Computerised tomogram abdomen, Computerised tomogram head, Headache; Magnetic resonance imaging head, Magnetic resonance imaging neck, Pain in extremity, Pain in jaw, Paraesthesia More
presented with bilateral arm tingling, jaw pain, chest tightness, and left arm soreness, which beca... presented with bilateral arm tingling, jaw pain, chest tightness, and left arm soreness, which became constant after receiving a Tdap shot several weeks ago. The patient also complained of a headache. More
โœ“ โœ“
2855640 6 F TX 08/26/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 Y49BZ
Injection site rash, Injection site swelling, Pyrexia, Urticaria Injection site rash, Injection site swelling, Pyrexia, Urticaria
Patient receive vaccines on 08/21/25. She received Kinrix vaccine on left deltoid area and Hepatitis... Patient receive vaccines on 08/21/25. She received Kinrix vaccine on left deltoid area and Hepatitis A (Havrix) on right deltoid area. Parents contacted the clinic by phone and email on 08/23/25 stating that left deltoid area started to get red and swollen from the night of 08/21 and getting worse through out the day of the 08/22 and associated low grade fever (38 C), reason why she was not sent to school that day. Parents stated swelling and redness got worse and they gave her Ibuprofen and Benadryl. Also, patient developed urticarial rash on left leg and back. I contacted parents on 08/23/25 when everything was explained to me with some language barrier (Patient is from another country) Recommended to continue with Benadryl 5 ml every 8 hours, Ibuprofen as needed for pain or fever and apply cold compresses on site of injection. Recommended to take her to urgent care for further management if they notice worsening. Parents verbalized understanding. Visit was schedule for 08/25/25. On 08/25 urticarial rash was resolved and swelling and redness of left deltoid area was minimal. More
2855641 33 M VA 08/26/2025 TDAP
TDAP
TDAP
TDAP
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8232AA
U8232AA
U8232AA
Unknown
Unknown
Unknown
Injected limb mobility decreased, Pain in extremity, Sleep disorder; Impaired wo... Injected limb mobility decreased, Pain in extremity, Sleep disorder; Impaired work ability, Joint range of motion decreased, Pain, Shoulder injury related to vaccine administration, Swelling; Ultrasound scan, X-ray; Injected limb mobility decreased, Pain in extremity, Sleep disorder; Impaired work ability, Joint range of motion decreased, Pain, Shoulder injury related to vaccine administration, Swelling; Ultrasound scan, X-ray More
Patient tried to sleep and had pain in arm that was vaccinated. Wife stated he was unable to lift ar... Patient tried to sleep and had pain in arm that was vaccinated. Wife stated he was unable to lift arm. Patient saw and doctor and prescriber thought it may be that vaccination was given to high on arm. Patient was possibly going to get MRI. Unable to contact patient for further information and resolution. More
2855642 4 M CA 08/26/2025 UNK
 UNKNOWN MANUFACTURER
 IPV
Urticaria Urticaria
Child broke out on hives, beginning on thigh and migrating all over the body Child broke out on hives, beginning on thigh and migrating all over the body
2855643 13 F NC 08/26/2025 MMRV
 MERCK & CO. INC.
 Y012076
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse event. Given at age 13. Unable to put date below for Energic B - 1/23/25 No adverse event. Given at age 13. Unable to put date below for Energic B - 1/23/25
2855644 0.5 M KS 08/26/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 49M2F
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient recently received rabies vaccine on 8/5. Provider signed off on 6-month vaccines. 6-month va... Patient recently received rabies vaccine on 8/5. Provider signed off on 6-month vaccines. 6-month vaccines administered as well as live MMR vaccine. Per protocol, live vaccines should be given at least 4 weeks apart. PCP, mother of patient, nursing staff, and nursing supervisor notified. Infectious disease contacted. More
2855645 69 F UT 08/26/2025 RSV
 PFIZER\WYETH
 md5462
Chest pain, Neck pain, Pain in extremity Chest pain, Neck pain, Pain in extremity
She said it feels like the vaccine went into her chest and felt it strongly in her arm, traveling up... She said it feels like the vaccine went into her chest and felt it strongly in her arm, traveling up her arm and down her neck. It was a painful, spreading feeling. No breathing issues or fainting. No heart rate changes. More
2855646 4 F 08/26/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 X021751
X026325
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
Physician spoke with patient's mother, per mother patient is not experiencing any adverse react... Physician spoke with patient's mother, per mother patient is not experiencing any adverse reaction. More
2855647 51 F CA 08/26/2025 TD
TD
 SANOFI PASTEUR
SANOFI PASTEUR
 332L4
332L4
Angioedema, Computerised tomogram head, Facial paralysis, Headache, Injection si... Angioedema, Computerised tomogram head, Facial paralysis, Headache, Injection site pain; Injection site swelling More
Severe pain, severe swelling on site, severe headache, left face dropping, and angioedema on lip. Tr... Severe pain, severe swelling on site, severe headache, left face dropping, and angioedema on lip. Treatment with steroid and anti viral medications. On going acupuncture for Left month/lip dropping., symptom slightly improved. More
2855648 74 F NY 08/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 GJ952
Influenza like illness Influenza like illness
Flu like symptoms day after administration Flu like symptoms day after administration
2855649 10 F OH 08/26/2025 HPV9
 MERCK & CO. INC.
