๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

๐Ÿ“– Help & Search Guide

Column Icons Legend

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

How to Search

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

Understanding the Data

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

Using the Table

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

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2867658 57 F TN 10/22/2025 COVID19
PNC20
 PFIZER\BIONTECH
PFIZER\WYETH
 NA0738
ma2523
Dizziness, Heart rate increased, Tinnitus; Dizziness, Heart rate increased, Tinn... Dizziness, Heart rate increased, Tinnitus; Dizziness, Heart rate increased, Tinnitus More
Patient got three vaccines at around 11:30 10/17/25. Fluarix, comirnaty, and prevnar 20. Patient has... Patient got three vaccines at around 11:30 10/17/25. Fluarix, comirnaty, and prevnar 20. Patient has had flucelvax before without issues. At 10:00 am on 10/18/25, patient woke up to full body rash, increased heart rate, tinnitus, and dizziness. Symptoms dissapeared by the end of the night except for tinnitus and dizziness. More
2867659 93 F NH 10/22/2025 COVID19
 MODERNA
Blood urine present, Decreased appetite, Hypersomnia, Nausea, Pyrexia Blood urine present, Decreased appetite, Hypersomnia, Nausea, Pyrexia
Blood in urine (4 days), high fever for 8 days, nausea, loss of appetite, slept most of the time. Ha... Blood in urine (4 days), high fever for 8 days, nausea, loss of appetite, slept most of the time. Have had every Moderna Covid vax, at the required frequency, since the pandemic and have never had these isdues More
2867660 79 M FL 10/22/2025 UNK
 UNKNOWN MANUFACTURER
 F4AC3
Erythema, Paraesthesia, Skin warm Erythema, Paraesthesia, Skin warm
Patient stated he is experiencing tingling and redness on the inside of his left arm. Patient report... Patient stated he is experiencing tingling and redness on the inside of his left arm. Patient reported his arm was warm to the touch. No swelling or shortness of breath reported. More
2867661 49 F FL 10/22/2025 FLU3
 SANOFI PASTEUR
 TFAA2542
Injection site bruising, Injection site haemorrhage, Injection site pain Injection site bruising, Injection site haemorrhage, Injection site pain
Bleeding right after vaccine. Pain and bruising at injection site for several days. Bleeding right after vaccine. Pain and bruising at injection site for several days.
2867662 52 F VA 10/22/2025 FLU3
 SANOFI PASTEUR
 U8823DA
Bursitis, Shoulder injury related to vaccine administration Bursitis, Shoulder injury related to vaccine administration
Patient states pain in shoulder and MD diagnosed her with bursitis of shoulder and SIRVA Patient states pain in shoulder and MD diagnosed her with bursitis of shoulder and SIRVA
2867663 21 M OR 10/22/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA4452
U8864AA
Injection site haemorrhage, Loss of consciousness, Syncope; Injection site haemo... Injection site haemorrhage, Loss of consciousness, Syncope; Injection site haemorrhage, Loss of consciousness, Syncope More
Patient had some mild bleeding from injection site after administration, pharmacist cleaned the bloo... Patient had some mild bleeding from injection site after administration, pharmacist cleaned the blood and applied a bandage, patient appeared to faint or briefly lose consciousness for ~15 seconds. Another pharmacist was brought into the room at that time. The patient was breathing and was attempted to be placed on the ground, when he suddenly awoke and stood up. He was asked to remain seated and was monitored for 15 minutes following the reaction. Patient denied any history of seizures. Patient reported feeling dizzy after the vaccines were administered, denied any other symptoms. He was given orange juice that he drank for the 15 minutes he was being monitored. Patient was allowed to leave the pharmacy after 15 minutes with no symptoms noted. Patient did not have someone available to pick him up, and he took public transportation home. Confirmed with patient that he had someone at home to monitor him. Called and left voicemail for patient at 3:53 PM to follow-up. More
2867753 57 M MO 10/22/2025 FLU3
 SANOFI PASTEUR
 u8859da
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
Patient is under the age of 65 and was not approved to get the higher dose flu vaccine. At the time... Patient is under the age of 65 and was not approved to get the higher dose flu vaccine. At the time of this report no adverse event has been reported. More
2867754 94 F NV 10/22/2025 FLU3
 SANOFI PASTEUR
 UT8794CA
Extra dose administered Extra dose administered
Patient was given flu shot twice a month apart. First dose on 9 /24/25 and a 2nd dose on 10/22/25 of... Patient was given flu shot twice a month apart. First dose on 9 /24/25 and a 2nd dose on 10/22/25 of the same HD Fluzone More
2867758 63 F TX 10/22/2025 COVID19
COVID19
 MODERNA
MODERNA
 )17M20A
048A21A
Bell's palsy, Lung hyperinflation, Rheumatoid arthritis; Bell's palsy,... Bell's palsy, Lung hyperinflation, Rheumatoid arthritis; Bell's palsy, Lung hyperinflation, Rheumatoid arthritis More
Bells Palsy Diagnosis after 2nd vaccine on 5/11/21 16:36 p.m., 2 weeks later back in ER for over-inf... Bells Palsy Diagnosis after 2nd vaccine on 5/11/21 16:36 p.m., 2 weeks later back in ER for over-inflated lungs 5/28/21 4:32 p.m. RA Diagnosis after 2nd vaccine. More
2867759 68 F ME 10/22/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR

Asthenia, Chills, Fatigue, Full blood count, Metabolic function test; Vomiting Asthenia, Chills, Fatigue, Full blood count, Metabolic function test; Vomiting
Vomiting, weakness, fatigue, chills, x5 days Vomiting, weakness, fatigue, chills, x5 days
2867761 69 M WI 10/22/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052133218DKX50
U8837AA2113124M
Dizziness, Headache, Nausea, Pain in extremity, Pyrexia; Dizziness, Headache, Na... Dizziness, Headache, Nausea, Pain in extremity, Pyrexia; Dizziness, Headache, Nausea, Pain in extremity, Pyrexia More
Headache, Nausea, dizziness, feverish within 10 minutes and sore arm for 2 days Headache, Nausea, dizziness, feverish within 10 minutes and sore arm for 2 days
2867764 70 F WI 10/22/2025 FLU3
 SANOFI PASTEUR
 U8800ca
Pain, Pain in extremity, Product administered at inappropriate site, Sleep disor... Pain, Pain in extremity, Product administered at inappropriate site, Sleep disorder More
Significant (L) arm pain in afternoon, pain "8" that continued. Unable to sleep 2 nights. ... Significant (L) arm pain in afternoon, pain "8" that continued. Unable to sleep 2 nights. Very painful day -> night, with increase at night/rest. Pain with ADL's, chores. Seemed to improve, but now pain increased. Will begin PT. Note: vaccine given very high (L) arm. More
2867765 10 F LA 10/22/2025 FLUN3
FLUN3
 MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.
