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
2696324 71 F AS 10/11/2023 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
UNK
Disorientation, Pain, Rash; Atrial fibrillation, Cardiac ablation, Cardiac failu... Disorientation, Pain, Rash; Atrial fibrillation, Cardiac ablation, Cardiac failure congestive, Cardioversion, Echocardiogram; Implantable defibrillator insertion, Pleural effusion, Pyrexia More
100 DEGREE TEMP. BODY ACHES, DISORIENTATION, SUBSEQUENTLY A RASH ABOUT 2 1/2" DIAM. 100 DEGREE TEMP. BODY ACHES, DISORIENTATION, SUBSEQUENTLY A RASH ABOUT 2 1/2" DIAM.
โœ“
2853840 F CT 08/12/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 AHBVB767BA
Expired product administered Expired product administered
expired vaccine used; This non-serious case was reported by a nurse via call center representative a... expired vaccine used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-month-old female patient who received HBV (Engerix B) (batch number AHBVB767BA) for prophylaxis. On 15-DEC-2009, the patient received Engerix B. On 15-DEC-2009, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired vaccine used). The outcome of the expired vaccine used 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: 23-JUL-2025 A nurse called in to request data about the possible administration of an expired dose of Engerix-B, which led to expired vaccine used. They wanted to verify if when administered, the lot number AHBVB767BA had expired. More
2853841 71 F CA 08/12/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 344J3
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late second dose; This non-serious case was reported by a pharmacist via call center representative ... Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received HAB (Twinrix) (batch number 344J3, expiry date 12-SEP-2026) for prophylaxis. Previously administered products included Twinrix (1st dose received in 2023). On 29-JUL-2025, the patient received the 2nd dose of Twinrix. On 29-JUL-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long 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: 01-AUG-2025 The pharmacist called to get guidance about a late second dose of Twinrix. She administered the second dose to a patient and after reviewing the records, she realized the patient got the first dose back in 2023. She wanted to know if this was a valid dose or if the completes series must be restarted. The patient received 2nd dose of Twinrix later then the recommended interval which led to lengthening of the vaccination scheduled. The vaccine administration facility was the same as primary reporter. More
2853842 GA 08/12/2025 COVID19
 UNKNOWN MANUFACTURER
Breakthrough COVID-19 Breakthrough COVID-19
SARS-CoV-2 infection post vaccine; This serious initial Spontaneous (Literature) safety report was r... SARS-CoV-2 infection post vaccine; This serious initial Spontaneous (Literature) safety report was received by Novavax on 04-Aug-2025 from a Consumer or other non-health professional. An individual of an unspecified age (65 year or older) and unspecified gender was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (Intramuscular) (Lot number was not provided in the report), on an unspecified date. No medical history was reported. No concomitant medications were reported. On an unspecified date after vaccination, the patient experienced "SARS-CoV-2 infection post vaccine" (Breakthrough COVID-19) (Serious: Caused/Prolonged Hospitalization). At the time of reporting, the event outcome of Breakthrough COVID-19 was Unknown.; Sender's Comments: This individual of an unspecified age (65 year or older) and unspecified gender experienced Breakthrough COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Breakthrough COVID-19 was reported as serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Breakthrough COVID-19 is considered Possible. More
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2853843 73 F FL 08/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7ZM55
Paraesthesia, Pruritus Paraesthesia, Pruritus
Patient came to pharmacy to pick up her medication and in passing by mentioned that the "shingl... Patient came to pharmacy to pick up her medication and in passing by mentioned that the "shingles vaccine" got her hospitalized. Patient received vaccine on 4/26/2025. She woke up in the middle of the night of 5/22/25 with her chin itching. Then the morning of 5/23/25, the entire right side of her face was tingling. Patient took herself to the emergency room. She stated that the doctors ruled stroke and everything and considered her symptoms due to Shingrix. More
2853844 11 M IL 08/12/2025 TDAP
 SANOFI PASTEUR
 u8564aa
Loss of consciousness Loss of consciousness
Pt passed out. Possible due to panic according to the mother. Pt passed out. Possible due to panic according to the mother.
2853845 0.17 F OR 08/12/2025 PNC21
 MERCK & CO. INC.
