๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2827863 85 F OH 02/24/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 227MG
Mobility decreased, Pain in extremity Mobility decreased, Pain in extremity
REPORTING SORE ARM/DIFFICULTY MOVING ARM SINCE TIME OF VACCINE UNTIL TODAY (FEB 24, 2025) REPORTING SORE ARM/DIFFICULTY MOVING ARM SINCE TIME OF VACCINE UNTIL TODAY (FEB 24, 2025)
2827864 5 F NJ 02/24/2025 COVID19
 PFIZER\BIONTECH
 LM2045
Expired product administered Expired product administered
VACCINE EXPIRED 02/11/2025. GIVEN TO PATIENT ON 02/21/2025 VACCINE EXPIRED 02/11/2025. GIVEN TO PATIENT ON 02/21/2025
2827865 10 M NC 02/24/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 4B47K
Injection site swelling, Injection site warmth, Pain in extremity, Rash Injection site swelling, Injection site warmth, Pain in extremity, Rash
Mom noticed a rash on patient's right arm on Friday, 2/21/25. Rash started off small, but got w... Mom noticed a rash on patient's right arm on Friday, 2/21/25. Rash started off small, but got worse throughout the night. Arm was swollen around the injection and area was warm to touch. Patient began complaining of arm pain the following Monday, 2/24/25. Mom brought patient back in on Monday afternoon, 2/24/25, patient was prescribed mupiroin ointment. More
2827866 37 M MA 02/24/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 57YT7
Confusional state, Hyperhidrosis, Pallor, Syncope Confusional state, Hyperhidrosis, Pallor, Syncope
The patient received the vaccination at approximately 3:30PM, and left the room. At approximately 3:... The patient received the vaccination at approximately 3:30PM, and left the room. At approximately 3:40, the patient was checking out of our clinic, and collapsed. The clinic responded to the incident and at approximately 3:41PM the patient came to. The patient was pale, diaphoretic and had mild confusion. The patient requested to go outside for fresh air, which was granted by the clinic team. The patient sat outside under close supervision by the medical team. At approximately 3:55PM, the patient returned to the clinic for further evaluation by the provider whom they had just seen. Vitals were taken throughout the incident and were stable. The patient was Awake, Alert and Oriented, and thus was cleared by the provider to leave the clinic. The provider instructed the patient that if symptoms were to return, that they needed to go to the emergency department. More
2827867 63 F MO 02/24/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 4T9312
Blood test normal, Pain in extremity, X-ray limb Blood test normal, Pain in extremity, X-ray limb
patient caregiver called clinic stating "patient came into the walk-in services to receive a He... patient caregiver called clinic stating "patient came into the walk-in services to receive a Hep A vaccination, the patient felt fine leaving the visit with arm being sore, over the week/weekend patient felt the pain progressing worse from hand up tp upper arm, patient went to Emergency Department at Hospital to be seen, ER took blood work (normal) x-ray pending at this time, sent home that day with pain patient medications, patient called PCP on 2/24/25 @ 10AM regarding pain in arm and vaccine reactions and call for further notice." More
2827868 50 F OH 02/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 27LR2
Arthralgia, Loss of consciousness, Malaise, Sleep disorder, Tremor Arthralgia, Loss of consciousness, Malaise, Sleep disorder, Tremor
Pt's arm hurt that evening, then she was shaky, then she didn't feel good. That night she ... Pt's arm hurt that evening, then she was shaky, then she didn't feel good. That night she didn't sleep good. Then the next morning she passed out. She called an ambulance. They took her vitals and said she didn't need further treatment. More
2827869 42 F TX 02/24/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8015AA
U8015AA
Asthenia, Decreased gait velocity, Feeling hot, Hyperhidrosis, Malaise; Nausea, ... Asthenia, Decreased gait velocity, Feeling hot, Hyperhidrosis, Malaise; Nausea, Pallor, Retching More
Donor received the Tdap vaccine after plasma donation. About 10 minutes after vaccine administration... Donor received the Tdap vaccine after plasma donation. About 10 minutes after vaccine administration, donor began experiencing symptoms of general Malaise: slowed her gait, appeared pale and sweaty. Donor stated that she felt unwell, she was feeling very warm, weak, and nauseated. Donor soon after experienced few dry heaves. Donor assisted to lie down on the examination bed with her feet elevated, ice packs applied. Donor initially had difficulty tolerating an oral electrolyte beverage due to recurrent nausea and weakness triggered by positional changes. Approximately two hours later after managing to consume 20 oz. of electrolyte beverage, donor recovered completely. More
2827870 3 M CA 02/24/2025 DTAPHEPBIP
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 77J49
X2233
Hypersensitivity, Injection site erythema, Injection site infection, Injection s... Hypersensitivity, Injection site erythema, Injection site infection, Injection site swelling; Hypersensitivity, Injection site erythema, Injection site infection, Injection site swelling More
Mom reported that patient received vaccines on 2/20/25 patient was accessed with a redness on the le... Mom reported that patient received vaccines on 2/20/25 patient was accessed with a redness on the left thigh on Friday 02/21/25 around 12pm by parents. Patients mom monitored patient until 02/22/25 where the area was more red and swollen she took patient to facility where they diagnosed him with left thigh infection and gave him antibiotics. Patient was D/C from urgent care and went home. In the evening the redness and swelling had traveled past the marked area from facility and mom took patient to ER where they diagnosed patient with an allergic reaction to the vaccine given. patient was D/C home patient received one dose of steroids in ER and PRN Benadryl and Prelone. Vaccine given on Left Thigh - Hep A More
2827871 37 F CA 02/24/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0161
EW0161