 YH3388
YH3388
Activated partial thromboplastin time normal, Blood iron normal, Chest X-ray nor... Activated partial thromboplastin time normal, Blood iron normal, Chest X-ray normal, Cough, Full blood count normal; Haematemesis, Prothrombin time normal, Secretion discharge More
Patient had 2 episodes where she started coughing and then vomited up blood and clear mucus. No trea... Patient had 2 episodes where she started coughing and then vomited up blood and clear mucus. No treatment given. Labs done 10/21. Chest xray done 10/20. More
โœ“
2867298 NY 10/21/2025 HPV9
 MERCK & CO. INC.
 Y015760
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; GARDASIL-9 was administered to a patient after the excursion.; This spontaneous re... No additional AE; GARDASIL-9 was administered to a patient after the excursion.; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 22-Sep-2025, the patient was vaccinated with an improper stored vaccine of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection (lot #Y015760, expiration date: 10-Feb-2027), dose number 1, 0.5 mL, total, administered by Intramuscular route.as prophylaxis (Product storage error). The improperly stored vaccine underwent a temperature excursion of 47.7 degrees Fahrenheit (F) for 12 minutes with of 46.8 F for 5 minutes; 47.1 F for 9 minutes; and 46.6 F for 4 minutes. No adverse events were reported. This is one of several reports received from the same reporter. More
2867299 M NV 10/21/2025 UNK
 UNKNOWN MANUFACTURER
Unevaluable event Unevaluable event
very severe reaction; This spontaneous report was received from a health professional via company em... very severe reaction; This spontaneous report was received from a health professional via company employee and refers to a male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (manufacturer unknown), administered at a pharmacy for prophylaxis (strength, dose, route, lot #, and expiration date were not reported). On an unknown date, the patient experienced a very severe reaction (Immunisation reaction), and it was really bad. At the reporting time, the outcome of very severe reaction was unknown. The reporter considered the event of very severe reaction to be related to Pneumococcal 21-valent Conjugate Vaccine (manufacturer unknown). Lot# is being requested and will be submitted if received. More
2867300 M WA 10/21/2025 PNC21
 MERCK & CO. INC.
 Z009681
Dizziness, Headache, Vision blurred Dizziness, Headache, Vision blurred
Pharmacist calling to report a patient with a tdap allergy was administered CAPVAXIVE. Patient is ex... Pharmacist calling to report a patient with a tdap allergy was administered CAPVAXIVE. Patient is experiencing blurred vision, dizziness and headaches. Caller reports no serious side effects. The CAPVAXIVE was administered on 10/13/2025 and the side; headaches; dizziness; This spontaneous report was received from a pharmacist and refers to a 70-year-old male patient. The patient's medical history and concomitant therapies were not reported. As concurrent conditions were reported cardiovascular disorder (reported as "cardiovascular") and high blood pressure. Historical drugs included Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid), Sulfa (Sulfanilamide), and Contrast media (Contrast media) all presented with allergy reactions. On 13-Oct-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine(CAPVAXIVE) (lot #Z009681, expiration date: 22-Oct-2026) (anatomical location and administration route were not reported) as prophylaxis. On 14-Oct-2025 (reported as "until the next day"), the patient experienced blurred vision, dizziness and headaches. On the same date (14-Oct-2025), the patient was hospitalized due to the events. The reporter did not have information on the name or location of the hospital. At the reporting time, the patient had not recovered from headache, blurred vision or dizziness. The causality assessment between the events of headache, blurred vision and dizziness and the vaccination with Pneumococcal 21-valent Conjugate Vaccine(CAPVAXIVE) was not provided. More
โœ“
2867301 16 F ID 10/21/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 YF3413 B
Product storage error Product storage error
PATIENT RECEIVED A FLUMIST VACCINE ON 10/07/2025 THAT HAD PREVIOUSLY EXPERIENCED A TEMPERATURE EXCUR... PATIENT RECEIVED A FLUMIST VACCINE ON 10/07/2025 THAT HAD PREVIOUSLY EXPERIENCED A TEMPERATURE EXCURSION OF 25.7 ๏ฟฝF FOR 4 HOURS AND 17 MINUTES.; A spontaneous report has been received from a other health professional. The report concerns a female patient born in 2009. No medical history was reported. No concomitant products were reported. The patient received Flumist (batch number(s) YF3413 B) (expiration date(s) 15-DEC-2025), via unknown on 07-OCT-2025. The patient received 1 dose(s). On an unknown date, the patient experienced patient received a flumist vaccine on 10/07/2025 that had previously experienced a temperature excursion of 25.7 ๏ฟฝf for 4 hours and 17 minutes. (preferred term: Body temperature decreased). The outcome of the event(s) of patient received a flumist vaccine on 10/07/2025 that had previously experienced a temperature excursion of 25.7 ๏ฟฝf for 4 hours and 17 minutes. was unknown. The event was considered non-serious. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUMIST Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No More
2867303 78 F NJ 10/21/2025 FLU3
 SANOFI PASTEUR
 U8855AA
Product storage error Product storage error
fridge went below the storage limit that it got to negative 11F and They ended up giving FLUZONE HD ... fridge went below the storage limit that it got to negative 11F and They ended up giving FLUZONE HD to patient when the vaccines were basically considered frozen with no AE; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 78 years old female patient who was received with Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] post excursion, when fridge went below the storage limit that it got to negative 11fahrenhiet and the vaccines were basically considered frozen with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8855AA, expiry date not reported , strength: High Dose, Frequency: once, via unknown route in unknown administration site for Influenza [Influenza immunisation] post excursion, fridge went below the storage limit that it got to negative 11 Fahrenheit, when the vaccines were basically considered frozen with no ae (poor quality product administered) (latency: same day). Reportedly,They ended up giving Fluzone HD to 8 patients when the vaccines were basically considered frozen. She asked if the patients will experience adverse reactions. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA311022:patient 1 US-SA-2025SA311029:patient 2 US-SA-2025SA311016:patient 4 US-SA-2025SA311063:patient 5 US-SA-2025SA311026:patient 6 US-SA-2025SA311032:patient 7 US-SA-2025SA311035:patient 8 More
2867310 76 M CA 10/21/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 M7G39
Angioedema, Dysphagia, Swollen tongue Angioedema, Dysphagia, Swollen tongue
I received the first dose of the Shingrix (zoster recombinant, adjuvanted) vaccine and developed ang... I received the first dose of the Shingrix (zoster recombinant, adjuvanted) vaccine and developed angioedema in approximately 16 hours. My symptoms included right side tongue swelling and moderate difficulty swallowing and speaking. I did not have difficulty breathing. I was treated in the emergency department with intravenous corticosteroids, famotidine, and antihistamines, then prescribed prednisone 60 mg daily for 3 days, famotidine 40 mg, benadryl, and cetirizine 10 mg. My symptoms resolved after treatment in the emergency department in approximately 2.5 hours. More
2867311 45 M GU 10/21/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 U8848BA
