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
2842005 17 M TX 05/21/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 G334J
U8375AA
Dizziness, Nausea, Syncope, Vision blurred; Dizziness, Nausea, Syncope, Vision b... Dizziness, Nausea, Syncope, Vision blurred; Dizziness, Nausea, Syncope, Vision blurred More
The teenager while walking in the hallway after been vaccinated experienced a brief episode of synco... The teenager while walking in the hallway after been vaccinated experienced a brief episode of syncope while standing. The event was preceded by lightheadedness, nausea, and blurred vision. The episode lasted for approximately 1 minute, and he regained consciousness spontaneously without any confusion or disorientation. The patient denies any similar episodes in the past. The child is on fasting today because of willingness to do lab work; he is active teenager, no history of exertion chest pain, palpitations. FH is non-contributory. Vitals taken and were stable, and patient was observed for 30 mins. More
2842006 66 M MI 05/21/2025 COVID19
 MODERNA
Underdose Underdose
A child dose was given instead of an adult does. A child dose was given instead of an adult does.
2842007 8 F IA 05/21/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 423NL
Inappropriate schedule of product administration Inappropriate schedule of product administration
The Havrix vaccine was provided 5 days to early, ( 1 day too early with the 4 day grace period.) The Havrix vaccine was provided 5 days to early, ( 1 day too early with the 4 day grace period.)
2842008 1.25 F WI 05/21/2025 DTAP
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 Y97N7
Y020586
Erythema, Injection site reaction, Rash erythematous, Rash macular, Rash papular... Erythema, Injection site reaction, Rash erythematous, Rash macular, Rash papular; Erythema, Injection site reaction, Rash erythematous, Rash macular, Rash papular More
Red raised rash-target like- appeared to the upper left thigh around the injection site after inject... Red raised rash-target like- appeared to the upper left thigh around the injection site after injection, within 5 minutes patients face/cheeks/back of neck became red and blotchy. Parent gave oral Tylenol within 1-2 minutes of administering vaccines. Oral Benadryl was administered within 30 minutes of the reaction. Rash began decreasing within 30 minutes of vaccine administration. Provider observed patient, vitals remained stable. Parent felt comfortable leaving facility within 40 -minutes of reaction More
2842009 19 M GA 05/21/2025 COVID19
 MODERNA
 001c21a
Autopsy, Death Autopsy, Death
Death Death
โœ“
2842010 0.25 F IA 05/21/2025 VARCEL
 MERCK & CO. INC.
 Y011019
Wrong product administered Wrong product administered
Varicella vaccine was given by mistake instead of Vaxelis. Varicella vaccine was given by mistake instead of Vaxelis.
2842012 93 M OR 05/21/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 DL32G
DL32G
Computerised tomogram head, Full blood count, Guillain-Barre syndrome, Lumbar pu... Computerised tomogram head, Full blood count, Guillain-Barre syndrome, Lumbar puncture, Metabolic function test; Muscular weakness More
Progressive bilateral lower limb weakness the day after his vaccine. Presented to the ER and diagno... Progressive bilateral lower limb weakness the day after his vaccine. Presented to the ER and diagnosed with Guillian Barre syndrome. More
โœ“ โœ“
2842013 21 M CA 05/21/2025 SMALLMNK
 BAVARIAN NORDIC
 96867
Incorrect route of product administration Incorrect route of product administration
Vaccine given IM rather than subcutaneous; no known adverse patient reaction related to administrati... Vaccine given IM rather than subcutaneous; no known adverse patient reaction related to administration site error More
2842014 31 F GA 05/21/2025 HEPAB
HPV9
TDAP
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
 P2443
y007193
U8353AA
y015559
Genital erythema, Pruritus, Vulvovaginal swelling; Genital erythema, Pruritus, V... Genital erythema, Pruritus, Vulvovaginal swelling; Genital erythema, Pruritus, Vulvovaginal swelling; Genital erythema, Pruritus, Vulvovaginal swelling; Genital erythema, Pruritus, Vulvovaginal swelling More
Patient called and stated she was itching all over. No injection site reaction, redness or swelling.... Patient called and stated she was itching all over. No injection site reaction, redness or swelling. Patient states she was especially itchy and red on her hands and neck. She also stated her labia was red and swollen. This reaction occurred after the patient left the pharmacy several hours later. More
2842015 60 M MA 05/21/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 Y013120
Underdose Underdose
Patient inadvertently received a pediatric formulation of the Hepatitis A vaccine. Patient was admin... Patient inadvertently received a pediatric formulation of the Hepatitis A vaccine. Patient was administered a 0.5 mL pediatric dose of the Hepatitis A vaccine. In consultation with the nurse, it was determined that the appropriate course of action was to administer an additional 0.5 mL of the pediatric formulation on the same day to complete the standard 1.0 mL adult dose. The patient returned on same day 5/20/25 for second 0.5 ml pediatric dose and has been advised to return in six months for the second 1.0 mL adult dose to complete the vaccination series. More
