๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2852275 21 M AR 08/01/2025 TDAP
 SANOFI PASTEUR
 U8353BA
Loss of consciousness, Syncope Loss of consciousness, Syncope
Patient came in for TDaP vaccine. We spoke prior to the vaccine, the patient says he has a history o... Patient came in for TDaP vaccine. We spoke prior to the vaccine, the patient says he has a history of fainting after vaccines. We discussed our plan in case he did faint (I would catch him, lay him down on the floor, elevate his feet and give him a cold compress. He was ok with the action plan. I administered the vaccine, he fainted about 1 minute after. we laid him on the floor and he gain consciousness immediately. I had patient remain in the room for 15 minutes following event and he left after he was feeling fine. More
2852276 12 F AZ 08/01/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Z002903
U8508AA
9JT4S
Pallor, Syncope; Pallor, Syncope; Pallor, Syncope Pallor, Syncope; Pallor, Syncope; Pallor, Syncope
Tdap and MCV4 were administered without incident, then HPV was administered last, as soon as this va... Tdap and MCV4 were administered without incident, then HPV was administered last, as soon as this vaccine was given, she became pale and had vasovagal syncope episode for about 3 seconds, she placed in low fowlers position, Pt. was fanned & wet towels were applied to forehead and back of neck, Father at bedside, tang juice and crackers were given. after approx. 3 minutes she sat up and stated she was feeling fine, 5 minutes after sitting she ambulated out with Father in stable condition More
2852277 0.08 F MI 08/01/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 42B22
Rash Rash
The patient's parent noticed a generalized rash on the patient the day after the immunization w... The patient's parent noticed a generalized rash on the patient the day after the immunization was given. Mother states that she had started aquafor and breast milk bath on 05/08/2025. Mother states that the rash had taken a week to go away. More
2852278 1.58 F MN 08/01/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 39KS9
Extra dose administered Extra dose administered
Received a extra dose of Hepatitis B Received a extra dose of Hepatitis B
2852279 51 M TX 08/01/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 y5aj9
No adverse event, Underdose No adverse event, Underdose
No adverse reaction reported. The pediatric dose was administered instead of the adult dose. No adverse reaction reported. The pediatric dose was administered instead of the adult dose.
2852280 17 M FL 08/01/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Chest X-ray normal, Chest pain, Drug screen negative, Electrocardiogram normal, ... Chest X-ray normal, Chest pain, Drug screen negative, Electrocardiogram normal, Laboratory test normal; Pericarditis, Troponin increased More
NO PREVIOUS MEDICAL ISSUES OR DIAGNOSES. NOW HAS DEVELOPED PERICARDITIS AFTER COVID VACCINATIONS. UN... NO PREVIOUS MEDICAL ISSUES OR DIAGNOSES. NOW HAS DEVELOPED PERICARDITIS AFTER COVID VACCINATIONS. UNKNOWN WHEN PERICARDITIS STARTED EXACTLY BUT WENT TO THE ER WITH CHEST PAINS AND ELEVATED TROPONIN LEVEL ON 8/1/25 AND WAS PREVIOUSLY HEALTHY, NO MEDS, NO OTHER DIAGNOSES, NO HEART ISSUES PRIOR TO COVID VACCINATIONS. More
โœ“ โœ“
2852281 13 M NE 08/01/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMXB072A
No adverse event, Product preparation issue No adverse event, Product preparation issue
Patient was given the diluent only, did not receive the powdered vaccine. Patient's mother deni... Patient was given the diluent only, did not receive the powdered vaccine. Patient's mother denies any adverse effects at this time. More
2852282 67 F FL 08/01/2025 PNC21
 MERCK & CO. INC.
 z005765
Arthralgia Arthralgia
Patient states that she has been experiencing intractable joint pain since receiving vaccine on 06/1... Patient states that she has been experiencing intractable joint pain since receiving vaccine on 06/19/2025. Her primary suspects she is experiencing some kind of inflammatory response from the vaccine. More
2852283 52 F 08/01/2025 COVID19
 PFIZER\BIONTECH
Pain of skin, Vomiting Pain of skin, Vomiting
COVID PFIZER VACCINE (every piece of skin hurt, could not sit, vomiting, felt like she was gonna die... COVID PFIZER VACCINE (every piece of skin hurt, could not sit, vomiting, felt like she was gonna die, lasted for about 3 days), More
2852284 11 M PA 08/01/2025 DTAP
 SANOFI PASTEUR
 3CA25C1
No adverse event, Wrong product administered No adverse event, Wrong product administered
DTaP was ordered and given instead of Tdap on 7/16/25. No adverse reaction. Patient's father wa... DTaP was ordered and given instead of Tdap on 7/16/25. No adverse reaction. Patient's father was called by provider and informed that the patient was given DTaP instead of Tdap. As per provider, no further vaccinations are needed. More
2852286 12 M NY 08/01/2025 HPV9
MNQ
 MERCK & CO. INC.
