🏥 VAERS Vaccine Data Browser

🔒 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.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 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 "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 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:

  • ✅ Early warning system for potential safety signals
  • ✅ Open and transparent - publicly accessible
  • ✅ Accepts all reports regardless of likelihood of causation
  • ✅ Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ 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?

⚠️ 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
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2853001 54 F 08/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 9C5T4
Myalgia, Rash Myalgia, Rash
annular rash and myalgia developing approx 1 week after first Shingrix dose annular rash and myalgia developing approx 1 week after first Shingrix dose
2853002 55 F TX 08/06/2025 COVID19
UNK
 MODERNA
UNKNOWN MANUFACTURER
 023M20A/008B21A
Cerebrovascular accident, Transient ischaemic attack; Cerebrovascular accident, ... Cerebrovascular accident, Transient ischaemic attack; Cerebrovascular accident, Transient ischaemic attack More
Two regular vaccines then 2 boosters First, TIAs then full CVA (stroke) Two regular vaccines then 2 boosters First, TIAs then full CVA (stroke)
2853003 16 F TX 08/06/2025 MENB
 PFIZER\WYETH
 ll0642
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
redness to the injection site. As per mom, pt woke up with swelling to the upper arm on 08/05/2025 redness to the injection site. As per mom, pt woke up with swelling to the upper arm on 08/05/2025
2853004 50 F GA 08/06/2025 HEP
TDAP
VARZOS
 DYNAVAX TECHNOLOGIES CORPORATION
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
37F34
Injection site pain, Injection site swelling; Injection site pain, Injection sit... Injection site pain, Injection site swelling; Injection site pain, Injection site swelling; Injection site pain, Injection site swelling More
Pain and swelling at injection site Pain and swelling at injection site
2853005 11 F ID 08/06/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 TH9NR
No adverse event, Wrong product administered No adverse event, Wrong product administered
On 8/23/24 MenQuadfi was ordered by provider FNP. Bexsero was administered to patient. Error was not... On 8/23/24 MenQuadfi was ordered by provider FNP. Bexsero was administered to patient. Error was noted 8/6/25 following an internal vaccine audit. Patient's family was notified 8/6/25. No adverse events reported following vaccine administration. More
2853006 16 F MI 08/06/2025 MENB
MENB
MNQ
MNQ
 PFIZER\WYETH
PFIZER\WYETH
SANOFI PASTEUR
SANOFI PASTEUR
 LL0641
LL0641
U8493AA
U8493AA
Disorientation, Head injury, Hyperhidrosis, Joint injury, Muscle rigidity; Skin ... Disorientation, Head injury, Hyperhidrosis, Joint injury, Muscle rigidity; Skin abrasion, Syncope, Tremor; Disorientation, Head injury, Hyperhidrosis, Joint injury, Muscle rigidity; Skin abrasion, Syncope, Tremor More
Patient had syncopal episode approximately 5 minutes after vaccine administration. Patient collapse... Patient had syncopal episode approximately 5 minutes after vaccine administration. Patient collapsed to the floor, striking the left, posterior aspect of skull on laminate flooring. Abrasion noted, but no laceration. Patient appeared to have a minimal amount of tremor and arm rigidity while falling to floor. Patient did not lose consciousness, but was disoriented and diaphoretic. EMS was contacted due to head injury, history of cardiomyopathy and concern for potential seizure. Patient's vital signs were assessed and deemed stable (BP 106/60, sPO2 98%, HR 90, RBG 92). EMS staff also provided assessment and cleared patient for discharge to home, no transport required, if parent so desired. Parent did choose not to have additional care by EMS or transport to emergency facility. Patient advised to follow up with office staff within 24 hours by phone. Advised to contact EMS/emergency medical provider for any new or concerning symptoms. More
2853007 12 F VA 08/06/2025 UNK
 UNKNOWN MANUFACTURER
