🏥 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 💀 🏥 🚑 ♿ ⚠️
2822273 58 F IL 01/22/2025 COVID19
 PFIZER\BIONTECH
 FH8028
Electrocardiogram, Ventricular extrasystoles Electrocardiogram, Ventricular extrasystoles
PVC PVC
2822274 52 F AZ 01/22/2025 FLU3
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 TFAA2432
LK6650
Neck mass, Oedema peripheral; Neck mass, Oedema peripheral Neck mass, Oedema peripheral; Neck mass, Oedema peripheral
Left armpit swelling (tennis ball size) and hard lump on collarbone Left armpit swelling (tennis ball size) and hard lump on collarbone
2822275 39 M CO 01/22/2025 HEP
 MERCK & CO. INC.
 941579
Expired product administered, No adverse event Expired product administered, No adverse event
The Employee Health Nurse administered a Hep B first dose, vaccine today that has an expiration date... The Employee Health Nurse administered a Hep B first dose, vaccine today that has an expiration date of 1/4/2025. No adverse events noted at this time. More
2822276 14 M IA 01/22/2025 COVID19
 MODERNA
 3044143
Unevaluable event Unevaluable event
NA NA
2822277 56 M AZ 01/22/2025 COVID19
 JANSSEN
Amnesia, Impaired work ability, Seizure Amnesia, Impaired work ability, Seizure
None stated. None stated.
2822278 12 M ME 01/22/2025 COVID19
 PFIZER\BIONTECH
No adverse event, Underdose No adverse event, Underdose
Patient was given wrong does. No adverse affects. Patient was given the 5-11yo dose. Patient was given wrong does. No adverse affects. Patient was given the 5-11yo dose.
2822279 0.17 F AL 01/22/2025 VARCEL
 MERCK & CO. INC.
 Y011015
Wrong product administered Wrong product administered
None, wrong vaccine given. None, wrong vaccine given.
2822280 66 F TX 01/22/2025 PNC20
 PFIZER\WYETH
 LG5575
Erythema, Skin warm Erythema, Skin warm
RED ARM & WARM TO TOUCH A FEW DAYS AFTER SHOT ADMINISTERED RED ARM & WARM TO TOUCH A FEW DAYS AFTER SHOT ADMINISTERED
2822282 68 M OR 01/22/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 LN0591Private
U8486BAPrivate
Underdose; Underdose Underdose; Underdose
Prior to lunch time, NCMA had asked me to administer vaccines for her last patient so she could go t... Prior to lunch time, NCMA had asked me to administer vaccines for her last patient so she could go to lunch on time. She gave me the sheet with the list of immunizations needed and advised that patient had the consent forms. I verified the insurance with her and went to get the vaccines from the fridge. The sheet said patient was a 63-year-old female. I had LPN verify my vaccines. Flublok was not available, so Vaccine coordinator advised it was ok to use Fluzone. However, after administering COVID and flu vaccines, I entered them in the system and saw it was a different patient listed on the consent forms (68-year-old male). Although patient received the vaccines that he needed, he should have received Fluzone High- I learned that I need to bring all forms with me including consent sheets whenever I verify vaccines and check the names on the sheets given to me to ensure it is the correct patient. More
2822283 11 M 01/22/2025 IPV
MNQ
TDAP
VARCEL
 SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 W1C741M
U8271AB
Cx4Hl
Y013349
Dizziness; Dizziness; Dizziness; Dizziness Dizziness; Dizziness; Dizziness; Dizziness
Patient became dizzy per parent lowered to the floor, monitored in office for about 15 minutes, dizz... Patient became dizzy per parent lowered to the floor, monitored in office for about 15 minutes, dizziness resolved prior to leaving the Pediatrician office. More
2822284 59 F CA 01/22/2025 FLU3
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
 745P4
LG5579
Rash erythematous, Rash pruritic; Rash erythematous, Rash pruritic Rash erythematous, Rash pruritic; Rash erythematous, Rash pruritic
Red itchy rash that showed up 6 days later Red itchy rash that showed up 6 days later
2822285 52 F RI 01/22/2025 PNC20
 PFIZER\WYETH
 LG5579
Hypoaesthesia, Pain in extremity, Peripheral coldness, Peripheral swelling Hypoaesthesia, Pain in extremity, Peripheral coldness, Peripheral swelling
L arm numb, swollen, cold and achy- Start Medrol (Pak) 4 mg tablets in a dose pack taper per pack in... L arm numb, swollen, cold and achy- Start Medrol (Pak) 4 mg tablets in a dose pack taper per pack instructions Start cephALEXin 500 mg capsule 1 capsule every 6 hours for 5 days More
2822286 84 F 01/22/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
3E99M
Headache, Nausea, Pruritus; Headache, Nausea, Pruritus Headache, Nausea, Pruritus; Headache, Nausea, Pruritus
itching, headache, nausea itching, headache, nausea
2822287 59 F PA 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 J327J
Extra dose administered, No adverse event Extra dose administered, No adverse event
No reported adverse events per patient, patient received a third dose of this vaccine. No reported adverse events per patient, patient received a third dose of this vaccine.