Delusion, Insomnia, Loss of personal independence in daily activities, Mental di... Delusion, Insomnia, Loss of personal independence in daily activities, Mental disorder, Psychotic disorder; Sleep deficit More
Hi! I must report what I suspect to be an adverse reaction to vaccines which function within the gen... Hi! I must report what I suspect to be an adverse reaction to vaccines which function within the genome (to my understanding), which would include the Zika vaccine I received in 2016 and would also apply to the mRNA covid19 vaccines, of which I received 3 doses Pfizer -- EW0161 4/14/21 and EW0176 5/5/21 Moderna -- 060H21A 12/7/21 In August of 2017 I experienced a bout of mental illness which was characterized by the following: brain fog, inability to concentrate, delusions, driving and navigating were very difficult. These cleared up after I had moved to to another state in October of 2017. I did not think the two were correlated until more recent events. From October of 2021 until May of 2022 I was in a prodromal type psychotic period and in June of 2022 I experienced a severe mental break characterized by intense delusions which interfered with my ability to carry on with my everyday life. This period persisted until January of 2023 when my symptoms started to improve and now finally I am trying to put my life back together. Comorbidities include: severe allergies while living in another state roughly from 2008-2017 to combat allergies, I was taking 2x25mg diphenhydramine and one zyrtec per day for up to 6mo at a time sleep deprivation (due to hectic schedule) 2016-2017 continued sleep deprivation (due to hectic schedule) after moving to another state 2017-2019 sleep deprivation due to insomnia beginning roughly Sept 2021 cessation of dreaming June 2022-Jan 2023 (these are all the ones I can think of off the top of my head) I do hope this email finds you well and that the information contained therein is used to prevent what happened to me from happening to anyone else. Maybe I just got so incredibly "lucky"! Thank you so much for all of the excellent work you do to combat threats to our health here worldwide. Even after what has transpired, even if my contribution possibly affected my health, I would gladly do it all again. God Bless Y'all Here are additional sources: my Post features, and a video I made detailing my experience Please make them stop trying to develop this technology! The health benefits in no way outweigh the danger. More
โœ“
2827872 46 F VA 02/24/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH

Asthenia, Blood test normal, Computerised tomogram normal, Deafness unilateral, ... Asthenia, Blood test normal, Computerised tomogram normal, Deafness unilateral, Dizziness; Fatigue, Tinnitus More
I got home around 12:30 PM, I was feeling okay. But then i started feeling weak and tired and i thou... I got home around 12:30 PM, I was feeling okay. But then i started feeling weak and tired and i thought it could have been an affect from the shot because the nurse told me my arm would be sore from the shot. I thought i would take a nap and that would make me feel better. I napped for 30 mins and then i got up and felt dizzy and light headed. I walked to the kitchen sick and I felt ringing in my ear right ear. And then my boyfriend started talking to me and i couldn't hear him and im like WOAH what is going on and it was ringing and i am completely deaf on my right side. So i panicked and i sat down for a moment and i thought it would go away. So by that time the docs office had closed and i was supposed to see them on thursday but there was bad weather so i went wednesday. So i then reached out to my heart team. And they told me to give it some time and it would go away and the check my blood pressure and my blood sugar every 2 hours and i did and that was fine. And then on Friday the same thing was going on so i reached out to my transplant team they told me to go the hospital. And they told me to go to the ER, Medical Center-There i had CT scan done and blood work. And after all that the doc came and checked both ear and there was no build up or wax and he said it was unexplainable and states that it had to come from the vaccine. Then i was discharged and he gave me a number to go see ENT. More
2827874 2 M WA 02/24/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 FJ47R
Extra dose administered Extra dose administered
Patient was given this dose unnecessarily. In September and October of 2023, patient received first ... Patient was given this dose unnecessarily. In September and October of 2023, patient received first 2 doses of influenza vaccine, so they should only have gotten one single dose for the 2024 season. More
2827875 5 M KS 02/24/2025 DTAPIPV
DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 34MF9
34MF9
Cough, Influenza A virus test positive, Injection site bruising, Injection site ... Cough, Influenza A virus test positive, Injection site bruising, Injection site erythema, Injection site nodule; Nasal congestion, Pyrexia More
Pt received Kinrix and Proquad on 2/20/25. Mom noticed on 2/22/25 that pt had large area of redness... Pt received Kinrix and Proquad on 2/20/25. Mom noticed on 2/22/25 that pt had large area of redness to left medial thigh. Reddened area turned to light colored bruising by 2/24/25. This was near the site of Kinrix injection. Pt also experiencing high fevers, cough, and nasal congestion. Mom brought pt to clinic on 2/24/25. There is a 8cm x 4 cm area of light colored blue bruising approx 2cm medial to injection site, there is a knot approx 2cm in diameter. Pt tested positive for flu at this visit 2/24/25. More
2827876 34 M IL 02/24/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00595
Nausea, Vomiting Nausea, Vomiting
acute nausea and vomiting x1, post emesis donor states that he felt better and the signs and symptom... acute nausea and vomiting x1, post emesis donor states that he felt better and the signs and symptoms subsided More
2827877 63 F MA 02/24/2025 TDAP
 SANOFI PASTEUR
 U8274AA
Abdominal pain upper, Dizziness, Rash Abdominal pain upper, Dizziness, Rash
Patient had stomach ache, dizziness and developed rash. Patient had stomach ache, dizziness and developed rash.
