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
2874116 10 M MI 11/21/2025 COVID19
 MODERNA
 3052741
Unevaluable event Unevaluable event
n/a n/a
2874119 F OH 11/21/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Autoimmune arthritis, Injection site nodule, Nausea, Rash, Rash erythematous; Ra... Autoimmune arthritis, Injection site nodule, Nausea, Rash, Rash erythematous; Rash papular, Rheumatoid factor negative More
a knot at injection site; nausea that lasted 48 hours; patient experienced painful, red, swollen ras... a knot at injection site; nausea that lasted 48 hours; patient experienced painful, red, swollen rash that grew; the redness went down her arm; as of today it was still red; she was diagnosed with an unspecified autoimmune arthritis; This spontaneous report was received from a medical assistant, reporting on herself, a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. She had no allergies and no previous history of vaccine reaction. On 04-Nov-2025, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. That same day (04-Nov-2025) in the evening, the symptoms started. The patient experienced painful, red, swollen rash that grew. The redness went down her arm. She also developed nausea that lasted 48 hours (till 06-Nov-2025). On an unknown day in November 2025, the patient was diagnosed with an unspecified autoimmune arthritis, however her rheumatoid labs were negative. On 11-Nov-2025 (reported as "as of today"), the rash was still red and there was a knot at the injection site. The patient reported no itching, no fever. It was unknown if she sought medical attention or if any treatment was given for adverse events. The outcome of rash and knot at injection site was not resolved. The outcome of autoimmune arthritis was not provided and the outcome of nausea was resolved. The action taken with the suspect vaccine regarding all events was assessed as not applicable. The causality assessment between all events and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) was not provided. Upon internal review, the event of autoimmune arthritis was determined to be medically significant. Lot# is being requested and will be submitted if received. More
2874120 74 M VA 11/21/2025 COVID19
 NOVAVAX
 6315mf001c
Asthenia Asthenia
Patient states he has weakness in his back 2 days post vaccine but now that he is thinking about it,... Patient states he has weakness in his back 2 days post vaccine but now that he is thinking about it, since he has parkinson's disease, he could be experiencing parkinson's symptoms. More
2874121 39 M MI 11/21/2025 COVID19
 PFIZER\BIONTECH
 NA4459
Immediate post-injection reaction, Injection site erythema, Injection site rash,... Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site warmth More
pt broke out in a histamine response - red, hot, rash, immediately after injection on same arm that ... pt broke out in a histamine response - red, hot, rash, immediately after injection on same arm that injection was given around the elbow area - pt used hydrocortisone cream and was advised by doctor in clinic to take 25mg Benadryl. More
2874127 35 F MD 11/21/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 948409
948409
Anaphylactic reaction, Anaphylaxis treatment, Dysphonia, Intensive care, Throat ... Anaphylactic reaction, Anaphylaxis treatment, Dysphonia, Intensive care, Throat irritation; Throat tightness More
Patient presented to [withheld name] clinic on 11/20/2025 for scheduled MA visit for flu vaccine and... Patient presented to [withheld name] clinic on 11/20/2025 for scheduled MA visit for flu vaccine and depo-provera injection. Patient received flu vaccine as IM injection in right deltoid by MA staff. Approximately 1-2 minutes after vaccine administration patient began feeling tightness and itchiness in her throat and was only able to speak in a whisper. Clinic RN was called to exam room for assistance. Doctor overseeing MA visits in clinic ordered benadryl 25mg PO and patient was able to take this medication with a sip of water. Doctor ordered IM Epi injection 0.3mg and RN administered medication in patient's right thigh. EMS was called by second clinic RN during this time. Patient reported progression of symptoms higher in her throat and sensation that her throat was being "encircled by a hand". RN administered second IM Epi injection 0.3mg in patient's left thigh. EMS arrived and took patient to [withheld] ER for evaluation and treatment of anaphylaxis reaction to flu vaccine. More
โœ“ โœ“
2874128 77 F VA 11/21/2025 COVID19
 MODERNA
Erythema, Pain Erythema, Pain
My buttock broke out with very painful redness along the inside butt crack all the way to the rectum... My buttock broke out with very painful redness along the inside butt crack all the way to the rectum. Very uncomfortable to sit. I put a butt paste on it that is used for diaper rash. Hasn't seemed to help so far. More
2874131 8 F MA 11/21/2025 COVID19
 MODERNA
 3052860
No adverse event No adverse event
no adverse effects to date no adverse effects to date
2874136 F OH 11/21/2025 HPV4
 MERCK & CO. INC.
Pituitary tumour, Road traffic accident, Smear cervix abnormal, Tumour biopsy Pituitary tumour, Road traffic accident, Smear cervix abnormal, Tumour biopsy
pituitary tumor; PAP smear showed abnormal cell growth.; car accident; This spontaneous report was r... pituitary tumor; PAP smear showed abnormal cell growth.; car accident; This spontaneous report was received from a pharmacist and refers to a 35-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 an unknown date (reported as in unspecified year ago), the patient received a series of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), (strength, dose, frequency, lot #, and expiration date were not reported) for prophylaxis. On an unspecified date in 2025 (reported as recently), the patient got into a car accident, and it was found out that she had pituitary tumor. On 07-NOV-2025, Papanicolaou (PAP) smear showed abnormal cell growth. Biopsy was done, but results were unknown yet. At the reporting time, the outcome of the events was not provided. The causal relationship between the events and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not provided. Upon internal review, the event of pituitary tumor was determined to be medically significant. More
2874138 11/21/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Anxiety, Deafness, Ear discomfort, Insomnia, Migraine; Nervous system disorder, ... Anxiety, Deafness, Ear discomfort, Insomnia, Migraine; Nervous system disorder, Restless legs syndrome More
Hearing loss; Migraine headache; Anxiety; Unbearable restless leg; Central nervous system related pr... Hearing loss; Migraine headache; Anxiety; Unbearable restless leg; Central nervous system related problems; Insomnia; This spontaneous case report was received on 13-Nov-2025 and additional information was received on 14-Nov-2025, male patient (weight: 168 lbs/ 76.20 kg and height: 5'3"/ 160.02 cm) who experienced "migraine headache"(PT: Migraine), "loss of hearing"(PT: Deafness), "anxiety"(PT: Anxiety), "unbearable restless leg"(PT: Restless legs syndrome), "central nervous system related problems"(PT: Nervous system disorder) and "insomnia"(PT: Insomnia), following BioThrax administration for immunisation. The patient's medical history included Lyme disease during childhood with no known allergies, and he was not taking any medications. On an unknown date, the patient administered BioThrax (Lot number: unknown, six doses of BioThrax between 2006 and 2007) for immunisation. It was reported that the patient received a total of six doses of BioThrax between 2006 and 2007. The patient had ongoing symptoms that attributes to prior BioThrax vaccination. No additional product details were available as National Drug Code (NDC), lot numbers, route of administration, dosage frequency, exact administration dates, or expiry dates. The patient experienced insomnia, which began after receiving the first BioThrax dose in 2006. He reported that since that time, he had "never slept more than four hours" per night. In 2007, he began noticing additional symptoms, including migraines associated with loss of hearing. He described these headaches as "hypertension migraines behind the ear," and further clarified that the sensation felt like pressure similar to an ear infection rather than a normal headache. The consumer stated that he began noticing his symptoms in 2009. The consumer reported additional ongoing symptoms, including anxiety, unbearable restless legs, and patient believed that central nervous system related problems related to BioThrax exposure. The patient had no other medical conditions aside from a history of Lyme disease during childhood. He reported having no known allergies and confirmed that he was not taking any medications. He further stated that he had not received any treatment for the symptoms described. No labs or imaging was reported. The patient was not recovered from reported events. Company comment: This case concerns a male patient of unknown age who experienced migraine headache (migraine), loss of hearing (deafness), anxiety, unbearable