Hyperhidrosis, Hypotension, Loss of consciousness, Pallor Hyperhidrosis, Hypotension, Loss of consciousness, Pallor
pt received vaccine in treatment room, per nurse report was well appearing and felt well at time of ... pt received vaccine in treatment room, per nurse report was well appearing and felt well at time of leaving tx room. she walked to lobby with mom and while mom was checking out, pt passed out in the lobby. no apparent injury. bp found to be low with sbp low in 70s, after 500ml ns bolus in clinic, sbp remained in 80s with map of 63 at time of this report. she continues to receive iv fluids at this time. glucose was checked, it was normal. she was pale and diaphoretic in appearance after event, remains pale but pallor is slightly improved, no longer diaphoretic, is free of pain, alert and oriented and answering questions appropriate without focal weakness. if bp does not improve with liter of ivf or if new or worsening symptoms develop will send to ER More
2853008 54 F ME 08/06/2025 COVID19
 MODERNA
Laboratory test, Road traffic accident, Ventricular fibrillation Laboratory test, Road traffic accident, Ventricular fibrillation
Was diagnosed with v fib, moo was riot symptoms of anything at all prior to taking vaccine es. No f... Was diagnosed with v fib, moo was riot symptoms of anything at all prior to taking vaccine es. No family history . More
✓ ✓ ✓
2853009 60 M MA 08/06/2025 PNC21
 MERCK & CO. INC.
 Z002626
Injection site reaction Injection site reaction
The PCV21 vaccine was given on 7/23 after discussion with the patient's primary doctor. On 7/28... The PCV21 vaccine was given on 7/23 after discussion with the patient's primary doctor. On 7/28, patient presented to the clinic with an injection site reaction and concern for an allergic reaction to the vaccine. Per physician note on 7/28, "notably multiple separate, circumscribed areas would be unlikely to be an allergic reaction". The patient was given antibiotics with a plan to follow up in 2 days (no encounters happened per chart review). More
2853010 7 F AZ 08/06/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9KB9G
Wrong product administered Wrong product administered
INCORRECT VACCINE ADMINISTERED INCORRECT VACCINE ADMINISTERED
2853011 65 F WV 08/06/2025 HEPAB
HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 324BY
UNK
Inappropriate schedule of product administration, Incomplete course of vaccinati... Inappropriate schedule of product administration, Incomplete course of vaccination; Inappropriate schedule of product administration, Incomplete course of vaccination More
The patient has not received a second dose of Twinrix; received first dose of Havrix on 29Jan2019/fi... The patient has not received a second dose of Twinrix; received first dose of Havrix on 29Jan2019/first dose of Twinrix on 10Apr2025/Inappropriate schedule of vaccine administered; 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 65-year-old female patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Previously administered products included Havrix (patient received the first dose of Havrix on 29-JAN-2019 Batch no: D94MK Exp date :05-JUL-2021). On 10-APR-2025, the patient received the 1st dose of Twinrix. The patient did not receive the 2nd dose of Twinrix. On 10-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received first dose of Havrix on 29Jan2019/first dose of Twinrix on 10Apr2025/Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: The patient has not received a second dose of Twinrix). The outcome of the drug dose administration interval too long and incomplete course of vaccination 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: 17-JUL-2025 A patient received the first dose of Havrix and Twinrix has not receive a second dose. The patient received a dose of Havrix and then received a dose of Twinrix as a booster of Havrix (Hepatitis A) later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination. More
2853012 68 M FL 08/06/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LP4947
LP4947
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
PATIENT HAD PREVNAR20 IN DECEMBER 2024 AND AGAIN IN AUGUST 2025 PATIENT HAD PREVNAR20 IN DECEMBER 2024 AND AGAIN IN AUGUST 2025
2853013 15 M MI 08/06/2025 HPV9
 MERCK & CO. INC.