2827878 6 M WA 02/24/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 C24B9
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient was given 2nd dose of Hepatitis A too soon. First dose was given on 7/9/2024. Patient should... Patient was given 2nd dose of Hepatitis A too soon. First dose was given on 7/9/2024. Patient should not have had 2nd dose until at least 1/9/2025. More
2827879 F TN 02/24/2025 DTAPIPVHIB
 SANOFI PASTEUR
 uj981aa
Expired product administered, No adverse event Expired product administered, No adverse event
Post giving vaccine it was noted that vaccine expiration was 02/11/2025. Date given 01/24/2025. No ... Post giving vaccine it was noted that vaccine expiration was 02/11/2025. Date given 01/24/2025. No adverse reaction noted at this time. Reaching out to see if we need to re vaccinate pt. More
2827886 WA 02/24/2025 HPV4
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
3rd HPV vaccine too early; Product origin unknown; This spontaneous report was received from an othe... 3rd HPV vaccine too early; Product origin unknown; This spontaneous report was received from an other health professional and refers to an adult patient of unknown gender. 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, the patient was vaccinated third (3rd) dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) or Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (reported as HPV vaccine) too early (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (Product origin unknown; Inappropriate schedule of product administration). It was questioned that would they need to repeat it? Lot# is being requested and will submitted if received. More
2827887 F 02/24/2025 FLU3
FLU3
FLU4
FLU4
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 3p993
3p993
UNK
UNK
Pruritus, Rash; Rash; Pruritus, Rash; Rash Pruritus, Rash; Rash; Pruritus, Rash; Rash
increased rash; itching; This non-serious case was reported by a consumer and described the occurren... increased rash; itching; This non-serious case was reported by a consumer and described the occurrence of rash in a 83-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 3p993) for prophylaxis. On 04-NOV-2024, the patient received Fluarix 2024-2025 season .5 ml. In DEC-2024, less than 2 months after receiving Fluarix 2024-2025 season, the patient experienced rash (Verbatim: increased rash) and pruritus (Verbatim: itching). The outcome of the rash and pruritus were not resolved. It was unknown if the reporter considered the rash and pruritus to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the rash and pruritus to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. 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: 26-JAN-2025 The patient self-reported this case for herself. The patient reported that she took the Fluarix vaccine and experienced increased rash and itching. The reporter specifically wanted to know if this vaccine had a preservative and if so, what it was, or plus any other possible contributors toward Grovers disease's. More
2827888 M 02/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity, Skin burning sensation Pain in extremity, Skin burning sensation
Burning skin; Painful arm; This non-serious case was reported by a consumer and described the occurr... Burning skin; Painful arm; This non-serious case was reported by a consumer and described the occurrence of burning skin in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included bupropion hydrochloride (Wellbutrin Xl). On 05-JUL-2024, the patient received Shingrix. On 05-JUL-2024, less than a day after receiving Shingrix, the patient experienced burning skin (Verbatim: Burning skin) and pain in arm (Verbatim: Painful arm). On 15-JUL-2024, the outcome of the burning skin was resolved (duration 10 days) and the outcome of the pain in arm was resolved. It was unknown if the reporter considered the burning skin and pain in arm to be related to Shingrix. It was unknown if the company considered the burning skin and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 27-JAN-2025 The reporter reported that the Shingrix was known to have injection pain and redness more than other types of injection. Please take the tylenol or ibuprofen as needed, especially the same night. The reporter was 20 and more year consultant with GSK and he/she know the difference between side effects and an adverse events. More
2827889 37 M TN 02/24/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 47XP4
Underdose Underdose
Adult patient received Engerix B pediatric; Adult patient received Engerix B pediatric; This non-ser... Adult patient received Engerix B pediatric; Adult patient received Engerix B pediatric; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of underdose in a 37-year-old male patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis. On 19-FEB-2025, the patient received Engerix B pediatric .5 ml. On 19-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult patient received Engerix B pediatric) and adult use of a child product (Verbatim: Adult patient received Engerix B pediatric). 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: 19-FEB-2025 The patient weight reported 67.59 kilogram. Adult patient received Engerix B pediatric, which led to an underdose and adult use of a child product. More
2827890 M VA 02/24/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 95DB2
Extra dose administered Extra dose administered
received a 3rd dose of HAVRIX (1440 EL.U./mL) in July 2024; This non-serious case was reported by ... received a 3rd dose of HAVRIX (1440 EL.U./mL) in July 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a male patient who received HAV (Havrix 1440) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis. Previously administered products included Havrix (received 1st dose of Havrix in 1998) and Havrix (received 2nd dose of Havrix in 1998). In JUL-2024, the patient received the 3rd dose of Havrix 1440. In JUL-2024, an unknown time after receiving Havrix 1440, the patient experienced extra dose administered (Verbatim: received a 3rd dose of HAVRIX (1440 EL.U./mL) in July 2024). The outcome of the extra dose administered was unknown. 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: 20-FEB-2025 The reporter reported that patient received 2 doses of Havrix 1440 vaccine in 1998 for prevention. The patient was going somewhere and eat a lot of seafood, and it was advised to get immunized. The patient received a 3rd dose of Havrix 1440 in July 2024, which led to extra dose administered. The manufacturer did not know how long the vaccines lasts. The patient did not have details of the Havrix from the 1998 immunization. More
2827891 02/24/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Cough, Respiratory syncytial virus infection, Vaccination failure Cough, Respiratory syncytial virus infection, Vaccination failure
Suspected vaccination failure; I had the RSV shot but I still got it 6 months later; This serious ca... Suspected vaccination failure; I had the RSV shot but I still got it 6 months later; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, 6 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: I had the RSV shot but I still got it 6 months later). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 09-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the RSV shot but still got it 6 months later. The patient thought he/she had covid, because the cough was bad. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for respiratory syncytial virus and laboratory confirmation regarding respiratory syncytial virus infection 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 RSV vaccine. More