restless leg (restless legs syndrome), central nervous system related problems (nervous system disorder) and insomnia, following BioThrax administration for immunization. The event deafness has been assessed as serious (important medical event), and events migraine, anxiety, restless legs syndrome, nervous system disorder and insomnia have been assessed as non-serious. The report lacks information regarding latency, complete medical history, concomitant medication, treatment provided, complete clinical course of the events. The information in the case does not provide evidence to support a causal association between the drug and the events. Hence, the causality for these events is assessed as not related to BioThrax.; Sender's Comments: This case concerns a male patient of unknown age who experienced migraine headache (migraine), loss of hearing (deafness), anxiety, unbearable restless leg (restless legs syndrome), central nervous system related problems (nervous system disorder) and insomnia, following BioThrax administration for immunization. The event deafness has been assessed as serious (important medical event), and events migraine, anxiety, restless legs syndrome, nervous system disorder and insomnia have been assessed as non-serious. The report lacks information regarding latency, complete medical history, concomitant medication, treatment provided, complete clinical course of the events. The information in the case does not provide evidence to support a causal association between the drug and the events. Hence, the causality for these events is assessed as not related to BioThrax. More
2874159 60 M 11/21/2025 COVID19
 MODERNA
Computerised tomogram, Dental caries, Pain in extremity, Sinus perforation Computerised tomogram, Dental caries, Pain in extremity, Sinus perforation
The tooth pull created a puncture in the sinus; Tooth cavity; slightly sore arm; This spontaneous ca... The tooth pull created a puncture in the sinus; Tooth cavity; slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUS PERFORATION (The tooth pull created a puncture in the sinus) in a 60-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Concurrent medical conditions included Chronic disease (Got chronic, like some health conditions). In October 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 PAIN IN EXTREMITY (slightly sore arm). In 2025, the patient experienced SINUS PERFORATION (The tooth pull created a puncture in the sinus) (seriousness criterion medically significant) and DENTAL CARIES (Tooth cavity). The patient was treated with Cefuroxime sodium (Cefuroxime) in 2025 at an unspecified dose and frequency. At the time of the report, SINUS PERFORATION (The tooth pull created a puncture in the sinus), PAIN IN EXTREMITY (slightly sore arm) and DENTAL CARIES (Tooth cavity) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2025, Computerised tomogram: They took a CAT scan and said that because of the sinus puncture, there might be a mild infection, or at least there was air in the sinuses. The patient was not feverish and did not show signs of a sinus infection. Concomitant medication use information was not provided by reporter. The patient always received the Moderna Covid vaccine every year (usually around October). The patient always felt a slightly sore arm for about 24 hours after the Covid vaccine, including the most recent dose in October of 2024. No other symptoms were reported other than a slightly sore arm; the patient had been totally fine. It was also reported that the patient had a tooth pulled recently due to decay under a crown. The tooth pull created a puncture in the sinus, and as a result, the patient was started on an antibiotic. The patient experienced something called a sinus puncture when the tooth was pulled about a month and a half ago, so they had the patient on an antibiotic called Cefuroxime. The patient was not going to get sick because of it. The patient was able to get a flu shot two weeks ago, and that was no problem whatsoever. The patient had a cavity. They put a crown over it. Decay got under the crown. They removed the crown. They said the tooth could not be saved, so it had to be pulled. So, it was not like the patient was in pain. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: Company comment: Events sinus perforation and dental caries were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of the product is not affected by this report. More
2874160 M 11/21/2025 COVID19
 MODERNA
Swelling Swelling
experienced swelling, which made him very uncomfortable; This spontaneous case was reported by a con... experienced swelling, which made him very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (experienced swelling, which made him very uncomfortable) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced SWELLING (experienced swelling, which made him very uncomfortable). At the time of the report, SWELLING (experienced swelling, which made him very uncomfortable) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medications were not reported. It was reported that patient was looking at the Moderna advertisement for the Moderna mRNA shot. Patient hadn't had any vaccines for a couple of years as of 2021. When Moderna first came out, patient received the shot he experienced swelling, which made him very uncomfortable. It was reported that patient was considering another shot at his age, patient thought he should get the new mNexSpike vaccine. It was reported that patient was enquiring does mNexSpike still use mRNA technology. Treatment information was not reported. More
2874161 66 M MA 11/21/2025 COVID19
COVID19
COVID19
COVID19-2
COVID19-2
COVID19-2
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA


3053669
3053669
3053669
Decreased appetite, Dehydration, Fluid intake reduced, Nausea, Renal failure; Vo... Decreased appetite, Dehydration, Fluid intake reduced, Nausea, Renal failure; Vomiting; Dehydration, Nausea, Renal impairment, Vomiting; Decreased appetite, Dehydration, Fluid intake reduced, Nausea, Renal failure; Vomiting; Dehydration, Nausea, Renal impairment, Vomiting More
throwing up/throwing up, had a piece of toast, he threw that all up, throwing up his supper, anythin... throwing up/throwing up, had a piece of toast, he threw that all up, throwing up his supper, anything he put down, he was throwing it up; nauseous; dehydrated; his kidneys were not functioning; not eating; not drinking; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (throwing up/throwing up, had a piece of toast, he threw that all up, throwing up his supper, anything he put down, he was throwing it up), NAUSEA (nauseous), DEHYDRATION (dehydrated), RENAL FAILURE (his kidneys were not functioning), DECREASED APPETITE (not eating) and FLUID INTAKE REDUCED (not drinking) in a 66-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS. Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. Concurrent medical conditions included Crohn's disease and Benign meningioma. On 08-Nov-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 08-Nov-2025, the patient experienced VOMITING (throwing up/throwing up, had a piece of toast, he threw that all up, throwing up his supper, anything he put down, he was throwing it up) (seriousness criterion hospitalization), NAUSEA (nauseous) (seriousness criterion hospitalization), DEHYDRATION (dehydrated) (seriousness criterion hospitalization), RENAL FAILURE (his kidneys were not functioning) (seriousness criteria hospitalization and medically significant), DECREASED APPETITE (not eating) (seriousness criterion hospitalization) and FLUID INTAKE REDUCED (not drinking) (seriousness criterion hospitalization). The patient was hospitalized from 11-Nov-2025 to 13-Nov-2025 due to DECREASED APPETITE, DEHYDRATION, FLUID INTAKE REDUCED, NAUSEA, RENAL FAILURE and VOMITING. In November 2025, VOMITING (throwing up/throwing up, had a piece of toast, he threw that all up, throwing up his supper, anything he put down, he was throwing it up), NAUSEA (nauseous), DEHYDRATION (dehydrated), RENAL FAILURE (his kidneys were not functioning), DECREASED APPETITE (not eating) and FLUID INTAKE REDUCED (not drinking) had resolved. No concomitant medications provided by the reporter. The patient had all the Moderna shots since 2021. It was reported that the patient got the COVID shot on 08-Nov-2025 on Saturday and he was sick for Saturday night, Sunday night, Monday night, and Tuesday morning at 4am, the patient was admitted to the hospital. On 08-NOV-2025 the patient was throwing up all night, on 09-NOV-2025 the patient was throwing up, had a piece of toast, he threw that all up, throwing up his supper, anything he put down, he was throwing it up, and had nauseous. The patient was admitted to the hospital on 11-Nov-2025. He was dehydrated and his kidneys were not functioning. The hospital kept the patient for a couple days to watch his kidneys and give him fluids and medicine through an IV. Post vaccination the patient was throwing up, not eating, not drinking. It was reported that the patient would try to drink, he would throw everything all back up. The patient was just released yesterday. It was confirmed that the patient symptoms were now resolved. This case was linked to US-MODERNATX, INC.-MOD-2025-791435 (E2B Linked Report).; Reporter's Comments: Company comment: Underlying Crohn's disease and Benign meningioma are confounders for vomiting, nausea, decreased appetite and decreased fluid intake, which could have led to dehydration and renal failure. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-791435:Same reporter, wife case More