2842016 72 M GA 05/21/2025 COVID19
 PFIZER\BIONTECH
Cerebrovascular accident Cerebrovascular accident
stroke stroke
โœ“ โœ“ โœ“
2842017 57 F NH 05/21/2025 TDAP
TDAP
VARZOS
VARZOS
TDAP
TDAP
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 EB499
EB499
E754F
E754F
eb499
eb499
e754f
e754f
Arthralgia, Limb injury, Pain; Injected limb mobility decreased, Injection site ... Arthralgia, Limb injury, Pain; Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth; Arthralgia, Limb injury, Pain; Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth; Arthralgia, Limb injury, Pain; Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth; Arthralgia, Limb injury, Pain; Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth More
shoulder injury related to vaccine administration. Extreme pain in shoulder joint of right arm throb... shoulder injury related to vaccine administration. Extreme pain in shoulder joint of right arm throbbing down to elbow. referral placed for steroid joint injection for treatment. More
2842018 86 F NH 05/21/2025 COVID19
COVID19
RSV
RSV
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\WYETH
PFIZER\WYETH
 MD3414
MD3414
MD5461
MD5461
Cellulitis; Cellulitis; Cellulitis; Cellulitis Cellulitis; Cellulitis; Cellulitis; Cellulitis
Pt seen in PCP office today after vaccine reaction from administration at pharmacy. Upon exam it was... Pt seen in PCP office today after vaccine reaction from administration at pharmacy. Upon exam it was determined patient had cellulitis and antibiotics were presribed by APRN who saw patient. More
2842073 F TN 05/21/2025 HPV9
 MERCK & CO. INC.
 X019863
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; HCP calling to report expired administration of GARDASIL-9 on 05/03/2025. The prod... No additional AE; HCP calling to report expired administration of GARDASIL-9 on 05/03/2025. The product was expired on 02/14/2025 with no TEs. No symptoms reported on behalf of patient. Supported outcome delivered verbally per memo. Case number provided. Received cons; This spontaneous report was received from a Pharmacist and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant therapies were not provided. On 03-MAY-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) suspension for injection, lot #X019863, expiration date: 14-FEB-2025, administered by unknown route for prophylaxis (dose and strength were not provided) (Expired product administered). No additional AE. At the reporting time, the outcome of the events was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) was not reported but established to be as not applicable. More
2842074 40 NY 05/21/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 X011425
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
Confirmed no symptoms or side effects; VARIVAX administered on 5/12/2025 that expired on 4/19/2025; ... Confirmed no symptoms or side effects; VARIVAX administered on 5/12/2025 that expired on 4/19/2025; This spontaneous report was received from a nurse and refers to a 40-year-old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 12-MAY-2025, the patient was vaccinated with expired varicella virus vaccine live (oka-merck) (VARIVAX) injection at a dose of 0.5 mL, administered once, lot #X011425, expiration date: 19-APR-2025 (route of administration and anatomical location were not reported) for prophylaxis (Expired product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiry date were not reported). No temperature excursion history. No symptoms or side effects were confirmed (No adverse event). More
2842075 11 F 05/21/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 Y009782
Headache, Lymphadenopathy, Oropharyngeal pain, Rash; Headache, Lymphadenopathy, ... Headache, Lymphadenopathy, Oropharyngeal pain, Rash; Headache, Lymphadenopathy, Oropharyngeal pain, Rash More
she starting having swollen lymph nodes, sore throat, headache and a rash on her belly. Caller advis... she starting having swollen lymph nodes, sore throat, headache and a rash on her belly. Caller advised she took her daughter to the HCP on 04/25/2025 and she had Epstein๏ฟฝBarr and tested positive for mono.; This spontaneous report was received from a consumer and refers to a 11-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-Apr-2025, the patient (her daughter) received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 mL injection in the arm (lot #Y009782, expiration date: 23-May-2026) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). Operator of device was reported as lay user/patient. On 24-Apr-2025 and 25-Apr-2025, the patient started having swollen lymph nodes, sore throat, headache and a rash on her belly. She took her daughter to the HCP on 25-Apr-2025 and she had Epstein-Barr and tested positive for "mono" (Epstein-Barr virus test positive). The reporter advised her daughter's lymph nodes had went down but they were still enlarged and she was tired and fatigue. At the reporting time, the patient had not recovered from the event. The action taken was not applicable. The causal relationship between the event, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and reconstituted suspect sterile diluent was not reported. More
2842076 NJ 05/21/2025 HEPA
 MERCK & CO. INC.