2822288 0.33 M WI 01/22/2025 DTPPVHBHPB
PNC20
 MSP VACCINE COMPANY
PFIZER\WYETH
 U7947AA
LG5578
Disturbance in attention, Eye movement disorder, Hypotonia, Pallor; Disturbance ... Disturbance in attention, Eye movement disorder, Hypotonia, Pallor; Disturbance in attention, Eye movement disorder, Hypotonia, Pallor More
10 hours after vaccination, patient went limp, eyes rolled back in his head and his color left him, ... 10 hours after vaccination, patient went limp, eyes rolled back in his head and his color left him, even his lips were white. His eyes seemed unfocused at this time. He laid very still for about 10 minutes. After 10-15 minutes his color slowly returned and he returned to his "normal self." Parents contacted the doctor's office to report the adverse event after it was over. More
2822289 0.33 M WI 01/22/2025 DTPPVHBHPB
PNC20
 MSP VACCINE COMPANY
PFIZER\WYETH
 U7947AA
LG5578
Disturbance in attention, Eye movement disorder, Hypotonia, Mydriasis, Pallor; D... Disturbance in attention, Eye movement disorder, Hypotonia, Mydriasis, Pallor; Disturbance in attention, Eye movement disorder, Hypotonia, Mydriasis, Pallor More
Patient had a spell starting at about 14:30pm on the day of vaccination. He was very limp and still ... Patient had a spell starting at about 14:30pm on the day of vaccination. He was very limp and still and mom thought he was sleeping at first, but then his color started leaving. His lips became white. His eyes rolled back in his head and then seemed unfocused. His eyes did dilate when his parents checked them. He laid very still for about 10-15 minutes and then his color and movement started to return, and he returned to his normal self. The doctor's office was contacted after the incident and parent's were instructed continue watching him. More
2822290 51 M MN 01/22/2025 HEP
IPV
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
 CT3Z7
X1D141M
U8274AA
Extra dose administered, Injection site discomfort; Extra dose administered, Inj... Extra dose administered, Injection site discomfort; Extra dose administered, Injection site discomfort; Extra dose administered, Injection site discomfort More
Patient received a Tdap vaccine 1/21/25, but was found to have recently received a Tdap vaccine on 1... Patient received a Tdap vaccine 1/21/25, but was found to have recently received a Tdap vaccine on 1/15/25 at a different clinic. Follow-up call with the patient the next day 1/22/25 and patient reports injection site discomfort of both arms, but worse on left. More
2822291 12 F TX 01/22/2025 HPV9
 MERCK & CO. INC.
Neck mass Neck mass
Small lump above collarbone on left side Small lump above collarbone on left side
2822292 16 F TX 01/22/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 495MK
Fall, Feeling hot, Nausea, Somnolence Fall, Feeling hot, Nausea, Somnolence
Mom gives history that about 10 minutes after the vaccine was given, child complained of being hot... Mom gives history that about 10 minutes after the vaccine was given, child complained of being hot , nauseous, got up the exam table and then fell down on the floor. Mother started screaming and medical assistant and myself rushed into the room, Child was on the floor, looked drowsy but was able to answer all questions. EMS was called before I went in , paramedics came and assessed. No recommendations were made to take her to ER by them. BP was normal- 109/75, Heart rate 99, o2 sat was 99. Child was observed for 30 minutes, water was given. Then discharged home. Child has had Flu shots before in another state from where had moved in August 2024 and never had any reaction to any vaccines More
2822308 U MD 01/22/2025 HPV9
 MERCK & CO. INC.
Incorrect dose administered Incorrect dose administered
No additional AEs were reported; Pharmacist reported that a patient received first dose of GARDASIL ... No additional AEs were reported; Pharmacist reported that a patient received first dose of GARDASIL 9 about 5 years ago and second dose on 1/14/2025; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported. On an unknown date in 2020 (reported as "about 5 years ago"), the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection. On 14-JAN-2025, the patient received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (Inappropriate schedule of product administration). Both doses were administered as prophylaxis and exact dosage, lot numbers, expiration dates, routes of administration, and anatomical locations were not provided. No additional adverse events (AEs) were reported and no further information was provided. Lot # is being requested and will be submitted if received. More
2822309 1.25 M ID 01/22/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y012594
Y011017
Extra dose administered, No adverse event, Wrong product administered; Extra dos... Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered More
the patient had experienced any adverse issues or side effects from the administrations; a patient (... the patient had experienced any adverse issues or side effects from the administrations; a patient (15-month-old boy) who is otherwise healthy was inadvertently administered a dose of PROQUAD and VARIVAX by his medical assistant (MA) instead of a dose of MMR II and VARIVAX that was ordered and prescribed by the HCP on 01/15/2025.; a patient (15-month-old boy) who is otherwise healthy was inadvertently administered a dose of PROQUAD and VARIVAX by his medical assistant (MA) instead of a dose of MMR II and VARIVAX that was ordered and prescribed by the HCP on 01/15/2025.; This spontaneous report was received from a nurse practitioner referring to a 15-month-old male patient. The patient's medical history and concurrent conditions were not reported. On 15-JAN-2025, the patient who was otherwise healthy was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml / once, lot #Y012594, expiration date: 14-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml / once, lot #Y011017, expiration date: 18-JUN-2026, administered for prophylaxis (strength, and route of administration were not provided); along with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, lot #1973283, expiration date: 08-OCT-2026 (strength, dose, route of administration, and indication were not provided) by his medical assistant (MA) (operator of device: health professional) instead of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (administered for prophylaxis, dose, strength, lot #, expiry date, and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) that was ordered and prescribed by the health care professional (HCP) (Wrong product administered and Accidental overdose). The HCP stated he called to check on the patient on the evening on that day after the administration who was "doing well" and the parents did not report the patient had experienced any adverse issues or side effects from the administrations (No adverse event). No other information provided during the call. More
2822310 0.42 M MI 01/22/2025 RV5
 MERCK & CO. INC.