โœ“
2874162 72 F SC 11/21/2025 COVID19
 MODERNA
 3052034
Blood electrolytes, Blood pressure measurement, Haemophagocytic lymphohistiocyto... Blood electrolytes, Blood pressure measurement, Haemophagocytic lymphohistiocytosis, Serum ferritin More
HLH/Decreased blood pressure/Lethargy/Slight fever/Chills; This spontaneous case was reported by a c... HLH/Decreased blood pressure/Lethargy/Slight fever/Chills; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH/Decreased blood pressure/Lethargy/Slight fever/Chills) in a 72-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052034) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052034) for COVID-19 prophylaxis. Hypertension Herpes- genital I have previously had pneumonia and sepsis- twice since 2018. The patient's past medical history included Pneumonia (twice since 2018) in 2018 and Sepsis (twice since 2018) in 2018. Concurrent medical conditions included Hypertension and Herpes genital. On 11-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 19-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH/Decreased blood pressure/Lethargy/Slight fever/Chills) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Sep-2025 due to HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS. The patient was treated with Etoposide (oral use) ongoing since an unknown date at a dose of UNK, once a week; Dexamethasone sodium succinate (Dexamethasone) ongoing since an unknown date at a dose of 2 milligram and Heparin sodium (Heparin) at an unspecified dose and frequency. At the time of the report, HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH/Decreased blood pressure/Lethargy/Slight fever/Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Sep-2025, Blood electrolytes: not all normal. On 25-Sep-2025, Blood pressure measurement: 90/68. On 25-Sep-2025, Serum ferritin: elevated. The patient did not have any additional medical history, concomitant disease or risk factor. No concomitant medications were reported. It was reported that, since the first Covid vaccines the patient had been vaccinated regularly. Her usual reaction was a slight fever, and it resolved in 24 hours. That reaction started that way, but she never quite fell back to normal. A week later, she became sicker with chills and then decreased blood pressure and lethargy. On 23-Sep-2025, she went to the hospital emergency room and was sent home after a few hours. On 25-Sep-2025, she went to the hospital emergency Room for BP of 90/68, chills and lethargy. Her electrolytes were not all normal and her Ferratin was elevated. She was admitted with probable HLH. On Monday, 29-Sep-2025 after a bone marrow biopsy she was diagnosed with HLH. She was admitted to MICU. The prognosis was grave, but she got better after high dose IV steroids and Etoposide chemotherapy. She still had not recovered and still received dexamethasone 2 mg and PO Etoposide once a week. She was not back to her previous activity level but was walking a lot and working hard on recovery. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. The patient was treated with IV blood transfusions 3 times, heparin and various electrolytes.; Reporter's Comments: Hemophagocytic lymphohistiocytosis (HLH) is a rare disease caused by caused by genetic mutations, or triggered by factors like infections, cancer, or autoimmune disease, tus based on above the company assessed the event as not related to vaccine. The benefit-risk relationship of product is not affected by this report. More
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2874163 78 F PA 11/21/2025 COVID19
 MODERNA
Malaise, Nausea Malaise, Nausea
malaise; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MA... malaise; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 07-Nov-2025, 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 07-Nov-2025, the patient experienced MALAISE (malaise) and NAUSEA (nausea). In November 2025, MALAISE (malaise) and NAUSEA (nausea) had resolved. The patient's date of birth was reported. The patient had no medical history, concomitant disease or risk factor. No concomitant medications were reported. The patient had nausea, malaise and no fever. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. No treatment information was provided. More
2874164 40 F OR 11/21/2025 COVID19
 MODERNA
 3052784
Vaccination site rash, Vaccination site swelling Vaccination site rash, Vaccination site swelling
swelling at injection site; red rash at injection site; This spontaneous case was reported by a cons... swelling at injection site; red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE RASH (red rash at injection site) in a 40-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052784) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052784) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Nov-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 16-Nov-2025, the patient experienced VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE RASH (red rash at injection site). At the time of the report, VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE RASH (red rash at injection site) was resolving. The concomitant medication was not reported by the reporter. The patient had swelling and red rash at the injection site. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2874165 74 F 11/21/2025 COVID19
FLUX
 MODERNA
UNKNOWN MANUFACTURER

Fatigue, Inflammation, Rash pruritic, Skin discolouration; Fatigue, Inflammation... Fatigue, Inflammation, Rash pruritic, Skin discolouration; Fatigue, Inflammation, Rash pruritic, Skin discolouration More
inflammation; My skin turned really dark; Rash around my stomach/right around my waistline and groin... inflammation; My skin turned really dark; Rash around my stomach/right around my waistline and groin area/rash on my arms/ itching my body; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation), SKIN DISCOLOURATION (My skin turned really dark), RASH PRURITIC (Rash around my stomach/right around my waistline and groin area/rash on my arms/ itching my body) and FATIGUE (fatigue) in a 74-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 and non-company product included Influenza vaccine for an unknown indication. No Medical History information was reported. In 2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. In October 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced INFLAMMATION (inflammation), SKIN DISCOLOURATION (My skin turned really dark), RASH PRURITIC (Rash around my stomach/right around my waistline and groin area/rash on my arms/ itching my body) and FATIGUE (fatigue). At the time of the report, INFLAMMATION (inflammation), SKIN DISCOLOURATION (My skin turned really dark), RASH PRURITIC (Rash around my stomach/right around my waistline and groin area/rash on my arms/ itching my body) and FATIGUE (fatigue) outcome was unknown. The concomitant medication was not reported by the reporter. Patient received the flu vaccine 10 days before the Spikevax 2025-2026. The patient got the Moderna vaccine. She did not have any reaction, but a week later she developed a rash around her stomach. Her skin turned really dark. She wondered if it was from the injection. The patient had some inflammation. She was not certain and was not 100 percent sure that it was from that, but that was the only thing she could think of. She had right around her waistline and groin area. She itched her body. She had a rash on her arms. A week or 10 days before that, she had received the flu vaccine. She ended up going to a dermatologist because of the itching and the rash around her waist. She also felt fatigued. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2874166 79 M TX 11/21/2025 COVID19
 MODERNA
 ICD-10 Z23 CPT9
Asthenia, Body temperature, Chills, Headache, Pyrexia Asthenia, Body temperature, Chills, Headache, Pyrexia
weakness; 99๏ฟฝ fever; chills; headache; This spontaneous case was reported by a consumer and descri... weakness; 99๏ฟฝ fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PYREXIA (99๏ฟฝ fever), CHILLS (chills) and HEADACHE (headache) in a 79-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. ICD-10 Z23 CPT91323) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. ICD-10 Z23 CPT91323) for COVID-19 prophylaxis. No Medical History information was reported. On 17-Nov-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 18-Nov-2025, the patient experienced ASTHENIA (weakness), PYREXIA (99๏ฟฝ fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, ASTHENIA (weakness), PYREXIA (99๏ฟฝ fever), CHILLS (chills) and HEADACHE (headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2025, Body temperature: 99. Concomitant medications were not reported. Patient had 99๏ฟฝ fever, chills, headache, weakness. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. More
