πŸ₯ VAERS Vaccine Data Browser

πŸ”’ 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.

πŸ“– Help & Search Guide

Column Icons Legend

πŸ’€ Death
πŸ₯ Hospitalized
πŸš‘ Emergency Room
β™Ώ Disability
⚠️ Life Threatening

How to Search

πŸ’‘ 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 "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ 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:

  • βœ… Early warning system for potential safety signals
  • βœ… Open and transparent - publicly accessible
  • βœ… Accepts all reports regardless of likelihood of causation
  • βœ… 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
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2854152 18 F TX 08/14/2025 MENB
 PFIZER\WYETH
 LW8911
Dizziness, Hypotension, Loss of consciousness Dizziness, Hypotension, Loss of consciousness
Patient started feeling faint a few minutes after the vaccine. She then passed out while at the chec... Patient started feeling faint a few minutes after the vaccine. She then passed out while at the check out desk and continued to have low blood pressure until she started to feel better, which was 20 minutes later. More
2854153 5 M TX 08/14/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
 A32BB
Expired product administered Expired product administered
expired vaccine was given expired vaccine was given
2854154 23 F WA 08/14/2025 HEP
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 4BX39
Z004245
Injection site erythema; Injection site erythema Injection site erythema; Injection site erythema
Patient presented to the ER on 08/14 at 10am c/o redness at the injection site of the Varicella va... Patient presented to the ER on 08/14 at 10am c/o redness at the injection site of the Varicella vaccine. Placed on the back of the right arm (SubQ). More
2854155 23 F NV 08/14/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 77KA5
Pain in extremity Pain in extremity
Patient had extreme pain in the arm that she went to the ER for Patient had extreme pain in the arm that she went to the ER for
2854156 11 F IL 08/14/2025 MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS

Blindness, Dizziness, Fatigue, Loss of consciousness, Unresponsive to stimuli; V... Blindness, Dizziness, Fatigue, Loss of consciousness, Unresponsive to stimuli; Vision blurred More
Within minutes of receiving injection, my daughter complained of extreme fatigue and lightheadedness... Within minutes of receiving injection, my daughter complained of extreme fatigue and lightheadedness. Within five minutes, on the car ride home, my daughter advised that she had blurred then lost vision. She complained of not being able to see. My daughter then blacked out in her seat and was unresponsive to touch or verbal communication. My daughter regained consciousness after about one minute. I drove her immediately back to the doctor's office where her vital signs were taken, to include blood pressure and blood sugar level. Both vitals were normal. I was advised that children about 11 years were fainting after being vaccinated. The physician's assistant related this to possibly hormones at this age or some type of immune system respone. My daughter had never had any issues with prior vaccinations, as well as no problems with anxiety prior to this shot. My daughter responded well to apple juice provided by the physician's office. After 15 minutes, my daughter was released. More
2854157 12 M MT 08/14/2025 HPV9
 MERCK & CO. INC.
 Z005055
Dizziness, Gait disturbance, Hyperhidrosis, Pallor Dizziness, Gait disturbance, Hyperhidrosis, Pallor
Several minutes after injection was given, patient and Father started to leave clinic and the nurse ... Several minutes after injection was given, patient and Father started to leave clinic and the nurse who gave vaccine seen him starting to have difficulty with walking, swaying. Patient went back to room became pale, diaphoretic, feeling lightheaded as he could pass out. Given cold packs, placed in head to knee position. After several minutes in this position was feeling better. Given some sips of water, time to collect and departed with out further incident. More
2854158 39 M 08/14/2025 COVID19
COVID19
 MODERNA
MODERNA

Brain fog, Memory impairment; Brain fog, Memory impairment Brain fog, Memory impairment; Brain fog, Memory impairment
Memory started to go bad. I had a hard time remember things. I because fuzzy minded. My short ter... Memory started to go bad. I had a hard time remember things. I because fuzzy minded. My short term memory was affected as I couldn't recall thing as sharply as I used to. More
2854159 17 F MO 08/14/2025 MENB
MENB
MNQ
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 55N34
55N34
JT347
JT347
Arthralgia, Feeding disorder, Formication, Immediate post-injection reaction, Mo... Arthralgia, Feeding disorder, Formication, Immediate post-injection reaction, Mobility decreased; Pain in extremity, Pruritus, Sleep disorder; Arthralgia, Feeding disorder, Formication, Immediate post-injection reaction, Mobility decreased; Pain in extremity, Pruritus, Sleep disorder More
Following the vaccine, my daughter had an intense sensation of her skin all over her body itching, t... Following the vaccine, my daughter had an intense sensation of her skin all over her body itching, tickling, crawling. It was so intense that she could not sleep or eat or sit still. She was almost hysterical from the sensation. This began an hour or two after the vaccine and lasted about 24 hours. Immediately following the vaccine, her left arm and shoulder hurt so badly that she could not lift or move her arm for 24 hours after vaccination and she still has intense pain in her left arm 8 days after the vaccine. Ibuprophen was administered but did not help ease the symptoms at all. More
2854168 PR 08/14/2025 MNP
 PFIZER\WYETH
Cellulitis, Erythema, Inflammation Cellulitis, Erythema, Inflammation
Redness; Inflammation; Cellulitis; This is a spontaneous report received from a Nurse and a Company ... Redness; Inflammation; Cellulitis; This is a spontaneous report received from a Nurse and a Company Representative. A patient (age and gender not provided) received meningococcal group abcwy vaccine (PENBRAYA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; INFLAMMATION (non-serious), outcome "unknown"; CELLULITIS (non-serious), outcome "unknown". Additional information: The company representative reported an adverse event that was passed by a Nurse for vaccine called, Penbraya and the adverse reported was skin issues. When probed for the skin issues, company representative stated redness, inflammation and cellulitis. It was unknown if patient had an emergency room visit. One patient visited a Physician, a pediatrician due to adverse event. The company representative did not know the Prescribing Healthcare Professional details, product details, vaccination details, medical history, concomitant medications, lab work, treatment, date and time, dosage, route of administration, formulation, indication, causality, vaccination facility details. It was unknown if any other vaccination on same date or other vaccination on 4 weeks prior to Penbraya. The company representative stated yes about the causality. The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received. More
2854169 PR 08/14/2025 MNP
 PFIZER\WYETH
Cellulitis, Erythema, Inflammation Cellulitis, Erythema, Inflammation
Redness; Inflammation; Cellulitis; This is a spontaneous report received from a Nurse. A patient (a... Redness; Inflammation; Cellulitis; This is a spontaneous report received from a Nurse. A patient (age and gender not provided) received meningococcal group abcwy vaccine (PENBRAYA), as dose 1, single (Batch/Lot number: unknown) intramuscular, in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; INFLAMMATION (non-serious), outcome "unknown"; CELLULITIS (non-serious), outcome "unknown". Additional information: Pfizer employee stated, they wanted to report an adverse event that was passed to them by a Nurse. It was a vaccine called, Penbraya and the adverse report was skin issues. When probed for the skin issues, Pfizer employee stated, Redness, inflammation and cellulitis. Pfizer employee stated, they do not know Pfizer drug safety, it was through a call. The patient details were not provided. They did not know prescribing physician and remember that these are vaccines. So, they were not prescribed. Pfizer employee stated, the nurse has Product details they do not. Concomitant medication, Dosage were not known. It was unknown if any other vaccination on same date or other vaccination on 4 weeks prior to Penbraya. One patient visited a physician, a pediatrician for AE. The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received. More
2854171 VA 08/14/2025 MMRV
 MERCK & CO. INC.