 Z002626
Wrong product administered Wrong product administered
Staff administered wrong vaccination to pt Staff administered wrong vaccination to pt
2853846 19 M IN 08/12/2025 MENB
MNQ
TDAP
 PFIZER\WYETH
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 HG6057
U8438AA
37R35
Confusional state, Loss of consciousness, Pallor, Syncope; Confusional state, Lo... Confusional state, Loss of consciousness, Pallor, Syncope; Confusional state, Loss of consciousness, Pallor, Syncope; Confusional state, Loss of consciousness, Pallor, Syncope More
syncope after administration. Patient was laid back on table, woke within 30 seconds. Patient pale... syncope after administration. Patient was laid back on table, woke within 30 seconds. Patient pale and confused for several seconds, then returned to normal LOC. Vitals HR: 71, BP 112/78, O2 99% More
2853847 11 M MT 08/12/2025 HPV9
HPV9
HPV9
MNQ
MNQ
MNQ
TDAP
TDAP
TDAP
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Y020531
Y020531
Y020531
537LH
537LH
537LH
37R53
37R53
37R53
Asthenia, Dizziness, Epistaxis, Fall, Head injury; Headache, Injection site pain... Asthenia, Dizziness, Epistaxis, Fall, Head injury; Headache, Injection site pain, Loss of consciousness, Malaise, Presyncope; Skin abrasion, Tearfulness; Asthenia, Dizziness, Epistaxis, Fall, Head injury; Headache, Injection site pain, Loss of consciousness, Malaise, Presyncope; Skin abrasion, Tearfulness; Asthenia, Dizziness, Epistaxis, Fall, Head injury; Headache, Injection site pain, Loss of consciousness, Malaise, Presyncope; Skin abrasion, Tearfulness More
Patient was given three vaccines. Without any indication or warning after the 3rd vaccine which was ... Patient was given three vaccines. Without any indication or warning after the 3rd vaccine which was HPV, patient reported that vaccine had hurt but proceeded to say he was okay. As I turned to dispose of capped needle into sharps container on nearby counter it looked like patient was getting up off the exam table in which mid standing up had vasovagal response. Father was nearby sitting in a chair and we had both realized what was happening as patient hit the floor. Patient did fall onto side of head and face. He was out for about a minute and then came to with tearfulness and complaining his head hurt. Patient was provided with juice box, water, cold pack and after a few moments of sitting with provider and father given childrens ibuprofen. He was complaining of head hurting with abrasion to bridge of nose as well as some bloody nose. He was also given zofran 4mg odt. Patient was given time to calm down and lay on floor to regain himself. He was still feeling weak, dizzy and not well after about 30minutes. At this point provider and father agreed best to proceed to emergency department for further workup. Patient was escorted out in a wheelchair by myself and helped into vehicle by myself and his father. More
2853859 78 F NY 08/12/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ft95n
Erythema, Mobility decreased, Pain Erythema, Mobility decreased, Pain
Almost immediate redness, pain, loss of range of motion, pt reports it's slowly resolving. Almost immediate redness, pain, loss of range of motion, pt reports it's slowly resolving.
2853860 29 F WA 08/12/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 062F22A
062F22A
062F22A
Arthralgia, Autonomic nervous system imbalance, Brain fog, Exercise tolerance de... Arthralgia, Autonomic nervous system imbalance, Brain fog, Exercise tolerance decreased, Fatigue; Hot flush, Hypotension, Impaired work ability, Loss of personal independence in daily activities, Muscular weakness; Nausea, Orthostatic intolerance, Postural orthostatic tachycardia syndrome, Pyrexia, Wheelchair user More
Fever, joint pain, fatigue, nausea, brain fog after injection, continued dysautnomia including POTS,... Fever, joint pain, fatigue, nausea, brain fog after injection, continued dysautnomia including POTS, hypotension, hot flashes, and orthostatic intolerance, joint pain, muscle weakness, brain fog, unrelenting fatigue, exercise intolerance resulting in significant disability including need for wheelchair and loss of ability to work or perform ADLS without assistance More
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2853861 56 F TX 08/12/2025 PNC20
 PFIZER\WYETH
 LJ5284
Headache, Injection site erythema, Injection site pruritus, Injection site swell... Headache, Injection site erythema, Injection site pruritus, Injection site swelling More
Patient came to the pharmacy on 8/12/2025 with an extremely red, swollen area surrounding her upper ... Patient came to the pharmacy on 8/12/2025 with an extremely red, swollen area surrounding her upper arm extending about 6 inches in diameter from the injection site. Patient stated it was very itchy and also complained of an pounding headache. Patient took benadryl 50mg and was advised to see a doctor if the swelling continues to spread. More
2853862 79 F FL 08/12/2025 FLU3
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 u8764bb
793pt
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Rph administered a dose of Boostrix while patient had it recently (09/07/2024). There was no justifi... Rph administered a dose of Boostrix while patient had it recently (09/07/2024). There was no justification for a dose so close to prior (i.e. cut/injury, Newborn baby etc) checked with patient. More
2853863 15 M AR 08/12/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR

Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
Administered vaccines 1 week before 16th birthday. Mom was notified that these vaccines would not c... Administered vaccines 1 week before 16th birthday. Mom was notified that these vaccines would not count due to administering too soon. Mom reports there was no adverse reactions More
2853864 12 F CA 08/12/2025 TDAP
 SANOFI PASTEUR
Computerised tomogram head, Eyelid function disorder, Facial paralysis, Full blo... Computerised tomogram head, Eyelid function disorder, Facial paralysis, Full blood count, Metabolic function test More
Patient presents with right-sided facial droop, inability to close right eye or wrinkle right forehe... Patient presents with right-sided facial droop, inability to close right eye or wrinkle right forehead More
2853865 65 F 08/12/2025 FLU3
FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.