 y003754
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No Additional AE; a patient received their initial dose of ROTATEQ at 5 months old.; This spontaneou... No Additional AE; a patient received their initial dose of ROTATEQ at 5 months old.; This spontaneous report was received from an Other Health Professional and refers to a 5-month-old male patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On an unknown date in 2024, at the age of 5 months old, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (2 ml, lot #y003754 has been verified to be a valid lot number, expiration date not reported but upon internal validation established as 25-OCT-2025) orally for prophylaxis (strength was not provided) (inappropriate schedule of product administration). No additional doses have been given at this time. No additional adverse event (no adverse event) was reported. More
2822311 M TX 01/22/2025 SMALLMNK
 BAVARIAN NORDIC
 unknown
Autoimmune disorder Autoimmune disorder
Autoimmune disorder; Case reference number US-BN-2025-000136 is a spontaneous case initially receive... Autoimmune disorder; Case reference number US-BN-2025-000136 is a spontaneous case initially received from consumer via Communication (reference number: USBAV25-0136) on 17-Jan-2025 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date in Sep-2022, the patient received the first dose of Jynneos vaccine (batch number: unknown), at unknown dose, route or site of administration for unknown indication. On an unspecified date in Oct-2022, for unknown of time from the first dose, the patient received the second dose of Jynneos vaccine (batch number: unknown), at unknown dose, route or site of administration. On an unspecified date, unknown of time after vaccination with Jynneos, reported as in the last 24 hours, the patient got diagnosed with autoimmune disorder. At the time of initial report, it was unknown if the patient recovered from the event of autoimmune disorder. The reporter assessed the event of autoimmune disorder as serious due to criteria of disability and medical significance and possible related to Jynneos. No further information was provided.; Reporter's Comments: A male patient received two doses of the Jynneos vaccine in Sep and Oct 2022. Recently, he was diagnosed with an autoimmune disorder. Recovery status is unknown. The patient's medical history and concomitant medication details were not provided. The reported event autoimmune disorder is considered unlisted as per RA v7.0 and RA. The causality is assessed as related due to lack of alternative explanation at this point, and since contributory role of suspect product cannot be excluded. The case is serious due to disability and medical significance.; Sender's Comments: A male patient received two doses of the Jynneos vaccine in Sep and Oct 2022. Recently, he was diagnosed with an autoimmune disorder. Recovery status is unknown. The patient's medical history and concomitant medication details were not provided. The reported event autoimmune disorder is considered unlisted as per RA v7.0 and RA. The causality was assessed as related due to lack of alternative explanation at this point, and since contributory role of suspect product and a plausible mechanism of action cannot be excluded. The case is serious due to disability and medical significance. More
✓
2822313 M 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Erythema, Feeling hot, Induration, Swelling Erythema, Feeling hot, Induration, Swelling
induration erythema; swelling; warmth; This serious case was reported by a other health professional... induration erythema; swelling; warmth; This serious case was reported by a other health professional via sales rep and described the occurrence of induration erythema in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On 07-JAN-2025, an unknown time after receiving Shingrix, the patient experienced induration erythema (Verbatim: induration erythema) (serious criteria GSK medically significant), swelling (Verbatim: swelling) and feeling of warmth (Verbatim: warmth). The outcome of the induration erythema, swelling and feeling of warmth were resolved. The reporter considered the induration erythema, swelling and feeling of warmth to be related to Shingrix. The company considered the induration erythema to be unrelated to Shingrix. The company considered the swelling and feeling of warmth to be related to Shingrix. Additional Information: GSK Receipt Date: 09-JAN-2025 The reporter reported that the patient received a first dose of Shingrix and had induration erythema, swelling, and warmth.; Sender's Comments: Erythema induratum is an unlisted event which is considered unrelated to GSK vaccine Shingrix. More
2822314 U 01/22/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain Herpes zoster, Pain
They hurt like hell.; This non-serious case was reported by a consumer via interactive digital media... They hurt like hell.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: They hurt like hell.). The patient was treated with diethylamine salicylate, methyl nicotinate (Aspercreme). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient had 1st dose was going to get the 2nd and it hit god people get the vaccine, it hurt like hell. Patient have it right at time of reporting. Almost finish, patient physician recommended asper cream 5 percent, it numbs the pain for a while. More
2822315 M OK 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never got the second dose; This non-serious case was reported by a pharmacist via call center repres... never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received the Shingrix vaccine back on 10th March 2022). 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 second dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 Pharmacy Manager reported that the patient never got the second dose of it. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.. More
2822316 F MI 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Wrong technique in product usage process Wrong technique in product usage process
she accidently removed flip cap from shingrix antigen; This non-serious case was reported by a pharm... she accidently removed flip cap from shingrix antigen; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process 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 wrong technique in drug usage process (Verbatim: she accidently removed flip cap from shingrix antigen). The outcome of the wrong technique in drug usage process was unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 The healthcare professional was the reporter. The reporter stated that she accidently removed flip cap from Shingrix antigen and was unsure when the antigen vial will be used. No further information was known. The adverse event filed after call disconnected. Minimal information obtained to file adverse event. More
2822317 24 M CA 01/22/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVA993A
Expired product administered, Extra dose administered Expired product administered, Extra dose administered
