🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2815402 61 M IL 12/11/2024 VARZOS
VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 G2XE5
G2XE5
G2XE5
G2XE5
CSF culture negative, CSF white blood cell count increased, Encephalitis, Pleocy... CSF culture negative, CSF white blood cell count increased, Encephalitis, Pleocytosis; Injection site pain, Meningitis; CSF culture negative, CSF white blood cell count increased, Encephalitis, Pleocytosis; Injection site pain, Meningitis; Encephalitis, Loss of consciousness More
Patient developed meningoencephalitis 8 days after receiving shingrix vaccine. CSF with minimal pleo... Patient developed meningoencephalitis 8 days after receiving shingrix vaccine. CSF with minimal pleocytosis. Culture negative LP. More
✓
2869899 93 F 10/31/2025 COVID19
 MODERNA
Device connection issue, No adverse event, Underdose Device connection issue, No adverse event, Underdose
No adverse effect; a couple of drops leaked from the connection between the PFS and the needle; coup... No adverse effect; a couple of drops leaked from the connection between the PFS and the needle; couple of drops leaked from the connection between the PFS and the needle; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (a couple of drops leaked from the connection between the PFS and the needle), UNDERDOSE (couple of drops leaked from the connection between the PFS and the needle) and NO ADVERSE EVENT (No adverse effect) in a 93-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 22-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 22-Oct-2025, the patient experienced DEVICE CONNECTION ISSUE (a couple of drops leaked from the connection between the PFS and the needle) and UNDERDOSE (couple of drops leaked from the connection between the PFS and the needle). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE CONNECTION ISSUE (a couple of drops leaked from the connection between the PFS and the needle), UNDERDOSE (couple of drops leaked from the connection between the PFS and the needle) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medication was reported. HCP reported that while administering the vaccine to the patient he saw that a couple of drops leaked from the connection between the PFS and the needle. These drops then fell on the patient's arm. The Device Problem Information included FDA code: 1250, Code: A050401, Device problem: Fluid Leak. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2025: Live non-significant follow up received: reference number added. More
2869900 64 F 10/31/2025 COVID19
COVID19
 MODERNA
MODERNA
 8146670
8146670
Chills, Dehydration, Expired product administered, Headache, Malaise; Pain in ex... Chills, Dehydration, Expired product administered, Headache, Malaise; Pain in extremity, Vomiting More
It looks like the vial expired 5/15/25; general malaise; she could not keep fluids down; a little bi... It looks like the vial expired 5/15/25; general malaise; she could not keep fluids down; a little bit of sore arm; chills; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (general malaise), DEHYDRATION (she could not keep fluids down), PAIN IN EXTREMITY (a little bit of sore arm), CHILLS (chills) and VOMITING (vomiting) in a 64-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 8146670) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection (batch no. 8146670) for COVID-19 prophylaxis No Medical History information was reported. On 20-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced MALAISE (general malaise), DEHYDRATION (she could not keep fluids down), PAIN IN EXTREMITY (a little bit of sore arm), CHILLS (chills), VOMITING (vomiting) and HEADACHE (headache). On 20-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced EXPIRED PRODUCT ADMINISTERED (It looks like the vial expired 5/15/25). At the time of the report, MALAISE (general malaise), DEHYDRATION (she could not keep fluids down), PAIN IN EXTREMITY (a little bit of sore arm), CHILLS (chills), VOMITING (vomiting) and HEADACHE (headache) was resolving and EXPIRED PRODUCT ADMINISTERED (It looks like the vial expired 5/15/25) outcome was unknown. No concomitant medications were reported. The patient had experienced general malaise, a slight sore arm, and chills, but was unsure about having a fever as she had not taken her temperature. She also stated that the worst part had been the headache and vomiting, and she was unable to keep fluids down. As hours passed, she had thought she could, however she was not able to. The reporter stated that she had been much better on 22-Oct-2025 and had been able to eat and drink, and food had stayed down. It was unknown if the patient experienced any additional symptoms or events. Treatment medication use information was not provided by reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-790515 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2025: Live significant follow-up information received contains patient information updated, suspect dose details added, additional events added (General malaise, Fluid loss, Pain in arm, Chills, Vomiting, Headache), narrative updated, and additional references added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790515:same patient different product More
2869901 F 10/31/2025 COVID19
 MODERNA
Chills, Immunisation reaction, Pyrexia Chills, Immunisation reaction, Pyrexia
Normally experiences a pretty bad reaction to the vaccine, usually being gone for 2 or 3 days with a... Normally experiences a pretty bad reaction to the vaccine, usually being gone for 2 or 3 days with a high fever and chills; High fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Normally experiences a pretty bad reaction to the vaccine, usually being gone for 2 or 3 days with a high fever and chills), PYREXIA (High fever) and CHILLS (Chills) 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Normally experiences a pretty bad reaction to the vaccine, usually being gone for 2 or 3 days with a high fever and chills), PYREXIA (High fever) and CHILLS (Chills). At the time of the report, IMMUNISATION REACTION (Normally experiences a pretty bad reaction to the vaccine, usually being gone for 2 or 3 days with a high fever and chills), PYREXIA (High fever) and CHILLS (Chills) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication use information was not provided by reporter. The patient had always taken Moderna for every single dose and booster since it was released. And she normally experienced a pretty bad reaction to the vaccine, usually being gone for 2 or 3 days with a high fever and chills with vaccine. The patient wanted to take the Moderna vaccine. The doctor had given a prescription for the mNEXSPIKE vaccine. The question was about the difference between mNEXSPIKE and Spikevax. The reporter wondered if mNEXSPIKE would have fewer side effects, as the reporter just wanted to know the advantages because the doctor prescribed mNEXSPIKE 2025-2026, but the pharmacy only carried Spikevax 2025-2026. The reporter asked which dose was recommended between the 25mcg and the 50mcg and if there was only one dose available for mNEXSPIKE. Additionally, the reporter inquired whether the studies showed that mNEXSPIKE had fewer side effects than Spikevax. Lastly, the reporter asked why Moderna developed mNEXSPIKE and what advantages it had over Spikevax. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-790562 (Patient Link). More
2869902 70 F PA 10/31/2025 COVID19
 MODERNA
Atrial fibrillation, Pericarditis Atrial fibrillation, Pericarditis
Developed atria fib; Pericarditis; This spontaneous case was reported by a consumer and describes th... Developed atria fib; Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Developed atria fib) and PERICARDITIS (Pericarditis) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer COVID-19 vaccine. In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In March 2024, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2024, the patient experienced ATRIAL FIBRILLATION (Developed atria fib) (seriousness criteria hospitalization and medically significant). In June 2024, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 03-Jun-2024 to 06-Jun-2024 due to PERICARDITIS, and then from 08-Jun-2024 to 13-Jun-2024 due to ATRIAL FIBRILLATION. The patient was treated with Metoprolol tartrate (Metoprolol) at an unspecified dose and frequency; Apixaban (Eliquis) at an unspecified dose and frequency; Indometacin (Indomethacin) at an unspecified dose and frequency and Colchicine at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Developed atria fib) outcome was unknown and PERICARDITIS (Pericarditis) had not resolved. The patient had a total of 6 COVID booster with the Pfizer been the first one when it came out. The first Moderna COVID vaccine patient had was in October 2023 and the last Moderna one was in March 2024. In June 2024 she developed pericarditis and was hospitalized (cardiac step-down care) from 03-Jun-2024 to 06-Jun-2024, then readmitted on 08-Jun-2024 until 13-Jun-2024 where she had developed atria fib. Patient was treated for an ongoing 4 months with Indomethacin and Colchicine. The patient was currently on Metoprolol and Eliquis (heart meds). The patient had an inquiry if mNEXSPIKE was a good option for her and cardiologist had advised her she should have it. No additional information was provided. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: Company Comment: The event of pericarditis could have contributed to the event atrial fibrillation. The benefit-risk relationship of the product is not affected by this report. More
✓
2869903 47 M MA 10/31/2025 COVID19
 MODERNA
 068H21A
Mechanical urticaria, Urticaria Mechanical urticaria, Urticaria
dermatagraphia; hives; This spontaneous case was reported by a consumer and describes the occurrence... dermatagraphia; hives; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (dermatagraphia) and URTICARIA (hives) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis. No Medical History information was reported. On 21-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In December 2021, the patient experienced MECHANICAL URTICARIA (dermatagraphia) and URTICARIA (hives). In March 2022, MECHANICAL URTICARIA (dermatagraphia) and URTICARIA (hives) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that patient had roughly 3 months of hives and dermatagraphia post administration. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. More
2869904 66 F NJ 10/31/2025 COVID19
COVID19
 MODERNA
MODERNA

Arthralgia, Burning sensation, Bursitis, Hypokinesia, Magnetic resonance imaging... Arthralgia, Burning sensation, Bursitis, Hypokinesia, Magnetic resonance imaging; Product preparation error More
