🏥 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 💀 🏥 🚑 ♿ ⚠️
2864488 55 F NH 10/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 AE435
Erythema, Infection, Local reaction, Skin warm Erythema, Infection, Local reaction, Skin warm
Patient had local reaction. Presented red and warm to the touch. Her provider determined it was infe... Patient had local reaction. Presented red and warm to the touch. Her provider determined it was infected and wrote a course of antibiotics More
2864489 3 M CA 10/08/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 73BN2
73BN2
Blood sodium decreased, Carbon dioxide normal, Lethargy, Lymphocyte count normal... Blood sodium decreased, Carbon dioxide normal, Lethargy, Lymphocyte count normal, Pyrexia; Urine ketone body present, White blood cell count decreased More
Fever, lethargy. Pt reported to the ER on 9/13/25 Fever, lethargy. Pt reported to the ER on 9/13/25
2864490 68 M CA 10/08/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Amyotrophic lateral sclerosis, Computerised tomogram, Dysarthria, Gait disturban... Amyotrophic lateral sclerosis, Computerised tomogram, Dysarthria, Gait disturbance, Laboratory test; Magnetic resonance imaging More
Received 2nd Pfizer COVID vaccine on 4/1/2021. On 4/3/2021 had slurred speech and difficulty in wal... Received 2nd Pfizer COVID vaccine on 4/1/2021. On 4/3/2021 had slurred speech and difficulty in walking. Admitted to ER on 4/4/2021. Initial diagnosis was stroke. Further evaluations ruled out stroke. Through several months and many tests, from bulbar Polly, PLS, MS,. Final diagnosis is ALS. More
✓ ✓
2864491 75 F AZ 10/08/2025 FLU3
RSV
 SANOFI PASTEUR
PFIZER\WYETH
 U8837CA
MD5461
Pruritus, Rash; Pruritus, Rash Pruritus, Rash; Pruritus, Rash
All over body rash and itching after receiving vaccines All over body rash and itching after receiving vaccines
2864492 75 F OH 10/08/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 NA0739
NA0739
Hyperventilation, Hypoaesthesia, Mobility decreased, Nausea, Pain; Sleep disorde... Hyperventilation, Hypoaesthesia, Mobility decreased, Nausea, Pain; Sleep disorder, Somnolence More
Patient reported a lot of pain all over that impacted her sleep. In the afternoon the day after vacc... Patient reported a lot of pain all over that impacted her sleep. In the afternoon the day after vaccination, she reported that she got very nauseous and started hyperventilating. She started feeling numb throughout her whole body and could barely make it to her couch to sit down. Once seated and felt like she could breathe again she said she was extremely drowsy and fell asleep for couple hours. More
2864493 64 F TX 10/08/2025 FLU3
 SEQIRUS, INC.
 AX6151A
Chest pain Chest pain
Flu vaccine given IM Rt Deltoid around 11:am, around 2:20pm client stated she had chest pain. v/s=12... Flu vaccine given IM Rt Deltoid around 11:am, around 2:20pm client stated she had chest pain. v/s=124/59, 98/1, 18,100% O2 Sat. More
2864494 70 F FL 10/08/2025 COVID19
 MODERNA
 tsx09xdf0p77
Aphasia, Blood test, Chills, Food refusal, Mental status changes Aphasia, Blood test, Chills, Food refusal, Mental status changes
Patient received Spikevax vaccine on 10/7 .Husband called on 10/8 stating patient had severe chills ... Patient received Spikevax vaccine on 10/7 .Husband called on 10/8 stating patient had severe chills throughout the night. She woke up this morning refusing to eat and was speaking "jiberish" (husbands words). He would ask her basic questions and she would not respond or responses did not make sense. He put her on the phone and I tried speaking with her but same results. He said she isnt usually like that and was very concerned. I advised him to call her primary and to consider taking her to urgent care. I called back a few hours later and husband said that he took her to the ER and they decided to keep her overnight and believes that she did have a reaction to vaccine. They are running test and blood work to make sure she is ok. But as of now husbands notices improvement in mental status. Husband was satisfied with service provided. More
2864500 58 F CA 10/08/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Z009681
4ZS72
Contusion, Injection site erythema, Pruritus; Contusion, Injection site erythema... Contusion, Injection site erythema, Pruritus; Contusion, Injection site erythema, Pruritus More
Pt complained redness/bruising and itchiness on her left arm after receiving shingrix and capvaxive ... Pt complained redness/bruising and itchiness on her left arm after receiving shingrix and capvaxive on that arm. The redness presented on the site of the vaccines all the way down to her elbow. It has been 6 days since pt received the vaccines and the adverse reaction is still present. Pharmacy will be following up with the pt in the next week. More