 Y015179
Lip injury, Skin laceration, Syncope Lip injury, Skin laceration, Syncope
Syncopal episode about 5 minutes after receiving HPV vaccine. Unknown signs or symptoms. During sync... Syncopal episode about 5 minutes after receiving HPV vaccine. Unknown signs or symptoms. During syncopal episode, patient sustained cut to upper lip and hit back of head. Patient was revaluated by the provider and advised of signs of concussion and what to watch for. More
2853014 0.33 M NY 08/06/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7NX57
7NX57
Asphyxia, Autopsy, Bed sharing, Death, Laboratory test; Sudden infant death synd... Asphyxia, Autopsy, Bed sharing, Death, Laboratory test; Sudden infant death syndrome More
I do not believe that the vaccination was a cause of adverse event, but given severity of event, I w... I do not believe that the vaccination was a cause of adverse event, but given severity of event, I would like to report to VAERS out of due diligence as as encourage by VAERS instructions. The patient passed away ~6/21, died from sudden unexpected infant death (SUID) versus asphyxiation due to accidental cause, sleeping in an adult bed. PLEASE NOTE, The official medical examiners office autopsy puts the cause as accidental asphyxiation because the pathologist "does not believe in SUID/SIDS as is my understanding. T More
✓
2853015 89 M NJ 08/06/2025 PNC21
 MERCK & CO. INC.
 Y019157
Dizziness, Fall, Injection site swelling, Urinary incontinence Dizziness, Fall, Injection site swelling, Urinary incontinence
Patient experienced extreme dizziness, fell twice, severe swelling at injection site & under the... Patient experienced extreme dizziness, fell twice, severe swelling at injection site & under the arm. Patient also reported urinating uncontrollably on himself which has never happened previously. More
2853016 5 M TN 08/06/2025 MMRV
 MERCK & CO. INC.
 Y003883
Expired product administered Expired product administered
Administered expired vaccine L thigh at 1310. Notified mother of patient and informed her of expired... Administered expired vaccine L thigh at 1310. Notified mother of patient and informed her of expired vaccine. Instructed mother to bring child back to clinic in one month for another vaccine. Mother verbalized understanding. Ensured mother watches out for adverse reactions, however, child will most likely be fine. More
2853017 16 F 08/06/2025 MENB
MENB
MNQ
MNQ
 PFIZER\WYETH
PFIZER\WYETH
SANOFI PASTEUR
SANOFI PASTEUR



Dizziness, Dyspnoea, Feeling cold, Headache, Nausea; Urticaria; Dizziness, Dyspn... Dizziness, Dyspnoea, Feeling cold, Headache, Nausea; Urticaria; Dizziness, Dyspnoea, Feeling cold, Headache, Nausea; Urticaria More
urticaria, that started the morning of 8/5/2025, also had headache, nausea, feeling cold, lightheade... urticaria, that started the morning of 8/5/2025, also had headache, nausea, feeling cold, lightheaded, and shortness of breath. Most of these symptoms resolved by the time she was seen in the office around 5 pm. She still had the urticaria. More
2853018 18 F TN 08/06/2025 FLU3
HPV9
MNQ
 SEQIRUS, INC.
MERCK & CO. INC.
SANOFI PASTEUR
 406983
Z007847
U8369BA
Loss of consciousness, Pallor, Retching; Loss of consciousness, Pallor, Retching... Loss of consciousness, Pallor, Retching; Loss of consciousness, Pallor, Retching; Loss of consciousness, Pallor, Retching More
The order of vaccines I administered was Flucelvax, Gardasil, then Menquadfi. After the third vaccin... The order of vaccines I administered was Flucelvax, Gardasil, then Menquadfi. After the third vaccine the patient's face went white, and she asked her mother to get her water. As the mother was out of the room the patient passed out for approximately 30 seconds while seated. When she came back up there was shaking and she felt the need to throw up (the patient dry heaved for approximately 30 seconds). She was able to recall who she was and where she was. The patient drank water, and ate something before leaving. More
2853019 20 F PA 08/06/2025 VARCEL
 MERCK & CO. INC.