2827892 IL 02/24/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
Wrong technique in product usage process Wrong technique in product usage process
used the Monoject SmartTip Needleless Cannula to withdraw Menveo; This non-serious case was reported... used the Monoject SmartTip Needleless Cannula to withdraw Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong technique in product usage process (Verbatim: used the Monoject SmartTip Needleless Cannula to withdraw Menveo). The outcome of the wrong technique in product usage process was not applicable. Additional Information: GSK Receipt Date: 27-JAN-2025 The medical assistant used the Monoject SmartTip needleless cannula to withdraw Menveo which led to wrong technique in product usage process. The case was reported with limited information based off of notes from medical information agent. More
2827893 20 F TX 02/24/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3X937
Pruritus, Urticaria Pruritus, Urticaria
Hives spread all over the body; Itching all over; This non-serious case was reported by a nurse via ... Hives spread all over the body; Itching all over; This non-serious case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 20-year-old female patient who received HBV (Engerix B) (batch number 3X937, expiry date 07-DEC-2025) for prophylaxis. Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On 29-JAN-2025, the patient received the 2nd dose of Engerix B. On 29-JAN-2025, 10 hrs after receiving Engerix B, the patient experienced generalized pruritus (Verbatim: Itching all over). On 30-JAN-2025, the patient experienced generalized urticaria (Verbatim: Hives spread all over the body). On 30-JAN-2025, the outcome of the generalized urticaria was resolved and the outcome of the generalized pruritus was resolved (duration 1 day). It was unknown if the reporter considered the generalized urticaria and generalized pruritus to be related to Engerix B and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the generalized urticaria and generalized pruritus to be related to Engerix B and Engerix B Pre-Filled Syringe Device. 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 04-FEB-2025 Nurse explained that a patient got 2 dose of Engerix-B but after the second dose, the patient experienced an adverse reaction approximately 10 hours later, the patient started itching all over and next morning she got hives on palms of her hands and then it started spread all over her body. On 30th January 2025, the patient went to an urgent care clinic and got a steroid injection, so currently symptoms were almost completely gone. More
2827894 M FL 02/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Erythema, Injection site discolouration, Injection site erythema, Rash Erythema, Injection site discolouration, Injection site erythema, Rash
Redness at injection site; injection site with white dots; red skin/extension to arm and neck; rash ... Redness at injection site; injection site with white dots; red skin/extension to arm and neck; rash that extended to the neck and back; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site), injection site hypopigmentation (Verbatim: injection site with white dots), erythema (Verbatim: red skin/extension to arm and neck) and rash (Verbatim: rash that extended to the neck and back). The outcome of the injection site erythema, injection site hypopigmentation, erythema and rash were unknown. It was unknown if the reporter considered the injection site erythema, injection site hypopigmentation, erythema and rash to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site hypopigmentation, erythema and rash to be related to Shingrix. Additional Information: GSK Receipt Date: 10-FEB-2025 A pharmacist contacted GSK to request information about administering the second dose of Shingrix male patient mentioned that they previously suffered from adverse events which consisted in redness, with white dots present on the red skin and a rash that extended to the neck and back. They mentioned that they do not have information about when this first vaccine was given, the lot number or expiration date. The Health Care Professional enquired if GSK had any information about administering the second dose after a patient with such symptoms. More
2827895 1 M KS 02/24/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 27gb4
Extra dose administered Extra dose administered
patient was inadvertently given an extra dose of Flulaval today; This non-serious case was reported ... patient was inadvertently given an extra dose of Flulaval today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 27gb4, expiry date 30-JUN-2025) for prophylaxis. Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL). On 11-FEB-2025, the patient received the 3rd dose of FluLaval 2024-2025 season. On 11-FEB-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: patient was inadvertently given an extra dose of Flulaval today). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-FEB-2025 The nurse stated that a patient was inadvertently given an extra dose of Flulaval on the date of reporting, which led to extra dose administered. The patient was indicated for two doses, but the second dose was not captured in the electronic medical record (EMR). Thus, when the patient was at his well-child check on the day of reporting, the system showed he was due for a dose of FluLaval. The dose was given, and then afterward the parent pointed out the patient had already been given the second dose. More
2827896 F VA 02/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Fatigue, Myalgia, Pyrexia Fatigue, Myalgia, Pyrexia
Fever; Tiredness; Muscle pain; This non-serious case was reported by a nurse via call center represe... Fever; Tiredness; Muscle pain; This non-serious case was reported by a nurse via call center representative and described the occurrence of fever in a female 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 fever (Verbatim: Fever), tiredness (Verbatim: Tiredness) and muscle pain (Verbatim: Muscle pain). The outcome of the fever, tiredness and muscle pain were unknown. It was unknown if the reporter considered the fever, tiredness and muscle pain to be related to Shingrix. It was unknown if the company considered the fever, tiredness and muscle pain to be related to Shingrix. Additional Information: GSK receipt Date: 12-FEB-2025 and 14-FEB-2025 The reporter mentioned during the call as an example that his mother felt muscle pain, tiredness and fever after receiving Shingrix. The reporter did not had lot number for the vaccine and refused to provide any additional details about this case and declined consent to follow up with Safety Team in regards to his mother's symptoms since he mentioned that was not the reason why he was calling and he felt it was a violation to his mother's privacy. Did not consent to follow-up.; Sender's Comments: US-GSK-US2025018347:same reporter More
2827897 0.5 F MI 02/24/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 M7422
Product preparation issue Product preparation issue