Alcohol intolerance, Allergy test negative, Anaphylaxis treatment, Dyspnoea, Ery... Alcohol intolerance, Allergy test negative, Anaphylaxis treatment, Dyspnoea, Erythema; Feeling hot, Lip swelling, Malaise, Perfume sensitivity, Swelling face; Urticaria More
The vaccine was given at Super Store in (withheld). The groceries I purchased, I thought had been p... The vaccine was given at Super Store in (withheld). The groceries I purchased, I thought had been poisoned as I was extremely sick for a week. My fav Xmas gift from my husband each year is perfume. That Xmas, I reacted to by becoming bright red and had a hard time breathing. From that day on ward, I was totally allergic to anything with scent [laundry soap, shampoo, conditioner, dish soap, perfume, flowers with scent] as well, hard drinks caused my face to become red and hot. I had to stop drinking wine or beer. I have been to the ER twice for the worse cases of hives because of air borne flowering bushes. Hives on my scalp and all over my body, with swollen lips and face that eppy shots were needed. More
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2853866 48 F CA 08/12/2025 YF
 SANOFI PASTEUR
Injection site reaction, Rash erythematous, Rash pruritic Injection site reaction, Rash erythematous, Rash pruritic
Pink rash at site of injection, approximately 2 inches wide, 1.5 inches tall. Still same size after ... Pink rash at site of injection, approximately 2 inches wide, 1.5 inches tall. Still same size after 7 days, but darker pink. Only itches once or twice a day. Does not hurt when pressed. More
2853867 57 F AZ 08/12/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 P2443
P2443
Arthralgia, Back pain, Confusional state, Fatigue, Lethargy; Vision blurred Arthralgia, Back pain, Confusional state, Fatigue, Lethargy; Vision blurred
4 DAYS AFTER RECEIVING TWINRIX - REPORTS SEVERE ADES: BACK & SHOULDER PAIN THAT HAS NOT IMPROVED... 4 DAYS AFTER RECEIVING TWINRIX - REPORTS SEVERE ADES: BACK & SHOULDER PAIN THAT HAS NOT IMPROVED IN INTENSITY SINCE THE DAY AFTER VACCINE ADMINISTRATION, TIRED AND CONFUSED/LETHARGIC, REPORTS VISION BLURRINESS AS WELL THAT HAS CONTINUOUOSLY GOTTEN WORSE SINCE THE DAY AFTER GETTING VACCINE. More
2853481 F 08/11/2025 PNC21
 MERCK & CO. INC.
Injection site erythema, Injection site inflammation, Injection site pruritus, I... Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth More
I still have inflammation around the injection site, as well as being warm to the touch, itchy, and ... I still have inflammation around the injection site, as well as being warm to the touch, itchy, and red.; I still have inflammation around the injection site, as well as being warm to the touch, itchy, and red.; I still have inflammation around the injection site, as well as being warm to the touch, itchy, and red.; I still have inflammation around the injection site; This spontaneous report was received from a patient (the Company employee) and refers to herself, a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 16-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Solution for injection (exact dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) administsred for prophylaxis. On an unspecified date in July 2025, the patient experienced inflammation around the injection site, as well as being warm to the touch, itchy, and red (vaccination site inflammation, vaccination site warmth, vaccination site pruritus, vaccination site erythema). It was reported that even after 6 days, the patient still had inflammation around the injection site, as well as being warm to the touch, itchy, and red. On 22-JUL-2025 (reported as of yesterday), she had been going to the site for monitoring. At the reporting time, the patient had not recovered from the events of inflammation around the injection site, as well as being warm to the touch, itchy, and red. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was assessed as not applicable. The reporter considered the events of inflammation around the injection site, as well as being warm to the touch, itchy, and red to be related to Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (reported as an adverse reaction to the suspect vaccine). Lot # is being requested and will be submitted if received. More
2853483 12 F IA 08/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB064A
Product preparation issue Product preparation issue
a female patient received the liquid conjugate component only of Menveo on 14-JUL-2025; a female pat... a female patient received the liquid conjugate component only of Menveo on 14-JUL-2025; a female patient received the liquid conjugate component only of Menveo on 14-JUL-2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 14-JUL-2025, the patient received Menveo (intramuscular, left deltoid). On 14-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: a female patient received the liquid conjugate component only of Menveo on 14-JUL-2025) and inappropriate dose of vaccine administered (Verbatim: a female patient received the liquid conjugate component only of Menveo on 14-JUL-2025). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 17-JUL-2025 The reporter was a nurse who called to report that a male patient had received only the liquid conjugate component of Menveo, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This was 1 of 3 linked case reported by the same reporter.; Sender's Comments: US-GSK-US2025091789:same reporter, Different patient, 3 of 3 report More
2853484 1 M NM 08/11/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
second dose of havrix administered less than one month after the first dose; This non-serious case ... second dose of havrix administered less than one month after the first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 20-month-old male patient who received HAV (Havrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact (Havrix). On 30-JUN-2011, the patient received the 2nd dose of Havrix. On 30-JUN-2011, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: second dose of havrix administered less than one month after the first dose). On 30-JUN-2011, the outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 23-JUL-2025 The reporter, the mother, called to report that her son, a minor who was 15 years old at the time, had received the second dose of Havrix on 30th June 2011, less than one month after the first dose, which had been received on 23rd June 2011, which led to Drug dose administration interval too short. The product had been verified with the pharmacist on duty at the local pharmacy to be Havrix; however, the pharmacy had not administered the vaccines and had no further information to provide. The reporter stated that the vaccines had been administered to her son at the physician's clinic. More