 Y015100
Headache, Limb discomfort, Musculoskeletal stiffness, Tremor Headache, Limb discomfort, Musculoskeletal stiffness, Tremor
Headache, neck stiffness, extremities felt heavy and was shaky. Headache, neck stiffness, extremities felt heavy and was shaky.
2853020 13 F NE 08/06/2025 MMRV
 MERCK & CO. INC.
 Z006282
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
patient was out the the recommended age group Staff at Merck was called. Was given case number... patient was out the the recommended age group Staff at Merck was called. Was given case number. Called 8/6/2025 at 12pm. Was told that there should be no adverse effects and that dose should be counted. More
2853021 11 M NV 08/06/2025 MNQ
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 u8361aa
37r35
Contusion, Head injury, Syncope, Unresponsive to stimuli; Contusion, Head injury... Contusion, Head injury, Syncope, Unresponsive to stimuli; Contusion, Head injury, Syncope, Unresponsive to stimuli More
Patient came in with Mom for back to school vaccinations Tdap and Meningitis; Shortly after giving b... Patient came in with Mom for back to school vaccinations Tdap and Meningitis; Shortly after giving both vaccines patient stood up immediately. Within a minute or two of standing up patient fainted hitting their head against door fame and was nonresponsive for less then a minute. Patient has not fainted after vaccines prior to today. After becoming alert Patient was given water and instructed to remain seated on the floor and to regulate breathing until fully calmed down. Patient suffered minor bruising to head from hitting the door. Guardian was instructed to seek medical attention if patient suffers any nausea or vomiting after. Patient did stay in facility for about 15-20 min after incident. More
2853022 35 F FL 08/06/2025 UNK
 UNKNOWN MANUFACTURER
 Pfizer I don't
Bell's palsy, Chills, Pyrexia Bell's palsy, Chills, Pyrexia
delivery date: 08/21/2025, Reaction: Bell's Palsy, Fever, chills. I am 130 Pounds delivery date: 08/21/2025, Reaction: Bell's Palsy, Fever, chills. I am 130 Pounds
2853023 18 M WI 08/06/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 LG749
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient presented to clinic for second dose of Hepatitis B vaccine series. Upon retrieving vaccine a... Patient presented to clinic for second dose of Hepatitis B vaccine series. Upon retrieving vaccine and confirming patient identity (name and DOB), RN identified discrepancy between patient's age (18 years) and vaccine order, which had been entered for patients aged 20 and older. RN promptly contacted ordering provider and requested correction of vaccine order to reflect appropriate dosing for 18-year-old. Correct vaccine and dose were obtained, verified, and administered; documentation was completed accurately. During post-vaccination documentation review, it was noted patient had previously received adult Hepatitis B dose (intended for patients 20 years and older) as first dose, rather than pediatric dose appropriate for age at that time. RN reported this to supervisor, and in absence of medical director, situation was escalated to clinic manager. Based on CDC guidelines, team determined to hold third scheduled dose and obtain Hepatitis B surface antibody titers. Agency was consulted for further guidance. As of today, response was received from agency advising patient should proceed with receiving third pediatric dose as originally scheduled. Patient has been notified accordingly. More
2853024 4 F KS 08/06/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Injection site erythema, Injection site mass, Injection site pain Injection site erythema, Injection site mass, Injection site pain
Mother states that later the same evening as patient received vaccine, the area where she had gotten... Mother states that later the same evening as patient received vaccine, the area where she had gotten the vaccine, started to get red, small lump and patient was complaining that the area really hurt. More
2853025 59 F AR 08/06/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.
 unknown
unknown
Chills, Fatigue, Injection site mass, Lymph node pain, Pain; Pyrexia Chills, Fatigue, Injection site mass, Lymph node pain, Pain; Pyrexia
Very tired night of receiving vaccine. Today (8/6/25) knot on left arm where injection was given, ... Very tired night of receiving vaccine. Today (8/6/25) knot on left arm where injection was given, chills, body (bone & muscle) aches, maybe fever(not sure) - don't have a way to check it here at work. Tender lymph nodes under left arm. More
2853026 62 M MN 08/06/2025 HEP
MMR
SMALLMNK
 DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.