 z007396
Fall, Head injury, Nausea, Syncope Fall, Head injury, Nausea, Syncope
Patient received HPV vaccine @11:10 am. Then had fingerstick testing for a lipid panel . after lea... Patient received HPV vaccine @11:10 am. Then had fingerstick testing for a lipid panel . after leaving the exam room @11:30 amthe patient had a syncope episode in the discharge area where she fell backwards hitting her head on the floor and her left arm on a file cabinet . She remained alert after she landed on the the floor. Dr. was at her side and the patient remained laying down with knees bent to recover. she had pain where she hit her head and left arm. she was nauseated. she was moved to an exam room to continue recovering until @ 12:40 pm when she left the office with her mother More
2855650 64 F OK 08/26/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Injection site pain; Injection site pain Injection site pain; Injection site pain
I was expecting to be sore, and I was. The pain was in my left arm injection site that day. Over th... I was expecting to be sore, and I was. The pain was in my left arm injection site that day. Over the next few days and weeks, it kept getting worse, and growing larger area. It was horrible holding my new granddaughter and driving. I finally complained to my Dr. She gave me Medrol pack. Said if it didn?t work, she would refer me to Physical Therapy. It didn?t work, so I went to therapy from 02/19/2025-05-14-2025. More
2855651 3 F NC 08/26/2025 DTAPIPV
 SANOFI PASTEUR
 U8383AB
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
none at this time per mom none at this time per mom
2855652 17 F IL 08/26/2025 HEP
HEPA
 MERCK & CO. INC.
MERCK & CO. INC.
 Y004552
Y013274
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No adverse side effects noted. Pt inadvertently received additional doses of Hep A and Hep B. No adverse side effects noted. Pt inadvertently received additional doses of Hep A and Hep B.
2855653 35 F KS 08/26/2025 HEP
MMR
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 N733B
Y020517
Bell's palsy, Eyelid function disorder, Facial paralysis, Hypoaesthesia; Be... Bell's palsy, Eyelid function disorder, Facial paralysis, Hypoaesthesia; Bell's palsy, Eyelid function disorder, Facial paralysis, Hypoaesthesia More
Left sided Face numbness satrted 8/21/2025 at HS. Next morning proceeded to urgent care and ER with ... Left sided Face numbness satrted 8/21/2025 at HS. Next morning proceeded to urgent care and ER with face droop and left eye not blonking. Dx bells palsy 8/22/2025, treated with prednisone. Acyclovir, eye lubricant More
2855654 55 F GA 08/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 pj353
Dizziness, Hot flush, Hypotension Dizziness, Hot flush, Hypotension
Patient received her vaccine, and sat on our bench for a few minutes, then came back asking if it wa... Patient received her vaccine, and sat on our bench for a few minutes, then came back asking if it was normal to feel "a little bit woozy." We took her back into the IMZ room, where she was also feeling flushed and hot. We gave her some water, an ice pack, and a fan. The other pharmacist checked, and the patient's BP was very low, although I cannot recall the number she told me. The patient never passed out, but we just continued supportive care until her BP normalized and she felt well enough to leave. More
2855655 36 F CA 08/26/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 330308D
FE3594
Eyelid cyst, Eyelid cyst removal, Eyelid discolouration, Oedema peripheral, Swel... Eyelid cyst, Eyelid cyst removal, Eyelid discolouration, Oedema peripheral, Swelling of eyelid; Eyelid cyst, Eyelid cyst removal, Eyelid discolouration, Oedema peripheral, Swelling of eyelid More
Armpit swelled the size of an orange after dose 1. After does 2 I developed cysts on both eyelids. T... Armpit swelled the size of an orange after dose 1. After does 2 I developed cysts on both eyelids. They swelled up and turned purple. I had to get the cysts surgically removed. Terrible reaction to Covid vaccine in BOTH eyes. Surgery needed. More
โœ“
2855656 3 M MO 08/26/2025 MMRV
 MERCK & CO. INC.
 X019102
No adverse event, Product storage error No adverse event, Product storage error
no adverse event; incorrect product storage; This spontaneous report was received from a Nurse and r... no adverse event; incorrect product storage; This spontaneous report was received from a Nurse and refers to a 3-year-old male patient. The patient had no medical history nor concurrent conditions. Concomitant therapies were not reported. On 14-Mar-2025, the patient was vaccinated at private doctor's office or hospital with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Solution for injection (lot #X019102, expiration date: 16-Jul-2025), dose number 1, administered by Subcutaneous route in Left Thigh. It was diluted with sterile diluent (BAXTER STERILE DILUENT). The vaccine underwent a temperature excursion of freezer. The vaccine was discarded after use.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-08-04 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : SL , Central date : 2025-07-31 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number : More
2855657 66 OK 08/26/2025 PNC15
PPV
 MERCK & CO. INC.
