🏥 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 💀 🏥 🚑 ♿ ⚠️
2847085 0.58 F NJ 06/24/2025 DTAPIPVHIB
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UK228AB
LG5578
Circumstance or information capable of leading to medication error; Circumstance... Circumstance or information capable of leading to medication error; Circumstance or information capable of leading to medication error More
There were two sets of Pentacel, Prenvar20, and Rota ordered. Two staff members were preparing vacc... There were two sets of Pentacel, Prenvar20, and Rota ordered. Two staff members were preparing vaccines next to one another. Nurse looked over at second staff member and saw her inject the Prevnar20 into the Pentacel vial. Nurse immediately stopped what she was doing and alerted staff member of what she witnessed. Nurse took those vaccines from staff member and set them aside not to use. Nurse then retrieved a new Pentacel set and Prevnar20, and prepared and administered the correctly mixed vaccines. The VFC program was notified of the wasted Pentacel and Prevnar20. The staff member was placed on a safety pause while she receives re-education on the vaccines and the immunization workflow. More
2847086 72 F TN 06/24/2025 COVID19
 MODERNA
 8081564
Expired product administered Expired product administered
Vaccine administration error. Vaccine expired on 6/22/25 and given on 6/24/25 Vaccine administration error. Vaccine expired on 6/22/25 and given on 6/24/25
2847088 85 M 06/24/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 5F5XK_35P2C_7J5
Pain in extremity Pain in extremity
Ongoing right localized arm pain 4 months post vaccine. Ongoing right localized arm pain 4 months post vaccine.
2847089 1.5 F TX 06/24/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y017914
Y017914
Injection site erythema, Injection site induration, Injection site mass, Injecti... Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling; Irritability, Pruritus, Rash, Urticaria More
06/20/25- Rash all over the body developed same day vaccine was given, hours later. Mother said it ... 06/20/25- Rash all over the body developed same day vaccine was given, hours later. Mother said it looked like hives, patient was very fussy and scratching. Mother gave benadryl and rash completely resolved within 2 hours of the medication. Mother gave benadryl the next morning to prevent rash from returning, but it did not return. The next day on 06/21/25 she had a red bump and swelling at the injection site. 06/24/25- Redness has resolved and just has a hard tender lump in the area. More
2847090 18 F 06/24/2025 MENB
 PFIZER\WYETH
 LL00641
Dizziness, Headache, Paraesthesia, Vomiting Dizziness, Headache, Paraesthesia, Vomiting
Headache, lightheadedness, vomiting, tingling in extremities-patient parent took patient to ED for f... Headache, lightheadedness, vomiting, tingling in extremities-patient parent took patient to ED for further evaluation, patient was treated and released home More
2847092 16 F TN 06/24/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 U8369BA
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
When I went to give the patient her meningococcal injection notice only had 0.25 ml. Pulled up anoth... When I went to give the patient her meningococcal injection notice only had 0.25 ml. Pulled up another injection only had 0.25 ml Ask Provider to come look to confirm. Call RN to advise on what to do. Was told to call someone else. Was told to give the other 0.25 to equal 0.5 ml More
2847093 33 M ID 06/24/2025 FLU3
 SEQIRUS, INC.
 P100715742
Aphasia, Blindness, Neurological symptom Aphasia, Blindness, Neurological symptom
Roughly 1/2 hr after receiving the flu vaccine, he endorsed stroke like symptoms that he couldn'... Roughly 1/2 hr after receiving the flu vaccine, he endorsed stroke like symptoms that he couldn't understand/comprehend people talking, couldn't see, and couldn't talk. He went to sleep it off and when he woke up many hours later, his symptoms resolved. This occurred while he was deployed to (redacted) in Dec 2024. More
2847094 65 M OH 06/24/2025 RSV
 PFIZER\WYETH
 hm9865
Expired product administered Expired product administered
Patient given expired vaccine Patient given expired vaccine
2847095 70 M IA 06/24/2025 FLU3
 SEQIRUS, INC.
 388483
Expired product administered Expired product administered
Administered an expired vaccine to patient. Expired May 21st 2025. Administered 6/23/25 Administered an expired vaccine to patient. Expired May 21st 2025. Administered 6/23/25
2847096 51 F TN 06/24/2025 HEP
HEPA
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 95BJ9
Z27PB
7KD5B
No adverse event, Underdose; No adverse event, Underdose; No adverse event, Unde... No adverse event, Underdose; No adverse event, Underdose; No adverse event, Underdose More
Gave children's dose to an adult. No other adverse reactions noted. Gave children's dose to an adult. No other adverse reactions noted.