only diluent administration instead of full dose with powder part; accidentally administered the liq... only diluent administration instead of full dose with powder part; accidentally administered the liquid part only; 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 6-month-old female patient who received Hib (Hiberix) (batch number M7422, expiry date 15-JUN-2027) for prophylaxis. On 17-FEB-2025, the patient received Hiberix. On 17-FEB-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: only diluent administration instead of full dose with powder part) and inappropriate dose of vaccine administered (Verbatim: accidentally administered the liquid part only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 18-FEB-2025 The certified medical assistant called to report that a nurse yesterday (day before reporting) accidentally administered the liquid part only, instead of a full complete dose with the powder to the patient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. Certified medical assistant wanted to know what safety concerns they have to address to the patient. The vaccine administration facility was the same as primary reporter. More
2827898 02/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
patients were late for their second dose after COVID years ago/ interval longer; This non-serious ca... patients were late for their second dose after COVID years ago/ interval longer; 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 an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. 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: patients were late for their second dose after COVID years ago/ interval longer). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 18-FEB-2025 Pharmacist stated various patients were late for their second dose after Covid years ago. Pharmacist stated no further information was available regarding number of patients (maybe 2 a year but unknown) and no further details were available. The patients received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. More
2827899 4 02/24/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration, Incorrect dose administered Inappropriate schedule of product administration, Incorrect dose administered
received first dose of a Kinrix vaccine to 4 year old patient; some of the vaccine was left inside t... received first dose of a Kinrix vaccine to 4 year old patient; some of the vaccine was left inside the syringe; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: received first dose of a Kinrix vaccine to 4 year old patient) and incomplete dose administered (Verbatim: some of the vaccine was left inside the syringe). The outcome of the inappropriate schedule of vaccine administered and incomplete dose administered were unknown. 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: 20-FEB-2025 The reporter reported that the patient that was administered a 1st dose of Kinrix vaccine and some of the vaccine was left inside the syringe, which led to inappropriate schedule of vaccine administered and incomplete dose administered. The reporter asked if they have to revaccinate a four year old More
2827900 F TX 02/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Late 2nd dose.; This non-serious case was reported by a pharmacist via call center representative an... 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 female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in July 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose.). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 20-FEB-2025 The pharmacist called to inform that a patient that had received the first dose of Shingrix back in July 2024 had not received the 2nd dose yet. The reporter also mentioned that the patient doctor had advised to restart the series. the vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2827901 11 F FL 02/24/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Wrong product administered Wrong product administered
accidentally administered Bexsero instead of MenQuadfi; This non-serious case was reported by a nurs... accidentally administered Bexsero instead of MenQuadfi; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis. On 31-JAN-2025, the patient received the 1st dose of Bexsero. On an unknown date, the patient received Menquadfi. On 31-JAN-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: accidentally administered Bexsero instead of MenQuadfi). 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: 21-FEB-2025 Other HCP they accidentally administered Bexsero instead of MenQuadfi to an 11 year old patient on January 31st 2025. This was the first dose of a Meningitis B vaccine for the patient. Patient receive Bexsero instead of MenQuafi which led to wrong vaccine administered. More
2827902 70 F 02/24/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test
tested positive, did get the flu and covid vaccine back at the beginning of oct; This spontaneous ca... tested positive, did get the flu and covid vaccine back at the beginning of oct; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive, did get the flu and covid vaccine back at the beginning of oct) in a 70-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. The patient's past medical history included COVID-19 (About 2 years ago). Previously administered products included for COVID-19: paxlovid (About 2 years ago). Past adverse reactions to the above products included No adverse effect with paxlovid. In October 2024, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 18-Oct-2024, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 50 microgram. In January 2025, the patient experienced COVID-19 (tested positive, did get the flu and covid vaccine back at the beginning of oct). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) ongoing from January 2025 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive, did get the flu and covid vaccine back at the beginning of oct) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2025, SARS-CoV-2 test: Positive. No concomitant medication was reported. It was unknown if the patient had previously received Pfizer vaccine. The reporter stated about 2 years ago she thought, she had tested positive and took it Paxlovid, and then just recently, and reporter had surprised that she and her husband tested positive, both did get the flu and covid vaccine back at the beginning of October. The reporter stated they have not had any problems, taking it, but noticed the metallic taste but had more of a bad sore throat and the sore throat seemed to be abating quickly but have still congestion but she only taken two doses so far. This case was linked to US-MODERNATX, INC.-MOD-2025-782516 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-782516:Husband case More
2827903 IN 02/24/2025 PNC20
 PFIZER\WYETH
 LK6651
Device connection issue Device connection issue
hub broke off; This is a spontaneous report received from a Nurse from product quality group. A pat... hub broke off; This is a spontaneous report received from a Nurse from product quality group. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LK6651, Expiration Date: 30Jun2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "hub broke off". The reporter considered "hub broke off" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "hub broke off" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). More