Headache Headache
persistent, moderate headache rating minimum 4/10 in severity for 6 days at time of this submission.... persistent, moderate headache rating minimum 4/10 in severity for 6 days at time of this submission. individual has attempted management with OTC medication (tylenol), will be reaching out to PCM for further evaluation and treatment. More
2867313 F CT 10/21/2025 FLU3
 SANOFI PASTEUR
 U8440AA
Expired product administered, No adverse event Expired product administered, No adverse event
expired flublok was accidentally given, what should they do, with no reported adverse event; Initial... expired flublok was accidentally given, what should they do, with no reported adverse event; Initial information received on 13-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to this US-SA-2025SA306990 This case involves an unknown age female patient who received expired dose of influenza trivalent recombinant vaccine [Flublok] with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, the patient received an expired 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection, lot U8440AA, expiry date:30-Apr-2025, strength: standard, frequency: once, via intramuscular route in the arm nos (not otherwise specified) for Influenza immunisation with no reported adverse event (expired product administered) (latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA306990: More
2867314 LA 10/21/2025 UNK
 UNKNOWN MANUFACTURER
No adverse event, Underdose No adverse event, Underdose
pre-assessed as a medication error (unintentional) due to administration of 0.4mL of FLUBLOK to a pa... pre-assessed as a medication error (unintentional) due to administration of 0.4mL of FLUBLOK to a patient, approximately 0.1mL of the vaccine shot out with no reported adverse event; Initial information received on 14-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who received 0.4ml of Influenza Trivalent Recombinant Vaccine [FLUBLOK TIV] pre-assessed as a medication error (unintentional) and approximately 0.1ml of the vaccine shot out with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.4ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (lot number, strength and expiry date -unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and approximately 0.1ml of the vaccine shot out with no reported adverse event (incorrect dose administered) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2867317 60 F AR 10/21/2025 COVID19
 PFIZER\BIONTECH
 NA0738
Refusal of vaccination Refusal of vaccination
PATIENT ENTERED THE PHARMACY AND REQUESTED TWO IMMUNIZATIONS. I THOUGHT SHE ASKED FOR A FLU AND COVI... PATIENT ENTERED THE PHARMACY AND REQUESTED TWO IMMUNIZATIONS. I THOUGHT SHE ASKED FOR A FLU AND COVID SHOT. I HAD HER FILL OUT THE REQUIRED IMMUNIZATION QUESTIONAIRE AND PREPARED THE SHOTS. AFTER EXAMINING HER QUESTIONAIRE I ASKED HER ID SHE WANTED A SHOT IN EACH ARM OR BOTH IN ONE ARTM AND SHE REQUESTED THEY BOTH BE PUT IN HER RIGHT ARM. I ADMINISTERED BOTH SHOTS IN THE DELTOID MUSCLE WITH PROPER SPACING. AFTER COMPLETION OF THE SHOTS PATIENT ASKED IF WE CARRY THE RSV VACCINE AND I INFORMED HER THAT WE DID THEN SHE STARTED TALKING ABOUT HOW SHE HAD RECEIVED THE FIRST SHINGLES SHOT IN MAY OF 2025. I SAID THAT'S GOOD YOU ARE STILL IN THE APPROPRIATE TIME RANGE FOR THE SECOND DOSE. AFTER I TOLD HER SHE LOOKED AT ME AND SAID THAT'S WHAT THIS IS, MY SECOND SHINGLES SHOT. I RESPONDED NO MA'AM I THOUGHT YOU ASKED FOR A COVID SHOT. SHE SAID NO I DONT WANT A COVID SHOT AND I TOLD HER THAT I WAS SORRY THAT I MUST NOT HAVE HEARD HER CORRECTLY AND I HAD ALREADY GIVEN HER THE SHOT. SHE THEN TOLD ME THAT SHE HAD NO INTENTIONS OF EVER TAKING ANOTHER COVID SHOT BECAUSE HER SISTER HAD A STROKE AND DIED AFTER A COVID SHOT. I APPOLOGISED AGAIN AND TOLD HER TO TAKE CARE OF HERSELF. SHE CALLED ABOUT 30 MINUTES LATER AFTER LEAVING AND SAID THAT SHE WANTED TO BE SURE THAT IS WAS NOTED SOMEWHERE THAT SHE DID NOT WANT THE SHOT AND THAT IT WAS GIVEN TO HER BY MISTAKE. I ASKED HER IF IT WOULD BE OK FOR ME TO FOLLOW UP WITH HER LATER IN THE WEEK TO BE SURE SHE IS DOING OK AND SHE AGREED. I AM FILLING THIS REPORT TO MAKE A RECORD OF WHAT OCCURED. More
2867319 70 M TX 10/21/2025 FLUX
 UNKNOWN MANUFACTURER
Asthenia, Dizziness, Headache, Impaired work ability, Vertigo Asthenia, Dizziness, Headache, Impaired work ability, Vertigo
Received FLUDARA (flu vaccine) on 09/29/2025. Headache onset approx 4hrs after getting dose. Headach... Received FLUDARA (flu vaccine) on 09/29/2025. Headache onset approx 4hrs after getting dose. Headache did not go away until 10/01/2025. Developed episode of severe Vertigo lasting approx 5min on 10/01/2025 @ 0530hrs followed by dizziness and weakness, resulting in call-in from work. Resulted one missed day of work. Symptoms resolved on 10/01/2025 after reported side effects and have not returned. More
2867320 F MD 10/21/2025 COVID19
 MODERNA
Asthenia, Chromaturia, Dysstasia, International normalised ratio normal, Urine a... Asthenia, Chromaturia, Dysstasia, International normalised ratio normal, Urine analysis normal More
After getting Moderna Vaccine on 10/4. I noticed very ugly dark brown urine. No fever, no pain, or b... After getting Moderna Vaccine on 10/4. I noticed very ugly dark brown urine. No fever, no pain, or burning when I urinated. I contacted my physician and also the anticoagulation clinic since I take warfarin. Because I have a history of kidney stones I always try and stay hydrated by drinking water every 20 minutes (I set the timed on my smart watch). While waiting to hear back from the clinic and my physician I just kept drinking water constantly at home and eventually the urine returned to the "normal" light yellow color for me. My INR appointment was brought forward today (10/10) and my INR is in the normal range. This was very abnormal for me because I do stay hydrated. In addition I noticed a slight side effect of weakness. On Sunday I was not able to stand from my chair or even my toilet bowl without holding the arms or grab bar. That went away by the next morning and I am not concerned about it. My physician did order a lab test for urine test if needed, but all is normal now. I am convinced that this was due to the Covid vaccine. More
2867321 M CA 10/21/2025 COVID19
COVID19
COVID19
FLU4
FLU4
FLU4
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
MODERNA
MODERNA
MODERNA
 NDC: 8077704006
NDC: 8077704006
NDC: 8077704006
u8800ba
u8800ba
u8800ba
NDC: 8077704006
NDC: 8077704006
NDC: 8077704006
Injection site pain, Pain; Arthralgia, Joint injury, Nerve injury, Wrong techniq... Injection site pain, Pain; Arthralgia, Joint injury, Nerve injury, Wrong technique in product usage process; Injection site pain, Pain; Injection site pain, Pain; Arthralgia, Joint injury, Nerve injury, Wrong technique in product usage process; Injection site pain, Pain; Injection site pain, Pain; Arthralgia, Joint injury, Nerve injury, Wrong technique in product usage process; Injection site pain, Pain More
I had normally received the Pfizer Covid vaccines at (withheld pharmacy name) all the previous years... I had normally received the Pfizer Covid vaccines at (withheld pharmacy name) all the previous years. This year I got the Moderna vaccine at (withheld pharmacy name) Pharmacy. My shoulder at the injection site has hurt ever since. There is pain in lifting my left arm up even now a month later. I never had this type of pain or reaction with Pfizer. I'll never get Moderna vaccine again. More
2867322 VA 10/21/2025 FLU3
 SANOFI PASTEUR
 U8881CA
Product packaging issue Product packaging issue
Flu vaccine prefilled syringes are being identified empty in sealed packaging. Flu vaccine prefilled syringes are being identified empty in sealed packaging.