Expired Dose Administered/6 days over the exp date; Extra dose administered; This non-serious case w... Expired Dose Administered/6 days over the exp date; Extra dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 24-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A, expiry date 31-DEC-2024) for prophylaxis. Previously administered products included Menveo (received first dose of Menveo on an unknown date). On 06-JAN-2025, the patient received the 2nd dose of Menveo. On 06-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered/6 days over the exp date) and extra dose administered (Verbatim: Extra dose administered). The outcome of the expired vaccine used and extra dose administered were unknown. Additional Information: GSK Receipt Date: 06-JAN-2025 The other health professional reported that an expired dose of Menveo was administered to a patient on the morning of the reporting day. The lyophilized component was 6 days over the expiration date which led to expired vaccine used, the liquid conjugate was still within the expiration date. The other health professional stated there were no adverse reactions after the administration. The patient received 2nd dose of Menveo which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter. More
2822318 69 F VA 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Abdominal discomfort, Nausea Abdominal discomfort, Nausea
Upset stomach; Nauseousness; This non-serious case was reported by a consumer via call center repres... Upset stomach; Nauseousness; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (The most recent was 4 months ago, and still has a little bit of pain from the Shingles.). In JAN-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced upset stomach (Verbatim: Upset stomach) and nausea (Verbatim: Nauseousness). The outcome of the upset stomach and nausea were not resolved. It was unknown if the reporter considered the upset stomach and nausea to be related to Shingrix. It was unknown if the company considered the upset stomach and nausea to be related to Shingrix. Additional Information: GSK Receipt Date: 07-JAN-2025 The reporter was the patient. About 3 days ago, the patient received the first dose of Shingrix. Ever since, the patient had been experiencing nauseousness and an upset stomach. The patient had developed Shingles 3 times in the past. The most recent was 4 months ago, and still had a little bit of pain from the Shingles More
2822319 66 M MN 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Dizziness, Dyspnoea, Syncope Dizziness, Dyspnoea, Syncope
fainted; feeling dizzy; Shortness of breath; This serious case was reported by a consumer via call c... fainted; feeling dizzy; Shortness of breath; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in OCT-2024). On 03-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 05-JAN-2025, 2 days after receiving Shingrix, the patient experienced fainting (Verbatim: fainted) (serious criteria GSK medically significant and other: serious as per reporter), dizziness (Verbatim: feeling dizzy) (serious criteria other: serious as per reporter) and shortness of breath (Verbatim: Shortness of breath) (serious criteria other: serious as per reporter). On 07-JAN-2025, the outcome of the fainting and dizziness were resolved (duration 2 days). The outcome of the shortness of breath was not resolved. It was unknown if the reporter considered the fainting, dizziness and shortness of breath to be related to Shingrix. The company considered the fainting, dizziness and shortness of breath to be related to Shingrix. Additional Information: GSK Receipt Date: 07-JAN-2025 The patient spouse reported that a patient receiving his 2nd Shingrix vaccine, had no symptoms after the 1st vaccine, however, he did have symptoms after the 2nd vaccine. 48 hours receiving the 2nd vaccine the patient started feeling dizzy, short of breath and fainted. The ambulance was called, and the patient stayed for 12 hours at the hospital, then he was discharged home. The patient continues to have some shortness of breath, but the dizziness and the fainting has subsided. ER (emergency room) visit required.; Sender's Comments: Syncope, Dizziness and Dyspnoea are unlisted events which, due to the following criteria (strong temporal association) are considered related to GSK vaccine Shingrix. More
2822320 45 M VA 01/22/2025 DTAP
 GLAXOSMITHKLINE BIOLOGICALS
 Y7JC3
Underdose, Wrong product administered Underdose, Wrong product administered
administration of Infanrix instead of Boostrix to an adult patient; the administration of Infanrix i... administration of Infanrix instead of Boostrix to an adult patient; the administration of Infanrix instead of Boostrix to an adult patient; the administration of Infanrix instead of Boostrix to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 45-year-old male patient who received DTPa (Infanrix) (batch number Y7JC3, expiry date 07-SEP-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 13-JAN-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 13-JAN-2025, immediately after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: administration of Infanrix instead of Boostrix to an adult patient), adult use of a child product (Verbatim: the administration of Infanrix instead of Boostrix to an adult patient) and underdose (Verbatim: the administration of Infanrix instead of Boostrix to an adult patient). The outcome of the wrong vaccine administered, adult use of a child product and underdose 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: 13-JAN-2025 The medical assistance reported that the administration of Infanrix instead of Boostrix to an adult patient which led to wrong vaccine administered, adult use of a child product and underdose. More
2822321 16 U NJ 01/22/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 4L274
Inappropriate schedule of product administration Inappropriate schedule of product administration
Early dose/received it twice, 26 days apart; This non-serious case was reported by a other health pr... Early dose/received it twice, 26 days apart; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old patient who received Men B NVS (Bexsero) (batch number 4L274, expiry date 30-SEP-2024) for prophylaxis. Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero). On 08-FEB-2024, the patient received the 2nd dose of Bexsero. On 08-FEB-2024, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Early dose/received it twice, 26 days apart). The outcome of the drug dose administration interval too short 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: 13-JAN-2025 The other health professional had a question about somebody who received the Bexsero vaccine. The other health professional reported that it was a meningitis b Bexsero vaccine, and then there was a question about, he/she know that it was recently updated, the guidance was recently updated for the first and second dose being 6 months but last in January and February of 2024 a patient received it twice, 26 days apart. The other health professional just wanted to know does the patient need to be revaccinated or what was recommended. The patient received second dose of Bexsero shorter than the recommended interval which led to shortening of vaccination schedule. More
2822323 F FL 01/22/2025 COVID19
 PFIZER\BIONTECH
Psoriasis Psoriasis