2827904 M NJ 02/24/2025 COVID19
 PFIZER\BIONTECH
Inappropriate schedule of product administration, Pre-existing condition improve... Inappropriate schedule of product administration, Pre-existing condition improved, Therapeutic response unexpected More
Unexpected therapeutic effect; very good for asthma; 2nd dose: Date: About 6 months later; This is a... Unexpected therapeutic effect; very good for asthma; 2nd dose: Date: About 6 months later; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "very good for asthma", "Unexpected therapeutic effect". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Unexpected therapeutic effect"; PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown", described as "very good for asthma"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "2nd dose: Date: About 6 months later". Additional information: Calling to let know caller got the COVID-19 shot from Pfizer two times and caller was suffering with asthma for a long time, many years, for 15 or 18 years. Confirmed asthma was prior to caller getting any of the Pfizer COVID-19 shots. After caller got the shot, hasn't for a long time, has no need for asthma medicine anymore. Usually by Spring time caller was not even able to go outside, after got the shot for the last 3 years feeling good. Confirmed both doses were the Pfizer COVID-19 shot. First dose date was unknown, doesn't remember, in Spring time, but does not have card at time of call to provide information. Patient received second dose, about 6 months later. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2827905 M NJ 02/24/2025 COVID19
 PFIZER\BIONTECH
Pre-existing condition improved, Therapeutic response unexpected Pre-existing condition improved, Therapeutic response unexpected
was suffering from asthma, after got the Pfizer COVID-19 shot, is feeling a lot better; was sufferin... was suffering from asthma, after got the Pfizer COVID-19 shot, is feeling a lot better; was suffering from asthma, after got the Pfizer COVID-19 shot, is feeling a lot better; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (ongoing), notes: used to get hospitalized every month. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "was suffering from asthma, after got the Pfizer COVID-19 shot, is feeling a lot better". Additional information: reporter friend was suffering from asthma, and reporter friend used to get hospitalized every month. After reporter friend got the Pfizer COVID-19 shot, reporter friend was feeling a lot better. Confirmed had asthma prior to getting the Pfizer COVID-19 shot. reporter stated Pfizer had the best reputation, and then reporter got the second shot because was very good for asthma, which was the same for reporter friend who was worse, reporter was with reporter friend last night. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2827907 41 F OR 02/24/2025 FLUX
PNC20
 UNKNOWN MANUFACTURER
PFIZER\WYETH
LJ5284
Cellulitis, Erythema, Infection; Cellulitis, Erythema, Infection Cellulitis, Erythema, Infection; Cellulitis, Erythema, Infection
redness over 13cm in diameters; cellulitis; infection; This is a spontaneous report received from a ... redness over 13cm in diameters; cellulitis; infection; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 41-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Feb2025 as dose number unknown, single (Lot number: LJ5284, Expiration Date: 30Jun2025) at the age of 41 years, in left arm for immunisation; influenza vaccine (INFLUENZA VACCINE), from 12Feb2025) to 12Feb2025 at single (dose number unknown, single) for immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (ongoing), notes: Ankylosing spondylitis is a autoimmune. Concomitant medication(s) included: SIMPONI taken for ankylosing spondylitis; LEVOTHYROXINE taken for thyroid disorder; KEFLEX [CEFALEXIN]. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "redness over 13cm in diameters"; CELLULITIS (non-serious), outcome "unknown"; INFECTION (non-serious), outcome "unknown". Therapeutic measures were taken as a result of erythema, cellulitis, infection. Additional Information: Caller, a 41-year-old patient, was injected with pneumococcal vaccine. When asked for the name of the vaccine, caller stated that it's from REDACTED. She received the vaccine and it cost her to have an infection, redness over 13cm in diameters. According to the doctors it was cellulitis and they are not taking responsibility. Consumer was unaware of the dose of vaccination. Consumer stated, Yes, she had taken Simponi (50 mg), and she had taken it for Ankylosing spondylitis and that is why she went her physician and that is why they gave her the vaccine. Other concomitant medication was taken consumer stated, Levothyroxine, 100 mg for thyroid. Vaccine administered on same date with the Pfizer vaccine was yes it was another vaccine in the off the arms and that the flu vaccine. More
2827908 18 M KS 02/24/2025 COVID19
 PFIZER\BIONTECH
 EW0171
Cardiomegaly, Loss of consciousness Cardiomegaly, Loss of consciousness
Pfizer COVID vaccine created large hearts/have a pacemaker for an enlarged heart; passing out; This ... Pfizer COVID vaccine created large hearts/have a pacemaker for an enlarged heart; passing out; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 19-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EW0153) and in 2021 as dose 2, single (Lot number: EW0171) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMEGALY (medically significant) with onset 2021, outcome "unknown", described as "Pfizer COVID vaccine created large hearts/have a pacemaker for an enlarged heart"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "passing out". The events "pfizer covid vaccine created large hearts/have a pacemaker for an enlarged heart" and "passing out" required physician office visit. Therapeutic measures were taken as a result of cardiomegaly, loss of consciousness. Additional information: The patient previously had no medical issues, a healthy football player had to have a pacemaker. The patient was not on Pacemakers before receiving the Pfizer COVID vaccine, he was playing football, baseball and basketball and every other sport that could possibly think of, until he was told he had to take the vaccine to be able to go to school. The patient's mother reached out to a doctor in 2021 back when patient had his pacemakers put in and the doctor "don't know anything". The patient has a job in life and he just has a pacemaker. The patient was a healthy 18-year-old kid took the Vaccine and now, he has pacemaker enlarged heart, an 18-year-old healthy boy but then had to have a pacemaker for an enlarged heart. He had to have a pacemaker because of the vaccine. He got the vaccine (Pfizer COVID-19 Vaccine) and then started having symptoms which then required him to have a pacemaker installed. "They tried medication for him because he was passing out and they gave the option of putting in a pacemaker at that time but caller thought that was a little extreme, so did not do it and then, the medication did not really do the tricks, so then caller had to go in and get the pacemaker." No prior vaccination. No investigations. More
2827909 F TX 02/24/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
