🏥 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 💀 🏥 🚑 ♿ ⚠️
2849811 19 M 07/15/2025 ANTH
TYP
UNK
 EMERGENT BIOSOLUTIONS
SANOFI PASTEUR
UNKNOWN MANUFACTURER
 300216A
X1A261M
3CA43C3
Bradycardia, Hyperhidrosis, Hypotension; Bradycardia, Hyperhidrosis, Hypotension... Bradycardia, Hyperhidrosis, Hypotension; Bradycardia, Hyperhidrosis, Hypotension; Bradycardia, Hyperhidrosis, Hypotension More
PT WAS DIAPHORETIC, HYPOTENSIVE, AND BRADYCARDIC FOR 15-20MIN. PT WAS MONITORED FOR 45MIN UNTIL VITA... PT WAS DIAPHORETIC, HYPOTENSIVE, AND BRADYCARDIC FOR 15-20MIN. PT WAS MONITORED FOR 45MIN UNTIL VITALS RETURNED TO NORMAL RANGES PER PT HX. More
2849812 37 F MD 07/15/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 7mn4c
Injection site reaction, Muscle mass Injection site reaction, Muscle mass
After the last Bexsero injection ( 6/21/25) 2-3 days later she developed a knot about 3-4 centimers ... After the last Bexsero injection ( 6/21/25) 2-3 days later she developed a knot about 3-4 centimers in the deltoid muscle of right arm. This did not happen with last injection. She reported this to Dr's nurse. they recommend she pre- medicate with Benadryl but she said it will make her too sleepy and cant do her work. the other recommendation was to alternate arm next time she does not want a reaction in the same arm again. More
2849814 8 F AZ 07/15/2025 HEPA
HPV9
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 22GP3
X024560
Product administered to patient of inappropriate age; Product administered to pa... Product administered to patient of inappropriate age; Product administered to patient of inappropriate age More
Pt and her father presented to clinic. They spoke vietnamese, I used the language line solutions 1-8... Pt and her father presented to clinic. They spoke vietnamese, I used the language line solutions 1-866-874-3972 spoke to vietnamese interpreter to verify pt's age and pt's father stated she was 9 years old and verified with interpreter. Pt received hpv first dose too soon she is not 9 years old she will be 9 years old on 8/12/2025. This nurse read what father wrote as 8/12/2015 not 8/12/2016. Notified nurse manager at clinic RN, Notified Vaccine Coordinator/Mgr RN, notified my clinic nurse manager Rn. Notified provider on duty NP at clinic. More
2849826 M CO 07/15/2025 DTAPHEPBIP
DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Abnormal behaviour, Breath sounds abnormal, Developmental delay, Dyskinesia, Gen... Abnormal behaviour, Breath sounds abnormal, Developmental delay, Dyskinesia, Genetic testing; Wheezing More
Medical and Developmental Concerns Timeline (2017) I first noticed concerning changes in my son... Medical and Developmental Concerns Timeline (2017) I first noticed concerning changes in my son's behavior shortly after his 2-month vaccinations. He began shaking his head frequently, both while awake and asleep. Additionally, I observed a gurgling, wheezing noise that was new and persistent. Around this time, I also noticed that he was not meeting developmental milestones expected for his age. Despite these signs, I continued with the scheduled vaccinations from August 2017 through December 2017. Over time, it became increasingly clear that my son was experiencing developmental delays. Based on our concerns and observations, our pediatrician referred us for further evaluation and support. More
✓
2849827 41 M SD 07/15/2025 PNC20
 PFIZER\WYETH
 LN4932
Extra dose administered Extra dose administered
I gave the patient a dose of PCV-20 in error. He had already received a PCV-20 on 6/10/2025. I gave the patient a dose of PCV-20 in error. He had already received a PCV-20 on 6/10/2025.