2867329 28 F CO 10/21/2025 FLU3
 SEQIRUS, INC.
 409412
Rash Rash
A few hours after receiving the flu vaccine I developed a rash on my hand and wrist following a derm... A few hours after receiving the flu vaccine I developed a rash on my hand and wrist following a dermatomal pattern. I had it checked by a physician and they are baffled by it but said it was definitely the vaccine that caused it. It's been 6 days now and the rash hasn't not gotten worse but has not gone away. I get the flu vaccine every year and have never had an adverse reaction to it. The manufacturer is Sequirus lot number 409412 expiration date 6/26/26. More
2867330 35 F TX 10/21/2025 TDAP
 UNKNOWN MANUFACTURER
Malaise, Tendonitis Malaise, Tendonitis
I went in urgent care to assess a cat scratch on my finger. The doctor recommended me getting a T da... I went in urgent care to assess a cat scratch on my finger. The doctor recommended me getting a T dap vaccination. The vaccination made me sick and gave me tendinitis. More
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2867331 F 10/21/2025 RV5
 MERCK & CO. INC.
 w002561
Intussusception, Surgery Intussusception, Surgery
Rota given 9/8/22, 10/13/22, transferred to hospital, intussusception, surgery, hospitalized for 3 d... Rota given 9/8/22, 10/13/22, transferred to hospital, intussusception, surgery, hospitalized for 3 days More
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2867332 M TX 10/21/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2xk44
Seizure Seizure
Flu vaccine 2/6/25. 2/7/25 ambulance to ER for multiple violent seizures, flown to hospital, 2 day h... Flu vaccine 2/6/25. 2/7/25 ambulance to ER for multiple violent seizures, flown to hospital, 2 day hospitalization More
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2867334 M 10/21/2025 RV5
 MERCK & CO. INC.
 r013861
Intussusception Intussusception
Describe Event, Problem, or Product Use Error: Rota given 4/14/25. Transported to hospital from ER d... Describe Event, Problem, or Product Use Error: Rota given 4/14/25. Transported to hospital from ER due to intussusception More
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2867335 0.33 F TX 10/21/2025 RV5
 MERCK & CO. INC.
 2139674
Diarrhoea, Haematochezia, Rotavirus test positive, Secretion discharge Diarrhoea, Haematochezia, Rotavirus test positive, Secretion discharge
Rota vaccine given 10/7/25, diarrhea, mucus, bloody stools 6/12/25, rota positive 10/16/25 Rota vaccine given 10/7/25, diarrhea, mucus, bloody stools 6/12/25, rota positive 10/16/25
2867336 M 10/21/2025 MMRV
 MERCK & CO. INC.
 x26219
Petechiae, Platelet count decreased, Rash Petechiae, Platelet count decreased, Rash
Describe Event, Problem, or Product Use Error: MMR, Varicella given 9/20/24, rash to body 9/28/25, E... Describe Event, Problem, or Product Use Error: MMR, Varicella given 9/20/24, rash to body 9/28/25, ER visit 10/25/24 for petechae, platelets at 24, transferred by ambulance to hospital, followed by hematology after More
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2867373 63 F MI 10/21/2025 PNC21
 MERCK & CO. INC.
Chills, Fatigue, Injection site erythema, Injection site pain Chills, Fatigue, Injection site erythema, Injection site pain
The caller stated that the injection site itself was not itchy, but the edges of the redness were; C... The caller stated that the injection site itself was not itchy, but the edges of the redness were; Consumer calling to report an AE on CAPVAXIVE. Caller stated that she received CAPVAXIVE at her local pharmacy on 09/17/2025. The caller stated that she had the "typical reaction" at first including redness and soreness at the injection site; the "typical reaction" at first including redness and soreness at the injection site along with chills and fatigue; the "typical reaction" at first including redness and soreness at the injection site along with chills and fatigue; the "typical reaction" at first including redness and soreness at the injection site along with chills and fatigue; The caller stated that she suspects she had an allergic reaction to one of the components of the vaccine; This spontaneous report was received from a consumer or other non-health professional and refers to a(n) 63-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-Sep-2025, the patient was vaccinated with dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (formulation, lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. On the same day, the patient experienced vaccination site pain, vaccination site erythema, chills and fatigue. The caller stated that she had the "typical reaction" at first including redness and soreness at the injection site along with chills and fatigue. On 19-Sep-2025 (reported as: about a day and a half after receiving the vaccine), the patient experienced pruritus. It was reported that, the redness at the injection site spread to be about the size of a dollar bill. The caller stated that the injection site itself was not itchy, but the edges of the redness were. The caller stated that she did not speak with her HCP about this but would have if it got worse. The caller stated that she put Hydrocortisone cream on the area and that helped. On 22-Sep-2025, the patient recovering from the event of vaccination site erythema (the redness is just about gone). On an unknown exact day in September 2025, the patient experienced allergic reaction (the caller stated that she suspects she had an allergic reaction to one of the components of the vaccine). At the reporting time, the outcome of the events vaccination site pain, chills, fatigue, pruritus and allergic reaction was unknown. The causal relationship between the reported events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided. More
2867375 10/21/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
 Unknown
Allergy to vaccine Allergy to vaccine
Allergy to any AZ medication; A spontaneous report has been received from a consumer. The report co... Allergy to any AZ medication; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided). No medical history was reported. No concomitant products were reported. The patient received Flumist, via unknown on an unknown date. The patient received 1 dose(s). No malfunction has been reported for the Accuspray Single Dose device. On an unknown date, the patient experienced allergy to any az medication (preferred term: Hypersensitivity). It was unknown if any action was taken with Flumist (flumist, influenza virus vaccine polyvalent, q/laiv). The outcome of the event(s) of allergy to any az medication was unknown. The event was considered non-serious. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUMIST Product Role:Suspect Device Problem code:Adverse Event Without Identified Device or Use Problem Manufacturer Name:ASTRAZENECA Labeled for single use:No Non-Significant correction 15-Oct-2025: County Patient info and Vaccine Facility Information set as NF. Non-significant correction on 18-Oct-2025: null flavor added. narrative updated. Non-Significant correction on 21-Oct-2025: Null flavor removed for telephone and fax, Narrative amended. More
2867376 M NC 10/21/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
Nasopharyngitis Nasopharyngitis
NASOPHARYNGITIS; A spontaneous report has been received from a consumer. The report concerns a male ... NASOPHARYNGITIS; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided). No medical history was reported. No concomitant products were reported. The patient received Flumist, via unknown on an unknown date. The patient received 1 dose(s). No malfunction has been reported for the Accuspray Single Dose device. On an unknown date, the patient experienced nasopharyngitis (preferred term: Nasopharyngitis). The outcome of the event(s) of nasopharyngitis was unknown. The event was considered non-serious. The reporter considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): nasopharyngitis. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): nasopharyngitis. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUMIST Product Role:Suspect Device Problem code:Adverse Event Without Identified Device or Use Problem Manufacturer Name:ASTRAZENECA Labeled for single use:No Corrected report on 18-Oct-2025: Patient County set as NASK, Potential SAE and Device malfunction updated as NO. Operator of device updated. Non-Significant correction on 21-Oct-2025: Null flavor removed for telephone and fax, Narrative amended. More
2867377 F IL 10/21/2025 FLUN3
FLUN3
 MEDIMMUNE VACCINES, INC.