2853485 39 F CT 08/11/2025 TDAP
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 95PUM
95PUM
Computerised tomogram head normal, Dizziness, Fatigue, Headache, Hypoaesthesia; ... Computerised tomogram head normal, Dizziness, Fatigue, Headache, Hypoaesthesia; Hypoaesthesia oral, Injection site pain, Migraine, Paraesthesia More
facial paresthesia /facial numbness; Dizziness; Head pain /cephalgia; Fatigue; Migraine; Injection s... facial paresthesia /facial numbness; Dizziness; Head pain /cephalgia; Fatigue; Migraine; Injection site pain /soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 39-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 95PUM) for prophylaxis. On 25-JUL-2025, the patient received Boostrix (intramuscular, right deltoid). On 25-JUL-2025, less than a day after receiving Boostrix, the patient experienced injection site pain (Verbatim: Injection site pain /soreness). On 26-JUL-2025, the patient experienced facial paresthesia (Verbatim: facial paresthesia /facial numbness), dizziness (Verbatim: Dizziness), headache (Verbatim: Head pain /cephalgia), fatigue (Verbatim: Fatigue) and migraine headache (Verbatim: Migraine). On 27-JUL-2025, the outcome of the headache was resolved (duration 1 day). On 28-JUL-2025, the outcome of the dizziness and fatigue were resolved (duration 2 days). The outcome of the injection site pain and migraine headache were unknown and the outcome of the facial paresthesia was not resolved. It was unknown if the reporter considered the injection site pain, facial paresthesia, dizziness, headache, fatigue and migraine headache to be related to Boostrix. It was unknown if the company considered the injection site pain, facial paresthesia, dizziness, headache, fatigue and migraine headache to be related to Boostrix. Additional Information: GSK Receipt Date: 28-JUL-2025 The patient reported that she received a Boostrix vaccination and in the evening, she had injection site soreness (pain). The patient mentioned 24 hours after the vaccination, she had dizziness, fatigue, headache, migraine headache and numbness to the left side of her face, upper and lower lips, tongue and under the sinus cavity on her left cheek. She visited the Emergency Department and was diagnosed with head pain, cephalgia, and facial paresthesia. A CT scan was performed with normal findings. She reported that her lips and the left side of her face are still numb. She denies any additional medications or vaccinations and any other health conditions. More
2853486 F 08/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Exposure during pregnancy, No adverse event, Product use issue, Wrong product ad... Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered More
pregnant patient received Arexvy instead of Abrysvo; pregnant patient received Arexvy instead of Abr... pregnant patient received Arexvy instead of Abrysvo; pregnant patient received Arexvy instead of Abrysvo within the health system; pregnant patient received Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On an unknown date, the patient received Arexvy. The patient did not receive Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received Arexvy instead of Abrysvo), wrong vaccine administered (Verbatim: pregnant patient received Arexvy instead of Abrysvo within the health system) and product use in unapproved population (Verbatim: pregnant patient received Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and product use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 28-JUL-2025 The pregnant patient received Arexvy instead of Abrysvo within the health system which led to wrong vaccine administered, product use in unapproved population and vaccine exposure during pregnancy. No negative outcomes apparent at the time of reporting provided. More
2853487 AZ 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Cellulitis Cellulitis
cellulitis; This non-serious case was reported by a other health professional via sales rep and desc... cellulitis; This non-serious case was reported by a other health professional via sales rep and described the occurrence of cellulitis in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced cellulitis (Verbatim: cellulitis). The outcome of the cellulitis was unknown. The reporter considered the cellulitis to be related to Shingrix. The company considered the cellulitis to be related to Shingrix. Additional Information: GSK Receipt Date:29-JUL-2025 Medical assistant noted that patients reported cellulitis as an adverse reaction to their shingles vaccine. It was a subsequent dose. More
2853488 F 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain, Pain Injection site pain, Pain
As the IM vaccine was being administered, I felt a pain at the injection site and up into my neck; p... As the IM vaccine was being administered, I felt a pain at the injection site and up into my neck; pain at the injection site and up into my neck; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypothyroidism, blood cholesterol increased and rheumatoid arthritis. Concomitant products included methotrexate, rosuvastatin and levothyroxine. On 30-JUL-2025, the patient received Shingrix. On 30-JUL-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: As the IM vaccine was being administered, I felt a pain at the injection site and up into my neck) and neck pain (with radiation) (Verbatim: pain at the injection site and up into my neck). The outcome of the injection site pain and neck pain (with radiation) were not resolved. It was unknown if the reporter considered the injection site pain and neck pain (with radiation) to be related to Shingrix. It was unknown if the company considered the injection site pain and neck pain (with radiation) to be related to Shingrix. Additional Information: GSK Receipt Date: 31-JUL-2025 Consumer was reported as the IM vaccine was being administered and felt a pain at the injection site and up into neck. The reporter also mentioned that receive weekly P.T. on my neck for disc calcification, and do not had nerve damage on the left side of my neck where the injection pain was felt. The end date was provided as 30-JUL-2025. More