pharmacy was quite busy, pharmacist told me she has to retrieve Covid booster from freezer. The phar... pharmacy was quite busy, pharmacist told me she has to retrieve Covid booster from freezer. The pharmacist must of waited about 10 to 15 minutes before she administered booster into my left arm; bursitis; 12 hours later left shoulder felt like it was on fire; started loosing my range of motion in left arm; lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (bursitis), BURNING SENSATION (12 hours later left shoulder felt like it was on fire), HYPOKINESIA (started loosing my range of motion in left arm), ARTHRALGIA (lot of pain) and PRODUCT PREPARATION ERROR (pharmacy was quite busy, pharmacist told me she has to retrieve Covid booster from freezer. The pharmacist must of waited about 10 to 15 minutes before she administered booster into my left arm) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Partial tear of muscle (cannot receive the booster in my right shoulder because I have a partial tear). On 30-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2024, the patient experienced BURSITIS (bursitis), HYPOKINESIA (started loosing my range of motion in left arm) and ARTHRALGIA (lot of pain). 2024, the patient experienced BURNING SENSATION (12 hours later left shoulder felt like it was on fire). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (pharmacy was quite busy, pharmacist told me she has to retrieve Covid booster from freezer. The pharmacist must of waited about 10 to 15 minutes before she administered booster into my left arm). The patient was treated with Cortisone acetate (Cortison) on 24-Mar-2025 at an unspecified dose and frequency and Manual therapy (used ice packs to try and cool it down) for Burning sensation. At the time of the report, BURSITIS (bursitis), BURNING SENSATION (12 hours later left shoulder felt like it was on fire) and PRODUCT PREPARATION ERROR (pharmacy was quite busy, pharmacist told me she has to retrieve Covid booster from freezer. The pharmacist must of waited about 10 to 15 minutes before she administered booster into my left arm) outcome was unknown and HYPOKINESIA (started loosing my range of motion in left arm) and ARTHRALGIA (lot of pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: showed had Frozen Shoulder. Concomitant medication was not reported. It was reported that patient went to the Pharmacy to receive the Moderna Covid Booster. The pharmacy was quite busy, and the pharmacist told, she had to retrieve the Covid booster from the freezer. The pharmacist must have waited about 10 to 15 minutes before she administered the booster into left arm. Patient sat there for about 15 minutes and then went on with day. 12 hours later her left shoulder felt like it was on fire. She used ice packs to try and cool it down. Then she started losing range of motion in left arm. Patient made an appointment with an Orthopedic because the range of motion in left arm was pretty bad. The orthopedic sent to PT for four weeks and had an MRI. The MRI showed she had Frozen Shoulder. Then she made an appointment with an Orthopedic. That Orthopedic told that she had Bursitis, not Frozen Shoulder. But throughout all this time she was in a lot of pain. The Orthopedic recommended a Cortisone Injection. Using an ultrasound he gave the Cortisone Injection. Patient had relief immediately and it had lasted about 7 months. It was Oct-2025 and returned to the Orthopedic for another Cortisone Injection. The injection lasted until Oct-2025. The point she was making was the Pharmacist was in too much of a hurry and administered the booster in the wrong spot or too soon after she retrieved from the freezer. Also because of the constant pain patient was unable to receive the booster this year on her left shoulder. She could not receive the booster in her right shoulder because she had a partial tear. So, no Covid Booster this year. Patient find PT did not help and the Orthopedic said any kind of surgery would help. Patient had X-Rays and MRI. She had an appointment with Orthopedic in Nov-2025 to have another injection. She still had a lot of pain. Range of motion had returned. It was unknown if the patient experienced any additional symptoms/events. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2025: Follow up received with non-significant information includes treatment drug details added. More
2869905 40 F OH 10/31/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Urticaria; Urticaria Urticaria; Urticaria
Hives - urticaria; This spontaneous case was reported by a consumer and describes the occurrence of ... Hives - urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives - urticaria) in a 40-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. Concurrent medical conditions included Urticaria since 2024. On 26-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 06-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced URTICARIA (Hives - urticaria). At the time of the report, URTICARIA (Hives - urticaria) was resolving. The patient had no medical history, or risk factor. No concomitant medication was reported. The patient had hives - urticaria for the second year in a row where it was bad. Dermatologist diagnosed the disease. If it was the same as last year, it would be a few months of flare-ups. The patient did not experience any additional symptoms/events. There were no lab data/results available. Patient was taking topical creams to help with the urticaria.; Reporter's Comments: Patient's concurrent medical condition was assessed as strong risk factor for reported event. The benefit-risk relationship of mRNA-1273 is not affected by this report. More
2869906 74 F SC 10/31/2025 COVID19
COVID19
 MODERNA
MODERNA

Back pain, Chest pain, Chills, Contusion, Fall; Joint injury, Loss of consciousn... Back pain, Chest pain, Chills, Contusion, Fall; Joint injury, Loss of consciousness, Musculoskeletal chest pain, Skin laceration More
passed out; right arm and breast have extreme bruising with pain./ have severe bruising on my right... passed out; right arm and breast have extreme bruising with pain./ have severe bruising on my right cheek and busted my chin; chest, ribs, and upper back are very painful; chest, ribs, and upper back are very painful; chest, ribs, and upper back are very painful; also have cuts on right elbow and both knees; fell on the ceramic tiled tub and landed on the tiled floor; also have cuts on right elbow and both knees; extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 74-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 16-Oct-2025 at 12:30 PM, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 16-Oct-2025, the patient experienced CHILLS (extreme chills). On 17-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), CONTUSION (right arm and breast have extreme bruising with pain./ have severe bruising on my right cheek and busted my chin), CHEST PAIN (chest, ribs, and upper back are very painful), MUSCULOSKELETAL CHEST PAIN (chest, ribs, and upper back are very painful), BACK PAIN (chest, ribs, and upper back are very painful), SKIN LACERATION (also have cuts on right elbow and both knees), FALL (fell on the ceramic tiled tub and landed on the tiled floor) and JOINT INJURY (also have cuts on right elbow and both knees). In October 2025, LOSS OF CONSCIOUSNESS (passed out) and CHILLS (extreme chills) had resolved. At the time of the report, CONTUSION (right arm and breast have extreme bruising with pain./ have severe bruising on my right cheek and busted my chin), CHEST PAIN (chest, ribs, and upper back are very painful), MUSCULOSKELETAL CHEST PAIN (chest, ribs, and upper back are very painful) and BACK PAIN (chest, ribs, and upper back are very painful) had not resolved and SKIN LACERATION (also have cuts on right elbow and both knees), FALL (fell on the ceramic tiled tub and landed on the tiled floor) and JOINT INJURY (also have cuts on right elbow and both knees) outcome was unknown. No concomitant medications provided by the reporter. It was reported that the patient had vaccination at 12:30, post vaccination the patient felt fine all day, and the patient went to bed at 11 pm and woke up with extreme chills during the night and the symptom was lasted for the patient a couple of hours. The patient got up around 7:30 am and she went to the bathroom and passed out. she fell on the ceramic tiled tub and landed on the tiled floor. She was in extreme pain and unable to move or get up. EMS had been called, and EMS checked the patient vital signs and wounds. EMS helped the patient get up. The patient experienced severe bruising on her right cheek and busted on her chin. She also had cuts on her right elbow and both knees. Her right arm and breast have extreme bruising with pain. The patient chest, ribs, and upper back were very painful with limited movement. It was 10 days from the vaccination, but the patient was still in pain. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report. More
2869907 M 10/31/2025 COVID19
 MODERNA
Fatigue, Headache, Immunisation reaction, Myalgia Fatigue, Headache, Immunisation reaction, Myalgia
couple of rounds were a little tough when we got the vaccine, definitely had a couple of things that... couple of rounds were a little tough when we got the vaccine, definitely had a couple of things that weren't wonderful when took it in everything; headache; muscle ache; general tiredness; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (couple of rounds were a little tough when we got the vaccine, definitely had a couple of things that weren't wonderful when took it in everything), HEADACHE (headache), MYALGIA (muscle ache) and FATIGUE (general tiredness) in an adult male patient 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (couple of rounds were a little tough when we got the vaccine, definitely had a couple of things that weren't wonderful when took it in everything), HEADACHE (headache), MYALGIA (muscle ache) and FATIGUE (general tiredness). At the time of the report, IMMUNISATION REACTION (couple of rounds were a little tough when we got the vaccine, definitely had a couple of things that weren't wonderful when took it in everything), HEADACHE (headache), MYALGIA (muscle ache) and FATIGUE (general tiredness) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not reported. It was mentioned that patient had been using Moderna's vaccine exclusively (COVID vaccines) since the beginning of COVID. It was stated that the first couple of rounds were a little tough when he got the vaccine, had a couple of things that weren't wonderful when took it in everything, the headache, the muscle ache, and all that stuff that went along with it. But it was also a matter of getting used to the material and everything because look as time had gone on those side effects or contraindications had become less, and that was a good thing. Patient had been taking Moderna's vaccines since the first one that was offered when everybody had to do the 2 shots and all that stuff all the way through. Now in the first case when he had a little bit of side effects from it with muscle ache and a few other things. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to MOD-2025-790655 (Patient Link). More
2869908 18 F AR 10/31/2025 MENB
 PFIZER\WYETH
 GF4142
Injection site pain, Injection site swelling Injection site pain, Injection site swelling