2864501 20 F CA 10/08/2025 MNQ
 SANOFI PASTEUR
 U8562AA
Rash, Rash pruritic, Urticaria Rash, Rash pruritic, Urticaria
The patient started experiencing itchy hives-like rashes on both upper and lower legs the night of v... The patient started experiencing itchy hives-like rashes on both upper and lower legs the night of vaccine administration. The patient denies having itching throat or shortness of breath. The patient reported that there was no other change to her daily routine since vaccination. The patient was provided with Benadryl over-the-counter for relief. The patient was advised to seek medical attention if symptoms get worse or not improved with OTC medications. More
2864502 70 F NH 10/08/2025 COVID19
 MODERNA
 3052736
Injection site inflammation, Pain Injection site inflammation, Pain
The patient states to have arm pain to move, no redness or inflammation at injection site. Stated i... The patient states to have arm pain to move, no redness or inflammation at injection site. Stated in the evening of 10/7/25 and continuing in the morning of 10/8/25 More
2864503 69 M DC 10/08/2025 COVID19
 MODERNA
Fatigue, Hallucination, auditory, Hallucination, visual, Pyrexia Fatigue, Hallucination, auditory, Hallucination, visual, Pyrexia
slight fever with visual, auditory, and physical hallucinations. significant fatigue/exhaustion. ha... slight fever with visual, auditory, and physical hallucinations. significant fatigue/exhaustion. hallucinations lasted three hours, fatigue lasted two days. More
2864504 56 M WA 10/08/2025 FLU3
PNC21
 SEQIRUS, INC.
MERCK & CO. INC.
 409415
Z005765
Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth More
On the left arm towards the body (biceps) ,a 2-3 inch diameter size red swollen spot was found by th... On the left arm towards the body (biceps) ,a 2-3 inch diameter size red swollen spot was found by the patient the day after the vaccine. This red, swollen spot was described as "hive" looking per patient and he described that spot was itchy and felt the heat. Currently, 5 days after the date of vaccination, the spot does not look swollen up yet still red, which the site became more noticeable today. More
2864505 37 F AZ 10/08/2025 FLU3
 SANOFI PASTEUR
 U8863BA
Brain fog, Dysgeusia, Headache Brain fog, Dysgeusia, Headache
About 30 minutes after receiving the vaccine, I noticed a metallic taste in my mouth and felt mental... About 30 minutes after receiving the vaccine, I noticed a metallic taste in my mouth and felt mentally foggy. The fogginess lasted approximately 1 hour, while the metallic taste lasted around 4 hours. Approximately 2 hours after the vaccination, I developed a headache. More
2864507 27 F LA 10/08/2025 FLU3
 SEQIRUS, INC.
 409414
Chest discomfort, Paraesthesia oral, Throat tightness Chest discomfort, Paraesthesia oral, Throat tightness
Patient felt chest tightness, tingle in the tongue, felt like throat was closing. Patient was give... Patient felt chest tightness, tingle in the tongue, felt like throat was closing. Patient was given with her consent 1 dose of Benadryl 50mg. Patient never lost consciousness . patient was given water and granola bar and candy after throat swelling sensation occured More
2864508 33 F CO 10/08/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 FA7585 HRSA
EW0185
Blood pressure increased, Caesarean section, Exposure during pregnancy, Spontane... Blood pressure increased, Caesarean section, Exposure during pregnancy, Spontaneous rupture of membranes; Blood pressure increased, Caesarean section, Exposure during pregnancy, Spontaneous rupture of membranes More
Pregnant at times of vaccine. Due date 5/28/2022 later adjusted to 5/20/2022. Blood pressure elevat... Pregnant at times of vaccine. Due date 5/28/2022 later adjusted to 5/20/2022. Blood pressure elevation starting 3/2022 (which has not resolved as of date) Spontaneous rupture of membrane without labor 5/3/2022 and c-section delivery 5/4/2022 without complications. Infant with true knot. APGARS 8 and 9. Weight 2.98kg. Infant with lip tie. Mild gross motor delay. Speech delay, moderate to severe eczema. Diagnosed with autism 8/2024 More
2864510 73 M TN 10/08/2025 COVID19
 MODERNA
No adverse event, Underdose No adverse event, Underdose
PATIENT RECEIVED PEDIATRIC VACCINE INSTEAD OF ADULT VACCINE, NO ISSUES REPORTED PATIENT RECEIVED PEDIATRIC VACCINE INSTEAD OF ADULT VACCINE, NO ISSUES REPORTED
2864511 0.33 F 10/08/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Vaccine given too soon. Vaccine given too soon.