2853489 F 08/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Injection site erythema, Injection site pruritus Injection site erythema, Injection site pruritus
Injection site redness; Injection site itching; This non-serious case was reported by a consumer and... Injection site redness; Injection site itching; This non-serious case was reported by a consumer and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 29-JUL-2025, the patient received Shingles vaccine. On 29-JUL-2025, less than a day after receiving Shingles vaccine, the patient experienced injection site erythema (Verbatim: Injection site redness) and injection site itching (Verbatim: Injection site itching). The outcome of the injection site erythema and injection site itching were resolving. It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingles vaccine. It was unknown if the company considered the injection site erythema and injection site itching to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-AUG-2025 The patient received the shingles vaccine and experienced itching and redness at injection site More
2853490 NY 08/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
No adverse event, Underdose No adverse event, Underdose
Drug administered to patient of inappropriate age; Underdose; This non-serious case was reported by ... Drug administered to patient of inappropriate age; Underdose; This non-serious case was reported by a physician via other manufacturer and described the occurrence of adult use of a child product in a 20-year-old patient who received HBV (Engerix B pediatric) for prophylaxis. On an unknown date, the patient received Engerix B pediatric .5 ml. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Drug administered to patient of inappropriate age) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 Caller reported pediatric dose of Engerix was administered to a patient that was 20 years 4 months old, which led to adult use of child product and underdose. No other information provided. No additional adverse event or PQC reported. More
2853491 08/11/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; I'm on my 3rd case; This serious case was reported by a consumer... Suspected vaccination failure; I'm on my 3rd case; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles and shingles. On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On 03-AUG-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I'm on my 3rd case). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 03-AUG-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she was on 3rd case. Patient just discovered it this afternoon. Patient had the older vaccine and the newer multi dose vaccine. Patient was going to see if he/she could get tomorrow off so that he/she might be able to get in to see the doctor in the morning. This case was considered as suspected vaccination failure as details regarding 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. More
2853492 08/11/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
diluent only administered to another patient; diluent only administered to another patient; This no... diluent only administered to another patient; diluent only administered to another patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: diluent only administered to another patient) and inappropriate dose of vaccine administered (Verbatim: diluent only administered to another patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 23-JUL-2025 As a general question, an anonymous healthcare provider (who later identified as a nurse) called asking, A baby had come in that day to receive some vaccines, and Priorix was not administered (it had not been included among them). The nurse had observed that the box contained only the powder (and not the diluent), and asked whether the powder could be mixed with another diluent. She stated that she knew it was sterile water, but inquired whether that would be acceptable. A potential adverse event was reported due to a possible scenario involving inappropriate reconstitution technique, in which the diluent may have been administered to another patient, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. More
2853493 F NY 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
Inappropriate Schedule of Vaccine; This non-serious case was reported by a consumer via call center ... Inappropriate Schedule of Vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2021). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt Date: 29-JUL-2025 Member of the public (patient) called after contacting the treating physicians that told to contact directly to the manufacturer, due to recent use of rituximab and Valtrex (no dosing schedule was specified) after receiving a single dose of Shingrix back in twenty twenty-one, was it okey for her to receive another dose and how much protection if she had only one dose of Shingrix. No specific vaccination date, no vaccine or product detail or complete patient demographics (besides patient gender) were obtained from the Member of the public (patient) in this call. No further information was obtained in this call. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2853494 F PA 08/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Extra dose administered Extra dose administered
patient was given Menveo at age 10 and 1 year later it was given a second dose of Menveo.; This non-... patient was given Menveo at age 10 and 1 year later it was given a second dose of Menveo.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Previously administered products included Menveo (at age of 10 years). On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: patient was given Menveo at age 10 and 1 year later it was given a second dose of Menveo.). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 29-JUL-2025 Pharmacist explained that a patient was given Menveo at age 10 and 1 year later it was given a second dose of Menveo, which led to extra dose administered. The reporter did not have patient initials or date of birth and they did not have dates of administration, lot number or expiration dates for any of the 2 vaccines. The reporter declined consent to follow up with Safety Team. Did not consent to follow-up. More