the pain at the site; the swelling at the site; they administered Trumenba subcutaneously instead in... the pain at the site; the swelling at the site; they administered Trumenba subcutaneously instead intramuscularly; This is a spontaneous report received from a Nurse from medical information team. An 18-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 04Feb2025 at 09:30 as dose 2, 0.5 ml single (Lot number: GF4142, Expiration Date: 30Aug2025) at the age of 18 years subcutaneous, in left arm for immunisation, Device Lot Number: GF4142, Device Expiration Date: 30Aug2025. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Meningococcal vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Feb2025 at 09:30, outcome "unknown", described as "they administered Trumenba subcutaneously instead intramuscularly"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "the pain at the site"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "the swelling at the site". Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling. Additional information: the nurse administered Trumenba subcutaneously instead intramuscularly, the NDC number was 0005010001. The patient was taking Tylenol and Ibuprofen for the pain at the site; Ibuprofen was also for the swelling at the site and other than that she was not taking any other medications at this time. The reporter stated that the patient mom probably gave her 500 of Tylenol and 400 of Ibuprofen, every 4 to 6 hours alternating. The patient did at her wellness. She had some lab work done, it all came back to normal. Follow-up (14Mar2025): Follow-up attempts are completed. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities. More
2869909 51 F 10/31/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EH9899
EH9899
EH9899
Arthralgia, Body temperature, Chills, Condition aggravated, Fatigue; Headache, J... Arthralgia, Body temperature, Chills, Condition aggravated, Fatigue; Headache, Joint stiffness, Joint swelling, Pain, Pyrexia; Vaccination site pain, Vaccination site swelling, Vaccination site warmth More
Pain, swelling, increased warmth at injection site; Pain, swelling, increased warmth at injection si... Pain, swelling, increased warmth at injection site; Pain, swelling, increased warmth at injection site; Pain, swelling, increased warmth at injection site; Onset fever of 100.8; severe headache; body aches; chills; Fatigue; stiffness multiple bilateral joints; had increased swelling, pain/Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine; chronic joint pain/had increased swelling, pain/Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine; had increased swelling, pain/Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine; This is a spontaneous report received from a Consumer or other non HCP. A 51-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 2, single (Lot number: EH9899) at the age of 51 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Intolerant to non-specific beta blockers" (unspecified if ongoing); "Intolerant to non-specific beta blockers" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Nitroglycerin, reaction(s): "Known allergies: nitroglycerin". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EH9899, in the right arm), for Covid-19 immunization, reaction(s): "swelling, pain, stiffness multiple bilateral joints", "Chills", "Fatigue", "Headache", "swelling, pain, stiffness multiple bilateral joints", "swelling, pain, stiffness multiple bilateral joints", "Body aches", "Fever", "Pain, swelling, increased warmth at injection site", "Pain, swelling, increased warmth at injection site". Vaccination date of dose 1 was 21Dec2021 (as reported. The following information was reported: FATIGUE (disability) with onset 11Jan2021, outcome "recovered with sequelae"; PYREXIA (disability) with onset 11Jan2021, outcome "recovered with sequelae", described as "Onset fever of 100.8"; VACCINATION SITE PAIN (disability), VACCINATION SITE SWELLING (disability), VACCINATION SITE WARMTH (disability) all with onset 11Jan2021, outcome "recovered with sequelae" and all described as "Pain, swelling, increased warmth at injection site"; PAIN (disability) with onset 11Jan2021, outcome "recovered with sequelae", described as "body aches"; CHILLS (disability) with onset 11Jan2021, outcome "recovered with sequelae"; ARTHRALGIA (disability) with onset 11Jan2021, outcome "recovered with sequelae", described as "chronic joint pain/had increased swelling, pain/Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine"; JOINT SWELLING (disability), CONDITION AGGRAVATED (disability) all with onset 11Jan2021, outcome "recovered with sequelae" and all described as "had increased swelling, pain/Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine"; HEADACHE (disability) with onset 11Jan2021, outcome "recovered with sequelae", described as "severe headache"; JOINT STIFFNESS (disability) with onset 11Jan2021, outcome "recovered with sequelae", described as "stiffness multiple bilateral joints". The events "stiffness multiple bilateral joints", "had increased swelling, pain/joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine" and "chronic joint pain/had increased swelling, pain/joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (11Jan2021) 100.8. Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site warmth, pyrexia, headache, pain, chills, fatigue, joint stiffness, joint swelling, arthralgia, condition aggravated. Adverse event: Pain, swelling, increased warmth at injection site lasting approximately 24 hrs. Onset fever of 100.8, severe headache, body aches, chills, fatigue approximately 8 hours after vaccine, lasting approximately 24 hours. After initial symptoms resolved, had increased swelling, pain, stiffness multiple bilateral joints. Symptoms very similar to reaction to first dose, though less severe with shorter duration of acute symptoms. Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine. No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500212222 same patient/suspect vaccine; different dose/AE; More
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2869910 51 F 10/31/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EH9899
EH9899
EH9899
Arthralgia, Body temperature, Chills, Fatigue, Headache; Joint stiffness, Joint ... Arthralgia, Body temperature, Chills, Fatigue, Headache; Joint stiffness, Joint swelling, Musculoskeletal stiffness, Nausea, Pain; Pyrexia, Vaccination site pain, Vaccination site swelling, Vaccination site warmth More
Stiffness of ankles, hips, shoulders, and knees; Severe fatigue; Joint swelling of bilateral multipl... Stiffness of ankles, hips, shoulders, and knees; Severe fatigue; Joint swelling of bilateral multiple joints; Joint pain; Stiffness; stiffness of hands, fingers, feet, and neck; Injection site pain; Injection site swelling; Injection site heat; Fever at 101.4; maximum at 103.4; Severe headache; Body aches; mild to moderate bilateral pain; Nausea; Chills; Severe fatigue; This is a spontaneous report received from a consumer. A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899) at the age of 51 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Does not tolerate non-selective beta blockers" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Nitroglycerin, reaction(s): "Does not tolerate". The patient had no known allergies but does not tolerate non-selective beta blockers or nitroglycerin. No other medication was given in two weeks. No other vaccine was administered within 4 weeks or on the same date as the suspect vaccine. The vaccine was administered in a public health clinic or Veterans administration facility. The following information was reported: PAIN (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020), described as "Body aches; mild to moderate bilateral pain"; CHILLS (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020); PYREXIA (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020), described as "Fever at 101.4; maximum at 103.4"; VACCINATION SITE WARMTH (disability) with onset 21Dec2020, outcome "recovered with sequelae" (23Dec2020), described as "Injection site heat"; VACCINATION SITE PAIN (disability) with onset 21Dec2020, outcome "recovered with sequelae" (23Dec2020), described as "Injection site pain"; VACCINATION SITE SWELLING (disability) with onset 21Dec2020, outcome "recovered with sequelae" (23Dec2020), described as "Injection site swelling"; ARTHRALGIA (disability) with onset 21Dec2020, outcome "recovered with sequelae", described as "Joint pain"; NAUSEA (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020); FATIGUE (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020), FATIGUE (disability), outcome "recovered with sequelae" and all described as "Severe fatigue"; HEADACHE (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020), described as "Severe headache"; MUSCULOSKELETAL STIFFNESS (disability) with onset 21Dec2020, outcome "recovered with sequelae", described as "Stiffness; stiffness of hands, fingers, feet, and neck"; JOINT SWELLING (disability) with onset 25Dec2020, outcome "recovered with sequelae" (Jan2021), described as "Joint swelling of bilateral multiple joints"; JOINT STIFFNESS (disability), outcome "recovered with sequelae", described as "Stiffness of ankles, hips, shoulders, and knees". On 21Dec2020 (around 4 hours post-vaccine), the patient experienced injection site pain, swelling, and heat lasting 3 days. On 21Dec2020 (approximately 12 hours post-vaccine), fever 101.4 onset (with maximum fever at 103.4 in Dec2020; intermittent with response to Tylenol and ibuprofen) with severe headache, body aches, nausea, chills, and severe fatigue, ongoing for 7 days. On 25Dec2020 (4 days post-vaccine), the patient had joint swelling of bilateral multiple joints lasting approximately 1 month, with gradual improvement after first 4 to 5 days. Since then, the patient had intermittent acute on chronic episodes of joint pain, swelling, stiffness, severe fatigue, each exacerbation lasts from 3 to 4 days up to 3 weeks, every 6 to 9 weeks. Chronic aspect - constant mild to moderate bilateral pain, swelling, or stiffness of hands, fingers, feet, ankles, hips, shoulders, knees, and neck. The adverse events were considered serious resulting in disability or permanent damage. Treatment to all events included intermediate steroids (acute flares) and oral NSAIDs. The patient recovered from the events but with lasting effects. No follow-up attempts are possible. More
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2869911 F 10/31/2025 COVID19
 PFIZER\BIONTECH
Death Death
It killed her mom; This is a spontaneous report and received from Consumer or other non HCPs from me... It killed her mom; This is a spontaneous report and received from Consumer or other non HCPs from medical information team, Program ID. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: DEATH (death, medically significant), outcome "fatal", described as "It killed her mom". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical details: The wife stated it killed her mom, her dad, her two older sisters, her husband had relatives die, they've had friends die and no one takes it off the market. It's got a whole bunch of stuff in it that is toxic to the body and it has the spike protein which causes harm to the body. (withheld) has had several conferences with these people that have gotten the covid jab and they almost died and a lot of them have died and they're, like, crippled now and they have heart disease and nobody's doing jack about it. 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-202500213572 Same reporter/vaccine/event, different patients;US-PFIZER INC-202500213573 Same reporter/vaccine/event, different patients;US-PFIZER INC-202500213574 Same reporter/vaccine/event, different patients;; Reported Cause(s) of Death: It killed her mom More