2864512 61 F NY 10/08/2025 COVID19
 MODERNA
 Don?t know
Fatigue, Nausea, Pain, Pyrexia Fatigue, Nausea, Pain, Pyrexia
Fever body aches nausea exhaustion Fever body aches nausea exhaustion
2864513 73 M IL 10/08/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 4TY55
Extra dose administered, No adverse event Extra dose administered, No adverse event
At the time of vaccine need determination, the admistration of Arexvy from 2-8-2024 was missed so he... At the time of vaccine need determination, the admistration of Arexvy from 2-8-2024 was missed so he received an additional RSV dose. Patient was notified of issue. Patient was not experiencing any issues but counseled on potential normal vaccine reactions/response More
2864514 63 F AZ 10/08/2025 FLU3
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 u8638aa
u8832aa
Fatigue, Feeding disorder, Headache, Nausea; Fatigue, Feeding disorder, Headache... Fatigue, Feeding disorder, Headache, Nausea; Fatigue, Feeding disorder, Headache, Nausea More
Patient stated that she had nausea, headache, fatigue, and inability to eat starting the day after t... Patient stated that she had nausea, headache, fatigue, and inability to eat starting the day after the vaccination and continuing into the present day. More
2864515 8 F TN 10/08/2025 FLU3
 SEQIRUS, INC.
 406990
Blood test, Rash pruritic, Urticaria Blood test, Rash pruritic, Urticaria
Patient developed an itchy rash with hives scattered all over her body and most prominent on her fac... Patient developed an itchy rash with hives scattered all over her body and most prominent on her face and around her eyes. She also had a few hives on her lower extremities. She did not have any redness or swelling near the injection site. She was started on anti-histamines, topical hydrocortisone cream and oral prednisolone. She did NOT have any signs of anaphylaxis including lip/tongue swelling, wheezing, or vomiting. She also did not have fever after the vaccination. More
2864530 56 10/08/2025 FLUX
 UNKNOWN MANUFACTURER
Dizziness, Vertigo, Vomiting Dizziness, Vertigo, Vomiting
Dizziness, Vomiting- Vertigo episode triggered. Dizziness, Vomiting- Vertigo episode triggered.
2864531 54 F IN 10/08/2025 FLU3
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 73BN2
27LR2
Burning sensation, Contusion, Facial pain, Swelling face; Burning sensation, Con... Burning sensation, Contusion, Facial pain, Swelling face; Burning sensation, Contusion, Facial pain, Swelling face More
Received the vaccines later afternoon Sunday, Monday was sore. Tuesday woke up with significant swel... Received the vaccines later afternoon Sunday, Monday was sore. Tuesday woke up with significant swelling and bruising on the R side of face L side was also swollen, but more painful. Also reports burning sensation mid back and feeling generally "off", no other symptoms. More
1518067 M AR 10/07/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


COVID-19, Drug ineffective; Anxiety, Depression, Disturbance in attention, Feeli... COVID-19, Drug ineffective; Anxiety, Depression, Disturbance in attention, Feeling abnormal, Investigation; Lyme disease, Memory impairment More
got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP. A 40-... got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP. A 40-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got COVID". Clinical course: It was reported that the patient got COVID after receiving two doses of the Pfizer COVID vaccine; the COVID was after receiving both doses. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100926372 same patient and drug, different dose and events; More
2863571 MS 10/07/2025 HPV9
 MERCK & CO. INC.
 2014634
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; an expired dose of GARDASIL 9 was inadvertently administered to a patient.; This s... No additional AE; an expired dose of GARDASIL 9 was inadvertently administered to a patient.; This spontaneous report was received from a pharmacy technician and refers to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported. On 03-Oct-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) SYRINGE with valid lot # 2014634 and expiration date 20-Sep-2025 (dose number, frequency, route of administration, were not provided) as prophylaxis (Expired product administered). There was confirmed no temperature excursion (TE), nor additional adverse event (AE). More
2863572 10/07/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pruritus, Vaccination failure; Herpes zoster, Pruritus, Vaccinati... Herpes zoster, Pruritus, Vaccination failure; Herpes zoster, Pruritus, Vaccination failure More
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interacti... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 26-SEP-2025 This case was reported by a patient via interactive digital media. Patient went to dermatologist scheduled soon as she looked at back, she said patient had shingles, patient said he/she had no pain just itching. Patient had shots but was in no pain just itching. The patient got 2 shots and had prescription and stated that hope they go away. 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: A case of Vaccination failure, unknown time after receiving 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2863573 F NY 10/07/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 522A7
