🏥 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 💀 🏥 🚑 ♿ ⚠️
2818140 F IL 12/26/2024 COVID19
FLUX
RVX
COVID19
FLUX
RVX
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER


UNK
UNK
UNK
Chills, Headache, Myalgia, Pain in extremity, Pruritus; Chills, Headache, Myalgi... Chills, Headache, Myalgia, Pain in extremity, Pruritus; Chills, Headache, Myalgia, Pain in extremity, Pruritus; Chills, Headache, Myalgia, Pain in extremity, Pruritus; Chills, Headache, Myalgia, Pain in extremity, Pruritus; Chills, Headache, Myalgia, Pain in extremity, Pruritus; Chills, Headache, Myalgia, Pain in extremity, Pruritus More
SORE ARMS; chills, especially at night; muscle aches; headache; some itching on the top of her head;... SORE ARMS; chills, especially at night; muscle aches; headache; some itching on the top of her head; Initial information received on 19-Dec-2024 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional(patient). The case is linked to US-SA-2024SA380026. This case involves a 71 years old female patient (71.202 kg) who had sore arms, chills, especially at night, muscle aches, headache and some itching on the top of her head after receiving RSV vaccine, COVID-19 vaccine and Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Modafinil (Modafinil); Cetirizine hydrochloride (Zyrtec); Trazodone hydrochloride (Trazodone HCL); Clonazepam ; Fluoxetine hydrochloride (Prozac); Ascorbic acid (Vitamin C); Colecalciferol (Vitamin d3); and Calcium . On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, a dose of suspect COVID-19 vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site nd a dose of suspect RSV vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for all the prophylactic vaccination (Immunization) (dosage, strength, expiry date formulation was unknown for all the suspects). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested. On 16-Dec-2024 the patient developed sore arms (pain in extremity), chills, especially at night (chills) , muscle aches (myalgia),headache and some itching on the top of her head (pruritus) (unknown latency) following the administration of Influenza Vaccine, COVID-19 vaccine and RSV vaccine. Reportedly "PATIENT REPORTS HER DOSE WAS DUE ON 12/16/2024.SO SHE DID NOT TAKE HER DOSE.NO TEMPURATURE" Action taken was not applicable for all the events. It was not reported if the patient received a corrective treatment for the events (SORE ARMS, muscle aches, headache, chills, especially at night, some itching on the top of her head). At time of reporting, the outcome was Unknown for all the events.; Sender's Comments: US-SA-2024SA380026:link case id More
2824987 U WV 02/06/2025 PNC15
PNC20
 MERCK & CO. INC.
PFIZER\WYETH

Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
no additional adverse event was reported; then PREVNAR 20 was mistakenly administered on 2/3/2025 to... no additional adverse event was reported; then PREVNAR 20 was mistakenly administered on 2/3/2025 to the same patient at a different location; This spontaneous report was received from Other Health Professional and refers to a. The patient's medical history was not reported. The patient's concurrent conditions included prophylaxis. Concomitant therapies were not reported. On 23-OCT-2024, the patient was vaccinated with first dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 03-FEB-2025, the patient was mistakenly vaccinated with pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided) (Wrong product administered). No additional adverse event was reported. More
2824988 0.5 U MI 02/06/2025 PNC21
 MERCK & CO. INC.
 Y011819
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE. No PQC.; HCP called to report that a 6 month old was inadvertently administered CA... No additional AE. No PQC.; HCP called to report that a 6 month old was inadvertently administered CAPVAXIVE on 02/04/2025. No additional information was provided. Caller did not provide full patient demographic information. Permission given to contact HCP. No additional AE. No; This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-FEB-2025, the patient was vaccinated with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE), strength 168 microgram per milliliter (mcg/ml) injection, (valid lot number Y011819, expiration date: 01-OCT-2025 upon internal review (reported as 11-OCT-2025, conflicting information) administered for prophylaxis (dose, anatomical location, route of administration was not provided) (product administered to patient of inappropriate age). No additional adverse event (AE). More
2824989 U 02/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never got the 2nd dose yet; This non-serious case was reported by a consumer via interactive digital... never got the 2nd dose yet; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine in 2019). 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: never got the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 13-JAN-2025 This case was reported by a patient via interactive digital media. The patient was enquiring whether he/she should start again from the 1st dose at this moment if he/she want to get shingrix or it was ok to get only 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2824990 U 02/06/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; I did get the 2 shot vaccine a few years ago and got the shingles; Th... Suspected vaccination failure; I did get the 2 shot vaccine a few years ago and got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I did get the 2 shot vaccine a few years ago and got the shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 30-JAN-2025 This case was reported by the patient via interactive digital media. The patient got the 2 shots of vaccine a few years ago and got the shingles last year and it was mild, so it helped. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose )and Shingles vaccine(2nd dose). More
2824991 U 02/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Diplopia, Vertigo Diplopia, Vertigo
I developed vertigo and double vision, 6 weeks after my first Shingrix shot; I developed vertigo and... I developed vertigo and double vision, 6 weeks after my first Shingrix shot; I developed vertigo and double vision, 6 weeks after my first Shingrix shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced vertigo (Verbatim: I developed vertigo and double vision, 6 weeks after my first Shingrix shot) and double vision (Verbatim: I developed vertigo and double vision, 6 weeks after my first Shingrix shot). The outcome of the vertigo and double vision were not reported. It was unknown if the reporter considered the vertigo and double vision to be related to Shingrix. It was unknown if the company considered the vertigo and double vision to be related to Shingrix. Additional Information: GSK Receipt Date: 03-FEB-2025 The reporter from digital media of GlaxoSmithKline that he/she received first dose of Shingrix vaccine and experienced vertigo and double vision in 6 weeks. The reporter asked that the Vertigo was known side effect of Shingrix. Two months had passed from first vaccination. More