2849828 32 M MA 07/15/2025 COVID19
 MODERNA
Eczema Eczema
New onset eczema, mainly on dorsal aspect of bilateral hands, that has been persistent three days af... New onset eczema, mainly on dorsal aspect of bilateral hands, that has been persistent three days after second dose and still present today. No history of eczema in patient. Prescription hydrocortisone used with minimal effectiveness. Various over the counter moisturizers do not work. Aquafor applied after showers has best results but still does not cure the problem. More
2849829 51 F 07/15/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LX4484
35A77
Injection site erythema, Injection site pruritus, Injection site swelling, Perio... Injection site erythema, Injection site pruritus, Injection site swelling, Perioral dermatitis; Injection site erythema, Injection site pruritus, Injection site swelling, Perioral dermatitis More
redness, itching, and swelling around injection sites one day later, vesicular rash around mouth res... redness, itching, and swelling around injection sites one day later, vesicular rash around mouth resembling herpes zoster 4 days later, reported at office visit on 7/14/25 that reaction on right arm improving (see item 20) More
2849830 11 F CA 07/15/2025 TD
 SANOFI PASTEUR
Erythema, Pain, Radiculitis brachial, Syncope Erythema, Pain, Radiculitis brachial, Syncope
Fainted the next morning, brachial neuritis, redness and radiating pain for 3 days Fainted the next morning, brachial neuritis, redness and radiating pain for 3 days
2849843 67 M WA 07/15/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 49N3Y
49N3Y
Chills, Chromaturia, Dyspnoea, Fatigue, Malaise; Metabolic function test, Myalgi... Chills, Chromaturia, Dyspnoea, Fatigue, Malaise; Metabolic function test, Myalgia, Oliguria, Urine analysis More
malaise, fatigue, myalgias, rigors, SOB, oliguria, dizziness dark urine malaise, fatigue, myalgias, rigors, SOB, oliguria, dizziness dark urine
2849543 F AR 07/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site pain, Injection site warmth Injection site pain, Injection site warmth
Pain at injection site; Heat at injection site; This non-serious case was reported by a consumer via... Pain at injection site; Heat at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypertension. Concomitant products included lisinopril dihydrate (Lisinopril). On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 30-JUN-2025, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: Heat at injection site). On an unknown date, the patient experienced injection site pain (Verbatim: Pain at injection site). The patient was treated with diclofenac sodium (Salonpas). The outcome of the injection site pain and injection site warmth were not resolved. It was unknown if the reporter considered the injection site pain and injection site warmth to be related to Shingrix. It was unknown if the company considered the injection site pain and injection site warmth to be related to Shingrix. Additional Information: GSK Receipt Date: 01-JUL-2025 The patient stated she received the vaccine approximately 18 weeks ago. As soon as she received the vaccination the injection was very painful, and the pain had not resolved. The patient had reported this twice to her pharmacy and examined twice by a Primary Care Professional. The patient stated she was told to put a Salonpas patch on the area and she had been doing that. She had blood work done yesterday by her Primary Care Professional to understand what the problem was may be. When examined yesterday the Health Care Professional stated she could feel heat at the injection site. The patient stated her Primary Care Professional told her when she was vaccinated the needle may have hit her bone. The patient mentioned she has hypertension and was prescribed Lisinopril (dose not disclosed) to be taken as needed for elevated blood pressure. More
2849544 F MA 07/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 99D52
Lymphadenopathy Lymphadenopathy
swollen lymph nodes at the location of her left collar bone and left upper arm; felt pain after the ... swollen lymph nodes at the location of her left collar bone and left upper arm; felt pain after the injection.; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) (batch number 99D52, expiry date 25-MAR-2027) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date). On 29-JUN-2025, the patient received the 2nd dose of Shingrix (left arm) .5 ml. On 29-JUN-2025, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: felt pain after the injection.). On 01-JUL-2025, the patient experienced swollen lymph nodes (Verbatim: swollen lymph nodes at the location of her left collar bone and left upper arm). The outcome of the pain in arm was resolving and the outcome of the swollen lymph nodes was not resolved. It was unknown if the reporter considered the pain in arm and swollen lymph nodes to be related to Shingrix. It was unknown if the company considered the pain in arm and swollen lymph nodes to be related to Shingrix. Additional Information: GSK Receipt Date: 02-JUL-2025 The reporter was the patient who received her 2nd dose of Shingrix on the 29th of June 2025 in her left arm. The reporter stated that she immediately felt pain after the injection. The pain was still ongoing, but it was not as severe as it was before. The reporter stated that yesterday the 1st of July 2025 she noticed swollen lymph nodes at the location of her left collar bone and left upper arm. The reporter did not want to give her date of birth and states she was an adult over the age of 50 years old. More
2849545 90 M 07/14/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product preparation issue Product preparation issue
Drug maladministration/administered prior to shaking the content for reconstitution; This non-seriou... Drug maladministration/administered prior to shaking the content for reconstitution; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of wrong technique in product usage process in a 90-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 01-JUL-2025, the patient received Boostrix. On 01-JUL-2025, an unknown time after receiving Boostrix, the patient experienced wrong technique in product usage process (Verbatim: Drug maladministration/administered prior to shaking the content for reconstitution). The outcome of the wrong technique in product usage process was not applicable. Additional Information: GSK Receipt Date: 02-JUL-2025 The patient received subsequent dose of Boostrix prior to shaking the content for reconstitution within the syringe, which led wrong technique in product usage process. More
2849546 86 F NY 07/14/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Incomplete course of vaccination, Malaise; Incomplete course of vaccination, Mal... Incomplete course of vaccination, Malaise; Incomplete course of vaccination, Malaise More