2847097 43 M RI 06/24/2025 TYP
YF
 SANOFI PASTEUR
SANOFI PASTEUR
 X1A271M
UK134AA
Disorientation, Dizziness, Hyperhidrosis, Mydriasis, Unresponsive to stimuli; Di... Disorientation, Dizziness, Hyperhidrosis, Mydriasis, Unresponsive to stimuli; Disorientation, Dizziness, Hyperhidrosis, Mydriasis, Unresponsive to stimuli More
Patient was instructed to wait in the pharmacy waiting area for RPH to monitor as that is protocol w... Patient was instructed to wait in the pharmacy waiting area for RPH to monitor as that is protocol with YF-VAX. After a few minutes the patient called out to RPH and said he felt faint. RPH went out to his side and patient then became disoriented in his chair, could not respond to RPH calling his name and pupils were dilated. RPH instructed lead tech to call 911. Patient became responsive again and did not want 911 to come by. RPH got patient an ice pack a water and an orange juice. Patient started to faint again and was sweating. EMS checked his vitals and he was cleared to be taken home with his partner that came into the store. Patient was alert and oriented when he left. More
2847098 65 F TX 06/24/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 d4j9l
47n3y
Arthralgia, Pain in extremity; Arthralgia, Pain in extremity Arthralgia, Pain in extremity; Arthralgia, Pain in extremity
Continued shoulder and arm pain. Continued shoulder and arm pain.
2847099 74 F MN 06/24/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 p2443
Face oedema, Lip oedema Face oedema, Lip oedema
Patient reports that 4 days after initial shot started to develop facial edema starting in lips and ... Patient reports that 4 days after initial shot started to develop facial edema starting in lips and progressing to cheeks. lasted for about 36 to 48 hours. Patient applied ice packs and self administered ibuprofen and diphenhydramine from over the counter. No further progression or adverse effects. No lasting effects . More
2847103 F PA 06/24/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More
no adverse event; Inbound call from pharmacist calling to inquire about GARDASIL-9 dosing schedule. ... no adverse event; Inbound call from pharmacist calling to inquire about GARDASIL-9 dosing schedule. Caller states that patient received her first dose of GARDASIL-9 a year prior on 13-JUN-2024 and received her second dose in 02-JUN-2025. Pharmacist states that patie; This spontaneous report was received from a pharmacist and refers to a 45-year-old female patient. Her concurrent conditions, medical history and concomitant therapies were not provided. On 13-JUN-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On 02-JUN-2025, she was administered the second dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (Inappropriate schedule of product administration). No adverse events were reported. Lot # is being requested and will be submitted if received. More
2847104 M PA 06/24/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AE/PQC; Patient was given their first dose of CAPVAXIVE in February 2025 and a second ... No additional AE/PQC; Patient was given their first dose of CAPVAXIVE in February 2025 and a second dose of CAPVAXIVE on 04JUN2025; This spontaneous report was received from an office manager who placed a physician on the line, and refers to a 75-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in February 2025, the adult patient was administered the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis. On 04-Jun-2025, the adult patient was administered the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (extra dose administered). No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). No additional information was reported. Lot # is being requested and will be submitted if received. More
2847106 UT 06/24/2025 HEPA
 MERCK & CO. INC.
 X026485
Expired product administered, No adverse event Expired product administered, No adverse event
no adverse event; Inbound call from HCP to report AE for VAQTA. HCP noted that a dose of expired VAQ... no adverse event; Inbound call from HCP to report AE for VAQTA. HCP noted that a dose of expired VAQTA was inadvertently administered to a patient. No symptomatic events were reported. Information regarding supported dose of VAQTA was provided via post-memo article. N; This spontaneous report was received from a Pharmacist 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 06-Jun-2025, the patient started therapy with Hepatitis A Vaccine, Inactivated Injection(VAQTA) (lot #X026485, expiration date: 11-May-2025)(a dose of expired VAQTA was inadvertently administered to a patient). No symptomatic events were reported. More
2847107 1 M MO 06/24/2025 VARCEL
 MERCK & CO. INC.