Incorrect route of product administration Incorrect route of product administration
intramuscular administration of Priorix; This non-serious case was reported by a pharmacist via call... intramuscular administration of Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) (batch number 522A7, expiry date 01-MAY-2027) for prophylaxis. On 23-SEP-2025, the patient received Priorix (intramuscular). On 23-SEP-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: intramuscular administration of Priorix). 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. More
2863574 F 10/07/2025 COVID19
 MODERNA
Chronic obstructive pulmonary disease, Diabetes mellitus Chronic obstructive pulmonary disease, Diabetes mellitus
diabetes; COPD; This spontaneous case was reported by a consumer and describes the occurrence of DIA... diabetes; COPD; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (diabetes) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS (diabetes) (seriousness criterion medically significant) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). At the time of the report, DIABETES MELLITUS (diabetes) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The reporter was inquiring about the lower dose of Moderna's COVID-19 vaccine for seniors, questioning its efficacy compared to the standard dose and whether it's suitable for patients with existing health conditions, such as COPD and diabetes. It was reported that the, the patient was interested in taking Moderna Vaccine only as she took all her pervious COVID Vaccines from Moderna. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.; Reporter's Comments: Given the chronic nature and pathophysiology of Chronic Obstructive Pulmonary Disease (COPD), a causal relationship with vaccination is considered unlikely. The benefit-risk relationship of product is not affected by this report. More
2863575 39 F MA 10/07/2025 TDAP
 SANOFI PASTEUR
Exposure during pregnancy, Extra dose administered, No adverse event Exposure during pregnancy, Extra dose administered, No adverse event
patient received a dose of Adacel single-dose prefilled syringe on 02 Sep 2025 but then was accident... patient received a dose of Adacel single-dose prefilled syringe on 02 Sep 2025 but then was accidentally administered a second dose of Adacel today, 29 Sep 2025 with no reported adverse event,; Patient is 32 weeks pregnant with no reported adverse event; Initial information received on 29-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 39 years old female patient who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] on 02-Sep-2025 but then was accidentally administered a second dose on 29-Sep-2025 with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date is Oct-2025. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies On 02-Sep-2025, the pregnant female patient received an unknown dose (dose 1) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number, strength and expiry date-unknown) in unknown administration site for Immunization with no reported AE (Exposure during pregnancy) (Latency Same day). On 29-Sep-2025 she also accidentally received a 0.5ml (dose 2) of vaccine Suspension for injection (lot-U8670BA and expiry date-31-Aug-2027) via intramuscular route in the left deltoid for Immunization with no reported adverse event (extra dose administered)(Latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2863576 58 10/07/2025 FLU3
 SANOFI PASTEUR
 U8847CA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
inappropriate use due to inadvertent administration of FLUZONE HD instead of regular dose with no ae... inappropriate use due to inadvertent administration of FLUZONE HD instead of regular dose with no ae; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case (along with live follow - up processed together with csd:01-Oct-2025) received from a pharmacist. This case is linked to this case US-SA-2025SA295677 This case involves a 58 years old patient of unknown gender who inadvertently received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] instead Of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2025, the patient inadvertently received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, Frequency :once, Strength :0.5 ml, lot U8847CA and expiry date 30-Jun-2026, via intramuscular route in the right arm for immunisation with no reported adverse event (wrong product administered) (latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA295677: More
2863593 36 M MN 10/07/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EN6203
EN6203
EN6203
EN6203
EN6203
EN6203
ER8733
ER8733
ER8733
ER8733
ER8733
ER8733
Blood test, Catheter placement, Cognitive disorder, Electric shock sensation, En... Blood test, Catheter placement, Cognitive disorder, Electric shock sensation, Endotracheal intubation; Fatigue, Gastrointestinal tube insertion, Guillain-Barre syndrome, Hyperacusis, Hypoaesthesia; Immunoglobulin therapy, Intensive care, Lumbar puncture abnormal, Magnetic resonance imaging, Muscular weakness; Orthosis user, Pain, Paraesthesia, Paralysis, Photophobia; Plasmapheresis, Pneumonia, Somnolence, Swallow study abnormal, Tracheostomy; Walking aid user, Wheelchair user; Blood test, Catheter placement, Cognitive disorder, Electric shock sensation, Endotracheal intubation; Fatigue, Gastrointestinal tube insertion, Guillain-Barre syndrome, Hyperacusis, Hypoaesthesia; Immunoglobulin therapy, Intensive care, Lumbar puncture abnormal, Magnetic resonance imaging, Muscular weakness; Orthosis user, Pain, Paraesthesia, Paralysis, Photophobia; Plasmapheresis, Pneumonia, Somnolence, Swallow study abnormal, Tracheostomy; Walking aid user, Wheelchair user More