2824992 F CA 02/06/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Pain, Scab, Vaccination failure; Herpes zoster, Pain, Scab, Vacci... Herpes zoster, Pain, Scab, Vaccination failure; Herpes zoster, Pain, Scab, Vaccination failure More
Suspected vaccination failure; got shingles/shingles across my back, under my arm and across my ches... Suspected vaccination failure; got shingles/shingles across my back, under my arm and across my chest; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles.shingles across my back, under my arm and across my chest). The patient was treated with valaciclovir hydrochloride (Valtrex). 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 and Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 31-JAN-2025 The reporter requested that change the advertising because it is deceptive. The reporter was 78 year old woman who has had both shingles shots and got shingles. Needless to say, the reporter and everyone to know was led to believe, through they advertising that, if you got both shingles shots, you would not got shingles. At first, the reporter thought it was just her. But every one told, about 25 people, all asked if the reporter had gotten the shots because if so, the reporter would not get shingles. It turns out that, if they did get shingles, supposedly they get a milder case So the reporter been through a Valtrex prescription and shingles across the patient back, under arm and across chest. Just as it was done scabbing 4 weeks ago and after the worst pain the patient had ever had, it was starting up again in distinct places. The reporter requested to please change there false advertising that leaves people thinking they would not get. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(1st dose) and Shingles vaccine(2nd dose) More
2824993 U 02/06/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Malaise Malaise
feeling very sick after taking Arexvy; This non-serious case was reported by a consumer via call cen... feeling very sick after taking Arexvy; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: feeling very sick after taking Arexvy). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Arexvy. It was unknown if the company considered the sickness to be related to Arexvy. Additional Information: GSK receipt date: 03-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she was feeling very sick after taking Arexvy vaccine. More
2824994 U 02/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product administered at inappropriate site Product administered at inappropriate site
When I was given my first Shingrix shot, it was injected into my tricep; This non-serious case was r... When I was given my first Shingrix shot, it was injected into my tricep; This non-serious case was reported by a consumer via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: When I was given my first Shingrix shot, it was injected into my tricep). The outcome of the vaccine administered at inappropriate site was unknown. Additional Information: GSK Receipt Date: 02-FEB-2025 The reporter reported that when the patient was given my first Shingrix shot, it was injected into my tricep which led to vaccine administered at inappropriate site. The reporter asked should not the shot be injected into the deltoid. More
2824995 U 02/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Skin reaction Skin reaction
skin reaction; This non-serious case was reported by a consumer and described the occurrence of skin... skin reaction; This non-serious case was reported by a consumer and described the occurrence of skin reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin reaction (Verbatim: skin reaction). The outcome of the skin reaction was not resolved. It was unknown if the reporter considered the skin reaction to be related to Shingrix. It was unknown if the company considered the skin reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 03-FEB-2025 The reporter reported that he/she just got the Shingrix vaccine. He/she was not told that there were 2 shots. He/she had a skin reaction after the first dose which had not gone away. More
2824996 U 02/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
I had a dose of Shingrix on 10/25/2020 and a second on 10/11/203; This non-serious case was reported... I had a dose of Shingrix on 10/25/2020 and a second on 10/11/203; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 25-OCT-2020). On 11-OCT-2023, the patient received the 2nd dose of Shingrix. On 11-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I had a dose of Shingrix on 10/25/2020 and a second on 10/11/203). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 31-JAN-2025 The reporter reported that the patient received first dose on 25th October 2020 and second dose received on 11th October 2023, which led to drug dose administration interval too long. More
2824997 F AR 02/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Erythema Erythema
breakout of red dots around her mouth/ looking like fever blisters before they blistered; This non-s... breakout of red dots around her mouth/ looking like fever blisters before they blistered; This non-serious case was reported by a consumer via call center representative and described the occurrence of red spotty rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced red spotty rash (Verbatim: breakout of red dots around her mouth/ looking like fever blisters before they blistered). The outcome of the red spotty rash was unknown. It was unknown if the reporter considered the red spotty rash to be related to Shingrix. It was unknown if the company considered the red spotty rash to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JAN-2025 Reporter was the patient who received her first dose of Shingrix a little over a week ago (from the date of reporting). She stated that the day after the vaccination, she experienced a breakout of red dots around her mouth. She described it as looking like fever blisters before they blistered. More
2824998 78 F FL 02/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Erythema, Injection site pain, Swelling face Erythema, Injection site pain, Swelling face