MERCK & CO. INC.
 Y010032
Y016291
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
patient received both PNEUMOVAX 23 and VAXNEUVANCE on the same day; No adverse symptoms reported; Th... patient received both PNEUMOVAX 23 and VAXNEUVANCE on the same day; No adverse symptoms reported; This spontaneous report was received from a Nurse and refers to a 66-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated on the same day with both Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) suspension for injection, lot #Y016291, expiration date: 06-Dec-2026 (dose, route and site of administration not provided), and with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) suspension for injection, lot #Y010032, expiration date: 17-Feb-2027, 0.5 ml (route and site of administration not provided) for prophylaxis (accidental overdose). No adverse symptoms reported (no adverse event). Permission to contact was given. More
2855659 WA 08/26/2025 VARCEL
 MERCK & CO. INC.
 Y015559
No adverse event, Product storage error No adverse event, Product storage error
No additional AE/PQC.; VARIVAX was administered after TE on 8/18/2025; This spontaneous report was r... No additional AE/PQC.; VARIVAX was administered after TE on 8/18/2025; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Between 01-Aug-2025 and 19-Aug-2025, a temperature excursion (TE) occurred with a cumulative time of 432 hours with a max temperature of (-12.5C) with 2 prior excursions (prior excursion: -10๏ฟฝC up to 8๏ฟฝC (-8.94C) for 0 hours, 11 minutes, 0 seconds; prior excursion: -10๏ฟฝC up to 8๏ฟฝC (-10C) for 1 hour, 54 minutes, 0 seconds; current excursion: -14๏ฟฝC up to -10๏ฟฝC (-12.5C) for 432 hours, 0 minutes, 0 seconds (cumulative for August 2025)). On 18-Aug-2025, after the TE, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y015559, expiration date reported as and upon internal validation confirmed to be 16-Sep-2026) for prophylaxis (dose, route of administration and vaccination site were not reported) (product storage error). TE evaluation was communicated as "supported". No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). More
2855660 TN 08/26/2025 PPV
 MERCK & CO. INC.
 X022827
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE/No PQC.; HCP called to report that an expired dose of PNEUMOVAX 23 was inadvertentl... No additional AE/No PQC.; HCP called to report that an expired dose of PNEUMOVAX 23 was inadvertently administered to a patient.; This spontaneous report was received from a nurse and refers to a 56-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-Aug-2025, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection 5 mL (lot #X022827 and expiration date reported as and upon internal validation confirmed to be 14-Aug-2025) (route of administration and vaccination site were not reported) administered for prophylaxis. On that day, an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was inadvertently administered to a patient (expired product administered). The potency of the dose was supported by post-expiry memo, with an expiration date of 14-Aug-2025 and administered on 20-Aug-2025. No adverse effects were reported (no adverse event). No additional adverse event (AE) and no product quality complaint (PQC) was noted. More
2855661 65 F CA 08/26/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Fatigue, Malaise, Photopsia, Product administered at inappropriate site, Visual ... Fatigue, Malaise, Photopsia, Product administered at inappropriate site, Visual impairment; Vitreous detachment More
Posterior vitreous detachment/saw a bright flash/felt crummy/saw poppy seed like dots; Tiredness; va... Posterior vitreous detachment/saw a bright flash/felt crummy/saw poppy seed like dots; Tiredness; vaccine was given too high on the shoulder/ it was given just below the shoulder bone; This serious case was reported by a consumer via call center representative and described the occurrence of posterior vitreous detachment in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Covid-19 vaccine (received a dose on an unknown date). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and paracetamol (Tylenol). On 02-AUG-2025, the patient received the 2nd dose of Shingrix (left arm) .5 ml. On 02-AUG-2025, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: vaccine was given too high on the shoulder/ it was given just below the shoulder bone). On 03-AUG-2025, the patient experienced tiredness (Verbatim: Tiredness). On 08-AUG-2025, the patient experienced posterior vitreous detachment (Verbatim: Posterior vitreous detachment/saw a bright flash/felt crummy/saw poppy seed like dots) (serious criteria GSK medically significant). The outcome of the posterior vitreous detachment and tiredness were unknown and the outcome of the vaccine administered at inappropriate site was not applicable. The reporter considered the posterior vitreous detachment to be possibly related to Shingrix. It was unknown if the reporter considered the tiredness to be related to Shingrix. The company considered the posterior vitreous detachment to be unrelated to Shingrix. It was unknown if the company considered the tiredness to be related to Shingrix. Additional Information: GSK Receipt Date: 11-AUG-2025 The patient self-reported this case for herself. The patient received the first dose of Shingrix on 31-MAY-2025. The patient further received the second dose of Shingrix on Saturday morning. The afternoon of Sunday 03-AUG-2025, 1 days after vaccination, the patient saw a bright flash on the right side of her right eye. The patient stated she felt crummy and tired. When asked to expand on felt crummy, the patient stated she felt like she did after a COVID vaccine. On Thursday, 07-AUG-2025, 5 days after vaccination, the patient saw 1000 poppy seed like dots in her right eye. The patient was seen by an eye physician on Friday 08-AUG-2025, 6 days after vaccination, and was diagnosed with posterior vitreous detachment (PVD). The patient was told by the physician that it was possible this (PVD) was related to the vaccine. The patient had no personal history or family history of eye problems, and the patient stated that the vaccine was given too high on the shoulder, it was given just below the shoulder bone, the placement of the vaccine seemed wrong to her, which led to vaccine administered at inappropriate site.; Sender's Comments: A case of Vitreous detachment, 6 days after receiving 2nd dose of Shingrix, in a 65-year-old female subject. and Report is inconsistent with causal relation to the vaccine product, considering implausible time to?onset and absence of biological plausibility and alternative risk factor(age) More