she has not been well; not received her second dose yet; This non-serious case was reported by a co... she has not been well; not received her second dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included cancer (diagnosed pre Shingrix vaccination). On 04-NOV-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced unwell (Verbatim: she has not been well) and incomplete course of vaccination (Verbatim: not received her second dose yet). The outcome of the unwell was not resolved and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the unwell to be related to Shingrix. It was unknown if the company considered the unwell to be related to Shingrix. Additional Information: GSK Receipt Date: 03-JUL-2025 The patient stated that she received the first dose of Shingrix on 04 November 2024 and had not received her second dose, yet which led to incomplete course of vaccination. The patient mentioned that she had not been well due to having cancer and receiving treatment (Cancer was diagnosed pre Shingrix). More
2849547 NJ 07/14/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Antibody test negative Antibody test negative
now has low titers; This non-serious case was reported by a other health professional via call cente... now has low titers; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a patient who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapy non-responder (Verbatim: now has low titers). The outcome of the therapy non-responder was not applicable. Additional Information: GSK Receipt Date : 01-JUL-2025 Pharmacy student called and reports a patient received the complete schedule for Engerix-B in 2021 and now has low titers. More
2849548 F OR 07/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
had the first dose of Shingrix vaccine back on 17 May 2023/Late second dose; This non-serious case w... had the first dose of Shingrix vaccine back on 17 May 2023/Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 17-MAY-2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: had the first dose of Shingrix vaccine back on 17 May 2023/Late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 01-JUL-2025 and 07-JUL-2025 She wanted to know if it was needed to restart the wholes series or just administer a booster dose. Health Care Provider confirmed that the patient got the shot on a different facility and no Expiration date nor Lot number were available for doing a follow-up. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. More
2849549 F AZ 07/14/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Incomplete course of vaccination Incomplete course of vaccination
Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and... Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who did not receive HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (on 16-AUG-2024 1st dose received). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). 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: 02-JUL-2025 The patient got the 1st dose of Twinrix and she came in (at the time of reporting) today to get the 2nd dose. Till the time of reporting the patient had not received the second dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up. More
2849550 NC 07/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Extra dose administered Extra dose administered
patient got an extra dose of Shingrix; This non-serious case was reported by a pharmacist via call c... patient got an extra dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient got an extra dose of Shingrix). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date: 02-JUL-2025 The pharmacist reported that a patient got an extra dose of Shingrix because it wasn't in the registry which led to extra dose administration. More
2849551 F TX 07/14/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 Y014446
Underdose Underdose
A 34 years old female patient received a pediatric dose of Havrix; A 34 years old female patient rec... A 34 years old female patient received a pediatric dose of Havrix; A 34 years old female patient received a pediatric dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 34-year-old female patient who received HAV (Havrix pediatric) (batch number Y014446, expiry date 01-FEB-2026) for prophylaxis. On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: A 34 years old female patient received a pediatric dose of Havrix) and adult use of a child product (Verbatim: A 34 years old female patient received a pediatric dose of Havrix). The outcome of the underdose and adult use of a child product 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:07-Jul-2025 A Medical Assistant called to report that they administered a pediatric dose of Havrix to a 34 years old female patient, which led to underdose and adult use of a child product. The reporter asked what were the next steps to follow and when did the patient had to receive the adult dose. The reporter consented to follow up. More
2849552 21 F NC 07/14/2025 TDAP
 SANOFI PASTEUR
 U8232AA
Erythema, Neck mass Erythema, Neck mass
5 Localized raised large red bumps on right side of neck under jawline in lymph node area; Initial i... 5 Localized raised large red bumps on right side of neck under jawline in lymph node area; Initial information received on 10-Jul-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves 21 years old female patient who had 5 localized raised large red bumps on right side of neck under jawline in lymph node area after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Jul-2025, the patient received a dose of 1 DF (total) (dosage form) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection (lot U8232AA) (strength and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation). On 10-Jul-2025, the patient developed 5 localized raised large red bumps on right side of neck under jawline in lymph node area (rash erythematous) (Ltency: 2 days). Action taken was not applicable. The patient was treated with Diphenhydramine hydrochloride (Benadryl) for Rash erythematous. At time of reporting, the outcome was Not Recovered / Not Resolved for the event. More
2849553 2 F TX 07/14/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK020AA
Expired product administered, No adverse event Expired product administered, No adverse event
inappropriate use due to expired product administered with no reported adverse event; Initial inform... inappropriate use due to expired product administered with no reported adverse event; Initial information received on 09-Jul-2025 regarding an unsolicited valid non-serious case received from Other Health Care Professional via Health Authorities. This case involves a 2 years old female patient who received expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] inappropriately with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Jul-2025, the patient received 0.5 ml expired dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, lot UK020AA ,expiry date:30-Jun-2025,frequency:once, strength:standard ,via intramuscular route in the left thigh for Immunization inappropriately with no reported adverse event (expired 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. More
2849555 4 M OH 07/14/2025 DTAPIPV
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.

Erythema, Skin warm, Urticaria; Erythema, Skin warm, Urticaria Erythema, Skin warm, Urticaria; Erythema, Skin warm, Urticaria
Large, red-colored welt on leg, warmth to area, defined edges. Area grew in size the next day, dark... Large, red-colored welt on leg, warmth to area, defined edges. Area grew in size the next day, darker in the middle of the area, less defined edges with color fading toward edges. Hyperpigmentation lasted in area for 2 months after vaccination. More
2849559 TX 07/14/2025 PNC15
 MERCK & CO. INC.