pain at the injection site; redness on her left shoulder/ redness on her face around her cheekbones;... pain at the injection site; redness on her left shoulder/ redness on her face around her cheekbones; swelling on her face around her cheekbones; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date). In JAN-2025, the patient received the 2nd dose of Shingrix (left arm). In JAN-2025, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site), redness (Verbatim: redness on her left shoulder/ redness on her face around her cheekbones) and facial swelling (Verbatim: swelling on her face around her cheekbones). The patient was treated with loratadine. The outcome of the injection site pain, redness and facial swelling were unknown. It was unknown if the reporter considered the injection site pain, redness and facial swelling to be related to Shingrix. It was unknown if the company considered the injection site pain, redness and facial swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JAN-2025 Reporter was the patient who received her second dose of Shingrix 3 days ago (from date of reporting). She experienced pain at the injection site (left arm) and redness on her left shoulder. She said that the pain was to the touch and did not restrict any daily activities. She also had redness and swelling on her face around her cheekbones. Her pharmacist recommended to start an antihistamine for the swelling and the patient took a 10 milligram dose of loratadine. More
2824999 0.5 F TX 02/06/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Inappropriate Reconstitution Technique; administered the diluent only portion of Hiberix; This non-s... Inappropriate Reconstitution Technique; administered the diluent only portion of Hiberix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 6-month-old female patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient received the 1st dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique) and inappropriate preparation of medication (Verbatim: administered the diluent only portion of Hiberix). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist states she was contacted by a clinic staff member who was concerned that they might have administered the diluent only portion of Hiberix to a patient within the past 1 to 2 months. The staff does not know for sure if this happened and did not know which patient it would have been, but they did have it narrowed down to 5 patients, of which one of them could have received diluent only, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. It was possible that the 5 patients might all be given another dose, but at the time of reporting this decision has not been made. The reporter consented to follow up. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025002649:Same reporter/Different patient US-GSK-US2025002647:Same reporter/Different patient US-GSK-US2025002645:Same reporter/Different patient US-GSK-US2025002639:Same reporter/Different patient More
2825000 0.33 F TX 02/06/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Inappropriate Reconstitution Technique; administered the diluent only portion of Hiberix; This non-s... Inappropriate Reconstitution Technique; administered the diluent only portion of Hiberix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old female patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient received the 1st dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: administered the diluent only portion of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist states she was contacted by a clinic staff member who was concerned that they might have administered the diluent only portion of Hiberix to a patient within the past 1 to 2 months. The staff does not know for sure if this happened and did not know which patient it would have been, but they did have it narrowed down to 5 patients, of which one of them could have received diluent only, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. It was possible that the 5 patients might all be given another dose, but at the time of reporting this decision has not been made. The reporter consented to follow up. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025002645:Same reporter/Different Patient US-GSK-US2025002649:Same reporter/Different Patient US-GSK-US2025002647:Same reporter/Different Patient US-GSK-US2025002641:Same reporter/Different patient More
2825001 F TX 02/06/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Inappropriate Reconstitution Technique; diluent only portion of Hiberix; This non-serious case was r... Inappropriate Reconstitution Technique; diluent only portion of Hiberix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a infant female patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient received the 1st dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique) and inappropriate preparation of medication (Verbatim: diluent only portion of Hiberix). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist states she was contacted by a clinic staff member who was concerned that they might have administered the diluent only portion of Hiberix to a patient within the past 1 to 2 months. The staff does not know for sure if this happened and did not know which patient it would have been, but they did had it narrowed down to 5 patients, of which one of them could have received diluent only, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. It was possible that the 5 patients might all be given another dose, but at the time of reporting this decision has not been made. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025002645:Same reporter/Different Patient US-GSK-US2025002639:Same reporter/Different Patient US-GSK-US2025002641:Same reporter/Different patient US-GSK-US2025002649:Same reporter/Different patient More
2825002 0.42 F TX 02/06/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Inappropriate Reconstitution Technique; Inappropriate dose of vaccine administered portion of Hiberi... Inappropriate Reconstitution Technique; Inappropriate dose of vaccine administered portion of Hiberix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 5-month-old female patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient received the 1st dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered portion of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist states she was contacted by a clinic staff member who was concerned that they might have administered the diluent only portion of Hiberix to a patient within the past 1 to 2 months. The staff does not know for sure if this happened and did not know which patient it would have been, but they did have it narrowed down to 5 patients, of which one of them could have received diluent only, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. It was possible that the 5 patients might all be given another dose, but at the time of reporting this decision has not been made. The reporter consented to follow up. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025002641:Same reporter/Different patient US-GSK-US2025002639:Same reporter/Different Patient US-GSK-US2025002649:Same reporter/Different Patient US-GSK-US2025002647:Same reporter/Different Patient More
2825003 50 M MN 02/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 TY7MZ
