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.
suicide / asphyxia; asphyxia; morning tremors lasting 3/4 of an hour / legs shaking 45 min every morning / trembling of the lower limbs; physical and moral exhaustion; paresthesias of the lower legs and the back of the 2 feet; important asthenia; Dizziness; Anguish / anxiety; Insomnia; sensation of drunkenness; desire to sleep all the time; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-NC20213788. An 81-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on the left arm on 25Feb2021 (Lot Number: EP9598) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 28Jan2021 (Lot Number: EJ6788) as single dose for COVID-19 immunization. For 4 months, describes morning tremors lasting 3/4 of an hour, persisting when getting up, with sensation of drunkenness, trembling of the lower limbs, paresthesias of the lower legs and the back of the 2 feet. Recurrence at the end of the afternoon with important asthenia. This began suddenly after a dizziness that occurred on returning from the beach on 01Mar2021, 4 days after vaccination. On 01Mar2021, the patient also experienced physical and moral exhaustion, dizziness, insomnia. The patient's legs shaking 45min every morning, desire to sleep all the time and anxiety. Phenomena of anguish 4 days after vaccination leading to moral and physical exhaustion resulting in suicide by VMI (voluntary drug intoxication) and asphyxia. On 19Jul2021, the patient died as asphyxia on suicide, intentionally took several sleeping pills before asphyxiating herself with a bag on the head. Biology / complementary examinations / etiological research: Neurological examination on 13Jun2021: No signs of radicular or neuropathic involvement visible in the lower extremities. Brain scan: discrete bi-frontotemporal and mesencephalic atrophy. Brain MRI on 24Jun2021: No detectable signal abnormality at the subtentorial level. At the supratentorial level: fairly marked periventricular leukopathy with numerous hyper signals in the white matter. No sign of recent ischemic or hemorrhagic lesion. Moderate cortical and subcortical atrophy without predominance in the medial temporal structures. Right hippocampal millimetric hypersignal. No significant dilatation of the ventricular system. No cerebral edema. Neurological examination on 01Jul2021: global hypokinesia but no patent extrapyramidal syndrome, no systematized muscle weakness, no orthostatic hypotension. Describes a more important drowsiness with Xanax that she does not wish to decrease for fear of a reappearance of the anguish phenomena. Decision to decrease aprazolam and prazepam anyway. Coronary scan on 07Jul2021: within normal limits. Biological check-up of 16Jul2021: discrete inflammatory syndrome. On 13Jun2021, the patient admission to the emergency room. Prescriptions: On 06Apr2021: Prazepam 10mg 1 tablet /d. On 16Apr2021 Seresta 10mg 1-0-1 stop prazepam. On 06May2021: Tanganil 200mg 2-2-2 for 3 days; prazepam 1/2 tablet morning; escitalopram 5mg 1 tablet evening. On 03Jun2021 : gabapentin 100. On13Jun2021: alprazolam 0.5mg 1-1-0. On 23Jun2021 : alprazolam 0.25 2 tablets/day.On 25Jun2021 : Brintellix 10mg 1 tablet / day. On 01Jul2021 : prazepam 1/2 tablet during 3 days then stop ; alprazolam 0.25 decrease from 4.5 tablets to 2 tablets / day in 3 weeks. On 13Jul2021: alprazolam 0.25mg 2cp/d. The cause of death included suicide and asphyxia. Autopsy was unknown. The outcome of suicide and asphyxia was fatal. The outcome of feeling drunk and drowsiness was unknown. The outcome of other events was not recovered.; Reported Cause(s) of Death: Asphyxia; suicide
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
Questions? Comments? Bugs?
Due to the high volume of inquiries, please be patient with response times.
AND PLEASE read the FAQ first.