No adverse event, Underdose No adverse event, Underdose
No additional AE; HCP calling to report an AE regarding the VARIVAX vaccine. HCP reported that a one... No additional AE; HCP calling to report an AE regarding the VARIVAX vaccine. HCP reported that a one year old male patient received a smaller than recommended dose of the VARIVAX vaccine. HCP stated that the patient did not receive the full dose of the vaccine and hal; This spontaneous report was received from a medical assistant and refers to a 1-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 23-JUN-2025, the patient was vaccinated with varicella virus vaccine live (Oka-Merck) (VARIVAX) solution for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) before administration (lot # and expiry date were not provided). The patient did not receive the full dose of the vaccine, and half the dose was given to him inadvertently (Accidental underdose). No additional adverse event (AE) was reported. Lot # is being requested and will be provided if received. More
2847108 70 F TX 06/24/2025 VARZOS
VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
Back pain, Cough, Cystitis, Fatigue, Gait disturbance; Headache, Hypothyroidism,... Back pain, Cough, Cystitis, Fatigue, Gait disturbance; Headache, Hypothyroidism, Injection site pain, Lung disorder, Musculoskeletal stiffness; Neck pain, Nocturia, Peripheral swelling, Somnolence, Stress; Weight increased More
I am very stiff; Bladder infection; 2 spot on lungs; Weight gain; walking differently; Shingles shot... I am very stiff; Bladder infection; 2 spot on lungs; Weight gain; walking differently; Shingles shot/Arm is swollen; Headaches; Neck hurts; Coughing; Urinates 5 times last night; Injection is really painful; low thyroid; severe fatigue/ excessively tired/extreme fatigue; recently been having back pains/constant backache/ lower back pain/it only lasted 1 day; This serious case was reported by a consumer and described the occurrence of thyroid function decreased in a female patient who received mepolizumab (Nucala) solution for injection in pre-filled pen (batch number 693S, expiry date 31-JUL-2027) for asthma. Co-suspect products included mepolizumab (Nucala) solution for injection in pre-filled pen (batch number Y34F, expiry date 31-MAY-2027) for asthma and Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included urinary incontinence, sulfonamide allergy, allergy to molds, drug allergy (ALLERGIC TO CODEINE, GLUCOSAMINE) and penicillin allergy. Concomitant products included salbutamol sulfate (Albuterol Sulfate Hfa), loratadine, meclozine hydrochloride (Meclizine Hcl) and levocetirizine dihydrochloride (Xyzal). On 18-JUN-2024, the patient started Nucala (subcutaneous use) 100 mg every 4 weeks. On an unknown date, the patient started Nucala (subcutaneous use) 100 mg every 4 weeks and Shingles vaccine. In MAR-2025, an unknown time after starting Nucala and Nucala and an unknown time after receiving Shingles vaccine, the patient experienced fatigue (Verbatim: severe fatigue/ excessively tired/extreme fatigue). On an unknown date, the patient experienced thyroid function decreased (Verbatim: low thyroid) (serious criteria GSK medically significant), back pain (Verbatim: recently been having back pains/constant backache/ lower back pain/it only lasted 1 day), stiffness (Verbatim: I am very stiff), bladder infection (Verbatim: Bladder infection), lung disorder (Verbatim: 2 spot on lungs), weight gain (Verbatim: Weight gain), walking difficulty (Verbatim: walking differently), injection site swelling (Verbatim: Shingles shot/Arm is swollen), headache (Verbatim: Headaches), neck pain (Verbatim: Neck hurts), cough (Verbatim: Coughing), nocturia (Verbatim: Urinates 5 times last night) and injection site pain (Verbatim: Injection is really painful). The action taken with Nucala was unknown. Nucala was continued with no change. The outcome of the thyroid function decreased, fatigue, lung disorder, weight gain, injection site swelling, headache, neck pain, cough, nocturia and injection site pain were unknown and the outcome of the back pain was resolved (duration 1 day) and the outcome of the stiffness, bladder infection and walking difficulty were not resolved. It was unknown if the reporter considered the thyroid function decreased, back pain, fatigue, stiffness, bladder infection, lung disorder, weight gain, walking difficulty, injection site swelling, headache, neck pain, cough, nocturia and injection site pain to be related to Nucala, Nucala Autoinjector Device, Nucala, Nucala Autoinjector Device and Shingles vaccine. The company considered the thyroid function decreased to be unrelated to Nucala, Nucala Autoinjector Device, Nucala, Nucala Autoinjector Device and Shingles vaccine. It was unknown if the company considered the back pain, fatigue, stiffness, bladder infection, lung disorder, weight gain, walking difficulty, injection site swelling, headache, neck pain, cough, nocturia and injection site pain to be related to Nucala, Nucala Autoinjector Device, Nucala, Nucala Autoinjector Device and Shingles vaccine. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. GSK Receipt Date: 08-MAY-2025 and 13-MAY-2025. The patient reported that she had recently been experiencing back pains, walking differently, and feeling very tired/severe fatigue. She said, "I didn't want to do anything other than sleep. I had a constant backache that was on and off. When I got up to move, I was very stiff, and it took a moment for my body to start moving once I got up." She was unsure if this was due to age, a side effect of Nucala, or an issue with her thyroid. She stated that she had gained 60 pounds and also had a thyroid issue. She also reported feeling "excessively tired and experiencing lower back pain which began about a month ago." She mentioned a previous doctor visit where no issues were found, but a bladder infection was suggested. She denied any missed doses and was not scheduled to see the prescriber until June. She did not provide dates of onset and gave no other details. The prescriber was not aware of these events, and the patient stated she would notify them. The patient reported extreme fatigue starting in March 2025. She took Nucala for a cough. Due to teaching in a moldy classroom, she had recently retired. Her doctor had found 2 spots on her lungs. She had previously reported back pain, but it no longer hurt and had only lasted for 1 day. She reported having low thyroid function and severe stress in her life due to personal issues. She had gained weight due to fatigue. Follow up information received on 13-JUN-2025. Patient says she had the shingles shot, was coughing and says that her arm was swollen, headaches, acheing and neck hurts. She Was fine until she had the shot. Had to urinate 5 times last night. Patient says the injection really painful, when she gets the shot it hurts really bad. Summary of changes: Product tab, event tab and narrative updated.; Sender's Comments: Hypothyroidism is an unlisted event which is considered unrelated to GSK drugs Mepolizumab and Mepolizumab AUTOINJECTOR DEVICE. More