 Y017516
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP reporting that a patient received a dose of improperly stored PROQUAD. Refere... No additional AE; HCP reporting that a patient received a dose of improperly stored PROQUAD. Reference TE case #02843001. HCP reported that she did not know the date the excursion occurred, but knows the PROQUAD was administered following the excursion. HCP reported; Information has been received from Business Partner on 22-Jul-2025. This spontaneous report was received from a Other health professional 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 23-May-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017516, expiration date: 19-Apr-2026) (0.5mL), for an unknown indication. On 23-May-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The vaccine underwent temperature excursion in 52.2 degree Fahrenheit (Improper storage of product in use). No additional adverse event was reported. More
2854172 VA 08/14/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y019318
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
No symptoms or side effects were reported by HCP.; HCP reporting that a patient received a dose of i... No symptoms or side effects were reported by HCP.; HCP reporting that a 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 was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-JUN-2025, the patient was vaccinated with improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #Y019318 was valid, expiration date: 21-NOV-2026, 0.5 mL, route of administration and anatomical location were not provided) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis (Product storage error). Temperature excursion of 52.2 F was reported. No symptoms or side effects were reported (No adverse event). No product quality complaint (PQC). More
2854174 MI 08/14/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
Antibody test negative Antibody test negative
Family Member is a Non-Responder; Initial report received on 25-Jul-2025. A physician reported that... Family Member is a Non-Responder; Initial report received on 25-Jul-2025. A physician reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was a non-responder. No medical history or concomitant medications were reported. On an unknown date, the patient received a dose of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On an unknown date, after receiving HEPLISAV-B, the patient was identified as a non-responder. The reporter was inquiring if the patient was protected against hepatitis B virus. No other information was reported. Company Comment: The company assessed the event as non-serious. The dosing schedule of Heplisav-B and the serological marker was not reported.; Sender's Comments: The company assessed the event as non-serious. The dosing schedule of Heplisav-B and the serological marker was not reported. More
2854175 F TN 08/14/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 947931
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Our Patient Received The First Dose of Heplisav-B On 6/23/2025, Received Engerix-B When They Returne... Our Patient Received The First Dose of Heplisav-B On 6/23/2025, Received Engerix-B When They Returned on 7/23/2025; Initial report received on 28-Jul-2025. A pharmacist reported that a 21-year-old female (race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) as the first dose for hepatitis B immunization and received ENGERIX-B as the second dose. No medical history or concomitant medications were reported. On 23-Jun-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 947931, expiration date 15-May-2027, NDC # 43528-003-05)] intramuscularly in the left deltoid. On 23-Jul-2025, 30 days after having been vaccinated with HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot #, expiration date, site and route not reported)]. No side effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious. More
2854176 08/14/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Death Death
Unknown cause of death; This serious case was reported by a consumer via interactive digital media a... Unknown cause of death; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant). The reported cause of death was unknown. The reporter considered the unknown cause of death to be possibly related to Shingles vaccine. The company considered the unknown cause of death to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 10-AUG-2025 This case was reported by a consumer via interactive digital media. The reporter's cousin got the shot, died three days later. It was reported as there seems to be a connection. Keep your shot.; Sender's Comments: A case of Death, 3 days after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR104452:Original Case Number : US2025AMR104452_Same reporter; Reported Cause(s) of Death: Unknown cause of death More
βœ“
2854177 M MA 08/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Influenza, Myalgia, Pain in extremity Influenza, Myalgia, Pain in extremity
Pain in arm; Flu symptoms; Muscle ache; This non-serious case was reported by a consumer via call c... Pain in arm; Flu symptoms; Muscle ache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis. In MAR-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Pain in arm), flu symptoms (Verbatim: Flu symptoms) and muscle pain (Verbatim: Muscle ache). The outcome of the pain in arm, flu symptoms and muscle pain were unknown. It was unknown if the reporter considered the pain in arm, flu symptoms and muscle pain to be related to Shingrix. It was unknown if the company considered the pain in arm, flu symptoms and muscle pain to be related to Shingrix. Additional Information: GSK Receipt Date: 05-AUG-2025 The reporter was the patient who stated that he received his first dose of Shingrix in March 2022. The patient had experienced a painful arm, flu symptoms, and muscle ache after the dose. Due to these side effects, he decided not to get another dose until 05th August 2025. More
2854178 M CO 08/14/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; shingles outbreaks; This serious case was reported by a consumer via ... Suspected vaccination failure; shingles outbreaks; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included varicella zoster vaccine live (oka/merck) (Zostavax) for prophylaxis. On an unknown date, the patient received Shingrix and Zostavax. On an unknown date, an unknown time after receiving Shingrix and an unknown time after starting Zostavax, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles outbreaks). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Zostavax. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Zostavax. It was unknown if the company considered the vaccination failure to be related to Zostavax. Additional Information: GSK Receipt Date: 07-AUG-2025 The reporter stated that her friend has had several shingles outbreaks since his vaccination. She does not know if it was Zostavax or Shingrix that he (patient) had. The reporter does not know if the patient had both doses of Shingrix vaccine. 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 and Zostavax vaccine. More