SANOFI PASTEUR
 Z007847
U8599AA
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, S... Immediate post-injection reaction, Syncope; Immediate post-injection reaction, Syncope More
Immediately <1 minute after vaccination. Experienced 1-2 seconds of vasovagal syncope. Immediately <1 minute after vaccination. Experienced 1-2 seconds of vasovagal syncope.
2852287 48 F PA 08/01/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Cellulitis, Rotator cuff syndrome, Swelling, X-ray Cellulitis, Rotator cuff syndrome, Swelling, X-ray
Swollen 15 days after treated for cellulitis and shoulder impingment and physical therapy still on... Swollen 15 days after treated for cellulitis and shoulder impingment and physical therapy still ongoing More
2852288 76 M 08/01/2025 FLU3
 SANOFI PASTEUR
 u8764bb
Dehydration, Pyrexia Dehydration, Pyrexia
Patient's wife said he ended up in the hospital with a fever of 103 and dehydration after getti... Patient's wife said he ended up in the hospital with a fever of 103 and dehydration after getting vaccinated. More
2852289 0.5 M CA 08/01/2025 DTAPIPVHIB
HEP
PNC20
 SANOFI PASTEUR
MERCK & CO. INC.
PFIZER\WYETH
 UK235AC
Z004729
LN4931
Rash erythematous, Rash maculo-papular; Rash erythematous, Rash maculo-papular; ... Rash erythematous, Rash maculo-papular; Rash erythematous, Rash maculo-papular; Rash erythematous, Rash maculo-papular More
Erythematous, maculopapular rash, not itchy, on face and trunk Erythematous, maculopapular rash, not itchy, on face and trunk
2852290 22 F VA 08/01/2025 HEPA
TDAP
TYP
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
 Z27PB
U8618AA
Y2A021M
Dizziness, Ear pain, Headache, Nausea; Dizziness, Ear pain, Headache, Nausea; Di... Dizziness, Ear pain, Headache, Nausea; Dizziness, Ear pain, Headache, Nausea; Dizziness, Ear pain, Headache, Nausea More
C/o of headache, right ear pain, dizziness, and nausea post injections. Assisted patient on Trendele... C/o of headache, right ear pain, dizziness, and nausea post injections. Assisted patient on Trendelenburg position on bed. Vital signs taken. Patient reported she did not eat anything since early morning around 7 AM. Sit up the patient and apple juice and bottle of water provided. Mother at bedside. Monitored patient for 25 minutes. Patient feels better and wanted to leave clinic. Patient left the unit accompanied by mother in no distress. More
2852291 74 F CA 08/01/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 9JT4S
5Y4TL
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
I entered the vaccine room and called the patients first and last name and th epatient and her aunt ... I entered the vaccine room and called the patients first and last name and th epatient and her aunt walked in. I confirmed the vaccines being administerd and they said yes to all three. Then the patients niece notified me that she is going to confirm with the aunt if she wants the COVID vaccine. After I patiently waited 10 minutes while they discussed, she notified me that her aunt does not want the COVID vaccine and she is going to only get tDap and Shingles. I administered the vaccines and they were pleased and happy. Then I stated the patients name and gave her the proof of vaccination. The niece turned to me and saif that is not my aunts name, you gave her the wrong vaccine. I stated to her that i confirmed her aunts name last name and the vaccines we were giving and she said yes to all of them. After speaking with them extensively, they left the pharmacy in a pleasant mood. I apologized to them that the error occured. I also stated to her that there is no harm in getting the tDap vaccine as she was eligible for a booster. The following day they called and were very upset with me. I apologized numerous times, asked her what I can do, besides apologize, to make the situation better. I showed as much empathy as I could have but she seemed to have made up her mind. She stated her aunts children are going to deal with this matter with a lawyer and that she will call me back. More
2852292 56 F 08/01/2025 MMR
 MERCK & CO. INC.
 P-Z003401
Inappropriate schedule of product administration Inappropriate schedule of product administration
Vaccine given after a live vaccine was given yesterday. Vaccine given after a live vaccine was given yesterday.
2852293 56 F IL 08/01/2025 HEPAB
PNC21
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 P2443
Z003579
Diarrhoea, Headache, Nausea; Diarrhoea, Headache, Nausea Diarrhoea, Headache, Nausea; Diarrhoea, Headache, Nausea
NAUSEA, DIARRHEA, HEADACHE NAUSEA, DIARRHEA, HEADACHE
2852294 58 F UT 08/01/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Y019157
PJ353
Injection site erythema, Injection site pain; Injection site erythema, Injection... Injection site erythema, Injection site pain; Injection site erythema, Injection site pain More
Patient complained of red, sore arm at injection site. Patient states she went to the emergency room... Patient complained of red, sore arm at injection site. Patient states she went to the emergency room and received Benadryl and was given a prescription for Augmentin as prophylaxis. More
2852345 18 M MD 08/01/2025 HPV9
 MERCK & CO. INC.