Psoriasis; This is a spontaneous report received from a Nurse. A 45-year-old female patient receive... Psoriasis; This is a spontaneous report received from a Nurse. A 45-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: comirnaty (Dose 1; lot: EL9262), administration date: 21Jan2021, when the patient was 45-year-old, for COVID-19 immunization; comirnaty (Dose 2; lot: EM9809), administration date: 11Feb2021, when the patient was 45-year-old, for COVID-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset Aug2021, outcome "unknown". Additional information: The patient called because she developed psoriasis after she took Pfizer COVID-19 Vaccine. Patient confirmed that she does not have psoriasis before she took it and then after she took the Pfizer Covid vaccine, she developed it. More
2822324 60 F TX 01/22/2025 COVID19
 PFIZER\BIONTECH
Body temperature increased, Fatigue, Feeling abnormal Body temperature increased, Fatigue, Feeling abnormal
Patient ran a temperature; exhausted; felt really bad; This is a spontaneous report received from a ... Patient ran a temperature; exhausted; felt really bad; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Patient ran a temperature"; FATIGUE (non-serious), outcome "unknown", described as "exhausted"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt really bad". Additional information: Caller calling in regards to the covid vaccine this year. The caller mentions that the callers daughter gotten sick with the vaccine and stated both of them, yes referring to the patients vaccines. Daughter had the vaccine at the same time as granddaughter and no reactions it just made her sick. Patient ran a temperature and felt really bad and had to stay in bed. Was exhausted and felt bad. This is the fist time had a reaction. Never had a reaction except this year. Stated we have never had a reaction to it except this year, Caller mentioned that everyone she talked thats received the Pfizer vaccine this year has gotten ill. Caller has no details to provide, No lot numbers to provide for any other patient. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2822325 F NC 01/22/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
I had 4 Pfizer covid vaccinations I had Covid 4 times.; I had 4 Pfizer covid vaccinations I had Covi... I had 4 Pfizer covid vaccinations I had Covid 4 times.; I had 4 Pfizer covid vaccinations I had Covid 4 times.; This is a spontaneous report received from an Other HCP. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had 4 Pfizer covid vaccinations I had Covid 4 times.". Therapeutic measures were taken as a result of drug ineffective, covid-19. Only treated with Paxlovid this last diagnosis-first time very sick with no Paxlovid Rx. The information on the batch/lot number for BNT162b2 omicron (kp.2) has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMICRON (KP.2) cannot be fully excluded. More
2822326 M TX 01/22/2025 COVID19
 PFIZER\BIONTECH
Infertility male Infertility male
he is trying to be a father again, after the vaccines it was not successful; This is a spontaneous r... he is trying to be a father again, after the vaccines it was not successful; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (Dose 1, lot number unknown), for COVID-19 immunisation; Pfizer covid vaccine (Dose 2, lot number unknown), for COVID-19 immunisation. The following information was reported: INFERTILITY MALE (non-serious), outcome "not recovered", described as "he is trying to be a father again, after the vaccines it was not successful". Additional information: Patient used Pfizer Covid vaccine. After they give him 3 applications, he is trying to be a father again, after the vaccines it was not successful. He is very worried about it and he need to know if he can count on Pfizer's help to solve this problem that is serious. The patient is the father of 3 beautiful children and he has never had this problem, after the vaccine, there was no result until currently. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2822327 F IN 01/22/2025 COVID19
 PFIZER\BIONTECH
Autoimmune disorder, Cardiac failure congestive, Pain Autoimmune disorder, Cardiac failure congestive, Pain
an auto immune disease; pain is unreal some days; congestive heart failure; This is a spontaneous re... an auto immune disease; pain is unreal some days; congestive heart failure; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 45-year-old female patient received BNT162b2 (BNT162B2), 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: CARDIAC FAILURE CONGESTIVE (medically significant) with onset 2024, outcome "unknown", described as "congestive heart failure"; AUTOIMMUNE DISORDER (medically significant), 6 months after the suspect product(s) administration, outcome "unknown", described as "an auto immune disease"; PAIN (non-serious), outcome "unknown", described as "pain is unreal some days". The event "an auto immune disease" required physician office visit. Clinical details: Fast forward to 10 months ago the patient was diagnosed with congestive heart failure. Not 1 case of any kind of heart disease anywhere in either side of her family. The patient is a married woman, with 4 kids, and just had her 1st grandbaby. Before she had the shot in 2020, she was healthy, played softball as adult, very on the go with kids and work, never slowed down. 6 months after Pfizer's covid vaccine, she is finding that she has an auto immune disease that most likely would have laid dormant rest of her life if she wouldn't have had. 7 different dermatology confirmed. Pain is unreal some days. Her girls have to brush her hair after. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2822328 10 F CA 01/22/2025 IPV
 SANOFI PASTEUR
 X1C891M
No adverse event, Product storage error No adverse event, Product storage error
data logger usually logs the temperature twice a day but for some reason, on 23dec2024, it did not p... data logger usually logs the temperature twice a day but for some reason, on 23dec2024, it did not pick up on the temperature excursion at 46.5 degrees f for 15 minutes with no reported ae; Initial information received on 14-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 years old female patient who received IPV (VERO) [IPOL] which was exposed to temperature excursion due to data logger usually logs the temperature twice a day but for some reason, it did not pick up on the temperature excursion at 46.5 degrees f for 15 minutes 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation; Varicella zoster vaccine (Varicella vaccine) for Immunisation; Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for Immunisation; Influenza vaccine (Influenza) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. On 09-Jan-2025, the patient received 0.5 ml of dose 2 of IPV (VERO) Suspension for injection (strength- standard, expiry date- 31-Oct-2026 and lot X1C891M) once via intramuscular route in the right deltoid as Immunization which was exposed to temperature excursion due to data logger usually logs the temperature twice a day but for some reason, it did not pick up on the temperature excursion at 46.5 degrees f for 15 minutes with no reported adverse event (Poor quality product administered) (latency- same day). 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