 X024966
Expired product administered, No adverse event Expired product administered, No adverse event
no adverse event; inadvertently administered a dose of expired VAQTA on 05/14/2025; This spontaneous... no adverse event; inadvertently administered a dose of expired VAQTA on 05/14/2025; This spontaneous report was received from a Registered Nurse on 15-MAY-2025 and refers to a patient of unknown age and gender. The patient's medical history concurrent conditions and concomitant therapies were not reported. On 14-MAY-2025, the patient was vaccinated with and expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), (lot #X024966, expiration date: 23-MAR-2025) (dose number, anatomical location and route of administration were not mentioned) for prophylaxis, Caller confirmed the product had no history of temperature excursion. No additional adverse event reported. More
2842077 9 M KY 05/21/2025 HPV9
 MERCK & CO. INC.
Skin papilloma Skin papilloma
Gardasil 9 used as treatment for eyelid and facial cutaneous warts; This literature marketed repor... Gardasil 9 used as treatment for eyelid and facial cutaneous warts; This literature marketed report was received from the authors as stated above and refers to A 9-year-old immunocompetent boy with history of asthma, obesity, nonalcoholic fatty liver disease, and sleep apnea, on daily albuterol, cetirizine, and fluticasone. On an unknown date, reported as "for the previous year", the family had noted growths in the skin of the patient's face, including both eyelids. The family reported that the lesions were getting progressively larger, leading to significant discomfort and disfigurement for the patient, resulting in social withdrawal and low self-esteem. The family also stated they tried treating the lesions with over-the-counter topical ointments (moisturizers and steroids), which had been unsuccessful. On an unspecified date, the patient presented at the medical institution with eyelid lesions. On examination, the patient's visual acuity was 20/25 In the right eye and 20/30 in the left eye. There were multiple flesh-colored, hyperkeratotic papules with irregular, "cauliflower-like" surface of various sizes on the upper and lower eyelids of both eyes, forehead, and nasal bridge as well as on the index finger of the right hand. All lesions were clinically suggestive of cutaneous viral warts. The patient's conjunctiva was not involved, and the remainder of the ocular examination was unremarkable. Given the location and multiplicity of lesions, HPV vaccination was recommended. Therefore, on an unknown date, 5 days after visit, the patient received the first and single dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (route, anatomical location lot # and expiration date were not reported) for cutaneous viral warts (Off label use). All lesions completely resolved 2 weeks after this single dose of vaccine. On the 2-month follow-up visit, the patient did not have any new complaints. Visual acuity was stable at 20/25 in both eyes, and no recurrence was observed. Although spontaneous resolution of cutaneous warts may occur, the temporal association between the vaccination and the resolution of the lesions was striking, suggesting a possible causal relationship. It has been demonstrated that younger individuals generate higher titers of HPV-specific B and T cells following vaccination, which likely results in a stronger immune response capable of clearing HPV-related cutaneous lesions. More
2842078 CA 05/21/2025 COVID19
FLUX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Immunology test, Kidney transplant rejection; Immunology test, Kidney transplant... Immunology test, Kidney transplant rejection; Immunology test, Kidney transplant rejection More
allograft rejection; Background: Studies in adults have demonstrated a risk for allograft rejection ... allograft rejection; Background: Studies in adults have demonstrated a risk for allograft rejection or development of donor-specific antibodies (DSA) following SARS-CoV-2 vaccination. We examined the incidence of acute rejection and de novo DSA following COVID-19 vaccination or infection among pediatric kidney transplant patients. Method: Retrospective analysis of 23 pediatric kidney transplant recipients without prior history of rejection, DSA, or COVID-19 infection who received the SARS-CoV-2 mRNA vaccine. Risk for rejection was evaluated via monitoring of serum creatinine, DSA, and donor-derived cell-free DNA per center protocol. Results concerning for rejection prompted allograft biopsy, graded by the Banff classification system. Results: Eight of 23 (34.8%) received two doses of SARS-CoV-2 mRNA vaccine, 15 (65.3%) received three doses. Two (8.7%) had rejection; one with de novo DSA, another without. There was no difference in the number of doses of COVID-19 vaccine received in those with rejection vs. no rejection (p = 0.53). 13 (56.5%) developed SARS-CoV-2 infection, with no difference in the number of vaccines received between those infected with COVID-19 vs. those who were not (p = 0.69). No adjustments were made to the maintenance immunosuppression during SARS-CoV-2 infection, and there was no evidence of rejection or DSA formation after infection. Median follow-up time was 29.9 months (IQR 25.0-33.4 months) after the first vaccine dose. Conclusion: In our small single-center cohort, SARS-CoV-2 vaccination or infection is unlikely to increase the risk for rejection or de novo DSA in pediatric kidney transplant recipients. Larger prospective studies with a control group are needed to further understand the immune effects of the COVID-19 vaccine and disease in this population. Initial information received via healthcare professional on 14-May-2025 regarding a unsolicited valid serious case issued from a literature article: This case involves an unknown age and gender patient who experienced allograft rejection (Kidney transplant rejection) while receiving vaccine influenza vaccine and COVID-19 Vaccine (Latency: Unknown). The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient's past medical history