 W033612
Expired product administered Expired product administered
vaccine administered past expiration date; soreness at vaccine site; This spontaneous report was rec... vaccine administered past expiration date; soreness at vaccine site; This spontaneous report was received from a Physician Assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-Jun-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), (lot #W033612, expiration date: 03-Mar-2025, dose not reported), dose number 1, for prophylaxis (expired product administered). No adverse event was reported. Follow up information has been received from the reporter on 02-Jul-2025 referring to an 18 year-old male patient. The patient's concurrent conditions included attention deficit hyperactivity disorder (ADHD). Historical drugs included Meningococcal vaccine (Meningococcal vaccine). Concomitant medications included Adderall (Amfetamine aspartate;Amfetamine sulfate;Dexamfetamine saccharate;Dexamfetamine sulfate) . On 04-Jun-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) past expiration date in Left Arm, by a trained healthcare professional at private doctor's office. The vaccine was purchased with private funds. The vaccine had been properly stored loading up to administration. Error discovered shortly after, patient was notified. Followed up via phone, no unexpected adverse outcomes. On an unspecified date in 2025, the patient experienced soreness at vaccine site (Vaccination site pain), consistent with expected response to vaccine. At the reporting time, the outcome of Vaccination site pain was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was not applicable. The causal relationship between the event of Vaccination site pain and Human Papillomavirus 9-valent Vaccine, Recombinant was not reported. More
2852346 F IL 08/01/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y008787
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
No additional AE; PROQUAD administered inadvertently with VARIVAX to a 16 year old,; This spontaneou... No additional AE; PROQUAD administered inadvertently with VARIVAX to a 16 year old,; This spontaneous report was received from a health professional and refers to a 16-year-old female patient. The patient's medical history, current conditions and concomitant therapies was not reported. On 08-JUL-2025, the patient was administered inadvertently with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at a dose of 0.5ml (lot #Y008787 who had been verified to be a valid lot number, expiration date reported and assessed as 30-OCT-2025) and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX). Both vaccines were administered as prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (Extra dose administered). No adverse events reported. More
2852347 VA 08/01/2025 VARCEL
 MERCK & CO. INC.
 Y019318
No adverse event, Product storage error No adverse event, Product storage error
No symptoms or side effects were reported by HCP. No additional AE; patient received a dose of impro... No symptoms or side effects were reported by HCP. No additional AE; patient received a dose of improperly stored VARIVAX; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 21-JUL-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 0.5 mL, administered for prophylaxis (lot number Y019318 has been verified to be valid for Varicella Virus Vaccine Live (Oka-Merck) [VARIVAX], expiration date 21-NOV-2026; formulation, route of administration, anatomical site of injection and vaccination scheme frequency were not provided), which was reconstituted with with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot number were not reported). The vaccine was administered after a temperature excursion at 52.2 degree Fahrenheit (F) that occurred on an unknown date and for an unknown time frame (Product storage error). No symptoms, side effects or additional adverse events were reported for the patient. No other information was provided. This is one of several reports from the same reporter. More
2852348 KY 08/01/2025 HEPA
 MERCK & CO. INC.
 H012673
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE/PQC.; HCP calling to check the expiration date for a VAQTA with lot number h012673.... No additional AE/PQC.; HCP calling to check the expiration date for a VAQTA with lot number h012673. Caller stated that upon checking the past immunization record for a patient, it appeared that someone might have mistyped the expiration date of the product as 2/27/2013 an; This spontaneous report was received from a consumer or other non-health professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On 14-Jun-2013, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot #H012673 has been verified to be a valid lot number, expiration date: 27-Feb-2015 (conflicting information, upon checking the past immunization record for the patient, it appeared that someone might have mistyped the expiration date of the product as 27-Feb-2013), administered for prophylaxis (dose, route of administration and anatomical site of injection were not provided) (Expired product administered). No additional adverse event was reported (No adverse event). More
2852349 F MA 08/01/2025 HPV9
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
received her first dose of GARDASIL-9 when she was 11 years old and is now 15 years old. Patient has... received her first dose of GARDASIL-9 when she was 11 years old and is now 15 years old. Patient has not received her second dose.; No additional AE.; This spontaneous report was received from a registered nurse and referred to a child female patient. 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, when the patient was 11-year-old, she was vaccinated with the first dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) (dose, strength, formulation, route, anatomical site, expiration date and lot# were not reported) for prophylaxis. The patient was now 15 years old and had not received her second dose of the vaccine (inappropriate schedule of product administration). No additional adverse event (no adverse event). The outcome of the events was unknown. Lot# is being requested and will be submitted if received. More
2852351 F 08/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Guillain-Barre syndrome Guillain-Barre syndrome