Underdose, Wrong technique in product usage process Underdose, Wrong technique in product usage process
HCP stated that a 2 month old patient did not receive a full dose of the VAXNEUVANCE vaccine. HCP s... HCP stated that a 2 month old patient did not receive a full dose of the VAXNEUVANCE vaccine. HCP stated that the patient may have received 0.1 to 0.2 mLs of the VAXNEUVANCE dose.; HCP reported that the needle came out during the administration of the vaccine and the patient did not receive the full dose of the VANEUVANCE.; HCP reported that the needle came out during the administration of the vaccine; No additional AE; This spontaneous report was received from a medical assistant and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) administered for prophylaxis (strength, dosage, lot # and expiration date, route and anatomical site of administration were not reported). Due to the needle came out during the administration of the vaccine (needle issue; poor quality device used) the patient did not receive a full dose of the vaccine; the patient may have received 0.1 to 0.2 mL (underdose). No additional adverse events (No adverse event). Reporter provided limited pertinent information and demographic data. More
2849564 0.08 M IL 07/14/2025 TDAP
 SANOFI PASTEUR
 U8618AA
Wrong product administered Wrong product administered
Tdap was administered rather than Hep-B vaccine Tdap was administered rather than Hep-B vaccine
2849566 16 M NY 07/14/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 2P77Y
Injection site cellulitis, Injection site erythema, Injection site induration, I... Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth More
16 y.o male with 4cm x 4cm area of warmth, tenderness, erythema & induration over left deltoid a... 16 y.o male with 4cm x 4cm area of warmth, tenderness, erythema & induration over left deltoid about 72 hrs after Bexsero was given. Will treat with 10 day Cephalexin course due to secondary Cellulitis More
2849601 0.33 F CA 07/14/2025 HPV9
 MERCK & CO. INC.
 Y012865
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
not symptomatic; administration of GARDASIL-9 to a 4-month-old patient; This spontaneous report was ... not symptomatic; administration of GARDASIL-9 to a 4-month-old patient; This spontaneous report was received from a nurse and refers to a 4-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Jul-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y012865, expiration date: 10-Oct-2026), administered for prophylaxis by a healthcare profession (strength, dose, and route were not reported) (Product administered to patient of inappropriate age). The patient was not symptomatic (No adverse event). More
2849602 NM 07/14/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
have received Gardasil 9 beyond age indication; No additional AE; This spontaneous report was receiv... have received Gardasil 9 beyond age indication; No additional AE; This spontaneous report was received from a nurse via company employee and referred to an Elderly (age reported as 70s) patient of unknown gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient received Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) (strength, formulation, dose, route, lot # and expiration date were not reported) for prophylaxis beyond age indication (Product administered to patient of inappropriate age). No additional event was reported. More
2849603 NM 07/14/2025 HPV9
 MERCK & CO. INC.
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
have received Gardasil 9 beyond age indication; No additional AE; This spontaneous report was receiv... have received Gardasil 9 beyond age indication; No additional AE; This spontaneous report was received from a nurse via company employee and referred to an adult (age reported as 50s) patient of unknown gender. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient received human papillomavirus 9-valent vaccine, recombinant (GARDASIL9) (strength, formulation, dose, route, lot # and expiration date were not reported) for prophylaxis beyond age indication (Product administered to patient of inappropriate age). No additional event was reported. This is one of 2 reports from the same reporter. More
2849604 F MD 07/14/2025 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 symptoms reported; Consumer received her second dose of GARDASIL 9 in May of 2025.; This spontane... no symptoms reported; Consumer received her second dose of GARDASIL 9 in May of 2025.; This spontaneous report was received from a 26-year-old female patient and refers to herself. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date in August 2023, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, administered for prophylaxis (strength, dose, route, lot #, and expiration date were not reported). On an unknown date in May 2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Inappropriate schedule of product administration). It was first identified by the patient and pharmacist on 08-Jul-2025. No symptoms were reported (No adverse event). Lot# is being requested and will be submitted if received. More
2849605 M TX 07/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash Rash
a small rash with no open lesions across his back at the belt line; This non-serious case was report... a small rash with no open lesions across his back at the belt line; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 24-APR-2025, the patient received the 1st dose of Shingrix (intramuscular). On 27-JUN-2025, 64 days after receiving Shingrix, the patient experienced rash (Verbatim: a small rash with no open lesions across his back at the belt line). The outcome of the rash was not resolved. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 01-JUL-2025 The patient called to ask if he should receive his 2nd dose of Shingrix. He described a small rash with no open lesions across his back at the belt line. It crosses the midline. This report was being submitted with minimal information. No additional information is known. More
2849606 M 07/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Intensive care, Nightmare, Pyrexia Intensive care, Nightmare, Pyrexia
Fever; This non-serious case was reported by a consumer via interactive digital media and described ... Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever). The outcome of the fever was resolved. It was unknown if the reporter considered the fever to be related to Shingles vaccine. It was unknown if the company considered the fever to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-JUN-2025 This case was reported by a consumer via interactive digital media. The first one caused her husband to have a fever for 1 and half month, intensive care, nightmare. More