2847109 F 06/24/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site cellulitis, Injection site rash Injection site cellulitis, Injection site rash
Rash became cellulitis/Cellulitis near Arexvy injection site; This non-serious case was reported by ... Rash became cellulitis/Cellulitis near Arexvy injection site; This non-serious case was reported by a consumer and described the occurrence of injection site cellulitis in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included asthma. Concurrent medical conditions included egg allergy (egg white and egg yolk allergy), grass allergy, spice allergy, allergy to plants (Mold and Ragweed) and drug allergy (Allergic to ampicillin, erythromycin, Avelox, Lincocin, Seconal, atropine, fillers used in Doxycycline tablets, NSAIDS). On 07-JUN-2025, the patient received Arexvy (right deltoid). On 08-JUN-2025, 1 days after receiving Arexvy, the patient experienced injection site cellulitis (Verbatim: Rash became cellulitis/Cellulitis near Arexvy injection site). The patient was treated with doxycycline (Doxycycline Monohydrate). The outcome of the injection site cellulitis was not resolved. It was unknown if the reporter considered the injection site cellulitis to be related to Arexvy. It was unknown if the company considered the injection site cellulitis to be related to Arexvy. Additional Information: GSK Receipt Date: 15-JUN-2025 This report was submitted via the online direct entry reporting system. The patient had vaccine, and rash became cellulitis and cellulitis occurred near Arexvy injection site. More
2847110 F 06/24/2025 VARZOS
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administ... Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure More
Suspected vaccination failure; I too have Shingles too it's really bad on my back I have on le... Suspected vaccination failure; I too have Shingles too it's really bad on my back I have on legs arms too; Received 3rd dose of vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included stress. Family history included alzheimer's disease (husband who has Alzheimer's.). On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I too have Shingles too it's really bad on my back I have on legs arms too) and extra dose administered (Verbatim: Received 3rd dose of vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 17-JUN-2025 This case was reported by a patient via interactive digital media. The patient got the 3 shots and after that have Shingles too it was really bad on the back, on legs and arms too. The patient was on different types of medicines too they told have a lot of stress in the life and that's what activated them. The patient had it over a year now. The stress was from taking care of husband who has Alzheimer's. This case was considered as suspected vaccination failure since the details regarding 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 the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles (Dose 1, 2 & 3) More
2847111 06/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Dyspnoea, Electric shock sensation, Pain, Performance status decreased Dyspnoea, Electric shock sensation, Pain, Performance status decreased
Pain; electric shocks; could not sleep; could not breathe; could not function; This non-serious case... Pain; electric shocks; could not sleep; could not breathe; could not function; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: Pain), electric shock (Verbatim: electric shocks), insomnia (Verbatim: could not sleep), difficulty breathing (Verbatim: could not breathe) and performance status decreased (Verbatim: could not function). The outcome of the pain, electric shock, insomnia, difficulty breathing and performance status decreased were not reported. It was unknown if the reporter considered the pain, electric shock, insomnia, difficulty breathing and performance status decreased to be related to Herpes Zoster vaccine. It was unknown if the company considered the pain, electric shock, insomnia, difficulty breathing and performance status decreased to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date:14-JUN-2025 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient could not, the pain was unreal and could not breathe, sleep or function. The reporter stated that it was sheer torture, stabbing, electric shocks, etc. More
2847112 06/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Illness Illness
be sick for 8 months; This non-serious case was reported by a consumer via interactive digital media... be sick for 8 months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose 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 sickness (Verbatim: be sick for 8 months). The outcome of the sickness was resolved (duration 8 months). It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 14-JUN-2025 This case was reported by a patient via interactive digital media. The patient stated others can take the vaccine shots (2 Shingrix) and be sick for 8 months, like he/she was after the vaccine. More
2847113 06/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; but she still had it; This serious case was reported by a consumer vi... Suspected vaccination failure; but she still had it; 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: but she still had it). 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: 15-JUN-2025 This case was reported by a patient via interactive digital media. The reporter just had it too even though having vaccines, but taking antibiotics right away, it was not bad but yes it was so painful. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case US2025AMR078645 reported by the same reporter; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR078645:Same reporter/ diff patient More
2847114 06/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Pain Pain
not as painful; This non-serious case was reported by a consumer via interactive digital media and d... not as painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: not as painful). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 14-JUN-2025 This case was reported by a patient via interactive digital media. Patient stated had 2 round of medicine 14 days starting to look better and I had the 2 shots few years back but didn't feel to bad shot make it not as painful still no you have them. More