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2869912 M CA 10/31/2025 COVID19
 PFIZER\BIONTECH
Cardiac ventricular thrombosis Cardiac ventricular thrombosis
severe blood clots in his heart; This is a spontaneous report received from a Consumer or other non ... severe blood clots in his heart; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 50-year-old male patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart attack" (unspecified if ongoing); "chest pain" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). In 2020, he did martial arts 7 days a week for 3 hours a day, weight training an hour a day and riding bike 5 miles a day before the heart attack, Covid shot or medication for heart, blood pressure. Concomitant medication(s) included: PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE] taken for chest pain, myocardial infarction. Patient started on PROTONIX 6 years ago. The patient also took other concomitant therapy. The following information was reported: CARDIAC VENTRICULAR THROMBOSIS (medically significant) with onset 2020, outcome "unknown", described as "severe blood clots in his heart". Therapeutic measures were taken as a result of cardiac ventricular thrombosis. Clinical course: The patient received the Pfizer Covid vaccine right after the heart attack, in 2020; probably right after the vaccine came out, within a few months of coming out. This first Pfizer Covid vaccine was in the hospital, they refused to treat him until he got it. He ended up with severe blood clots in his heart in 2020 after the Pfizer Covid vaccine. They put 5 stents in his heart in Jun2020, patient thought on 18Jun2020. His treating healthcare professionals blamed the heart attack on acid-reflux, then on clogged arteries, then blamed it on the Pfizer Covid vaccine (as reported, no further details were provided as to which vaccine formulation or number of vaccinations), then blamed it on blood clots in his heart. The lot number for BNT162b2, was not provided and will be requested during follow up. More
2869913 56 F MO 10/31/2025 COVID19
 PFIZER\BIONTECH
Cerebral haemorrhage, Neoplasm malignant, Ocular stroke, Reversible cerebral vas... Cerebral haemorrhage, Neoplasm malignant, Ocular stroke, Reversible cerebral vasoconstriction syndrome, Spinal cord injury More
Spinal ruptures; eye strokes; brain bleed; RCVS; cancer; This is a spontaneous report received from ... Spinal ruptures; eye strokes; brain bleed; RCVS; cancer; This is a spontaneous report received from a Consumer or other non HCP. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No other vaccine on same date, no other vaccine in four weeks, no other medications in two weeks. The following information was reported: REVERSIBLE CEREBRAL VASOCONSTRICTION SYNDROME (hospitalization, disability, life threatening) with onset 15Nov2021, outcome "unknown", described as "RCVS"; SPINAL CORD INJURY (hospitalization, disability, life threatening) with onset 15Nov2021, outcome "unknown", described as "Spinal ruptures"; CEREBRAL HAEMORRHAGE (hospitalization, disability, life threatening) with onset 15Nov2021, outcome "unknown", described as "brain bleed"; NEOPLASM MALIGNANT (hospitalization, disability, life threatening) with onset 15Nov2021, outcome "unknown", described as "cancer"; OCULAR STROKE (hospitalization, disability, life threatening) with onset 15Nov2021, outcome "unknown", described as "eye strokes". Clinical details: Spinal ruptures, eye strokes, brain bleed, RCVS, list goes on now cancer. The events resulted in Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
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2869914 WA 10/31/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Device breakage Device breakage
broken glass; This is a spontaneous report received from an Other HCP from product quality group. A... broken glass; This is a spontaneous report received from an Other HCP from product quality group. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Lot number: NA0589, Expiration Date: 23Jun2026) for covid-19 immunisation, Device Lot Number: NA0589, Device Expiration Date: 23Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "broken glass". Additional information: A pharmacist wanted to request a replacement for Comirnaty 2025-2026 because the plunger is broken. A broken syringe was observed during the evaluation of the returned complaint sample. Pictures shows broken glass. The reporter considered "broken glass" not related to BNT162b2 omicron (lp.8.1). Causality for "broken glass" was determined associated to device constituent of BNT162b2 omicron (lp.8.1) (malfunction). More
2869915 M FL 10/31/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Blood pressure measurement, Brain fog, COVID-19, Chest pain, Drug ineffective; P... Blood pressure measurement, Brain fog, COVID-19, Chest pain, Drug ineffective; Pain More
everything is a little foggy because my brain is not quite thinking clearly; several pains; chest pa... everything is a little foggy because my brain is not quite thinking clearly; several pains; chest pains; got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 73-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Oct2025, outcome "unknown" and all described as "got COVID"; BRAIN FOG (non-serious), outcome "unknown", described as "everything is a little foggy because my brain is not quite thinking clearly"; PAIN (non-serious), outcome "unknown", described as "several pains"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pains". The event "got covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Fine. Clinical course: During an inbound call for financial assistance, the patient stated that diagnosed on 22Oct2025 morning at the doctor's office with COVID. So, physician put the patient on Paxlovid 300-100 mg. Patient wife went back over on 22Oct2025 afternoon and she started feeling the symptoms patient already had. After confirming the reason for the call and confirming that patient has a prescription for the medication stated that everything is a little foggy because the brain is not quite thinking clearly now that patient have got that mess. After providing the program requirements stated maybe that's patient didn't know he looked that bad on 22Oct2025 that patient's wife thought patient got COVID was just looking at the discount cards because some of the patient's medications may switch over to that next year, patient realized their jumping up two tiers on two of the medicines patient have. Patient guessed that just bite the bullet and go ahead and pay it and patient could die it happens, patient guessed that trying to get the Paxlovid and especially the other day patient had several pains involved with that so patient was talked to the rental car she go just had. Patient got over that about two weeks ago then think about COVID being around that area were patient lives in. They fortunately dodged a bullet, for what's been now five years. Of course they took the vaccines, which patient have now elected not to do for the last year or so. Got to talk to his doctor cause patient started experience chest pains, various times in the evening and which had started occurring. They said something about the side effects of miramir that this could have an effect on that, so strangely enough once patient just decided not to do the booster when that was time for that and then again. Then this year it's been two years, Patient hadn't had that, that's no wonder patient hadn't had that thing, it's gone away so that issue had gone away but so patient had a feeling it might have had something to do with the vaccine but created a something going on within that area it felt like there's pressure on the heart. Patient had one day, one evening, usually patient have when he laying down in bed at night and wake up, patient couldn't, patient was switching positions, everything trying and that lasted about ten minutes when patient called the doctor to asked about that and said that he don't know what's going on here and he said that it would recommend the hydrogen chlorine (inaudible) check the blood pressures and do all that cause yeah that's not something you want to play around with. Let's see if it goes down first. In the end, blood pressure and everything was fine, patient went to the doctor to check. Patient guessed because he signed up during that COVID time, assumed that must be what it's for. Talked about the past experience when patient took the shots no cause that was what's the other one. Patient did take and then he had, he forget what the other company. Maybe it was, it's two companies over a period of time. That happened in a facility where we were at or went to down in, one had one, one had the other. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2869916 10/31/2025 COVID19
 PFIZER\BIONTECH
Chronic kidney disease, Diabetes mellitus, Gait disturbance, Illness Chronic kidney disease, Diabetes mellitus, Gait disturbance, Illness
CKD; diabetes; Couldn't walk well; sick; This is a spontaneous report received from a Consumer ... CKD; diabetes; Couldn't walk well; sick; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An elderly patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown", described as "CKD"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; GAIT DISTURBANCE (non-serious), outcome "recovered", described as "Couldn't walk well"; ILLNESS (non-serious), outcome "recovered", described as "sick". Clinical course: The following events were reported: Couldn't walk well after COVID-19 booster vaccine. Was sick for 12 days. Felt that diabetes treatment caused CKD. Unknown which diabetic treatments received, unsure if it was a Pfizer treatment. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2869917 M 10/31/2025 COVID19
 PFIZER\BIONTECH
Myocarditis Myocarditis
Myocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An... Myocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 85-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Oct2025 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: MYOCARDITIS (medically significant) with onset Oct2025, outcome "unknown". The patient received the shot 10 days ago and he develop Myocarditis - a condition in his heart. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2869918 84 M OR 10/31/2025 COVID19
 MODERNA
 3052917
Breath sounds abnormal, Dyspnoea, Hypoxia Breath sounds abnormal, Dyspnoea, Hypoxia
COVID-19 vaccine administered by LN at 1253. Resident reported shortness of breath approximately 30-... COVID-19 vaccine administered by LN at 1253. Resident reported shortness of breath approximately 30-35 minutes after vaccine administration. Resident had hypoxia (SpO2 of 70%) on 6 Liters of oxygen. NP assessed and lung sounds were diminished at the bases posteriorly- she ordered to call 911 for emergency medical services for resident to be sent to ER. EMS left facility with resident at approximately 1351. More
2869919 52 M TX 10/31/2025 FLU3
FLU3
PNC21
PNC21
 SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.