MEDIMMUNE VACCINES, INC.

Decreased appetite, Dysaesthesia, Nasal congestion, Nasal polyps, Pyrexia; Vomit... Decreased appetite, Dysaesthesia, Nasal congestion, Nasal polyps, Pyrexia; Vomiting More
PYREXIA, DYSAESTHESIA, VOMITING, DECREASED APPETITE, NASAL CONGESTION, NASAL POLYPS; dysaesthesia; v... PYREXIA, DYSAESTHESIA, VOMITING, DECREASED APPETITE, NASAL CONGESTION, NASAL POLYPS; dysaesthesia; vomiting; decreased appetite; nasal congestion; nasal polyps; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided). No medical history was reported. No concomitant products were reported. The patient received Flumist, via unknown on an unknown date. The patient received 1 dose(s). It was unknown who administered Flumist to the patient. On an unknown date, the patient experienced pyrexia, dysaesthesia, vomiting, decreased appetite, nasal congestion, nasal polyps (preferred term: Pyrexia), nasal polyps (preferred term: Nasal polyps), nasal congestion (preferred term: Nasal congestion), decreased appetite (preferred term: Decreased appetite), vomiting (preferred term: Vomiting) and dysaesthesia (preferred term: Dysaesthesia). The outcome of the event(s) of decreased appetite, dysaesthesia, nasal congestion, nasal polyps, pyrexia, dysaesthesia, vomiting, decreased appetite, nasal congestion, nasal polyps and vomiting was unknown. The events were considered non-serious. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUMIST Product Role: Suspect Manufacturer Name: ASTRAZENECA Labeled for single use: No Corrected report on 18-Oct-2025: data fields County, email and Vaccine Facility Information set as NF. Narrative amended. Case corrected as a result of MCQC. Non-Significant correction on 20-Oct-2025: Vaccine facility state field updated. Narrative amended. Non-Significant correction on 21-Oct-2025: Nullflavor removed for telephone and fax, Narrative amended. More
2867378 10/21/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Intensive care, Malaise, Respiratory syncytial virus infection Intensive care, Malaise, Respiratory syncytial virus infection
My friend got this vaccine then ended up extremely ill in ICU with RSV; This serious case was report... My friend got this vaccine then ended up extremely ill in ICU with RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced illness (Verbatim: My friend got this vaccine then ended up extremely ill in ICU with RSV) (serious criteria hospitalization). The outcome of the illness was not reported. It was unknown if the reporter considered the illness to be related to RSV vaccine. The company considered the illness to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 14-OCT-2025 This case was reported by a patient via interactive digital media. Consumer reported that here's another one heck no to all those vaccines. The reporter mentioned never got them and never will. The reporter mentioned everyone he/she knows that gets Covid jab-gets covid, flu shot-gets flu. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Illness, on an unknown time after receiving RSV vaccine, 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
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2867379 61 F LA 10/21/2025 VARZOS
VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
Burning sensation, Fatigue, Herpes zoster, Herpes zoster oticus, Paraesthesia; R... Burning sensation, Fatigue, Herpes zoster, Herpes zoster oticus, Paraesthesia; Rash erythematous, Rash papular, Rash pruritic, Vaccination failure; Burning sensation, Fatigue, Herpes zoster, Herpes zoster oticus, Paraesthesia; Rash erythematous, Rash papular, Rash pruritic, Vaccination failure More
Suspected vaccination failure; diagnosed with shingles/ outbreak encompassed her trigeminal area and... Suspected vaccination failure; diagnosed with shingles/ outbreak encompassed her trigeminal area and mandibular area.; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (when she was in her 20's she was diagnosed with shingles.). Previously administered products included aveeno (Aveeno to treat the rash.). On 26-DEC-2020, the patient received the 2nd dose of Shingrix (unknown arm). In OCT-2020, the patient received the 1st dose of Shingrix (intramuscular). On 06-OCT-2025, 1745 days after receiving Shingrix and more than a year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: diagnosed with shingles/ outbreak encompassed her trigeminal area and mandibular area.). The patient was treated with valaciclovir (Valacyclovir) and pregabalin (Lyrica). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster was not reported. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the herpes zoster to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 16-OCT-2025 Consumer was the reporter. Consumer stated she was received both doses of SHINGRIX in2020. Consumer stated her second dose was administered on 26 DEC 2020, was an injection but does not remember which arm the injection was administered. Consumer stated she believes her first dose was administered 2 months prior to her second dose; however, she was unable to provide the date of administration for the first dose. Consumer states on 6-OCT-2025 she broke out in a rash and on 8-OCT- 2025 she went to her doctor and was diagnosed with shingles. Consumer stated shingles rash was present on the left side of her face, neck, chin, left ear, and chest area. Consumer did go to an eye doctor and was told she did not have ocular shingles. The eye doctor told the consumer the outbreak encompassed her trigeminal area and mandibular area. Consumer stated this bout of shingles had caused her an extreme amount of fatigue. Consumer stated the rash was itchy, red, and raised. Consumer described the rash as puffy. The rash was burning and tingling. Consumer was provided medication to take on 8-OCT-2025. Medication prescribed was valacyclovir 1gm take three times daily and Lyrica 75mg take twice daily. No further information was provided/obtained. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, more than a year and 1745 days after receiving Shingrix (Dose 1 and Dose 2) in a 65-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (h/o shingles and laboratory confirmation test unknown). More
2867380 70 F PA 10/21/2025 COVID19
COVID19
 MODERNA
MODERNA

Blood test, Fatigue, Feeling abnormal, Malaise, Muscle tightness; Vaccination si... Blood test, Fatigue, Feeling abnormal, Malaise, Muscle tightness; Vaccination site pain More
she has always had a reaction to the injection site where she gets lots of pain, and constricting mu... she has always had a reaction to the injection site where she gets lots of pain, and constricting muscle tightness; she felt sick at night towards the evening; Felt so crappy; she has always had a reaction to the injection site where she gets lots of pain, and constricting muscle tightness; it was like a double whammy and she was so tired and felt so crappy; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (she has always had a reaction to the injection site where she gets lots of pain, and constricting muscle tightness), MALAISE (she felt sick at night towards the evening), FEELING ABNORMAL (Felt so crappy), VACCINATION SITE PAIN (she has always had a reaction to the injection site where she gets lots of pain, and constricting muscle tightness) and FATIGUE (it was like a double whammy and she was so tired and felt so crappy) in an 8-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Carpal tunnel syndrome (More painful. in left hand; had surgery for it (the hand is very weak as a result of it), but it came back within a year or two. since she is ambidextrous, she switched over to the right hand but now she has carpel tunnel in that hand. She