2874167 F 11/21/2025 COVID19
 MODERNA
Chest pain, Depressed mood, Eye pain, Neck pain, Pain in extremity Chest pain, Depressed mood, Eye pain, Neck pain, Pain in extremity
sad and preoccupied; a strong pain on her left side of the chest, part of her neck which extended to... sad and preoccupied; a strong pain on her left side of the chest, part of her neck which extended to her arm and hand / like her chest was breaking; a strong pain on her left side of the chest, part of her neck which extended to her arm and hand.; a strong pain on her left side of the chest, part of her neck which extended to her arm and hand.; something behind her left eye/like a pain behind the cornea; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (something behind her left eye/like a pain behind the cornea), CHEST PAIN (a strong pain on her left side of the chest, part of her neck which extended to her arm and hand / like her chest was breaking), NECK PAIN (a strong pain on her left side of the chest, part of her neck which extended to her arm and hand.), PAIN IN EXTREMITY (a strong pain on her left side of the chest, part of her neck which extended to her arm and hand.) and DEPRESSED MOOD (sad and preoccupied) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1) in 2021. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine. Concurrent medical conditions included Decreased immune responsiveness (low defenses). In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced EYE PAIN (something behind her left eye/like a pain behind the cornea). In 2024, the patient experienced CHEST PAIN (a strong pain on her left side of the chest, part of her neck which extended to her arm and hand / like her chest was breaking), NECK PAIN (a strong pain on her left side of the chest, part of her neck which extended to her arm and hand.) and PAIN IN EXTREMITY (a strong pain on her left side of the chest, part of her neck which extended to her arm and hand.). On an unknown date, the patient experienced DEPRESSED MOOD (sad and preoccupied). At the time of the report, EYE PAIN (something behind her left eye/like a pain behind the cornea), CHEST PAIN (a strong pain on her left side of the chest, part of her neck which extended to her arm and hand / like her chest was breaking), NECK PAIN (a strong pain on her left side of the chest, part of her neck which extended to her arm and hand.) and PAIN IN EXTREMITY (a strong pain on her left side of the chest, part of her neck which extended to her arm and hand.) had not resolved and DEPRESSED MOOD (sad and preoccupied) outcome was unknown. No concomitant medications provided by the reporter. It was reported that the patient had no issues with the first dose, but after the second dose almost immediately within five minutes after the vaccination the patient felt something was behind her left eye and then she felt like a pain behind the cornea. Then about a year ago the patient started to feel a strong pain on the left side of the chest, part of her neck which extended to her arm and hand. She went to the cardiologist for about a year now and the patient was sad and preoccupied. Because she has seen 2 types of doctors with whom they found nothing and most recently she was instructed to wear a heart monitor. The patient worked and on the other day she felt like her chest was breaking. It was reported that before getting the vaccine she rarely went to the doctor, except for routine checks but now she was going to the doctor all the time and this has her frustrated. No treatment medications provided by the reporter. More
2874168 11/21/2025 COVID19
 MODERNA
Cough, Fatigue, Illness, Myalgia, Rhinorrhoea Cough, Fatigue, Illness, Myalgia, Rhinorrhoea
sick; body aches; cough; runny nose; tired; This spontaneous case was reported by a consumer and des... sick; body aches; cough; runny nose; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), MYALGIA (body aches), COUGH (cough), RHINORRHOEA (runny nose) and FATIGUE (tired) in a patient of an unknown age and gender 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 14-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced ILLNESS (sick), MYALGIA (body aches), COUGH (cough), RHINORRHOEA (runny nose) and FATIGUE (tired). At the time of the report, ILLNESS (sick), MYALGIA (body aches), COUGH (cough), RHINORRHOEA (runny nose) and FATIGUE (tired) had not resolved. No concomitant medication was reported. The patient got a COVID-shot of Spikevax on 14-Oct-2025 and has been sick ever since, had body aches, cough, runny nose, and was tired. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. More
2874169 57 F NJ 11/21/2025 PNC20
 PFIZER\WYETH
 MA2506
Erythema, Peripheral swelling, Vaccination site erythema, Vaccination site swell... Erythema, Peripheral swelling, Vaccination site erythema, Vaccination site swelling More
possible cellulitis; reaction with erythema and swelling which spread to involve the whole left uppe... possible cellulitis; reaction with erythema and swelling which spread to involve the whole left upper arm; reaction with erythema and swelling which spread to involve the whole left upper arm; reaction with erythema and swelling which spread to involve the whole left upper arm; reaction with erythema and swelling which spread to involve the whole left upper arm; The initial case was missing the following minimum criteria: (No adverse effect). Upon receipt of follow-up information on (12Nov2025), this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP. A 57-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Oct2025 as dose 1, 0.5 ml single (Lot number: MA2506, Expiration Date: 31Oct2026) at the age of 57 years intramuscular for immunisation. The patient's relevant medical history included: "Sleep Apnea", start date: Jun2024 (unspecified if ongoing); "Overweight" (unspecified if ongoing). Concomitant medication(s) included: WEGOVY taken for overweight. The following information was reported: VACCINATION SITE CELLULITIS (medically significant) with onset 18Oct2025, outcome "recovering", described as "possible cellulitis"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 18Oct2025, outcome "recovering" and all described as "reaction with erythema and swelling which spread to involve the whole left upper arm". Therapeutic measures were taken as a result of vaccination site cellulitis, vaccination site erythema, vaccination site swelling, erythema, peripheral swelling. Treatment received for the adverse event included Keflex for possible cellulitis. On 30Oct2025, the patient still has residual redness. Causality for "possible cellulitis" and "reaction with erythema and swelling which spread to involve the whole left upper arm" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein). More
2874170 49 F PA 11/21/2025 COVID19
FLUX
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Pancreatitis acute; Pancreatitis acute Pancreatitis acute; Pancreatitis acute
acute pancreatitis; This is a spontaneous report received from a Consumer or other non HCP. A 49-ye... acute pancreatitis; This is a spontaneous report received from a Consumer or other non HCP. A 49-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 08Nov2025 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 08Nov2025 as dose number unknown, single for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PANCREATITIS ACUTE (hospitalization, life threatening) with onset 09Nov2025, outcome "not recovered", described as "acute pancreatitis". The patient was hospitalized for pancreatitis acute (hospitalization duration: 14 day(s)). Therapeutic measures were taken as a result of pancreatitis acute. 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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2874171 77 F FL 11/21/2025 COVID19
 PFIZER\BIONTECH
Body temperature, Chills, Pyrexia Body temperature, Chills, Pyrexia
Severe chills; severe 103 fever; This is a spontaneous report received from a Consumer or other non ... Severe chills; severe 103 fever; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 06Nov2025 at 02:30 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "variant angina" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "peripheral neuropathy" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "anemia" (unspecified if ongoing); "Allergy: bactrim" (unspecified if ongoing); "Allergy: iodine dyes" (unspecified if ongoing). Concomitant medication(s) included: ISOSORBIDE MONONITRATE; RANEXA [RIVAROXABAN]; VERAPAMIL; PLAVIX; SYNTHROID; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: CHILLS (non-serious) with onset 10Nov2025 at 21:00, outcome "recovered" (Nov2025), described as "Severe chills"; PYREXIA (non-serious) with onset 10Nov2025 at 21:00, outcome "recovered" (12Nov2025 at 21:00), described as "severe 103 fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia. Additional information: The patient didn't received any other vaccines on the same date as the vaccine(s) for which reporting and patient didn't received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which reporting. The Patient taking any other medications within 2 weeks of the event starting. Reported Event: Severe chills and 103 fever. Chills resolved within 24 hours, fever in 48 hours. Symptoms started a full 4 days after receiving vaccination. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2874173 F SC 11/21/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