2854179 F FL 08/14/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Burning sensation, Dizziness, Ear pain, Fatigue, Neck pain; Pain in extremity Burning sensation, Dizziness, Ear pain, Fatigue, Neck pain; Pain in extremity
sore arm; Tiredness; Dizziness; burning all over the body; Ear pain; Neck pain; This non-serious cas... sore arm; Tiredness; Dizziness; burning all over the body; Ear pain; Neck pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-AUG-2025, the patient received Shingrix. In AUG-2025, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm), tiredness (Verbatim: Tiredness), dizziness (Verbatim: Dizziness), burning sensation (Verbatim: burning all over the body), ear pain (Verbatim: Ear pain) and neck pain (Verbatim: Neck pain). The outcome of the pain in arm, tiredness, dizziness, burning sensation, ear pain and neck pain were unknown. It was unknown if the reporter considered the pain in arm, tiredness, dizziness, burning sensation, ear pain and neck pain to be related to Shingrix. It was unknown if the company considered the pain in arm, tiredness, dizziness, burning sensation, ear pain and neck pain to be related to Shingrix. Additional Information: GSK Receipt Date: 08-AUG-2025 The reporter reports that after she received a Shingrix vaccine on 04-AUG-2025 she started to experience arm soreness, tired, dizziness, burning all over the body, pain in the ears and neck. More
2854180 08/14/2025 VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interacti... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a consumer via interactive digital media. Patient received both shots and still got shingles, but a very mild case. 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 (Dose 1 & 2). More
2854181 62 F VA 08/14/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 93N4J
Extra dose administered, Inappropriate schedule of product administration, Wrong... Extra dose administered, Inappropriate schedule of product administration, Wrong product administered; Extra dose administered, Inappropriate schedule of product administration, Wrong product administered More
Shingrix third dose; Shingrix given inadvertently and intended vaccine to be administered was Arexvy... Shingrix third dose; Shingrix given inadvertently and intended vaccine to be administered was Arexvy; patient had previously received a late second dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 93N4J, expiry date 25-APR-2027) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on 20 Jun 2023). On 09-JUL-2025, the patient received the 3rd dose of Shingrix. On 04-JAN-2024, the patient received the 2nd dose of Shingrix. The patient did not receive Arexvy. On 04-JAN-2024, after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient had previously received a late second dose of Shingrix). On 09-JUL-2025, the patient experienced extra dose administered (Verbatim: Shingrix third dose) and wrong vaccine administered (Verbatim: Shingrix given inadvertently and intended vaccine to be administered was Arexvy). The outcome of the extra dose administered, drug dose administration interval too long and wrong vaccine administered were not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 The reporter reported that while gathering information it was discovered patient had previously received a late second dose of Shingrix. The First dose given on 20 Jun 2023 and second dose on 04 Jan 2024 which led to Drug dose administration interval too long. On 09 Jul 2025 a third dose of the Shingrix vaccine was given to a patient. The third dose of the Shingrix vaccine was given to a patient which led to Extra dose administered. Stated it was given inadvertently and intended vaccine to be administered was Arexvy which led to Wrong vaccine administered. More
2854182 F 08/14/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
Wrong product administered Wrong product administered
Hiberix administration instead of Hepatitis B immunization; This non-serious case was reported by a ... Hiberix administration instead of Hepatitis B immunization; 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 female patient who received Hib (Hiberix) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hiberix and did not receive Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong vaccine administered (Verbatim: Hiberix administration instead of Hepatitis B immunization). The outcome of the wrong vaccine administered was not applicable. Additional Information: GSK Receipt Date: 04-AUG-2025 The health care provider requested to know a vaccine based on a lot number, to find out which was the vaccine that her daughter received. The agent asked which was the vaccine that her daughter should have received to which she replied Hepatitis B and the agent confirmed that the lot number corresponds to Hiberix, which led to wrong vaccine administered. The health care provider declined sharing adverse event details, although granted permission to store her contact details, but did not provide zip code yet the agent confirmed that the call was from the country with the phone number's area code. More
2854183 F IL 08/14/2025 MNQ
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 GB73Y
X449Y
Incorrect route of product administration, Local reaction; Incorrect route of pr... Incorrect route of product administration, Local reaction; Incorrect route of product administration, Local reaction More
Incorrect Site of Administration; Local reaction; This non-serious case was reported by a nurse via ... Incorrect Site of Administration; Local reaction; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect route of product administration in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X449Y, expiry date 20-OCT-2026) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number GB73Y, expiry date 31-JUL-2026) for prophylaxis. On an unknown date, the patient received Boostrix (right arm) and Menveo (right arm). On an unknown date, an unknown time after receiving Boostrix and Menveo, the patient experienced incorrect route of product administration (Verbatim: Incorrect Site of Administration) and local reaction (Verbatim: Local reaction). The outcome of the incorrect route of product administration was not applicable and the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to Boostrix, Boostrix Pre-Filled Syringe Device and Menveo. It was unknown if the company considered the local reaction to be related to Boostrix, Boostrix Pre-Filled Syringe Device and Menveo. 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: 05-AUG-2025 The reporter reported that patient came over the weekend and one of our staff members administered the Menveo vaccine but she, that was administered in the arm but, approximately 3 to 4 inches below the deltoid, it did not hit anywhere in the deltoid, there was a minor local reaction then reporters concern was would the vaccine be absorbed correctly or would that need to be repeat. Boostrix was administered in the same arm, the same day and same place, which led to incorrect route of administration. More