Decreased appetite, Headache, Injection site inflammation, Injection site pain, ... Decreased appetite, Headache, Injection site inflammation, Injection site pain, Injection site swelling; Injection site warmth, Muscle fatigue, Pyrexia; Decreased appetite, Headache, Injection site inflammation, Injection site pain, Injection site swelling; Injection site warmth, Muscle fatigue, Pyrexia More
I had the following after receiving my vaccinations, which are still present on day three post injec... I had the following after receiving my vaccinations, which are still present on day three post injection. Swelling at injection site, inflammation, hot to the touch, very sensitive, headache, loss of appetite, low grade fever, and muscle fatigue. These symptoms started roughly with in 12 hours of injection, and I took Tylenol to help. minor relief with the Tylenol. the systems never decreased from the initial onset. On 10-31-25 at 0600 I went to an urgent care facility and was told that I had a bacterial infection from the shots that were administered in the left should in close proximity two each other. I was given some oral medication of antibiotics, Benadryl, and steroid. More
2869920 48 F 10/31/2025 COVID19
 MODERNA
Shoulder injury related to vaccine administration Shoulder injury related to vaccine administration
Patient reports SERVA - symptoms began ~ 3 hrs after receiving vaccine. Reports needing PT and possi... Patient reports SERVA - symptoms began ~ 3 hrs after receiving vaccine. Reports needing PT and possible continued therapy/imaging/etc- did not specify More
2869921 31 F NE 10/31/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 9cc9k
Injury associated with device Injury associated with device
Needlestick. Pharmacist administered vaccine, and upon retracting needle, poked own finger after ad... Needlestick. Pharmacist administered vaccine, and upon retracting needle, poked own finger after administration More
2869924 53 M NV 10/31/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052835
410515
Condition aggravated, Loss of consciousness, Malaise, Seizure; Condition aggrava... Condition aggravated, Loss of consciousness, Malaise, Seizure; Condition aggravated, Loss of consciousness, Malaise, Seizure More
My technician administered moderna first, followed by his flu vaccine. Immediately after the second ... My technician administered moderna first, followed by his flu vaccine. Immediately after the second vaccine he stated "I don't feel right". My tech told him to stay seated and take as long as he needed. My technician called out for me to assist. As I entered the room (within 15 seconds) he appeared unconscious and was starting to fall out of the chair. My tech and I helped lower him to the ground, protecting his head and placed him on his side. I called 911 and answered all of their questions while waiting for EMS. He continued to seize and remain unconscious for about 8 minutes and slowly regained some consciousness as EMS arrived. The patient's wife was shopping and came to the pharmacy. She stated that he has daily seizures and appeared unbothered. The patient had a total of 4 seizures and was transported to the hospital (against the wife's wishes). More
2869925 40 F MA 10/31/2025 FLU3
 SANOFI PASTEUR
 U8832BA
Hypoaesthesia, Paraesthesia, Peripheral swelling Hypoaesthesia, Paraesthesia, Peripheral swelling
Patient experiences numbness from below injection area to their finger tips. Tingling sensation and... Patient experiences numbness from below injection area to their finger tips. Tingling sensation and swelling compared to the other arm. More
2869926 31 F NM 10/31/2025 COVID19
 PFIZER\BIONTECH
 NA0739
Wrong product administered Wrong product administered
Patient wanted the Nuvaxovid. Patient was mistakenly given the pfizer covid vaccine instead by a tec... Patient wanted the Nuvaxovid. Patient was mistakenly given the pfizer covid vaccine instead by a technician. Contacted patient, can't get ahold of them, no response. Left Voicemail. Can't get a hold of district manager, left voicemail/text. More
2869927 67 M FL 10/31/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.

Amnesia, Anxiety, Blood test normal, Computerised tomogram normal, Confusional s... Amnesia, Anxiety, Blood test normal, Computerised tomogram normal, Confusional state; Electroencephalogram normal, Magnetic resonance imaging normal, Obsessive-compulsive disorder, Urine analysis normal More
Woke-up at approx 7 am on 10/15/25 seemingly normal, exercised, drove home and arrived approx 9:30 a... Woke-up at approx 7 am on 10/15/25 seemingly normal, exercised, drove home and arrived approx 9:30 am and began to ?feel not himself.? Showered and when came out had long-term memory loss/confusion. Gave him baby aspirin and drove to Emergency arrived at approx 10:30 am. He was taken in within minutes and tests run over the next 9 hours: 2 separate CT scans, MRI, blood work, urinalysis. No evidence of stroke, disease, trauma or dementia was identified. He was admitted into the Hospital at approx 9 pm. While in the hospital he began to experience short-term memory loss and began to exhibit anxiety and compulsive behavior. Was released approx 4:00 pm on 10/17/25 and saw his Primary Care doctor on 10/22/25. Since release from hospital has shown steady improvement but not at 100% yet. Still has some short-term memory loss and anxiety that did not exist prior to 10/15/25. More
✓
2869937 81 F OK 10/31/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
PATIENT HAD SWELLING AND RENESS AT INJECTION SITE PATIENT HAD SWELLING AND RENESS AT INJECTION SITE
2869938 75 F FL 10/31/2025 COVID19
FLU3
PNC21
RSV
 PFIZER\BIONTECH
SEQIRUS, INC.
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 na4452
407258
z006889
b5nj9
Erythema, Inflammation, Pain in extremity, Pruritus; Erythema, Inflammation, Pai... Erythema, Inflammation, Pain in extremity, Pruritus; Erythema, Inflammation, Pain in extremity, Pruritus; Erythema, Inflammation, Pain in extremity, Pruritus; Erythema, Inflammation, Pain in extremity, Pruritus More
patient presented with red inflammation in left arm which she stated was itching and hurting on 10... patient presented with red inflammation in left arm which she stated was itching and hurting on 10/31/25 but started on 10/28/25 . she was recommended to use benadryl , tylenol extra strength and heating pads to help with the soreness and to see her doctor if symptoms do not resolve in a timely manner or increase. More
2869939 39 M UT 10/31/2025 COVID19
FLU3
HEP
 PFIZER\BIONTECH
SANOFI PASTEUR
DYNAVAX TECHNOLOGIES CORPORATION
 NA0589
u8832ca
946913
Dizziness, Nausea; Dizziness, Nausea; Dizziness, Nausea Dizziness, Nausea; Dizziness, Nausea; Dizziness, Nausea
Patient received 3 vaccines, 1 in the right arm and 2 in the left arm. Before the vaccinations pati... Patient received 3 vaccines, 1 in the right arm and 2 in the left arm. Before the vaccinations patient says they have a hard time with vaccines and they have gotten dizzy in the past. After the 3 vaccines were given patient was sitting in the immunization room waiting as his wife received her immunizations. About 2 minutes after his 3rd vaccination patient started to feel dizzy and nauseous. He was advised to lay down on the floor and he was given a garbage can. While on the floor we were able to continue conversation. Patient did not fall, patient did not pass out, patient did not throw up. We gave patient some apple juice about 10 minutes after being on the floor within about 5 minutes the apple juice seemed to help and he was able to sit back up. Patient was monitored for 30 minutes while his wife and 2 kids also received vaccinations. Patient left with his family and was encouraged to have his wife watch over him to drive and to call if anything more severe occurs. More
2869941 76 F OH 10/31/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8837AA
U8837AA
Blood pressure increased, Computerised tomogram normal, Disturbance in attention... Blood pressure increased, Computerised tomogram normal, Disturbance in attention, Dizziness, Feeling cold; Laboratory test normal, Paraesthesia, Peripheral coldness More
Patient woke up at 8:30am on 10/26/2025 feeling dizzy, had tingling and cold feeling in the arms and... Patient woke up at 8:30am on 10/26/2025 feeling dizzy, had tingling and cold feeling in the arms and chest. She also had focus issues over the next couple of hours. Her blood pressure was also increasing and it got to 190/100 at one point. ER did CT scan and ruled out a stroke. Did other tests and all came back negative. Patient got discharged and her symptoms attributed to possibly the flu shot. The patient stated that the physician stated that they has another case with similar symptoms after a Flu vaccine. More
2869942 5 F GA 10/31/2025 COVID19
 UNKNOWN MANUFACTURER
Injection site reaction, Rash papular Injection site reaction, Rash papular
She developed a papular rash around her injection site the day after her vaccine She developed a papular rash around her injection site the day after her vaccine
2869944 14 F CO 10/31/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
 NA0590
NA0590
U8832BA
U8832BA
Blood glucose normal, Electrocardiogram normal, Nausea, Pallor, Syncope; Tachypn... Blood glucose normal, Electrocardiogram normal, Nausea, Pallor, Syncope; Tachypnoea, Vomiting; Blood glucose normal, Electrocardiogram normal, Nausea, Pallor, Syncope; Tachypnoea, Vomiting More
After being injected with Comirnaty in the left deltoid, patient became tachypneic and started losin... After being injected with Comirnaty in the left deltoid, patient became tachypneic and started losing color in her face. After the second injection of flublok in the right deltoid, the patient became very pale and nauseated. After attempting to keep her in the facility for several minutes to recover she and her mother insisted she was fine and attempted to leave the store - that's when two syncopal episodes occurred and two episodes of emesis occurred as well. She was then carried by myself and her mother into the clinic patient room and EMS arrived to further evaluate her. She was found to have a syncopal episode and was kept in observation until her color returned and EMS escorted her to her mother's care with instructions to seek emergent care if she were to have another episode at home. More
