Source: VAERS.HHS.GOV
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
epilepsy has returned in massive form; This is a spontaneous report received from a contactable reporter(s)(Consumer or other non HCP). The reporter is the patient. A 8 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left (Batch/Lot number: unknown) at the age of 8 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Brain tumour removed age 1 (choroid plexus papalloma), epilepsy, adhd, moderate intellectual disability, gdd" (unspecified if ongoing); "epilepsy" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "moderate intellectual disability" (unspecified if ongoing), notes: Global Developmental Delay (gdd). Concomitant medication(s) included: KEPPRA [LEVETIRACETAM]; CLOBAZAM. The following information was reported: EPILEPSY (medically significant) with onset 29Nov2021, outcome "not recovered", described as "epilepsy has returned in massive form". The event "epilepsy has returned in massive form" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of epilepsy. Clinical course: The patient was epileptic, he was 3yrs seizure free due to epilepsy surgery in 2019. He took the first shot 3 days later seizures returned for about 3-4 weeks then it settled out and none again for 4-5 weeks. Note massively increased his meds to stop the seizures as several were quite severe. At week 9 or so they went for the next Covid shot and 4 days later boom same thing his epilepsy has returned in massive form. He's having a tone of seizures. There appears to be correlation between the seizures starting just after he got both shots. There was seen two possibilities either the shot interacts with one of his meds or had an unforeseen side effect that it could cause epilepsy to reoccur. The patient had medication increase and a full medical checkup as a treatment for the event. The patient received Keppra and clobazem both anti-seizure meds within 2 weeks of vaccination. Reason why batch/lot was unknown: Unable to locate or read the details. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/ Administration facility. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | Unknown | Unknown |
| RECVDATE: | 02-24-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | KEPPRA [LEVETIRACETAM]; CLOBAZAM |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: ADHD; Choroid plexus papilloma; Epilepsy; Intellectual disability (Global Developmental Delay (gdd)) |
| PRIOR_VAX: | |
| SPLTTYPE: | CAPFIZER INC202200256040 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 02-23-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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