she developed Guillain Barre Syndrome; This serious case was reported by a consumer via interactive ... she developed Guillain Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had twice). Previously administered products included Shingles vaccine (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: she developed Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. The reporter considered the guillain barre syndrome to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 19-JUL-2025 This case was reported by a consumer via interactive digital media. The second one was Shingrix, and she developed Guillain barre syndrome form the vaccine. Now patient had trouble walking and could not take most vaccines. The reporter was 50 but the reporter scared to get it after seeing what it did to her.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingrix, in a female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2852352 F 08/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Rash Rash
painful rash not at the injection site; This non-serious case was reported by a consumer and describ... painful rash not at the injection site; This non-serious case was reported by a consumer and described the occurrence of painful rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 06-JUN-2025, the patient received Shingrix. On 08-JUN-2025, 2 days after receiving Shingrix, the patient experienced painful rash (Verbatim: painful rash not at the injection site). On 13-JUN-2025, the outcome of the painful rash was resolved (duration 5 days). It was unknown if the reporter considered the painful rash to be related to Shingrix. It was unknown if the company considered the painful rash to be related to Shingrix. Additional Information: GSK receipt date: 23-JUL-2025 Patient reported that she had painful rash not at the injection site. More
2852353 08/01/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Illness, Respiratory syncytial virus infection, Sputum discoloured, Vaccination ... Illness, Respiratory syncytial virus infection, Sputum discoloured, Vaccination failure More
Suspected vaccination failure; contracted RSV; coughing up green phylem; Sickness; This serious cas... Suspected vaccination failure; contracted RSV; coughing up green phylem; Sickness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sickness). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: contracted RSV) and phlegm discolored (Verbatim: coughing up green phylem). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the sickness was resolved (duration 1 month) and the outcome of the phlegm discolored was not resolved. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, sickness and phlegm discolored to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection, sickness and phlegm discolored to be related to RSV vaccine. Additional Information: GSK Receipt Date: 11-JUL-2025 This case was reported by a consumer via interactive digital media. The patient was vaccinated too but still contracted RSV. The patient was sick for a month and that was 2 months ago and he/she was still coughing up green phlegm. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection) is considered unrelated to GSK's RSV vaccine. More
2852354 08/01/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Burning sensation, Electric shock sensation, Herpes zoster, Pain, Pruritus; Rash... Burning sensation, Electric shock sensation, Herpes zoster, Pain, Pruritus; Rash, Scab, Vaccination failure More
Suspected vaccination failure; currently have a mild case of shingles; This serious case was reporte... Suspected vaccination failure; currently have a mild case of 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. Concurrent medical conditions included immunocompromised. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: currently have a mild case of shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccines and currently have a mild case of shingles. The patient thought it was poison ivy and was not able to see the doctor until the rash was already scabbed over. The patient was immunocompromised, however, so even though it was on the upswing, he/she was taking 10 days, 3 pills per day, of valacyclovir (1 gram each). The patient had experienced very little pain and now that it was scabbing, the patient was feeling more of a mild zapping sensation. The patient had itching and burning sensation in the first couple days, but nothing like the pain he/she had been told to expect with shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 Shingles vaccine. More
2852356 08/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain Pain
very painful; This non-serious case was reported by a consumer via interactive digital media and des... very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had at the age of 21). On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: very painful). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Additional Information: GSK Receipt Date: 23-JUL-2025 This case was reported by a patient via interactive digital media. The patient mentioned it was the worst pain they ever had, and it (shingles) wrapped halfway around his/her body, mid torso, at age of 21. The patient had received the Shingrix vaccines, which were very painful, but is now worry-free and grateful More
2852357 08/01/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Insomnia, Pruritus, Vaccination failure Herpes zoster, Insomnia, Pruritus, Vaccination failure
Suspected Vaccination failure; I had shingles before or after I got the vaccine/Luckily mine was on ... Suspected Vaccination failure; I had shingles before or after I got the vaccine/Luckily mine was on the front towards the waist,; I do remember how hard it was to sleep; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had shingles before or after I got the vaccine/Luckily mine was on the front towards the waist,) and difficulty sleeping (Verbatim: I do remember how hard it was to sleep). The outcome of the vaccination failure, shingles and difficulty sleeping were not reported. It was unknown if the reporter considered the vaccination failure, shingles and difficulty sleeping to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and difficulty sleeping to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-JUL-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she was prayed that it would go away. He/she could not even remember whether he/she had shingles before or after the vaccine, but he/she did remember how hard it was to sleep and not scratch. Luckily mine was on the front towards the waist, so at least he/she could lie on back and try to be still, to sleep. Good luck to you and hope many people pray for you. If you have not had the shingles shot, ask your doctor whether you should get it now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 Shingles vaccine. More