2855662 M 08/26/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Guillain-Barre syndrome, Loss of personal independence in daily activities Guillain-Barre syndrome, Loss of personal independence in daily activities
Guillain Barre Syndrome; This serious case was reported by a consumer via interactive digital media ... Guillain Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male 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 guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine. The company considered the guillain barre syndrome to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 12-AUG-2025 This case was reported by the patient's friend's wife via interactive digital media. A healthy friend had just got guillain barre syndrome after the first shot. He could not even put on his own socks.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingles vaccine, in a male 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
2855663 F 08/26/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Erythema, Eye pruritus, Malaise, Nausea, Pruritus; Pyrexia, Swelling, Swelling o... Erythema, Eye pruritus, Malaise, Nausea, Pruritus; Pyrexia, Swelling, Swelling of eyelid More
itchy eyes; Fever; nausea; felt like I got hit by a bus; swollen shut eyes; Red, itchy spots everywh... itchy eyes; Fever; nausea; felt like I got hit by a bus; swollen shut eyes; Red, itchy spots everywhere; swollen spots everywhere; This non-serious case was reported by a consumer and described the occurrence of eye swelling in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 21-MAY-2025, the patient received the 1st dose of Shingrix. On 22-MAY-2025, 1 days after receiving Shingrix, the patient experienced eye swelling (Verbatim: swollen shut eyes), itchy rash (Verbatim: Red, itchy spots everywhere) and generalized swelling (Verbatim: swollen spots everywhere). On an unknown date, the patient experienced eye pruritus (Verbatim: itchy eyes), fever (Verbatim: Fever), nausea (Verbatim: nausea) and feeling abnormal (Verbatim: felt like I got hit by a bus). The patient was treated with cetirizine hydrochloride (Zyrtec). The outcome of the eye swelling, itchy rash and generalized swelling were not resolved and the outcome of the eye pruritus, fever, nausea and feeling abnormal were not reported. It was unknown if the reporter considered the eye swelling, itchy rash, generalized swelling, eye pruritus, fever, nausea and feeling abnormal to be related to Shingrix. It was unknown if the company considered the eye swelling, itchy rash, generalized swelling, eye pruritus, fever, nausea and feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 28-JUL-2025 Patient went to the physician after the first shot and was given zyrtec and a cream for the itching. She used ice on her eyes, which had become itchy and swollen shut. She was absolutely miserable. After the first shot, she had a fever, nausea, and felt like she had been hit by a bus. She developed red, itchy, swollen spots all over her body, even her eyes swelled shut. The symptoms were not treated. More
2855664 F MA 08/26/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Incomplete course of vaccination, Pruritus; Herpes zoster, Incomp... Herpes zoster, Incomplete course of vaccination, Pruritus; Herpes zoster, Incomplete course of vaccination, Pruritus More
if it is Shingles; The patient received the first dose of SHINGRIX (reporter did not know the date) ... if it is Shingles; The patient received the first dose of SHINGRIX (reporter did not know the date) over 6 months ago and has not yet received the second dose; The patient experienced itchiness last night; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. The patient did not receive the 2nd dose of Shingrix. On 13-AUG-2025, an unknown time after receiving Shingrix the patient experienced pruritus (Verbatim: The patient experienced itchiness last night). On an unknown date, the patient experienced shingles (Verbatim: if it is Shingles) and incomplete course of vaccination (Verbatim: The patient received the first dose of SHINGRIX (reporter did not know the date) over 6 months ago and has not yet received the second dose). The outcome of the pruritus was not reported and the outcome of the shingles was unknown and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the pruritus and shingles to be related to Shingrix. It was unknown if the company considered the pruritus and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 14-AUG-2025 The patient received the first dose of shingrix reporter did not know the date over 6 months ago and had not yet received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient experienced itchiness last night on 13th August 2025 and this morning that is on 14th August 2025. The patient went to urgent care. The diagnosis of the itchiness had not be defined yet. The reporter stated that there was an insect bite nearby, but was not sure if this was the cause of the itchiness or if it was shingles. Shingles was included as an adverse event to be cautious. More
2855665 F CA 08/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Blister Blister