Guillain-Barre' Syndrome GBS. Numbness and tingling feeling in hands and feet. Muscle weakness ... Guillain-Barre' Syndrome GBS. Numbness and tingling feeling in hands and feet. Muscle weakness being unable to pick up a something like a water bottle and increased fatigue being unable to stay awake all day. Woke up one day and couldn't move anything except hands, which caused pain and numbness. Brought to emergency room and from lumbar puncture doctors diagnosed as GBS. Rushed to ICU and intubated to perform plasmapheresis and intravenous immunoglobulin treatments. Upon exiting the intubation, body remained in full body paralysis. Tracheostomy placed, food tube, G&J tubes placed, catheter placed. Round the clock care needed. Round the clock care needed, daily physical therapy, occupational therapy and speech therapy. Ceiling lift and large power wheelchair needed for all movements out of bed. Pneumonia set in following failed swallow study. As paralysis lessened in certain areas, intense electrical nerve pain set in requiring massive amounts of pain medication such as Fentanyl, oxy, hydromorphone, gabapentin, pregabalin, duloxetine and many others. After about two months at hospital, I was then transported to another facility for continues care and rehab with each day filled with PT, OT, ST until around October 2021. Upon retuning home without nurses or aids, I became a "vegetable" unable to move due to limited function and extreme pain and weakness. Auditory sounds and light caused cognitive issues to think and concentrate on anything. Outpatient therapy continue to this day. Sometimes a power wheel chair is needed, 4 wheel rollator, ankle foot orthotics, cane and wrist braces and gloves. Utilizing electronics is very difficult and requires speech accessibility when it can understand what I am saying around the remaining face paralysis. More
✓ ✓ ✓
2863602 OR 10/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Hallucination Hallucination
hallucinations with 24 hours of having the vaccine; This serious case was reported by a other health... hallucinations with 24 hours of having the vaccine; This serious case was reported by a other health professional via sales rep and described the occurrence of hallucination in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced hallucination (Verbatim: hallucinations with 24 hours of having the vaccine) (serious criteria GSK medically significant). The outcome of the hallucination was not reported. It was unknown if the reporter considered the hallucination to be related to Shingrix. The company considered the hallucination to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 27-SEP-2025 The patient experienced hallucinations within 24 hours of receiving a vaccine at a pharmacy. This side effect was not listed in the prescribing information; Sender's Comments: A case of Hallucination,, 24 hrs after receiving Shingrix, in a patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2863604 FL 10/07/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Incorrect dose administered Incorrect dose administered
Bexsero incomplete doses; This non-serious case was reported by a physician via call center represen... Bexsero incomplete doses; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (a patient who received one men be at 13). The patient did not receive Bexsero. The patient had incomplete course of vaccination (Verbatim: Bexsero incomplete doses). The outcome of the incomplete course of vaccination 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: 10-SEP-2025 The reported wanted to know what to do with a patient who received one Men B at 13 and now (at the time of reporting) was 14. If they should complete the series or wait until 16 and give two doses. More
2863605 76 F HI 10/07/2025 FLU3
 SANOFI PASTEUR
 U8874aa
Contusion, Erythema, Pain Contusion, Erythema, Pain
Patient reports significant bruising approximately 3 inches across and redness. Also reports signifi... Patient reports significant bruising approximately 3 inches across and redness. Also reports significant soreness. I visually confirmed this with physical examination More
2863610 33 F VA 10/07/2025 FLU3
 SEQIRUS, INC.
Hypoaesthesia, Paraesthesia, Sensory disturbance Hypoaesthesia, Paraesthesia, Sensory disturbance
numbness and tingling in groin area, a vibration like symptom, happened that night, then nightly for... numbness and tingling in groin area, a vibration like symptom, happened that night, then nightly for 3 nightly, then intermittently for 2 weeks then stopped More
2863611 31 F NY 10/07/2025 FLU3
 SANOFI PASTEUR
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
None observed. Possible High Dose Flu vaccine given to patient. No reaction from patient. Unable to ... None observed. Possible High Dose Flu vaccine given to patient. No reaction from patient. Unable to verify dosage of flu vaccine. More
2863652 AZ 10/07/2025 HPV9
 MERCK & CO. INC.