2849607 07/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; still got them; This serious case was reported by a consumer via int... Suspected vaccination failure; still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got them). 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: 08-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and still got them (shingles). It was more mild than most he/she guesses. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving 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
2849608 17 F 07/14/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
My 17 year old daughter received one dose on June 23 and the second dose today on July 7; This non-s... My 17 year old daughter received one dose on June 23 and the second dose today on July 7; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero). On 07-JUL-2025, the patient received the 2nd dose of Bexsero. On 07-JUL-2025, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: My 17 year old daughter received one dose on June 23 and the second dose today on July 7). The outcome of the drug dose administration interval too short 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: 07-JUL-2025 The reporter reported that the patient received one dose of Bexsero vaccine on June 23 and the second dose today on July 7 as directed by our provider, which led to drug dose administration interval too short. The reporter was ask this was correct dosage, according to what reporter seeing on the site it looks like it should have been 6 months apart. More
2849609 F NM 07/14/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 42Y93
Wrong product administered Wrong product administered
patient received a dose of Kinrix instead of Pediarix; This non-serious case was reported by a other... patient received a dose of Kinrix instead of Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Pediarix (Patient has 2 previous doses of Pediarix) and Pediarix (Patient has 2 previous doses of Pediarix). On an unknown date, the patient received Kinrix and Pediarix. On an unknown date, an unknown time after receiving Kinrix and Pediarix, the patient experienced wrong vaccine administered (Verbatim: patient received a dose of Kinrix instead of Pediarix). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 30-JUN-2025 Other reported that they administered a dose of Kinrix to a female patient who was 2 years old instead of Pediarix, which led to wrong vaccine administered. Do they need to revaccinate? What are the next steps? Any safety information available? Patient had 2 previous doses of Pediarix. More
2849610 F OH 07/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
I got my first shingrix shot in 2019 and second in 2025; This non-serious case was reported by a pha... I got my first shingrix shot in 2019 and second in 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (first Shingrix shot in 2019). 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 drug dose administration interval too long (Verbatim: I got my first shingrix shot in 2019 and second in 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 30-JUN-2025 Reporter stated that patient got first Shingrix shot in 2019 and second in 2025, which led to drug dose administration interval too long. Also asked if they need another one or not. More
2849611 07/14/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation error Product preparation error
Priorix was reconstituted using DTaP IPV liquid (component of Pentacel); Priorix was reconstituted u... Priorix was reconstituted using DTaP IPV liquid (component of Pentacel); Priorix was reconstituted using DTaP IPV liquid (component of Pentacel)/Reconstitution with a different diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Priorix was reconstituted using DTaP IPV liquid (component of Pentacel)) and inappropriate dose of vaccine administered (Verbatim: Priorix was reconstituted using DTaP IPV liquid (component of Pentacel)/Reconstitution with a different diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-JUL-2025 The reporter mentioned that Priorix was reconstituted using DTaP-IPV liquid (component of Pentacel) which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered The pharmacist enquired if they have any information on safety and stability when Priorix was reconstituted with anything else other than the provided diluent. More
2849612 12 M WY 07/14/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB064A
Product preparation issue Product preparation issue
Menveo - Administration of only the liquid component.; Menveo - Administration of only the liquid co... Menveo - Administration of only the liquid component.; Menveo - Administration of only the liquid component.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 01-JUL-2025, the patient received Menveo. On 01-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo - Administration of only the liquid component.) and inappropriate dose of vaccine administered (Verbatim: Menveo - Administration of only the liquid component.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 08-JUL-2025 The medical assistant reported that a patient received only the liquid component of Menveo on July 1st, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reported asked for recommendations on this situation. More
2849613 53 F KS 07/14/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 M4B34
Inappropriate schedule of product administration Inappropriate schedule of product administration
Twinrix late second dose; This non-serious case was reported by a pharmacist via call center represe... Twinrix 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 53-year-old female patient who received HAB (Twinrix) (batch number M4B34, expiry date 28-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 19-NOV-2024 with batch number 2553X and lot expiry 25-SEP-2026). On 08-JUL-2025, the patient received the 2nd dose of Twinrix. On 08-JUL-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-JUL-2025 The pharmacist asked what was the recommended time interval between dose two and three of Twinrix taking into account that the second dose was given late, which led to drug dose administration interval too long. The vaccine administration facility was the same as primary reporter. More
2849614 F 07/14/2025 PNC20
 PFIZER\WYETH