you can still get Covid, even though you've gotten your boosters and flu shots, second another ... you can still get Covid, even though you've gotten your boosters and flu shots, second another booster, another booster; you can still get Covid, even though you've gotten your boosters and flu shots, second another booster, another booster; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. Vaccination history included: Flu shots, for Covid-19 Immunization; Bnt162b2 (Primary immunization series complete), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 Immunization; Pneumonia shots. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "you can still get Covid, even though you've gotten your boosters and flu shots, second another booster, another booster". Therapeutic measures were taken as a result of drug ineffective, covid-19. More
2827910 M VA 02/24/2025 COVID19
 PFIZER\BIONTECH
Psoriasis Psoriasis
Psoriasis; This is a spontaneous report received from an Other HCP. A male patient received BNT162b... Psoriasis; This is a spontaneous report received from an Other HCP. A male patient received BNT162b2 (COMIRNATY), in 2020 as dose number unknown, 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: PSORIASIS (non-serious), outcome "unknown". Additional information: A Pfizer vaccine sales representative was talking to a physician assistant that shared that he personally experienced a side effect with the Covid vaccine and he wanted to report that incident. He experienced Psoriasis, a very severe case of Psoriasis. The patient got the vaccine many years ago, like 2020. He just shared it with the Pfizer vaccine sales representative. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2827911 F CA 02/24/2025 COVID19
 PFIZER\BIONTECH
Vaccination site pruritus, Vitiligo Vaccination site pruritus, Vitiligo
Vitiligo; the whole area itches/Itching was on the left upper arm where got the vaccine; This is a s... Vitiligo; the whole area itches/Itching was on the left upper arm where got the vaccine; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Melanoma" (unspecified if ongoing), notes: Melanoma was 13 years ago. The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (DOSE 1; SINGLE), for Covid-19 immunization. The following information was reported: VITILIGO (non-serious), outcome "not recovered"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "the whole area itches/Itching was on the left upper arm where got the vaccine". The events "vitiligo" and "the whole area itches/itching was on the left upper arm where got the vaccine" required physician office visit. Therapeutic measures were not taken as a result of vitiligo. Additional information: The patient was not allergic to any previous vaccination, medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The AEs did not require a visit to the Emergency Room. The patient called about second vaccine, for covid. This is the Pfizer Covid Vaccine. Had severe reaction to it. She ended up getting vitiligo. She explained she started to first notice spots. She noticed spot on arm and then the next morning there were more spots. When she started breaking out she did not know what was going on so she went to the dermatologist. That was when she called the dermatologist and saw dermatologist 9 days later after getting the second vaccine. She clarified that she noticed the spots on both the left and right arm. She later added, since she received the second dose of the Pfizer Covid Vaccine the whole area itched. It was not constant, but it woke up at night from scratching the arm. This itching was on the left upper arm where got the vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2827913 M 02/24/2025 COVID19
 PFIZER\BIONTECH
Rash Rash
Broke out in a rash; This is a spontaneous report received from a Consumer or other non HCP. A male... Broke out in a rash; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown, 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: RASH (non-serious), outcome "unknown", described as "Broke out in a rash". Additional information: Reporter stated that his husband got a COVID-19 vaccination back in 2022 and since then he broke out in a rash and they had gone to Dermatologist, gone to allergy doctor, nothing to get rid of it. Reporter wondered if the Pfizer vaccine could have cause it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2827915 F CA 02/24/2025 COVID19
 PFIZER\BIONTECH
Biopsy, Folliculitis Biopsy, Folliculitis
developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or oth... developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 2, 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 (dose 1), for COVID-19 immunization, reaction(s): "folliculitis". The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of folliculitis. Additional information: After taking the 5 Pfizer COVID-19 vaccines between 2021 and 2022 she experienced folliculitis. Caller states that first time the vaccine came out she got it and it started on her scalp. Ended up in clinic and they were not able to help her either and nothing happened because all of the prescription that was given to her did not work, she even had shots in her scalp but did not work, had special medications made in the special pharmacy but did not work. Folliculitis is very painful and nothing could have been done. It started on the scalp and it moved under the scalp now. Had 3 biopsies done by different clinics. Had some outside on her scalp but she used to have a lot on the beginning when it started. Was taking the medications, had shots and she had a lot of different things, it went inside her scalp now. It's no longer 100% on top of the scalp, patient some but not many but most of the spots right now are inside the scalp. When patient touches scalp, feels bumps with the size of a little rice. It started it was like little pimples with little 'pops' on top of it and a lot of them. The thing developed when patient started having this is that it hurts a lot and it itches a lot. Feels like has a rash and has to scratch her head because it bother her. Lost a lot of hair and whenever drives, have the window rolled down, just the air touching her hair, it hurts her. It's painful. It burns a lot. Was specifically diagnosed with 'Folliculitis'. 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-202500038076 same patient, different vaccine doses; More
2827916 F CA 02/24/2025 COVID19
 PFIZER\BIONTECH
Biopsy, Folliculitis Biopsy, Folliculitis
developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or oth... developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 79-year-old female patient received BNT162b2 (COMIRNATY NOS), as dose 4 (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 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis"; Bnt162b2 omicron (kp.2) (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis". The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of folliculitis. Additional information: After taking the 5 Pfizer COVID-19 vaccines between 2021 and 2022 she experienced folliculitis. Caller states that first time the vaccine came out she got it and it started on her scalp. Ended up in clinic and they were not able to help her either and nothing happened because all of the prescription that was given to her did not work, she even had shots in her scalp but did not work, had special medications made in the special pharmacy but did not work. Folliculitis is very painful and nothing could have been done. It started on the scalp and it moved under the scalp now. Had 3 biopsies done by different clinics. Had some outside on her scalp but she used to have a lot on the beginning when it started. Was taking the medications, had shots and she had a lot of different things, it went inside her scalp now. It's no longer 100% on top of the scalp, patient some but not many but most of the spots right now are inside the scalp. When patient touches scalp, feels bumps with the size of a little rice. It started it was like little pimples with little 'pops' on top of it and a lot of them. The thing developed when patient started having this is that it hurts a lot and it itches a lot. Feels like has a rash and has to scratch her head because it bother her. Lost a lot of hair and whenever drives, have the window rolled down, just the air touching her hair, it hurts her. It's painful. It burns a lot. Was specifically diagnosed with 'Folliculitis'. 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-202500038076 same patient, different vaccine doses; More