circle of Blister her left ankle; This non-serious case was reported by a consumer via call center r... circle of Blister her left ankle; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Covid-19 vaccine with an associated reaction of erythema (allergic reaction consists of arm getting huge, red, hot and swollen. Stabbing feeling in heart and ears that goes down her neck. Consumer stated she will report to manufacturer of Covid vaccine.). Concurrent medical conditions included allergy to vaccine (allergic to tetanus toxoid) and food allergy (allergic to specific foods allergic to turkey, trout, soul fish and pumpkin). On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced blister (Verbatim: circle of Blister her left ankle). The outcome of the blister was unknown. It was unknown if the reporter considered the blister to be related to Shingrix. It was unknown if the company considered the blister to be related to Shingrix. Additional Information: GSK Receipt Date: 14-AUG-2025 The patient had the complete series of Shingrix administered in the later months of 2019. Consumer stated after her first dose of Shingrix she had a circle of blister to her left ankle. The consumer stated she was immune to chickenpox and never had a case, however, she had been exposed several times personally with family and professionally with patients. The consumer stated she had a chickenpox titer done (date not disclosed) and the range was 150 or 160. Consumer stated she presently takes enzymes, D3 and K2 for a reaction she had after Covid vaccination (date not disclosed.) She stated her allergic reaction consists of arm getting huge, red, hot and swollen. Stabbing feeling in heart and ears that goes down her neck. Consumer stated she will report to manufacturer of Covid vaccine. More
2855666 08/26/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Rash Rash
I had the shot last Monday, broke out on Thursday/ have a rash but no blisters; This non-serious cas... I had the shot last Monday, broke out on Thursday/ have a rash but no blisters; 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 28-JUL-2025, the patient received Shingles vaccine. On 31-JUL-2025, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I had the shot last Monday, broke out on Thursday/ have a rash but no blisters). 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: 04-AUG-2025 This case was reported by a patient via interactive digital media. The patient had the shot last Monday (from the reporting day) and broke out on Thursday and on medications for it. It did hurt, but the patient was early in the process and was hoping the medications cure it. The patient had a rash but no blisters. More
2855667 M 08/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Nervous system disorder, Vaccination failure Herpes zoster, Nervous system disorder, Vaccination failure
Suspected vaccination failure; shingles; disrupted my whole nervous system; This serious case was r... Suspected vaccination failure; shingles; disrupted my whole nervous system; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male 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), shingles (Verbatim: shingles) and nervous system disorder (Verbatim: disrupted my whole nervous system). The outcome of the vaccination failure and shingles were not reported and the outcome of the nervous system disorder was not resolved. The reporter considered the vaccination failure, shingles and nervous system disorder to be possibly related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles and nervous system disorder to be possibly related to Shingrix. Additional Information: GSK Receipt Date: 14-AUG-2025 This case was reported by a patient via interactive digital media. The patient mentioned that (Shingrix) shingles vaccine actually gave them shingles and has now disrupted whole nervous system. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2855668 F 08/26/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Oropharyngeal pain, Pyrexia Oropharyngeal pain, Pyrexia
Fever; Sore throat.; This non-serious case was reported by a consumer via interactive digital media ... Fever; Sore throat.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 15-AUG-2025, the patient received Shingles vaccine. In AUG-2025, less than a week after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever) and sore throat (Verbatim: Sore throat.). The outcome of the fever and sore throat were not reported. It was unknown if the reporter considered the fever and sore throat to be related to Shingles vaccine. It was unknown if the company considered the fever and sore throat to be related to Shingles vaccine. Additional Information: GSK receipt date: 16-AUG-2025 This case was reported by a patient via interactive digital media. The reporter's sister was in bed today from the shingles shot she took yesterday. She had fever and sore throat. More
2855669 F 08/26/2025 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; Shingles; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (The patient received single vaccine for shingles on an unknown date). 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: Shingles). The outcome of the vaccination failure was not reported, and the outcome of the shingles was resolving. 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: 20-AUG-2025 This case was reported by a patient via interactive digital media. The reporter's sister got the single vaccine for shingles and years later got the 2-dose vaccine. She was recovering from a severe case of shingles, and the doctor was going to give her another vaccine against shingles. The reporter wanted to know so it doesn't work, so why. 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 completion of primary vaccine schedule, TTO of an event and laboratory confirmation of shingles) is considered unrelated to GSK' Shingles vaccine. More
2855670 F 08/26/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; My friend had the vaccines and still got it; This serious case was re... Suspected vaccination failure; My friend had the vaccines and still got it; 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: My friend had the vaccines and still got it). 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. 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: 21-AUG-2025 This case was reported by a patient via interactive digital media. The reporter's friend had the vaccines and still got it. Hopefully not as bad as she would have but, she had them now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2855671 58 F NH 08/26/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 32YB4