Hyperhidrosis, Injection site pain, Pyrexia, Sleep disorder Hyperhidrosis, Injection site pain, Pyrexia, Sleep disorder
fever/started having 102 F (38.9 C) fever; I couldn't sleep; sweating; pain at injection site; ... fever/started having 102 F (38.9 C) fever; I couldn't sleep; sweating; pain at injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: 002191. A 57-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 09Jul2025 at 09:00 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 09Jul2025, outcome "unknown", described as "I couldn't sleep"; VACCINATION SITE PAIN (non-serious) with onset 09Jul2025, outcome "not recovered", described as "pain at injection site"; HYPERHIDROSIS (non-serious) with onset 09Jul2025, outcome "unknown", described as "sweating"; PYREXIA (non-serious) with onset 09Jul2025 at 21:00, outcome "not recovered", described as "fever/started having 102 F (38.9 C) fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: The patient had fever after getting the shot of Prevnar 20 and is asking if fever is normal after getting it. She received Prevnar 20 yesterday (09Jul2025) at ~9am and at 9pm, she started having 102 F (38.9 C) fever that was unbearable. She couldn't sleep and took Tylenol at midnight. Besides the fever, she was sweating and had pain at injection site. She felt better after 2 hours and pain was reduced. The next morning morning, the fever is bearable and under control but there is still pain at the injection site, it still hurts. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2849615 07/14/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, Respiratory disorder COVID-19, Drug ineffective, Respiratory disorder
Still having adverse effects and bad symptoms of your vaccine; Still having all the symptoms of Covi... Still having adverse effects and bad symptoms of your vaccine; Still having all the symptoms of Covid-19; Still having adverse effects and bad symptoms of your vaccine; Still having all the symptoms of Covid-19; Respiratory issues; This is a spontaneous report received from a Consumer or other non HCP. 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Still having adverse effects and bad symptoms of your vaccine; Still having all the symptoms of Covid-19"; RESPIRATORY DISORDER (non-serious), outcome "not recovered", described as "Respiratory issues". Clinical course: Consumer stated, "I wanted to see where, it's been a while and I have been like, I have got into the research and medicine myself and I am still experiencing many symptoms of adverse effect of vaccine, and I wanted to see if you still have like trials open. Maybe if I could be part of your research of any reports being done that were mistakenly made or, because I am still having, like I said, adverse effects and bad symptoms of your vaccine and still having respiratory issues and all the symptoms of Covid-19." When probed to clarify if consumer took the Pfizer Covid-19 Vaccine, consumer stated, "I had the Pfizer and I am still having all the symptoms of Covid-19." When paraphrased the concern, consumer stated, "Yes, what's available? Who could I report it to? Where do I report it to and if I could speak with someone in person about the symptoms. Do you have a clinic to welcome the people who were affected from vaccine or where it did not work, and I am still having Covid-19 symptoms." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2849616 M TX 07/14/2025 COVID19
 PFIZER\BIONTECH
 EW0175
Tremor Tremor
ill with tremors and basically crippled now; This is a spontaneous report received from a Consumer o... ill with tremors and basically crippled now; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EW0175) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (disability), outcome "not recovered", described as "ill with tremors and basically crippled now". More
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2849617 M 07/14/2025 COVID19
 PFIZER\BIONTECH
 EW0181
Heart rate increased, Palpitations, Specialist consultation Heart rate increased, Palpitations, Specialist consultation
an increased heartrate; palpitations; This is a spontaneous report received from a Consumer or other... an increased heartrate; palpitations; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 2, single (Lot number: EW0181) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE; BATCH/LOT NUMBER: EW0181), administration date: 04Jul2021, for Covid-19 immunisation. The following information was reported: HEART RATE INCREASED (non-serious) with onset 14Aug2021, outcome "not recovered", described as "an increased heartrate"; PALPITATIONS (non-serious) with onset 14Aug2021, outcome "not recovered". The events "an increased heartrate" and "palpitations" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate increased, palpitations. Additional information: A few days after receiving the 2nd of the 3 Pfizer COVID-19 vaccines, reporter said he experienced an increased heartrate and palpitations during rest. Over next several years, these same symptoms would happen on occasion. Reporter saw a Cardiologist this past month to get it checked.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500141443 same patient/events, different dose; More
2849618 M 07/14/2025 COVID19
 PFIZER\BIONTECH
Heart rate increased, Palpitations, Specialist consultation Heart rate increased, Palpitations, Specialist consultation
an increased heartrate; palpitations; This is a spontaneous report received from a Consumer or other... an increased heartrate; palpitations; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (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: comirnaty (DOSE 1, SINGLE; BATCH/LOT NUMBER: EW0181), administration date: 04Jul2021, for Immunisation; comirnaty (DOSE 2, SINGLE; BATCH/LOT NUMBER: EW0181), administration date: 11Aug2021, for Immunisation, reaction(s): "Heart rate increased", "Palpitations". The following information was reported: HEART RATE INCREASED (non-serious), outcome "not recovered", described as "an increased heartrate"; PALPITATIONS (non-serious), outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate increased, palpitations. Additional information: A few days after receiving the 2nd of the 3 Pfizer COVID-19 vaccines, reporter said he experienced an increased heartrate and palpitations during rest. Over next several years, these same symptoms would happen on occasion. Reporter saw a Cardiologist this past month to get it checked. 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-202500141424 same patient/events, different dose; More