that's probably when we had COVID before. This is our second COVID, and we had all the vaccines... that's probably when we had COVID before. This is our second COVID, and we had all the vaccines except for the very last one... And it was Pfizer.; an account created in Jan2024 was located for her, x stated, " Okay, that's probably when we had COVID before.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 81-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "that's probably when we had COVID before. This is our second COVID, and we had all the vaccines except for the very last one... And it was Pfizer."; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "an account created in Jan2024 was located for her, x stated, " Okay, that's probably when we had COVID before.". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: During an inbound transfer from the Pfizer dedicated support team, the Pfizer agent, (name), stated, "I do have a patient on my back line, she has questions regarding Paxlovid. From what it sounds like she's already got her medication, and she already paid for it at the pharmacy." The patient was then transferred to [withheld] for reimbursement assistance. Once the call was transferred, the patient, (name), stated, " I am on Paxlovid My husband and I both have, we both have COVID, and he probably got it a couple of days before I did. So, I'm assuming I caught it from him. Then we didn't test, until it was Thursday of last week, I believe, and when we tested, we both tested positive. So, then we called our doctor and told them, you know, that we had COVID, and they called in a prescription We go to different doctors. So, his doctor called his in and my doctor called mine in. Well, he went to the pharmacy and got his Then it was several hours later, and the pharmacy called me, and they said that they were out of it when my doctor sent my prescription in ... So finally, they got it filled, and I went to pick it up and when I picked it up, they charged me dollar 47. When asked for the date her medication was purchased, (name) stated " Yes, it was on November the 6th." After advising that an enrollment would need to be completed, (name) stated," Does this mean, I would have to take more Paxlovid if I get sicker or don't get well?" After advising of the options for enrollment, (name) stated, " I don't really feel well enough to answer questions for 25 minutes." When assisting (name) locate the online enrollment form, (name) stated, " My brain's not working" After advising (name) that an account created in Jan2024 was located for her, (name) stated, " Okay, that's probably when we had COVID before. This is our second COVID, and we had all the vaccines except for the very last one. And it was Pfizer. You probably have information on me because we've we had the Pfizer vaccine, my husband and I." When offered to be transferred to the Drug Safety Unit, (name) stated, " Well, I think it's working, we're better. Okay, I will. I'm about worn out now, though, but it won't be much longer." (name) continued to state,". I started out with a sore throat, but my husband, he didn't have a sore throat, and he doesn't have one now. But I've still got a terrible sore throat. My throat is very red." After transferring to the Drug safety Unit (name) stated, "just pray for us to get well and this Paxlovid to work."Note to DSU: This source document contains events for two patients (name) and her husband. During this source call only (name) full name, date of birth, phone number, gender and zip code were verbally confirmed. (name) demographic information as well as the prescriber information was obtained from a previous online enrollment created on 31Jan2024. However, it was not confirmed if the prescriber listed is the current prescribing doctor for (name). During this source call it was confirmed that both patients do not share the same doctor. The only information for the second patient verbally provided during this call was (name) husband's gender. It was not confirmed if both of the patient's share any of the same demographic information. This call was warm transferred to Pharmacist (name) with the Pfizer Drug Safety, reference number #. However, the reportable safety information provided to Pharmacist (name) was incorrect. Sending this source document to provide clarity on interaction: This is a two-person event for (name) and her husband. Both patients have COVID again, taken Paxlovid previously, also mentioned taking the Pfizer vaccines but missed one of the vaccines. The information on the batch/lot number for BNT162B2 OMI XBB.1.5 will be requested and submitted if and when received. More
2874174 F SC 11/21/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
Okay, that's probably when we had COVID before. We had all the vaccines except for the very las... Okay, that's probably when we had COVID before. We had all the vaccines except for the very last one... And it was Pfizer.; Okay, that's probably when we had COVID before. We had all the vaccines except for the very last one... And it was Pfizer.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 79-year-old female patient 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: Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Okay, that's probably when we had COVID before. We had all the vaccines except for the very last one... And it was Pfizer.". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was on Paxlovid. Her husband and patient both have, they both have COVID, and he probably got it a couple of days before patient did. So patient was assuming she caught it from him. Then they didn't test, until it was Thursday of last week, she believe, and when we tested, we both tested positive. So, then we called our doctor and told them, you know, that we had COVID, and they called in a prescription. We go to different doctors. So, his doctor called his in and her doctor called in. Well, he went to the pharmacy and got his. Then it was several hours later, and the pharmacy called her, and they said that they were out of it when her doctor sent her prescription in. So finally, they got it filled, and she went to pick it up and when she picked it up, they charged her dollar 47. When asked for the date her medication was purchased, stated Yes, it was on 06Nov. After advising that an enrollment would need to be completed, (withheld) stated, Does this mean, she would have to take more Paxlovid if she get sicker or don't get well. After advising of the options for enrollment, (withheld) stated, she don't really feel well enough to answer questions for 25 minutes. When assisting (withheld) locate the online enrollment form, (withheld) stated, "her brain's not working" After advising (withheld) that an account created in Jan2024 was located for her, (withheld) stated, " Okay, that's probably when we had COVID before. This is our second COVID, and we had all the vaccines except for the very last one. And it was Pfizer. You probably have information on me because we've we had the Pfizer vaccine, she and her husband. When offered to be transferred to the Drug Safety Unit, (withheld) stated, " Well, she thought it's working, we're better. Okay, she will. She was about worn out now, though, but it won't be much longer." (withheld) continued to state," she started out with a sore throat, but her husband, he didn't have a sore throat, and he doesn't have one now. But she had still got a terrible sore throat. This is a two-person event for (withheld) and her husband. Both patients have COVID again, taken Paxlovid previously, also mentioned taking the Pfizer vaccines but missed one of the vaccines. The information on the batch/lot number for (BNT162B2 OMI XBB.1.5) will be requested and submitted if and when received. More
2874175 M 11/21/2025 COVID19
 PFIZER\BIONTECH
Colonoscopy, Condition aggravated, Eczema, Pyrexia, Weight Colonoscopy, Condition aggravated, Eczema, Pyrexia, Weight