also has numbness in her fingers in her left hand and a little bit in the right hand now.) in 1998 and Ulnar tunnel syndrome (she had major surgery on the left elbow a year or 2 ago because of the ulnar tunnel. This surgery has been since vaccination but the ulnar tunnel is pre-existing.). Previously administered products included for Drug use for unknown indication: ampecillin in 1990, ampecillin in 1990 and Sulfa drugs in 1990; for Product used for unknown indication: Flu (welts on upper torso) in 1996 and RSV. Past adverse reactions to the above products included Difficulty breathing with Sulfa drugs; Felt ill with ampecillin; Nauseous with ampecillin; and No adverse effect with Flu and RSV. Concurrent medical conditions included Type 2 diabetes mellitus since 2004, Scoliosis (she has 3 of them, one in the neck, one in the thoracic region and one in the lumbar region. This takes the heart and shifts it to the left. don't know if that affects the heart at all.), Bundle branch block (Left) since 2006, Fibromyalgia, Arthritis (Severe), High cholesterol (controlled with medications), Blood pressure high (hypertension, controlled with medications) since 2003, Allergy to animal (Patient stated she had numerous allergy shots many years ago in the same arm due to cat allergy), Vascular disorder NOS (grape seed extract for vascular issues,), Vein disorder (clogged lower veins), Asthma, Hypersensitivity reaction, Hives, Hay fever, Hyperlipidemia since 2003, Neuropathy since 2004, Osteoarthritis since 2006, Allergy to antibiotic (ampecillin - felt ill, nauseous.) since 1990, Allergy to nuts (swelling of tongue, mild to moderate) since 1999, Drug allergy (no antibiotic reaction, caused nausea.) since 1990, Fragrance sensitivity (caused some allergic asthma, issue has mostly gone/resolved itself over time) since 2000, Sulfonamide allergy (Sulfa drugs - difficulty breathing) since 1990 and Pain. Concomitant products included Losartan potassium and Labetalol hydrochloride (Labetalol HCL) for Blood pressure, Simvastatin for Cholesterol, Linum usitatissimum seed oil, Ubiquinol (Ubiquinol) for Energy increased, Gabapentin for Pain, Iron for Supplementation therapy, Metformin hydrochloride (Metformin hcl er) for Type 2 diabetes mellitus, Citrus x aurantium fruit, Vitis vinifera seed (Grape seed extract) for Vascular disorder NOS, Horse chestnut extract for Vein disorder. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (she has always had a reaction to the injection site where she gets lots of pain, and constricting muscle tightness), MALAISE (she felt sick at night towards the evening), FEELING ABNORMAL (Felt so crappy), VACCINATION SITE PAIN (she has always had a reaction to the injection site where she gets lots of pain, and constricting muscle tightness) and FATIGUE (it was like a double whammy and she was so tired and felt so crappy). At the time of the report, MUSCLE TIGHTNESS (she has always had a reaction to the injection site where she gets lots of pain, and constricting muscle tightness) and VACCINATION SITE PAIN (she has always had a reaction to the injection site where she gets lots of pain, and constricting muscle tightness) had resolved and MALAISE (she felt sick at night towards the evening), FEELING ABNORMAL (Felt so crappy) and FATIGUE (it was like a double whammy and she was so tired and felt so crappy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: she is immune. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Patient was on facial oil that has anchovies oil, key lime flavor and sardine oil. It was stated she got the mNEXSPIKE (08-Oct-2025 at around 11:15 am) and has been getting the shots during the pandemic and after that as well. She has been getting them whenever they were available, once a year or once every 6 months, or one was 3 months apart, something like that. " It was stated that she has always had a reaction to the injection site where she got lots of pain, and constricting muscle tightness. It was stated that this time, she got the mNEXSPIKE and she felt nothing, it was like she never got the shot. She was wondering if Moderna has fixed or resolved the issue so that she would not feel these symptoms anymore. did not knew if the shot was done properly, because she never had no reaction within several hours. It was stated it was done by a nurse in a doctor's office. It was stated that this time, she did not know what's going to happen because she normally felt pain and she did not felt anything in that spot no tenderness, no pain, no muscle restriction. It was not like want the pain or those restrictive muscle pains or the tightness. It was questioning if the shot didn't take or if the HCP didn't do it right or if it was a bad batch because she did not get any symptoms. This was not typical for her. She had two severe reactions and then a bunch of serious pain in that location with very serious muscle restriction for a long time. One of them took almost 2 months for it to go away. Patient had another reaction but couldn't remember what it was at that time because it was too far back. Too many things have happened since then for her to remember, that normally with the other vaccines, it was a great deal of pain and very strong muscle restriction in the injection site. It lasted anywhere between a couple of weeks to a couple of months. No treatment medication was reported. This case was linked to MOD-2021-235384 (Patient Link). More
2867381 F PA 10/21/2025 COVID19
 MODERNA
Post-traumatic stress disorder, Weight, Weight decreased Post-traumatic stress disorder, Weight, Weight decreased
extreme PTSD/PTSD was off the charts; Patient had lost 40 pounds/weight loss; This spontaneous case ... extreme PTSD/PTSD was off the charts; Patient had lost 40 pounds/weight loss; This spontaneous case was reported by a consumer and describes the occurrence of POST-TRAUMATIC STRESS DISORDER (extreme PTSD/PTSD was off the charts) and WEIGHT DECREASED (Patient had lost 40 pounds/weight loss) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS (Patient received all the Moderna Covid vaccines). Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST-TRAUMATIC STRESS DISORDER (extreme PTSD/PTSD was off the charts) and WEIGHT DECREASED (Patient had lost 40 pounds/weight loss). At the time of the report, POST-TRAUMATIC STRESS DISORDER (extreme PTSD/PTSD was off the charts) and WEIGHT DECREASED (Patient had lost 40 pounds/weight loss) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Patient had lost 40 pounds. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were provided. The patient had received all the Moderna Covid vaccines and had developed extreme PTSD and weight loss due to watching a family member. The patient had two doctors, a psychiatrist and a therapist who had told that PTSD was off the charts. It was reported that patient never had a reaction to the vaccine. The patient did not experience any additional symptoms/events. Between two of them, they had lost 100 pounds. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790240 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2025: Live follow-up received which contains significant information, events verbatim updated and reference numbers added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790240:Master case (reporter's sister case) More
2867382 72 F 10/21/2025 COVID19
 MODERNA
Asthenia, Colitis, Fatigue Asthenia, Colitis, Fatigue