2849619 F FL 07/14/2025 PNC20
 PFIZER\WYETH
Pyrexia, Vaccination error Pyrexia, Vaccination error
Fever; Patient was injected with Prevnar 20 in error by her healthcare provider; This is a spontaneo... Fever; Patient was injected with Prevnar 20 in error by her healthcare provider; This is a spontaneous report received from a consumer from medical information team. A female patient received Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), 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: PYREXIA (non-serious), outcome "unknown", described as "Fever"; PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown", described as "Patient was injected with Prevnar 20 in error by her healthcare provider". Additional Information: The patient was injected with Prevnar 20 in error by her healthcare provider. The patient's husband would like to know how to get the vaccine (also reported as poison) out of the patient's body, such as how to dilute it or if there is an antidote. As for the reason for wanting to remove the vaccine, the patient's husband said that they don't take vaccines. The patient's husband mentioned that it is not because of an adverse event or side effect, but he did say that the patient experienced a fever and all the other side effects. The patient's husband said he will seek out legal assistance. The information on the batch/lot number for Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) will be requested and submitted if and when received. More
2849620 F 07/14/2025 COVID19
 PFIZER\BIONTECH
Infertility female Infertility female
anger regarding the perceived impact of a vaccine on their daughter's fertility; This is a spon... anger regarding the perceived impact of a vaccine on their daughter's fertility; This is a spontaneous report received from a Consumer or other non HCP. A female 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. The following information was reported: INFERTILITY FEMALE (non-serious), outcome "unknown", described as "anger regarding the perceived impact of a vaccine on their daughter's fertility". Additional information: The caller expressed frustration and anger regarding the perceived impact of a vaccine on their daughter's fertility and sought information on how to sue the company. The agent attempted to de-escalate the situation by requesting the caller to refrain from using profanity and offered to transfer the caller to the global security operations center for further assistance. The agent also noted the caller's experience for the drug safety team. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2849621 M 07/14/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Disease recurrence, Drug ineffective COVID-19, Disease recurrence, Drug ineffective
got the COVID/got COVID again; got the COVID; got COVID again; This is a spontaneous report received... got the COVID/got COVID again; got the COVID; got COVID again; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing), notes: four times; "respiratory system is weak" (unspecified if ongoing); "hospital" (unspecified if ongoing), notes: pneumonia, and the fourth time send me in the hospital; "Flu" (unspecified if ongoing), notes: right away I have to do something; "sick" (unspecified if ongoing), notes: see doctors and I don't allow the sickness to become worse; "memory not that good" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (hospitalization, medically significant) with onset 2021, 3 months after the suspect product(s) administration, outcome "unknown", described as "got the COVID"; DRUG INEFFECTIVE (hospitalization, medically significant) with onset 2021, 3 months after the suspect product(s) administration, outcome "unknown", described as "got the COVID/got COVID again"; DISEASE RECURRENCE (medically significant) with onset 2022, outcome "recovered", described as "got COVID again". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 9 day(s)). Therapeutic measures were taken as a result of drug ineffective, disease recurrence. Clinical course: The patient informed that he got COVID, yesterday. He discovered he got COVID, and went to the urgent care. This morning, they gave him this prescript, they prescribed him this medicine, Paxlovid, for the COVID, 2 years ago, he got COVID. He got this medicine, and it was free, and she explained to me that it was free, it was in COVID times, and now the COVID times were over. He has to pay more than for the, he knew he has to do it, because he got COVID three times. The first time he ended up in the hospital and it was nine days in the hospital. He didn't want to end up in the hospital again, that means he has to get the medicine one way or another. He didn't want to be in the hospital for a week from now. The patient informed that in his life, he got four pneumonias, four times pneumonia, four times in his life it was very easy for him to jump from flu to pneumonia, it takes only ten days. When asked to confirm if he had COVID three times, he responded, "Yes, I got COVID in 2021, and I went to the hospital. I got Pfizer, the two vaccines, and still three months later I got the COVID, and I ended up in the hospital, and in 2022, I got COVID again, I got the medicine, no hospital, one week later I was okay, and now I've got COVID again. Yesterday I start coughing, and with a runny nose, and my son, he has a COVID test over here, available, and it was positive. I have it in front of me. Then I went to the urgent care this morning to get the medicine to get the prescription. I have to get the medicine one way or another. I have to get the medicine because otherwise, I know in ten days from now I will be in the hospital with pneumonia I know, always, my respiratory system is weak, that's why I suffer in my life four times pneumonia, and the fourth time send me in the hospital that's why when I got Flu right away I have to do something, I got sick I see doctors and I don't allow the sickness to become worse. I know in ten days, from now I know Imma be in the hospital, with pneumonia, 100% sure. My memory not that good. I will call you back later, because I no want to risk myself, I have to take the medicine. I must take the medicine between the first 5 days, and then it doesn't work up to 5 days." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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2849622 F 07/14/2025 RSV
 PFIZER\WYETH
Cardiac disorder Cardiac disorder
