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.
Dysuria; Hyperreflexia; Extensor plantar response; Anal sphincter atony; Urinary retention; Myelitis transverse; Paraesthesia; This is a spontaneous report from a contactable physician from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202101191454133610 with Safety Report Unique Identifier GB-MHRA-ADR 24615906. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EEG993), via an unspecified route of administration from on 11Jan2021 at a single dose for COVID-19 immunisation. Medical history included suspected covid-19: unsure when symptoms started and stopped and was Covid-19 virus test "Yes - Positive COVID-19 test" on an unspecified date; and spinal osteoarthritis. The patient is usually fit and well; not pregnant and is not enrolled in clinical trial. Concomitant medications were not reported. On 14Jan2021, the patient experienced myelitis transverse and paraesthesia. On an unspecified date, the patient experienced dysuria, hyperreflexia, extensor plantar response, anal sphincter atony and urinary retention. The events were described as: 3 days after administration of vaccine noted paraesthesia to feet and legs. This subsequently rose to her hips. She has also noted difficulty in passing urine. Admitted to hospital 7 days following vaccination (18Jan2021). At this time, she had paraesthesia up to the level of her hips, brisk lower limb tendon reflexes and upgoing plantars. Power normal. She has reduced anal tone as well as significant post void residual on bladder scan. She has been reviewed by one of the consultant neurologists who has clinically diagnosed transverse myelitis and commenced treatment with intravenous steroids. Patient has not tested positive for COVID-19 since having the vaccine. MRI Spine showed degenerative cervical spine disease but no other changes. The regulatory authority assessed the events as serious requiring hospitalization and medically significant. The patient has not recovered from myelitis transverse. The outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported serious events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.