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.
PALLOR; HEADACHE; DIZZINESS; SEIZURE; This regulatory authority case was reported by an other health care professional and describes the occurrence of PALLOR (PALLOR), HEADACHE (HEADACHE), DIZZINESS (DIZZINESS) and SEIZURE (SEIZURE) in a 20-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 007H21A and 010G21B) for an unknown indication. No Medical History information was reported. On 03-Nov-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Dec-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PALLOR (PALLOR) (seriousness criterion death), HEADACHE (HEADACHE) (seriousness criterion death), DIZZINESS (DIZZINESS) (seriousness criterion death) and SEIZURE (SEIZURE) (seriousness criterion death). The patient died on 02-Dec-2021. The reported cause of death was Pallor, Headache, Dizziness and Seizure. It is unknown if an autopsy was performed. Not Provided For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided. Treatment information was not provided DOA 06:10PM at Company comment: This regulatory authority case concerns a 20-year-old male patient, with no reported medical history, who experienced the fatal events of PALLOR, HEADACHE, DIZZINESS and SEIZURE. The events occurred on the same day after receiving a second dose of mRNA-1273 and patient died on that same day. No further information was provided for medical reviewing. It is stated on the narrative that patient was dead on arrival. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event terms and seriousness criterion was captured as provided by the Regulatory Authority.; Sender's Comments: This regulatory authority case concerns a 20-year-old male patient, with no reported medical history, who experienced the fatal events of PALLOR, HEADACHE, DIZZINESS and SEIZURE. The events occurred on the same day after receiving a second dose of mRNA-1273 and patient died on that same day. No further information was provided for medical reviewing. It is stated on the narrative that patient was dead on arrival. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event terms and seriousness criterion was captured as provided by the Regulatory Authority.; Reported Cause(s) of Death: PALLOR; HEADACHE; DIZZINESS; SEIZURE
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 010G21B | OT |
| RECVDATE: | 01-07-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 12-02-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | PHMODERNATX, INC.MOD20214 |
| FORM_VERS: | |
| TODAYS_DATE: | 01-05-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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