2852358 08/01/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Discomfort, Herpes zoster, Vaccination failure Discomfort, Herpes zoster, Vaccination failure
Suspected vaccination failure; Got a shingles shot and then shingles; This serious case was reported... Suspected vaccination failure; Got a shingles shot and then 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got a shingles shot and then 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. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-JUL-2025 This case was reported by a patient via interactive digital media. The patient got a Shingles shot and then shingles on right breast, underarm, and upper arm. It was super uncomfortable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory test confirming shingles) is considered unrelated to GSK's Shingles vaccine. More
2852359 08/01/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Vaccination failure, Zoster sine herpete Vaccination failure, Zoster sine herpete
Suspected vaccination failure; have internal shingles as we speak; This serious case was reported by... Suspected vaccination failure; have internal shingles as we speak; 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. The patient's past medical history included shingles (had first shingles episode before the vaccination). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: have internal shingles as we speak). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was not resolved. It was unknown if the reporter considered the vaccination failure and zoster sine herpete to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the zoster sine herpete to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-JUL-2025 This case was reported by a patient via interactive digital media. The patient mentioned they have internal shingles as they speak, and this was the 3rd time of shingles. The patient stated he/she had received the Shingles vaccine after the first episode, and it obviously do not work for this type of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 completion of primary vaccination schedule, time to onset and laboratory test confirming shingles) is considered unrelated to GSK's Shingles vaccine. More
2852360 IA 08/01/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
an adult was given a pediatric dose of Engerix B; an adult was given a pediatric dose of Engerix B; ... an adult was given a pediatric dose of Engerix B; an adult was given a pediatric dose of Engerix B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis. On 16-JUL-2025, the patient received Engerix B pediatric. On 16-JUL-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: an adult was given a pediatric dose of Engerix B) and underdose (Verbatim: an adult was given a pediatric dose of Engerix B). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 17-JUL-2025 Pharmacist reported that an adult was given a pediatric dose of Engerix B, which led to adult use of a child product and underdose. The reporter was consented to follow up. No further details were available regarding patient or product. More
2852361 F NM 08/01/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
back today to start the completion of the series; This non-serious case was reported by a pharmacist... back today to start the completion of the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 20-FEB-2019). On an unknown date, the patient did not receive the 2nd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: back today to start the completion of the series). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-JUL-2025 The pharmacist reported that the patient received 1st dose of Twinrix on 20-FEB-2019 and was back on the day of reporting to start the completion of the series. The pharmacist was unsure if patient had received 2 doses or just the 1 dose, how should they proceed with completing the series for the patient. Patient had not received next dose of Twinrix at the time of the reporting. Till the time of reporting, the patient did not receive 2nd dose of Twinrix vaccine, which led to incomplete course of vaccination. More
2852362 7 F MN 08/01/2025 MMR
 GLAXOSMITHKLINE BIOLOGICALS
 4ZC23
Incorrect route of product administration Incorrect route of product administration
Subcutaneous injection formulation administered intramuscularly; This non-serious case was reported... Subcutaneous injection formulation administered intramuscularly; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 7-year-old female patient who received MMR (Priorix) (batch number 4ZC23, expiry date 01-SEP-2025) for prophylaxis. Previously administered products included Priorix (patient received 1st dose on unknown date). On 18-JUL-2025, the patient received the 2nd dose of Priorix (intramuscular). On 18-JUL-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Subcutaneous injection formulation administered intramuscularly). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 23-JUL-2025 Other HCP informed that a Priorix dose was given by the intramuscular route instead of subcutaneous one to a 7-year-old female patient, which led to subcutaneous injection formulation administered by other route. Vaccine was administered on 18 July 2025 as second dose. She wanted to know how to proceed after this incident. More
2852363 F TX 08/01/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 T5D73
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
They administered an adult dose of Engerix-B (1 mL dose) to a patient who is 18 years old.; They adm... They administered an adult dose of Engerix-B (1 mL dose) to a patient who is 18 years old.; They administered an adult dose of Engerix-B (1 mL dose) to a patient who is 18 years old.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) (batch number T5D73, expiry date 10-APR-2027) for prophylaxis. On an unknown date, the patient received the 1st dose of Engerix B adult 1 ml. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: They administered an adult dose of Engerix-B (1 mL dose) to a patient who is 18 years old.) and accidental overdose (Verbatim: They administered an adult dose of Engerix-B (1 mL dose) to a patient who is 18 years old.). The outcome of the adult product administered to child and accidental overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JUL-2025 The reporter called to report a vaccination error. They administered an adult dose of Engerix-B (1 mL dose) to a patient who was 18 years old, which led to adult product administered to child and accidental overdose. More