2847115 06/24/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Frustration tolerance decreased, Herpes zoster, Vaccination failure; Frustration... Frustration tolerance decreased, Herpes zoster, Vaccination failure; Frustration tolerance decreased, Herpes zoster, Vaccination failure More
Suspected vaccination failure; shingles on his/her face; This serious case was reported by a consume... Suspected vaccination failure; shingles on his/her face; 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 facial herpes zoster (Verbatim: shingles on his/her face). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving. It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-JUN-2025 This case was reported by a patient via interactive digital media. Patient had received both shots and was recovering from shingles on his/her face. It had been very frustrating and annoying trying to deal with them. It was everything they said it would be. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose) and Shingles (2nd dose) . More
2847116 06/24/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete cours... Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete course of vaccination More
Shingles; Incomplete course of vaccination; This non-serious case was reported by a consumer via int... Shingles; Incomplete course of vaccination; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. In DEC-2024, the patient received the 1st dose of Shingles vaccine. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the shingles was not resolved and the outcome of the incomplete course of vaccination was not applicable. 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: 16-JUN-2025 This case was reported by a patient via interactive digital media. The patient received the first shot 6 months ago and had shingles now. Till the time of reporting the patient did not receive the second dose of Shingles vaccine which led to incomplete course of vaccination. More
2847117 F 06/24/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure
Suspected vaccination failure; but she still had it; This serious case was reported by a consumer vi... Suspected vaccination failure; but she still had it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: but she still had it). 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: 15-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported that reporter sister had shots, but she still had it, terrible pain for months. 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 linked with US2025AMR077327 reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR077327:Same reporter/ diff patient More
2847118 NY 06/24/2025 HEP
HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS


Extra dose administered, Inappropriate schedule of product administration; Extra... Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration; Extra dose administered, Inappropriate schedule of product administration More
Patient received 4th dose; Second dose: Jan 29 2025 Third dose: Feb 26 2025; First Dose: Sept 03 202... Patient received 4th dose; Second dose: Jan 29 2025 Third dose: Feb 26 2025; First Dose: Sept 03 2024 Second dose: Jan 29 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis. Previously administered products included Engerix b (received 1st dose on 03-SEP-2024). On 29-MAY-2025, the patient received the 4th dose of Engerix B. On 26-FEB-2025, the patient received the 3rd dose of Engerix B. On 29-JAN-2025, the patient received the 2nd dose of Engerix B. On 29-JAN-2025, not applicable after receiving Engerix B and Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: First Dose: Sept 03 2024 Second dose: Jan 29 2025). On 26-FEB-2025, the patient experienced drug dose administration interval too short (Verbatim: Second dose: Jan 29 2025 Third dose: Feb 26 2025). On 29-MAY-2025, the patient experienced extra dose administered (Verbatim: Patient received 4th dose). The outcome of the extra dose administered, drug dose administration interval too short and drug dose administration interval too long 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: 09-JUN-2025 A registered nurse reported that the patient received their first dose of Engerix B on 3rd September 2024, their second dose on 29th January 2025, the third dose on 25th February 2025 and the fourth dose on 29th May 2025. The nurse initially stated they wanted data about the administration of a vaccine because the intervals were shorter than recommended. They also stated the need to test for titers. The Vaccine Administration Facility was the same as Primary Reporter The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix B earlier than recommended interval, which led to shortening of vaccination schedule. The patient received 4th dose of Engerix B not as per local schedule, which led to extra dose administered.; Sender's Comments: US-GSK-US2025071733:same reporter More
2847119 37 F NY 06/24/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
Engerix-B late third dose; Engerix-B late second dose; This non-serious case was reported by a pharm... Engerix-B late third dose; Engerix-B late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 37-year-old female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (received 1st dose on 03-NOV-2014). On an unknown date, the patient received the 3rd dose of Engerix B. On 20-JUL-2015, the patient received the 2nd dose of Engerix B. On 20-JUL-2015, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Engerix-B late second dose). On an unknown date, the patient experienced drug dose administration interval too long (Verbatim: Engerix-B late third dose). The outcome of the drug dose administration interval too long and drug dose administration interval too long were not applicable. Additional Information: GSK Receipt Date: 13-JUN-2025 The pharmacist reported that an adult female patient had received a first Engerix-B dose on 03rd November 2014 and a second Engerix-B on 20th July 2015 and received 3rd dose late. No data about lot number or expiration dates. The vaccine administration facility was the same as primary reporter. The patient received 2nd and 3rd dose later than official recommendation which led to lengthening of vaccination schedule. More
2847120 20 M WA 06/24/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 9532Y
Expired product administered Expired product administered