2854184 IL 08/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Shingrix late second dose; This non-serious case was reported by a other health professional via cal... Shingrix late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in February 2022). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 05-AUG-2025 The reporter had an individual who received their first Shingrix vaccine in February 2024 and did not return until August 2025 to get second vaccine. The reporter asked was patient protected since there was a long lapse between the 2 vaccines or was there a recommendation for full protection since vaccines were not given in timely manner. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. More
2854185 24 F IN 08/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 33FD3
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
Shingrix vaccine received at the age of 24; Shingrix administered instead of varicella vaccine; This... Shingrix vaccine received at the age of 24; Shingrix administered instead of varicella vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 24-year-old female patient who received Herpes zoster (Shingrix) (batch number 33FD3, expiry date 30-JAN-2027) for prophylaxis. Co-suspect products included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylaxis. On 04-AUG-2025, the patient received Shingrix. The patient did not receive VARICELLA VACCINE. On 04-AUG-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Shingrix vaccine received at the age of 24) and wrong vaccine administered (Verbatim: Shingrix administered instead of varicella vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable. Additional Information: GSK Receipt Date 06-AUG-2025 Licensed Practical Nurse explained that a 24-year-old patient who was not immunocompromised came for a varicella vaccine and a healthcare provider thought Shingrix might be used for varicella and administered it , which led to wrong vaccine administered. Patient received Shingrix vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. More
2854186 70 F IN 08/14/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
only one dose administered back on June twenty-twenty three; This non-serious case was reported by a... only one dose administered back on June twenty-twenty three; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 11-JUN-2023). The patient did not receive the 2nd dose of Twinrix. The patient had incomplete course of vaccination (Verbatim: only one dose administered back on June twenty-twenty three). 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: 06-AUG-2025 The registered pharmacist called and asking about a patient a vaccine schedule with Twinrix (only has one dose). The reporter wanted to know that did they need to revaccinate/restart the schedule. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. More
2854187 M LA 08/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
want to have the second shot this year.; This non-serious case was reported by a pharmacist via call... want to have the second shot this year.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose back in 2018 with batch number NX952 and lot expiry 06-MAR-2020). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: want to have the second shot this year.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-AUG-2025 The pharmacist called to get guidance on the Shingrix vaccination series the patient got the first shot back in 2018 and want to have the second shot this year. The health care professional wanted to know if the complete series have to be restarted. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. This case is linked with US2025103484, reported by same reporter. More
2854188 08/14/2025 HPV4
 MERCK & CO. INC.
Exposure during pregnancy, Foetal death, Foetal malformation, Investigation norm... Exposure during pregnancy, Foetal death, Foetal malformation, Investigation normal, Ultrasound antenatal screen abnormal More
Drug exposure during pregnancy; Death; Absent limb; Congenital limb malformation NOS; Exomphalos; Th... Drug exposure during pregnancy; Death; Absent limb; Congenital limb malformation NOS; Exomphalos; This spontaneous report was received from a/an Other health professional and refers to a(n) Foetus patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-May-2011, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), Injection administered by Unknown route (lot # and expiration date were not reported). On 27-Jul-2011, the patient started therapy with Injection (lot #668229/1569Z) administered by Transplacental route (expiration date was not reported). The patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), for the treatment of ??. The patient started therapy with GARDASIL Aqueous Suspension for Intramuscular Injection Syringe for the treatment of ??. On Sep-2011, the patient experienced Death. On 2011, the patient experienced Absent limb. On 2011, the patient experienced Congenital limb malformation NOS. On 2011, the patient experienced Exomphalos. On an unknown date, the patient experienced Drug exposure during pregnancy. On Sep-2011, Investigation showed Test Result: normal. On 14-Sep-2011, Ultrasound scan showed Test Result: Fetus was no longer viable/ alive.. At the reporting time, the patient had not recovered from Absent limb, Congenital limb malformation NOS and Exomphalos. At the reporting time, the outcome of Drug exposure during pregnancy was unknown. On 01-Sep-2011, the patient died because of the event(s) of Death. It was unknown whether an autopsy was performed. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was reported as not applicable. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Suspension for injection was reported as not applicable. The reporter considered the event of Drug exposure during pregnancy to be not related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine. The causal relationship between the event of Death and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The causal relationship between the event of Absent limb and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The causal relationship between the event of Congenital limb malformation NOS and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The causal relationship between the event of Exomphalos and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was unknown/not reported/not provided. The reporter considered the event(s) of Absent limb Congenital limb malformation NOS and Exomphalos to be congenital anomaly/birth defect.; Reported Cause(s) of Death: death More
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2854189 39 F 08/14/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Abdominal pain, Angina pectoris, Back pain, Dyspnoea, Headache; Hyperventilation... Abdominal pain, Angina pectoris, Back pain, Dyspnoea, Headache; Hyperventilation, Hypoaesthesia, Malaise, Mental impairment, Myalgia; Palpitations, Paraesthesia, Spinal pain More