BAVARIAN NORDIC
 946904
Z002520
96868
Wrong patient; Wrong patient; Wrong patient Wrong patient; Wrong patient; Wrong patient
Patient was administered 3 vaccines that were ordered for another patient on 8/5/2025 around 9am. Pr... Patient was administered 3 vaccines that were ordered for another patient on 8/5/2025 around 9am. Provider was notified of patient receiving vaccines and discussion whether there were any risk involved. Provider assure that vaccines were appropriate and would not cause any harm to patient. Patient was contacted and informed of error and giving information of assurance that no harm was indicated in event of vaccines received. Patient humbly verbalized understanding. Vaccines Heplisav-B, Mpox and MMRII was document and noted event in patient chart. More
2853027 58 F NC 08/06/2025 TDAP
 SANOFI PASTEUR
 U7983AA
Injection site erythema, Injection site mass, Injection site pain, Injection sit... Injection site erythema, Injection site mass, Injection site pain, Injection site warmth More
Red, hot, sore, and small lump at injection site Red, hot, sore, and small lump at injection site
2853028 17 M NM 08/06/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 49M9N
9X7CD
No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More
Not an adverse event but an administration error. Men B was inadvertently administered instead of Me... Not an adverse event but an administration error. Men B was inadvertently administered instead of Men 4. The patient could optionally receive Men B. The provider entered an order for Men B and both Men B and Men 4 were administered the same day. More
2853029 18 F NM 08/06/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 49M9N
Arthralgia, Mobility decreased Arthralgia, Mobility decreased
Left shoulder pain with restricted range of motion in abduction. Symptom started with soreness on d... Left shoulder pain with restricted range of motion in abduction. Symptom started with soreness on day of vaccine administration and continues to persist >2 days after date of administration More
2853030 6 GA 08/06/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Adult dose Havrix given to 6 yr old; Adult dose Havrix given to 6 yr old; This non-serious case was ... Adult dose Havrix given to 6 yr old; Adult dose Havrix given to 6 yr old; This non-serious case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 6-year-old patient who received HAV (Havrix adult) for prophylaxis. On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Adult dose Havrix given to 6 yr old) and overdose (Verbatim: Adult dose Havrix given to 6 yr old). The outcome of the adult product administered to child and overdose were not applicable. Additional Information: GSK Receipt Date: 24-JUL-2025 Adult dose Havrix vaccine given to 6 year old, which led to adult product administered to child and overdose. More
2853031 18 F NY 08/06/2025 MENB
 PFIZER\WYETH
 LL0641
Vaccination site pain Vaccination site pain
Prolonged pain at vaccination site and tenderness without swelling and redness Prolonged pain at vaccination site and tenderness without swelling and redness
2853032 51 F DC 08/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Arthralgia, Chills, Erythema, Joint swelling, Tenderness Arthralgia, Chills, Erythema, Joint swelling, Tenderness
Patient with initial left shoulder soreness following vaccine. Also brief chills subsequently. Since... Patient with initial left shoulder soreness following vaccine. Also brief chills subsequently. Since then ongoing left shoulder soreness with some subsequent development of mild swelling, redness, and mild tenderness. More
2853033 11 M NY 08/06/2025 HPV9
HPV9
MNQ
 MERCK & CO. INC.
MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 ZOO2580
ZOO2580
DL4YY
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Pt receive 2 doses of same vaccines instead of 1 dose as ordered no reaction noted Pt is fine the... Pt receive 2 doses of same vaccines instead of 1 dose as ordered no reaction noted Pt is fine the second dose was supposed to be administered in 6months More
2853034 85 F CO 08/06/2025 PNC20
 PFIZER\WYETH
 LX2497
Chills, Dyspnoea, Injection site oedema, Injection site rash, Pruritus Chills, Dyspnoea, Injection site oedema, Injection site rash, Pruritus
After about an hour and half after receiving vaccine resident developed rash and edema to injection ... After about an hour and half after receiving vaccine resident developed rash and edema to injection site , shortness of breath, chills, and itching. More
2853035 1 M IA 08/06/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 2345B
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
PT WAS GIVEN ADULT DOSE IN ERROR; VIAL DOES NOT STATE ADULT OR PEDIATRIC, ONLY ON BOX PT WAS GIVEN ADULT DOSE IN ERROR; VIAL DOES NOT STATE ADULT OR PEDIATRIC, ONLY ON BOX
2853036 53 F OR 08/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 e754f
Urticaria Urticaria
Patient experienced skin colored non-itchy hives within 1 hour of receiving her first dose of Shingr... Patient experienced skin colored non-itchy hives within 1 hour of receiving her first dose of Shingrix More
2853037 8 M CA 08/06/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3N2ND
Dizziness, Syncope Dizziness, Syncope
After vaccine administration, the patient and his mom walked to their car then the child felt dizzy ... After vaccine administration, the patient and his mom walked to their car then the child felt dizzy and fainted as reported by the mother. The mother returned to the clinic carrying the child. When the nurse arrived, the child was already alert and oriented, he was pale. 911 was notified and arrived immediately at the scene assessment was done and all vitals taken. Child was taken to Hospital via gurney. More
2853038 72 F FL 08/06/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
Patient received two shots of RSV in a two year period, first one was on 12/21/2023 and second one o... Patient received two shots of RSV in a two year period, first one was on 12/21/2023 and second one on 08/05/2025 More
2853039 66 M FL 08/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 F95YS
Arthralgia, Rash Arthralgia, Rash
sore shoulder; rash on back; The patient reported that because of the rash he researches more about ... sore shoulder; rash on back; The patient reported that because of the rash he researches more about the vaccine and that was when he found out about the warning of not shaking vigorously.; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number F95YS, expiry date 31-MAR-2027) for prophylaxis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and paracetamol (Tylenol). On 23-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 23-JUN-2025, an unknown time after receiving Shingrix, the patient experienced wrong technique in product usage process (Verbatim: The patient reported that because of the rash he researches more about the vaccine and that was when he found out about the warning of not shaking vigorously.). In JUL-2025, the patient experienced rash (Verbatim: rash on back). On an unknown date, the patient experienced shoulder soreness (Verbatim: sore shoulder). The patient was treated with hydrocortisone. Rechallenge with Shingrix was positive. The outcome of the shoulder soreness and rash were unknown and the outcome of the wrong technique in product usage process was not applicable. It was unknown if the reporter considered the shoulder soreness and rash to be related to Shingrix. It was unknown if the company considered the shoulder soreness and rash to be related to Shingrix. Linked case(s) involving the same patient: US-GSK-US2025098396 Additional Information: GSK Receipt Date: 25-JUL-2025 The reporter was the patient. He stated that when the 2nd dose was administered, he saw how the vials were mixed. He reported the person that gave it to hm shook it very vigorously and reacted to it, which led to wrong technique in device usage process. Gently swirl the vial until powder was completely dissolved. Did not shake vigorously vaccination it was sent to the public health service of region. He reported after the second dose having a sore shoulder and reports a month later he developed a rash on his back. He believes the rash was related to heat and sweat. He used topical Hydrocortisone cream. The patient reported that because of the rash he researches more about the vaccine and that was when he found out about the warning of not shaking vigorously. No additional information was provided. For tolerance of 1st dose refer case US2025096373.; Sender's Comments: US-GSK-US2025096373:Same patinet dose 1st More
2853040 08/06/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Post herpetic neuralgia, Vaccination failure Herpes zoster, Post herpetic neuralgia, Vaccination failure