Boostrix less than 30 days expired dose administration; This non-serious case was reported by a othe... Boostrix less than 30 days expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9532Y, expiry date 23-MAY-2025) for prophylaxis. On 16-JUN-2025, the patient received the 4th dose of Boostrix. On 16-JUN-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix less than 30 days expired dose administration). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 16-JUN-2025 A nurse manager wanted to know how to proceed after giving an expired dose of Boostrix (05.23.25) on 16th Jun 2025 (less than 30 days between both dates) which led to expired vaccine use. It was the fourth dose in the immunization schedule and the second o Boostrix that the patient received More
2847121 F 06/24/2025 COVID19
 MODERNA
Lymphoedema Lymphoedema
Lymphedema; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOE... Lymphedema; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (Lymphedema). At the time of the report, LYMPHOEDEMA (Lymphedema) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No Concomitant medication was reported. She added that similar symptoms happened around 3 years ago, after Moderna vaccine, she started manual lymphatic drainage, for lymphedema after first episode. She contacted GP 3rd week in May for pain relief, and started manual lymphatic drainage again as was successful after 18 months. It was unknown if the patient experienced any additional symptoms/events. No treatment drug was reported. This case was linked to MOD-2025-787680 (Patient Link). More
2847122 F 06/24/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Immune system disorder, Interchange of vaccine produ... COVID-19, Drug ineffective, Immune system disorder, Interchange of vaccine products, Post-acute COVID-19 syndrome More
long COVID; developed "auto-immune" problems; developed COVID19; developed COVID19; interc... long COVID; developed "auto-immune" problems; developed COVID19; developed COVID19; interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccines (Primary immunization series completed), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Oct2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) both with onset Nov2022, outcome "unknown", described as "developed COVID19"; POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown", described as "long COVID"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "developed "auto-immune" problems". Clinical course: Reporter states received a Pfizer mRNA shot in Oct2022 (after receiving the Moderna vaccines for her primary series). She states that she developed COVID19 in Nov2022. Since that time, she stated she has developed autoimmune problems and wonders if she has "long COVID". It was unknown if patient received any other vaccines on the same date as the vaccine and 4 weeks prior to the vaccine. It was also unknown if the patient was taking any other medication 2 weeks prior to the event starting The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received. More
2847123 F 06/24/2025 COVID19
 PFIZER\BIONTECH
 ER2613
Cerebrovascular accident, Dysstasia, Gait disturbance Cerebrovascular accident, Dysstasia, Gait disturbance
the patient began experiencing difficulty walking; they could no longer stand or walk; stroke; This ... the patient began experiencing difficulty walking; they could no longer stand or walk; stroke; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 2, single (Lot number: ER2613) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 23Feb2021, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Nov2021, outcome "recovered", described as "stroke"; GAIT DISTURBANCE (non-serious), outcome "recovered", described as "the patient began experiencing difficulty walking"; DYSSTASIA (non-serious), outcome "recovered", described as "they could no longer stand or walk". Therapeutic measures were taken as a result of cerebrovascular accident, gait disturbance, dysstasia. Clinical course: Patient experienced a stroke in Nov2021 (Stated afterwards that she doesn't recall the date, but was before getting the Pfizer Covid 19 Shot). After 8 weeks of therapy, made a full recovery, regaining the ability to walk, go up and down stairs, and showing no remaining reactions, whatsoever. Prior to the stroke, the patient received the first dose of the Pfizer COVID-19 vaccine in Feb2021, with no adverse reaction. Approximately a month later (Mar2021), received the second dose. Within a few days of the second shot, the patient began experiencing difficulty walking, which progressed to the point where they could no longer stand or walk. Patient would like to know if those side effects are common or rarely common after the Covid 19 shot. No follow-up attempts are possible. More
2847124 M FL 06/24/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
did have the COVID/I got two vaccines from Pfizer; did have the COVID/I got two vaccines from Pfizer... did have the COVID/I got two vaccines from Pfizer; did have the COVID/I got two vaccines from Pfizer; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 74-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did have the COVID/I got two vaccines from Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: "I was just calling, I have a patient on my back line who express that he was taken the Paxlovid in 2020 when he did have the COVID. So, I was just transferring him over to you all to let him express his experience on the medication." When paraphrased the above concern, transferring agent stated, "Yes, that is correct 2020." When paraphrased the above concern, consumer confirmed the same. Consumer stated, "I got to go to the drugstore. I am very sick." When probed if consumer has taken the Paxlovid medication before, consumer stated, "I took in 2020 and I also got my shots from you. I got two vaccines from Pfizer." Consumer stated, "I just got to go to drugstore and get my medicine." During an inbound call for financial assistance, the patient stated, "I have COVID, and I'm sick, and they called in my prescription last time I think I spent 10 or 15 Dollar". After confirming the reason for the call, the patient stated, "I took it like in 2020. I got COVID back then" Then the patient stated, "I also got your shots, I also got the two Pfizer shots just so you know." After providing enrollment options, the patient stated, "I'm not feeling well at all" The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2847125 62 F MD 06/24/2025 COVID19
 PFIZER\BIONTECH
Back pain, Chills, Cough, Nausea Back pain, Chills, Cough, Nausea