2869945 73 F TX 10/31/2025 FLU3
 SANOFI PASTEUR
 u8764bb
Injection site erythema, Injection site warmth Injection site erythema, Injection site warmth
Pt said there was a round-ish area of her arm south of the injection site that became visibly red an... Pt said there was a round-ish area of her arm south of the injection site that became visibly red and warm. It was clearly at least 2 inches below the vaccination site (the band-aid that marked the vaccine was still on at the time). Pt was advised to keep watch and report to dr if any changes or worsening. During follow up pt reported that the mark gradually went away over the course of a week. More
2869416 M SD 10/30/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 5N9L9
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Under age administration (this is the first dose of Diphtheria, Tetanus, and Pertussis series); Unde... Under age administration (this is the first dose of Diphtheria, Tetanus, and Pertussis series); Under age administration (this is the first dose of Diphtheria, Tetanus, and Pertussis series); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5N9L9, expiry date 28-NOV-2027) for prophylaxis. On 13-OCT-2025, the patient received the 1st dose of Boostrix. On 13-OCT-2025, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Under age administration (this is the first dose of Diphtheria, Tetanus, and Pertussis series)) and underdose (Verbatim: Under age administration (this is the first dose of Diphtheria, Tetanus, and Pertussis series)). The outcome of the inappropriate age at vaccine administration and underdose 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: 14-OCT-2025 Clinic Manager/Registered nurse called asking for advice about the underage administration of Boostrix on a three year old patient (this is the first dose of Diphtheria, Tetanus, and Pertussis series). Vaccination date, vaccine detail and patient demographics were obtained in this call. More
2869417 F NJ 10/30/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH






Alanine aminotransferase, Aldolase, Antibody test, Antinuclear antibody, Asparta... Alanine aminotransferase, Aldolase, Antibody test, Antinuclear antibody, Aspartate aminotransferase; Biopsy muscle, Blood creatine phosphokinase, Blood lactate dehydrogenase, C-reactive protein, Cell marker; Computerised tomogram thorax, Condition aggravated, Cytomegalovirus test, Echocardiogram, Electrocardiogram; Epstein-Barr virus antibody, HMG CoA reductase antibody test, Immune-mediated myositis, Immunohistochemistry, Magnetic resonance imaging; Muscle strength test, Myoglobin urine, Physical examination, Pulmonary function test, Pulmonary imaging procedure; Red blood cell sedimentation rate, Rheumatoid factor, Skin test, Venogram, Vital signs measurement; White blood cell analysis More
Immune-Mediated Necrotizing Myopathy flared; Immune-Mediated Necrotizing Myopathy flared; This is a ... Immune-Mediated Necrotizing Myopathy flared; Immune-Mediated Necrotizing Myopathy flared; This is a literature report for the following literature source(s): A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's disease" (ongoing); "May- Thurner Syndrome" (unspecified if ongoing); "pulmonary embolus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer/biontech (DOSE 1), administration date: 2021, for Covid-19 immunization; Pfizer/biontech (DOSE 2), administration date: Jun2021, for Covid-19 immunization, reaction(s): "Immune-Mediated Necrotizing Myopathy". The following information was reported: IMMUNE-MEDIATED MYOSITIS (medically significant), CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "Immune-Mediated Necrotizing Myopathy flared". Juvenile idiopathic inflammatory myopathies (JIIMs) are a group of heterogeneous autoimmune disorders affecting skeletal muscle, resulting in acute or subacute onset of symmetric progressive proximal muscle weakness and elevated muscle enzymes JIIMs are rare, with an incidence between 1.6 and 4 cases per million children per year and a prevalence of 2.5 cases per 100,000 children. The most common type of JIIM is juvenile dermatomyositis (JDM) (80% of JIIMs); other JIIMs include amyopathic dermatomyositis, inclusion body myositis, polymyositis, and immune-mediated necrotizing myopathy (IMNM). The etiology of JDM is unclear, but it may result from an autoimmune reaction triggered by environmental factors in genetically susceptible individuals. A 15-year- old female presented to the pediatric emergency department in October 2021 with 2 months of worsening muscle weakness, calf pain, and limited range of arm motion. Other recent symptoms included right hip stiffness, color changes in the fingertips with cold exposure, increasing fatigue, and decreased appetite, along with an unintentional 10-pound weight loss over the past month. Previously active in multiple sports, she was no longer able to participate in any sport and required assistance with activities of daily living. She denied fevers, chills, rashes, difficulty swallowing, or bowel or bladder incontinence. She had received mRNA coronavirus disease 2019 (COVID-19) vaccine (Pfizer/BioNTech) earlier that year, with the second vaccination (June 2021) occurring approximately 7 weeks before the reported onset of symptoms. She had no known recent exposures to COVID-19 or mononucleosis. On initial physical exam, she had normal vital signs and reduced strength in proximal muscles (3/5 at shoulders and hips, 4/5 at elbows and knees, and 5/5 at wrists and ankles). She walked slowly and was unable to rise from a chair without using her arms. The rest of the physical exam, including skin exam, was unremarkable. Initial bloodwork revealed marked elevations in creatine phosphokinase (CK) (28,138), aspartate aminotransferase (928), alanine transaminase (619), lactate dehydrogenase (3152), and urinary myoglobin (> 8750). Inflammatory markers were elevated (C-reactive protein 4.68, erythrocyte sedimentation rate 39), and blood cell counts were normal. The patient's presentation was concerning for viral myositis, rhabdomyolysis, or JIIM. A magnetic resonance imaging (MRI) of the right lower extremity revealed extensive proximal intermuscular and sub-fascial edema, which was consistent with the expected findings seen in JIIM. Additional testing revealed positive antinuclear antibodies (1:1280 titer, cytoplasmic pattern), positive anti-Sjogren's Syndrome antigen A (SSA/Ro), and positive rheumatoid factor (RF). Additional history-taking revealed a recent increase in dental caries and dry mouth, without dry or burning eyes or a history of cheek swelling, concerning for Sjogren's disease. Epstein Bar Virus (EBV) VCA IgG was positive, but EBV IgM and cytomegalovirus PCR were negative. Aldolase was markedly elevated (> 360). She did not have any unexplained fevers, hair loss, oral or nasal ulcers, or joint swelling or stiffness. She did not have recent medication use to suggest drug-induced myopathy. Muscular dystrophies were considered unlikely based on her age and sex. On hospital day 8, the patient experienced sudden-onset chest pain and hemoptysis. Computerized tomography angiogram of the chest revealed a pulmonary embolus. Electrocardiogram, echocardiogram, and high-resolution chest computed tomography were all normal. Pulmonary function testing showed a mixed obstructive and restrictive pattern with normal diffusion capacity for carbon monoxide. MRI/magnetic resonance venogram of the abdomen showed compression of the left common iliac vein, consistent with a diagnosis of May-Thurner Syndrome. Enoxaparin was initiated. The patient's muscle biopsy of the right thigh revealed necrotic fibers with limited inflammatory cells, suggestive of IMNM (Figure 1: Muscle biopsy. Hemotoxylin and eosin stained cryosections magnified 100x (A) and 200x (B) show several necrotic (asterisk) and regenerating muscle fibers (cross). Paraffin section-immunohistochemistry illustrates numerous CD68(+) macrophages (C, thin/red arrows) and rare perivascular CD3(+) T-cells (D, thick/black arrows) within the necrotic fibers). Additional testing showed high-titer anti-signal recognition particle (anti-SRP) antibody (1:61,440) and negative anti-3- hydroxy- 3- methylglutaryl coenzyme A reductase (anti-HMGCR), consistent with a diagnosis of IMNM. She was treated with intravenous immunoglobulin (IVIG) and pulse solumedrol, followed by rituximab and prolonged oral prednisone taper. She was transferred to an inpatient rehabilitation center 22 days after hospitalization with a rolling walker. Two months after hospital discharge, she developed chest pain and cough with blood-tinged mucus and tested positive for COVID-19 for the first time. Repeat CK was increased, but she did not experience worsening muscle weakness and continued with the scheduled prednisone taper. Nonetheless, continued CK elevations prompted initiation of mycophenolate mofetil (later switched to mycophenolic acid due to gastrointestinal intolerance) and an increase in prednisone dose, followed by monthly IVIG infusions. On this regimen, her muscle strength improved, she regained the ability to walk, the CK normalized, and prednisone was again tapered. However, within 1 week after receiving her COVID-19 booster, she experienced worsening fatigue and rapidly worsening proximal muscle weakness, with renewed difficulty lifting her legs and arms, rising from a seated position, and swallowing. There were no symptoms or signs of recurrent COVID-19. Repeat CK in the emergency room was 6311 (up from 167 pre-booster), and she received another pulse of methylprednisolone. She did not require hospitalization at that time. Oral prednisone was increased to 60 mg daily, and she started another course of rituximab soon thereafter. Subsequent lung imaging revealed subpleural reticulation, compatible with interstitial lung disease. Conclusion: Authors report an adolescent girl who developed progressive symptoms of a rare chronic muscle disease, immune-mediated necrotizing myopathy, within 2 months following completion of the primary COVID-19 mRNA vaccination series and who flared within 1 week following booster vaccination. This patient also had clinical features of Sjogren's disease, another rare pediatric condition that has not previously been reported to co-occur with IMNM in children. This unique case raises the hypothesis that the COVID-19 vaccine may, in rare cases, trigger autoimmune muscle disease in susceptible children. More research is needed to better understand the potential mechanistic link between COVID-19 vaccination and autoimmune myositis as a possible vaccine-related adverse event.; Sender's Comments: The events immune-mediated myositis, and condition aggravated are conservatively assessed as related to the suspect drug BNT162B2 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.,Linked Report(s) : US-PFIZER INC-PV202500125702 Same article/drug/patient and different event; More