2852364 AZ 08/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
it has been more than 1 year since patient received first dose,; This non-serious case was reported ... it has been more than 1 year since patient received first dose,; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date). The patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: it has been more than 1 year since patient received first dose,). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 24-JUL-2025 Physician reported that it had been more than 1 year since patient received first dose, did they need to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2852365 M 08/01/2025 COVID19
 MODERNA
Schizophrenia Schizophrenia
mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary; This spontan... mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary; This spontaneous case was reported by a consumer and describes the occurrence of SCHIZOPHRENIA (mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCHIZOPHRENIA (mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary) (seriousness criteria disability and medically significant). At the time of the report, SCHIZOPHRENIA (mental health problems/ schizophrenic now/ hearing voices in his head, like, how scary) outcome was unknown. No concomitant medication was reported. Patient took 2 shots and felt sick. He was permanently disabled. He had mental health problems because the shots cross the blood-brain barrier. He was schizophrenic at the time of reporting. Before taking the shot, he had never had any signs of mental health issues. Then he was like hearing voices in his head, like scary. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, Updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:For nephew More
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2852366 F 08/01/2025 COVID19
 MODERNA
Neoplasm malignant Neoplasm malignant
her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cance... her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. She had never heard of anybody having two cancers at the same time; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. She had never heard of anybody having two cancers at the same time) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. She had never heard of anybody having two cancers at the same time) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. She had never heard of anybody having two cancers at the same time) outcome was unknown. No concomitant medication was reported. Patient got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. Reporter stated that her neighbor across the street, her sister, got cancer after taking a bunch of the shots, really bizarre cancer, two different cancers in the same area. She had never heard of anybody having two cancers at the same time. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:Master case More
2852367 55 F MA 08/01/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Dizziness, Haemoglobin, Haemophagocytic lymphohistiocytosis, Headache, Hypotensi... Dizziness, Haemoglobin, Haemophagocytic lymphohistiocytosis, Headache, Hypotension; Intestinal barrier dysfunction, Multiple organ dysfunction syndrome, Nausea, Pancreatitis, Swelling; Syncope, Vomiting More
pancreatitis; multiple organ failure; HLH - Secondary induced by 2nd does of Moderna covid vaccine.;... pancreatitis; multiple organ failure; HLH - Secondary induced by 2nd does of Moderna covid vaccine.; fainting; leaky gut; low bp; swelling; headache; nausea; light headedness after 1st dose; vomiting's, could not keep any food down/only liquid diet/stomach upset/Severe stomach upset; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (pancreatitis), MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiple organ failure), HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH - Secondary induced by 2nd does of Moderna covid vaccine.) and SYNCOPE (fainting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hemoglobin low and Blood transfusion (due to low Hb, required blood transfusion (10 years before moderna vaccine) - but nothing after that) in 2011. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PANCREATITIS (pancreatitis) (seriousness criteria death and medically significant), MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiple organ failure) (seriousness criteria death and medically significant), HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH - Secondary induced by 2nd does of Moderna covid vaccine.) (seriousness criteria death and medically significant), SYNCOPE (fainting) (seriousness criterion medically significant), INTESTINAL BARRIER DYSFUNCTION (leaky gut), HYPOTENSION (low bp), SWELLING (swelling), HEADACHE (headache), NAUSEA (nausea), DIZZINESS (light headedness after 1st dose) and VOMITING (vomiting's, could not keep any food down/only liquid diet/stomach upset/Severe stomach upset). The patient died in April 2021. The reported cause of death was hlh (secondary), pancreatitis, multiple organ failure, hlh (secondary), pancreatitis, multiple organ failure and hlh (secondary), pancreatitis, multiple organ failure. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (fainting), INTESTINAL BARRIER DYSFUNCTION (leaky gut), HYPOTENSION (low bp), SWELLING (swelling), HEADACHE (headache), NAUSEA (nausea), DIZZINESS (light headedness after 1st dose) and VOMITING (vomiting's, could not keep any food down/only liquid diet/stomach upset/Severe stomach upset) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: low. It was unknown if the patient had any additional medical history, concomitant disease, or risk factor. No concomitant medications were reported. The patient died 15 days after 2nd dose administration. All medicine in response to adverse event administered at emergency room by IV or oral, medicines and dosage details were not available. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: HLH (Secondary), Pancreatitis, Multiple organ failure; HLH (Secondary), Pancreatitis, Multiple organ failure; HLH (Secondary), Pancreatitis, Multiple organ failure More
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2852368 54 F MA 08/01/2025 COVID19
 MODERNA
 040C21A
Discomfort, Hypoaesthesia, Vaccination site pain Discomfort, Hypoaesthesia, Vaccination site pain