couldn't think through her process; Heart pain; felt like she couldn't breathe; was hyperv... couldn't think through her process; Heart pain; felt like she couldn't breathe; was hyperventilating; she wasn't feeling good; waking with abdominal pain; woke with her heart racing and heart pain; Sick back pain; weird pain in her spine; she woke with numbness in her arm; A weird electrical feeling in her hand; Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (couldn't think through her process) and ANGINA PECTORIS (Heart pain) in a 39-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. 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 MENTAL IMPAIRMENT (couldn't think through her process) (seriousness criterion medically significant), ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant), DYSPNOEA (felt like she couldn't breathe), HYPERVENTILATION (was hyperventilating), MALAISE (she wasn't feeling good), ABDOMINAL PAIN (waking with abdominal pain), PALPITATIONS (woke with her heart racing and heart pain), BACK PAIN (Sick back pain), SPINAL PAIN (weird pain in her spine), HYPOAESTHESIA (she woke with numbness in her arm), PARAESTHESIA (A weird electrical feeling in her hand), MYALGIA (Body aches) and HEADACHE (Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain). At the time of the report, MENTAL IMPAIRMENT (couldn't think through her process), ANGINA PECTORIS (Heart pain), DYSPNOEA (felt like she couldn't breathe), HYPERVENTILATION (was hyperventilating), MALAISE (she wasn't feeling good), ABDOMINAL PAIN (waking with abdominal pain), PALPITATIONS (woke with her heart racing and heart pain), BACK PAIN (Sick back pain), SPINAL PAIN (weird pain in her spine), HYPOAESTHESIA (she woke with numbness in her arm) and PARAESTHESIA (A weird electrical feeling in her hand) outcome was unknown, MYALGIA (Body aches) had resolved and HEADACHE (Headache/headaches began again/she's continued to have episodes of crazy headaches/weird brain pain) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication information was not provided. Patient experienced a bad reaction to the Moderna Covid Vaccine and wanted information in regards to the Pfizer Covid pill. Patient reported adverse effects after receiving Paxlovid. Patient experienced headache and body aches and weird episodes once per week for four weeks. Patient woke up with numbness in her arm, and felt like she couldn't breathe and was hyperventilating. Patient had a weird electrical feeling in her hand. On the next morning, she wasn't feeling good, so, she went to the hospital. The hospital staff did not believe that she was having an adverse reaction to the vaccine but she was given IV fluids and then began to feel better. The headaches began again and patient had this weird brain pain and couldn't think through her process. Patient reported going to bed and having a dream and then waking with abdominal pain. On the next night, when she slept, she had another dream but during this time, she woke with her heart racing and heart pain, so then she went back to the emergency room visit. Patient did not state outcome of this emergency room visit. Patient continued to have episodes of crazy headaches. Patient purchased something with which she could check blood pressure and oxygen level. Patient was also having sick back pain, weird pain in her spine and felt like crap from January to March. Reporter did not allow further contact; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2854190 44 LA 08/14/2025 COVID19
COVID19
 MODERNA
MODERNA

Blindness, General physical health deterioration, Glomerulonephropathy, Immune s... Blindness, General physical health deterioration, Glomerulonephropathy, Immune system disorder, Multisystem inflammatory syndrome in adults; Nervous system disorder, Organ failure, Respiratory failure More
Severe multisystem inflammatory response; Glomerular disease; Progressive respiratory failure; Perma... Severe multisystem inflammatory response; Glomerular disease; Progressive respiratory failure; Permanent vision loss; Systemic immune dysfunction; Disabling neurological complications; Permanent organ damage; Experienced a rapid and devastating decline in health; This spontaneous case was reported by a consumer and describes the occurrence of MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response), GLOMERULONEPHROPATHY (Glomerular disease), RESPIRATORY FAILURE (Progressive respiratory failure), BLINDNESS (Permanent vision loss), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction) and NERVOUS SYSTEM DISORDER (Disabling neurological complications) in a 44-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. 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 MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response) (seriousness criterion medically significant), GLOMERULONEPHROPATHY (Glomerular disease) (seriousness criterion medically significant), RESPIRATORY FAILURE (Progressive respiratory failure) (seriousness criterion medically significant), BLINDNESS (Permanent vision loss) (seriousness criterion medically significant), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (Disabling neurological complications) (seriousness criterion medically significant), ORGAN FAILURE (Permanent organ damage) and GENERAL PHYSICAL HEALTH DETERIORATION (Experienced a rapid and devastating decline in health). At the time of the report, MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Severe multisystem inflammatory response), GLOMERULONEPHROPATHY (Glomerular disease), RESPIRATORY FAILURE (Progressive respiratory failure), BLINDNESS (Permanent vision loss), IMMUNE SYSTEM DISORDER (Systemic immune dysfunction), NERVOUS SYSTEM DISORDER (Disabling neurological complications), ORGAN FAILURE (Permanent organ damage) and GENERAL PHYSICAL HEALTH DETERIORATION (Experienced a rapid and devastating decline in health) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. It was reported that they never provided full and truthful disclosure of known risks, nor afforded a meaningful opportunity to decline without severe consequences. The patient was at risk for both lung and kidney transplants, dependent on supplemental oxygen, and required coordinated care from over 14 medical specialties and ongoing high-cost treatments. There was no family history or genetic predisposition to the autoimmune and systemic complications that currently faced by the patient. The patient's condition arose in direct temporal proximity to the Moderna vaccine and progressed immediately thereafter. The patient's treating physicians supported this causal link. It was reported that the patient sustained a permanent medical disability, loss of life insurance eligibility, loss of retirement security and earning potential, ongoing costs of care (infusions, transplant evaluation, mobility aids, etc.), and irreversible harm to physical and mental health. Treatment medication name was not reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2854191 74 M 08/14/2025 COVID19
COVID19
 MODERNA