2827917 F CA 02/24/2025 COVID19
 PFIZER\BIONTECH
Biopsy, Folliculitis Biopsy, Folliculitis
developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or oth... developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 79-year-old female patient received BNT162b2 (COMIRNATY NOS), in 2022 as dose 5 (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 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis"; Bnt162b2 omicron (kp.2) (DOSE 3, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis"; Comirnaty (DOSE 4, SINGLE), for COVID-19 immunization, reaction(s): "folliculitis". The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of folliculitis. Additional information: After taking the 5 Pfizer COVID-19 vaccines between 2021 and 2022 she experienced folliculitis. Caller states that first time the vaccine came out she got it and it started on her scalp. Ended up in clinic and they were not able to help her either and nothing happened because all of the prescription that was given to her did not work, she even had shots in her scalp but did not work, had special medications made in the special pharmacy but did not work. Folliculitis is very painful and nothing could have been done. It started on the scalp and it moved under the scalp now. Had 3 biopsies done by different clinics. Had some outside on her scalp but she used to have a lot on the beginning when it started. Was taking the medications, had shots and she had a lot of different things, it went inside her scalp now. It's no longer 100% on top of the scalp, patient some but not many but most of the spots right now are inside the scalp. When patient touches scalp, feels bumps with the size of a little rice. It started it was like little pimples with little 'pops' on top of it and a lot of them. The thing developed when patient started having this is that it hurts a lot and it itches a lot. Feels like has a rash and has to scratch her head because it bother her. Lost a lot of hair and whenever drives, have the window rolled down, just the air touching her hair, it hurts her. It's painful. It burns a lot. Was specifically diagnosed with 'Folliculitis'. 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-202500038076 same patient, different vaccine doses; More
2827918 64 02/24/2025 FLU3
 SANOFI PASTEUR
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
he vaccinated a 64 year old patient with Fluzone High Dose although the prescribing information says... he vaccinated a 64 year old patient with Fluzone High Dose although the prescribing information says that it is indicated for those 65 and older with no adverse event; Initial information received on 18-Feb-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 64 years old and unknown gender patient who had vaccinated with Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] although the prescribing information says that it is indicated for those 65 and older with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided. On an unknown date, the patient received a unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization) (strength, expiry date was unknown) and he vaccinated a 64 year old patient with fluzone high dose although the prescribing information says that it is indicated for those 65 and older with no adverse event (off label use) (latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. Action taken was not applicable. More
2827919 5 M CO 02/24/2025 IPV
 SANOFI PASTEUR
 W1C831M
Extra dose administered, No adverse event Extra dose administered, No adverse event
administration of extra dose of IPOL with no adverse event; Initial information received on 18-Feb-2... administration of extra dose of IPOL with no adverse event; Initial information received on 18-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who was administered with an extra dose of poliomyelitis vaccine (INACTIVATED) [IPOL] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3) (MMR II) for Immunisation. On 13-Feb-2025, the patient received extra dose with 0.5 ml of IPV (VERO) Suspension for injection with standard strength (lot W1C831M and expiry date- 21-NOV-2025) via intramuscular route in the left thigh as Immunization with no adverse event (extra dose administered) (latency- same day). Reportedly, reporter said that the patient had already received the full series. They wanted to know what adverse events they should be expecting 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
2827920 0.42 F MI 02/24/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK174AB
No adverse event, Product storage error No adverse event, Product storage error
pentacel given post temperature excursion not covered by extended stability with no reported adverse... pentacel given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case was linked to other cases US-SA-2025SA054065, US-SA-2025SA054013, US-SA-2025SA054381, US-SA-2025SA054097, US-SA-2025SA054040. This case involves a 5 months old female patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] post temperature excursion not covered by extended stability 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 reassort oral 5V (rotateq) and pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20), both for Immunisation. On 14-Feb-2025, the patient received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of standard strength once with lot UK174AB and expiry date 31-Mar-2026 via intramuscular route in right leg for immunization post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (Latency same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA054065:FLUZONE HD Patient 1 US-SA-2025SA054013:FLUZONE HD Patient 2 US-SA-2025SA054381:ADACEL US-SA-2025SA054097:PENTACEL Patient 1 US-SA-2025SA054040:PENTACEL Patient 3 More
2827922 4 F WA 02/24/2025 MMRV
 MERCK & CO. INC.
 Y012594
Extra dose administered Extra dose administered
Patient was given a 3rd dose of MMR. First 2 doses were given on 11/14/2022 and 09/21/2021. Patient ... Patient was given a 3rd dose of MMR. First 2 doses were given on 11/14/2022 and 09/21/2021. Patient should have only been given Varicella vaccine, not MMRV. More
2827923 75 F NY 02/24/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7ZM55
Erythema Erythema
Redness at the area with no swelling noted Redness at the area with no swelling noted
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