Severe back aches and pain; cough; chills; stomach nausea; This is a spontaneous report received fro... Severe back aches and pain; cough; chills; stomach nausea; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Jun2025 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Covid in January 2023 with some continuing symptoms.", start date: Jan2023 (ongoing), notes: Covid in January 2023 with some continuing symptoms. The patient took concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 05Jun2025, outcome "not recovered", described as "Severe back aches and pain"; CHILLS (non-serious) with onset 05Jun2025, outcome "not recovered"; COUGH (non-serious) with onset 05Jun2025, outcome "not recovered"; NAUSEA (non-serious) with onset 05Jun2025, outcome "not recovered", described as "stomach nausea". Therapeutic measures were not taken as a result of back pain, cough, chills, nausea. Additional information: The patient was received unspecified concomitant on 03Mar2025 and no allergies were reported. The patient received vaccine on upper arm. The patient did not receive any other vaccines on the same date as the vaccine(s). The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). The patient was taking other medications within 2 weeks of the event starting. Reported Event: Severe back aches and pain, chills, stomach nausea, cough (which continues thru this reporting date). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2847127 F NY 06/24/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

COVID-19, Drug ineffective; COVID-19, Drug ineffective COVID-19, Drug ineffective; COVID-19, Drug ineffective
COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID. An elderly f... COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID. An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for COVID-19 treatment. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2025, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The event "covid-19" required physician office visit. The patient was on the line, she wanted to share her experience with previous use of Pfizer. She had COVID again after nirmatrelvir/ritonavir (PAXLOVID). The patient and her husband got COVID again despite all the vaccination and everything. They are senior citizens, so now they wanted to take Paxlovid again, at least her husband. The patient didn't know if she was going to take it and now of course it's no longer paid for and there is outrageous cost because it's listing as it might cost an amount to make but it's listed number of dollars and then the insurance is not paying that much. The patient and her husband took all the vaccination and again came positive for COVID but clarified that the patient did not have them all (only her husband had it all). She had been called for them, but did not have the last one. When clarified if the vaccines are of Pfizer, the patient confirmed they had some of the vaccines that were mixed, Pfizer and Moderna. After asking for confirmation if both the patient and her husband have COVID and were prescribed Paxlovid, the patient confirmed but thinks she was not going to take it because she was already in her fifth day, and she was not as sick. 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-202500126535 Same reporter, product, and event; different patient;US-PFIZER INC-202500126535 same reporter/product/event; different patient; More
2847128 M NY 06/24/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
came positive for COVID; My husband took all of them; came positive for COVID; My husband took all o... came positive for COVID; My husband took all of them; came positive for COVID; My husband took all of them; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid, start date: 2024, stop date: 2024, for COVID-19 treatment. Vaccination history included: Bnt162b2 (some of the vaccines were mixed, Pfizer (Unspecified Vaccine) and Moderna (Unspecified Vaccine)), for Covid-19 Immunization; Moderna (some of the vaccines were mixed, Pfizer (Unspecified Vaccine) and Moderna (Unspecified Vaccine)), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "came positive for COVID; My husband took all of them". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2025) Positive. Clinical course: Patient is in his 1st or 2nd day of being sick. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500126534 same reporter/product/event; different patient; US-PFIZER INC-202500126534 Same reporter, product, and event; different patient; More
2847129 06/24/2025 COVID19
 PFIZER\BIONTECH
Pain in extremity Pain in extremity
Sore arm; This is a spontaneous report received from a consumer, Program ID. A patient (age and gen... Sore arm; This is a spontaneous report received from a consumer, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Additional Information: The patient had a barely sore arm after getting the COVID-19 vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2847130 F 06/24/2025 RSV
 UNKNOWN MANUFACTURER
Pain in extremity, Peripheral swelling Pain in extremity, Peripheral swelling
swollen & sore arm; swollen & sore arm; This is a spontaneous report received from a Consume... swollen & sore arm; swollen & sore arm; This is a spontaneous report received from a Consumer or other non HCP,. An elderly female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in 2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "swollen & sore arm". Additional information: Patient had the RSV vaccine last fall. Patient experienced a swollen & sore arm for more than a week after. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2847131 06/24/2025 COVID19
 PFIZER\BIONTECH
Chronic obstructive pulmonary disease Chronic obstructive pulmonary disease
COPD; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient... COPD; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in May2024 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series complete), for COVID-19 immunization. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". Additional information: During an inbound call with general vaccine questions, the patient stated, "I'm curious about getting a COVID vaccine. Initially, when they first came out, I took nothing but Pfizer, and now-the last time I've had a vaccine was May of 2024....I have COPD, so I'm sort of in a position to really want to make sure I've got myself covered with booster protection." The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2847132 M MA 06/24/2025 RAB
 SANOFI PASTEUR
 Y1A86P1
Chest discomfort Chest discomfort