included Renal transplant. On an unknown date, the patient received influenza vaccine and COVID-19 vaccine (Dose, formulation, frequency, expiry date: Unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed rejection received their influenza vaccine 73days prior to COVID-19 (coronavirus disease-2019) vaccination. Relevant laboratory test results included: Immunology test - On an unknown date: [Patient had both de novo DSA]. Seriousness Criteria: Medically significant Action Taken: Not applicable Corrective treatment: Not provided Outcome: Unknown Allograft Rejection is considered to be related to influenza vaccine by the reporter and unassessable by the company based on company causality assessment.; Sender's Comments: Sanofi company comment dated 20-MAY-2025: This case involves an unknown age and gender patient who experienced allograft rejection (Kidney transplant rejection) while receiving vaccine influenza vaccine and COVID-19 Vaccine. Based on the information provided regarding this case along with compatible temporal relationship, the causal role of the company suspect product cannot be excluded in the occurrence of the reported event. However, lack of information of past and concomitant medication, any family history, any relevant medical history, any concurrent conditions and risk factors precludes comprehensive case assessment. More
2842080 F SC 05/21/2025 TTOX
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
Herpes zoster, Rash, Sensory disturbance, Vaccination failure; Herpes zoster, Ra... Herpes zoster, Rash, Sensory disturbance, Vaccination failure; Herpes zoster, Rash, Sensory disturbance, Vaccination failure; Herpes zoster, Rash, Sensory disturbance, Vaccination failure More
Suspected vaccination failure; Shingles; This serious case was reported by a other health profession... Suspected vaccination failure; Shingles; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and TETANUS VACCINE for prophylaxis. The patient's past medical history included shingles (she had shingles prior to receiving the vaccine in 2013 or 2014). On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix (unknown arm) and TETANUS VACCINE (unknown arm). In APR-2025, more than 2 years after receiving Shingrix and Shingrix, 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 resolved with sequelae. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 13-MAY-2025 and 14-MAY-2025 The patient reported that she had 2 doses of Shingrix (2 to 6 months apart) back in 2019 and the last month she had nerve sensory discomfort and a rash on left side of back. She went to her health care professional and was diagnosed with shingles and antiviral medication for 10 days. She stated that the rash was gone but she was still having sensory issues in her back. At the beginning she delayed going to the doctor because she was already vaccinated and she thought the 2 doses of Shingrix are enough for lifetime protection. Caller also mentioned she got a Tetanus vaccine (unknown brand, lot number or expiration date) at the same time (but different arm) than the first Shingrix shot, and she forgot to gave that information to the prior agent from GlaxoSmithKline response center. It was unknown if the reporter considered the vaccination failure and shingles to be related to Tetanus vaccine. This case was considered as suspected vaccination failure as details regarding 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 laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and 2) More
2842081 F 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Erythema, Muscular weakness, Peripheral swelling, Pyrexia Erythema, Muscular weakness, Peripheral swelling, Pyrexia
Tenderness in arm; Redness in arm; swelling in arm; Fever; This non-serious case was reported by a n... Tenderness in arm; Redness in arm; swelling in arm; Fever; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 06-MAY-2025 08:15, the patient received the 2nd dose of Shingrix. On 06-MAY-2025, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: Tenderness in arm), erythema of extremities (Verbatim: Redness in arm), swelling arm (Verbatim: swelling in arm) and fever (Verbatim: Fever). The patient was treated with paracetamol (Tylenol). On 11-MAY-2025, the outcome of the pain in arm, erythema of extremities, swelling arm and fever were resolved (duration 5 days). The reporter considered the pain in arm, erythema of extremities, swelling arm and fever to be related to Shingrix. The company considered the pain in arm, erythema of extremities, swelling arm and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 13-MAY-2025 The nurse reported that the patient received the second dose of Shingrix and shortly after receiving this second dose, she experienced tenderness in arm and started to run a fever. She took a few Tylenol and the fever resolved and the redness, swelling and tenderness of arm continued for 4 to 5 days then resolved. She shared that she applied an ice pack to her arm which helped and had previously reported an adverse event with her first dose of Shingrix which had discouraged her from receiving the second dose until now. The reaction with this second dose not as strong at the first one. More
2842082 F MA 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never receiving the second dose; This non-serious case was reported by a consumer via call center re... never receiving the second dose; 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 received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine in 2022). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never receiving the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 14-MAY-2025 The reporter had received the first dose of Shingrix in 2022 but never got the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2842083 F 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Feeling hot, Insomnia, Pyrexia Feeling hot, Insomnia, Pyrexia