fever of 98.8; flare up of eczema with red, dry itchy skin; flare up of eczema with red, dry itchy s... fever of 98.8; flare up of eczema with red, dry itchy skin; flare up of eczema with red, dry itchy skin; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA157683 (Sanofi), AE-021598 (BioNTech). A 17-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Scar" (unspecified if ongoing), notes: when patient was an infant; "eczema severe" (ongoing), notes: sometimes better, sometimes worse, face dry, used lotion, now redness on forehead, skin around eyes; "small intestine obstruction/small bowel obstruction", start date: Apr2025, stop date: 2025, notes: hospitalization for 1 week for small intestine obstruction from scar tissue, took pain medicines; "hospitalization "having symptoms again"" (unspecified if ongoing), notes: 1 week after discharge home, admitted for about 6 days for monitoring, no surgery was required; "urinary tract infection", start date: 2025 (unspecified if ongoing), notes: catheter in hospital, took antibiotics for 7 days at home, bowel fine; "urinary symptoms came back" (unspecified if ongoing), notes: 1-2 week after antibiotics done, again took antibiotics 7 days, better now; "cold", "runny nose", "stuffy nose/ congestion", "sore throat", start date: May2025 (unspecified if ongoing), notes: primary care medical doctor (MD) gave inhaler, latency: approximately 2 months; "redness on forehead, skin around eyes/ red skin", start date: 2025 (unspecified if ongoing); "face dry/dry skin", start date: 2025 (unspecified if ongoing), notes: used lotion; "patient was not gaining weight since procedure", start date: 2025 (unspecified if ongoing), notes: prescribed cyproheptadine for appetite stimulant due to no weight gain; "hospitalized 2 more times since surgery" (unspecified if ongoing), notes: Most recently hospitalization 2 weeks ago (Jul2025) to monitor bowel prep for endoscopies; "upper and lower endoscopy" (unspecified if ongoing), notes: Admitted for 5-6 days for preparation of planned colonoscopy and colonoscopy because of low weight; "low weight", start date: 2025 (unspecified if ongoing); "allergy to pet dander" (unspecified if ongoing), notes: they had cats; "skin was clear completely while in the hospital 2 weeks ago but now that he is home started to have a moderate breakout/ flare up of eczema", start date: 05Aug2025 (unspecified if ongoing), notes: since returning home; "a moderate breakout", start date: 05Aug2025 (unspecified if ongoing), notes: since returning home; "skin is very dry and flaky", start date: 2025 (unspecified if ongoing). Concomitant medication(s) included: MENINGOCOCCAL VACCINE taken for immunisation, on 01Oct2025 as dose number unknown, single; INFLUENZA VACCINE taken for immunisation, on 01Oct2025 as dose number unknown, single; DUPIXENT subcutaneous taken for dermatitis atopic, start date: Mar2025. The following information was reported: PYREXIA (non-serious) with onset 02Oct2025, outcome "unknown", described as "fever of 98.8"; CONDITION AGGRAVATED (non-serious), ECZEMA (non-serious) all with onset Oct2025, outcome "not recovered" and all described as "flare up of eczema with red, dry itchy skin". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of condition aggravated, eczema. Additional information: The patient's mom reported the patient has taken DUPIXENT late a couple of time by one or two days (dates unknown) because he forgot to take the dose. No adverse events reported related to missed doses. The patient's mom reported the patient has flare up of eczema with red, dry itchy skin that started about 3 days ago (as reported) and was ongoing. The patient's mom reported the patient had meningitis, COVID, and influenza vaccines on 01Oct2025, and on 02OCt2025, he had a fever of 98.8, the patient was using tacrolimus topically for eczema flare up. Medical doctor was aware of hospitalizations, not aware of late doses, flare up and fever. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2874184 42 F 11/21/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 410515
410515
Ear discomfort, Hypoacusis, Malaise, Nausea, Nervousness; Pain Ear discomfort, Hypoacusis, Malaise, Nausea, Nervousness; Pain
Difficulty hearing; Wasn't feeling great; Headache; Feeling a little bit achy; Nauseous; Might ... Difficulty hearing; Wasn't feeling great; Headache; Feeling a little bit achy; Nauseous; Might be affecting the nerves; Very nervous; Difficulty with my ears, they were feeling clogged, or like full; This spontaneous case, initially received on 10-Nov-2025, was reported by a non-health professional and concerns an adult female patient. Concomitant medication: refer to appropriate report section. Historical vaccines included Flu shot (reaction: soreness in my arm). Administration of company suspect drug: On 06-Nov-2025, the patient received Flucelvax (TIV) for Indicated for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: 410515. No additional suspect drugs. Adverse reactions/events and outcomes: On 07-Nov-2025, 1 day after vaccination, the patient experienced Difficulty with my ears, they were feeling clogged, or like full (outcome: Not recovered / Not resolved), Wasn't feeling great (outcome: Not recovered / Not resolved), Headache (outcome: Not recovered / Not resolved), Feeling a little bit achy (outcome: Not recovered / Not resolved), Nauseous (outcome: Not recovered / Not resolved), Might be affecting the nerves (outcome: Not recovered / Not resolved), Very nervous (outcome: Not recovered / Not resolved). On 08-Nov-2025, 2 days after vaccination, the patient experienced Difficulty hearing (outcome: Not recovered / Not resolved). The patient reported that she was calling to report a medical reaction to the flu vaccine that she received. She received the flu vaccine at her local pharmacy on Thursday (06-Nov-2025). On Friday (07-Nov-2025) she woke up, and she was not feeling great she had a headache, she was feeling a little bit achy and nauseous, almost like she has a type of the flu, but nothing crazy, it was taking easy. By that night, that evening on Friday, she was having difficulty with her ears, they were feeling clogged, or like full, and by Saturday she woke up and she had difficulty hearing, so she went directly to the ear, nose, and throat (ENT) to get her ears checked and there was nothing going on in her ears at all, they look completely healthy, she had no history of any ear issues, but she was experiencing some hearing issues then, after having the vaccine. And she was on her way right then to the doctor again to get a hearing exam. They put her on a high dose of steroid to try to mitigate whatever was going on. It appeared like reacting poorly to the vaccine and it might be affecting the nerves instead of her ears. She did speak with the pharmacy and they said they did report it also, but she wanted to make sure she was calling because this was really distressing for her. She literally never experienced any issues ever, with her ears, she had the flu shot every year. She never had a reaction to a flu shot before, never. The only reaction she had ever had in her life was like soreness in her arm, that was it. She also mentioned that she would really appreciate someone calling her because she was really very nervous. She did not know what was going on, she wanted to know if other people were experiencing this issue, and she wanted to make sure that the treatment she was receiving was adequate. The only medication she was taking was Minoxidil 2.5mg a day. She was healthy, she did not take any medications, she did not have a history of any medical issues, never had any hearing issues in her life, nothing at all. They were having her on a steroid, 60mg for 10 days and then she tapered it off, that was it, there was nothing else she could do right then, and she was going to get the hearing test and see what says. There was nothing else to report. Flucelvax (TIV) action taken: Not Applicable Treatment medication: unspecified steroids Reporter's assessment: The reporter assessed the events (Difficulty with my ears, they were feeling clogged, or like full, Wasn't feeling great, Headache, Feeling a little bit achy, Nauseous, Might be affecting the nerves, Very nervous, Difficulty hearing) as non-serious and causality assessment was not provided.; Reporter's Comments: Due to the spontaneous nature of the case, the events (Difficulty with my ears, they were feeling clogged, or like full, Wasn't feeling great, Headache, Feeling a little bit achy, Nauseous, Might be affecting the nerves, Very nervous, Difficulty hearing) are considered related for reporting purposes More
2874185 31 M CA 11/21/2025 COVID19
 MODERNA
 8146545
Dizziness, Feeling abnormal, Syncope Dizziness, Feeling abnormal, Syncope
Patient received the vaccine and stated he was feeling a little "off" afterwards and a lit... Patient received the vaccine and stated he was feeling a little "off" afterwards and a little lightheaded. Patient wen on with day after some rest and the proceeded to have a syncopal episode with slow recovery. More
2874186 15 M RI 11/21/2025 COVID19
 MODERNA
 3052860
Underdose Underdose
Patient is 15 years old and received COVID vaccine dose meant for patients 6 months- 11 years. Spoke... Patient is 15 years old and received COVID vaccine dose meant for patients 6 months- 11 years. Spoke to State Vaccine Unit. No concerns. Advised getting 12+ dose in 8 weeks from 11/15/25. More
2874218 20 M IL 11/21/2025 COVID19
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 8146670
5r4cy
Dry throat, Headache, Throat irritation; Dry throat, Headache, Throat irritation Dry throat, Headache, Throat irritation; Dry throat, Headache, Throat irritation
scratchy/dry throat every day and headaches lasting roughly 30 minutes every 3-4 hours daily since g... scratchy/dry throat every day and headaches lasting roughly 30 minutes every 3-4 hours daily since getting these vaccines More
2874219 67 M ME 11/21/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SEQIRUS, INC.
SEQIRUS, INC.