MODERNA

COVID-19, Condition aggravated, Illness, Oropharyngeal pain, Pain; Respiratory s... COVID-19, Condition aggravated, Illness, Oropharyngeal pain, Pain; Respiratory symptom, SARS-CoV-2 test More
Sore throat; mild upper respiratory symptoms; he walks in the cold or the wind, the faster he walks,... Sore throat; mild upper respiratory symptoms; he walks in the cold or the wind, the faster he walks, it becomes sore; worst sore throat that you can possibly imagine, the 'so-called razor blade; had the hallmark symptom of the nimbus strain; acute illness lasted about a week to a week and a half; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RESPIRATORY SYMPTOM (mild upper respiratory symptoms), PAIN (he walks in the cold or the wind, the faster he walks, it becomes sore), CONDITION AGGRAVATED (worst sore throat that you can possibly imagine, the 'so-called razor blade) and COVID-19 (had the hallmark symptom of the nimbus strain) in a 74-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 20-May-2025, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RESPIRATORY SYMPTOM (mild upper respiratory symptoms), PAIN (he walks in the cold or the wind, the faster he walks, it becomes sore), CONDITION AGGRAVATED (worst sore throat that you can possibly imagine, the 'so-called razor blade), COVID-19 (had the hallmark symptom of the nimbus strain) and ILLNESS (acute illness lasted about a week to a week and a half). In 2025, ILLNESS (acute illness lasted about a week to a week and a half) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RESPIRATORY SYMPTOM (mild upper respiratory symptoms), PAIN (he walks in the cold or the wind, the faster he walks, it becomes sore), CONDITION AGGRAVATED (worst sore throat that you can possibly imagine, the 'so-called razor blade) and COVID-19 (had the hallmark symptom of the nimbus strain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2025, SARS-CoV-2 test: (Negative) he didn't have a positive test. No concomitant medication was reported. It was reported that around 8 months after patient received the vaccine in September of 2024 in 20-May-2025, he had the hallmark symptom of the nimbus strain. It was the worst sore throat that he could possibly imagine, the 'so-called razor blade, sore throat'. He was highly vaccinated; there was some correlation between that (his symptoms) and being highly vaccinated. Patient didn't had a positive test and the test he did have at home, he did not used because it was past the expiration date. That ever since he started having those symptoms, he had it continuously after. The acute illness lasted about a week to a week and a half. The other symptoms he had were just mild upper respiratory symptoms, sore throat, if he drank alcohol, it became sore, if he drank at 5 in the evening, he would wake up with a sore throat. When he walked in the cold or the wind, the faster he walked, it became sore. If he stopped walking, it went away. These symptoms seemed to be getting better although it was all a sudden onset. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2025: Live significant follow-up received with patient DOB updated. More
2854192 76 F TX 08/14/2025 COVID19
COVID19
 MODERNA
MODERNA

Arthritis, Blindness, Brain stem haemorrhage, Brain stem stroke, Pain in extremi... Arthritis, Blindness, Brain stem haemorrhage, Brain stem stroke, Pain in extremity; Pigmentation disorder More
She had a brain bleed on her medulla oblongata, the brain stem; she had a massive stroke; After rece... She had a brain bleed on her medulla oblongata, the brain stem; she had a massive stroke; After receiving her 2 Spikevax vaccines in her left arm, there is a black mark on her arm; There is not a day that goes by where her arm does not hurt, and today she can't use it / excruciating pain / arm hurts so bad / walking is painful; She would probably say it's just arthritis; went blind/in and out of blindness; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN STEM HAEMORRHAGE (She had a brain bleed on her medulla oblongata, the brain stem), BRAIN STEM STROKE (she had a massive stroke) and BLINDNESS (went blind/in and out of blindness) in a 76-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. Previously administered products included for Product used for unknown indication: smallpox; for Drug use for unknown indication: penicillin (a long time ago as a young girl and hard shot.). Past adverse reactions to the above products included Mobility decreased with penicillin; and No adverse effect with smallpox. Concurrent medical conditions included Blood pressure high (hereditary). On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced BRAIN STEM HAEMORRHAGE (She had a brain bleed on her medulla oblongata, the brain stem) (seriousness criteria hospitalization and medically significant) and BRAIN STEM STROKE (she had a massive stroke) (seriousness criteria hospitalization and medically significant). On 21-Jul-2025, the patient experienced BLINDNESS (went blind/in and out of blindness) (seriousness criterion medically significant). On an unknown date, the patient experienced PIGMENTATION DISORDER (After receiving her 2 Spikevax vaccines in her left arm, there is a black mark on her arm), PAIN IN EXTREMITY (There is not a day that goes by where her arm does not hurt, and today she can't use it / excruciating pain / arm hurts so bad / walking is painful) and ARTHRITIS (She would probably say it's just arthritis). The patient was treated with Lidocaine hydrochloride (Lidocaine) at an unspecified dose and frequency. At the time of the report, BRAIN STEM HAEMORRHAGE (She had a brain bleed on her medulla oblongata, the brain stem) and BRAIN STEM STROKE (she had a massive stroke) had resolved, BLINDNESS (went blind/in and out of blindness), PIGMENTATION DISORDER (After receiving her 2 Spikevax vaccines in her left arm, there is a black mark on her arm) and PAIN IN EXTREMITY (There is not a day that goes by where her arm does not hurt, and today she can't use it / excruciating pain / arm hurts so bad / walking is painful) had not resolved and ARTHRITIS (She would probably say it's just arthritis) outcome was unknown. Concomitant medication was not reported. It was reported that patient did not receive any vaccines 4 weeks prior to her Spikevax Moderna COVID-19 vaccines. She was healthy and mother of 8 children all by natural birth. On 21-Jul-2021, she had a massive stroke. She had a brain bleed on her medulla oblongata, the brain stem. She went blind. And then they transported her. From that vantage, she also had a DNR and then the doctors gave her up, they told she not gonna make it. Patient had been suffering. The 2 injections were put in her left arm. She was dominant in her right arm, she was right-handed. She wanted her Moderna shot in her left arm in case she had some of the same effects of the penicillin vaccine. After receiving her 2 Spikevax vaccines in her left arm, there was a black mark on her arm near her smallpox vaccination and it was never gone away. Her left arm, she had been in pain. It