tightness of chest with breathing; Initial information received on 20-Jun-2025 regarding an unsolici... tightness of chest with breathing; Initial information received on 20-Jun-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an unknown age male patient who had tightness of chest with breathing after receiving Rabies (HDC) vaccine [IMOVAX Rabies]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Jun-2025, the patient received an unknown dose of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection (lot Y1A86P1) (strength and expiry date-unknown). On 15-Jun-2025 he also received an unknown dose of vaccine On 19-Jun-2025 he also received an unknown dose of vaccine all via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On an unknown date the patient developed tightness of chest with breathing (chest discomfort) (unknown latency). Reportedly- Rabies wanting to know if his vaccine he received has a recall due to seeing a recall from 2004. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Not Recovered / Not Resolved for the event. More
2847133 NJ 06/24/2025 YF
 SANOFI PASTEUR
No adverse event, Wrong product administered No adverse event, Wrong product administered
patient needed to be revaccinated for YF VAX when it was injected intramuscular instead of subcutane... patient needed to be revaccinated for YF VAX when it was injected intramuscular instead of subcutaneous with no adverse event; Initial information received on 23-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who received Yellow fever vaccine - [YF-VAX] intramuscular instead of subcutaneous with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of 0.5ml of suspect Yellow fever vaccine - Solution for injection standard strength, frequency-once (lot number and expiry date-unknown) via intramuscular route in unknown administration site for Immunization instead of subcutaneous with no adverse event (incorrect route of product administration) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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
2847134 06/24/2025 HIBV
 SANOFI PASTEUR
 UK092AB
Expired product administered, No adverse event Expired product administered, No adverse event
expired ACTHIB was given with no reported adverse event; Initial information received on 23-Jun-2025... expired ACTHIB was given with no reported adverse event; Initial information received on 23-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Infant patient with unknown gender who was administered to expired HIB (PRP/T) Vaccine [ACT-HIB] was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Jun-2025, the patient received expired 0.5mL of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK092AB, strength standard, frequency once and expiry date not reported) via unknown route in unknown administration site for Immunization (expired product administered) (latency same day). Reportedly, they wanted to know if it has to be re-administered. 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
2847142 51 F MN 06/24/2025 PNC20
 PFIZER\WYETH
 LN4930
Peripheral swelling, Pruritus, Skin tightness, Skin warm Peripheral swelling, Pruritus, Skin tightness, Skin warm
Swollen arm, tight skin, hot to touch, itching Swollen arm, tight skin, hot to touch, itching
2847143 73 F UT 06/24/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 3ZH27
Mobility decreased, Periarthritis, Spinal pain, X-ray limb Mobility decreased, Periarthritis, Spinal pain, X-ray limb
Pain and decreased mobility in shoulder that started to intensify 7 to 14 days post injection.. Rece... Pain and decreased mobility in shoulder that started to intensify 7 to 14 days post injection.. Received shot of cortisone on 6/24/25 which is today. More
2847144 26 F CA 06/24/2025 TDAP
 SANOFI PASTEUR
 U8503AA
Injection site bruising, Injection site urticaria, Pain in extremity, Sleep diso... Injection site bruising, Injection site urticaria, Pain in extremity, Sleep disorder More
26-year-old female, with no past medical history of vaccine reactions, experienced a reaction follow... 26-year-old female, with no past medical history of vaccine reactions, experienced a reaction following a Tdap vaccine administered on Friday 06/20/25. The next day, she reported pain in her left arm, which disrupted her sleep. The pain was initially severe but has since improved, although it remains present. She also experienced itching and a bruise at the injection site. Patient has never had a reaction to vaccines before and has never received a tetanus vaccine before this. She took Tylenol 500 mg, which provided temporary relief, but symptoms returned after 10 hours. No Benadryl was taken. Additionally, no reported anaphylactic symptoms. More
2847145 4 F CA 06/24/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
Circumstance or information capable of leading to medication error, Injection si... Circumstance or information capable of leading to medication error, Injection site erythema, Injection site pain More
Pt received e all vaccines appropriately and getting booster #5 DTaP and IPV #4 via Kinrix., the va... Pt received e all vaccines appropriately and getting booster #5 DTaP and IPV #4 via Kinrix., the vaccine was given in distal humeral area, with 1in 23 g needle, yet unsure how far down needle went and likely not into muscle. Pt had erythema noted over injection site the next day which progressed for another day and then as of date erythema is decreasing. Pt did not have any fever. had soreness at site. More
2847146 36 F IL 06/24/2025 MMRV
 MERCK & CO. INC.
 Y003882
Underdose, Wrong product administered Underdose, Wrong product administered
Patient was given wrong Vaccine. Patient came in to get MMR vaccine, but the staff accidentally admi... Patient was given wrong Vaccine. Patient came in to get MMR vaccine, but the staff accidentally administered MMRV peds vaccine. More
2847147 39 F UT 06/24/2025 MENB
MMR
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 b4j48
3er79
Fatigue, Nausea; Fatigue, Nausea Fatigue, Nausea; Fatigue, Nausea
Tiredness, nausea. Tiredness, nausea.
2847153 38 F CA 06/24/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 797PT
Chest pain, Dyspnoea, Exposure during pregnancy, Heart rate increased Chest pain, Dyspnoea, Exposure during pregnancy, Heart rate increased
vaccine given at 3:44PM and patient complained of shortness of breath, chest pains and rapid heart r... vaccine given at 3:44PM and patient complained of shortness of breath, chest pains and rapid heart rate, this LVN rechecked vitals signs and reported to provider at 3:45PM, provider did reevaluation at 3:55PM, patient is 31 weeks and 4 days gestation, estimated date of delivery is 08/22/025 More
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