 MY9J48 or M49J4
MY9J48 or M49J4
407255
407255
Aura, Blindness unilateral, Blood test, Cerebrovascular accident, Computerised t... Aura, Blindness unilateral, Blood test, Cerebrovascular accident, Computerised tomogram; Hemiparesis, Magnetic resonance imaging head abnormal, Typical aura without headache, Ultrasound scan; Aura, Blindness unilateral, Blood test, Cerebrovascular accident, Computerised tomogram; Hemiparesis, Magnetic resonance imaging head abnormal, Typical aura without headache, Ultrasound scan More
- On 10/2, I had about a 3 minute visual aura that some people get with migraine headaches. I had p... - On 10/2, I had about a 3 minute visual aura that some people get with migraine headaches. I had previously had about 5 of these "migraines without the headache" or "silent migraines" in my life - By 10/7, I had had an additional 4 or 5 of these silent migraines. - On 10/8, I saw an ophthalmologist who dilated and checked my eyes thoroughly and said everything looked fine. - On 10/9, I woke up and felt weak in my right leg and right arm and could not see out my right eye for a few minutes. I went to the ER and was admitted for a stroke (2 days in the hospital). - I am being treated with Clopidogrel (75mg), aspirin (81mg), and atorvastatin (80mg). - I have no visible deficits from this stroke. More
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2874222 60 F VA 11/21/2025 COVID19
 PFIZER\BIONTECH
 NA0590
Injection site bruising, Injection site haemorrhage, Injection site inflammation... Injection site bruising, Injection site haemorrhage, Injection site inflammation, Nervousness More
Patient consulted with me (PharmD) prior to receiving vaccine to confirm it would be safe to receive... Patient consulted with me (PharmD) prior to receiving vaccine to confirm it would be safe to receive the covid vaccine after having corticosteroid injection on Monday for tendonitis in the right arm. She stated that the orthopedics office administering the corticosteroid said it would be fine due to and I confirmed, as well as advised administering in the opposite arm of steroid injection. Patient received the vaccine via trained and certified pharmacy technician. She had a bit more bleeding than typically expected after vaccine. I also noticed slight inflammation at the site of injection and a small bruise. The bleeding stopped fairly quick with pressure. I reviewed all signs and symptoms of anaphylaxis and the patient denied any of the signs/symptoms (no shortness of breath, difficulty breathing or swallowing). She stated that she primarily felt nervous but was not sweating, did not state she was experiencing dizziness, or feel clammy/jittery. I cleaned the patient's arm with warm water, applied a cold compress, and monitored the patient for 15 minutes. I re-iterated that we had followed all protocol at administering the vaccine properly and that a small capillary in her arm may have triggered the bleeding and site injection. I informed her that I follow up with her primary care physician, as well as document within VAERS. I also let her know that I would be contacting her over the weekend to confirm how she was doing afterwards. I instructed her to take nsaids/acetaminophen for the site reaction and call EMS or report to urgent care/ER if anything changed. More
2874228 17 M CA 11/21/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
 00069-2528-10
00069-2528-10
49281-0725-10
49281-0725-10
Blood test, Computerised tomogram normal, Crying, Headache, Immediate post-injec... Blood test, Computerised tomogram normal, Crying, Headache, Immediate post-injection reaction; Lumbar puncture normal, Magnetic resonance imaging, Malaise, Pyrexia; Blood test, Computerised tomogram normal, Crying, Headache, Immediate post-injection reaction; Lumbar puncture normal, Magnetic resonance imaging, Malaise, Pyrexia More
Patient received the vaccine on Sunday, 10/26/25, and immediately began to complain of a headache an... Patient received the vaccine on Sunday, 10/26/25, and immediately began to complain of a headache and a low-grade fever. Over the course of the next couple days, patient continued to complain about his head hurting. We treated the headache with Advil and Tylenol. Over the weekend he continued to complain about the headache, and I said to him that I would take him to the doctor Monday morning if he still didn?t feel well. In the middle of the night on Sunday, early Monday morning (11/3@3am), patient came in crying that he had a terrible headache. This persisted so long that his father took him to the emergency department. They they tested him with a CT scan and three lumbar punctures (2 were unable to draw enough CSF) to determine if he had meningitis. Patient did not have meningitis, and was released. His headache persisted such that on Thursday. November 6, patient was admitted to the emergency department and ultimately to the hospital for 2 nights. He had an MRI and another lumbar puncture. Today is November 21, and patient continues to have headaches in which the pain ranges from a 3-8 out of 10. We are currently under the care of a pediatric neurologist. More
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2873717 47 M TX 11/20/2025 COVID19
 PFIZER\BIONTECH
Dizziness, Fall Dizziness, Fall
Dizziness, Falls x 2 Dizziness, Falls x 2
2873730 61 F IN 11/20/2025 UNK
 UNKNOWN MANUFACTURER
 406999
Chills, Erythema, Pain, Tenderness Chills, Erythema, Pain, Tenderness
Local tenderness after taking the vaccine; Redness after taking the vaccine; Pain after taking the v... Local tenderness after taking the vaccine; Redness after taking the vaccine; Pain after taking the vaccine; Chills; This spontaneous case, initially received on 06-Nov-2025, was reported by a non health professional and concerns an adult female patient. Concomitant Medications: Unknown Medical History: Unknown Administration of company suspect drug: On 05-Nov-2025, the patient received Flucelvax (TIV) for Influenza prophylaxis, Dose regimen: 0.5 ml, route of administration: other, specified as PFS (pre-filled syringe), anatomical location: not reported, Lot number: 406999. No additional suspect drugs. Adverse reactions/events and outcomes: On 05-Nov-2025, the patient experienced Local tenderness after taking the vaccine (outcome: Unknown), Redness after taking the vaccine (outcome: Unknown), Pain after taking the vaccine (outcome: Unknown), Chills (outcome: Unknown). The consumer reported having received a Flucelvax shot on 05-Nov-2025. The patient stated that right before the healthcare professional was about to administer the vaccine, there had been something in a very small bottle from which some fluid was withdrawn, and this was not documented on the patient's visit summary. The patient inquired what that liquid could have been and whether that was normal procedure, since Flucelvax comes in a pre-filled syringe. The caller stated that she had been in contact with the clinic, but they had not called her back. The patient mentioned having experienced some local tenderness, redness and pain, and some chills, but nothing serious after taking the vaccine. Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with the event was reported as unknown Reporter's assessment: The reporter considered the events as non serious and did not provide the causality assessment.; Reporter's Comments: The events are related due to chronological plausibility. More
2873732 76 F AZ 11/20/2025 COVID19
 PFIZER\BIONTECH
Dizziness, Injection site pain, Nausea, Pyrexia, Syncope Dizziness, Injection site pain, Nausea, Pyrexia, Syncope
Nausea fever dizziness sore at injection site fainting Nausea fever dizziness sore at injection site fainting
2873796 57 M MN 11/20/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052784
410514
Pruritus, Rash; Pruritus, Rash Pruritus, Rash; Pruritus, Rash
Client reported rash on his wrists and ankles for 3-4 days beginning the day he received the vaccine... Client reported rash on his wrists and ankles for 3-4 days beginning the day he received the vaccine. He had this before but not as severe. Recommended he discuss this with his PCP, get his vaccines at his PCP, and notify the vaccinator. He did not take anything for the "itching". More
2873797 9 F NJ 11/20/2025 COVID19
 MODERNA
 3052586
Incorrect dose administered Incorrect dose administered
Patient received Covid Spikevax for 12+ yo dosage instead of the 11 and under dosage. Provider follo... Patient received Covid Spikevax for 12+ yo dosage instead of the 11 and under dosage. Provider followed up with parents and patient is doing well and has experienced no side effects. More
2873803 71 F MD 11/20/2025 FLU3
FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 U8862BA
U8862BA
U8862BA
Areflexia, CSF glucose increased, CSF protein increased, CSF white blood cell co... Areflexia, CSF glucose increased, CSF protein increased, CSF white blood cell count negative, Cervical spinal stenosis; Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal; Muscular weakness, Paraesthesia, Spinal osteoarthritis More
Gullain Barre Syndrome. Vaccinated 11/3/25, developed bilateral lower extremity numbness and tingli... Gullain Barre Syndrome. Vaccinated 11/3/25, developed bilateral lower extremity numbness and tingling 11/14/25, presented 11/17/25 to the emergency department. Exam consistent with GBS bilateral lower extremity weakness 4/5 diffusely with decreased light touch from the knees distally and absent reflexes. Started IVIG on 11/19 following LP. Worsening weakness on 11/20, upgraded to ICU stepdown. More
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2873805 10 F 11/20/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 MY9547
TFAA2537
Incorrect dose administered, No adverse event; Incorrect dose administered, No a... Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event More
No adverse events or treatments needed. Patient was given dose for 12 and over. No adverse events or treatments needed. Patient was given dose for 12 and over.