2853495 M NE 08/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMXV072A
Product preparation issue Product preparation issue
Administration of only the diluent portion; Administration of only the diluent portion; This non-ser... Administration of only the diluent portion; Administration of only the diluent portion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXV072A) for prophylaxis. On 22-JUL-2025, the patient received Menveo. On 22-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration of only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: Administration of only the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 29-JUL-2025 A medical assistant mentioned that they have one extra vial of the lyophilized component of Menveo, which means that a patient received only the liquid portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. There were two possible patients that received only the diluent portion. For one of the patients, it was the second shot and for one of them it was the first dose. The reporter asked for recommendations on this situation. More
2853496 4 F IL 08/11/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 T343U
Expired product administered Expired product administered
Expire dose; This non-serious case was reported by a nurse via call center representative and descri... Expire dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number T343U, expiry date 31-JAN-2025) for prophylaxis. On 31-JUL-2025, the patient received Kinrix. On 31-JUL-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expire dose). The outcome of the expired vaccine used 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: 01-AUG-2025 The Vaccine Administration Facility is the same as Primary Reporter A registered nurse called and reported that they had a pediatric patient, who was there last evening for vaccines, and she was given an expired dose of Kinrix which led to expired vaccine used. More
2853497 71 M WI 08/11/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 324BY
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late Second dose; This non-serious case was reported by a pharmacist via call center representative ... Late Second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose of vaccine on 27th August 2024). On 04-AUG-2025, the patient received the 2nd dose of Twinrix. On 04-AUG-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late Second dose). The outcome of the drug dose administration interval too long 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: 04-AUG-2025 Pharmacist reported that they had a couple that was leaving to go over the Country this December first so they were looking to do the expedite schedule. The first they got was about a year ago and the second dose, they got it today (on the day of reporting). So, looking at the schedule looks like they had to wait at least two weeks between getting dose number 3, but pharmacist question was for dose number four, said it had to be a year after the first dose that had already happened. So, was there a minimum interval between dose number 3 and 4 they would have to wait or could they just get dose number four when they came back. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case was linked with US2025100212, reported by same reporter different patient.; Sender's Comments: US-GSK-US2025100212: More
2853505 M SC 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient got the first back in 2020; This non-serious case was reported by a pharmacist via call cent... patient got the first back in 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient got the first back in 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient got the first back in 2020). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 31-JUL-2025 Other HCP reported that the second dose of Shingrix after the patient got the first back in 2020. She only provided patient's gender for adverse event details. Transfer to second line was made. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is liked with US2025099401 reported by same reporter.; Sender's Comments: US-GSK-US2025099401: More
2853506 11 F CA 08/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMAB044A
Expired product administered Expired product administered
Menveo expired dose; This non-serious case was reported by a other health professional via call cen... Menveo expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAB044A, expiry date 31-JUL-2025) for prophylaxis. On 01-AUG-2025, the patient received Menveo. On 01-AUG-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Menveo expired dose). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 04-AUG-2025 The practice manager called on 4th August 2025, to report that on 1st August 2025, a dose of Menveo with an expiration date of 31st July 2025, had been administered to a patient, which led to Expired vaccine used. The Menveo given was the 2-vial formulation. More
2853507 F 08/11/2025 COVID19
 MODERNA
Brain fog Brain fog
brain fogging issues related to this specific vaccine; This spontaneous case was reported by a consu... brain fogging issues related to this specific vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN FOG (brain fogging issues related to this specific vaccine) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced BRAIN FOG (brain fogging issues related to this specific vaccine). At the time of the report, BRAIN FOG (brain fogging issues related to this specific vaccine) had not resolved. No concomitant medication was reported. She was confused about if she had reactions upon getting the second vaccine and she had brain fogging issues related to this specific vaccine. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. More
2853508 51 F IL 08/11/2025 COVID19
COVID19
 JANSSEN
JANSSEN
 1802068
1802068
Angiotensin converting enzyme abnormal, Condition aggravated, Electromyogram, Ep... Angiotensin converting enzyme abnormal, Condition aggravated, Electromyogram, Epstein-Barr virus infection reactivation, Epstein-Barr virus test; Neuropathy peripheral, Pain, SARS-CoV-2 antibody test More
Neuropathy, Chronic pain, Reactivated EBV, abnormal Angiotensin Converting Enzyme Neuropathy, Chronic pain, Reactivated EBV, abnormal Angiotensin Converting Enzyme
2853510 68 M NC 08/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 LL8398
Arthralgia Arthralgia