very localized discomfort; Arm turned numb; still have a sore spot where the shot was administered; ... very localized discomfort; Arm turned numb; still have a sore spot where the shot was administered; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (very localized discomfort), HYPOAESTHESIA (Arm turned numb) and VACCINATION SITE PAIN (still have a sore spot where the shot was administered) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (very localized discomfort), HYPOAESTHESIA (Arm turned numb) and VACCINATION SITE PAIN (still have a sore spot where the shot was administered). At the time of the report, DISCOMFORT (very localized discomfort), HYPOAESTHESIA (Arm turned numb) and VACCINATION SITE PAIN (still have a sore spot where the shot was administered) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. It was reported that the patient still had a sore spot where the shot was administered 4 years later. It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease, or risk factor. Treatment medication was not reported. More
2852369 08/01/2025 COVID19
 UNKNOWN MANUFACTURER
Pancreatic failure Pancreatic failure
EPI; This is a spontaneous report received from a Consumer or other non HCP from medical information... EPI; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATIC FAILURE (medically significant), outcome "unknown", described as "EPI". Clinical course: Patient was diagnosed with EPI just after getting the covid shots. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2852370 16 F OK 08/01/2025 MENB
 PFIZER\WYETH
 LX2636
Face injury, Fall, Syncope Face injury, Fall, Syncope
severe fainting episode/single severe syncope episode/syncopy; collapsed; This is a spontaneous repo... severe fainting episode/single severe syncope episode/syncopy; collapsed; This is a spontaneous report received from a Physician and a Consumer or other non HCP from medical information team. A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 28Jul2025 as dose 1, 0.5 ml single (Lot number: LX2636, Expiration Date: 31Jan2027) at the age of 16 years intramuscular, in left deltoid for immunisation, Device Lot Number: LX2636, Device Expiration Date: 31Jan2027. The patient's relevant medical history included: "Scoliosis" (unspecified if ongoing). There were no concomitant medications (The patient was not on any medication). The patient did not have any allergic to anything, had not had an illness in the month or got any other vaccines. The following information was reported: CIRCULATORY COLLAPSE (medically significant) with onset 28Jul2025, outcome "unknown", described as "collapsed"; SYNCOPE (medically significant) with onset 28Jul2025, outcome "unknown", described as "severe fainting episode/single severe syncope episode/syncopy". Clinical course: The patient had collapsed and get single severe syncope episode/severe fainting episode, and fell down in the room within like a minute later after due to syncopy and got hurt near the eye, they did not let her go and observed her for 0-40 minutes, she came to baseline, she was able to walk, everything so they let her go home. The physician had been using it for three years now and never had problems like this before. Physician expressed concern of this particular of lot of Trumenba, since he recognized the adverse reaction of two patients to same lot of vaccine as "uncommon". The physician wanted to return whole lot# LX2636 due to concern that the next patient will also get the same reaction. Had 14 remaining doses of this lot.; Sender's Comments: Based on known drug safety profile, and close temporal association the event syncope is assessed as related to the suspect drug MENINGOCOCCAL GROUP B RLP2086. The event circulatory collapse is conservatively assessed as related to the suspect drug based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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
2852371 F 08/01/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Alopecia, Blindness unilateral, Cystitis, Deafness, Disturbance in attention; Fa... Alopecia, Blindness unilateral, Cystitis, Deafness, Disturbance in attention; Fall, Feeling abnormal, Gait inability, Headache, Kidney infection; Memory impairment, Muscle spasms More
had a kidney and bladder infection; had a kidney and bladder infection; lost her right eye/ cannot s... had a kidney and bladder infection; had a kidney and bladder infection; lost her right eye/ cannot see; losing her hearing; feel different/She's not herself; lost her hair; She cannot walk and had to be in bed for 3 months; It seized up all her muscles; She has fallen 6 times; cannot think straight; cannot remember where she is; headaches; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 immunization. The following information was reported: KIDNEY INFECTION (hospitalization), CYSTITIS (hospitalization), outcome "unknown" and all described as "had a kidney and bladder infection"; BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "lost her right eye/ cannot see"; DEAFNESS (medically significant), outcome "unknown", described as "losing her hearing"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel different/She's not herself"; ALOPECIA (non-serious), outcome "unknown", described as "lost her hair"; GAIT INABILITY (non-serious), outcome "unknown", described as "She cannot walk and had to be in bed for 3 months"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "It seized up all her muscles"; FALL (non-serious), outcome "unknown", described as "She has fallen 6 times"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "cannot think straight"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "cannot remember where she is"; HEADACHE (non-serious), outcome "unknown", described as "headaches". The events "had a kidney and bladder infection", "lost her right eye/ cannot see", "losing her hearing", "feel different/she's not herself", "lost her hair", "she cannot walk and had to be in bed for 3 months" and "it seized up all her muscles" required physician office visit. Clinical course: After the second dose she started to feel different. She's not herself. She lost her right eye and lost her hair. Also, she's losing her hearing. She had a kidney and bladder infection that made her go in and out of the hospital. She cannot walk and had to be in bed for 3 months before she could stand up. It seized up all her muscles. She used to consider herself a healthy person. The doctors tried to put her in a psychiatric ward and thinks doctors don't want to talk about it because they are well paid off. She lost her home and had to sleep under a bridge in her car. Now she cannot do that because she also lost her vehicle. She cannot see and needs help now. She has fallen 6 times and cannot think straight anymore. She cannot remember where she is and has headaches. Caller wonder why she bothers to be in this world. She lost everything and has nothing to live for. She cannot work, she cannot counsel people and cannot travel to do her work. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500151734 same patient, same vaccine, different doses; More