Incorrect route of product administration Incorrect route of product administration
administration of Priorix intramuscularly instead of subcutaneously; This non-serious case was repor... administration of Priorix intramuscularly instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 58-year-old female patient who received MMR (Priorix) (batch number 32YB4, expiry date 01-DEC-2026) for prophylaxis. On 08-AUG-2025, the patient received Priorix (intramuscular). On 08-AUG-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: administration of Priorix intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 08-AUG-2025 Other HCP stated about the administration of Priorix intramuscularly instead of subcutaneously. Asked if they have to revaccinate? No further information was obtained. More
2855672 58 F CA 08/26/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
Pediatric dose (10 mcg) of Engerix-B was administered to a female adult; Pediatric dose (10 mcg) of ... Pediatric dose (10 mcg) of Engerix-B was administered to a female adult; Pediatric dose (10 mcg) of Engerix-B was administered to a female adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 58-year-old female patient who received HBV (Engerix B 10 mcg) for prophylaxis. On 08-AUG-2025, the patient received the 2nd dose of Engerix B 10 mcg. On 08-AUG-2025, an unknown time after receiving Engerix B 10 mcg, the patient experienced adult use of a child product (Verbatim: Pediatric dose (10 mcg) of Engerix-B was administered to a female adult) and underdose (Verbatim: Pediatric dose (10 mcg) of Engerix-B was administered to a female adult). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK receipt date: 08-AUG-2025 Other HCP reported that a Pediatric dose (10 mcg) of Engerix-B was administered to a female adult that morning on 8th August 2025. She mentioned they needed to get guidance on how to proceed. More
2855673 F SC 08/26/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4N222
Product preparation issue Product preparation issue
patients were administered with the diluent only or maybe one of them was vaccinated with a full dos... patients were administered with the diluent only or maybe one of them was vaccinated with a full dose; patients were administered with the diluent only or maybe one of them was vaccinated with a full dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 32-year-old female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 14-MAY-2025, the patient received Priorix. On 14-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate dose of vaccine administered (Verbatim: patients were administered with the diluent only or maybe one of them was vaccinated with a full dose) and inappropriate preparation of medication (Verbatim: patients were administered with the diluent only or maybe one of them was vaccinated with a full dose). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-AUG-2025 Pharmacist called to report that don't know if two patients were administered with the diluent only or maybe one of them was vaccinated with a full dose, which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The reporter was also wanted to be asked which would be the timeframe for revaccination or not. No further information was obtained in this call. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: US-GSK-US2025105576:2nd patient, same reporter More
2855674 15 M IL 08/26/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Inappropriate schedule of product administration Inappropriate schedule of product administration
PX received the vaccine at 15 YO, however they reported as "Guidelines are 16-18 but it was ina... PX received the vaccine at 15 YO, however they reported as "Guidelines are 16-18 but it was inadvertently given a year early; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 19-JUL-2023, the patient received the 1st dose of Menveo. On 19-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: PX received the vaccine at 15 YO, however they reported as "Guidelines are 16-18 but it was inadvertently given a year early). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK receipt date 15-AUG-2025: The reporter had a patient receive Menveo at age 15. Their school requiring it to be received at age 16. Is patient needing another dose since it was received at 15 versus 16. That was correct. Guidelines are 16 to 18 but it was inadvertently given a year early, which led to Inappropriate age at vaccine administration. The parent does not want the patient to have to receive another one. More
2855675 18 F NJ 08/26/2025 MENB
MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS


Back pain, Computerised tomogram head, Computerised tomogram neck, Computerised ... Back pain, Computerised tomogram head, Computerised tomogram neck, Computerised tomogram thorax, Deafness; Fatigue, Gait disturbance, Headache, Lymph node pain, Lymphadenopathy; Mononucleosis heterophile test negative, Myalgia, Presyncope, Tunnel vision More
tunnel vision; hearing loss; almost passing out/ she was almost passed out this morning; severe head... tunnel vision; hearing loss; almost passing out/ she was almost passed out this morning; severe headache; muscle pain; lymph nodes are all dilated and painful, supraclavicular even/ lymph are so enlarged 2 days; can barely walk/ not being able to walk; Fatigue; This serious case was reported by a physician via call center representative and described the occurrence of tunnel vision in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received first dose on an unknown date, refer case US2025AMR109704). On 11-AUG-2025, the patient received the 2nd dose of Bexsero. In AUG-2025, 2 days after receiving Bexsero, the patient experienced tunnel vision (Verbatim: tunnel vision) (serious criteria GSK medically significant), hearing loss (Verbatim: hearing loss) (serious criteria GSK medically significant), presyncope (Verbatim: almost passing out/ she was almost passed out this morning) (serious criteria GSK medically significant), headache (Verbatim: severe headache), muscle pain (Verbatim: muscle