Wrong product administered Wrong product administered
patient incorrectly received the Shingrix instead of the Varicella vaccine.; This non-serious case w... patient incorrectly received the Shingrix instead of the Varicella vaccine.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number TY7MZ, expiry date 29-OCT-2026) for prophylaxis. Co-suspect products included Varicella (Varicella vaccine) for prophylaxis. On 03-JAN-2025, the patient received Shingrix. On an unknown date, the patient did not receive Varicella vaccine. On 03-JAN-2025, an unknown time after receiving Shingrix and Varicella vaccine, the patient experienced wrong vaccine administered (Verbatim: patient incorrectly received the Shingrix instead of the Varicella vaccine.). The outcome of the wrong vaccine administered was unknown. Additional Information: GSK Receipt Date: 13-JAN-2025 The public health nurse reported that the patient was completing his process for which he needed to receive the Varicella vaccine but he was administered the Zoster (Shingrix) instead at 10 days ago. The reporter asked can they administer the varicella vaccine after the Shingrix and how long should they wait to administer the varicella vaccine. The reporter confirmed that the patient incorrectly received the Shingrix instead of the Varicella vaccine, which led to wrong vaccine administered. More
2825004 70 F MS 02/06/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
Injection site pain Injection site pain
injection site soreness; This non-serious case was reported by a consumer via call center representa... injection site soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concomitant products included Influenza vaccine. In SEP-2024, the patient received Arexvy (intramuscular, right deltoid). In SEP-2024, less than a day after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site soreness). The outcome of the injection site pain was not resolved. It was unknown if the reporter considered the injection site pain to be related to Arexvy. It was unknown if the company considered the injection site pain to be related to Arexvy. Additional Information: GSK Receipt Date: 13-JAN-2025 The patient self-reported this case. The patient received her Arexvy vaccine and her flu shot (manufacturer unknown) and her right deltoid became sore at the injection site on the day of the injection and had not yet resolved and it was still sore. The patient denied redness, swelling or warmth at the injection site and had not yet seen her doctor since her vaccination, and didn't plan to see him until April 2025 More
2825005 53 F KY 02/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Swelling face Swelling face
bump near eye; This non-serious case was reported by a consumer via call center representative and d... bump near eye; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (Shingles near eye). Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). On 18-MAR-2019, the patient received the 2nd dose of Shingrix. On an unknown date, 1 year after receiving Shingrix, the patient experienced swelling (Verbatim: bump near eye). The outcome of the swelling was not resolved. It was unknown if the reporter considered the swelling to be related to Shingrix. It was unknown if the company considered the swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 29-JAN-2025 The patient self-reported this case for herself. The patient had a history of shingles, near her eye (did not mention a side). The patient had dose 2 of Shingrix. The patient state a year later she had a bump near her eye in the same place where she had shingles bump. It comes and goes and healthcare professional would order valacyclovir that she takes when it comes back. The patient's healthcare professional recommended she gets a booster of Shingrix. More
2825006 18 U TN 02/06/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVA993A
Expired product administered Expired product administered
Expired vaccine; This non-serious case was reported by a nurse via call center representative and de... Expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A, expiry date 31-DEC-2024) for prophylaxis. On 31-JAN-2025, the patient received Menveo .5 ml. On 31-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired vaccine). The outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 31-JAN-2025 The Healthcare Professional reported that a medical assistant administered the Menveo vaccine to a pair of twins and the dosage was 0.5 ml. But it had expired on 31st December 2024, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. This case is linked with US2025013445, reported by same reporter.; Sender's Comments: US-GSK-US2025013445:twin patients with same initials More
2825007 M KY 02/06/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
child of 5 years of age was given Twinrix adult formulation; Adult product administered to child; Th... child of 5 years of age was given Twinrix adult formulation; Adult product administered to child; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 5-year-old male patient who received HAB (Twinrix) for prophylaxis. On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced overdose (Verbatim: child of 5 years of age was given Twinrix adult formulation) and adult product administered to child (Verbatim: Adult product administered to child). The outcome of the overdose and adult product administered to child 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: 04-FEB-2025 The healthcare professional reported a child of 5 years of age was given Twinrix adult formulation which led to overdose and adult product administered to child. More
2825008 F 02/06/2025 COVID19
 JANSSEN
Myocarditis Myocarditis
MYOCARDITIS; This spontaneous report received from a consumer concerned a female patient of unspecif... MYOCARDITIS; This spontaneous report received from a consumer concerned a female patient of unspecified age via social media. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose and frequency not reported, administered on Mar-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 21-Dec-2021, the patient experienced myocarditis. (dose series 1) The reporter did some research and found that myocarditis was a side-effect of Pfizer vaccine. the reporter informed if myocarditis is listed, then the reporter will be going to the lawyer. It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable. Reported cause of death was myocarditis. The patient died of myocarditis on 21-Dec-2021. The reporter considered the causality between janssen covid-19 vaccine and myocarditis as related. Company causality between janssen covid-19 vaccine and myocarditis as possible. This report was serious (death).; Sender's Comments: V0; Myocarditis; The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: myocarditis More
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2825009 M 02/06/2025 COVID19