 Y007197
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; Customer called to report TE. GARDASIL9 was administered to 2 patients. 2 separate... No additional AE; Customer called to report TE. GARDASIL9 was administered to 2 patients. 2 separate AE cases were filled. AE case # 02873617 and AE case# 02873597. No additional AE/no PQC. ? Names of vaccines involved (including lot/exp) GARDASIL9 Y007197 08/1; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 25-Aug-2025, the patient was vaccinated with improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), formulation: injection, lot #Y007197, expiration date: 18-Aug-2026, exact dose 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, administered dose of vaccine was exposed to the temperature excursion of 71.11 degrees Fahrenheit (F) for 5 minutes. The previous temperature excursion of 52.16 F for 1 hour (product storage error). No additional adverse event reported (no adverse event). This is one of two reports received from the same reporter. More
2863653 F 10/07/2025 UNK
UNK
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Y011819
Y011819
PJ353
PJ353
Chills, Injection site erythema, Injection site pain, Injection site warmth, Pru... Chills, Injection site erythema, Injection site pain, Injection site warmth, Pruritus; Pyrexia; Chills, Injection site erythema, Injection site pain, Injection site warmth, Pruritus; Pyrexia More
CHILLS; INJECTION SITE WARMTH; PYREXIA; INJECTION SITE PAIN; PRURITUS; INJECTION SITE ERYTHEMA; This... CHILLS; INJECTION SITE WARMTH; PYREXIA; INJECTION SITE PAIN; PRURITUS; INJECTION SITE ERYTHEMA; This spontaneous report was received from FDA (agency# 2848498) and refers to a 60-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Historical drugs included Influenza vaccine (Influenza vaccine). Concomitant therapies were not reported. On 27-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y011819, which was confirmed to be a valid lot#, expiration date: 01-Oct-2025), dose number 1, administered by Intramuscular route in Right Arm for an unknown indication. On 27-Jun-2025, the patient was vaccinated with Shingrix (Varicella zoster vaccine rgE (CHO)) (lot #PJ353) dose 1, administered by Intramuscular route in the left arm (indication and expiration date were not reported). On 30-Jun-2025, the patient experienced injection site warmth, pyrexia, chills, injection site pain, pruritus, and injection site erythema. Patient had a reaction of redness around the injection site which seemed like spreading but slowly, tenderness with warm touch, fever, chills, and itchiness. Patient started to react around 3rd day of injection, and it has not healed after a week. Recommended patient to apply cold compresses and to take ibuprofen, Tylenol to help reach remission of fever and chills. Also, asked them to get medical attention but patient refused. At the reporting time, the outcome of the events was unknown. The causal relationship between all events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) and Shingrix (Varicella zoster vaccine rgE (CHO)) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : (withheld) , Index date : 2025-09-16 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2848498 , Central date : 2025-09-16 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2863654 MI 10/07/2025 HPV9
HPV9
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y015180
Z007940
Z005232
Extra dose administered, No adverse event, Product preparation issue; Extra dose... Extra dose administered, No adverse event, Product preparation issue; Extra dose administered, No adverse event, Product preparation issue; Extra dose administered, No adverse event, Product preparation issue More
No reported side effects/symptoms from the patient at time of call. No additional AE details provide... No reported side effects/symptoms from the patient at time of call. No additional AE details provided. No additional AE reported.; Caller reports this occurred due to her removing the label from the GARDASIL 9 and then when she went to reconstitute the VARIVAX she had forgotten that she had done this and grabbed it because she thought it was diluent.; Inbound call from medical assistant who reports she inadvertently administered VARIVAX that was reconstituted with GARDASIL 9 instead of diluent to a patient. She also administered an additional dose GARDASIL 9 to this patient.; Caller reports this occurred due to her removing the label from the GARDASIL 9 and then when she went to reconstitute the VARIVAX she had forgotten that she had done this and grabbed it because she thought it was diluent.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 16-Sep-2025, the reporter inadvertently administered the varicella virus vaccine live (Oka-Merck) (VARIVAX) (lot #Z005232, expiration date: 27-Feb-2027) that was reconstituted with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (lot #Y015180, expiration date: 28-Jan-2027) instead of diluent to the patient. She also administered an additional dose human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (lot #Z007940, expiration date: 05-Mar-2026) to this patient (Accidental overdose). This occurred due to her removing the label from the human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9), and then when she went to reconstitute the varicella virus vaccine live (Oka-Merck) (VARIVAX) she had forgotten that she had done this and grabbed it because she thought it was diluent (Product preparation issue). No reported side effects/symptoms from the patient at time of call as patient has left the office and medical assistant realized after (No adverse event). More
2863655 72 M IL 10/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2XB45
Left atrial enlargement, Underdose Left atrial enlargement, Underdose
the patient didn't receive the full dose; since it leaked; This non-serious case was reported b... the patient didn't receive the full dose; since it leaked; This non-serious case was reported by a consumer via call center representative and described the occurrence of accidental underdose in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number NY2AT, expiry date 26-APR-2027) and (batch number 2XB45, expiry date 26-APR-2027) for prophylaxis. On 15-SEP-2025, the patient received Shingrix (left arm). On 15-SEP-2025, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: the patient didn't receive the full dose) and product leakage (Verbatim: since it leaked). The outcome of the accidental underdose and product leakage were not applicable. Additional Information: GSK Receipt Date: 15-SEP-2025 and 16-SEP-2025 According to reporter, the patient did not receive the full dose, since it leaked. The reporter had a patient that was administered the Shingrix vaccine, and they pulled back unexpectedly, the reporter was not sure how many dose the patient got. According to reporter, the patient did not receive the full dose, since it leaked. No further details were provided. More