was reported that, there was not a day that goes by where her arm did not hurt, and she can't use it. She was suffering. Patient suffers with her left arm every day, excruciating pain and then it will let up. She could tell the team they can see the black mark on her arm. Her arm hurts so bad, she could not hold it up, it was just hanging on her body and walking was painful. She went blind. She was going in and out of blindness. patient thought it was her glasses. She drove herself to the ophthalmologist and doesn't know how she got there without having a wreck. The doctor told her she was having a brain stroke. Caller was in and out of consciousness then. She went to hospital, and then took an ambulance. The doctor said they will give her something to probably get her there in time. After that, she was in the ICU. It was confirmed that resolved over time and she now still had the symptom of pain in her left arm and a black mark that was never there. It was where the vaccine was injected. There was only 1 black mark.; Reporter's Comments: Concurrent medical condition Blood pressure high is a contributor for the events. In view of the long non-suggestive onset latency the causality of the event blindness was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
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2854193 61 M TX 08/14/2025 COVID19
 MODERNA
 088D21A
Overdose, Psoriatic arthropathy Overdose, Psoriatic arthropathy
Psoriatic arthritis; Vaccine overdose; This spontaneous case was reported by an other health care pr... Psoriatic arthritis; Vaccine overdose; This spontaneous case was reported by an other health care professional and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 062E21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 2 milliliter. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criteria disability and medically significant) and OVERDOSE (Vaccine overdose). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) had not resolved and OVERDOSE (Vaccine overdose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had no medical history, concomitant disease, or risk factor. Vaccine had compromised his immune system and had induced psoriatic arthritis. It was reported as 95,000.00 a year as an MRI Technologist, 43-year career gone because the vaccine altered his immune system. It was unknown if the patient experienced any additional symptoms or events. The patient was taking topical steroids. The patient had dermatology biopsy. There were no additional lab data or results available.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
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2854194 MD 08/14/2025 PNC20
 PFIZER\WYETH
 LN4927
Product container issue Product container issue
one vial was broken; The initial case was missing the following minimum criteria: product complaint ... one vial was broken; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on 28May2025, this case now contains all required information to be considered valid. This is a spontaneous report and received from Consumer or other non HCPs from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5 ml, single (Lot number: LN4927, Expiration Date: 30Jun2026) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "one vial was broken". Causality for "one vial was broken" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: NDC Number: 0005-2000-01. More
2854195 M AZ 08/14/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A male patien... COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. 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. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500097878 Same reporter/product/event, different patient; More
2854196 08/14/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
did not prevent covid or transmission of covid; did not prevent covid or transmission of covid; This... did not prevent covid or transmission of covid; did not prevent covid or transmission of covid; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did not prevent covid or transmission of covid". Clinical course: Covid shot did not prevent covid or transmission of covid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2854197 F AZ 08/14/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A 45-year-old... COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A 45-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 NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2025, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2025) Positive. Additional Information: During an inbound call for financial assistance, the patient stated, she actually tested positive today for COVID, her doctor sent in a prescription for Paxlovid for her because she had a lot of other medical conditions and she just got out the hospital for one of them. Her insurance wasn't approving Paxlovid. She guesses that's stopped or something How do she could get help getting the antibodies, the Paxlovid, because she means, she had been vaccinated. She got the Pfizer vaccines. She was getting sick" Additionally she stated, "she's antigen...she has got two dogs that she need to make sure survive, so she guessed she should probably survive too." Toward the end of the call, she stated, This is the first time she had ever gotten COVID, and she didn't even leave her house. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2854198 F AZ 08/14/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. An 87-year-ol... COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. An 87-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. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500162422 Same reporter/product/event, different patient; More
2854199 0.58 M ID 08/14/2025 DTAPHEPBIP
PNC20
RV5
 GLAXOSMITHKLINE BIOLOGICALS
PFIZER\WYETH
MERCK & CO. INC.
 K25M5
LN4928
Y018147
Induration, Injection site erythema, Rash, Rash macular, Rash papular; Induratio... Induration, Injection site erythema, Rash, Rash macular, Rash papular; Induration, Injection site erythema, Rash, Rash macular, Rash papular; Induration, Injection site erythema, Rash, Rash macular, Rash papular More
received vaccinations 3 days prior. Shortly after vaccinations developed few red spots on legs. Has ... received vaccinations 3 days prior. Shortly after vaccinations developed few red spots on legs. Has appeared more on the legs and arms. No other symptoms and has been very happy. Well appearing and stable vitals. No splenomegaly, friction rub, no oral lesions, no hematochezia, no hematuria, no urinary changes, no diarrhea. Indurated palpable erythematous macules and papules with few with target like appearance on extensor surfaces of extremities and buttocks More
2854200 55 M CA 08/14/2025 FLU3
 SANOFI PASTEUR
 u8790aa
Incorrect route of product administration, No adverse event Incorrect route of product administration, No adverse event
Accidentally gave subcutaneously instead of intramuscular, but has no known adverse event Accidentally gave subcutaneously instead of intramuscular, but has no known adverse event