made her heart worse.; This is a spontaneous report received from an Other HCP and a Consumer or oth... made her heart worse.; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP. A 63-year-old female patient (unknown if pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "made her heart worse.". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2849623 F TX 07/14/2025 COVID19
 PFIZER\BIONTECH
Body temperature, COVID-19 pneumonia, Drug ineffective Body temperature, COVID-19 pneumonia, Drug ineffective
pneumonia on top of Covid, fever is 102.3, I take Tylenol. It was 103 at first; pneumonia on top of ... pneumonia on top of Covid, fever is 102.3, I take Tylenol. It was 103 at first; pneumonia on top of Covid, fever is 102.3, I take Tylenol. It was 103 at first; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 200250. A 46-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "compromised" (unspecified if ongoing), notes: when I had covid before, I always end up in the hospital because I'm compromised; "flu", start date: 2024 (unspecified if ongoing); "pneumonia", start date: 2024 (unspecified if ongoing); "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 PNEUMONIA (medically significant), outcome "unknown" and all described as "pneumonia on top of Covid, fever is 102.3, I take Tylenol. It was 103 at first". The patient underwent the following laboratory tests and procedures: Body temperature: 103; 102.3. Therapeutic measures were taken as a result of covid-19 pneumonia. Clinical course: During an inbound call for financial assistance, the patient (name) stated. "I have to get Paxlovid filled. I have pneumonia on top of Covid, and I was asking, you know, how important is me taking Paxlovid if I don't get it because I can't afford it. Well the concerns is because last year I had the flu and I end up having pneumonia and when I had Covid before, I always end up in the hospital because I'm compromised and so it was like, yes you're treating the pneumonia but they're just worried that it's gonna lead me back to the hospital if I don't take the Paxlovid like I did before because of me being, you know compromised. I know it's a possibility, well which I know I'll end up in the hospital if I don't take this." While providing her demographic information, (name) asked, "Will that help with the fever? My fever is 102.3, I take Tylenol. It was 103 at first. It's not, and that's, that's another thing that they you know concerned because my fever not breaking. I had all my vaccines, I had the Pfizer. I had both vaccines and the booster." After an explanation as to why she would not qualify for the (withheld) card, (name) stated, "because they say it covers the, I guess Paxlovid is it a double? It's a combination with the nirmatrelvir or the ritonavir?" "Is Paxlovid, Paxlovid is the brand of it". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2849624 07/14/2025 PNC13
 PFIZER\WYETH
Drug ineffective, Pneumonia Drug ineffective, Pneumonia
it stopped working I'm getting pneumonia like 3-4 times a year; it stopped working I'm get... it stopped working I'm getting pneumonia like 3-4 times a year; it stopped working I'm getting pneumonia like 3-4 times a year; it stopped working I'm getting pneumonia like 3-4 times a year; This is a spontaneous report received from a Consumer or other non HCP. A patient in his/her 50's received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2014 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "kidney disease" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "it stopped working I'm getting pneumonia like 3-4 times a year". Clinical course: the patient had a pneumonia vaccine but it was 11 years ago (2014), and it worked for lots of years, but it stopped working, the patient was getting pneumonia like 3-4 times a year. The information on the batch/lot number for [PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)] will be requested and submitted if and when received. More
2849625 65 M NC 07/14/2025 DTAPIPVHIB
 SANOFI PASTEUR
No adverse event, Stem cell transplant No adverse event, Stem cell transplant
Intentional Off Label Prescription by HCP: Pentacel is prescribed with off label diagnosis Stem cell... Intentional Off Label Prescription by HCP: Pentacel is prescribed with off label diagnosis Stem cells transplant status with no reported adverse event; Initial information received on 08-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 65 years old male patient who had prescription by hcp (healthcare professional) intentional off label: Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] is prescribed with off label diagnosis stem cells transplant status with no reported 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 0.5mL of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (frequency 4 times) (lot number, expiry date and strength not reported) via intramuscular route in unknown administration site and intentional off label prescription by hcp: pentacel is prescribed with off label diagnosis stem cells transplant status with no reported adverse event (off label use). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. No follow up possible since reporter denied to respond to Sanofi PV Follow up. More
2849626 0.17 M TX 07/14/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK023AA
Expired product administered, No adverse event Expired product administered, No adverse event
Pentacel was administered that expired 3 months ago with no reported adverse event; Initial informat... Pentacel was administered that expired 3 months ago with no reported adverse event; Initial information received on 10-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 weeks old male patient who was administered to Diphtheria, Tetanus, Ac Pertussis, Ipv And Hib Vaccine [Pentacel] that expired 3 months ago with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine Live Oral 1v (Rotarix) and Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) for Immunisation. On 10-Jul-2025, the patient received 0.5mL (dose 1) of suspect Diphtheria, Tetanus, Ac Pertussis, Ipv And Hib Vaccine, Suspension for injection (lot UK023AA; expiry date 30-Apr-2025, strength standard and frequency once) via intramuscular route in the left thigh for Immunisation and it was administered that expired 3 months ago with no reported adverse event (expired product administered) (latency same day). Reportedly, they wanted to know if they need to readminister and recommendations that were available for this situation. 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
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