2863656 F 10/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 47N3Y
Product preparation issue Product preparation issue
administered just the diluent of Shingrix without the powder; administered just the diluent of Shing... administered just the diluent of Shingrix without the powder; administered just the diluent of Shingrix without the powder; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number 47N3Y, expiry date 30-MAR-2027) for prophylaxis. On 12-SEP-2025, the patient received Shingrix. On 12-SEP-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered just the diluent of Shingrix without the powder) and inappropriate dose of vaccine administered (Verbatim: administered just the diluent of Shingrix without the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. More
2863657 79 M IL 10/07/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 9PT2F
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Infanrix was administered to an adult/ Vaccine underdose; The administration of Infanrix instead of ... Infanrix was administered to an adult/ Vaccine underdose; The administration of Infanrix instead of Boostrix; 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 79-year-old male patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 16-SEP-2025, the patient received Infanrix (intramuscular, unknown deltoid). The patient did not receive Boostrix. The patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix was administered to an adult/ Vaccine underdose) and wrong vaccine administered (Verbatim: The administration of Infanrix instead of Boostrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt date: 17-SEP-2025 The HCP reports that on 16-Sep-2025 a dose of Infanrix was administered to an adult patient. The vaccine should have been Boostrix. More
2863659 F GA 10/07/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Asthenia, Decreased appetite, Dizziness Asthenia, Decreased appetite, Dizziness
Low energy; Dizziness; low appetite; patient received a second dose of Arexvy; This non-serious case... Low energy; Dizziness; low appetite; patient received a second dose of Arexvy; This non-serious case was reported by a other health professional via sales rep and described the occurrence of energy decreased in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Arexvy (1st dose received in AUG-2024). Concurrent medical conditions included hypertension, osteoarthritis and allergic rhinitis. Concomitant products included lisinopril dihydrate (Lysinopril), celecoxib (Celebrex) and azelastine. On 10-SEP-2025, the patient received the 2nd dose of Arexvy. On 10-SEP-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received a second dose of Arexvy). On an unknown date, the patient experienced energy decreased (Verbatim: Low energy), dizziness (Verbatim: Dizziness) and decreased appetite (Verbatim: low appetite). The outcome of the energy decreased, dizziness and decreased appetite were not resolved and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the energy decreased, dizziness and decreased appetite to be related to Arexvy. It was unknown if the company considered the energy decreased, dizziness and decreased appetite to be related to Arexvy. Additional Information: GSK Receipt Date: 19-SEP-2025 The patient received a second dose of Arexvy. She was complaining of on-going symptoms since second dose. The low energy, low appetite, dizziness was reported as worsened were after the second dose. There was no additional information around the adverse event. The chronic kidney disease was actively being treated at the time of the Arexvy vaccination 2nd dose. Still being treated for chronic kidney disease after the Arexvy vaccine. More
2863660 F CA 10/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Feeling abnormal, Headache, Influenza like illness Feeling abnormal, Headache, Influenza like illness
Headache; Flu-like symptoms; felt terrible; This non-serious case was reported by a consumer via cal... Headache; Flu-like symptoms; felt terrible; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), influenza-like symptoms (Verbatim: Flu-like symptoms) and feels awful (Verbatim: felt terrible). The outcome of the headache, influenza-like symptoms and feels awful were resolved. It was unknown if the reporter considered the headache, influenza-like symptoms and feels awful to be related to Shingrix. It was unknown if the company considered the headache, influenza-like symptoms and feels awful to be related to Shingrix. Additional Information: GSK Receipt Date:19-SEP-2025 Reporter reported that the patient had a bad reaction to the Shingrix shot 2 which included flu-like symptoms and headache. Patient felt terrible for a day or two. Patient felt so miserable that was concerned about how she was going to get to the hospital if she needed to go (as she did not think she would be able to drive due to how terrible she felt). These events resolved. More
2863661 10/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Hypersensitivity Hypersensitivity
Allergic reaction to the first shot; This serious case was reported by a consumer via interactive di... Allergic reaction to the first shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Allergic reaction to the first shot) (serious criteria other: Serious as per reporter). The outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Shingrix. The company considered the allergic reaction to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 22-SEP-2025 This case was reported by a patient via interactive digital media. The patient reported allergic reaction to the first shot.; Sender's Comments: A case of Hypersensitivity, an unknown date, an unknown time after receiving Shingrix, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2863662 F 10/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Injection site rash, Pain Fatigue, Injection site rash, Pain