2869418 F NJ 10/30/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH





Alanine aminotransferase, Aldolase, Angiogram, Antibody test, Antinuclear antibo... Alanine aminotransferase, Aldolase, Angiogram, Antibody test, Antinuclear antibody; Aspartate aminotransferase, Biopsy muscle, Blood creatine phosphokinase, Blood lactate dehydrogenase, C-reactive protein; Cell marker, Computerised tomogram thorax, Cytomegalovirus test, Echocardiogram, Electrocardiogram; Epstein-Barr virus antibody, Full blood count, HMG CoA reductase antibody test, Immune-mediated myositis, Immunohistochemistry; Magnetic resonance imaging, Magnetic resonance imaging abdominal, Muscle strength test, Myoglobin urine, Physical examination; Pulmonary function test, Red blood cell sedimentation rate, Rheumatoid factor, Skin test, Venogram More
Immune-Mediated Necrotizing Myopathy; This is a literature report for the following literature sourc... Immune-Mediated Necrotizing Myopathy; This is a literature report for the following literature source(s): A 15-year-old female patient received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's disease" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 2021, for covid-19 immunisation. The following information was reported: IMMUNE-MEDIATED MYOSITIS (hospitalization, medically significant) with onset 2021, 7 weeks after the suspect product(s) administration, outcome "recovering", described as "Immune-Mediated Necrotizing Myopathy". Juvenile idiopathic inflammatory myopathies (JIIMs) are a group of heterogeneous autoimmune disorders affecting skeletal muscle, resulting in acute or subacute onset of symmetric progressive proximal muscle weakness and elevated muscle enzymes JIIMs are rare, with an incidence between 1.6 and 4 cases per million children per year and a prevalence of 2.5 cases per 100,000 children. The most common type of JIIM is juvenile dermatomyositis (JDM) (80% of JIIMs); other JIIMs include amyopathic dermatomyositis, inclusion body myositis, polymyositis, and immune-mediated necrotizing myopathy (IMNM). The etiology of JDM is unclear, but it may result from an autoimmune reaction triggered by environmental factors in genetically susceptible individuals. A 15-year- old female presented to the pediatric emergency department in October 2021 with 2 months of worsening muscle weakness, calf pain, and limited range of arm motion. Other recent symptoms included right hip stiffness, color changes in the fingertips with cold exposure, increasing fatigue, and decreased appetite, along with an unintentional 10-pound weight loss over the past month. Previously active in multiple sports, she was no longer able to participate in any sport and required assistance with activities of daily living. She denied fevers, chills, rashes, difficulty swallowing, or bowel or bladder incontinence. She had received mRNA coronavirus disease 2019 (COVID-19) vaccine (Pfizer/BioNTech) earlier that year, with the second vaccination (June 2021) occurring approximately 7 weeks before the reported onset of symptoms. She had no known recent exposures to COVID-19 or mononucleosis. On initial physical exam, she had normal vital signs and reduced strength in proximal muscles (3/5 at shoulders and hips, 4/5 at elbows and knees, and 5/5 at wrists and ankles). She walked slowly and was unable to rise from a chair without using her arms. The rest of the physical exam, including skin exam, was unremarkable. Initial bloodwork revealed marked elevations in creatine phosphokinase (CK) (28,138), aspartate aminotransferase (928), alanine transaminase (619), lactate dehydrogenase (3152), and urinary myoglobin (> 8750). Inflammatory markers were elevated (C-reactive protein 4.68, erythrocyte sedimentation rate 39), and blood cell counts were normal. The patient's presentation was concerning for viral myositis, rhabdomyolysis, or JIIM. A magnetic resonance imaging (MRI) of the right lower extremity revealed extensive proximal intermuscular and sub-fascial edema, which was consistent with the expected findings seen in JIIM. Additional testing revealed positive antinuclear antibodies (1:1280 titer, cytoplasmic pattern), positive anti-Sjogren's Syndrome antigen A (SSA/Ro), and positive rheumatoid factor (RF). Additional history-taking revealed a recent increase in dental caries and dry mouth, without dry or burning eyes or a history of cheek swelling, concerning for Sjogren's disease. Epstein Bar Virus (EBV) VCA IgG was positive, but EBV IgM and cytomegalovirus PCR were negative. Aldolase was markedly elevated (> 360). She did not have any unexplained fevers, hair loss, oral or nasal ulcers, or joint swelling or stiffness. She did not have recent medication use to suggest drug-induced myopathy. Muscular dystrophies were considered unlikely based on her age and sex. On hospital day 8, the patient experienced sudden-onset chest pain and hemoptysis. Computerized tomography angiogram of the chest revealed a pulmonary embolus. Electrocardiogram, echocardiogram, and high-resolution chest computed tomography were all normal. Pulmonary function testing showed a mixed obstructive and restrictive pattern with normal diffusion capacity for carbon monoxide. MRI/magnetic resonance venogram of the abdomen showed compression of the left common iliac vein, consistent with a diagnosis of May-Thurner Syndrome. Enoxaparin was initiated. The patient's muscle biopsy of the right thigh revealed necrotic fibers with limited inflammatory cells, suggestive of IMNM (Figure 1: Muscle biopsy. Hemotoxylin and eosin stained cryosections magnified 100x (A) and 200x (B) show several necrotic (asterisk) and regenerating muscle fibers (cross). Paraffin section-immunohistochemistry illustrates numerous CD68(+) macrophages (C, thin/red arrows) and rare perivascular CD3(+) T-cells (D, thick/black arrows) within the necrotic fibers). Additional testing showed high-titer anti-signal recognition particle (anti-SRP) antibody (1:61,440) and negative anti-3- hydroxy- 3- methylglutaryl coenzyme A reductase (anti-HMGCR), consistent with a diagnosis of IMNM. She was treated with intravenous immunoglobulin (IVIG) and pulse solumedrol, followed by rituximab and prolonged oral prednisone taper. She was transferred to an inpatient rehabilitation center 22 days after hospitalization with a rolling walker. Two months after hospital discharge, she developed chest pain and cough with blood-tinged mucus and tested positive for COVID-19 for the first time. Repeat CK was increased, but she did not experience worsening muscle weakness and continued with the scheduled prednisone taper. Nonetheless, continued CK elevations prompted initiation of mycophenolate mofetil (later switched to mycophenolic acid due to gastrointestinal intolerance) and an increase in prednisone dose, followed by monthly IVIG infusions. On this regimen, her muscle strength improved, she regained the ability to walk, the CK normalized, and prednisone was again tapered. However, within 1 week after receiving her COVID-19 booster, she experienced worsening fatigue and rapidly worsening proximal muscle weakness, with renewed difficulty lifting her legs and arms, rising from a seated position, and swallowing. There were no symptoms or signs of recurrent COVID-19. Repeat CK in the emergency room was 6311 (up from 167 pre-booster), and she received another pulse of methylprednisolone. She did not require hospitalization at that time. Oral prednisone was increased to 60 mg daily, and she started another course of rituximab soon thereafter. Subsequent lung imaging revealed subpleural reticulation, compatible with interstitial lung disease. Conclusion: Authors report an adolescent girl who developed progressive symptoms of a rare chronic muscle disease, immune-mediated necrotizing myopathy, within 2 months following completion of the primary COVID-19 mRNA vaccination series and who flared within 1 week following booster vaccination. This patient also had clinical features of Sjogren's disease, another rare pediatric condition that has not previously been reported to co-occur with IMNM in children. This unique case raises the hypothesis that the COVID-19 vaccine may, in rare cases, trigger autoimmune muscle disease in susceptible children. More research is needed to better understand the potential mechanistic link between COVID-19 vaccination and autoimmune myositis as a possible vaccine-related adverse event.; Sender's Comments: The event immune-mediated myositis is conservatively assessed as related to the suspect drug BNT162B2 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.,Linked Report(s) : US-PFIZER INC-202500211358 Same article/patient and different event/drug;US-PFIZER INC-202500212311 Same article/drug/patient and different event;US-PFIZER INC-202500212359 Same article/drug/patient and different event; More
✓
2869438 6 F OK 10/30/2025 DTAPIPV
FLU3
HEPA
MMRV
 SANOFI PASTEUR
SEQIRUS, INC.