Mild fever; extremely HOT/feeling like I'm baking inside a; insomnia; This non-serious case was... Mild fever; extremely HOT/feeling like I'm baking inside a; insomnia; This non-serious case was reported by a consumer and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for vaccination. Concomitant products included verapamil hydrochloride (Verapamil). On 09-MAY-2025, the patient received Shingrix. On 09-MAY-2025, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Mild fever) and feeling hot (Verbatim: extremely HOT/feeling like I'm baking inside a). In MAY-2025, the patient experienced insomnia (Verbatim: insomnia). On 11-MAY-2025, the outcome of the fever was resolved (duration 2 days). The outcome of the insomnia and feeling hot were not resolved. It was unknown if the reporter considered the fever, insomnia and feeling hot to be related to Shingrix. It was unknown if the company considered the fever, insomnia and feeling hot to be related to Shingrix. Additional Information: GSK receipt date: 15-MAY-2025 The patient feels like baking inside a side effect. The patient also have insomnia which might be because patient was hot. No fever since Sunday. Asked how long will this feeling last. Mild fever and extremely hot . More
2842084 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being ... Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: Adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 15-MAY-2025 Other HCP reported that Adjuvant was given without being mixed with the active ingredient. Reporter asked MA to call medical line and report the incident. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. More
2842085 51 F CA 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
just got a second vaccine on 5/6/2025; This non-serious case was reported by a consumer via call cen... just got a second vaccine on 5/6/2025; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on 05-OCT-2023). On 06-MAY-2025, the patient received the 2nd dose of Shingrix. On 06-MAY-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: just got a second vaccine on 5/6/2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 16-MAY-2025 The patient self-reported this case for herself. The reporter had her first shingles vaccine on but forgot to get a second dose. The reporter just got a second vaccine. The reporter asked was the vaccine still effective or were these dosages too far apart, does she need to have another vaccine within 6 months of this last does for it to be effective. The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule. More
2842086 M 05/21/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspeceted vaccination failure; Patient stated that he contracted shingles after taking both vaccina... Suspeceted vaccination failure; Patient stated that he contracted shingles after taking both vaccinations.; This serious case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JAN-2020, the patient received the 2nd dose of Shingrix. In DEC-2019, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient stated that he contracted shingles after taking both vaccinations.). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 19-MAY-2025 The patient stated that he contracted shingles after taking both vaccinations. No other information provided. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(Dose 1 & 2). More
2842087 05/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Hypersensitivity Hypersensitivity
I AM ALLERGIC TO IT SHOULD BE ON MY RECORDS THERE; This non-serious case was reported by a consumer ... I AM ALLERGIC TO IT SHOULD BE ON MY RECORDS THERE; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy (Verbatim: I AM ALLERGIC TO IT SHOULD BE ON MY RECORDS THERE). The outcome of the allergy was unknown. It was unknown if the reporter considered the allergy to be related to Shingles vaccine. It was unknown if the company considered the allergy to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 07-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she was allergic to it should be on his/her records there. More
2842088 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
I am getting sicker and sicker; Tired of being sick; This non-serious case was reported by a consume... I am getting sicker and sicker; Tired of being sick; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 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 sickness (Verbatim: I am getting sicker and sicker; Tired of being sick). The outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK receipt date: 14-MAY-2025 Consumer stated that he/she had called in before about the adverse reactions from the Pfizer booster vaccine (Name of the booster vaccine was not available over the call, hence captured as Unspecified Booster Vaccine) and looked like the patient was getting sicker and sicker, was tired of being sick. Consumer was requested to contact Pfizer Drug Safety as consumer voice was breaking and offered with the number of Pfizer Drug Safety. Further probing could not be done as the consumer hung up the call abruptly. Thus, product details (LOT number, NDC number, UPC number and expiration date), purchase details and other details were unknown. More
2842089 05/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; breakout; This serious case was reported by a consumer via interactiv... Suspected vaccination failure; breakout; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: breakout). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 10 days). 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: 14-MAY-2025 This case was reported by a patient via interactive digital media. Reporter was just sharing his/her experience. The vaccine had been 95 percent effective, but he/she was among the 5 percent for whom it did not fully prevent illness. His/her breakout had lasted about 10 days. He/she had known others without the vaccine who had suffered much worse cases. He/she had not regretted getting the vaccine, everyone had their own opinion on it. 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 Shingles vaccine. More