pain), supraclavicular lymph nodes enlarged (Verbatim: lymph nodes are all dilated and painful, supraclavicular even/ lymph are so enlarged 2 days), unable to walk (Verbatim: can barely walk/ not being able to walk) and fatigue (Verbatim: Fatigue). The outcome of the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue were not resolved. The reporter considered the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero. It was unknown if the reporter considered the tunnel vision, hearing loss, presyncope, headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero Pre-Filled Syringe Device. The company considered the tunnel vision, hearing loss and presyncope to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero. It was unknown if the company considered the headache, muscle pain, supraclavicular lymph nodes enlarged, unable to walk and fatigue to be related to Bexsero 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. Linked case(s) involving the same patient: US2025AMR109704 Additional Information: GSK Receipt Date: 18-AUG-2025 On 18 August 2025, a physician called to inform her college-aged daughter just starting freshman year on last Monday took her for a Bexsero second vaccine, she got it at a pharmacy, and on Tuesday was brought to her to school. She did fine with the first dose, but the arm was very sore way back. However, within two days of receiving the second dose, she began experiencing severe systemic symptoms. She developed a severe headache, headache, fatigue, lymphadenopathy. The reporter stated as she walks feels like almost passing out, she started to get tunnel vision, muscle pain and her lymph nodes are all dilated and painful supraclavicular even, like out of the blue. The reporter enquired if patient was having cancer as the lymph were enlarged, she ended up going, her roommate took her to the hospital, yesterday emergency (not hospitalized) She had a CAT scan of the neck, head and chest because she got lymphadenopathy up the wazoo, huge, painful in the sentinel area/ supraclavicular. She was going to student services they may have to put her in the hospital as she had almost passed out this morning with tunnel vision and hearing loss. The reporter stated that her daughter (patient) was not immunocompromised and did not have any weight loss or fatigue. There were no signs of lymphoma (like she was getting some signs of issues before). Her daughter was a healthy and happy kid. The patient had sentinel area with huge lymph nodes and then another hard lymph node. The patient had severe headaches and, all of a sudden, upon getting up, was unable to walk, requiring her to lie back down. She experienced fatigue and muscle aches in her legs and the back of her shoulders. Today, this morning, a mono test that was run came back negative. The patient was going to try to get a TB test since she had been out of the country. She has no coughing or respiratory condition. The reporter stated it was all systemic and when she looked at GlaxoSmithKline list of things it included fatigue, severe headaches, muscle aches, and maybe even lymphadenopathy, she feels like it was all related. The reporter mentioned that now, a week later, the patient was still experiencing symptoms. They were continuing to evaluate what steps needed to be taken next. The patient was not immunocompromised.; Sender's Comments: A case of Tunnel vision, Deafness and Presyncope, 2 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device in a 18-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. US-GSK-US2025AMR109704:same reporter More
2855676 9 F OH 08/26/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 LM99N
Incorrect dose administered Incorrect dose administered
9-year-old female patient received an adult dose of Havrix; 9-year-old female patient received an ad... 9-year-old female patient received an adult dose of Havrix; 9-year-old female patient received an adult dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 9-year-old female patient who received HAV (Havrix adult) (batch number LM99N, expiry date 01-MAR-2026) for prophylaxis. On 04-AUG-2025, the patient received the 1st dose of Havrix adult. On 04-AUG-2025, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: 9-year-old female patient received an adult dose of Havrix) and adult product administered to child (Verbatim: 9-year-old female patient received an adult dose of Havrix). The outcome of the overdose and adult product administered to child were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-AUG-2025 The medical assistant reported that a 9-year-old patient received an adult dose of Havrix vaccine, which led to an adult product administered to child and overdose. She called to know how to proceed after this incident. The vaccine administration facility was the same as primary reporter. More
2855677 F IL 08/26/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
did not receive a second dose yet; This non-serious case was reported by a other health professional... did not receive a second dose yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 09-AUG-2019). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: did not receive a second dose yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 18-AUG-2025 The patient received her first Shingrix dose which is outside the second dose window. The reporter enquired if the patient can second dose now or does she need to repeat the series She did not receive a second dose of Shingrix vaccine yet, which led to incomplete course of vaccination More
2855678 1.58 M MD 08/26/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 DL4YY
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
underage administration; This non-serious case was reported by a nurse via call center representativ... underage administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number DL4YY, expiry date 30-APR-2026) for prophylaxis. Concurrent medical conditions included sickle-cell anemia. On 21-AUG-2025, the patient received Menveo. On 21-AUG-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: underage administration). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 21-AUG-2025 The nurse reported that a patient suffers sickle cell anemia received the Menveo one vial vaccine (nineteen-month-old patient), which led to inappropriate age at vaccine administration. Since the patient was not administered with the two vial Menveo, wanted to know there was any concern/advise on this situation. The vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. More
