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.
Dizziness; This case was received via Drug Safety (Reference number: PH-PHFDA-300121807) on 02-Dec-2021 and was forwarded to Moderna on 02-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizziness) in a 45-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 046G21A) for an unknown indication. No Medical History information was reported. On 16-Nov-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion death). The reported cause of death was Dizziness. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication was provided. No Treatment medication was provided. Patient experienced Dizziness on 16 Nov 2021 at 05:20 and ended on 16 Nov 2021 at 05:22. The Nurse did not saw any abnormal breathing or any untoward symptoms thus he allowed the patient to be vaccinated. The patient was observed for any AEFI for 15minutes only due to undeclared co-morbidities then was sent home. On 300 meters away from Vaccination Site, the patient declared dizziness, nausea, vomiting, palpitations and difficulty of breathing then relative call for help. The Nurse Vaccinator saw that patient was unresponsive, noted foaming of mouth with initial GCS of 3/15 thus the Nurse activated emergency response and started continuous chest compression and the midwife manually removed oral secretions. The nurse continue chest compression at ambulance after 8mins the patient regained pulse and vomited. The Vaccinator Nurse position patient in Left lateral recumbent position. The patient was sent at Emergency Room in Hospital in adjacent city. This case concerns a 45-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) with no relevant medical history who experience the serious fatal unexpected event of dizziness one day after a dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender's Comments: This case concerns a 45-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) with no relevant medical history who experience the serious fatal unexpected event of dizziness one day after a dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Reported Cause(s) of Death: Dizziness
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)) | 0 | COVID19 | MODERNA | 046G21A | OT |
| RECVDATE: | 12-08-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | |
| 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: | 12-08-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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