2854221 62 F 08/14/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 U8823CA
Y013009
Injection site erythema, Injection site swelling, Injection site warmth; Injecti... Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth More
Pt complaining of hot spot, redness, swelling, and heat around injection site. Advised pt to take Ty... Pt complaining of hot spot, redness, swelling, and heat around injection site. Advised pt to take Tylenol and use ice. Advised pt to monitor over next few days and if it seems to be getting worse, contact her provider. More
2854222 16 M VA 08/14/2025 MNQ
MNQ
 SANOFI PASTEUR
SANOFI PASTEUR
 U8600AA
U8600AA
Blood creatine phosphokinase increased, Blood potassium decreased, Carbon dioxid... Blood creatine phosphokinase increased, Blood potassium decreased, Carbon dioxide decreased, Chest X-ray normal, Chest pain; Computerised tomogram thorax normal, Dyspnoea, Electrocardiogram normal, Full blood count normal More
During afternoon workout pt developed chest pain and shortness of breath which persisted for 6-7 hou... During afternoon workout pt developed chest pain and shortness of breath which persisted for 6-7 hours and resulted in ER visit. More
2854223 75 F FL 08/14/2025 FLU3
 SANOFI PASTEUR
 u8764bb
Asthenia, Dizziness, Throat tightness Asthenia, Dizziness, Throat tightness
Patient returned to the pharmacy after some shopping complaining of dizziness, feeling weak, and tha... Patient returned to the pharmacy after some shopping complaining of dizziness, feeling weak, and that her throat felt restricted. I offered to use an epipen and call 911, but she declined and said she would call her daughter to pick her up. She accepted 1 tablet of Benadryl 25mg. She was wearing a continuous glucose monitor and her sugar level was at 105. She wanted to check her blood pressure and it was 92/72 which she was was normal for her. We monitored her until her daughter picked her up. I recommended that she went to the emergency room for monitoring and to follow up with her doctor. More
2854224 13 M CA 08/14/2025 HPV9
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 Z007397
AMVB072A
Head injury, Loss of consciousness; Head injury, Loss of consciousness Head injury, Loss of consciousness; Head injury, Loss of consciousness
Patient received HPV vaccine and then was sitting on patient exam table and talking with mom before ... Patient received HPV vaccine and then was sitting on patient exam table and talking with mom before he loss consciousness and head started hitting the wall. Mother thought he was joking around and then realized he had lost consciousness and called for help. Staff arrived and patient had already regained consciousness and started talking and asking his mother what happened. More
2854225 44 F TX 08/14/2025 TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
 U8115AA
U8115AA
Injection site discomfort, Injection site erythema, Injection site induration, I... Injection site discomfort, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain; Injection site pruritus, Injection site warmth, Pain More
THE MORNING AFTER VACCINATION AT APPROXIMATLEY 08:00 , DONOR STATED THEY FELT DISCOMFORT, INFLAMATIO... THE MORNING AFTER VACCINATION AT APPROXIMATLEY 08:00 , DONOR STATED THEY FELT DISCOMFORT, INFLAMATION, INDURATION, WARMTH, ITHCINESS, REDNESS, AND 04/10 PAIN RADIATING FROM THE INJECTION TO THE BICEP. DONOR DENIES ANY TREATMENT AS SYMPTOMS RESOLVED SLOWLY. ON 08/11/2025, DONOR PRESENTED BACK TO FACILITY TO REPORT THEY HAD A REACTION AND STILL HAD INFLAMATION, WARMTH, REDNESS, INDURATION, AND PAIN AT THE AFFECTED SITE. More
2854226 83 F NC 08/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 NR4T5
Erythema, Pruritus Erythema, Pruritus
PATIENT DEVELOPED ERYTHEMA ON THE UPPER ARM WITH ITCHING. PATIENT WAS ADVISED TO TAKE BENADRYL AND T... PATIENT DEVELOPED ERYTHEMA ON THE UPPER ARM WITH ITCHING. PATIENT WAS ADVISED TO TAKE BENADRYL AND TYLENOL AND FOLLOW UP. TRIED CALLING THE PATIENT BACK AND SHE DIDN'T ANSWER AND HAD NO OPTION FOR US TO LEAVE A MESSAGE More
2854227 80 F MD 08/14/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 Z002626
FT95N
Pruritus, Rash; Pruritus, Rash Pruritus, Rash; Pruritus, Rash
Patient had a rash on her left arm that was itchy. She used some hydrocortisone and it was looking b... Patient had a rash on her left arm that was itchy. She used some hydrocortisone and it was looking better. More
2854228 56 M IL 08/14/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 2M7GR
Device connection issue Device connection issue
PARTIAL DOSE ADMINISTRED (NEEDLE TIP SLIPPED OFF BEFORE VACCINE WAS FULLY INJECTED). FULL DOSE WAS... PARTIAL DOSE ADMINISTRED (NEEDLE TIP SLIPPED OFF BEFORE VACCINE WAS FULLY INJECTED). FULL DOSE WAS THEN RE-ADMINISTERED PER GLAXOSMITH RECOMMENDATION TO COMPLETED FIRST DOSE. More
2854229 1.75 F MO 08/14/2025 HIBV
 SANOFI PASTEUR
 UK33UAA
Dermatitis atopic Dermatitis atopic
Atopic dermatitis flared over multiple areas 3 days after vaccine. Atopic dermatitis flared over multiple areas 3 days after vaccine.
2854230 64 M CA 08/14/2025 UNK
UNK
UNK
UNK
UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 37F34
37F34
37F34
LP4948
LP4948
LP4948
Ageusia, Dysphagia, Gait disturbance, Guillain-Barre syndrome, Headache; Hyperre... Ageusia, Dysphagia, Gait disturbance, Guillain-Barre syndrome, Headache; Hyperreflexia, Immunoglobulin therapy, Intensive care, Muscular weakness, Myalgia; Nausea, Paraesthesia; Ageusia, Dysphagia, Gait disturbance, Guillain-Barre syndrome, Headache; Hyperreflexia, Immunoglobulin therapy, Intensive care, Muscular weakness, Myalgia; Nausea, Paraesthesia More
Pt to ED cc of muscle pain in back of calves, arms and thighs, difficulty walking and swallowing, na... Pt to ED cc of muscle pain in back of calves, arms and thighs, difficulty walking and swallowing, nausea and headache that has been progressively getting worse since Sunday. Loss of taste since yesterday. Currently admitted to neuro ICU w/ working diagnosis of Guillain-BarrοΏ½ syndrome - Possibly secondary to pneumonia and DTAP vaccination on 8/1/2025. 8/14/2025 exam notable for diffusely reflexia, weakness in all 4 extremities most prominent in the proximal lower extremities but worsening overnight in the proximal upper extremities right worse than left. Diffuse paresthesias improved, no true sensory deficits. Receiving Privigin and s/p two doses of Solu-Medrol More
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2854231 13 F MO 08/14/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 9549B
Hypotonia, Immediate post-injection reaction, Seizure like phenomena Hypotonia, Immediate post-injection reaction, Seizure like phenomena
Patient slumped over in the chair immediately after the vaccine had been administered and exhibited... Patient slumped over in the chair immediately after the vaccine had been administered and exhibited tonic seizure-like symptoms for a brief 2-3 seconds and resumed to normal behavior afterwards. More
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