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2852372 OK 08/01/2025 COVID19
 PFIZER\BIONTECH
Autoimmune disorder Autoimmune disorder
Autoimmune diseases; This is a spontaneous report received from a consumer. A patient (age and gend... Autoimmune diseases; This is a spontaneous report received from a consumer. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tick fever" (ongoing); "Alpha gal" (ongoing). The patient's concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Autoimmune diseases". When COVID came out, the patient kept thinking she will just keep getting COVID over and over. The patient had tick fever around 2 years before he/she was finally diagnosed. The patient took the shot not knowing he/she had tick fever, and he/she was alpha gal. The patient believed the COVID shot having tick fever and alpha gal gave the patient autoimmune diseases. The patient did not blame anyone but maybe people can all learn from this, and the patient can start feeling better. The patient had insurance, and the insurance will pay for this. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2852373 F 08/01/2025 HIBV
 SANOFI PASTEUR
 UK227AC
No adverse event, Product preparation error No adverse event, Product preparation error
vaccine given with wrong diluent with no reported adverse event; Initial information received on 28-... vaccine given with wrong diluent with no reported adverse event; Initial information received on 28-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient to whom vaccine (HIB (PRP/T) Vaccine [ACT-HIB]) given with wrong diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength, dose unknown) lot UK227AC expiry date- 30-APR-2026 via unknown route in unknown administration site for prophylactic vaccination (Immunisation) with wrong diluent with no reported adverse event (product preparation error) (same day latency). Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2852383 GA 08/01/2025 DTAP
DTAPIPVHIB
HIBV
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
UK227AB
No adverse event, Product packaging confusion, Wrong product administered; No ad... No adverse event, Product packaging confusion, Wrong product administered; No adverse event, Product packaging confusion, Wrong product administered; No adverse event, Product packaging confusion, Wrong product administered More
received DTap and PENTACEL with no reported adverse event; patient was supposed to get acthib as wel... received DTap and PENTACEL with no reported adverse event; patient was supposed to get acthib as well but was given pentacel instead with no reported ae; PENTACEL and ACTHIB looked very similar in packaging; Initial information received on 25-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)], patient was supposed to get HIB (PRP/T) vaccine [ACT-HIB] as well but was given pentacel instead and pentacel and ACT-HIB looked very similar in packaging with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength- unknown, expiry date- 31-Oct-2026 and lot- UK227AB) and diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength, expiry date and lot not reported) (extra dose administered), patient was supposed to get HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, expiry date and lot not reported) as well but was given pentacel instead (wrong product administered) and pentacel and ACT-HIB looked very similar in packaging (product packaging confusion) for prophylactic vaccination with no reported adverse event (latency- same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2852384 18 F CA 08/01/2025 MEN
 UNKNOWN MANUFACTURER
 U8493AA
No adverse event, Product preparation error No adverse event, Product preparation error
HCP got confused and reconstituted MENQUADFI with sterile diluent for vaccines, with no reported adv... HCP got confused and reconstituted MENQUADFI with sterile diluent for vaccines, with no reported adverse event; Initial information received on 30-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old female patient who received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] which was reconstituted with sterile diluent for vaccines, 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 Meningococcal vaccine (Meningococcal vaccine) for Immunisation. On 29-Jul-2025, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (once) Strength Standard, lot U8493AA and expiry date 31-May-2028 via intramuscular route in the left deltoid for immunization which was reconstituted with sterile diluent for vaccines, with no reported adverse event (product preparation error). Reportedly, HCP (health care professional) got confused and reconstituted Menquadfi with sterile diluent for vaccines. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2852385 66 F IL 08/01/2025 PNC21
 MERCK & CO. INC.
 z002626
Injection site rash Injection site rash
Patient had large rash area of the shot, that grew in size to about 8 inches round. The rash went aw... Patient had large rash area of the shot, that grew in size to about 8 inches round. The rash went away on it's own More
2852386 76 F GA 08/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 47N3Y
Mobility decreased, Pain, Sleep disorder, Swelling Mobility decreased, Pain, Sleep disorder, Swelling
Patient receieved vaccine about 11am. She called back to store around 2pm and said she was having so... Patient receieved vaccine about 11am. She called back to store around 2pm and said she was having some pain and we discussed some remedies to try. She called back at 5:30pm and said that she had tried Tylenol, ice pack and even a pain patch with no relief. She said it was the worst pain she has ever had from a vaccine and that she could not use her arm nor look at it by herself. Iinstructed her to call her son to come over to view it for her and to go to the emergency room if the pain was not bearable. Spoke with patient again on 8/1 and she stated that it was not as painful now but did give her difficulty sleeping last night. Son was able to come over and look at it for her and said it was not red but did appear swollen. Patient sounded better about it today. She did not state that she went to the ER to be checked out. More
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