she experienced a severe flare-up diagnosed as pan colitis, leading to hospitalization with symptoms... she experienced a severe flare-up diagnosed as pan colitis, leading to hospitalization with symptoms including significant bleeding; Weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (she experienced a severe flare-up diagnosed as pan colitis, leading to hospitalization with symptoms including significant bleeding) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Delivery (The Patient had only two childbirths), Pregnancy, Tonsillectomy, Heat therapy (ultrasonic heat therapy) and Polyp removal. Concurrent medical conditions included Colitis and Bone spur (The Patient had Bad arm and spine). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In June 2025, the patient experienced COLITIS (she experienced a severe flare-up diagnosed as pan colitis, leading to hospitalization with symptoms including significant bleeding) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ASTHENIA (Weakness) and FATIGUE (Fatigue). The patient was treated with Potassium chloride (Potassium) at an unspecified dose and frequency. At the time of the report, COLITIS (she experienced a severe flare-up diagnosed as pan colitis, leading to hospitalization with symptoms including significant bleeding), ASTHENIA (Weakness) and FATIGUE (Fatigue) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. The patient used to experience symptoms of significant fatigue and weakness. It was reported that the patient had a history of colitis last year, which was initially linked to a polyp that was removed. In June-2025 the patient experienced a severe flare-up, and which was diagnosed with pancolitis. Due to pancolitis, the patient was hospitalized with symptom of significant bleeding. The patient received treatment medication of potassium and antibiotics. The physician stated that all of the patient's colon was inflamed and infected. The patient was going to the chiropractor for ultrasonic heat therapy for a bone spur in her arm and back. It was also reported that symptom of pancolitis might cause possible links between COVID-19 vaccines and bowel issues. The patient had no family history of colitis and was generally healthy. This case was linked to US-MODERNATX, INC.-MOD-2025-790267 (Patient Link).; Reporter's Comments: Concurrent medical condition Colitis is a contributor for the mentioned event. Due to lack of biological plausibility, the causality of the event colitis was assessed as not related . The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. More
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2867383 10/21/2025 COVID19
 MODERNA
Illness Illness
got a Moderna shot got sick; This spontaneous case was reported by a non-health professional and des... got a Moderna shot got sick; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (got a Moderna shot got sick) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got a Moderna shot got sick). At the time of the report, ILLNESS (got a Moderna shot got sick) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication was not reported. It was reported that, the last time patient received a Moderna shot and got sick. It was inquired that patient would prefer a Pfizer vaccine and would it be possible. Treatment medication was not reported. More
2867384 34 F NY 10/21/2025 COVID19
 MODERNA
Myalgia Myalgia
felling very achy; This spontaneous case was reported by a consumer and describes the occurrence of ... felling very achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (felling very achy) in a 34-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 15-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 16-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced MYALGIA (felling very achy). At the time of the report, MYALGIA (felling very achy) outcome was unknown. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. It was reported that patient received the vaccine on 15-Oct-2025, and woke up at 4 a.m. feeling very achy. No other additional details were provided. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. More
2867385 51 F CA 10/21/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Asthenia, Burning sensation, Chronic active Epstein-Barr virus infection, Hand d... Asthenia, Burning sensation, Chronic active Epstein-Barr virus infection, Hand deformity, Hyperreflexia; Investigation, Limb discomfort, Mast cell activation syndrome, Neck pain, Neurological symptom; Spinal cord injury, Tremor More
Chronic Epstein-Barr; Mast cell activation syndrome; had no use of my arms; I had severe weakness; I... Chronic Epstein-Barr; Mast cell activation syndrome; had no use of my arms; I had severe weakness; I had burns all over my body; my hands turn to claws; I would start vibrating; It felt like I had a spinal cord injury and it caused some kind of neurological damage to my body; neurological damage; severe neck pain; I had hyperreflexia; This is a spontaneous report received from a Consumer or other non HCP. A 51-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 2,SINGLE, Lot Number: EW0150, Anatomical location: Left arm), administration date: 31Mar2021, when the patient was 50-year-old, for Covid-19 Immunization, reaction(s): "stroke"; Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: HYPERREFLEXIA (non-serious) with onset 2021, outcome "unknown", described as "I had hyperreflexia"; SPINAL CORD INJURY (medically significant) with onset 2021, outcome "unknown", described as "It felt like I had a spinal cord injury and it caused some kind of neurological damage to my body"; NEUROLOGICAL SYMPTOM (non-serious) with onset 2021, outcome "unknown", described as "neurological damage"; NECK PAIN (non-serious) with onset 2021, outcome "unknown", described as "severe neck pain"; CHRONIC ACTIVE EPSTEIN-BARR VIRUS INFECTION (medically significant), outcome "unknown", described as "Chronic Epstein-Barr"; MAST CELL ACTIVATION SYNDROME (medically significant), outcome "unknown"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "had no use of my arms"; ASTHENIA (non-serious), outcome "unknown", described as "I had severe weakness"; BURNING SENSATION (non-serious), outcome "unknown", described as "I had burns all over my body"; HAND DEFORMITY (non-serious), outcome "unknown", described as "my hands turn to claws"; TREMOR (non-serious), outcome "unknown", described as "I would start vibrating". The patient underwent the following laboratory tests and procedures: spike protein levels: replicating. Therapeutic measures were taken as a result of spinal cord injury, chronic active epstein-barr virus infection, mast cell activation syndrome, neck pain, hyperreflexia, limb discomfort, asthenia, burning sensation, hand deformity, neurological symptom, tremor. Clinical course: Consumer stated "I had a severe reaction 3 weeks after the third shot (Pfizer COVID-19 Vaccine) and I had not had other one since obviously and I only had Pfizer's." Consumer stated, "Yes, and I did not correlate the stroke like event to the vaccine because I would had it 3 weeks before, it never occurred to me that you could have a response or reaction, adverse reaction several weeks after the shot, but it was like clockwork 3 weeks and 3 weeks for both of them and when I did a timeline, I realized this is the vaccine and it was so extreme that I really feel like I almost died, it was very. I was bedridden for almost two years and severe neck pain. It felt like I had a spinal cord injury and it caused some kind of neurological damage to my body. I had hyperreflexia. Yes, it was terrible and I was first in line, I am very pro-vaccine. So, I am really excited to get it, but nobody should be getting these." When clarified if hyperreflexia as a medical history or experienced it after taking Pfizer COVID-19 Vaccine, consumer stated, "After the shots, I experienced severe neck pain that was the first terrible response. I could not lay down. I could not sit up. I could not find out