2842090 05/21/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; still got the shingles very painful; This serious case was reported b... Suspected vaccination failure; still got the shingles very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got the shingles very painful). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and still got the shingles very painful. 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
2842091 M 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
We had a patient in our office that got his first dose of Shingrix December of 2022 and just got his... We had a patient in our office that got his first dose of Shingrix December of 2022 and just got his second dose May of 2025; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (got his first dose of Shingrix December of 2022). On an unknown date, the patient received the 2nd dose of Shingrix. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: We had a patient in our office that got his first dose of Shingrix December of 2022 and just got his second dose May of 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 14-MAY-2025 This case was reported by a consumer via interactive digital media. The reporter reported that they had a patient in our office that got his first dose of Shingrix December of 2022 and just got his second dose May of 2025, which was the clearly past the recommended 6 months. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter wanted to ask if the patient should start the series over and get a third dose or only the two doses or not. More
2842092 F 05/21/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; contracted shingles; This serious case was reported by a consumer via... Suspected vaccination failure; contracted 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: contracted shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 02-MAY-2025 The reporter reported that he/she knew a woman (patient) who contracted shingles after getting the Shingrix booster or second dose. 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. This was 1 of the 2 linked cases, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and 2) US-GSK-US2025AMR062323:Same reporter/ Different patient More
2842093 05/21/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Incomplete course of vaccination, Malaise; Incomplete course of vaccination, Mal... Incomplete course of vaccination, Malaise; Incomplete course of vaccination, Malaise More
I got really sick from the first one; incomplete course of vaccination; This non-serious case was re... I got really sick from the first one; incomplete course of vaccination; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 and the did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness (Verbatim: I got really sick from the first one) and incomplete course of vaccination (Verbatim: incomplete course of vaccination). The outcome of the sickness was not reported and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 16-MAY-2025 Patient asked if they can get second dose of Shingrix at month 7 or do they need to start the series over, and if they have to start over can they wait a year. Also stated that they got really sick from the first one. More
2842094 18 F OH 05/21/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 52N4S
Syringe issue, Underdose Syringe issue, Underdose
leakage on a BEXSERO dose; Product complaint; Underdose/Incomplete dose; This non-serious case was r... leakage on a BEXSERO dose; Product complaint; Underdose/Incomplete dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 52N4S, expiry date 30-NOV-2027) for prophylaxis. This case was associated with a product complaint. On 05-MAY-2025, the patient received Bexsero. On 05-MAY-2025, an unknown time after receiving Bexsero, the patient experienced accidental underdose (Verbatim: Underdose/Incomplete dose). On an unknown date, the patient experienced product leakage (Verbatim: leakage on a BEXSERO dose) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the accidental underdose, product leakage and pharmaceutical product complaint 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: 12-MAY-2025 and 13-MAY-2025 The nurse reported a leakage on a Bexsero dose given to a patient which led to accidental underdose and mentions maybe only one drop leaked and was not administered to the patient. More
2842095 VA 05/21/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 77KA5
Incorrect dose administered Incorrect dose administered
due to difficulty expelling the air bubble possibility that approximately 150 patients received inco... due to difficulty expelling the air bubble possibility that approximately 150 patients received incomplete doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in an unspecified number of patients who received Men B NVS (Bexsero) (batch number 77KA5, expiry date 30-NOV-2027) and (batch number 3L339, expiry date 30-SEP-2027) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: due to difficulty expelling the air bubble possibility that approximately 150 patients received incomplete doses). The outcome of the incomplete dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 14-MAY-2025 Nurse called and inform that due to difficulty expelling the air bubble of Bexsero Prefilled Syringe there was a possibility that approximately 150 patients received incomplete doses during the last 3 months. Reporter was not sure of the total amount of patients and the dates of administration. More
2842096 27 F MN 05/21/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Underdose Underdose
An adult 27 years old female patient received a pediatric dose of Engerix-B.; An adult 27 years old ... An adult 27 years old female patient received a pediatric dose of Engerix-B.; An adult 27 years old female patient received a pediatric dose of Engerix B; 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 27-year-old female patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (patient took 1st dose on unknown date). On 07-MAY-2025, the patient received the 2nd dose of Engerix B. On 07-MAY-2025, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: An adult 27 years old female patient received a pediatric dose of Engerix-B.) and underdose (Verbatim: An adult 27 years old female patient received a pediatric dose of Engerix B). The outcome of the adult use of a child product and underdose 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: 14-MAY-2025 Other HCP reported that they accidentally administered a pediatric dose of Engerix-B to 27 years old adult patient, which led to adult use of a child product and underdose. The vaccine was administered on 7th MAY 2025. It was her second dose of the series. Reporter asked if dose needs to be repeated. Also asked are there any safety concerns. More