 MODERNA
Guillain-Barre syndrome Guillain-Barre syndrome
guillain barre syndrome; This spontaneous case was reported by a patient family member or friend and... guillain barre syndrome; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GUILLAIN-BARRE SYNDROME (guillain barre syndrome) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced GUILLAIN-BARRE SYNDROME (guillain barre syndrome) (seriousness criteria disability and medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (guillain barre syndrome) outcome was unknown. No concomitant medication was reported. He received three of Moderna COVID vaccinations back in 2021. He developed particular autoimmune disease and was disabled. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
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2825010 35 F 02/06/2025 RSV
 PFIZER\WYETH
 KD0161
Exposure during pregnancy, Injection site cellulitis Exposure during pregnancy, Injection site cellulitis
Cellulitis of arm / where the vaccine was injected; This is a spontaneous report received from a Phy... Cellulitis of arm / where the vaccine was injected; This is a spontaneous report received from a Physician. A 35-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 12Nov2024 as dose 1, 0.5ml single (Lot number: KD0161) at the age of 35 years, in left deltoid for maternal immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), (Lot number: 3RE73) for immunization and IRON. It was reported the Tdap vaccine was administered about four weeks before rsv vaccine prot.subunit pref 2v (ABRYSVO), date unspecified. The following information was reported: VACCINATION SITE CELLULITIS (medically significant), outcome "unknown", described as "Cellulitis of arm / where the vaccine was injected". Therapeutic measures were taken as a result of vaccination site cellulitis. The patient took clindamycin, antibiotics. Causality for "cellulitis of arm / where the vaccine was injected" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible.; Sender's Comments: Based on the temporal relationship and location, the association between the event vaccination site cellulitis with ABRYSVO can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. More
2825011 4 M MI 02/06/2025 IPV
 SANOFI PASTEUR
 W1C83IM
No adverse event, Product storage error No adverse event, Product storage error
ipol vials punctured and they were also administered post excursion to 3 patients.the temperature re... ipol vials punctured and they were also administered post excursion to 3 patients.the temperature reached 8.1 degrees c for 6 minutes with no ae; Initial information received on 21-Nov-2024 regarding an unsolicited non-valid non-serious case received from Nurse. This case is linked to US-SA-2024SA351869 This case involves, a 4 year old child male patient who was administered punctured vials IPV (Vero) [IPOL] post excursion and.the temperature reached 8.1 degrees c for 6 minutes with no adverse event The unspecified patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Nov-2024, the unspecified patient received 0.5 ml dose of suspect punctured IPV (VERO) Suspension for injection post excursion (lot-W1C83IM, expiry date: 21-Nov-2025) (strength was unknown) via intramuscular route in left thigh as prophylactic vaccination and the temperature reached 8.1 degrees c for 6 minutes with no adverse event (poor quality product administered) (latency: same day). Reportedly, There had been no adverse event at this time. 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. Additional information regarding the unsolicited valid non-serious case received on 03-Feb-2025; follow up information includes gender, route, Anatomical Location, dosage, start date, expiry date, batch number, clinical course added, indication updated and narrative amended accordingly.; Sender's Comments: US-SA-2024SA351869:linked case More
2825103 39 F NV 02/06/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 423NL
Underdose Underdose
Pediatric dose given to adult Pediatric dose given to adult
2825104 14 F CO 02/06/2025 UNK
 UNKNOWN MANUFACTURER
 7GF79
Erythema, Peripheral swelling, Skin tightness, Skin warm, Urticaria Erythema, Peripheral swelling, Skin tightness, Skin warm, Urticaria
6-8 hives on left arm, swollen, erythematous, hot to touch, tight without normal elasticity; treatme... 6-8 hives on left arm, swollen, erythematous, hot to touch, tight without normal elasticity; treatment currently is ice to arm, benadryl, ibuprofen, hydrocortisone cream 1% with return precautions if it worsens More
2825105 70 F 02/06/2025 COVID19
COVID19
 MODERNA
MODERNA
 8081564
8081564
Injection site erythema, Injection site pain, Injection site reaction, Joint sti... Injection site erythema, Injection site pain, Injection site reaction, Joint stiffness, Musculoskeletal stiffness; Pyrexia More
patient reported injection site reaction --- large redness/tenderness--- low grade fever --- reporte... patient reported injection site reaction --- large redness/tenderness--- low grade fever --- reported severe stiffness in neck, knee, arm (injection site arm) -- patient reported going to ER and was treated/discharged with medication More
2825119 0.17 U IN 02/06/2025 PPV
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
A 2 month old infant in our facility was given PPSV23. What action do you recommend?"; No addit... A 2 month old infant in our facility was given PPSV23. What action do you recommend?"; No additional AEs were reported.; This spontaneous report was received from pharmacist and refers to a 2-month-ol 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 with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No additional AEs were reported (Product administered to patient of inappropriate age). More
2825120 69 F NC 02/06/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 388474
388474
Headache, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, ... Headache, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Malaise; Muscle tightness, Pain More