Rash at injection site; severe aches; Fatigue; This non-serious case was reported by a nurse via sal... Rash at injection site; severe aches; Fatigue; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site rash (Verbatim: Rash at injection site), pain (Verbatim: severe aches) and fatigue (Verbatim: Fatigue). The outcome of the injection site rash, pain and fatigue were resolved (duration 5 days). The reporter considered the injection site rash, pain and fatigue to be related to Shingrix. The company considered the injection site rash, pain and fatigue to be related to Shingrix. Additional Information: GSK Receipt Date:30-SEP-2025 The pediatric nurse practitioner was the patient who experienced the side effects herself. But it was not serious. No other products were received by the patient. The reporter stated she did not mind reporting the incident but did not want to be contacted for follow up. The batch number was not provided, and unable to contact the reporter. More
2863663 10/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Allergy to vaccine Allergy to vaccine
allergic to the vaccine; This serious case was reported by a consumer via interactive digital media ... allergic to the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergy to vaccine (Verbatim: allergic to the vaccine) (serious criteria other: Serious as per reporter). The outcome of the allergy to vaccine was unknown. It was unknown if the reporter considered the allergy to vaccine to be related to Shingrix. The company considered the allergy to vaccine to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 09-SEP-2025 This case was reported by a patient via interactive digital media. The patient had told numerous people that he/she was allergic to the vaccine and had been instructed by his/her physician not to take the second one. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Allergy to vaccine, an unknown time after receiving Shingrix, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2863664 F 10/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Hypersensitivity Hypersensitivity
Allergic; This non-serious case was reported by a consumer via interactive digital media and describ... Allergic; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Allergic). The outcome of the allergic reaction was unknown. The reporter considered the allergic reaction to be related to Shingrix. The company considered the allergic reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 14-SEP-2025 and 25-SEP-2025 This case was reported by a patient via interactive digital media. The patient received the vaccine shot and had an allergic reaction. The doctor advised the patient not to receive the second dose of the (Shingrix) shingles vaccine. The batch number was not provided, and we are unable to contact the reporter. More
2863666 F TN 10/07/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Exposure during pregnancy, Product use issue Exposure during pregnancy, Product use issue
Administered arexvy to the pregnant patient; Administered arexvy to the pregnant patient; This non-s... Administered arexvy to the pregnant patient; Administered arexvy to the pregnant patient; This non-serious prospective pregnancy case was reported by a nurse via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Administered arexvy to the pregnant patient) and product use in unapproved population (Verbatim: Administered arexvy to the pregnant patient). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 22-SEP-2025 The patient had visited one of the organization's clinics to receive an RSV vaccine during pregnancy. The site had Arexvy in stock and administered it to the pregnant patient, although the specific week of pregnancy was unknown. Upon realizing the error, the treatment site contacted both the patient and the vaccine adverse event reporting system (VAERS). As of the date of reporting, the patient had not yet given birth, and the expected delivery date remained unknown. The batch number was not provided, and unable to contact the reporter. More
2863668 F 10/07/2025 MENB
MNQ
 PFIZER\WYETH
NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
UNK
Nausea, Road traffic accident, Syncope; Nausea, Road traffic accident, Syncope Nausea, Road traffic accident, Syncope; Nausea, Road traffic accident, Syncope
Fainted; car accident; Nauseated; This serious case was reported by a nurse via other manufacturer a... Fainted; car accident; Nauseated; This serious case was reported by a nurse via other manufacturer and described the occurrence of fainting in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis. On 10-SEP-2025, the patient received Menveo and Trumenba. On 10-SEP-2025, less than a day after receiving Menveo and 15 min after receiving Trumenba, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant), automobile accident (Verbatim: car accident) and nausea (Verbatim: Nauseated). The outcome of the fainting, automobile accident and nausea were unknown. It was unknown if the reporter considered the fainting, automobile accident and nausea to be related to Menveo and Trumenba. The company considered the fainting to be unrelated to Menveo. It was unknown if the company considered the automobile accident and nausea to be related to Menveo and Trumenba. It was unknown if the company considered the fainting to be related to Trumenba. Additional Information: GSK Receipt Date: 25-SEP-2025 The reporter said that they had a patient that they administered Menveo and Trumenba together and 15 minutes later, after getting the vaccine patient left the office and was involved in a car accident because she fainted. No one was hurt. The representative said that patient got nauseated and tried to pull over, he/she was not sure if patient hit another vehicle or what the circumstances were. The representative said that adverse events happened after patient left the office. So, he/she did not think patient had got anything before she left. The representative did not know about treatment but thought that treatment was done. The batch number was not provided and unable to contact the reporter.; Sender's Comments: A case of Syncope, 15 min after receiving Menveo in a female patient. Causal relation is indeterminate considering two vaccines given concomitantly (Trumenba). More
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