MERCK & CO. INC.
MERCK & CO. INC.
 U8623AA
410514
Z005472
Z009665
Injection site pain, Injection site pruritus, Injection site rash, Injection sit... Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling; Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling; Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling; Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling More
Large red rash, moderate itching, significant swelling of the injection site, pain ? all symptoms de... Large red rash, moderate itching, significant swelling of the injection site, pain ? all symptoms developed within 24 hours of the injection of the MMRV vaccine (had a previous reaction in March 2023 to the same vaccine). Treated with children's Benadryl, administered ibuprofen, alternating heat and ice ? treatment still ongoing. More
2869439 26 M NJ 10/30/2025 FLU3
 SANOFI PASTEUR
 U8847BA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient did not have an adverse event after vaccination. Patient did not have an adverse event after vaccination.
2869440 24 M NJ 10/30/2025 FLU3
 SANOFI PASTEUR
 U8847BA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient did not have an adverse event after vaccine administration. Patient did not have an adverse event after vaccine administration.
2869441 33 F NJ 10/30/2025 FLU3
 SANOFI PASTEUR
 U8847BA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient did not have any adverse effects after vaccination administration. Patient did not have any adverse effects after vaccination administration.
2869443 M AR 10/30/2025 FLUN4
 MEDIMMUNE VACCINES, INC.
 YF3413
Wrong technique in product usage process Wrong technique in product usage process
NURSE REPORTED THERE WAS 40 MINUTES BETWEEN SPRAY 1 OF FLUMIST AND SPRAY 2 AS THE PATIENT INITIALLY ... NURSE REPORTED THERE WAS 40 MINUTES BETWEEN SPRAY 1 OF FLUMIST AND SPRAY 2 AS THE PATIENT INITIALLY REFUSED SPRAY 2. PATIENT DID RECEIVE BOTH SPRAY 1 AND SPRAY 2 OF FLUMIST.; A spontaneous report has been received from a other health professional. The report concerns a male child patient (age 10 years). No medical history was reported. No concomitant products were reported. The patient received Flumist Quadrivalent (batch number(s) YF3413) (expiration date(s) 08-DEC-2025), via unknown on 16-SEP-2025. The patient received 1 dose(s). On an unknown date, the patient experienced nurse reported there was 40 minutes between spray 1 of flumist and spray 2 as the patient initially refused spray 2. patient did receive both spray 1 and spray 2 of flumist. (preferred term: Incorrect dose administered). The outcome of the event(s) of nurse reported there was 40 minutes between spray 1 of flumist and spray 2 as the patient initially refused spray 2. patient did receive both spray 1 and spray 2 of flumist. was unknown. The event was considered non-serious. The reporter did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): nurse reported there was 40 minutes between spray 1 of flumist and spray 2 as the patient initially refused spray 2. patient did receive both spray 1 and spray 2 of flumist.. The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): nurse reported there was 40 minutes between spray 1 of flumist and spray 2 as the patient initially refused spray 2. patient did receive both spray 1 and spray 2 of flumist.. Device Information: Combination Product Report: Yes Product As Reported: Flumist Quadrivalent Brand Name: FLUMIST QUADRIVALENT Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No More
2869444 10/30/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Guillain-Barre syndrome Guillain-Barre syndrome
developed Guillian-Barre after receiving Shingrix.; This serious case was reported by a consumer and... developed Guillian-Barre after receiving Shingrix.; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: developed Guillian-Barre after receiving Shingrix.) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was resolved. 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: 18-OCT-2025 The patient self-reported this case. The patient was injured from the Shingrix vaccine that gave guillain barre syndrome. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingrix, in a patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received. More
2869445 KS 10/30/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 JS74h
Incorrect dose administered, Product storage error Incorrect dose administered, Product storage error
administered a partial dose from the syringe; single syringe was partially frozen; This non-serious ... administered a partial dose from the syringe; single syringe was partially frozen; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incomplete dose administered in a patient who received Flu Seasonal TIV Dresden (Fluarix) (batch number JS74h, expiry date 30-JUN-2026) for prophylaxis. On an unknown date, the patient received the 1st dose of Fluarix. On an unknown date, an unknown time after receiving Fluarix, the patient experienced incomplete dose administered (Verbatim: administered a partial dose from the syringe) and incorrect storage of drug (Verbatim: single syringe was partially frozen). The outcome of the incomplete dose administered and incorrect storage of drug 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: 03-OCT-2025 The pharmacist mentioned the single syringe was partially frozen, but the nurse administering the vaccine did not notice this and administered a partial dose from the syringe. More
2869448 10/30/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Gastrointestinal tube insertion, Respiratory syncytial virus infection, Tracheos... Gastrointestinal tube insertion, Respiratory syncytial virus infection, Tracheostomy, Vaccination failure More
had my shot in mid. October of 2023 by Dec. I had RSV in December; Suspected vaccination failure; T... had my shot in mid. October of 2023 by Dec. I had RSV in December; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In OCT-2023, the patient received RSV vaccine. In DEC-2023, between 2 and 3 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant and clinically significant/intervention required) and respiratory syncytial virus infection (Verbatim: had my shot in mid. October of 2023 by Dec. I had RSV in December) (serious criteria hospitalization and clinically significant/intervention required). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 22-OCT-2025 This case was reported by a patient via interactive digital media. The patient had his/her RSV shot in mid-OCT of 2023 by DEC the patient had RSV and ended up with a track feeding tube they did not think, and the patient would made it, so the patient was sent to a hospital. The patient refused to give up, and it could have been worse had the patient not had shot. The batch number was not provided, and unable to contact the reporter. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Respiratory syncytial virus infection, between 2 and 3 months after receiving RSV 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. More
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2869449 28 NC 10/30/2025 FLU3
 SANOFI PASTEUR
 UT873KA
Blood glucose increased, Blood pressure decreased, Dizziness, Fatigue Blood glucose increased, Blood pressure decreased, Dizziness, Fatigue
Patient reports she drove away after receiving flu vaccine. States she became super lightheaded, diz... Patient reports she drove away after receiving flu vaccine. States she became super lightheaded, dizzy and felt like she was going to pass out. Pulled in to store and was able to call 911. States she was coming to when 911 arrived. 911 obtained VS and FSBS. States she started to feel better. Reports she declined to go to ER by EMS. States she just feels tired with receiving flu shot. She was able to work the following day. More
2869499 0.5 MT 10/30/2025 PNC21
 MERCK & CO. INC.
 Z003579
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Confirmed patient not symptomatic/No additional AE; Pharmacist calling to report CAPVAXIVE administe... Confirmed patient not symptomatic/No additional AE; Pharmacist calling to report CAPVAXIVE administered to a 6 month old patient on 10/10/2025; This spontaneous report was received from a pharmacist and refers to a 6-month-old 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 10-Oct-2025, the pharmacist inadvertently administered Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), (lot #Z003579, expiration date: 07-Sep-2026) for prophylaxis to the patient of 6 months (Product administered to patient of inappropriate age). Confirmed patient not symptomatic, no additional AE (no adverse event). More
2869500 1 AL 10/30/2025 PNC21
 MERCK & CO. INC.
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No additional AE reported.; CAPVAXIVE was administered to a 1 year old patient; This spontaneous rep... No additional AE reported.; CAPVAXIVE was administered to a 1 year old patient; This spontaneous report was received from a nurse and refers to a 1-year-old 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 15-Oct-2025, the patient of 1 year was vaccinated Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), 0.5 mL (0.5 mL), (lot # and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age). The nurse denied any vaccine reaction at time of call; no additional AE reported (no adverse event). More
2869503 54 F CO 10/30/2025 UNK
 UNKNOWN MANUFACTURER
 Unknown
Impaired work ability, Injected limb mobility decreased, Pain in extremity, Slee... Impaired work ability, Injected limb mobility decreased, Pain in extremity, Sleep disorder More
Pneumonia vaccine , severe pain in left arm 12 hours after vaccination. Prevented sleeping and loss ... Pneumonia vaccine , severe pain in left arm 12 hours after vaccination. Prevented sleeping and loss of work the following day. Unable to use left arm for much of the following day. More
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