It's travelling up my neck, the tightness; Perhaps some of the fluid leaked into the tissue; It... It's travelling up my neck, the tightness; Perhaps some of the fluid leaked into the tissue; It's like my muscles are paralyzed; Motion difficulty in the arm that took the needle; Restriction in the movements of my arm / can't put my arm over my head; Restriction in the movements of my arm / it's like an ache, not a pain, it's not a 10 it's more like an 8; Fingers are getting numb on my left side; Slight headaches; Malaise; Injection site sore; This spontaneous case, initially received on 27-Jan-2025, was reported by a non health professional and concerns an elderly female patient. No medical history or concomitant medications were reported. Administration of company suspect drug: On 07-Jan-2025, the patient received Fluad (TIV) for an unknown indication, dose, anatomical location and route of administration: not reported. Lot number: 388474. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Jan-2025, the patient experienced , Injection site sore (outcome: Recovered / Resolved). On 10-Jan-2025, the patient experienced Restriction in the movements of my arm / can't put my arm over my head (outcome: Not recovered / Not resolved), Restriction in the movements of my arm / it's like an ache, not a pain, it's not a 10 it's more like an 8 (outcome: Not recovered / Not resolved),It's like my muscles are paralyzed (Medically Significant, outcome: Not recovered / Not resolved), Motion difficulty in the arm that took the needle (outcome: Not recovered / Not resolved), Fingers are getting numb on my left side (outcome: Not recovered / Not resolved), Slight headaches (outcome: Not recovered / Not resolved), Malaise (outcome: Not recovered / Not resolved). On an unknown date, the patient experienced It's travelling up my neck, the tightness (outcome: Not recovered / Not resolved), Perhaps some of the fluid leaked into the tissue (outcome: Not recovered / Not resolved). Patient reported that recently got the Fluad and has been having some reactions in terms of motion difficulty in the arm that took the needle. She took the injection on 07-Jan-2025, and got the injection site sore, and that went away, and then by 09-Jan-2025 or 10-Jan-2025 started to notice restriction in the movements of her arm. It was like an ache, not a pain, it was not a 10 it was more like an 8. She couldn't put her arm over her head. Her fingers were getting numb on her left side. It was like her muscles were paralyzed, it was weird. And she was also getting slight headaches and malaise. She called her immunologist a couple of days after, and he said that of course it was going to be sore, he advised intermittent ice and anti-inflammatory. Called him back at the 14-Jan-2025 and he said it could still take a while. But what she was noticing was that it was not getting better, it was travelling up her neck, the tightness. Referred that was taking the anti-inflammatory as needed, and that never experienced any kind of allergic reaction to any other vaccine. Added that it made she wonder on the administration of the shot, like it went into the muscle, but perhaps some of the fluid leaked into the tissue, she did not know, but this one hurt. Fluad (TIV) action taken: Not Applicable Treatment medication: ice and unspecified anti-inflammatory Reporter assessment: the reporter considered the seriousness as unknown and did not provide a causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purpose. Related for injection site events, administration site movement pain due to anatomic proximity. Related for the rest of the events due to plausible temporal relationship of around 3 days post vaccination. More
2825121 66 M DE 02/06/2025 PNC20
 PFIZER\WYETH
Extra dose administered, Injection site pain Extra dose administered, Injection site pain
Mistakenly had his doctor office give him another shot of Prevnar; Pain in his upper arm at the site... Mistakenly had his doctor office give him another shot of Prevnar; Pain in his upper arm at the site; This is a spontaneous report received from a consumer. A 66-year-old male patient received Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), on 29Jan2025 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol increased. Vaccination history included: Prevnar 20 (DOSE 1), administration date: 13Jan2024, when the patient was 65-year-old, for Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 29Jan2025, outcome "unknown", described as "Mistakenly had his doctor office give him another shot of Prevnar"; VACCINATION SITE PAIN (non-serious) with onset 2025, outcome "recovered" (2025), described as "Pain in his upper arm at the site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain. Additional Information: No other vaccine administered on the same date of the suspect product. This is in reference to Prevnar 20. The patient wanted to know what Pfizer has in reference to somebody that has taken Prevnar 20 and what do they think would happen if that person takes another Prevnar 20 (or possibly Prevnar 13; pending clarification) just over a year later because the patient was told that Prevnar 20 is good for life. The patient mistakenly had his doctor office give him another shot (second dose) of Prevnar on 29Jan2025; he took the first dose of Prevnar 20 on 13Jan2024. The patient had no side effects except the pain in his upper arm at the site where it was injected so and it was like 4 to 5 days ago. Regarding the adverse event, that's the normal thing for an injection according to the patient. The patient only had that pain there for about a day it's gone too now. It's normal to experience that thing. The patient didn't have any problem with that. So, the patient was not having any problem. That was it and no other problems. The patient was just wondering what Pfizer says about somebody that got it, and it is just over a year later. They said it was good for five years so would that be the Prevnar 13 or that wouldn't be the Prevnar 20. 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
2825122 M PA 02/06/2025 RSV
 PFIZER\WYETH
Anxiety, Nervousness Anxiety, Nervousness
He is wanting to know if jumpiness or a feeling of jumpiness or anxiety; He is wanting to know if ju... He is wanting to know if jumpiness or a feeling of jumpiness or anxiety; He is wanting to know if jumpiness or a feeling of jumpiness or anxiety; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 84-year-old male patient 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: ANXIETY (non-serious), NERVOUSNESS (non-serious), outcome "unknown" and all described as "He is wanting to know if jumpiness or a feeling of jumpiness or anxiety". Additional information: Caller just stated Pfizer RSV shot. He doesn't know the name of it. He is wanting to know if jumpiness or a feeling of jumpiness or anxiety, If that could be a side effect of it or if that wears off. Caller stated "I noticed it 2 - 3 days ago. I was wondering if that could be, Is that a side effect of the RSV shot." The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received. More
2825123 34 F 02/06/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Back pain, Fatigue, Lethargy, Pain; Back pain, Fatigue, Lethargy, Pain Back pain, Fatigue, Lethargy, Pain; Back pain, Fatigue, Lethargy, Pain