Reported Symptoms: 10003239:ARTHRALGIA; Narrative: Other Relevant HX: Other: Reported Symptoms: 10003239:ARTHRALGIA; Narrative: Other Relevant HX: Other:
2853543 M TX 08/11/2025 PPV
PPV
PPV
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


Antibody test negative, Hypogammaglobulinaemia; Antibody test negative, Hypogamm... Antibody test negative, Hypogammaglobulinaemia; Antibody test negative, Hypogammaglobulinaemia; Antibody test negative, Hypogammaglobulinaemia More
No immunologic response to pneumococcal vaccination; This literature marketed report has been receiv... No immunologic response to pneumococcal vaccination; This literature marketed report has been received from the authors of a published literature article, and refers to a 51-year-old male patient. The patient's concomitant therapies were not reported. On an unknown date, about 20 years prior to presentation, the patient a mediastinal mass found; at that time, biopsies were non-diagnostic. The patient was empirically treated for tuberculosis with reported improvement in the mass size. On an unknown date in early 2024, the patient developed influenza pneumonia, and computerized tomography (CT) scan showed a 10 cm mediastinal mass with bronchiectasis and ground glass opacities concerning for infection. Positron emission tomogram (PET)/CT scan showed moderate uptake in the mass, but no evidence of extra-thoracic FDG-avidity. On an unknown date in 2024, the patient underwent resection of the mass with wedge resection of the left upper lobe with clear margins and lymph nodes negative for malignancy. Pathology test showed thymoma, predominantly type A, 11.8 x 8.1 x 5.8 cm with pulmonary parenchymal invasion. On an unknown date, two months after tumor resection, the patient was admitted to hospital with pneumonia and found to have hypogammaglobulinemia with IgA less than 25 mg/dL, IgM less than 25 mg/dL and IgG 133 mg/dL. Screening serologies were negative for connective tissue disease. Pulmonary function testing showed severe restrictive lung physiology, forced vital capacity (FVC) was 1.11 (unit not provided) (z-score -5.94), forced expiratory volume in 1 second (FEV1) was 1.11 (unit not provided) (z-score -4.60), and FEV1/FVC was 1.00 (unit not provided). Serologic evaluation, lung function, and imaging findings supported a clinical diagnosis of granulomatous lymphocytic interstitial lung disease (GL-ILD) related to Good Syndrome. On an unknown date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown), administered for prophylaxis (dose, route of administration, anatomical location, lot# and expiry date were not reported). On an unknown date, the patient had no immunologic response to pneumococcal vaccination, confirming a diagnosis of primary hypogammaglobulinemia The outcome of the event was not reported. The authors considered the event of no immunologic response to pneumococcal vaccination to be related to suspect vaccine. Lot# is being requested and will be submitted if received. More
2853544 1 OK 08/11/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 W019423
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
No side effects reported. No additional AE; HBP is calling to report an expired vaccine MMR II 0.5 m... No side effects reported. No additional AE; HBP is calling to report an expired vaccine MMR II 0.5 mil was given to patient on 06/24/2024.; This spontaneous report was received from a Nurse and refers to an 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 24-Jun-2024, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection (lot #W019423, expiration date was reported as confirmed as: 20-Jun-2024) 0.5 mL administered for prophylaxis; vaccine was reconstituted with sterile diluent, Solution for injection (expiration date, and lot # were not reported) (Expired product administered). No side effects were reported; no additional adverse event (AE) (no adverse event). More
2853545 AR 08/11/2025 HEPA
 MERCK & CO. INC.
 y007472
No adverse event, Product storage error No adverse event, Product storage error
No additional AEs were reported; The nurse is reporting that a patient received improperly stored va... No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine. No additional AEs were reported, no further information provided. Names of vaccines involved (including lot/exp) VAQTA (y007472 10/19/2025) Temperature and Time frame: 35.6; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot #y007472, expiration date: 19-Oct-2025, dose number 1, (strength, dose, route, and anatomical location were not provided) for prophylaxis. The temperature excursion was: 35.6๏ฟฝF for 15 minutes 46.9๏ฟฝF for 30 minutes 46.9๏ฟฝF for 15 minutes No adverse events reported and there was no previous temperature excursion. More
2853548 F WI 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Nausea Fatigue, Nausea
Nausea; Fatigue; This non-serious case was reported by a consumer via call center representative and... Nausea; Fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 12-APR-2025, the patient received the 1st dose of Shingrix (intramuscular). On 13-APR-2025, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea) and fatigue (Verbatim: Fatigue). On 16-APR-2025, the outcome of the nausea and fatigue were resolved (duration 3 days). It was unknown if the reporter considered the nausea and fatigue to be related to Shingrix. It was unknown if the company considered the nausea and fatigue to be related to Shingrix. Additional Information: GSK receipt date: 25-JUL-2025 The patient reports that she received her first dose of Shingrix on 12th April 2025 and on the following day experienced nausea and fatigue for two or three days after. More
2853549 F 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pruritus, Urticaria Pruritus, Urticaria