a resting position. It felt like my neck was sick, like my body was sick. It was extreme pain and I went to the neurologist. She had no idea what was going on with me and so, she gave me a shot of Botox (Unspecified injection) to try to help with neck pain that did nothing to help me. In fact, it was probably not a great thing to do either because it could not hold my head up for several months, but from that, I just went downhill. I had no use of my arms. I had severe weakness. I had burns all over my body. My body felt like it was electrified. I could not exercise. I could not stretch. The hyperreflexia, I could not touch my toes. I felt like my deep tendons in my body were all contracting, anything I did they were contracting and I had a couple episodes that were extremely severe, I could not ride in a car, every bump. I could not lay my head down on a pillow because my occipital, the nerves. Could not wash my hair, could not lift my arms to wash my hair so when I did, my skin hurt so badly all over my body that I could not even brush my hair, I could not even wash my hair. Just laying on a pillow is extreme." Consumer was informed that same would be mentioned here in the report. Consumer stated, " Yes, also, my hands turn to claws. I would start vibrating, my hands would turn to claws. It was really extreme." Other medical conditions or concomitant medications: Consumer stated, "No, I am not. The only thing I am taking is hormones, but other than that no." Treatment: Consumer stated, "I have tried many treatments for it, which has been a very lonely journey. When probed to clarify the name of the Botox shot, consumer stated, "To be honest, I do not know the actual name of it, unfortunately. It was a Botox like injection to try to calm what she thought was muscle pain of some kind. It was not really muscle pain." I still I am not able to exercise and my body is still burning. It seems to reactivated Chronic Epstein-Barr in my system which is apparently very common for people who do respond to these vaccines. So, I have Chronic Epstein-Barr (Chronic Epstein-Barr virus) that has been activated by this and that is horrible in and of itself. Yes, it has caused that, it has caused Mast cell activation syndrome for me as well. My mast cells are just on fire for everything, it is like an oversensitivity to absolutely everything. I have had spike protein levels tested in my body. Years later, my body is just continually replicating the spike protein in my system, it seems. Most people are not elevated like this all the time (further clarification unknown), but for some reason that vaccine has made my protein levels just keep replicating which is just really unfortunate. I am really lucky to be alive. I have made a lot of progress. I am functioning 80%, but literally, I really look back, I almost died from this. I could not even get out of bed. It was just extreme." Lot for the third COVID-19 vaccine: Consumer stated, "It is 3203080 (Lot). The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2867386 F 10/21/2025 COVID19
 PFIZER\BIONTECH
Arthralgia Arthralgia
My doctor recommended it because of the possibility of joint pain that I had a couple of years ago/g... My doctor recommended it because of the possibility of joint pain that I had a couple of years ago/got the Pfizer covid 19 vaccine booster two years ago and she got joint pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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; unknown manufacturer), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "My doctor recommended it because of the possibility of joint pain that I had a couple of years ago/got the Pfizer covid 19 vaccine booster two years ago and she got joint pain". Additional information: The caller inquired about the viability of splitting the Pfizer COVID-19 vaccine dose into two administrations from the same vial, citing past joint pain after a previous vaccine. And it was reported that the doctor recommended it because of the possibility of joint pain that patient had a couple of years ago, which patient not sure if was from the COVID vaccine or from something else. That being said, he recommends using the same vial a week later and giving a half dose and then another half dose after he refrigerates it for an week that is something that can be done or is not good because of pollution or whatever? Caller also mentioned that she got the Pfizer covid 19 vaccine booster two years ago and she got joint pain. PQC not applicable. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2867387 56 M IL 10/21/2025 COVID19
 PFIZER\BIONTECH
Vestibular neuronitis Vestibular neuronitis
Acute vestibular neuritis.; This is a spontaneous report received from a Consumer or other non HCP. ... Acute vestibular neuritis.; This is a spontaneous report received from a Consumer or other non HCP. A 56-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Oct2025 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: VESTIBULAR NEURONITIS (hospitalization, medically significant) with onset 14Oct2025 at 20:15, outcome "not recovered", described as "Acute vestibular neuritis.". The patient was hospitalized for vestibular neuronitis (hospitalization duration: 1 day(s)). The event "acute vestibular neuritis." required emergency room visit. Therapeutic measures were taken as a result of vestibular neuronitis. Clinical course: No other vaccine on same date. No other vaccine in four weeks. Unknown if other medications in two weeks. Event Acute vestibular neuritis resulted in emergency room trip and an overnight stay for observation. Event occurred 11 days after vaccination dose. Treatment: Meclizine. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
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2867388 SC 10/21/2025 PNC20
 PFIZER\WYETH
 MA2502
Device connection issue Device connection issue
There is a clear part below that that connects to the medication, and it broke in 2, it snapped; Thi... There is a clear part below that that connects to the medication, and it broke in 2, it snapped; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: MA2502, Expiration Date: 31Oct2026) for immunisation, Device Lot Number: MA2502, Device Expiration Date: 31Oct2026. 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 "There is a clear part below that that connects to the medication, and it broke in 2, it snapped.". Causality for "there is a clear part below that that connects to the medication, and it broke in 2, it snapped." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: at the very top there is a blue tip to twist off to put the needle on. There is a clear part below that that connects to the medication, and it broke in 2, it snapped. The consumer states the medication is still in it. There was no unusual force getting blue part off. Product strength and count size dispensed: 1 from box of 10. The sample of the product is available to be returned. It was also reported that one of the prefilled syringes broke when a nurse was going to give it, at the top. There is only one with a problem. NDC Number: 0005-2000-01. More
2867390 1 F FL 10/21/2025 FLU3
MMR
 SANOFI PASTEUR
MERCK & CO. INC.
 UT8852MA
2005855
Injection site urticaria; Injection site urticaria Injection site urticaria; Injection site urticaria
Patient received flu and MMR in right thigh. Within two minutes of administration, child developed ... Patient received flu and MMR in right thigh. Within two minutes of administration, child developed a hive under the flu vaccine administration site. Child was observed for 50mins. No other symptoms, hive nearly resolved at time of discharge. More
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