2822329 75 F AK 01/22/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Condition aggravated, Cystitis, Ear discomfort, Ear haemorrhage, Eye infection; ... Condition aggravated, Cystitis, Ear discomfort, Ear haemorrhage, Eye infection; Otorrhoea, Pneumonia More
lung infection; infections all the way from the bladder; ear exploding; mucus that was coming out of... lung infection; infections all the way from the bladder; ear exploding; mucus that was coming out of their ears; eye infection; ear exploding and bleeding; patient is still experiencing symptoms despite treatment with fluzone hd/ short period of efficacy of FLUZONE HD; Initial information received on 16-Jan-2025 regarding an unsolicited valid serious case received from a Patient. This case involves a 75 years old female patient who experienced lung infection, infections all the way from the bladder, ear exploding and bleeding, eye infection and patient is still experiencing symptoms despite treatment / short period of efficacy of Influenza usp trival a-b high dose subvirion vaccine [Fluzone HD]. The patient's past medical history included Ear tube insertion. The patient's past medical treatment(s), and family history were not provided. The patient has been getting flu shots since the age of 23 years (unspecified manufacturer) At the time of the event, the patient had ongoing Hypersensitivity and Otorrhoea. On an unknown date in 2024, the patient received a 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 (dose, route, strength, lot/batch number and expiration date: not provided) for Influenza immunization. Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. On an unknown date; patient was still experiencing symptoms despite treatment with FLUZONE HD. Patient also complained about the short period of efficacy of FLUZONE HD (therapeutic response shortened) (latency: approximately 5 months). Patient said that they were calling about the flu shot that they had. They said this year, its effects only lasted for five months and that their doctor told them not to get another one. They shared that they have four infections all the way from the bladder, (cystitis) (unknown latency) to their ear exploding (otorrhoea) (unknown latency) and bleeding (ear haemorrhage) (unknown latency), to their eyes (eye infection) (unknown latency), and lungs (pneumonia) (unknown latency). They said that they were also taking antibiotics "and all that stuff" but they said that they also needed the protection of a flu shot. They said that if it is not going to work, they wanted to know if it will also be like this next year. They said that "whatever it was" that used to work was taken out. Patient said that everybody had flu and said that the flu shots are really bad this year. After five months, their doctor told them to not go get another one. They said that they do not know what they are supposed to do. They said that they are unprotected. They said that they are a PCA (personal care assistant) and that they take care of sick people. They said that they don't know what to do multiple times. Patient said that they took another dose of FLUZONE HD after it "wore off" in eight months. They tried to get another one five months after this and was advised by their doctor to not get another one. They were frustrated that it took less time this year to not work. MIS inquired more about the blood and explosion in their ears. Patient clarified that it was actually mucus that was coming out of their ears and that the flu shots used to "take care of that." They shared that they were born in city with smog which was why they had natural allergies "and stuff." They said that mucus also got out of their ear twice when they were younger. They said that they "knew it didn't work anymore when" their ears went bad. They said that they ended up with their doctor and had tubes in their ears. They said that this was when they realized that it was the flu shot all along which made them get another one. They said that this flu shot lasted for four years. Patient said that the flu shot started lasting only a year and then eight months for the next one. Now, they are frustrated this time it only lasted for five months. They clarified that when mucus gets out of their ears, their eardrums pop and that this only happens when they don't take the flu shot. They said that the flu shots have saved their life for 40 years and now that it is not working, they are afraid because they are a PCA and that they feel like a "vat of germs." They said that they do not know if they should even be taking care of clients. They reiterated that they were a personal care assistant. They said that if the flu shots continue to not work, they might have to move "or something." Patient inquired about an RSV (respiratory syncytial virus) shot that has recently "come out" and wanted to know if it can help control their mucus. MIS inquired about the brand name of the aforementioned RSV vaccine, then referred them to their HCP (healthcare professional). Patient was not able to confirm the brand name of the RSV vaccine. Patient said that they have plans and that they needed information. They said that they have been taking flu shots since they were 23 years old, during which it lasted for 35 years. Patient made a brief observation about how it was also in the middle of winter in their area Action taken- not applicable for all the events An unknown antibiotic as an corrective treatment was received for the events (eye infection, lung infection; otorrhoea; ear haemorrhage and cystitis) At time of reporting, the outcome was not recovered/ not resolved for otorrhoea and Unknown for all the events. Seriousness criteria- Medically significant for Pneumonia.; Sender's Comments: Sanofi Company Comment dated 21-Jan-2025: This case involves a 75 years old female patient who experienced lung infection, after receiving Influenza usp trival a-b high dose subvirion vaccine [Fluzone HD]. The causal role of the company suspect vaccine cannot be assessed in the absence of information regarding temporal relevance. Further information regarding concurrent condition during vaccination, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. Additionally the role of patient's allergies; occupational exposure to infections cannot be overlooked either. More
2822347 41 F CT 01/22/2025 RSV
RSV
RSV
RSV
RSV
RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH






Abdominal discomfort, Abdominal pain, Basophil count decreased, Basophil percent... Abdominal discomfort, Abdominal pain, Basophil count decreased, Basophil percentage decreased, Delivery; Diarrhoea, Eosinophil count decreased, Eosinophil percentage decreased, Exposure during pregnancy, Foetal heart rate increased; Haematocrit normal, Haemoglobin normal, Immature granulocyte count, Lymphocyte count decreased, Lymphocyte percentage decreased; Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count normal; Monocyte percentage, Nausea, Neutrophil count normal, Neutrophil percentage increased, Platelet count normal; Premature labour, Promyelocyte count decreased, Protein urine present, Red blood cell count normal, Red blood cell nucleated morphology present; Red cell distribution width normal, Urine ketone body present, Uterine irritability, White blood cell count normal More