Suspected vaccination failure; Chronic Shingles for years, vaccines are no help.; Nerve Pain along t... Suspected vaccination failure; Chronic Shingles for years, vaccines are no help.; Nerve Pain along the whole right side of my body; 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), shingles (Verbatim: Chronic Shingles for years, vaccines are no help.) and post herpetic neuralgia (Verbatim: Nerve Pain along the whole right side of my body). The outcome of the vaccination failure, shingles and post herpetic neuralgia were not reported. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia 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 and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK receipt date: 25-JUL-2025 This case was reported by a patient via interactive digital media. The patient had chronic shingles for years. They had been internalized. There were no more rash but nerve pain along the whole right side of the body. The vaccines were of no help. 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 completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine. More
2853041 08/06/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Blister, Herpes zoster, Pain Blister, Herpes zoster, Pain
I got the vaccine, and it gave me Shingles; This non-serious case was reported by a consumer via int... I got the vaccine, and it gave me Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got the vaccine, and it gave me Shingles). The outcome of the shingles was resolving. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine, and it gave his/her shingles. The patient was just where the blisters were dried up, and so painful. The patient was not getting the second shot. More
2853042 M 08/06/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Post herpetic neuralgia, Vaccination failure Herpes zoster, Post herpetic neuralgia, Vaccination failure
Suspected vaccination failure; had the vaccine and got a bad case of shingles; still has nerve pain ... Suspected vaccination failure; had the vaccine and got a bad case of shingles; still has nerve pain two years later; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had the vaccine and got a bad case of shingles) and post herpetic neuralgia (Verbatim: still has nerve pain two years later). The outcome of the vaccination failure and shingles were not reported, and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia 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 and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-JUL-2025 This case was reported by a patient's wife via interactive digital media. The patient (reporter's husband) had the vaccine and got a bad case of shingles. He still had nerve pain two years later. 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
2853043 08/06/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
suspected vaccination failure; got the shot and came down with shingles; This serious case was repor... suspected vaccination failure; got the shot and came down with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shot and came down with shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 30-JUL-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the shot and came down with shingles. The patient was against the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine. More
2853044 48 M NY 08/06/2025 MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 G334J
Z39XM
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
48 year old patient that got 2 doses of Bexsaro; 48 year old patient that got 2 doses of Bexsaro; Th... 48 year old patient that got 2 doses of Bexsaro; 48 year old patient that got 2 doses of Bexsaro; 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 48-year-old male patient who received Men B NVS (Bexsero) (batch number G334J, expiry date 31-OCT-2027) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) (batch number Z39XM, expiry date 31-OCT-2026) for prophylaxis. On 06-JUN-2025, the patient received the 2nd dose of Bexsero. On 01-MAY-2025, the patient received the 1st dose of Bexsero. On 01-MAY-2025, not applicable after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 48 year old patient that got 2 doses of Bexsaro). On 06-JUN-2025, the patient experienced inappropriate age at vaccine administration (Verbatim: 48 year old patient that got 2 doses of Bexsaro). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration 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: 28-JUL-2025 Reporter stated that a 48 year old patient that got 2 doses of Bexsaro which is not approved for over 25 years of age, which led to Inappropriate age at vaccine administration. Also stated that he is not immunocompromised and he was going to nursing school so they assume that is why. More
2853045 F FL 08/06/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient has 1st dose in Dec 2024, 2nd dose May 2025; This non-serious case was reported by a pharmac... Patient has 1st dose in Dec 2024, 2nd dose May 2025; 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 female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose in December 2024). In MAY-2025, the patient received the 2nd dose of Twinrix. In MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Patient has 1st dose in Dec 2024, 2nd dose May 2025). 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: 29-JUL-2025 and 30-JUL-2025 The reporter reported that a patient was late for her second dose due to being out of the country. The HCP who originally called regarding medical information question in (withheld) case was different from Pharmacist who provided additional AE information upon callback from (withheld). This pharmacist's details who provided more information regarding AE are in AE form. The original HCP did not provide details regarding there being 2 patients. At this time, it was unknown if both patients had their doses on the same dates. Upon call back HCP who originally contacted (withheld) she states that both patients (husband and wife) got their 1st dose in Dec 2024, 2nd dose in May 2025. 3rd dose had not yet been administered. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case had been linked with US2025097730, reported by the same reporter; Sender's Comments: US-GSK-US2025097730:Same reporter/Diffrent patient More