Experiencing light hives on both sides of my torso, at tail bone, and itching on shins and ankles.; ... Experiencing light hives on both sides of my torso, at tail bone, and itching on shins and ankles.; This non-serious case was reported by a consumer and described the occurrence of hives in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included drug allergy (the patient allergic to Sulfas, Flagyl, Amoxicillain.). On 09-JUL-2025, the patient received the 1st dose of Shingrix. On 11-JUL-2025, 2 days after receiving Shingrix, the patient experienced hives (Verbatim: Experiencing light hives on both sides of my torso, at tail bone, and itching on shins and ankles.). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the hives was not resolved. It was unknown if the reporter considered the hives to be related to Shingrix. It was unknown if the company considered the hives to be related to Shingrix. Additional Information: GSK Receipt Date: 31-JUL-2025 The reporter reported that she experiencing light hives on both sides of my torso, at tail bone, and itching on shins and ankles. The reporter wondering if the reporter maybe allergic to any ingredients. The reporter was allergic to sulfas, flagyl, amoxicillain. The reporter asked should the reporter keep taking Benadryl. The reporter also asked should the reporter got a second shot on 10th September 2025. The symptoms were not treated. More
2853550 F FL 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Break through case of shingles; This serious case was reported by a p... Suspected vaccination failure; Break through case of shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included immunocompromised (Immunocompromised patient with kidney disease) and renal disease (Immunocompromised patient with kidney disease). 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: Break through case of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. The reporter considered the vaccination failure and shingles to be unrelated to Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 04-AUG-2025 Physician reported that patient had Break through case of shingles. The reporter also mentioned patient was immunocompromised with kidney disease. Patient was taking 2 immunosuppressive medications for her kidney disease. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. More
2853551 F UT 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product storage error Product storage error
SHINGRIX was received by the office in a cold pack on 1 AUG 2025 but was not placed into the refrige... SHINGRIX was received by the office in a cold pack on 1 AUG 2025 but was not placed into the refrigerator until 4 AUG 202; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug 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 incorrect storage of drug (Verbatim: SHINGRIX was received by the office in a cold pack on 1 AUG 2025 but was not placed into the refrigerator until 4 AUG 202). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 05-AUG-2025 The health care professional was received by the office in a cold pack on 01- AUG- 2025 but was not placed into the refrigerator until 04 -AUG -2025 (incorrect product storage.), which led to incorrect storage of drug. No further information was provided / obtained. More
2853552 F TN 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise, Pain in extremity Malaise, Pain in extremity
general unwell feeling; arm soreness; This non-serious case was reported by a consumer via sales rep... general unwell feeling; arm soreness; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: general unwell feeling) and pain in arm (Verbatim: arm soreness). The outcome of the feeling unwell and pain in arm were resolved. The reporter considered the feeling unwell and pain in arm to be related to Shingrix. The company considered the feeling unwell and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 14-JUL-2025 The reporter stated that Shingrix caused arm soreness and general unwell feeling for 3-4 days after dose. Patient did return when the time came for dose 2 and reported no side effects after dose 2. More
2853553 08/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
2nd shot was definitely the downturn of my overall health; This non-serious case was reported by a ... 2nd shot was definitely the downturn of my overall health; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (patient took 1st dose on unknown date). 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 unwell (Verbatim: 2nd shot was definitely the downturn of my overall health). The outcome of the unwell was not reported. It was unknown if the reporter considered the unwell to be related to Shingles vaccine. It was unknown if the company considered the unwell to be related to Shingles vaccine. Additional Information: GSK receipt date: 14-JUL-2025 This case was reported by a patient via interactive digital media. Patient had a 2 part shingles vaccine and that 2nd shot was definitely the downturn of my overall health. Also indicated that they never should have done it. More
2853554 08/11/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Extra dose administered Extra dose administered
i had 3 shots by mistake; This non-serious case was reported by a consumer via interactive digital m... i had 3 shots by mistake; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (patient had 1st dose on unknown date) and Shingles vaccine (patient had 2nd dose on unknown date). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced extra dose administered (Verbatim: i had 3 shots by mistake). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 17-JUL-2025 Patient had 3 shots by mistake, asked if it is ok or not. Patient had 3 doses of shingles vaccine, which led to extra dose administered. More
2853555 F TN 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Chills, Pyrexia Chills, Pyrexia
fever; severe chills; This non-serious case was reported by a consumer via sales rep and described t... fever; severe chills; This non-serious case was reported by a consumer via sales rep and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever) and chills (Verbatim: severe chills). The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). The outcome of the fever was resolved and the outcome of the chills was not reported. It was unknown if the reporter considered the fever and chills to be related to Shingrix. It was unknown if the company considered the fever and chills to be related to Shingrix. Additional Information: GSK Receipt Date: 28-JUL-2025 Shingrix first dose had caused a fever on the night of the first dose. The day after receiving the first dose, she had developed a 105-degree fever accompanied by severe chills. She had taken Advil and Tylenol to help manage the fever. The fever had lasted overnight, and she had recovered by the third day with no remaining symptoms. This had occurred following dose 1. She had not yet received dose 2. More
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