2842097 M NY 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
patient who got his first Shingrix vaccine 7 months ago; This non-serious case was reported by a phy... patient who got his first Shingrix vaccine 7 months ago; This non-serious case was reported by a physician 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 (who got his first Shingrix vaccine 7 months ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who got his first Shingrix vaccine 7 months ago). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date : 15-MAY-2025 Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. More
2842098 7 M IL 05/21/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 223Y9
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Administration of Infanrix over age; This non-serious case was reported by a other health profession... Administration of Infanrix over age; 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 7-year-old male patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis. On 15-MAY-2025, the patient received Infanrix. On 15-MAY-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Infanrix over age). The outcome of the inappropriate age at vaccine administration 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: 15-MAY-2025 Medical assistance reported that a patient received by error Infanrix. The school required a Tdap vaccine for catch up. The reporter did not consent to follow-up. A 7 years old patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. More
2842099 F MO 05/21/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 DL32D
Product storage error Product storage error
Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This no... Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 The Vaccine Administration Facility was the same as Primary Reporter. A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Arexvy, which led to incorrect storage of vaccine. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025061548:SAME REPORTER US-GSK-US2025061546:Same reporter,Different patient More
2842100 F MO 05/21/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 39LB7
Product storage error Product storage error
Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This no... Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.). The outcome of the incorrect storage of drug 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: 16-MAY-2025 Other HCP reported after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for Arexvy (lot numbers: 44TR9 & DL32D), Boostrix (39LB7 & 2B723), Menveo (1 vial: AMVBO44A & LB93L), Havrix (423NO), Fluarix (PG52S) & Shingrix (M7G39), which led to incorrect storage of drug. Consented to follow up.; Sender's Comments: US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient More
2842101 F MO 05/21/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 39LB7
Product storage error Product storage error
Administration after a below temperature excursion of 29.9 degree fahrenheit; This non-serious case ... Administration after a below temperature excursion of 29.9 degree fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree fahrenheit). The outcome of the incorrect storage of drug 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: 15-MAY-2025 The nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Boostrix which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient More
2842102 M MO 05/21/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 39LB7
Product storage error Product storage error
Administration after a below temperature excursion; This non-serious case was reported by a nurse vi... Administration after a below temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion). The outcome of the incorrect storage of drug 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: 15-MAY-2025 The nurse reported after giving several vaccines that were exposed to a temperature of 29.9 degree Fahrenheit as the lowest reached for Boostrix, which led to incorrect storage of drug.; Sender's Comments: US-GSK-US2025061574:same reporter,Different patient US-GSK-US2025061574:same reporter,Different patient US-GSK-US2025061573:same reporter,Different patient US-GSK-US2025061573:same reporter,Different patient US-GSK-US2025061572:same reporter,Different patient US-GSK-US2025061571:same reporter,Different patient US-GSK-US2025061570:same reporter,Different patient US-GSK-US2025061569:same reporter,Different patient US-GSK-US2025061568:same reporter,Different patient US-GSK-US2025061567:same reporter,Different patient US-GSK-US2025061565:same reporter,Different patient US-GSK-US2025061564:same reporter,Different patient US-GSK-US2025061563:same reporter,Different patient US-GSK-US2025061562:same reporter,Different patient US-GSK-US2025061561:same reporter,Different patient US-GSK-US2025061560:same reporter,Different patient US-GSK-US2025061559:same reporter,Different patient US-GSK-US2025061558: US-GSK-US2025061557: US-GSK-US2025061556: US-GSK-US2025061555: US-GSK-US2025061554: US-GSK-US2025061553: US-GSK-US2025061552: US-GSK-US2025061551: US-GSK-US2025061550: US-GSK-US2025061549: US-GSK-US2025061547: US-GSK-US2025061546: US-GSK-US2025061545: US-GSK-US2025061538: US-GSK-US2025061537: US-GSK-US2025061536: US-GSK-US2025061534: US-GSK-US2025061546:Same reporter,Different patient More
2842103 F MO 05/21/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 39LB7
Product storage error Product storage error
Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached.; This non-ser... Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 52-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached.). The outcome of the incorrect storage of drug 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: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Boostrix, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: US-GSK-US2025061548:SAME REPORTER US-GSK-US2025061546:Same reporter,Different patient More
2842104 M MO 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 M7G39
Product storage error Product storage error
Administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non... Administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number M7G39) 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: Administration after a below temperature excursion of 29.9 degree F as the minimum reached). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 The Vaccine Administration Facility was the same as Primary Reporter. A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Shingrix, which led to incorrect storage of vaccine. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient More
2842105 F MO 05/21/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 423NO
Product storage error Product storage error
Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This no... Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number 423NO) for prophylaxis. On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.). The outcome of the incorrect storage of drug 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: 21-MAY-2025 Other HCP reported after giving several vaccines that were exposed to a temperature of 29.9 degree F as the lowest reached for Havrix, which led to incorrect storage of drug.; Sender's Comments: US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient More
2842106 1 M MO 05/21/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 T9TL9
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Wrong age; Wrong dose; This non-serious case was reported by a nurse via call center representative ... Wrong age; Wrong dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis. On 12-MAY-2025, the patient received Havrix adult. On 12-MAY-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Wrong age) and overdose (Verbatim: Wrong dose). The outcome of the adult product administered to child and overdose 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-MAY-2025 Registered Nurse explained that a 1 year old patient received an adult dose of Havrix on May 12th 2025, which led to adult product administered to child and overdose. More
2842107 74 F PA 05/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3G5T3
Injection site warmth Injection site warmth
hot area on the arm below the injection site; This non-serious case was reported by a pharmacist via... hot area on the arm below the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G5T3, expiry date 20-JUL-2026) for prophylaxis. On 12-MAY-2025, the patient received Shingrix. On 15-MAY-2025, 3 days after receiving Shingrix, the patient experienced injection site warmth (Verbatim: hot area on the arm below the injection site). The outcome of the injection site warmth was unknown. The reporter considered the injection site warmth to be related to Shingrix. The company considered the injection site warmth to be related to Shingrix. Additional Information: GSK receipt date: 16-MAY-2025 The pharmacist reported they had a patient who received her Shingrix shot on Monday (12th MAY 2025). The patient had a raised, hot area about 4 inches below the injection site. The reporter assumed that the adverse event was related to the Shingrix vaccine. More
2842108 32 F ND 05/21/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 95DB2
Expired product administered Expired product administered
a patient received a dose of Havrix that had already expired; This non-serious case was reported by ... a patient received a dose of Havrix that had already expired; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis. On 16-JAN-2025, the patient received the 1st dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: a patient received a dose of Havrix that had already expired). 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: 16-MAY-2025 A pharmacist called to inform that a patient received a dose of Havrix that had already expired, which led to Expired vaccine used. Reporter mentioned that was the 1st dose of the series for such patient. The reporter consented to follow up. More
2842109 42 F ND 05/21/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 95DB2
Expired product administered Expired product administered
Expired dose administered; This non-serious case was reported by a pharmacist via call center repres... Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis. On 30-JAN-2025, the patient received the 1st dose of Havrix. On 30-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). 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: 16-MAY-2025 The patient received a dose of Havrix that had already expired, which led expired vaccine used. The reporter consented to follow up. More
2842110 MO 05/21/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
clinics have been administering Kinrix vaccine in children less than 4 yo; This non-serious case was... clinics have been administering Kinrix vaccine in children less than 4 yo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis. On an unknown date, the patients received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: clinics have been administering Kinrix vaccine in children less than 4 yo). The outcome of the inappropriate age at vaccine administration 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: 16-MAY-2025 The pharmacist reported that in the multiple clinics have been administering Kinrix vaccine in children less than 4 years of age, which led to inappropriate age at vaccine administration. The reporter asked if Kinrix was given prior to age 4 does it need to be repeated More
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