Contractions (Preterm); Maternal Exposure During Pregnancy, third trimester; A PHASE 3, RANDOMIZED, ... Contractions (Preterm); Maternal Exposure During Pregnancy, third trimester; A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY This is a Pfizer sponsored study report for protocol. This is the maternal case. This is a case for a 41-year-old maternal participant, who received study vaccine (PF-06928316; PLACEBO), while pregnant via intramuscular route in left deltoid on 19Jul2021 at 11:23 as single dose, at age of 41-year-old for prevention of respiratory syncytial virus (RSV) in the infant. No adverse events/reactions were reported in the e-diary on 19Jul2021. Participant was not unblinded. Medical history included fibroid from 2019 and ongoing, ongoing uterine fibroids diagnosed from Apr2018 with myomectomy in Apr2018, ongoing uterine fibroids diagnosed from May2019 with myomectomy in 2019, ongoing obesity from Nov2010 with laproscopic band placement and lap band removal in 2010, ongoing allergies (seasonal allergies, birch tree and apples) from 1980, ongoing mild bilateral pedal edema from 2021; pregnancy (C-section) on 12Mar2020, shoulder pain from Dec2008 to Dec2009 with shoulder surgery from Dec2008 to Dec2009, spontaneous abortion (SAB) from 2017 and from 1995. The mother never smoked, used alcohol, or used illicit drugs. Ongoing concomitant medications included fluticasone propionate (FLONASE) for seasonal allergies since 02Apr2021, and minerals NOS/vitamins NOS (PRENATAL VITAMINS) as supplement since Dec2020. There were no concomitant vaccines, prior vaccinations within 4 weeks, or family medical history relevant to the event. Current pregnancy details were as follows: first day of last menstrual period (LMP) was in Nov2020. Gestation at time of initial vaccination was 35 weeks 4 days. The mother had 4 pregnancies with 1 live birth via C-section, 1 elective abortion, 2 spontaneous abortions. The maternal participant experienced contraction (preterm) on 20Jul2021 at 02:00 which was caused hospitalization for less than one day. The clinical course was reported as follows: On 20Jul2021 at 02:00, about 14 hours after IP receipt, the participant woke up with nausea and diarrhea. At 03:00, the participant had abdominal pains, which worsened around 06:00 and she called her obstetrician-gynecologist (OBGYN) who instructed her to go to the labor and delivery suite for further evaluation at 07:06. At 08:37, the participant was admitted to the labor and delivery ward of the hospital (inpatient) with contractions. She presented to triage with complaints of abdominal pain-tightening, coming and going that she found very uncomfortable and thought she was having contractions. No leakage of amniotic fluid was observed, and fetal movements were present. Following evaluations were completed, fetal heart rate assessment: baseline 150, variability moderate and acceleration present. Normal fetal heart rate (FHR) category was: 1. Abdominal assessment: gravid and presentation: vertex. Uterine contractions: tocodynamometer (TOCO)-uterine irritability noted initially, resolved after 1 liter ringer's lactate (RL) and rest. Tests performed on 20Jul2021 included urine analysis which showed +1 protein, +1 ketones. The participant underwent the following laboratory tests and procedures: Basophil count (0.0-0.0): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Basophil percentage (0.0-4.0): (20Jul2021) 0.1 %, notes: at 11:14; Eosinophil count (0.0-1.0): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Eosinophil percentage (0.0-7.0): (20Jul2021) 0.3 %, notes: at 11:14; Foetal heart rate: (unspecified date) baseline 150, notes: variability moderate and acceleration present. Normal fetal heart rate (FHR) category was: 1; Haematocrit (37.0-52.0): (20Jul2021) 39.2 %, notes: at 11:14; Haemoglobin (12.0-18.0): (20Jul2021) 12.6 g/dl, notes: at 11:14; Immature granulocyte count (0.0-3.0): (20Jul2021) 0.4 %, notes: at 11:14; TOCO: (unspecified date) uterine irritability noted initially, notes: resolved after 1 liter ringers lactate (RL) and rest; Lymphocyte count (1.0-4.0): (20Jul2021) 0.7 x10 3/mm3, notes: low at 11:14; Lymphocyte percentage (8.0-49.0): (20Jul2021) 7.8 %, notes: low at 11:14; Mean cell haemoglobin (27.0-31.0): (20Jul2021) 28.4 pg, notes: at 11:14; Mean cell haemoglobin concentration (31.0-36.0): (20Jul2021) 32.1 g/dl, notes: at 11:14; Mean cell volume (78.0-94.0): (20Jul2021) 88.5, notes: fL, at 11:14; Mean platelet volume (6.0-11.0): (20Jul2021) 9.2, notes: fL, at 11:14; Monocyte count (0.0-2.0): (20Jul2021) 0.4 x10 3/mm3, notes: at 11:14; Monocyte percentage (4.0-15.0): (20Jul2021) 4.4 %, notes: at 11:14; Neutrophil count (1.0-11.0): (20Jul2021) 7.8 x10 3/mm3, notes: at 11:14; Neutrophil percentage (37.0-84.0): (20Jul2021) 87 %, notes: high at 11:14; Platelet count (140-440): (20Jul2021) 380 x10 3/mm3, notes: at 11:14; Promyelocyte count (0.0-0.3): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Red blood cell count (3.8-5.9): (20Jul2021) 4.4 x10 6/mm3, notes: M/uL, at 11:14; Red blood cell nucleated morphology present (0.0-1.0): (20Jul2021) 0.0 %, notes: at 11:14; Red blood cell nucleated morphology present (0.0-0.0): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Red cell distribution width (11.5-14.5): (20Jul2021) 13.1 %, notes: at 11:14; Urine analysis: (20Jul2021) +1 protein, +1 ketones; Weight: (unspecified date) 129 kg; White blood cell count (4.0-10.0): (20Jul2021) 9.0 x10 3/mm3, notes: at 11:14. Participant was discharged at 11:57 on 20Jul2021. The maternal participant delivered a normal female infant with live delivery, gestational age at birth was 39 weeks, clear amniotic fluid. Apgar scores 1 min and 5 mins were 9. Birthweight was 2.98 kgs, length at birth was 50 cm and head circumference at birth was 33 cm. The action taken in response to the event for blinded study vaccine (PF- 06928316; PLACEBO) was not applicable. The outcome of the event was recovered on 20Jul2021. The investigator considered there was a reasonable possibility that the event "contractions (preterm)" was related to blinded study vaccine, but unrelated to concomitant drugs or clinical trial procedure. The blind was broken by sponsor due to serious, related, unexpected event. Follow-up (30Aug2021): New information reported includes: medical history and pregnancy outcome details. Follow-up (08Sep2021 and 11Sep2021): New information reported includes: Updated relevant medical history, unblinding status, last action taken as not applicable, and reaction data (updated outcome and date of recovery). Follow-up (18Feb2022 and 22Feb2022): This is a Pfizer Sponsored Interventional Study follow-up report for Protocol. Updated information: medical history details (TAB updated to SAB from 1995, myomectomy date updated), reaction data (hospital stay days added), added lab data, additional clinical course (LMP, event details). Follow-up (04Mar2022): This is a Pfizer Sponsored Interventional Study follow-up report for Protocol. Updated information: reporter details and medical history (start date of obesity updated to Nov2010). Follow-up (18Mar2022): This is a Pfizer Sponsored Interventional Study follow-up report for Protocol. Updated information: updated first date of LMP. Follow-up (15Jan2025): This is a literature report for the following literature source:. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Updated information: Updated Reporter and Literature information. The participant was found to be treated with a single PF-06928316 120 ug dose. It was reported that "premature labor the day after vaccination, which resolved that day after fluids and rest, with uncomplicated delivery at 39 weeks".; Sender's Comments: The event Premature Uterine Contractions is unlisted in the Single Reference Safety Document of the Investigational Product and unrelated to the study drug per company assessment and related per investigator. Based on the current information available, in a maternal participant with a history of 3 abortions and uterine fibroids, it is the company position that there is not a reasonable possibility study vaccine could have contributed to the event Premature Uterine Contractions. There is not enough evidence available to attribute a causal association between the event Premature Uterine Contractions and the study vaccine. Causality will be further reevaluated based on any additional information during the follow-up The impact of this report on the benefit/risk profile of the Pfizer PF-06928316; PLACEBO on the conduct of the study 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 Committee and Investigators, as appropriate More
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2822349 86 F FL 01/22/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255t2
Extra dose administered, No adverse event Extra dose administered, No adverse event
The patient got a dose of RSV vaccine in 2023. Patient got 2nd dose on 01-21-25 when not indicated. ... The patient got a dose of RSV vaccine in 2023. Patient got 2nd dose on 01-21-25 when not indicated. No adverse event reported from the patient at this time. More
2822350 55 F VA 01/22/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 72M55
72M55
Arthralgia, Fatigue, Headache, Hypersomnia, Limb mass; Pain in extremity, Pyrexi... Arthralgia, Fatigue, Headache, Hypersomnia, Limb mass; Pain in extremity, Pyrexia More
Vaccinated Friday 1/10/25, starting Saturday morning 1/11/25 headache, temperature 103.0, pain in al... Vaccinated Friday 1/10/25, starting Saturday morning 1/11/25 headache, temperature 103.0, pain in all joints, exhaustion (slept 16 hrs). L arm sore starting then with a lump but not red or hot. Continued headache, joint pain, fatigue but not fever thru 1/13/25, felt better 1/14/15, return of symptoms 1/15/25 which is when pt reported it. More
2822351 46 F WA 01/22/2025 FLU3
 SANOFI PASTEUR
 TFAA242
Contusion, Pain in extremity Contusion, Pain in extremity
Pt reported bruise below the deltoid and a sore arm. Pt did not seek treatment. Time of course not s... Pt reported bruise below the deltoid and a sore arm. Pt did not seek treatment. Time of course not specified. More
2822352 84 F FL 01/22/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 255T2
Extra dose administered, No adverse event Extra dose administered, No adverse event
No adverse events were reported from patient. The pharmacy was alerted by our clinicial team via ema... No adverse events were reported from patient. The pharmacy was alerted by our clinicial team via email that this patient recieved a 2nd dose of RSV. (1st dose was 1/11/2024 and 2nd dose was 1/21/2025) Patient did not need a 2nd dose of RSV Arexvy vaccine. More
2822353 15 M CO 01/22/2025 HEP
 MERCK & CO. INC.
 X021477
Unevaluable event Unevaluable event
NONE NONE
2822372 25 F 01/22/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Caesarean section, Cholestasis, Exposure during pregnancy, Infertility female, L... Caesarean section, Cholestasis, Exposure during pregnancy, Infertility female, Labour induction; Menstrual disorder, Polycystic ovarian syndrome, Pre-eclampsia More
Due date was November 9th, ended up with Preeclampsia, cholestasis, and needing induction/c section.... Due date was November 9th, ended up with Preeclampsia, cholestasis, and needing induction/c section. Now struggle with PCOS, menstruation changes, and conceiving. Child has stomach issues, behavioral concerns, and eye issues that do not run in family More
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2822373 69 M FL 01/22/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 52Z52
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient had already received a dose of Arexvy on 10/11/23 and was unaware that he didn't need a... Patient had already received a dose of Arexvy on 10/11/23 and was unaware that he didn't need another dose. Patient is not claiming any injury. More
2822374 74 F ID 01/22/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 M7639
Chills, Fatigue, Headache Chills, Fatigue, Headache
Pt had already received doses of Shingrix from MD office 2018 - reported at wellness exam on 1/21/25... Pt had already received doses of Shingrix from MD office 2018 - reported at wellness exam on 1/21/25 that she had her 2nd dose of Shingrix (2nd series) and had headache, chills and fatigue following dose on 1/17/25. MD reports at wellness visit on 1/21/25 no fever and no other issues. More
2822375 3 F CA 01/22/2025 HPV9
 MERCK & CO. INC.
 Y008640
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
The patient was given by mistake the HPV vaccine on 01/16/2025. When we realized the error on 01/17/... The patient was given by mistake the HPV vaccine on 01/16/2025. When we realized the error on 01/17/2025 the provider called the parents to check in on the patient and reassured there would not be adverse reaction to vaccine. All questions were answered by provider and parent had no further questions. More
2822376 68 F WA 01/22/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Arthritis, Chills, Headache, Injection site erythema, Injection site swelling; M... Arthritis, Chills, Headache, Injection site erythema, Injection site swelling; Mouth breathing, Musculoskeletal stiffness, Nasal congestion, Pain in extremity, Pyrexia; Sinus congestion More
Response lasted 9 days this time - severe headache beginning within 15 mins of vaccine , lasted 4 da... Response lasted 9 days this time - severe headache beginning within 15 mins of vaccine , lasted 4 days then followed with a medium headache lasting an additioal 5 days- Fevers plus fevers w/ chills by that evening and lasting 4 days - joint inflamation beging at same time as fever and lasting 4 days - muscle stiffness started same time as fevers and lasted 9 days -swelling in nose and sinuses that was felt around day 3 and lasted for 5 days - had to mouth breathe for 2-3 days injection site swelled and redness to about the size of my fist. Arm was sore for almost 2 weeks After very first dose my response same as above except facial swelling lasted 3-4 days, With each continuing year my reaction lasted longer and longer. With the addition of facial swelling that interferred with my breathing I will no longer get vaccinated and take my chances with the perscribed medication . I am someone who seldom is sickened by viruses or colds. This latest response is not acceptable. More
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