2873806 1.25 F NC 11/20/2025 COVID19
DTAPHEPBIP
FLU3
HIBV
PNC15
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 3052579
5G5S2
5R4CY
Z007710
Z009838
Condition aggravated, Eczema, Wrong product administered; Condition aggravated, ... Condition aggravated, Eczema, Wrong product administered; Condition aggravated, Eczema, Wrong product administered; Condition aggravated, Eczema, Wrong product administered; Condition aggravated, Eczema, Wrong product administered; Condition aggravated, Eczema, Wrong product administered More
Patient was in for their 15 month well visit and was ordered to receive Dtap (Infanrix). The patient... Patient was in for their 15 month well visit and was ordered to receive Dtap (Infanrix). The patient was given Pediarix (Dtap, hep B, IPV) instead. This error was found on 11/18/25 during a routine vaccine audit. Provider, nurse, and parent notified. Mom stated child did not have any more of a reaction than usual, maybe just a little fussier and wanting to nurse more, but she thought it was due to receiving 5 injections at the visit. Mom also noticed her eczema had flared after vaccines. More
2873807 16 M WA 11/20/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA4452
U8864AA
Blindness transient, Deafness, Malaise, Syncope; Blindness transient, Deafness, ... Blindness transient, Deafness, Malaise, Syncope; Blindness transient, Deafness, Malaise, Syncope More
PT MENTIONED HE DIDN'T FEEL WELL SO I WAS GOING TO GET A CHAIR AND MOVE IT CLOSER WHEN HE START... PT MENTIONED HE DIDN'T FEEL WELL SO I WAS GOING TO GET A CHAIR AND MOVE IT CLOSER WHEN HE STARTED TO COLLAPSE. THE DAD HAD MOVED CLOSE AND SLOWED DOWN THE DESEND AND WE MANAGED TO GET THE SON ON THE RED STOOL WITH WHEELS BECAUSE IT WAS THE CLOSEST. TECHNICIAN CALLED PHARMACIST ON DUTY WHO CAME OVER. TECHNICIAN GOT PT TO TAKE A SIP OF WATER AND FOUND OUT HE HAD EATEN BREAKFAST BUT NOT LUNCH. PT SAID HE LOST SIGHT AND SOME HEARING. AS TIME PASSED, PT WAS ABLE TO EAT A BITE OF CHOCOLATE AND HE STARTED TO FEEL BETTER. TECHNICIAN LEFT FOR A MOMENT AND THEN PATIENT WAS IN THE MORE STABLE CHAIR UNTIL HE WAS FEELING WELL ENOUGH TO LEAVE. More
2873813 1.33 M MA 11/20/2025 COVID19
 MODERNA
 3052668
Incorrect dose administered Incorrect dose administered
patient received the wrong dose of vaccine. he should have received the Moderna Spikevax 6month -11y... patient received the wrong dose of vaccine. he should have received the Moderna Spikevax 6month -11years More
2873815 51 F PA 11/20/2025 COVID19
COVID19
COVID19
FLU3
FLU3
FLU3
 MODERNA
MODERNA
MODERNA
SEQIRUS, INC.
SEQIRUS, INC.
SEQIRUS, INC.
 3052864
3052864
3052864
407010
407010
407010
Arthralgia, Chills, Dyspepsia, Fatigue, Headache; Injection site pain, Injection... Arthralgia, Chills, Dyspepsia, Fatigue, Headache; Injection site pain, Injection site swelling, Myalgia, Nausea, Pain; Productive cough; Arthralgia, Chills, Dyspepsia, Fatigue, Headache; Injection site pain, Injection site swelling, Myalgia, Nausea, Pain; Productive cough More
moderate pain and swelling at injection site; moderate chills, muscle aches, joint/body aches, moder... moderate pain and swelling at injection site; moderate chills, muscle aches, joint/body aches, moderate headache, nausea/indigestion, severe fatigue for 2-3 days after vaccines; also developed chronic productive cough for about a week since getting vaccines More
2873816 36 M AL 11/20/2025 COVID19
COVID19
 NOVAVAX
NOVAVAX
 RS-AD26
RS-AD26
Chronic inflammatory demyelinating polyradiculoneuropathy, Endotracheal intubati... Chronic inflammatory demyelinating polyradiculoneuropathy, Endotracheal intubation, Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care; Laboratory test abnormal, Magnetic resonance imaging, Neuritis, Respiratory failure More
COVID-19 (JANSSEN), VECTOR-NR, RS-AD26, PF, 0.5 ML - I was diagnosed with GBS about 12 weeks after g... COVID-19 (JANSSEN), VECTOR-NR, RS-AD26, PF, 0.5 ML - I was diagnosed with GBS about 12 weeks after getting the Janssen vaccine. I spent 6 days in ICU intubated due to lung failure and another 12 days in the hospital. I continue to get IVIG regularly for CIDP to this day (nearly 4 days later. There was no drop down for the Johnson and Johnson vaccine, so I added the information in this box. More
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2873817 74 F MN 11/20/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA4457
U8859DA
Fatigue, Headache, Magnetic resonance imaging head, Mobility decreased, Muscular... Fatigue, Headache, Magnetic resonance imaging head, Mobility decreased, Muscular weakness; Fatigue, Headache, Magnetic resonance imaging head, Mobility decreased, Muscular weakness More
Patient start to experience severe fatigue and an episode of immobility the evening after receiving ... Patient start to experience severe fatigue and an episode of immobility the evening after receiving injections. She describes as feeling paralyzed. She was unable to move her body, including her legs, which felt as if they were glued together. She could open her eyes but could not move. This sensation persisted even after she fell back asleep and woke up again. Upon waking the next morning, she was able to slowly regain mobility in her legs and arms, although they felt weak and rubbery. She managed to get out of bed and sit on the toilet, where she gradually regained strength. It took a couple of hours (approximately 3) for her to feel normal again. Since then, she has been feeling constantly tired and has experienced several headaches More
2873822 58 M MI 11/20/2025 COVID19
COVID19
 MODERNA
MODERNA
 3053777
3053777
Arthralgia, Back pain, Joint stiffness, Musculoskeletal stiffness, Pain in extre... Arthralgia, Back pain, Joint stiffness, Musculoskeletal stiffness, Pain in extremity; Pyrexia More
Patient reported that about 9 hours after receiving Mnexspike, he reached a fever of 103.5 degrees F... Patient reported that about 9 hours after receiving Mnexspike, he reached a fever of 103.5 degrees Fahrenheit (which has remain elevated between there and 102 degrees Fahrenheit), tenseness in his joints and muscles, pain down his back/hips/legs, stiffness in his neck and back, and nausea to the point where he can't keep down food and can only drink water. More
2873824 65 F WA 11/20/2025 COVID19
FLU3
 MODERNA
SEQIRUS, INC.
 3052583
AX5812A
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Given Afluria instead of adjuvanted Fluad as indicated by age of 65 Given Afluria instead of adjuvanted Fluad as indicated by age of 65
2873830 30 F 11/20/2025 COVID19
 MODERNA
 3052733
Syncope Syncope
vasovagal syncope vasovagal syncope
2873833 18 F CO 11/20/2025 COVID19
 MODERNA
 3052741
Pruritus, Urticaria Pruritus, Urticaria
COVID vaccine administered at approximately 3:05 P.M in left deltoid by RN. Pt observed for 5 minute... COVID vaccine administered at approximately 3:05 P.M in left deltoid by RN. Pt observed for 5 minutes post vaccination, client denied symptoms at this time. Client and RN observed hives in left arm around vaccination site approximately 10 minutes after vaccination. Client reports generalized itchiness but denies other associated symptoms. Pt took one Benadryl tablet, that she carries on her person, at onset of hives. Pt reports that this reaction is "normal" for her condition after exposure to many things, sometimes unidentifiable at the time of hive onset. Had RN and another observe pt and consulted care. Discussed with patient to contact provider if symptoms worsen and 911 if symptoms become severe and encouraged her to stay in department for observation for another 20 min. At 3:35p, 30 min post vaccination RN observed slight spreading of hives to back of neck and chest. Client still reports mild itchiness but denies dizziness, SOB, swelling of tongue, mouth or face. Due to other medical conditions, it was determined that this is a normal reaction for client with exposure to many things and it was decided that it was safe for patient to leave. Client walked to car by this RN. More
2873845 48 F IL 11/20/2025 COVID19
COVID19
 MODERNA
MODERNA
 8146751
8146751
Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Loss of pe... Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain; Pain in extremity, Paraesthesia More
The patient is a 48-year-old female presenting for evaluation of left arm pain that began after rece... The patient is a 48-year-old female presenting for evaluation of left arm pain that began after receiving a COVID-19 vaccination approximately two weeks ago. - She reports the injection itself was unusually painful, which she has not experienced with prior vaccinations. - The pain progressed throughout the day, and for the first 2-3 days post-vaccination, she experienced severe pain that made it difficult to lift her arm, wash her hair, or take off her shirt. - While the initial severe pain has lessened, she continues to experience a constant ache and jolting pain with certain movements, such as reaching forward. - She also reports intermittent sensations of her arm falling asleep and some tingling, though this has improved. - Symptoms were exacerbated over the weekend by carrying grocery bags. - She has been taking Advil, which provides some relief. - She denies any fevers, redness, or swelling at the injection site. - She denies any other injury, exercise, or workout around the time of the vaccine that could account for these symptoms. - She has never had a similar reaction to a vaccine before. More
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