2855679 F 08/26/2025 COVID19
 MODERNA
 030L20A
Arthralgia Arthralgia
Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours; This spontaneo... Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 024M20A, 017E21A and 033K21-2A) for COVID-19 prophylaxis. Concurrent medical conditions included Lupus syndrome (Lupus). On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours). At the time of the report, ARTHRALGIA (Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours) had resolved. No concomitant medication was reported. After each COVID vaccine her shins and joints ache for 8-10 hours. She thought it was just her body trying to make antibodies. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-788866 (Patient Link). More
2855680 F 08/26/2025 COVID19-2
 MODERNA
 AS7143C
Arthralgia Arthralgia
after each COVID vaccine her shins and joints ache for 8-10 hours; This spontaneous case was reporte... after each COVID vaccine her shins and joints ache for 8-10 hours; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7143C and AS7180B) for COVID-19 prophylaxis. Concurrent medical conditions included Lupus syndrome (Lupus). On 14-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours). At the time of the report, ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours) had resolved. No concomitant medication was reported. After each COVID vaccine her shins and joints ache for 8-10 hours. She thought it was just her body trying to make antibodies. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788866 (Patient Link). More
2855681 68 M GA 08/26/2025 COVID19
 MODERNA
COVID-19 COVID-19
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ... Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 68-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. No concomitant medications provided by the reporter. It was reported that the patient received six different vaccines in past and patient had COVID. Patient received the older strain vaccines, but he wanted the new one. It was reported that patient inquired about obtaining the most current Moderna COVID-19 vaccine before traveling internationally and he would be taken treatment medication Paxlovid if require. No treatment medications provided by the reporter. More
2855682 0.17 M AZ 08/26/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7374BA
Expired product administered Expired product administered
Administration of expired VAXELIS; This non-serious spontaneous safety report was received by partne... Administration of expired VAXELIS; This non-serious spontaneous safety report was received by partner on 16-MAY-2025 and forwarded on 19-MAY-2025 from a medical assistant. Due to the nature of the event, the causality assessment between Vaxelis and "Administration of expired VAXELIS" is assessed as not applicable. Further information is expected. Significant follow-up information was received by the partner on 18-JUN-2025 and forwarded on 18-JUN-2025, from other health professional. The case is maintained as non-serious. Due to the nature of the event, the causality assessment between Vaxelis and "Administration of expired VAXELIS" is assessed as not applicable. Further information is not expected. More
2855684 PA 08/26/2025 DTPPVHBHPB
HEP
 MSP VACCINE COMPANY
MERCK & CO. INC.
 U7788AA
Y014090
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
patient inadvertently received RECOMBIVAX HB and VAXELIS on the same day/Vaxelis and Hep B given res... patient inadvertently received RECOMBIVAX HB and VAXELIS on the same day/Vaxelis and Hep B given resulting in 2 Hep B doses being administered; patient inadvertently received RECOMBIVAX HB and VAXELIS on the same day; This non-serious spontaneous safety report, with reference number 02809188 (Interaction# 02809129), was received by a partner on 21-MAY-2025 and forwarded to RA on 21-MAY-2025 from a Nurse Practitioner. The reporter did not assess the causal relationship between Vaxelis and the reported events of "patient inadvertently received RECOMBIVAX HB and VAXELIS on the same day." Due to the nature of the event, the causality between the events "Extra dose administered", "Overdose" and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION for this non-serious spontaneous safety report, with reference number 02809188 (Interaction# 02809129), was received by a partner on 28-MAY-2025 and forwarded to RA on 29-MAY-2025 from a Nurse Practitioner. The reporter did not assess the causal relationship between Vaxelis and the reported events of "patient inadvertently received RECOMBIVAX HB and VAXELIS on the same day." Due to the nature of the event, the causality between the events "Extra dose administered", "Overdose" and Vaxelis was not applicable. Further information is not expected. This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 16-JUL-2025 with the following VAERS primary ID: 2842845-1. The original narrative from the sender is AS FOLLOWS: No symptomatic adverse events were reported; patient inadvertently received RECOMBIVAX HB and VAXELIS on the same day; This spontaneous report was received from a Licensed Nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-May-2025, the patient inadvertently vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB),, dose number 1, (lot # and expiration date were not reported) and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus(VAXELIS), dose number 1, (lot # and expiration date were not reported) (accidental overdose). No adverse event was reported.; Reporter's Comments: Due to the nature of the event, the causality between the events 'Extra dose administered, Overdose' and Vaxelis was not applicable. No further information is expected. More
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