Lower back pain; body aches; lethargy; tiredness; This is a spontaneous report received from a Consu... Lower back pain; body aches; lethargy; tiredness; This is a spontaneous report received from a Consumer or other non HCP. A 34-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Penicillin Allergy" (unspecified if ongoing). Concomitant medication(s) included: NORTREL [LEVONORGESTREL]. The following information was reported: BACK PAIN (non-serious) with onset Nov2024, outcome "recovered" (Nov2024), described as "Lower back pain"; PAIN (non-serious) with onset Nov2024, outcome "recovered" (Nov2024), described as "body aches"; LETHARGY (non-serious) with onset Nov2024, outcome "recovered" (Nov2024); FATIGUE (non-serious) with onset Nov2024, outcome "recovered" (Nov2024), described as "tiredness". Therapeutic measures were not taken as a result of back pain, pain, lethargy, fatigue. Additional information: No prolonged hospitalization for Lower back pain; tiredness and lethargy; body aches. The patient did not receive any other vaccines within 4 weeks prior to the vaccine for which they are reporting. The patient taking other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2825124 63 U IL 02/06/2025 COVID19
 PFIZER\BIONTECH
Brain fog Brain fog
brain fog; This is a spontaneous report received from a Nurse. A 67-year-old patient received BNT16... brain fog; This is a spontaneous report received from a Nurse. A 67-year-old patient received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 09Apr2021, when the patient was 63-year-old, for COVID-19 immunisation. The following information was reported: BRAIN FOG (non-serious), outcome "not recovered". Additional information: Brain fog began after the second COVID vaccination. 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-PV202400148524 same patient, same product, different dose and similar event; More
2825125 2 M MD 02/06/2025 DTAP
 SANOFI PASTEUR
 3CA25C1
Extra dose administered, No adverse event Extra dose administered, No adverse event
patient received DAPTACEL two days in a row with no reported adverse event; Initial information rece... patient received DAPTACEL two days in a row with no reported adverse event; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 27 months old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] two days in a row with no reported adverse. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB vaccine; Hepatitis a vaccine; Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and Fluvacil for Immunisation. On 30-Jan-2025, the patient received 0.5 ml (dose 2) of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) ( lot 3CA25C1 and expiry date: 30-Apr-2026) via unknown route in the right thigh and on 31-Jan-2025 he again received 0.5 ml (dose 3 ) of the same vaccine, two days in a row, with an unknown batch number and expiry date (strength: standard, frequency twice) via unknown route in the left vastus lateralis for Immunization (extra dose administered) (latency: same day). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested Action taken was not applicable. Reportedly, Pediatric charge nurse reported that a patient received DAPTACEL two days in a row, yesterday and today. Patient only needed 1 shot of the vaccine. Nurse wanted to make sure that patient is not going to have any adverse reactions. Nurse said that patient missed a bunch of shots so the DAPTACEL dose yesterday was only the patient's second dose. Today's extra dose is the third. Nurse mentioned it was a medical assistant who administered both of the injections. 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
2825137 73 F NY 02/06/2025 PNC20
 PFIZER\WYETH
 LG5576
Chills, Headache, Pain, Sensitive skin Chills, Headache, Pain, Sensitive skin
Woke up next morning with chills, body aches, headache, and the skin sensitivity you get when you ar... Woke up next morning with chills, body aches, headache, and the skin sensitivity you get when you are sick and have a fever. Took Tylenol . Body ache and headache diminished. The skin sensitivity (cutaneous hyperesthesia) remains to this day. I saw the P.A. Who recommended seeing allergy dr. However I don?t believe it?s an allergy. I have an appointment with blood doctor, who I hope will check my blood. Then I will see my dermatologist. It?s very frustrating not to know where to go or who to talk to. More
2825138 37 F NY 02/06/2025 COVID19
COVID19
UNK
UNK
 MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Amyotrophic lateral sclerosis, Blood creatine phosphokinase increased, Chills, E... Amyotrophic lateral sclerosis, Blood creatine phosphokinase increased, Chills, Electromyogram abnormal, Hyperhidrosis; Immediate post-injection reaction, Pyrexia; Amyotrophic lateral sclerosis, Blood creatine phosphokinase increased, Chills, Electromyogram abnormal, Hyperhidrosis; Immediate post-injection reaction, Pyrexia More
Fever, shivering and sweating for 3-4 days immediately after the vaccine. In 01/2023, started develo... Fever, shivering and sweating for 3-4 days immediately after the vaccine. In 01/2023, started developing symptoms of ALS and was diagnosed with ALS in 01/2024. More
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2825139 80 F FL 02/06/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Pain in extremity Pain in extremity
Patient reported a sore arm Patient reported a sore arm
2825140 80 F FL 02/06/2025 PNC20
 PFIZER\WYETH
 LK6650
Pain in extremity Pain in extremity
Patient reports a sore arm Patient reports a sore arm
2825141 65 M TN 02/06/2025 RSV
 PFIZER\WYETH
 KC7884
Injection site haemorrhage, Injection site pain, Product preparation issue Injection site haemorrhage, Injection site pain, Product preparation issue
WHILE PREPARING THE VACCINE I CLEANED THE TOP OF THE VACCINE VIAL WITH ALCOHOL AND ATTACHED THE ADAP... WHILE PREPARING THE VACCINE I CLEANED THE TOP OF THE VACCINE VIAL WITH ALCOHOL AND ATTACHED THE ADAPTER TO THE DILUENT SYRINGE. I WAS INTERUPTED AND DID NOT PRESS THE SYRINGE TO MIX THE DILUENT WITH THE POWDER, BUT INSTEAD TOOK THE SYRINGE OFF AND PREPARED IT WITH A NEEDLE. WHEN THE IM DOSE WAS GIVEN THE PATIENT'S ARM BLED A LITTLE AND HE SAID THAT IT STUNG. I WAS CONCERNED AND LOOKED AT THE VIAL OF ABRYSVO THAT I HAD USED AND REALIZED THAT I HAD NOT MIXED IT. I APPOLOGIZED AND HE CHOSE TO GET A NEW DOSE OF ABRYSVO IN THE OPPOSITE ARM. I CALLED HIM AT 7:47 PM THAT NIGHT AND HE ASSURED ME THAT HE WAS FINE AND THAT "I DIDN'T HURT A THING" More
2825142 76 F OH 02/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 M7G39
Product preparation issue Product preparation issue
Patient was only administered the diluent, not the actual vaccine. When this was discovered, manage... Patient was only administered the diluent, not the actual vaccine. When this was discovered, management was notified by phone. More
2825143 89 M FL 02/06/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 X357E
Extra dose administered, No adverse event Extra dose administered, No adverse event
PATIENT RECEIVED A DUPLICATE VACCINE ON 07/20/2024. NO ADVERSE EVENTS WERE APPARENT TO PATIENT PATIENT RECEIVED A DUPLICATE VACCINE ON 07/20/2024. NO ADVERSE EVENTS WERE APPARENT TO PATIENT
2825144 58 F NY 02/06/2025 PNC21
 MERCK & CO. INC.