2853046 82 F GA 08/06/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 29Z7E
Expired product administered Expired product administered
Vaccine expired on 1 July 2025, and 19 days later the vaccine was administered to a patient; This no... Vaccine expired on 1 July 2025, and 19 days later the vaccine was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 29Z7E, expiry date 01-JUL-2025) for prophylaxis. On 20-JUL-2025, the patient received the 1st dose of Arexvy. On 20-JUL-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Vaccine expired on 1 July 2025, and 19 days later the vaccine was administered to a patient). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 30-JUL-2025 The pharmacist reported that the maladministration of an expired dose of Arexvy., which led to expired vaccine used The vaccine expired on 1st July 2025, and 19 days later the vaccine was administered to a patient someone called to ask was it needed to revaccinate the patient The pharmacist confirmed the vaccine was administered in other place and she only got the call asking for some guidance. More
2853047 WV 08/06/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
suspected vaccination failure; Shingles; This serious case was reported by a 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 patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 25-NOV-2019, the patient received the 2nd dose of Shingrix. On 07-AUG-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: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported. 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: 30-JUL-2025 The nurse reported that they all experience a case of shingles after getting Shingrix. The nurse reported that 2 other patients, had a case of shingles after getting Shingrix vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule and laboratory confirmation of 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 (1st dose)and Shingrix(2nd dose) US-GSK-US2025098394:same reporter, Different patient More
2853048 WV 08/06/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
suspected vaccination failure; shingles; This serious case was reported by a nurse via sales rep and... suspected vaccination failure; shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 09-JUL-2020, the patient received the 2nd dose of Shingrix. On 09-JAN-2020, 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: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported. 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: 30-JUL-2025 The reporter stated that the patient experienced case of shingles after getting Shingrix. 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 case is one of the three linked cases reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). US-GSK-US2025098302:same reporter, Different patient US-GSK-US2025098299:same reporter, Different patient More
2853049 31 F 08/06/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB064A
Product preparation error Product preparation error
Menveo (2 vial) powder administration with a non-approved diluent; Menveo (2 vial) powder administra... Menveo (2 vial) powder administration with a non-approved diluent; Menveo (2 vial) powder administration with a non-approved diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 31-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 29-JUL-2025, the patient received Menveo. On 29-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Menveo (2 vial) powder administration with a non-approved diluent) and wrong solution used in drug reconstitution (Verbatim: Menveo (2 vial) powder administration with a non-approved diluent). The outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were not applicable. Additional Information: GSK Receipt Date: 31-JUL-2025 The pharmacist wanted to obtain information regarding the administration of Menveo's powder with a non-approved diluent (saline water), which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. More
2853050 73 M KS 08/06/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 7975C
Incorrect route of product administration Incorrect route of product administration
Intramuscular administration; This non-serious case was reported by a nurse via call center represen... Intramuscular administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 73-year-old male patient who received MMR (Priorix) (batch number 7975C, expiry date 01-MAR-2027) for prophylaxis. On 01-AUG-2025, the patient received Priorix (intramuscular). On 01-AUG-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Intramuscular administration). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-AUG-2025 The registered nurse reported that an adult received a Priorix intramuscularly today (date of reporting), which led to Subcutaneous injection formulation administered by other route. More
📋 Privacy Policy & Data Disclaimer