 Y011819
Erythema, Injection site pain, Oedema peripheral Erythema, Injection site pain, Oedema peripheral
patient came into pharmacy on 2/5/25 and explained how she noticed a red area on her arm, it hurt wh... patient came into pharmacy on 2/5/25 and explained how she noticed a red area on her arm, it hurt when vaccine was being injected and she had some swelling under her arm. More
2825145 60 F CA 02/06/2025 FLU3
FLU3
FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 TFAA2411
TFAA2411
TFAA2411
TFAA2411
Impaired work ability, Injected limb mobility decreased, Injection site pain, My... Impaired work ability, Injected limb mobility decreased, Injection site pain, Myalgia; Pain in extremity; Impaired work ability, Injected limb mobility decreased, Injection site pain, Myalgia; Pain in extremity More
Patient is experiencing ongoing pain at injection site from flu vaccination that occurred 1 month ag... Patient is experiencing ongoing pain at injection site from flu vaccination that occurred 1 month ago on 1/6/2025. The patient had proceeded to vacation and continued to experience severe pain to the point where her mobility is affected. Patient complains of muscle pain and decreased range of motion resulting in job limitations, which she has not reported. Patient has been advised to follow-up with a medical provider. More
2825146 67 F CA 02/06/2025 COVID19
 MODERNA
 8080803
Blood pressure increased, Dizziness Blood pressure increased, Dizziness
Dizziness developed 50minutes after vaccination, blood pressure was elevated to 180/100, repeated af... Dizziness developed 50minutes after vaccination, blood pressure was elevated to 180/100, repeated after 10 min still elevated More
2825158 0.08 F NJ 02/06/2025 UNK
 UNKNOWN MANUFACTURER
Incorrect dose administered Incorrect dose administered
Dr ordered pt to receive .5ML RSV vaccine, I made a mistake and administered 1ML RSV vaccine. I spok... Dr ordered pt to receive .5ML RSV vaccine, I made a mistake and administered 1ML RSV vaccine. I spoke to Dr and employee, Dr advised that it was okay and the pt health was not at risk. More
2824613 U TX 02/05/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Death, Guillain-Barre syndrome Death, Guillain-Barre syndrome
got GB; Unknown cause of death; This serious case was reported by a physician via sales rep and desc... got GB; Unknown cause of death; This serious case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant) and guillain barre syndrome (Verbatim: got GB) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not reported. The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death and guillain barre syndrome to be related to Arexvy. The company considered the unknown cause of death and guillain barre syndrome to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 30-JAN-2025 The physician just stated that one of his patients received a RSV (Arexvy) vaccine and got GB (Guillain Barre syndrome), was admitted to the hospital and died. The GSK representative was not sure about the outcome of death or the patient demographics.; Sender's Comments: Death and Guillain-Barre syndrome are unlisted events which are considered unrelated to GSK vaccine Arexvy.; Reported Cause(s) of Death: Unknown cause of death More
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2824614 U 02/05/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Injection site mass Injection site mass
large knot left after vaccination; This non-serious case was reported by a consumer via interactive ... large knot left after vaccination; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mass 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 mass (Verbatim: large knot left after vaccination). The outcome of the mass was not reported. It was unknown if the reporter considered the mass to be related to Shingrix. It was unknown if the company considered the mass to be related to Shingrix. Additional Information: GSK Receipt Date: 10-JAN-2025 The case was received from the patient via interactive digital media. The reporter reported that what if you had large knot left after vaccination it's had been since Tuesday. More
2824615 66 F GA 02/05/2025 RSV
RSV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Cough, Eyelid cyst, Injection site erythema, Injection site infection, Injection... Cough, Eyelid cyst, Injection site erythema, Injection site infection, Injection site pain; Injection site swelling, Nasal congestion, Pulmonary pain, Rhinorrhoea, Sneezing More
redness - injection site; swelling - injection site; pain - injection site; infection - injection si... redness - injection site; swelling - injection site; pain - injection site; infection - injection site; eyelid cyst; lung pain; cough; stuffy nose; runny nose; sneezing; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concomitant products included pregabalin (Lyrica). On 09-DEC-2024, the patient received Arexvy (intramuscular, unknown deltoid). In DEC-2024, less than a month after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness - injection site), injection site swelling (Verbatim: swelling - injection site), injection site pain (Verbatim: pain - injection site) and injection site infection (Verbatim: infection - injection site). On an unknown date, the patient experienced eyelid cyst (Verbatim: eyelid cyst), pulmonary pain (Verbatim: lung pain), cough (Verbatim: cough), nasal stuffiness (Verbatim: stuffy nose), runny nose (Verbatim: runny nose) and sneezing (Verbatim: sneezing). In DEC-2024, the outcome of the injection site erythema, injection site swelling, injection site pain and injection site infection were not resolved. The outcome of the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing were not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and injection site infection to be related to Arexvy. The reporter considered the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing to be related to Arexvy. It was unknown if the company considered the injection site erythema, injection site swelling, injection site pain and injection site infection to be related to Arexvy. The company considered the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing to be related to Arexvy. Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter reported that a patient received Arexvy on 9th December 2024. About two weeks later the vaccination, she developed injection site redness, swelling and pain. The area was about the size of a fifty cent piece. She believed the injection site was infected but not diagnosed by Healthcare professional. The local or injection site effects had not resolved. About three weeks after the vaccine, she developed sneezing, runny nose, stuffy nose, cough, and lung pain. At first, she thought the sneezing, runny nose, stuffy nose, cough and lung pain were due to environmental allergies. After reading about the potential side effects of Arexvy, she believed all these effects were due to the vaccine. She saw her physician a day before reporting. The physician prescribed an unknown topical treatment for the cyst on her eyelid. The patient would see a dermatologist in two weeks regarding the injection site effects. Nothing else was reported. More
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